2/24/2022

speaker
Operator

Greetings and welcome to the Myriad Genetics 4th Quarter 2021 Financial Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will 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. If at any time during the conference you need to reach an operator, please press star 0. As a reminder, this conference is being recorded Thursday, February 24, 2022. I would now like to turn the conference over to Nathan Smith, Senior Vice President of Investor Relations. Please go ahead.

speaker
Nathan Smith

Thank you, Kevin. Good afternoon, and welcome to the Myriad Genetics fourth quarter 2021 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 morning on Form 8K and can be found on our website at investor.myriad.com. I'm Nathan Smith, the Senior Vice President of Investor Relations. And on the call today with me are Paul Diaz, our President and Chief Executive Officer, Brian Rigsby, our Chief Financial Officer, and Nicole Lambert, our Chief Operating Officer. This call can be heard live via webcast at investor.myriad.com. And recording will be archived in the Investor section of our website. In addition, following the call, The slide presentation will be available on the investor section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission. Specifically, the company's annual transition reports 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 will now turn the time over to Paul.

speaker
Kevin

Thanks, Nathan. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss our Q4 results along with highlights of the quarter and updates on our strategic transformation and growth plans. As always, I want to thank all of our teammates for all their hard work and dedication this year. I also want to thank our healthcare provider partners and their patients for their continued competence in us. 2021 posed many challenges for everyone. but I am proud of everything we have done to advance our mission and improve the health and well-being of our patients. When we step back and look at the millions of patients we've reached over the years, the importance of our work is clear. We see an opportunity to reach more patients, lower costs, create a seamless user experience, and combine data from millions of diagnostic tests with other clinical data sets to help physicians, health systems, and payers better managed care. Despite COVID-19 headwinds and inflationary pressures, we saw solid quarterly operating and financial results during the fourth quarter of 2021. In the quarter, revenues of $160.8 million increased 4% year over year, and diagnostic test volumes of $237,000 were flat compared to last year. Importantly, excluding the impact of our divested assets, quarterly revenue increased 19% year-over-year and 34% for the year, demonstrating strong growth in our core business. Average revenue per test in the quarter increased 10% year-over-year, a reflection of the investments made in and the execution of our rev cycle plan. Total operating expenses were $158.1 million, and adjusted operating expenses decreased $6.2 million sequentially to 115.3 million as we continue to manage our costs more effectively and prioritize our operating expenses to our strategic initiatives our gap operating loss in the quarter was 43.1 million with an adjusted operating income that was break even and an adjusted operating loss per share of two cents at the end of the fourth quarter we had approximately 400 million in cash cash equivalents and investments, and no long-term debt. As noted last quarter, our progress toward long-term profitability will not be linear. The COVID-19 virus and its variant strains continue to limit access to providers and patients and has challenged our workforce. This can be seen in our hereditary cancer business as women are visiting their doctors less, delaying routine screening. However, our path of profitability remains clear and our confidence in our financial guidance for 2022 is unchanged and reflects the challenges we face as well as the benefits of our transformation plan. Myriad's position as a trusted, differentiated partner with specialized expertise is underpinned by three strategic priorities. First, we are working to develop best-in-class products, services, and accessibility to accelerate growth and reach more patients of all backgrounds. Second, we are building new enterprise capabilities to accelerate growth and leverage our scope and scale and to capture new market opportunities, including M&A. Third, we are focused on disciplined execution and consistent results as we work to deliver on a key set of initiatives to fulfill our mission and drive long-term growth and profitability. We continue to make progress on each of these priorities and are excited about the opportunities they will create in 2022 and beyond. Our transformation and growth strategy has been focused on three phases. The first phase, resetting our base of operations, was successfully completed ahead of schedule, reinforcing who we are as a company, developing our new commercial model, recovering test volumes, completing multiple divestitures, and returning roughly $400 million to the balance sheet. In the second phase, we work to elevate our current portfolio to its full potential, debuting a new brand and marketing strategy, restructuring our sales force, enhancing reimbursement and rev cycle capabilities, fostering diversity and inclusion, and launching new and exciting products that reflect our mission and our value proposition. As we enter the third phase and look to accelerate growth, we have the opportunity to expand on the foundation we've established over the past year. We continue to scale our technology-enabled commercial capabilities with an investment of over $50 million intended to drive volume and improve customer engagement with myriad more than 60,000 active ordering positions. We will build on these capabilities to support new product development, consumer engagement channels, the launch and expansion of our unified portal, and the rollout of new sequencing technologies in our lab of the future. At the same time, we are seeking acquisitions, and partnerships, we continue to invest in our technology infrastructure and core capabilities. Our commercial platform is gaining traction, fueled by a $12 million investment in commercial and marketing capabilities. We recently gave guidance for top-line organic growth of 9% to 12% from 2022 through 2024. This begins with stabilizing revenue from myRISC with risk score for all ancestries by streamlining our ordering and billing services, further integrating electronic medical records into our systems, and developing more consumer engagement. We anticipate a 4% to 5% revenue growth contribution from our mental health business driven by the continued momentum in Genesight. For our women's health business, we expect a 3% to 4% contribution in revenue driven by enhancements to our current products, favorable medical association guidelines, and the future launch of Firstgene, our combined carrier and prenatal screening test. In our oncology business, we anticipate a modest 2 to 3 percent revenue contribution through 2024. We expect this growth will be driven by our entry into the tumor profiling market with Precise Oncology Solutions launching in the next few weeks. Nicole will talk more about the power of Precise in a few minutes. Looking to 2024 and beyond, we are excited to pursue additional growth areas such as liquid biopsy and measurable residual disease monitoring, women's health products and channel expansion, and additional pharma partnerships to take advantage of our companion diagnostic capabilities. With that, I'd like to turn things over to Nicole, our Chief Operating Officer, to discuss the Q4 operating results and the new innovations in more detail.

