Myriad Genetics, Inc.

Greetings and welcome to the Myriad Genetics 4th Quarter 2022 Financial Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we'll conduct a question-and-answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. Should you require operator assistance at any time, please press star 0. As a reminder, this conference is being recorded Tuesday, February 28, 2023. I'd now like to turn the call over to Matt Fagallo. Please go ahead.

Okay, good afternoon, and welcome to the Myriad Genetics fourth quarter and full year 2022 earnings call. During the call, we will review financial results we released today, and afterwards, we will host a Q&A session. Our quarterly earnings release was issued this afternoon on Form 8K and can be found on our website at investor.myriad.com. I'm Matt Scalab, Senior Vice President of Investor Relations, and on the call with me today are Paul Diaz, our President and Chief Executive Officer, Ryan Rigsby, our Chief Financial Officer, Nicole Lambert, our Chief Operating Officer, and Mark Verratti, our Chief Commercial Officer. This call can be heard live via webcast at investor.mary.com, and a recording will be archived in the investor section of our website along with this slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or future financial performance of the company. These statements are based on the 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 the fourth quarter and full year. We will also provide updates on the strategic initiatives that are driving our long-term growth plan. First, I want to thank all of our teammates at Myriad for their hard work and dedication this year to advance our mission and our vision to make genetic testing and precision medicine more accessible to help people take more control of their health and enable providers to better detect, treat, and prevent disease. With so many positive changes happening across the organization, I'm incredibly proud of how our teams have kept their focus on our patients and providers. Myriad Genetics ended the year with a strong fourth quarter performance. Total revenue grew 11% year over year, driven by double-digit volume growth in both MyRisk hereditary cancer testing and GeneSight. We believe these results reflect the market's growing response to our commercial initiatives, and we are confident in our ability to achieve our financial guidance, as well as reach profitability and positive operating cash flow in Q4 of this year. Additionally, our continued commercial execution, robust pipeline, strong capital structure, and top-tier talent will fuel our long-term growth even further. Transitioning to slide five, we closed and have successfully integrated the acquisition of Gateway Genomics and are excited to be working with Chris Jacobs, its CEO, and the entire Gateway team. The Sneak Peek early gender DNA test continues to perform well across all of its commercial channels. In 2023, we will continue to look for cross-selling opportunities with other Myriad products and aim to increase Sneak Peek's attachment rate to our NIPS test prequel without disrupting Sneak Peek's performance. We entered 2023 with a tremendous amount of positive momentum as we take advantage of our improved commercial capabilities with an increased focus on sales operations and execution. GeneSight has been an incredibly successful example of this, and we plan to extend elements of the GeneSight and Sneak Peek direct-to-consumer commercial models across other businesses, primarily in women's health. I also want to point out what a great job our teams have done in listening to our patients and providers. We have re-approached the way we have engaged with customers, and they are starting to notice. A great example being our move to an open source data strategy with ClinVar, which is something that the genetic counselor community has been quite vocal about. I'll let Nicole talk more about this and give more examples later during the call. Nicole will also touch on how this increased engagement with patients and providers has significantly changed and improved the perception of myriad genetics among our customers. Keeping patients and providers at the center of everything we do is starting to pay dividends, and we are excited about finding ways to make it easier to do business with us. Everything from increased price transparency and affordability for patients to the rollout of initiatives like our EMR integrations with Epic and our unified ordering portal, along with improvements to MiriComplete, our customized suite of services and workflow solutions. Please check out our substantially upgraded website when you have a chance as well. These are just a few examples of the things that we are excited about here at Myriad Genetics. And we have a number of new hires to the franchise, which will be instrumental in bringing these initiatives to their full potential. With that, I'll turn the call over to Chief Commercial Officer Mark Verratti, who will speak to our increased focus on sales operations and execution. Mark?

Thanks, Paul. I'd like to start on slide eight with our enterprise commercial platform. First, I'd like to give a special shout out to our commercial team, which is made up of almost 1,000 teammates from our outside and inside sales, marketing, medical, and customer service personnel. In the quarter, the commercial team reached over 42,000 providers and helped hundreds of thousands of patients. We've been working tirelessly over the past two years while making significant investments in technologies, that aim to improve our engagement with patients and providers to help solve their medical needs across our product lines. Turning to slide nine, we've done our best to help visualize the progress that the team has made, especially in the last six months across multiple capabilities. We've made improvements in product management, customer targeting, digital experience, and learned how to better troubleshoot and use our market intelligence to evaluate what is and what is not working. It's important to note we're not starting from scratch with this commercial platform. It's really a story of going from good to great. And the key to reaching great is to continuing to execute and constantly improve in these areas. The landscape is ever-changing, and the commercial team is constantly working to adapt and improve our ability to connect providers and patients directly to our products. Coming out of the pandemic, we've learned that providers don't have as much time on their hands as they've had in the past. We've learned that our outside sales team doesn't have the same access they once had either. Physicians and patients are spending more of their own time researching to better understand healthcare products and solutions. For example, we've rebuilt our sales infrastructure with new Salesforce tools and dashboards so our commercial teams know exactly who we're targeting, how our message is being received, and whether or not we're meeting the needs of our providers and patients. By really putting these customers and their needs at the center of everything we do, we're becoming easier to do business with. Turning to slide 10, I'll talk about our digital platform in more detail. I've spoken about our digital platform before, primarily as it relates to Genesight. And I want to give a shout out to the Genesight team for the success they've had in developing these capabilities. I also want to highlight the fact that these capabilities are transferable to other parts of the business, specifically women's health. And you'll start to see more of that happening in the upcoming quarters. Now let's take a look at this funnel. which should help visualize some examples of these digital capabilities. As you can see, last year, we increased our total website traffic by over 10%. And more importantly, we've learned how to convert that traffic into greater qualified leads. In other words, we've learned how to connect people who need GeneSight directly to our website. Last year, we increased the number of qualified leads from website traffic by more than 50% compared to last year from both patients and healthcare providers. Then our inside sales, outside sales, and marketing teams, equipped with new digital tools and automation technologies, are better able to convert those leads into actual orders. In 2022, we increased the number of leads converted to order tests by more than 30% compared to 2021. These results are outstanding, and I just want to thank the team again for doing such a great job developing and executing on this digital platform. We'll turn to slide 11 now and talk about our core business units. Mental illness continues to have a lasting effect on patients and their families in the US, as those suffering often fail to receive proper medical treatment. GeneSight helps physicians better understand how antidepressants and other drugs will affect their patients. Importantly for this patient group, after an order is placed by a provider, the test can be performed with a single cheek swab sample that can be taken in the privacy of their own home. In the quarter, GeneSight volumes grew 23% over the prior year, as we've added more than 3,000 new clinicians to the franchise. The new PLA code, pricing gene site at $13.36 per test, went into effect in Q4, and the results of the VA PrimeCare study were included in the Genome Medicine's list of most significant advances and accomplishments in genomic medicine in 2022. MIRI Genetics is proud to be a part of the solution to this ongoing mental health crisis by providing physicians the information they need to treat their patients. We believe that the ongoing success of Genesteit demonstrates the effectiveness of our new commercial capabilities, digital marketing strategies, and patient-centric engagement initiatives implemented over the past year. We look forward to bringing these capabilities into our women's health and oncology business units soon. We'll now move to women's health on slide 12. The 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. With productivity per salesperson of 10% in Q4, we saw quarterly volume increase of 35% from the fourth quarter in 2021. In prenatal, we continue to face headwinds as we try to win back accounts lost due to the State of California's revised prenatal screening program. However, we remain excited about this business considering our recent acquisition of Gateway Genomics, and the upcoming launch of our 4-in-1 prenatal and carrier screening test first gene later this year. We are also excited about the American College of Medical Genetics recommendation to include 22q deletion syndrome in all prenatal screens. MIRAID will be presenting at the upcoming ACMG meeting, demonstrating prequels positive predictive value of 80%, much higher than the competition. Let's move now to slide 13 and talk about oncology. Our oncology business delivered $75.9 million in revenue in the fourth quarter. Reported test volumes were roughly 50,000. Polaris, our market-leading prostate cancer, continues to reach patients with diagnosed prostate cancer to provide them and their physicians the important information needed for better treatment decisions. In the fourth quarter, Polaris volumes grew 17% year over year. Polaris is the only test with a validated threshold to identify which patients can safely forego additional therapy including hormone therapy and third-party research shows that Polaris identifies more patients for active surveillance based on each test threshold. Now, let's take a look at how some of our products have been performing so far this year on slide 14. Taking a step back, you can see that we are off to a great start in 2023 across our entire product portfolio. While the first quarter of last year was negatively impacted by COVID, We cannot ignore the positive trends we are seeing in our businesses so far this year. We attribute this significant growth to our commercial capabilities and our increased focus on sales operations and execution, and above all, our very committed team. We will continue to execute this year as we strive to unlock the full potential of these capabilities. With that, I'll now turn the call over to our Chief Operating Officer, Nicole Lambert, to talk more about our customers and our products.

