Myriad Genetics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 3, 2023

There are 10 speakers on the call.

Operator

Greetings, and welcome to the Myriad Genetics Second Quarter 2023 Financial Earnings Call. During the presentation, all participants will be in a listen only mode. Afterwards, we will conduct a question and answer session. As a reminder, this conference is being recorded Thursday, August 3, 2023. I'd now like to turn the call over to Matt Scalo, Senior Vice President, Investor Relations.

Operator

Please go ahead, sir.

Speaker 1

Thanks, Dave, and good afternoon, and welcome to the Myriad Genetics' 2nd 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 ks and can be found on our website at investor. Myriad.com. On the call with me today are Paul Diaz, our President and Chief Executive Officer Brian Rigsbee, our Chief Financial Officer Nicole Lambert, our Chief Operating Officer and Mark Faraday, our Chief Commercial Officer.

Speaker 1

This call can be heard live via web cast@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 All results may differ materially and adversely from these expectations for a variety of reasons. We refer 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 ks, its quarterly reports on Form 10 Q and its current reports on Form 8 ks, These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward looking statements. With that, I will now turn the call over to Paul.

Speaker 2

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss highlights from the Q2 and provide an update on the progress we are making towards profitability in the Q4 of this year And sustainable growth and profitability in 2024 and beyond. Before we begin, I'd like to announce that we will be hosting an Investor Day September 19 with a presentation and tour of our new state of the art facility in San Francisco named Doctor. Walter Gilbert Innovation Center after the Nobel Laureate and Co Founder of Mira Genetics.

Speaker 2

An invite will be sent out and registration details for this event will be posted to the Investor page of our website soon. Transitioning to the quarter, I first want to thank our Myriad teammates and our provider partners for their continued support and commitment Advancing our mission and vision to making genetic testing and precision medicine more accessible and helping people take more control of their health, enabling providers to better treat and prevent disease. Total revenue grew 10% year over year After excluding an out of period adjustment of approximately $12,000,000 revenue in Q2 of last year, Our 3rd consecutive quarter of double digit top line growth. This growth was despite payer related headwinds in the quarter That are transitory and administrative in nature, which have largely been addressed for future periods. Brian will discuss this in more detail shortly.

Speaker 2

Neurogenetics drove significant volume growth in the 2nd quarter across all of our products as our commercial and lab operations teams continue to execute in these underpenetrated markets. We believe we are gaining share in the hereditary cancer testing market each quarter, Growing 20% in Q2 over the period of the quarter last year, driven by competitive account wins And increased adoption by providers of myRisk for patients whose family history puts them at a higher risk of cancer. Despite payer headwinds and a difficult operating environment, 2nd quarter saw Myriad maintain industry leading gross margins and reduce operating costs by $11,000,000 for the Q1, all while improving on our operating key metrics, which Nicole will address on the call, and exiting the quarter having generated $5,900,000 of adjusted operating cash flow And significantly lowered our cash burn. In the quarter, we closed on a new $90,000,000 asset based credit facility to replace are expiring line of credit and maintain a healthy level of financial flexibility. I'm also pleased to announce that we reached a settlement Subject to court approval with a longstanding shareholder lawsuit and can now move forward without this distraction.

Speaker 2

Brian will speak to the details of both the new facility and the settlement later. Lastly, I want to reaffirm our financial guidance for the full year And reiterate, we are on track to be profitable in the Q4 of this year. Transitioning to Slide 5, I'd like to outline again exactly what we think it takes to win in our sector. First, we strive to have the best science and products whose access and adoption are enabled by technology in our field. For us, this means having products that deliver value in real world clinical settings to high quality, actionable and differentiated tests that help support early detection and treatment decisions.

Speaker 2

2nd, we need to continue to automate, scale and build cost effective lab operations to deliver on our mission and grow profitably. Our Labs of the Future strategy allows us to improve workflows, test turnaround times and reduce costs through advanced technology and automation. Similarly, the investments we are making to modernize our IT platform will allow us to better serve our patients and provider partners at scale across all products and channels at lower cost. 3rd, a strong commercial platform ensures that our providers and patients benefit from partnering with So we can grow efficiently. And finally to win, one needs best in class regulatory and revenue cycle management capabilities.