speaker
Nathan

Thank you, Paul. I'd like to start with Our core business unit performance.

speaker
Paul

There's no question that the mental health crisis in the US has worsened as a result of the pandemic. Trial and error are still prevalent when it comes to determining the most effective medications to treat depression, anxiety, ADHD, and other mental illnesses. Our research shows that more than half of those diagnosed with depression have tried four or more medications in their lifetimes in an effort to find the right one. Our GeneSight psychotropic test addresses this mental health crisis by helping physicians better understand how antidepressants and other drugs will affect their patients with just a single cheek swab sample that can be taken at a patient's home. Driven by GeneSight, our mental health business reported $29.4 million in revenue for the fourth quarter of 2021, an increase of 63% year-over-year and 22% sequentially from the third quarter of 2021. With roughly 78,000 tests ordered in the quarter, we saw some 2,900 physicians ordering GeneSight for the first time. The total number of ordering physicians for GeneSight increased 7% from last year, and 95% of our ordering physicians are now using our online portal. Volumes for GeneSight are growing in new provider segments, including general practice physicians and nurse practitioners. About 30% of our tests are home-based kits. We look forward to exploring new partnerships in neurology to develop early detection and treatment selection options for Alzheimer's patients. GeneSight also recently earned two-year certification from the High Trust Alliance for safeguarding sensitive information, privacy, and information systems. I should also note that the peer-reviewed journal Psychiatry Research highlighted the advantages of GeneSight in its February 2022 edition. This is now the third study published by Psychiatry Research articulating how GeneSight can help clinicians better understand gene drug interactions and how they may affect patient outcomes with commonly prescribed antidepressants and other psychiatric medications. Shifting now to our women's health business, last year we launched our MyRisk Hereditary Cancer Test with Risk Score for All Ancestries, which is the only polygenic breast cancer risk assessment available for all women. With this new test, we estimate that 56% of women qualify for medical management changes after myriad testing versus 10% who would qualify with standard hereditary cancer testing. Since launching MyRisk with RiskGore for all ancestries, we have been able to provide genetic insights to some 16,000 women of non-European descent who would otherwise not have been able to benefit from RiskGore. We plan to significantly increase that number this year, and we are excited about the potential opportunities to develop risk score stratification capabilities. With risk score, clinicians can gain critical insights to help treat women with increased risk for breast cancer who likely do not have an identifiable mutation in one of the breast cancer genes. As Paul mentioned, we're progressing towards the launch of FIRST genes, our combined noninvasive prenatal screen and carrier test, which is expected to be available early next year. Today, only one in three patients undergo both carrier screening and non-invasive prenatal screening during their pregnancy. First gene combines the two tests into one, simplifying the screening process and making it easier for patients to get the answers they need from just one single maternal blood drawn. In the fourth quarter, our women's health business reported 64 million in revenue, a 14% increase year over year, and 8% sequentially from the third quarter of 2021. Reported test volumes were roughly 114,000. Hereditary cancer volumes were adversely affected by continued COVID-19 challenges, including physician office staffing constraints, fewer in-person office visits, and limited Salesforce productivity due to the high levels of positive cases. Under Melissa Gonzalez's leadership, we have overcome many operational challenges that included limited technology tools, leading to friction in our customer experience, a Salesforce with high levels of turnover, We are excited about the number of new initiatives, including the launch of our unified ordering portal in mid-2022, a more stabilized sales force that is gaining traction, as well as investments in additional consumer-driven channels that we expect will help improve hereditary cancer performance in the back half of the year. Our oncology business delivered 67.4 million in revenue in the fourth quarter, an increase of 12% year-over-year, and a decrease of 12% sequentially from the third quarter of 2021. Reported test volumes were roughly 45,000. This month, we soft-launched a precise tumor pilot program and saw that roughly 82% of the precise tumor tests also had an attached MyRisk or MyChoice CDX order attached. And as Paul mentioned, we will be launching our comprehensive suite of precise oncology solutions in the next few weeks to guide treatment decisions and provide personalized integrated care for patients. This follows extensive consultation and feedback from leading physicians, members of our medical advisory board, and development partners. We've taken a very rigorous approach to field readiness, training, and marketing, all of which are in their final stages of development. This new suite of solutions will include our precise tumor molecular profiling test, the first of its kind to provide a streamlined testing experience that combines germline testing, tumor profiling, and companion diagnostic options, including Myriad's leading MyChoiceCDX companion diagnostic HRD test. With this new solution, Myriad Genetics is advancing in oncology, keeping up with Intermountain Precision Genomics and Illumina to merge the power of companion diagnostics, next-gen sequencing, and world-class testing services. In urology, the new NCCN prostate guidelines are favorable for both our Prolaris prostate cancer test as well as our Myris hereditary cancer test. Myriad Genetics is the only company that is able to offer both a tumor prognostic and a hereditary cancer test to our partner urologist, as well as a companion diagnostic for therapy selection. Myriad was also recently awarded a contract with Blue Cross Blue Shield of Michigan, which we believe unlocks a substantial market in the US for Prolaris. We believe we will continue to expand the biopsy market for patients with prostate cancer for Prolaris and look forward to continued growth there. Looking to the near future, we plan to continue to broaden and deepen our oncology product portfolio to support the needs of cancer patients across the entirety of the continuum of care. Myriad offers EndoPredict to help breast cancer patients make the right treatment decisions. We offer BRAC Analysis CDX and MyChoice CDX, our proprietary and patented germline and HRD companion diagnostic tests. We are working to expand our oncology portfolio by adding liquid biopsy therapy selection testing, as well as MRD capabilities. Myriad's vision is to become a precision medicine partner for cancer patients, supporting them throughout their difficult journey with simple and high-quality testing solutions. I would now like to turn the call over to Brian to discuss our Q4 financial results.