Thanks, Mark. I'd like to start on slide 16 and talk about the changing perceptions of Myriad Genetics among our healthcare practitioners. In addition to the new commercial processes and capabilities that Mark discussed, we also have been doing a much better job of listening to our patients and providers, and we are seeing the results of that improved customer engagement in our quarterly results. They know that we're listening and that we want to hear their feedback. We want to hear what we can do better, what needs to change, and what we should keep doing. For example, we heard that we needed to expand our gene content, so we added more genes to our primary MyRisk test, and customers responded. We heard that we needed to be more engaged with sharing our data and contribute more holistically to the broader medical community, so we recently announced a partnership to share data with ClinVar, and customers responded, especially the genetic counseling community. Everything from improving our customer service as measured by our net promoter scores, to the faster turnaround times that providers depend on, We are listening to customers and taking action to make it easier to do business with us. Turning to slide 17, we are proud of the fact that we've increased Myriad's perception among healthcare providers relative to our peers over the last year. And the general instability at our market over the same period has created a tremendous amount of opportunity for us to get into new accounts with the Myriad that we are today versus who we were six months ago. This gives us a lot to look forward to in 2023. with our approach of continuous improvement while keeping patients, providers, and payers at the center of everything we do. Now, on slide 18, our efforts are aimed at addressing friction points across the business, particularly with respect to the customer experience journey. As Paul mentioned earlier, we are getting much better at listening to our customers and using their feedback to make it easier to do business with us. Our new provider ordering portal and our unified order management system not only ensure that we are getting the information required by payers, but it also makes it much easier for providers to order tests from us and reduces the number of times that we have to call them back for missing information. Our EMR integrations with Epic and others not only ensure that we are getting patient medical records, which are often required by payers, but it also means that providers who are already in those EMR systems can push information to us directly from the medical records. These are just a few examples of how we're making it easier to do business with Myriad Genetics. We also have unified our internal structure to ensure that the teams that touch the customer journey from our physician customer service team all the way through our billing and payer markets team work very closely together. Now on slide 19, we'll discuss some exciting products that are coming through the pipeline. We are excited about First Gene, Myriad's next generation prenatal offering. From broader coverage and faster turnaround times to fewer inclusive results, we expect Firstgene to make a significant impact on the prenatal care of our patients. Firstgene is complementary to our current prenatal portfolio and targets a market of over 1 million patients in the US. We are preparing for a launch in the fourth quarter of this year. We also plan to launch our liquid biopsy technology for tumor profiling in the second half of 2023. With this new test offering as part of our suite of Precise Oncology solutions, our provider partners will benefit from a seamless customer experience and a unified interpretation of results. We continue to invest in new and emerging technologies to ensure that Myriad Genetics continues its legacy of innovation in oncology. Lastly, Precise MRD is on track with a research use only introduction in the second half of 2023 with our pharma and oncology partners. This will be followed by a commercial launch, which we expect in 2025. Turning to slide 20, you can see how these new products fit into the broader Myriad Genetics continuum of cancer care. From high-risk screening with MyRisk to monitoring recurrence with Precise MRD and everything in between, Myriad is building a foundation that aims to address real-world oncology needs. With that, I would like to turn it over to Brian to discuss our Q4 financial results in more detail.

Thanks, Nicole. I'd like to start by reviewing product volume trends on slide 22. As Paul mentioned earlier, hereditary cancer testing and gene site volumes each saw double-digit growth in the fourth quarter. This paved the way for both the 26% quarterly testing volume growth figure compared to Q4 of last year, as well as a 14% full-year testing volume growth rate in our core product categories for 2021. Also in the quarter, prenatal volumes increased 40% year-over-year, including contributions from our recent gateway genomics acquisition. Excluding gateway, prenatal volumes increased a modest 2% sequentially from the prior quarter. Now on slide 23, our full-year 2022 revenue of $678 million represents a 6% increase from 2021. Excluding revenue from divested businesses, and we continue to maintain industry-leading gross margins. 2022 was a year of strategic investment as we deployed our strong balance sheet in a disciplined manner. In addition to the acquisition of Gateway, we have invested in product innovation, core infrastructure, automated customer journey, and new talent. We remain confident that these investments will materialize in a way that complements our current strengths and sets us apart from our peers. Turning to slide 24 now to discuss our financial guidance. As released today, we are providing financial guidance for both the full year and first quarter of 2023. While we don't anticipate offering quarterly guidance on a regular basis going forward, there's been significant volatility in the capital markets recently, and we felt compelled to provide additional transparency with respect to Q1. Therefore, we believe our top line growth assumptions for the year position as well to reach our long-term revenue goal of 10% growth in 2024. We have successfully maintained strong gross margins throughout our transformation and plan to continue our focus there this year. Going into the first quarter of 2023, we anticipate adjusted operating expenses to remain flat sequentially from the fourth quarter of 2022. Moving to the bottom line, we expect adjusted EPS for the year to range between a loss of 40 cents and 20 cents per share. We plan to be profitable in Q4 of this year. Now on slide 25, we have tried to visualize what we see as the current payer environment and how we are adapting to keep our revenue cycle management team competitive and compliant. Before I start though, I first want to call out the great work of our entire revenue cycle team. As we have noted previously, over the last two years of our transformation journey, this team has collected almost $40 million of out-of-period cash which represents payments above their historical experience. While we have highlighted this frequently in the past as those amounts have been more significant, the amount in the quarter was less significant. Going forward, we will update our practice to only call out material amounts. Moving to the slide content, obtaining prior authorization is a significant hurdle for a variety of reasons, including providers not giving proper or complete prior authorization. To combat this issue, we have made significant investments in tech solutions that support the prior authorization process, making it easier for providers to give prior authorization. Payers are also requiring more information on patient claims before they are willing to provide reimbursement to our RevCycle team. Our new provider ordering portal and unified order management system make it easier for providers to give us all the required information on a given patient to reduce this friction point with payers. Lastly, providers may fail to provide patient medical records, which is a requirement of payers. Our investments in EMR integration aim to solve this pain point by giving us better access to this information. I'll now turn it back over to Paul for closing remarks.