Speaker 2

Great science used to develop practical high quality diagnostic tests, operating in state of the art facilities that reduce costs With the ability to get paid for our efforts is key. Our payer markets team is deeply with deep industry experience continues to play an integral role in this And the development of our product pipeline as well as our commercial reimbursement strategies, we see this as a competitive advantage. With that, I'll turn the call over to our Chief Commercial Officer, Mark Baratte, to speak to our commercial capabilities in more detail.

Speaker 3

Thanks, Paul. I'd like to start on Slide 7 and talk about our commercial team. We have made great strides in our commercial execution over the past year With changes made across the organization that enabled our sales force to effectively target and penetrate both new and existing accounts, The results speak for themselves with robust volume growth over the past 4 quarters, the majority of which are coming from existing accounts. This gives us confidence in the changes that we've made to the commercial team because growth in existing accounts means that tailwinds like market dislocation Have to date not been the key drivers of our commercial performance. With that said, this location in select markets that Myriad operates in is starting to get noticed by our providers.

Speaker 3

As peers in our industry struggle with everything from lengthening turnaround times to decreasing quality of service, A true driver of our volume growth is our skilled and focused sales force with years of experience at Myriad working alongside providers and their patients equipped with new digital tools, scientific insights that help them better serve our current customers while adding new accounts every quarter. We'll now turn to Slide 8 and talk about our core business units. Our oncology business delivered $80,700,000 in revenue in the 2nd quarter. Reported test volumes were roughly 52,000. Hereditary cancer testing volumes from our oncology sales team grew 18% year over year After growing 16% in the Q1 of the year.

Speaker 3

Prolaris, our market leading prostate cancer test continues to reach patients with diagnosed prostate cancer to provide them and their physicians with important information needed In the Q2, Polaris volumes grew 13% year over year. Myriad is making strides with Precise MRD as we are working with researchers at the MD Anderson Cancer Center Using our high definition MRD testing platform to inform treatment selection, surveillance And respond for individuals with metastatic renal cell carcinoma. There is a significant lack of non invasive testing platforms for this patient group. And while most MRD tests monitor 50 or fewer variants from a patient's tumor, Myriad's MRD assay can track thousands of variants Using our whole genome approach for higher sensitivity. With improved operational efficiencies paying dividends, a high net promoter score amongst Oncology providers and a fully equipped sales force, we anticipate continued strong growth from our core oncology tests.

Speaker 3

We'll now move to women's health on Slide 9. 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. In the quarter, Hereditary Cancer testing volumes in women's health increased 21% year over year, marking 4 consecutive quarters of positive volume growth. This strong momentum is driven by competitive account wins and increased adoption by providers of myRisk for patients whose family history puts them at higher risk for cancer. In prenatal, we are pleased to report a 12% increase in quarterly test volumes compared to Q2 of last year.

Speaker 3

This figure excludes any contributions from our recent acquisition Gateway Genomics. Also in the quarter, we are proud to announce We have reached over 1,000,000 patients who have taken our prequel non invasive prenatal screening test. Let's move now to Slide 10 and talk about mental health and GeneSight. Mental illness continues to have a lasting effect on patients and their families in the U. S.

Speaker 3

As those suffering 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, the test can be performed with Single cheek swab sample that can be taken in the privacy of their own home. In the second quarter GeneSight broke another all time quarterly volume record With 117,000 tests processed in Q2, up 23% over the prior year, as we've added approximately 4,000 new clinicians to Myriad continues to build on GeneSight's solid foundation of clinical data, including a collaboration with Optum Genomics To create a multi phase study designed to better understand GeneSight's ability to improve clinical outcomes and reduce overall healthcare costs. We believe that the ongoing success of GeneSight further demonstrates the effectiveness of our new commercial capabilities, digital marketing strategies And focus on the patient and the provider.

Speaker 3

I'll now pass the call over to our Chief Operating Officer, Nicole Lambert, to talk about our operations.