speaker
Paul

Thank you, Nicole. I would like to start by reviewing our financial highlights. We had another good quarter as we reported total revenue of $160.8 million, up 4% year-over-year, and excluding divested assets increased 19% year over year. Our quarterly results were driven by stable test volumes, which despite COVID-19 disruptions, increased 13% year over year, excluding divested assets. Additionally, we saw improving average selling prices across our businesses. The stability in ASP and better than expected cash collections on orders from prior periods was driven by our improved execution on revenue cycle management, which has been a major component of our transformation and growth plan. In the fourth quarter, we reported an adjusted loss per share of two cents. We remain on track to return to profitability and deliver consistent growth in 2022. Adjusted gross margin was 71.8%, and adjusted operating expenses were $115.3 million. We have experienced increased inflationary pressures, increased labor costs due to staffing constraints, and competition for talent, as well as increased material costs due to global supply chain disruption. In addition, volumes at the end of the quarter and end of January were negatively impacted by the Omicron variant, which significantly disrupted physician office access and limited our own sales force, which experienced high numbers of positive cases. However, as the number of reported cases, both within and outside of Myriad, are beginning to decrease, we are seeing volumes return to expected levels. Turning to revenue by product, hereditary cancer revenue in the fourth quarter was $74.8 million versus $78.7 million in the fourth quarter of last year. Our hereditary cancer test volumes increased 2% sequentially and decreased 9% year over year, excluding positive revenue adjustments related to better than expected cash collections on tests ordered in prior periods ASP for hereditary cancer during the quarter increased 3% year-over-year and decreased 3% sequentially. In women's health, revenue was $64 million in the fourth quarter, an increase of 14% year-over-year and 8% sequentially. Prenatal revenue increased 43% year-over-year and 27% sequentially. Our proprietary amplified technology, which significantly enhances the performance of our prequel non-invasive prenatal screening test, and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures. And oncology revenue in the fourth quarter was $67.4 million, an increase of 12% year over year and a decrease of 12% sequentially. Tumor profiling revenue increased 57% compared to the same period in the prior year and decreased 19% sequentially. The decrease sequentially is partially due to a $4 million milestone payment received in the prior quarter. Pharmacogenomic testing and mental health delivered fourth quarter revenue of $29.4 million, an increase of 63% year-over-year and 22% sequentially, representing consistent growth six quarters in a row. Now looking at product performance this quarter compared to last quarter and the fourth quarter of 2020, total Q4 test volumes were flat year-over-year and down 5% sequentially. Total revenue increased 4% year-over-year and decreased 4% sequentially. Excluding revenue from divested businesses, total revenue in Q4 increased 19% year-over-year and 1% sequentially. Excluding divested business, quarterly volumes were up 13% year-over-year and 5% sequentially. These results demonstrate strong growth in the core business despite COVID headwinds. In January, we provided 2022 financial guidance that we would like to reiterate. We are giving revenue guidance at $670 to $700 million based off an 8% to 13% baseline growth rate from 2021 revenue that excludes divested assets of $53 