Thanks, Brian. On slide 26, we have laid out timelines for most of the initiatives discussed today on the call. On the commercial side, as Mark discussed, our renewed focus on sales operation and execution is setting up up for a great 23 and 24. Nicole touched on the improved perceptions of mirror genetics among healthcare providers, not just because we are starting to really listen to our patients' providers, but because we are taking action and showing our customers that we are listening. We're also excited about a number of differentiating features of our liquid and MRD technologies and how we can uniquely position them in a fast-growing market to win share. With so many ongoing organizational changes happening at once, we remain focused and confident on reaching profitability in Q4 of this year. Balancing growth and innovation while keeping an eye on profitability is no small task, and it's certainly not something that can be measured quarter by quarter. Before we move to the Q&A portion of the call, I want to summarize five key takeaways on slide 27 in the context for our strengths and strategic advantages. First, we are growing volumes consistently every quarter, and we know how to get paid for our test. Second, pricing for our products is stable, and we have visibility into pricing moving forward. Third, we have a disciplined cost management structure as we work to maintain our strong gross margins and manage our COPX, which specifically targets opportunistic investments, which we've laid out today and at previous events this year. Fourth, we are committed to effective capital deployment in key areas that will improve the customer experience, including new tech-enabled tools and commercial capabilities, product innovation, and our labs of the future. Fifth and finally, our growth catalysts are clear as we continue to elevate our products to their full potential and roll out new solutions like First Gene, MRD, and Liquid. And opportunistically, look for strategic tuck-in acquisitions like Gateway Genomics. All of this reinforcing our position as a trusted, differentiated lab with specialized expertise, best-in-class quality, a strong, scalable commercial engine underpinned by data, research, and technology, with leading industry margins and business management. With now, I'll turn it back over to Matt for Q&A.

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

Thank you. If you would like to register a question, please press the one followed by the four on your telephone. You will hear a three-tone prompt to acknowledge that request. If your question has been answered and you would like to withdraw your registration, please press the one followed by the three. Our first question comes from the line of Tom Stevens with Cowan & Company. Your line is open.

Hi, all. Thanks for taking the question here. So just on your 23 guidance, I was hoping you could walk through some more of the puts and takes on it, kind of areas that could prove a bit more conservative, given it's a bit below your long-run plan. So if we could start there, and I've got one more follow-up.

Yeah, thanks for the question. You know, I think we didn't give product-specific guidance in the long-term guide, but I would say that we're focused on the top end of the guidance range. which is at 11% growth year over year, and that's in line with our long-term plan. So we feel good about really where we're starting the year and the momentum that we've seen in Q4.

Yeah, and that's primarily driven by continued adoption and growth in my risk of hereditary cancer tests, which, again, beginning in Q3, we really started to see an inflection point, as Mark pointed out, that continued momentum in Q4 and how that's continued here in Q1. That is clearly the product we have the right to win and both share, but I think the market is also opening up just generally for most providers, and we're seeing that, I think, in many of the reports of the last couple weeks. Genesight, we continue to think will grow at 20% plus, and so those two products are will continue to lead, but I'd underscore the growth in MyChoice and Polaris and the turnaround we've seen in our prenatal products, particularly over the last couple of months. So lots of different products contributing to the growth. And again, coupled with disciplined cost management will get us to the guidance and hopefully to the upper end of the guidance, as Brian said, as we get through the next few quarters.

Great, thanks. That was really, really useful. And just as a quick follow-up, have you got any, I mean, what kind of expectations for any newer tests have you got contemplated in your guide today?

There's nothing in 23 for our new guide at all. We have soft launches for new products in the back half of the year. You know, we'll beta test some of those, whether it's first gene or We do have a nice pipeline of conversations happening on the biopharma side, both for our existing companion diagnostics as well as a lot of interest in MRD for research. But there's roughly 20 million budgeted for that all in, and there's upside to that going into 24 as well. But the new products are not contemplated to be big contributors to 23 guide. Great.

Thanks very much. I'll call back with you. Thank you.

Your next question comes from the line of Matt Sykes with Goldman Sachs. Your line is open.

Hey, Matt. This is Prashant on for Matt. Congrats on the quarter. Could you tell us more about the competitive landscape of mental health psychotropic tests and where particularly GeneSight stands within that? How much market share is it capturing to date?

Yeah, sure. I'll be happy to comment on GeneSight. So within the GeneSight space, GeneSight has been the market leader and is continuing to pull away and maintain its market leadership by over 50% market share. We do have competition from LabCorp, Quest, and other individuals that have tried to enter the market, but we continue to execute and continue to make GeneSight the best test on the market and the easiest to use for our providers.

Got it. Thank you. And one follow-up, how are you thinking about the revenue contribution of First Gene in the back half of 2023 post-launch? And then, if at all, any thoughts on how you expect that revenue contribution to progress in 2024 and 2025?

Well, modest contribution in the soft launch in Q4 with some investment. You know, so there will be front-end investment there that's contemplated in the guidance, some of which is already – in our product management process that we've instituted is starting to happen. So as I said before, de minimis contribution in Q4 to the first gene launch, but real excitement about the differentiation of that product, particularly around ease of use, to be able to collect the sample from maternal mom and be able to get both NIPS tests and carrier screening tests, it's just great science making it more accessible to more patients. So we'll talk more about that later in the year. So we think it will contribute to 24 and 25, but certainly won't be a meaningful contributor in 24, probably more so by 25. Great. Thank you.

And your next question comes from line of Derek de Bruin with Bank of America. Your line is open.