Speaker 4

Thanks, Mark. I'll begin on Slide 12 and give an update on our laboratory operations team. Thanks to our commercial customer service and laboratory operations teams, We grew volumes over 17% and reduced COGS by 6% in the quarter despite a challenging operating environment. Our lab operations team has shown tremendous resilience against these challenges, including a complex upgrade to our genetic sequencing platform, A successful FDA inspection of our Salt Lake City lab and the beginning of our lab move in Salt Lake City and South San Francisco. After some technical challenges in our myRisk lab in early Q2 that impacted our turnaround times, our average lab turnaround times across the enterprise Have returned to approximately 5.5 days.

Speaker 4

Turnover is also down to 9.6%, half of what it was in 21 and our employee engagement scores are up to 61%. We announced last quarter that we are a certified Great Place to Work, where over 86% of our employees voted us a great place to work. Our net promoter score among providers remained strong between 63% 84%. We also announced in Q1 that we have started sharing data with ClinVar. Providers and genetic counselors have been quite vocal about the importance of working with ClinVar And 81% of the providers that were asked are aware of our partnership with 13% saying they now have a more favorable view of Myriad.

Speaker 4

We encourage providers and counselors alike to share their thoughts and opinions with us because we are listening and we want to hear their feedback. Turning to the next slide. We have begun our transition to our new labs of the future, both in Salt Lake City and South San Francisco, which will be unveiled at our Investor Day on September In July of this year, the FDA conducted an inspection of our Salt Lake City laboratory, which focused on the quality systems related to myChoice CDx effective approach to running tests, but they foster an environment of innovation and collaboration amongst our commercial and enterprise support and our scientific teams. Our operating expenses and capital expenditures as they relate to the labs of the future are expected to decline over the next few years as we start to settle in and operate our businesses from those new facilities. I'll now turn to Slide 14 and talk about the progress of our EMR integrations and our unified order management system.

Speaker 4

Here we can see the tremendous progress that we have made working with clinics using EMR integrations to deliver more test results for our my risk hereditary cancer test. Our EMR integrations with the likes of Epic and others not only help us get patient medical records from providers, but also means that providers who are already in those EMR systems Do not have to provide those documents to us in addition to their normal workflow. We are pleased with the ongoing rollout of our new unified Provider portal and our unified order management system, which not only help us get the information required by payers, but make it easier for providers to order tests from us, reducing the number of times we need to recontact them. We talk a lot about making it easier to do business with Myriad Genetics, And our operational initiatives revolve around improving the customer experience. EMR integrations and Unified Order Management are examples of how we are doing exactly that.

Speaker 4

I'll now turn the call over to Brian to discuss financial highlights from the quarter.

Speaker 5

Thanks, Nicole. I'd like to start by reviewing product volume trends on Slide 16. Total 2nd quarter organic volumes grew 17% over last year, representing 4 consecutive quarters of double digit volume growth for the business, driven by strong double digit growth in both hereditary cancer testing at 20% and GeneSight volumes at 23% in the 2nd quarter. Prolaris saw 13% quarterly volume growth from Q2 of last year and prenatal volumes excluding contributions from sneak peak grew 12% year over year. Overall, the quarter reflected broad based volume growth across the portfolio.

Speaker 5

Turning to total revenue on Slide 17, Recall that the Q2 of last year benefited from approximately $12,000,000 in positive out of period adjustments, which were immaterial in the Q2 of this year. Excluding these adjustments, revenue in the Q2 of $183,500,000 grew 10% year over year, marking a 3rd consecutive quarter of double digit revenue growth, a reflection of consistent volume growth and execution of our commercial strategy. Consistent with others in our industry, during the Q2, we experienced a negative impact to our rev cycle process From the transition of multiple Blues health plans to a new claims administrative process, the process changes left many health plans unprepared to handle the sometimes Complicated pre authorization process, leaving providers unable to obtain the necessary pre authorization required to support testing for patients as well as reimbursement. This administrator transition resulted in a headwind of approximately $4,000,000 in the quarter. As of today, we have seen these systems issues mostly return to normal.