million and $16 million of positive cash collections from prior periods. Using our annualized fourth quarter revenue as a base, our top line guidance represents a growth rate of roughly 4% to 9%. In January, we experienced constraints in access to healthcare providers and a large number of positive COVID cases within Myriad Salesforce. As a direct result, we expected a negative $7 to $9 million impact on our total revenue for the first quarter of 2022. While these obstacles were most prevalent in January, we have seen recent volumes return to levels that are within our expectations. As an offset to the Q1 COVID impact, the delay of PAMA in 2022 will provide a pricing benefit of approximately $7 million. As such, we remain confident in our revenue targets for 2022 and expect to see acceleration of growth in the second half of the year with the rollout in Q1 and Q2 of our new commercial model, tech-enabled tools, and the launch of precise oncology solutions. Our guidance for gross margins is 70% to 72%, which is in line with the adjusted gross margins of 71.8%, reported in Q4 and includes the impact of inflationary pressures offset by lab optimization initiatives and efficiencies. Adjusted operating expenses are expected to be $470 to $480 million. The growth in adjusted operating expenses of 2% to 4% is based off our annualized fourth quarter adjusted operating expense of $116 million and includes investments in technology, commercial tools and R&D, as well as the impact of various inflationary pressures. Finally, we are guiding adjusted earnings per share of zero to 20 cents per share based on a pro forma share count of 82 million shares. We continue to be excited about the business going into 2022 and believe that we have set the stage for a profitable year. While we remain confident in these long-term goals, we are focused on mitigating the COVID-19 and inflationary pressures we are experiencing due to the current macroeconomic environment. We believe that over time, the market will favor the most efficient, effective providers, and that our focus on improving customer service levels, our new commercial strategy, and our plans for an automated lab of the future will position us to deliver on our long-term goals. We exited the year with a strong balance sheet that has approximately $400 million of cash and equivalents and $250 million undrawn on our revolver that will help fund our growth initiatives and M&A activity. I'll now turn it back over to Paul for closing remarks.

speaker
Kevin

Thanks, Brian. We are pleased with the progress that we have made this past year in a tough operating environment. Our primary focus now is the launch of our new products and commercial initiatives in Q1 with the goal of accelerating growth in the second half of 2022. As we continue to invest in our business, elevate our products to their full potential, and introduce new innovative offerings while pursuing strategic acquisitions and partnerships. Now more than ever, we're exploring new ways to illuminate the path to better health through genetic insights. We look forward to a bright future ahead for Mira Genetics as we continue to work to better serve our patients and customers and deliver sustained growth and profitability for our shareholders. Now I'll turn it back to Nathan for Q&A.

speaker
Nathan Smith

Thanks, Paul. As a reminder, during today's call, we used certain non-GAAP financial measures. The reconciliation of the GAAP financial measures to non-GAAP financial results and a reconciliation of GAAP to non-GAAP financial guidance can be found under the investor relations section of our website. Now, we are 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 are now ready for the Q&A portion of the call.