Hey guys, this is Nitsar Ghan for Derek. So maybe you wanted to start off, HCT volumes came in pretty strong. Can you provide any color on how you plan to manage, you know, some of these continuing competitive pressures in the market into 23? I know we talked about the PLA code last quarter, you know, how should we kind of think about that into 23?

I'll start. We have more visibility on MI-RISC hereditary cancer tests than pretty much anything. The fact that we got a MI-RISC specific code because of the strength of the MI-RISC technically and the fact that MI-RISC comes with risk score, which gives the PRS test with more about future risk for breast cancer is differentiating. As Nicole said, we've expanded the panel size there. We actually think... Without calling out anybody specifically, the competitive landscape there has gotten easier. But the bigger opportunity, quite frankly, is for unaffected women that meet guidelines. And you're seeing that in our women's health channel. We're also growing in where we've given up share over the years for our competitors for affected patients.

so we think we have a lot of visibility into continuing to grow my risk in 23 and you know what would you add mark yeah the only thing i would add to that excuse me the only thing i would add is exactly what paul stated when we look at our volume increases in q4 and the momentum into q1 we're seeing it coming from all from all three segments we're going deeper with our current customers And we're adding new customers that are both by expanding the market as well as stealing from the competition. So nothing else to add there other than we feel really good about how the team is executing and really about the way the new myriad is showing up for our customers.

Great. Maybe one more looking forward. So on MRD, you know, it's a test with a lot of investor focus. It's good to see the research use only launch in the middle of 2023. How do you kind of think about the timing of the full commercial launch versus some competitors that might have been in the market a little bit sooner?

Yeah, I mean, it's probably the biggest opportunity for precision medicine as we see it. And as Dale presented at J.P. Morgan, We really do think that we'll have a very competitive product. Our analytical validation work has gone well. We'll be announcing shortly the clinical work that we're doing with a couple of academic medical centers on the clinical validation. But we have a lot of interest on the research side already. And that coincides with our other biopharma work on companion diagnostics, as I mentioned before. So, we're looking for 23 to start that research, contribute more meaningfully in 24, and then a commercial launch in 25. I think that's a realistic timeframe. And I do think some of the great work some of our competitors have done have paved the way, quite frankly. for us to be able to get reimbursement. And that's a great expertise of the company. Our proudness may be overstating a little bit, but one of our strengths is clearly reimbursement, regulatory, and working through FDA and other channels. So it's a big market. We think there'll be room for many of us. And quite frankly, I'm really focused with some of our big customers on not only the clinical piece, but how does it get integrated into practice, and how do we make a good case for payers that in the course of treatment they should pay for it? I think this industry has struggled with not answering those last two questions, and those are front and center in our product management deliberations. We've got to have a really good product, but it has to be something that fits into the clinic, into the course of treatment, and payers need to be able to see the value proposition as well. in terms of their total cost of care. Got it. Thank you.

As a brief reminder to all to register for a question, it is 1-4 on your telephone keypad. And your next question will come from the line of Jack Meehan with Nefron Research. Your line is open.

Thank you. Good afternoon. I had a two-part question on GeneSight. So first, could you talk about the sequential trends in the quarter? Looked like volume and revenue were down a touch. Haven't seen that move in volume in a while. So just was there anything notable there? And then second, Paul, you talked about 20% plus growth kind of long-term. Is that inclusive of 2023? Yes. I mean,

There are quarterly variations for different reasons. Look, we have to report out things quarterly, but we don't run the company that way. And the healthcare system doesn't really work that way, Jack. So we are plus 20 start for the year through January and February on volume. You know, deductibles affect things in the first quarter. There's a lot of moving parts in the first quarter. We have a lot of volume that we got to push through the lab. So our folks are working overtime and weekends to make sure that, you know, the demand is actually gets by the end of the quarter reported. So there's a lot of work happening and keep in mind that this is all happening while we're trying to stand up our labs of the future and all of that and keep turnaround times at an industry 5.5 days. But there's nothing with GeneSight other than upward momentum. And we're making great progress on the coverage front as well, and we'll probably be able to talk about that, you know, over the next couple quarters.

Super. Okay. And then I wanted to ask about the implementation of the PLA code this year. So Medicare seems relatively straightforward in terms of the reimbursement rate. I was curious on the non-Medicare side whether there – You've seen any impact on collections there where you might have been paid previously under some other method?

Zero impact there. We think it's all supportive of our payer market strategy. And so far, good dialogue with United and other payers across all of our product portfolio. And so, as we said at the beginning of the call, we've got really good visibility within that 3% to 5% range on collections. on ASP. And as we've talked about today, increasing confidence in our 10% top line growth number and hopefully better going into 24, but certainly feel more confident about that. After a little bit of a bumpy Q3, we're right back on track. And January and February point to further evidence of that. And as Brian said, confident we can reach profitability and and operating free cash flow by Q4.

Got it. And Brian, is there any color you can share on the forecast for CapEx this year? Thank you.

Yeah, thanks, Jack. Yeah, I think the only thing I would add is just that, you know, obviously you've seen capital increase in the back part of last year as we've been building out our labs of the future or You know, we expect to take possession of those laboratories around the middle part of the year. So we would expect for those to be completed substantially in 23 and for 24 to return to more of a normalized sort of capital type year.

Yeah. And to add to that part of the savings, as we think about 24 and 25 rents coming down. as we move out of more expensive space and into more cost-effective, more efficient space where we can automate. And, you know, it's going to take a lot of work to maintain these 70% gross margins, but that's where the automation and the process improvement will come from.

And your next question comes from the line of Mason Carrico with Stevens Incorporated. Your line is open.

Hey, guys. This is Jacob on for Mason. Thanks for taking our question. I'll just ask a quick one here and apologize if it was covered earlier in the call. I've been hopping around a few calls tonight. So looking at this year and into 2024, how should we think about the proportion of growth in gene site revenue coming from volume growth versus ASP moving higher from expanding coverage or reducing the no pay rate?

Yeah, that's a great question. Again, we expect to maintain continue to grow at 20% on the volume side. And we do expect ASP improvement as we improve coverage over the course of the year. And again, we'll have more updates there. But we're absolutely making progress with a couple of payers that we hope to be talking about here soon. But we haven't really broken out. But maybe in a couple of quarters, we'll be able to give you some more details around that. But ASP is stable. Volume is growing. and it's dropping to the bottom line. That lab is incredibly efficient. Kavita and the team there do a great job. Our cogs there are really tight, and we're trying to get more productivity on the sales force, so our customer acquisition cost is coming down with more inside sales and the digital conversions that we're getting that Mark talked about. So lots of leverage on GeneSight, but clearly more coverage on no pays drops to the bottom line. So that's something we're focused on across the portfolio.

All right. Got it. Thanks, guys. Thank you.

And all that does conclude the question and answer session for today. I'll turn it back to your presenters for closing remarks. Thank you very much.

Okay. Thanks, operator. 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. Thank you. Thank you. you Thank you. Thank you. Thank you. Thank you. music music

Thank you.