Speaker 5

However, there was some spillover into Q3. With respect to the claims which were denied payment and not included in 2nd quarter revenue, we are engaging with a number of large payers to discuss payment for claims that we believe should have been paid and would have historically been paid. However, at this point, we do not have enough support to record revenue for those claims. Despite these payer issues, average revenue per test in the Q2 was flat sequentially from the Q1 of 2023. I'll now turn to Slide 18 and discuss operating trends from the quarter year to date.

Speaker 5

Healthy growth across our business units reflects comments Paul, Mark and Nicole have already mentioned, including improved execution By strengthened and highly motivated commercial team as well as investments in core infrastructure and improving customer experience. Recall in Q1, we stated that adjusted operating expense would decline in the Q2 as the company implemented tighter cost controls across the organization and certain sales and marketing program costs subsided. Q2 reflects the impact of these initiatives with adjusted operating expense $143,400,000 a decline of $11,000,000 sequentially. Continuing to manage operating cost is an important step in our path to profitability in Q4. We'll turn to Slide 19 now to review our liquidity and cash flow.

Speaker 5

We are excited to announce that we generated $5,900,000 of adjusted operating cash flow in And looking at the balance sheet, we ended the quarter with $127,800,000 of cash, including approximately $40,000,000 drawn on our new asset based credit facility that Paul mentioned earlier. I would like to provide some additional detail on changes to our capital structure from last quarter. As we have stated in the past, our previous revolving credit facility was set to expire in July of this year. This facility was a cash flow based revolver put in place in 2016. Leading up to the credit facility's termination, the company's lack of positive cash flow and profitability hindered our ability to use this facility.

Speaker 5

As a result and to provide additional liquidity, the company entered into a new asset based credit facility where cash availability is now determined by our accounts receivable balance and the size of the facility rather than by our cash flow. This new facility which was provided by 3 of our banking partners, JPMorgan, Wells Fargo and Bank of America is now available to us. As of June 30, our accounts receivable balance allotted us $23,500,000 of additional available cash from this new facility. As you can see from our cash flow statement, We are adjusted operating cash flow positive and the capital needs for the construction of our new labs are substantially behind us. As noted in our press release today, we have agreed to settle a shareholder lawsuit subject to court approval related to a number of alleged misrepresentation and disclosure items from 2019 for a total of $77,500,000 We will pay $20,000,000 of the settlement in cash next quarter this quarter, leaving the remaining $57,500,000 to be paid in early 2024 with either cash or equity.

Speaker 5

We expect the ultimate payment to be more weighted towards cash rather than stock. For example, if we were to pay an additional $30,000,000 with cash, the remaining $27,500,000 would then be paid in Myriad stock, which assuming a $21 price per share would translate to approximately 1,300,000 shares or 1.5% of total shares outstanding. Ultimately, we have allowed ourselves significant financial flexibility in how we choose to settle the final payment out of operating cash flows and available cash, But we will continue to evaluate various financing options including the expansion of our ABL credit facility as the year progresses. Now on slide 20, note that we are reaffirming our full year revenue and non GAAP financial guidance and we reiterate our previously disclosed target of Generating positive adjusted operating cash flow and profitability in the Q4 of this year. I'll now turn it back over to Paul for closing remarks on the next slide.

Speaker 2

Thanks, Brian. As you've heard, we've had a lot of exciting organizational changes happen this year, but we remain focused and confident in reaching profitability in 4th quarter. Balancing growth and innovation while keeping an eye on profitability is an ongoing challenge and opportunity, but we are In closing, I'd like to offer what we believe are our strength and strategic advantages. First, we continue to grow volumes and revenues consistently every quarter across our businesses and we get paid for the tests that we offer. 2nd, we have a disciplined cost management structure as we expect to maintain our strong gross margins and manage our OpEx as we did this quarter responsibly.