speaker
Operator

Thank you. So, everyone, if you would like to register a question, please press the 1 followed by the 4 on your telephone. you'll hear a three-tone prompt that acknowledges your request. If your question has been answered and you would like to withdraw your registration, please press the 1 followed by the 3. So again, for questions, it's 1-4. First question is from Andrew Cooper with Raymond James, and your line is open.

speaker
Andrew Cooper

Hi, guys. This is Liam on for Andrew. I appreciate you taking my question. So with divestitures in the rear view now, The balance sheet has cleaned up significantly. There's capacity on the revolver. How are you viewing the M&A market today, especially with valuations at much lower levels? And has that changed your thinking at all? And looking at liquid biopsy and MRD specifically, is your disposition to acquire or partner?

speaker
Kevin

So, great question. And it's evolving. I mean, as you know, Valuations in the private part of the market always take longer, and sellers' expectations don't come down very quickly. But we are emboldened by the opportunities we have to deploy capital. And I sort of want to reiterate that the 9% to 12% growth rate is funded by the things that we have in sight that we've developed business cases for. And it's $30 million to $50 million of CapEx that we've budgeted for that. It does not really draw upon acquisitions to drive that. If we see opportunities, particularly in MRD, to accelerate growth and accelerate that entry in that marketplace, that's certainly a sweet spot. Looking for additional women's health products to broaden our product channel there is another area that we'd look at. But with respect to liquid and MRD, quite frankly, and we just had a meeting on this this morning, We have a path, a solo path going forward and a couple of partnership discussions that can absolutely get us there and have products that are competitive. And so I just want to reiterate that dry powder is not necessary for us to achieve the liquid goal or the MRD goal, quite frankly. We have the capabilities in-house with investments embodied in our five-year plan to do that with modest investments of op-ex and capital.

speaker
Andrew Cooper

Thanks. I appreciate that color. And just as a quick follow-up, you guys briefly mentioned physician office access being constrained in January, which is understandable given the COVID case dynamics. How are we looking so far in terms of a February rebound, and how do you feel about that access going forward? Thanks again, and I appreciate it.

speaker
Paul

Sure. Thanks for the question. We absolutely are seeing that rebound. I think in January there were a number of cases, you know, we had some of our own reps that had COVID and weren't able to go in the field, but also the reps that were able to go in the field, many times doctor's offices weren't open. You know, they would only open for limited hours or certain days a week because they just didn't have the staff to keep the office open.

speaker
Nathan

And we're seeing a very different picture in February. Things are starting to rebound fairly quickly.

speaker
spk15

Great. Thanks again.

speaker
Operator

So again, for questions, it's the one followed by the four on your keypad. Next question is from Jack Meehan with Nefron Research. Please go ahead.

speaker
Jack Meehan

Thank you, and good afternoon. I wanted to start with Brian, just with the guidance here. You talked about some of the headwinds to start the quarter. Can you just tell us within the revenue guidance of 670 to 700 million you laid out, like, what's an appropriate landing spot for the first quarter?

speaker
Paul

Yeah, Jack, we didn't give guidance for the first quarter. We just talked about how we see the profile for the year in terms of the impact in Q1 from COVID and then the PAMA offset sort of being spread over the remainder of the year and then the acceleration of some of the commercial strategies, you know, through the back half of the year. So we just gave qualitative guidance relative to the quarterly profile.

speaker
Kevin

Yeah, and well, I think it's pretty straightforward, Jack. I mean, you know, we have a hit in the first quarter for COVID. And then we have a good guy in terms of PAMA that will be spread out over the course of the year. And as I said, we've got a significant number of initiatives that are rolling out this quarter. To some extent, it's worked out well because our sales force has been locked down, so we've been able to do some sales training. But really look to the back half of the year as you think about your modeling your quarters where you should see an acceleration. And, again, I just want to underscore – To try to simplify this, if you look at our fourth quarter and you adjust it, which usually is a seasonally strong quarter and adjust it for COVID, but net the divestiture so it's a clean quarter, it's a great way to gain confidence in our guidance for 22 because it's modest growth levers on the revenue side. And we've tried to help investors by giving you each component piece from revenue to gross margins to OPEX to EPS. modeling from that fourth quarter. And so, you know, again, we're trying to do everything we can to help everyone and their models. And from an operator standpoint, I thought using the Q4 baseline should increase everybody's confidence that our numbers are achievable in our guidance.