Greetings and welcome to the Myriad Genetics 4th Quarter 2022 Financial Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we'll conduct a question-and-answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. Should you require operator assistance at any time, please press star 0. As a reminder, this conference is being recorded Tuesday, February 28, 2023. I'd now like to turn the call over to Matt Fagallo. Please go ahead.

Okay, good afternoon, and welcome to the Myriad Genetics fourth quarter and full year 2022 earnings call. During the call, we will review financial results we released today, and afterwards, we will host a Q&A session. Our quarterly earnings release was issued this afternoon on Form 8K and can be found on our website at investor.myriad.com. I'm Matt Scalab, Senior Vice President of Investor Relations, and on the call with me today are Paul Diaz, our President and Chief Executive Officer, Ryan Rigsby, our Chief Financial Officer, Nicole Lambert, our Chief Operating Officer, and Mark Verratti, our Chief Commercial Officer. This call can be heard live via webcast at investor.mary.com, and a recording will be archived in the investor section of our website along with this slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or future financial performance of the company. These statements are based on the 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 the fourth quarter and full year. We will also provide updates on the strategic initiatives that are driving our long-term growth plan. First, I want to thank all of our teammates at Myriad for their hard work and dedication this year to advance our mission and our vision to make genetic testing and precision medicine more accessible to help people take more control of their health and enable providers to better detect, treat, and prevent disease. With so many positive changes happening across the organization, I'm incredibly proud of how our teams have kept their focus on our patients and providers. Myriad Genetics ended the year with a strong fourth quarter performance. Total revenue grew 11% year over year, driven by double-digit volume growth in both MyRisk hereditary cancer testing and Genesight. We believe these results reflect the market's growing response to our commercial initiatives, and we are confident in our ability to achieve our financial guidance, as well as reach profitability and positive operating cash flow in Q4 of this year. Additionally, our continued commercial execution, robust pipeline, strong capital structure, and top-tier talent will fuel our long-term growth even further. Transitioning to slide five, we closed and have successfully integrated the acquisition of Gateway Genomics and are excited to be working with Chris Jacobs, its CEO, and the entire Gateway team. The Sneak Peek early gender DNA test continues to perform well across all of its commercial channels. In 2023, we will continue to look for cross-selling opportunities with other Myriad products and aim to increase Sneak Peek's attachment rate to our NIPS test prequel without disrupting Sneak Peek's performance. We entered 2023 with a tremendous amount of positive momentum as we take advantage of our improved commercial capabilities with an increased focus on sales operations and execution. GeneSight has been an incredibly successful example of this, and we plan to extend elements of the GeneSight and Sneak Peek direct-to-consumer commercial models across other businesses, primarily in women's health. I also want to point out what a great job our teams have done in listening to our patients and providers. We have re-approached the way we have engaged with customers, and they are starting to notice. A great example being our move to an open source data strategy with ClinVar, which is something that the genetic counselor community has been quite vocal about. I'll let Nicole talk more about this and give more examples later during the call. Nicole will also touch on how this increased engagement with patients and providers has significantly changed and improved the perception of myriad genetics among our customers. Keeping patients and providers at the center of everything we do is starting to pay dividends, and we are excited about finding ways to make it easier to do business with us. Everything from increased price transparency and affordability for patients to the rollout of initiatives like our EMR integrations with Epic and our unified ordering portal, along with improvements to Miri Complete, our customized suite of services and workflow solutions. Please check out our substantially upgraded website when you have a chance as well. These are just a few examples of the things that we are excited about here at Myriad Genetics. And we have a number of new hires to the franchise, which will be instrumental in bringing these initiatives to their full potential. With that, I'll turn the call over to Chief Commercial Officer Mark Berati, who will speak to our increased focus on sales operations and execution. Mark?

Thanks, Paul. I'd like to start on slide eight with our enterprise commercial platform. First, I'd like to give a special shout out to our commercial team, which is made up of almost 1,000 teammates from our outside and inside sales, marketing, medical, and customer service personnel. In the quarter, the commercial team reached over 42,000 providers and helped hundreds of thousands of patients. We've been working tirelessly over the past two years while making significant investments in technologies that aim to improve our engagement with patients and providers to help solve their medical needs across our product lines. Turning to slide nine, we've done our best to help visualize the progress that the team has made, especially in the last six months across multiple capabilities. We've made improvements in product management, customer targeting, digital experience, and learned how to better troubleshoot and use our market intelligence to evaluate what is and what is not working. It's important to note we're not starting from scratch with this commercial platform. It's really a story of going from good to great. And the key to reaching great is to continuing to execute and constantly improve in these areas. The landscape is ever-changing, and the commercial team is constantly working to adapt and improve our ability to connect providers and patients directly to our products. Coming out of the pandemic, we've learned that providers don't have as much time on their hands as they've had in the past. We've learned that our outside sales team doesn't have the same access they once had either. Physicians and patients are spending more of their own time researching to better understand healthcare products and solutions. For example, we've rebuilt our sales infrastructure with new Salesforce tools and dashboards so our commercial teams know exactly who we're targeting, how our message is being received, and whether or not we're meeting the needs of our providers and patients. By really putting these customers and their needs at the center of everything we do, we're becoming easier to do business with. Turning to slide 10, I'll talk about our digital platform in more detail. I've spoken about our digital platform before, primarily as it relates to Genesight. And I want to give a shout out to the Genesight team for the success they've had in developing these capabilities. I also want to highlight the fact that these capabilities are transferable to other parts of the business, specifically women's health. And you'll start to see more of that happening in the upcoming quarters. Now let's take a look at this funnel. which should help visualize some examples of these digital capabilities. As you can see, last year, we increased our total website traffic by over 10%. And more importantly, we've learned how to convert that traffic into greater qualified leads. In other words, we've learned how to connect people who need GeneSight directly to our website. Last year, we increased the number of qualified leads from website traffic by more than 50% compared to last year from both patients and healthcare providers. Then our inside sales, outside sales, and marketing teams, equipped with new digital tools and automation technologies, are better able to convert those leads into actual orders. In 2022, we increased the number of leads converted to order tests by more than 30% compared to 2021. These results are outstanding, and I just want to thank the team again for doing such a great job developing and executing on this digital platform. We'll turn to slide 11 now and talk about our core business units. Mental illness continues to have a lasting effect on patients and their families in the US, as those suffering often fail to receive proper medical treatment. GeneSight helps physicians better understand how antidepressants and other drugs will affect their patients. Importantly for this patient group, after an order is placed by a provider, the test can be performed with a single cheek swab sample that can be taken in the privacy of their own home. In the quarter, GeneSight volumes grew 23% over the prior year, as we've added more than 3,000 new clinicians to the franchise. The new PLA code, pricing gene site at $13.36 per test, went into effect in Q4, and the results of the VA PrimeCare study were included in the Genome Medicine's list of most significant advances and accomplishments in genomic medicine in 2022. MIRI Genetics is proud to be a part of the solution to this ongoing mental health crisis by providing physicians the information they need to treat their patients. We believe that the ongoing success of Genesteit demonstrates the effectiveness of our new commercial capabilities, digital marketing strategies, and patient-centric engagement initiatives implemented over the past year. We look forward to bringing these capabilities into our women's health and oncology business units soon. We'll now move to women's health on slide 12. The 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. With productivity per salesperson of 10% in Q4, we saw quarterly volume increase of 35% from the fourth quarter in 2021. In prenatal, we continue to face headwinds as we try to win back accounts lost due to the State of California's revised prenatal screening program. However, we remain excited about this business considering our recent acquisition of Gateway Genomics, and the upcoming launch of our 4-in-1 prenatal and carrier screening test first gene later this year. We are also excited about the American College of Medical Genetics recommendation to include 22q deletion syndrome in all prenatal screens. MIRAID will be presenting at the upcoming ACMG meeting, demonstrating prequels positive predictive value of 80%, much higher than the competition. Let's move now to slide 13 and talk about oncology. Our oncology business delivered $75.9 million in revenue in the fourth quarter. Reported test volumes were roughly 50,000. Polaris, our market-leading prostate cancer, continues to reach patients with diagnosed prostate cancer to provide them and their physicians the important information needed for better treatment decisions. In the fourth quarter, Polaris volumes grew 17% year over year. Polaris is the only test with a validated threshold to identify which patients can safely forego additional therapy and including hormone therapy and third-party research shows that Polaris identifies more patients for active surveillance based on each test threshold. Now, let's take a look at how some of our products have been performing so far this year on slide 14. Taking a step back, you can see that we are off to a great start in 2023 across our entire product portfolio. While the first quarter of last year was negatively impacted by COVID, We cannot ignore the positive trends we are seeing in our businesses so far this year. We attribute this significant growth to our commercial capabilities and our increased focus on sales operations and execution, and above all, our very committed team. We will continue to execute this year as we strive to unlock the full potential of these capabilities. With that, I'll now turn the call over to our Chief Operating Officer, Nicole Lambert, to talk more about our customers and our products.