Speaker 2

3rd, we are committed to effective capital deployment in key areas that will improve the customer experience, including new tech enabled tools and capabilities, Product innovation, our commercial capabilities and our labs of the future. 4th and finally, our growth catalysts are clear as we continue to elevate our products All of this reinforcing our position as a trusted differentiated lab with specialized expertise, Best in class quality, strong scalable commercial engine underpinned by data, research and technology with industry leading margins and business management. Keeping patients and providers at the center of everything we do Starting to pay dividends and we are excited about finding new 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 Myriad Complete, Our customized suite of services and workflow solutions. And now, I'll turn it back to Matt for Q and A.

Speaker 2

Thanks, Paul. And as

Speaker 1

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 GAAP to non GAAP financial guidance can be found in our earnings release and under the Investor Relations section of our website. Now we are ready to begin our Q and 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 for the Q and A portion of the call.

Operator

Thank And your first question will come from the line of Matt Sykes with Goldman Sachs. Your line is open.

Speaker 6

Good afternoon. Thanks for taking my questions. Hey, guys. Paul, maybe first, you made some comments about the Market share gains in women's health. Maybe could you kind of talk a little bit about that market, the share dynamics there?

Speaker 6

And then what is your kind of view on the duration Of the market share gains that you can achieve just given the dynamics in that industry right now?

Speaker 2

Yes. We're really pleased by the progress we're making. And as Mark said, I think we're in the early innings here. First, as we've commented on that, we think adoption rates are still low. We saw a nice increase in adoption rates For prenatal testing, when we move to average risk, we believe there will be expansion of guidelines around carrier screening soon.

Speaker 2

And as you see, our hereditary cancer, myRisk testing opportunity For unaffected patients, is a huge opportunity for patients and for us to continue to grow. So we're really excited about that platform. It is a market that others are really struggling to find a path to profitability, But we are on the verge of profitability in women's health and we have a path to that. So the leverage in Women's Health for us is pretty significant as we continue to grow, and we see a lot more opportunity for market share gains As well as this broader adoption as we continue to come out of the pandemic.

Speaker 6

Great. And maybe if I just Two quick ones. And just one quickly, Brian, just you mentioned spillover from the administrator change into Q3. If you could quantify that? And then just secondly, The Lab in the Future, I think on the slide you said it's going to result in a 6% reduction in COGS.

Speaker 6

Can you just talk about the phasing of cost Reduction as the lab in the future kind of gets rolled out?

Speaker 5

Yes. I think with respect to the first question, on the Spillover, it was a system conversion that took place really at the really end of Q1. So we had a full quarter. So when we think about that $4,000,000 that was a full quarter and as of today, we're largely back to normal in terms of the processing issues. So it would be obviously significantly less than $4,000,000 as we look at the next quarter.

Speaker 5

And we tried Capture it, we provided some additional detail in our deck regarding sort of our profile in the remainder of the year as we track

Speaker 2

You and I have talked about this. We're certainly striving for more Gains in gross margins and we do see the opportunity as we automate, as we move into the new labs. I mean, our teams are so excited. We were in San Francisco altogether last week. The space is just to afford When you think about time and motion studies and the ability to get work done and process the volume, We're terribly excited about it.

Speaker 2

But as I've said, us maintaining gross margins of 69%, 70%, Net of inflation and with the increased regulatory burdens that we see and expanding panels as our has become more complicated. That's just incredible work by R and D and lab teams. And there's just so much leverage. If we can grow continue to grow the top side of this company 10% plus, which is what we're working towards, Even as we mitigate payer noise, maintain those margins and then manage OpEx Effectively, the EPS and cash flow leverage is pretty significant as we go into 2024 and 2025. So, all of that is to say, Nicole and team did a great job lowering COGS in the quarter.

Speaker 2

We expected to do that a little bit because But given the lab moves, the move to NGS sequencing, CLIA surveys, FDA surveys and A 17% growth in volume. I'm not sure if I could expect much more of the lab teams that we got this quarter.

Speaker 6

Great. Thanks very

Speaker 2

much. Thanks, Matt. Thanks, Matt.

Operator

And your next question comes from the line of Andrew Cooper with Raymond James. Your line is open.

Speaker 7

Hey, everybody. Thanks for the questions. Maybe first, going to stick with one On gross margins here, if we do the math on that $4,000,000 assuming you did run all those volumes and just not get paid, That puts your gross margin north of 71% for the quarter. I guess just help me think about is that the right way to think about things? When we think about the guide, it seems like that maybe implies a little bit of a step back from that sort of adjusted, adjusted number.