speaker
Jack

Mm-hmm.

speaker
Jack Meehan

Yeah, typically 4Q, like you mentioned, seasonally strong, and then 1Q seasonally weak, but you also have this COVID dynamic you know, kind of a play. So I was going to model, you know, my model now has it flat sequentially. Do you think those things balance out or do you think it should be down?

speaker
Kevin

We're trying to be helpful, but that's as much color as we, as we can give you. And I think the underscore is the confidence in the annual number has not diminished at all. And even with the COVID hit, I guess that that's the bottom line.

speaker
Jack Meehan

I guess, Speaking of the annual number, what's your forecast for hereditary cancer testing within the overall guidance?

speaker
Kevin

We don't break out guidance. I think we give you folks a lot more details around each of our product lines and our competitors certainly, but we don't give guidance on a product-by-product basis. As Nicole spoke to and I've spoken to over the last couple of quarters, we continue to work on a turnaround in our women's health business. And for those unaffected women, they've been particularly resistant and hesitant to go in the office for doing screening. But the initiatives we're rolling out this quarter, we really think we'll see a nice rebound in hereditary cancer volumes in the rest of the year. And our pilots and modeling around that that we've seen from the pilots of some of these products, some of these initiatives, reinforce our view that we can continue to see stabilizing moderate growth in volumes. And as you've seen the last couple of quarters, very stable ASP.

speaker
Jack Meehan

Okay. Last question, you know, you've talked about the cash balance and I think you've accrued 62 million related to the legal liabilities. Just what's the timing you expect to pay that out and where do you expect the end, maybe to end the year in terms of cash on hand?

speaker
Paul

Yeah, Jack, I mean, I would just say relative to the timing, it's somewhat dependent on, you know, when related to the key TAM, there are certain things that have to happen prior to the payment. So I don't know that I can provide a specific time, but I would just say probably it's likely in the first half of the year. And then we didn't give guidance for the full year cash balance. But, you know, we've made some adjustments to our EPS sort of over the course of the years in terms of breaking out stock comp and tangible amortization. that make it a pretty good proxy for cash. And the fact that we're guiding zero to 20 cents, I wouldn't expect any sort of significant cash burn in the year.

speaker
Kevin

No, I think that we're going to have most of the powder we talked about to invest in strategic initiatives going into 23 to the extent we don't deploy that capital in the back half of this year. And we're more actively starting to look at those kinds of opportunities through partnerships and M&A and And as I said, our five-year plan really calls for us self-financing our growth initiatives and leaving capital for M&A. So we feel like we're in a really good spot in a market where changes are happening that give us some opportunities.

speaker
spk14

Thank you, guys. Thanks, Josh.

speaker
Operator

So again, for questions, it's the one followed by the four on your keypad. Next question is from , with BTIG, and your line's open.

speaker
spk08

Hi, thanks for taking the questions. For the first gene test that's expected to launch next year, what's the barrier to, you know, replicating that for your competitors? Are there proprietary aspects to the technology, or is the differentiation really the first mover advantage?

speaker
Kevin

No, there's actually one competitor out there that is working on a similar kind of product. I think what's been lost a little bit is the accuracy of and the ability for us to scale the product when you look at the automated lab of the future in South San Francisco and the robots that we have there, plus the amplified technology and the sequencing that we do there. So we just think it's, like most products, we should always be looking over our shoulders. There's going to be a lot of competition, a lot of innovation. We're striving here to have a differentiated product and a differentiated customer experience with one simple maternal blood draw. And that's where we think we can really hold our own and grow our women's health business and expand into other product lines.

speaker
spk08

Gotcha. And then for the improving ASP across all your product lines, obviously great to see that. Do you think that's sustainable throughout 2022 or are there potential other puts and takes that we should take into consideration?

speaker
Paul

Yeah, I would say, you know, I've said consistently, I think there's an element of some of our out of period that has some carryover effect. In other words, it leads to an overall stability and improvement in your ASP. When we look at hereditary cancer as an example, year over year, excluding out of period, it was positive 3% in the quarter. You know, I think that you're going to continue to see us focus on ways to make sure that, you know, we get paid for the testing that we run. And so I think as we see, you know, pressure on contracted rates over time, you know, our goal will be to offset that with better collection capability and a better experience for our patients and customers.

speaker
spk08

Gotcha. Great. Thank you for taking the questions.