Thanks, Mark. I'd like to start on slide 16 and talk about the changing perceptions of Myriad Genetics among our healthcare practitioners. In addition to the new commercial processes and capabilities that Mark discussed, we also have been doing a much better job of listening to our patients and providers, and we are seeing the results of that improved customer engagement in our quarterly results. They know that we're listening and that we want to hear their feedback. We want to hear what we can do better, what needs to change, and what we should keep doing. For example, we heard that we needed to expand our gene content, so we added more genes to our primary MyRisk test, and customers responded. We heard that we needed to be more engaged with sharing our data and contribute more holistically to the broader medical community, so we recently announced a partnership to share data with ClinVar, and customers responded, especially the genetic counseling community. Everything from improving our customer service as measured by our net promoter scores, to the faster turnaround times that providers depend on, We are listening to customers and taking action to make it easier to do business with us. Turning to slide 17, we are proud of the fact that we've increased Myriad's perception among healthcare providers relative to our peers over the last year. And the general instability in our market over the same period has created a tremendous amount of opportunity for us to get into new accounts with the Myriad that we are today versus who we were six months ago. This gives us a lot to look forward to in 2023. with our approach of continuous improvement while keeping patients, providers, and payers at the center of everything we do. Now, on slide 18, our efforts are aimed at addressing friction points across the business, particularly with respect to the customer experience journey. As Paul mentioned earlier, we are getting much better at listening to our customers and using their feedback to make it easier to do business with us. Our new provider ordering portal and our unified order management system not only ensure that we are getting the information required by payers, but it also makes it much easier for providers to order tests from us and reduces the number of times that we have to call them back for missing information. Our EMR integrations with Epic and others not only ensure that we are getting patient medical records, which are often required by payers, but it also means that providers who are already in those EMR systems can push information to us directly from the medical records. These are just a few examples of how we're making it easier to do business with Myriad Genetics. We also have unified our internal structure to ensure that the teams that touch the customer journey from our physician customer service team all the way through our billing and payer markets team work very closely together. Now on slide 19, we'll discuss some exciting products that are coming through the pipeline. We are excited about First Gene, Myriad's next generation prenatal offering. From broader coverage and faster turnaround times to fewer inconclusive results, we expect Firstgene to make a significant impact on the prenatal care of our patients. Firstgene is complementary to our current prenatal portfolio and targets a market of over 1 million patients in the US. We are preparing for a launch in the fourth quarter of this year. We also plan to launch our liquid biopsy technology for tumor profiling in the second half of 2023. With this new test offering as part of our suite of Precise Oncology solutions, our provider partners will benefit from a seamless customer experience and a unified interpretation of results. We continue to invest in new and emerging technologies to ensure that Myriad Genetics continues its legacy of innovation in oncology. Lastly, Precise MRD is on track with a research use only introduction in the second half of 2023 with our pharma and oncology partners. This will be followed by a commercial launch, which we expect in 2025. Turning to slide 20, you can see how these new products fit into the broader Myriad Genetics continuum of cancer care. From high-risk screening with MyRisk to monitoring recurrence with Precise MRD and everything in between, Myriad is building a foundation that aims to address real-world oncology needs. With that, I would like to turn it over to Brian to discuss our Q4 financial results in more detail.

Thanks, Nicole. I'd like to start by reviewing product volume trends on slide 22. As Paul mentioned earlier, hereditary cancer testing and gene site volumes each saw double-digit growth in the fourth quarter. This paved the way for both a 26% quarterly testing volume growth figure compared to Q4 of last year, as well as a 14% full-year testing volume growth rate in our core product categories for 2021. Also in the quarter, prenatal volumes increased 40% year over year, including contributions from our recent gateway genomics acquisition. Excluding gateway, prenatal volumes increased a modest 2% sequentially from the prior quarter. Now on slide 23, our full year 2022 revenue of $678 million represents a 6% increase from 2021. Excluding revenue from divested businesses, and we continue to maintain industry-leading gross margins. 2022 was a year of strategic investment as we deployed our strong balance sheet in a disciplined manner. In addition to the acquisition of Gateway, we have invested in product innovation, core infrastructure, automated customer journey, and new talent. We remain confident that these investments will materialize in a way that complements our current strengths and sets us apart from our peers. Turning to slide 24 now to discuss our financial guidance. As released today, we are providing financial guidance for both the full year and first quarter of 2023. While we don't anticipate offering quarterly guidance on a regular basis going forward, there's been significant volatility in the capital markets recently, and we felt compelled to provide additional transparency with respect to Q1. Therefore, we believe our top-line growth assumptions for the year position as well to reach our long-term revenue goal of 10% growth in 2024. We have successfully maintained strong gross margins throughout our transformation and plan to continue our focus there this year. Going into the first quarter of 2023, we anticipate adjusted operating expenses to remain flat sequentially from the fourth quarter of 2022. Moving to the bottom line, we expect adjusted EPS for the year to range between a loss of 40 cents and 20 cents per share. We plan to be profitable in Q4 of this year. Now on slide 25, we have tried to visualize what we see as the current payer environment and how we are adapting to keep our revenue cycle management team competitive and compliant. Before I start though, I first want to call out the great work of our entire revenue cycle team. As we have noted previously, over the last two years of our transformation journey, this team has collected almost $40 million of out of period cash which represents payments above their historical experience. While we have highlighted this frequently in the past as those amounts have been more significant, the amount in the quarter was less significant. Going forward, we will update our practice to only call out material amounts. Moving to the slide content, obtaining prior authorization is a significant hurdle for a variety of reasons, including providers not giving proper or complete prior authorization. To combat this issue, we have made significant investments in tech solutions that support the prior authorization process, making it easier for providers to give prior authorization. Payers are also requiring more information on patient claims before they are willing to provide reimbursement to our RevCycle team. Our new provider ordering portal and unified order management system make it easier for providers to give us all the required information on a given patient to reduce this friction point with payers. Lastly, providers may fail to provide patient medical records, which is a requirement of payers. Our investments in EMR integration aim to solve this pain point by giving us better access to this information. I'll now turn it back over to Paul for closing remarks.