Speaker 7

But just help me think about What the moving parts are through the back half of the year on the gross margin side?

Speaker 5

Yes, Andrew. I mean, I think that We certainly ran the test and that would have been a helper, but there are always a number of puts and takes anytime you look at the numbers. And we say in the When we talk about the 68% to 70% that it will fluctuate throughout the year. So I guess I just we still feel comfortable in that range Around 70% gross margin. I don't know that I would put a finer point on it relative to that.

Speaker 2

Yes. Andrew, Look, I think the thing that we're most encouraged about going into the Q3 and more importantly that the momentum that causes Going into the Q4, which is our strongest quarter, is that volumes are we're not seeing the seasonal Yes, that we typically see. We're growing through that right now. That's the bigger leverage in terms of gross margin. The payer stuff is just frustrating and we're pretty good at that.

Speaker 2

And we certainly see some upside in the back half of the year, as Brian said, Trying to work through that. But let's be clear, the payers are have raised the level of difficulty on prior auth And just the administrative part of doing business here. And we're Doing a lot of soul searching to think about how we can continue to up our game leveraging AI and other things. But as Brian said, I would resist the urge to focus too much on any one lever. The bigger lever is growing volumes And then continuing to manage cost and again, the drop in OpEx cost quarter over quarter, which is what we committed to, I'd point your attention back to and again, we're just we're working hard to make sure that we deliver on our commitments.

Speaker 2

And I think we're Really positioned to do that in the back half of the year.

Speaker 7

Okay, great. And maybe just one more from me. I don't think you went into too much detail on And anything on new products still to come. So maybe just can you confirm timelines or if there's any updates to first gene MRD RUO launch And others in the Precise portfolio, if those are on track or anything else we should be contemplating in terms of timing?

Speaker 2

So happy to talk about it a little bit. We're going to really spend some time at our Investor Day talking about that and hopefully you and others can attend And get from Dale and the rest of the team some more insights. And you're going to hear from our product management team that is fully integrated now more. What I would say is we continue to listen to our customers, do pilots, listen to what people are expecting pre launch here. And so we're much more focused on launching with a go to market strategy that we think will win and be differentiated.

Speaker 2

Generally, everything is on track. We are working on carrier screening panel expansion in front of guidelines, which To me is a precedent before the first gene launch. We've got to kind of get that done, more flexibility around our myRisk panels. So we just continue every quarter to look at how do we need to position our products. With respect to MRD, Really enthusiastic.

Speaker 2

We are processing samples as we speak for Memorial Sloan Kettering. We are close to announcing some other clinical validation studies. And so again, we'll get into more detail. But As we've talked about in terms of our 3 year growth path, 1st gene MRD are not big contributors to that. That's sort of on top of the 10% to 12% 10% plus that we expect, but we'll have a lot to talk about on Investor Day and generally things are progressing.

Speaker 7

Great. Appreciate the time. Looking forward to hearing more in September.

Speaker 2

Yes, great. Hopefully, you can attend. Thank you,

Operator

Your next question comes from the line of Daniel Sarmarco With TD Cowen, your line is open.

Speaker 8

Hey, guys. Thank you for taking the call tonight. Quick question on GeneSight, grew 23% this quarter, volume at 117,000. How should we think about performance for the remainder of the year? And should we be looking at any additional payer announcements in the near future?

Speaker 8

And if you can provide any timeline on additional publications supporting this utility, that would be great too. Thanks.

Speaker 3

Yes. Related to GeneSight, I mean, I think you've seen almost 8 quarter, 9 quarter double digit growth. And given Given the new providers that we're adding every quarter, we expect to continue to see strong volume growth for GeneSight. Related to new clinical data, we were We should hope to see some clinical data announced at the end of this year. So the second half that we're coming up into and we're going to continue to see Some new data coming out at the beginning of next year as well.

Speaker 3

So I don't expect any slowdown related to the GeneSight franchise.