speaker
Operator

Thank you. Next question is from Matt Sykes with Goldman Sachs. And your line's open.

speaker
Matt Sykes

Hey, guys. This is Dave on from Matt. Thanks for the question. Really excited to hear about your ambition to enter MRD and Liquid and your internal capabilities there and potential for partnerships. Any thoughts on what indications could be best fit for Myriad to go in for your first product in the space?

speaker
Kevin

Yeah, I think we're going to pretty much stay close to home in the areas where You know, we're already good at breast, ovarian, prostate, pancreatic. And similarly, as we think about companion diagnostic expansion, you know, these are areas and channels that we know well where we have relationships where, you know, everything from the labs to production to reimbursement, and there's plenty of market opportunity there. So, yeah. We don't need to capture $5 billion. A billion would be fine. So we have what we think are actionable, total addressable markets that we're focusing on.

speaker
Matt Sykes

Great. That makes sense. And then on first, Gene, can you tell us more about the value proposition of combining those two tests? And is there any way you could quantify how much you expect that to drive revenue growth?

speaker
Paul

Sure. So a little bit about a customer experience with First Gene. I think, you know, right now you have patients that come in for carrier screening. Often women are not screened, so they're doing the carrier screen at the same time as they're doing their non-invasive prenatal screen. And if something comes up positive on the mother's carrier screen, we've got to track down the father. They've got to come in for a blood draw. They've got to see what their results are. Are they carriers for the same thing? you know, and then we're trying to decide, do we do an invasive procedure to diagnosis? It's a very long timeline, and it causes a lot of anxiety for families, and so this is an opportunity to combine that, that you go in for one single blood draw, and around the same time, you would go in for your non-invasive prenatal screen, and we would be able to get all of those answers at once, and you're done. You don't have to, you know, you don't have to track down additional patients. You don't have to wait for the results, it's a much cleaner experience for these expectant mothers and for these families. In terms of the revenue lift that we would expect from First Gene, I don't think that we've given any guidance on that yet.

speaker
Kevin

No, but our base case there, and this is net of some patients that would otherwise have chosen prequel or foresight, is about a 10% to 15% lift once we get to full deployment, I think is what is in our business case model roughly. So it's it's a substantial opportunity for us to grow market share. And I think there's upside to there, but that's sort of our modest case based on the business, the bottom-up business case we developed.

speaker
spk15

Thanks, guys.

speaker
spk14

Thank you.

speaker
Operator

Next question is from Derek Dabroon with the Bank of America. Please go ahead.

speaker
spk13

Hi, Derek. Hey guys, this is Nisar gone for Derek. Thanks for the question. So to start on the precise tumor combo test launch, can you talk us through when you expect material sales from the launch? How should we think about differentiating factors? You know, it's a pretty competitive environment here.

speaker
Paul

It is. It is a very competitive environment. And I think what is different about our offering is that it combines You know, all of these tests into one. So for a busy practicing oncologist to have to track down a tumor specimen that they're going to send to us for my choice for the FDA approved companion diagnostic. And then also they want to get a broader panel. So they're sending out to another lab. then at some point they want germline, and there really isn't anyone in the market that is able to offer all three, whereas the oncologist can package up the tumor and the blood in one box, send them to one laboratory, and get one comprehensive result. The other difficult thing for these physicians is they get a result back from three different laboratories, and they may differ. The BRCA test you may get in a tumor versus a germline test. may differ and how should they be thinking about that, right? It really leaves the physician in a quandary to use their own judgment to figure out how to synchronize these different test results and go forward and treat their patient. This is a different offering and that Myriad does that for them. Myriad is able to put together with our team of scientists, what do all of these things mean together? I think that we have a clear advantage in something like ovarian cancer, where we have an FDA-approved companion diagnostic, and we're really a leader in hereditary cancer testing and have been for many, many years in that indication. So that's a place where we feel like we have a real clear right to win, and we offer a different experience to what any other given competitor might be able to offer.

speaker
Kevin

Yeah, and it's early, but the pilot exceeded expectations so far. and in a number of the anecdotal things coming out of the pilot, people switched over from some of those competitors that you referenced because of the ease of use, because all three tests, they want them. Our survey work that we did with Bain before we went down this path was that 80% of oncologists wanted all three tests, but what they also wanted one set of interpretations so they can go treat. And, you know, that's the linchpin of what we're trying to do here is bring relevant science in the hands of physicians that is more easily actionable and can be integrated into care plans in a much more seamless way. And this offering goes right to that. And with an 82% attachment rate, we think this really can lift all the boats, particularly going into the back half of the year and helping hereditary cancer and these other products as well.