Thanks, Brian. On slide 26, we have laid out timelines for most of the initiatives discussed today on the call. On the commercial side, as Mark discussed, a renewed focus on sales operation and execution is setting up up for a great 23 and 24. Nicole touched on the improved perceptions of mirror genetics among healthcare providers, not just because we are starting to really listen to our patients' providers, but because we are taking action and showing our customers that we are listening. We're also excited about a number of differentiating features of our liquid and MRD technologies and how we can uniquely position them in a fast-growing market to win share. With so many ongoing organizational changes happening at once, we remain focused and confident on reaching profitability in Q4 of this year. Balancing growth and innovation while keeping an eye on profitability is no small task, and it's certainly not something that can be measured quarter by quarter. Before we move to the Q&A portion of the call, I want to summarize five key takeaways on slide 27 in the context for our strengths and strategic advantages. First, we are growing volumes consistently every quarter, and we know how to get paid for our test. Second, pricing for our products is stable, and we have visibility into pricing moving forward. Third, we have a disciplined cost management structure as we work to maintain our strong gross margins and manage our COPX, which specifically targets opportunistic investments, which we've laid out today and at previous events this year. Fourth, we are committed to effective capital deployment in key areas that will improve the customer experience, including new tech-enabled tools and commercial capabilities, product innovation, and our labs of the future. Fifth and finally, our growth catalysts are clear as we continue to elevate our products to their full potential and roll out new solutions like First Gene, MRD, and Liquid. And opportunistically, look for strategic tuck-in acquisitions like Gateway Genomics. All of this reinforcing our position as a trusted, differentiated lab with specialized expertise, best-in-class quality, a strong, scalable commercial engine underpinned by data, research, and technology, with leading industry margins and business management. With now, I'll turn it back over to Matt for Q&A.

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

Thank you. If you would like to register a question, please press the one followed by the four on your telephone. You will hear a three-tone prompt to acknowledge that request. If your question has been answered and you would like to withdraw your registration, please press the one followed by the three. Our first question comes from the line of Tom Stevens with Cowan & Company. Your line is open.

Hi, all. Thanks for taking the question here. So just on your 23 guidance, I was hoping you could walk through some more of the puts and takes on it, kind of areas that could prove a bit more conservative, given it's a bit below your long-run plan. So if we could start there, and I've got one more follow-up.

Yeah, thanks for the question. You know, I think we didn't give product-specific guidance in the long-term guide, but I would say that we're focused on the top end of the guidance range. which is at 11% growth year over year, and that's in line with our long-term plan. So we feel good about really where we're starting the year and the momentum that we've seen in Q4.

Yeah, and that's primarily driven by continued adoption and growth in my risk of hereditary cancer tests, which, again, beginning in Q3, we really started to see an inflection point, as Mark pointed out, that continued momentum in Q4 and how that's continued here in Q1. That is clearly the product we have the right to win and both share, but I think the market is also opening up just generally for most providers, and we're seeing that, I think, in many of the reports of the last couple weeks. Genesight, we continue to think will grow at 20% plus, and so those two products are will continue to lead, but I'd underscore the growth in MyChoice and Polaris and the turnaround we've seen in our prenatal products, particularly over the last couple of months. So lots of different products contributing to the growth. And again, coupled with disciplined cost management will get us to the guidance and hopefully to the upper end of the guidance, as Brian said, as we get through the next few quarters.

Great. Thanks. That was really, really useful. And just as a quick follow-up, have you got any, I mean, what kind of expectations for any newer tests have you got contemplated in your guide today?

There's nothing in 23 for our new guide at all. We have soft launches for new products in the back half of the year. You know, we'll beta test some of those, whether it's first gene or We do have a nice pipeline of conversations happening on the biopharma side, both for our existing companion diagnostics as well as a lot of interest in MRD for research. But, you know, there's roughly 20 million budgeted for that all in, and there's upside to that going into 24 as well. But the new products are not contemplated to be big contributors to 23 guys.

Great. Thanks so much. I'll call back with you. Thank you.

Your next question comes from the line of Matt Sykes with Goldman Sachs. Your line is open.

Hey, Matt. This is Prashant on for Matt. Congrats on the quarter. Could you tell us more about the competitive landscape of mental health psychotropic tests and where particularly GeneSight stands within that? How much market share is it capturing to date?

Yeah, sure. I'll be happy to comment on GeneSight. So within the GeneSight space, GeneSight has been the market leader and is continuing to pull away and maintain its market leadership by over 50% market share. We do have competition from LabCorp, Quest, and other individuals that have tried to enter the market, but we continue to execute and continue to make GeneSight the best test on the market and the easiest to use for our providers.

Got it. Thank you. And one follow-up, how are you thinking about the revenue contribution of First Gene in the back half of 2023 post-launch? And then, if at all, any thoughts on how you expect that revenue contribution to progress in 2024 and 2025?

Well, modest contribution in the soft launch in Q4 with some investment. So there will be front-end investment there that's contemplated in the guidance, some of which is already – in our product management process that we've instituted is starting to happen. So as I said before, de minimis contribution in Q4 to the first gene launch, but real excitement about the differentiation of that product, particularly around ease of use, to be able to collect the sample from maternal mom and be able to get both NIPS tests and carrier screening tests, it's just great science making it more accessible to more patients. So we'll talk more about that later in the year. So we think it will contribute to 24 and 25, but certainly won't be a meaningful contributor in 24, probably more so by 25. Great. Thank you.

And your next question comes from line of Derek de Bruin with Bank of America. Your line is open.