Speaker 2

Well, and to the second part of your question, we've had some preliminary readout from our study with Optum Genomics on the clinical utility, which is really pointing towards GeneSight as a really effective tool To reduce psychiatric hospital days and emergency room visits, this is like the real world stuff that I like to talk about. Mark mentioned in his script the meta analysis work that all continues to be confirmatory. We've had a number of states, 3 specifically now pick up the PLA codes and we are generating revenue From that expansion, that's some state fee for service Medicaid plans as well as some managed Medicaid plans, and we are making progress with some commercial Payers, we had hoped to announce one here this quarter and it's just taking a little bit more time, but we do expect To be able to announce several additional commercial coverages before the end of the year and more Coverages from different Medicaid plans as well. One of the things that we're working really hard on that's been a source of frustration Many of the Medicare Advantage plans are not, who are required to cover GeneSight because it's a covered service are not paying.

Speaker 2

And that's one of the things in our payer markets and rev cycle teams that we are really getting much more assertive on When clearly a covered service by Medicare Advantage Plan is not being covered, ostensibly because of prior auth issues or other documentation issues. And so, And so, we do see upside in ASP for GeneSight in the back half of the year and more momentum

Operator

Yes, we have another question coming from the line of Jack Meehan with Nephron Research. Your line is open.

Speaker 9

Hey, Jack. Thank you. Good afternoon. Brian, I wanted to start with what's your expectation for free cash burn In the second half of the year, and could you just call out some of the one timers we might be looking for like the legal payment?

Speaker 5

Yes. Jack, we had a slide in the deck and a little section in the press release where we talk about where we show our liquidity As well as the payment coming out for the legal settlement and also our CapEx and cash flow expectations, trying to give a view as to Kind of where we think we'll end the year from a cash and availability on the credit line perspective. So it should answer your question in the release.

Speaker 2

Yes, it's pretty much a checkbook version, Jack. So it should be very clear. And the thing that I would underscore is The settlement as well as our ability to access other capital remains. We have a lot of financial flexibility. We have till Q4 to complete the settlement and a number of different levers, whether expanding the ABL

Speaker 8

All right.

Speaker 2

Thanks. But there is a very simple walk through on Slide 19, I don't have glasses. I'm going to kind of get you there.

Speaker 9

And based on the way things are trending with Gateway with sneak peek, would you expect to make the $32,000,000 milestone payment in 2024 there as well?

Speaker 2

Yes, unfortunately not, but which Again, if they were hitting their other metrics, we would be happy to pay it and they have an ability to get paid later. Right now, their volumes are flat. We're starting to see some attachment rate to NIPS testing. We're going to have some more announcements about acceleration around sneak peek and some new Channel opportunities there at the Investor Day, but that is not a payment we expect to make right now. They've been managing costs well, so It hasn't been a big cash flow or EBITDA drain.

Speaker 2

In fact, they've done a they're under budget on the cash perspective, but they are only Flat year over year right now on volume, but we're not even a year into it yet and we're really proud of the integration and how it's going. And I think we'll get some more momentum here as the year progresses.

Speaker 9

Okay. One last The FDA is about to release new rules as it pertains to LVTs coming back again. I was curious if you've had Any recent discussions with them about GeneSight? How you think these rules might impact Myriad?

Speaker 2

I'm not sure if I could be any clearer, but I will restate this. We have not had any exchanges Or the FDA has made any inquiries about GeneSight in 2019. And we don't expect the FDA to have any inquiries about GeneSight. Most of the focus of the And other things that they view are high risk. And so we are not concerned nor do we have any new information since 2019 about concerns from the FDA on GeneSight.

Speaker 2

Any other questions, folks?

Operator

There are no further questions pending. I'll turn the call back to Matt Scala for closing remarks. Thank you.

Speaker 1

Okay. This concludes our earnings call. A replay will be available via webcast on our website for 1 week. Thank you again for joining us this afternoon and see you at our investor event in September.

Operator

And all that does conclude the conference call for today. We thank you very much for your participation. You may now disconnect your lines.

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Myriad Genetics Q2 2023
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