speaker
spk13

Great. Thank you. And then another one on genetic testing for MRD liquid biopsy. Again, it's a pretty competitive environment. What's your, as an approach to securing share here, like what's kind of the key focus for those tests?

speaker
Kevin

Well, it's a, it's a big market. It's highly competitive, but we've had, you know, a 25 year history in oncology and very well-established relationships and brand and reputation. You know, the unified order portal allows people to do business with us a lot easier. And so, you know, again, we're conscious of competitive factors. And as we think about the total addressable market that often our competitors talk about, our focus is on what's the actionable market. And in the portion of that actionable market, we think we can win more than our fair share. And so we think this can be a real contributor to getting us to the high end of that growth range and beyond.

speaker
spk14

Great, thank you.

speaker
Kevin

Thank you.

speaker
Operator

Next question is from Tycho Peterson with JP Morgan, and your line's open.

speaker
Kevin

Hi, Tycho.

speaker
Eric Sintz

Hi, this is Rachel. Hey, this is Rachel. I'm for Tycho. Thanks for taking the questions, you guys. So we've talked a lot about oncology here, so maybe I'll ask a few on GeneSight. Your long-term guidance assumes 4% to 5% contribution from mental health. So can you just walk us through how you arrived at that number? Is there anything included from expansion into other tests like Alzheimer's or neuro that you mentioned today? And then how much of that growth includes deeper penetration in gene site in primary care channel versus private payer adoption?

speaker
Kevin

Well, there's sort of one and the same, but We continue to see just great momentum in GeneSight, which has been enabled by the commercial and technological capabilities that Nicole spoke to. 95% of the doctors are ordering online, 30% growing our home-based kits. This is where healthcare is being provided today. And we are, and Eric Sintz is working really hard on expanding our telehealth partnerships. So when we talk about consumer engagement, which is different than a consumer ordering the test. Let me just underscore that. If a consumer comes to our website because their family member is struggling with depression or anxiety and they're drawn to what we do, if they don't have a physician, we can link them to a physician who can then order the test. And then at that point, make determinations about what the appropriate drug use. But this is such an important issue in the context of mental health today. and the challenges we have in workforce and productivity. I don't know anybody on this call or in this room that hasn't struggled or somebody in their family hasn't struggled with anxiety and depression. And so when we see 2,900 new ordering physicians, that's because people are coming into their office and they're struggling. And they're struggling with, you know, trying four or five meds. And we said we had a new clinical study put out last night that I think further the bodies of evidence. We have a VA study that should come out later this year. Again, that's an important constituency that we think GeneSight could help. So, you know, a 20% plus growth rate, which is I think how you get to the math to its component, is really what we are seeing and expecting. And I'll tell you, while other parts of the business are slow to bounce back, as of yesterday, GeneSight was at 110% of target going into the week. So, you know, it is continuing to perform well.

speaker
Eric Sintz

Great. And then a follow-up to that. So on private payer coverage, can you just talk about how the private payer conversations are going for GeneSight? And do you expect any coverage decisions this year? And then as a follow-up to that, can you just talk about how you're leveraging value-based agreements as well for GeneSight?

speaker
Kevin

Yeah, we've talked about this in the last several calls. I wouldn't expect some big announcement that moves the needle, quite frankly. It's more of a ground game, including Medicaid managed care plans, where we have some really good active discussion, as you mentioned, some value-based arrangements. But both on building a broader clinical body of evidence, there's a whole team continuing to work on that. And we've got quite a strategic work going on in expanding more broadly the payer coverage, including in Medicaid and the Medicare Advantage plans. So, again, we've got a couple of smaller contracts that we just recently signed, and it's something that obviously the group is attentive to. But our growth plan is not predicated on some big expansion of coverage. So I just want to underscore that. It's continuing to win the hearts and minds of patients. and nurse practitioners that are dealing with the mental health issues.

speaker
Eric Sintz

Great. That's it for me. Thank you.

speaker
Kevin

Awesome. Thanks.

speaker
Operator

Nothing further from the phone. I'll turn it back to the presenters.

speaker
Nathan Smith

All right. 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.

speaker
Kevin

Thanks, everybody.

speaker
Operator

And that does conclude our call for today, and we thank everyone for participating, and you can now disconnect.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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