Hey guys, this is Nitsar Ghan for Derek. So maybe you wanted to start off, HCT volumes came in pretty strong. Can you provide any color on how you plan to manage, you know, some of these continuing competitive pressures in the market into 23? I know we talked about the PLA code last quarter, you know, how should we kind of think about that into 23? I'll start.

So We have more visibility on MI-RISC hereditary cancer tests than pretty much anything. The fact that we got a MI-RISC specific code because of the strength of the MI-RISC technically and the fact that MI-RISC comes with risk score, which gives the PRS test with more about future risk for breast cancer is differentiating. As Nicole said, we've expanded the panel size there. We actually think... without calling out anybody specifically, the competitive landscape there has gotten easier. But the bigger opportunity, quite frankly, is for unaffected women that meet guidelines. And you're seeing that in our women's health channel. We're also growing in where we've given up share over the years to our competitors for affected patients. We think we have a lot of visibility into continuing to grow my risk in 23. And, you know, what would you add, Mark?

Yeah, the only thing I would add to that, excuse me, the only thing I would add is exactly what Paul stated.

When we look at our volume increases in Q4 and the momentum into Q1, we're seeing it coming from all three segments. We're going deeper with our current customers and we're adding new customers that are both by expanding the market as well as stealing from the competition. So nothing else to add there other than we feel really good about how the team is executing and really about the way the new myriad is, is showing up for our customers.

Great. Maybe one more looking forward. So on MRD, you know, it's a test with a lot of investor focus. It's good to see the research use only launch in the middle of 2023. How do you kind of think about the timing of the full commercial launch versus some competitors that might have been in the market a little bit sooner?

Yeah. I mean, it's, it's a, probably the biggest opportunity for precision medicine as we see it. And as Dale presented at JPMorgan, we really do think that we'll have a very competitive product. Our analytical validation work has gone well. We'll be announcing shortly the clinical work that we're doing with a couple of academic medical centers on the clinical validation. But we have a lot of interest on the research side already. And that coincides with our other biopharma work on companion diagnostics, as I mentioned before. So, we're looking for 23 to start that research, contribute more meaningfully in 24, and then a commercial launch in 25. I think that's a realistic timeframe. And I do think some of the great work some of our competitors have done have paved the way, quite frankly. for us to be able to get reimbursement. And that's a great expertise of the company. Our proudness may be overstating a little bit, but one of our strengths is clearly reimbursement, regulatory, and working through FDA and other channels. So it's a big market. We think there'll be room for many of us. And quite frankly, I'm really focused with some of our big customers on not only the clinical piece, but how did it get integrated into practice, and how do we make a good case for payers that in the course of treatment they should pay for it? I think this industry has struggled with not answering those last two questions, and those are front and center in our product management deliberations. We've got to have a really good product, but it has to be something that fits into the clinic, into the course of treatment, and payers need to be able to see the value proposition as well. in terms of their total cost of care. Got it. Thank you.

As a brief reminder to all to register for a question, it is 1-4 on your telephone keypad. And your next question will come from the line of Jack Meehan with Nefron Research. Your line is open.

Thank you. Good afternoon. I had a two-part question on Gene's site. So first, could you talk about the sequential trends in the quarter? Looked like volume and revenue were down a touch. Haven't seen that move in volume in a while. So just was there anything notable there? And then second, Paul, you talked about 20% plus growth kind of long-term. Is that inclusive of 2023? Yes. I mean,

There are quarterly variations for different reasons. We have to report out things quarterly, but we don't run the company that way. The healthcare system doesn't really work that way, Jack. We are plus 20 start for the year through January and February on volume. Deductibles affect things in the first quarter. There's a lot of moving parts in the first quarter. We have a lot of volume that we got to push through the lab. So our folks are working overtime and weekends to make sure that, you know, the demand is actually gets by the end of the quarter reported. So there's a lot of work happening and keep in mind that this is all happening while we're trying to stand up our labs of the future and, and all of that and keep turnaround times at a, at an industry 5.5 days. But there's nothing with GeneSight other than upward momentum. And we're making great progress on the coverage front as well, and we'll probably be able to talk about that, you know, over the next couple quarters.

Super. Okay. And then I wanted to ask about the implementation of the PLA code this year. So Medicare seems relatively straightforward in terms of the reimbursement rate. I was curious on the non-Medicare side whether there – You've seen any impact on collections there where you might have been paid previously under some other method?

Zero impact there. We think it's all supportive of our payer market strategy. And so far, good dialogue with United and other payers across all of our product portfolio. And so, as we said at the beginning of the call, we've got really good visibility within that 3% to 5% range on collections on ASP, and as we've talked about today, increasing confidence in our 10% top line growth number, and hopefully better going into 24, but certainly feel more confident about that. After a little bit of a bumpy Q3, we're right back on track, and January and February point to further evidence of that, and as Brian said, confident we can reach profitability and operating free cash flow by Q4.

Got it. And Brian, is there any color you can share on the forecast for CapEx this year? Thank you.

Yeah, thanks, Jack. Yeah, I think the only thing I would add is just that, you know, obviously you've seen capital increase in the back part of last year as we've been building out our labs of the future. You know, we expect to take possession of those laboratories around the middle part of the year. So we would expect for those to be completed substantially in 23 and for 24 to return to more of a normalized sort of capital type year.

Yeah. And to add to that part of the savings, as we think about 24 and 25 rents coming down. as we move out of more expensive space and into more cost-effective, more efficient space where we can automate. And, you know, it's going to take a lot of work to maintain these 70% gross margins, but that's where the automation and the process improvement will come from.

And your next question comes from the line of Mason Carrico with Stevens Incorporated. Your line is open.

Hey, guys. This is Jacob on for Mason. Thanks for taking our question. I'll just ask a quick one here and apologize if it was covered earlier in the call. I've been hopping around a few calls tonight. So looking at this year and into 2024, how should we think about the proportion of growth in gene site revenue coming from volume growth versus ASP moving higher from expanding coverage or reducing the no pay rate?

Yeah, that's a great question. Again, we expect to maintain continue to grow at 20% on the volume side. And we do expect ASP improvement as we improve coverage over the course of the year. And again, we'll have more updates there. But we're absolutely making progress with a couple of payers that we hope to be talking about here soon. But we haven't really broken out. But maybe in a couple of quarters, we'll be able to give you some more details around that. But ASP is stable. Volume is growing. and it's dropping to the bottom line. That lab is incredibly efficient. Kavita and the team there do a great job. Our cogs there are really tight, and we're trying to get more productivity on the sales force, so our customer acquisition cost is coming down with more inside sales and the digital conversions that we're getting that Mark talked about. So lots of leverage on GeneSight, but clearly more coverage on no pays drops to the bottom line. So that's something we're focused on across the portfolio.

All right. Got it. Thanks, guys. Thank you.

And all that does conclude the question and answer session for today. I'll turn it back to your presenters for closing remarks. Thank you very much.

Okay. Thanks, operator. 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.