Greetings, and welcome to the Myriad Genetics Second Quarter 2022 Financial Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded today, Thursday, August 4, 2022. I would now like to turn the conference over to Foster Harris. Please go ahead.

Thank you. Good afternoon, and welcome to the Myriad Genetics' Second Quarter 2022 Earnings Call. On the call, we will review the financial results we released today and afterwards, we'll host a Q&A session. Our quarterly earnings release was issued this morning on Form 8-K and can be found on our website at investor.myriad.com. I'm Foster Harris, Senior Associate of Investor Relations. On the call with me today are Paul Diaz, our President and Chief Executive Officer; Bryan Riggsbee, our Chief Financial Officer; and Nicole Lambert, our Chief Operating Officer. This call can be heard live via webcast at investor.myriad.com, and a recording will be archived in the Investors section of our website, along with this slide presentation. Please note that some of the information presented today 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 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 forward-looking statements. With that, I will now turn the call over to Paul.

Thank you, Foster. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss our Q2 results, along with highlights from the quarter and updates on our strategic transformation and growth plan. First, I want to thank all of our teammates for their hard work and dedication this quarter 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. I also want to thank our health care provider partners and their patients for their continued trust and confidence in us. And as '22 remains an exciting year for Myriad Genetics, we continue to build a foundation for accelerated growth and advancing our mission of improving health and well-being for all. We are pleased with the progress we made in the second quarter of 2022. After excluding divested businesses, quarterly revenues of $179.3 million increased 7% year-over-year and 9% for the 6 months ended June 30, 2022, in line with our long-term revenue guidance. Diagnostic test volumes of 260,000 increased 9% year-over-year, demonstrating strong continued growth in our core business. Average revenue per test in the quarter decreased 2% year-over-year, excluding divested businesses, primarily due to shifts in our product mix as compared to the second quarter of last year. Despite ongoing COVID disruptions and significant inflationary pressure in the quarter, our team did a great job from an operation standpoint. GeneSight, Prolaris and myChoice CDx saw their highest quarterly volumes ever this quarter. And our Hereditary Cancer business is beginning to stabilize. And our prenatal business saw a healthy growth in the quarter, with potential opportunities in the near future to increase market share. Adjusted gross margins improved 30 basis points…

Thank you, Paul. I'd like to start with our core business unit performances, beginning with our Mental Health business unit. Mental health continues to have a lasting effect on patients and their families in the U.S., as those suffering failed to receive proper medical treatment for a variety of reasons. Trial and error are common when determining the most effective medications to treat depression, anxiety, ADHD and other mental illnesses. Recently, the Journal of American Medical Association published results of our PRIME Care study, the largest pharmacogenomics randomized controlled trial ever conducted in mental health. The study, funded and conducted by the U.S. Department of Veterans Affairs, achieved both of its co-primary endpoints and found that major depressive disorder remission rates were significantly improved when clinicians had access to GeneSight Psychotropic test results. The PRIME Care study further reinforces the body of evidence supporting the clinical utility of pharmacogenomic testing and the GeneSight test as important tools for medication selection in the treatment of major depressive disorder and other mental illnesses. Driven by GeneSight, our Mental Health business reported $33.1 million in revenue for the second quarter of 2022, an increase of 46% year-over-year. Reported test volumes were roughly 95,000, our highest quarterly volume for GeneSight ever. We believe that the performance of GeneSight this quarter demonstrates the effectiveness of our new commercial capabilities, digital marketing strategies and patient-centric engagement initiatives implemented over the past year. Our GeneSight test helps physicians better understand how antidepressants and other drugs will affect their patients with just a single cheek swab sample that can be taken in the privacy of their own home. In the quarter, approximately 99% of total GeneSight orders were made through our Unified Ordering Portal. We are excited about the continued success of GeneSight and new initiatives that are…

Thank you, Nicole. I would like to start by reviewing our revenue by product. Total revenue in the second quarter of 2022 was $179.3 million, an increase of 7% year-over-year and 9% sequentially after excluding divested businesses. Total revenue was adversely impacted by approximately $2 million in the quarter and $3 million year-to-date, as a result of foreign exchange rate differences compared to rates during 2021, which represents a headwind of approximately 100 basis points to these growth rates. Hereditary Cancer revenue in the second quarter was $79.4 million, a decrease of 8% compared to the second quarter of last year, with quarterly volumes decreasing 4% year-over-year. This compared to the first quarter of 2022 when Hereditary Cancer quarterly revenue decreased 7% year-over-year and quarterly volumes decreased 12% year-over-year, shows relative stabilization in our hereditary cancer testing business. Further evidence of this can be seen in our sequential growth of 12% in Q2 compared to last quarter, with sequential volume growth at 7%. Prenatal revenue in the quarter increased 13% year-over-year and 4% sequentially, with ASP increasing approximately 17% as compared to the prior year. Improvements in ASP reflect the benefit of investments made in our revenue cycle management plan and the incredible performance of our revenue cycle team. In Oncology, tumor profiling revenue increased 11% compared to the same period in the prior year and increased 3% sequentially. Contributing to that growth, both Prolaris and myChoice CDx exited the second quarter with their highest reported quarterly volume levels to date. Pharmacogenomic testing and Mental Health delivered first quarter revenue of $33.1 million, an increase of 46% year-over-year and 13% sequentially. GeneSight volumes in the second quarter of approximately 95,000 set the record for the test's highest quarterly volumes. We are updating our fiscal year 2022 financial guidance. While we…

Thanks, Bryan. We are pleased with the progress we made this quarter in a tough operating environment. Lastly, we'd like to reiterate that we will be hosting an Investor Day next week on August 11, to give an update on the company's progress on our new commercial strategy, our plans for the labs of the future, our new technology tools and our research and development product pipeline. We know our sector is facing significant market pressure and that some of our competitors are struggling to deploy financially sustainable value proposition and growth model. While our transformation is still underway, I'd like to emphasize that our scientific, technological and commercial platforms are built on a sustainable and solid financial foundation. We are continuing to take concrete steps to make our platform scalable, including investments in technology, marketing capabilities and remote selling. And we are excited to bring new products like FirstGene, Precise Liquid and MRD to market on our platform over the next few years. We are confident that this sets Myriad apart from its peers and puts the company on a trajectory for innovation, growth and shareholder value creation. As mentioned on the call today, we will be hosting an Investor Day next week in New York City on August 11 at the NASDAQ market site, with presentations taking place from 10:00 a.m. to 12:00 p.m. Eastern. We are excited to have our speakers, including Dale Muzzey, our Chief Science Officer, to speak about our upcoming product launches and enhancements. Kevin Hass, our Chief Technology Officer, will speak about the technology enablement and other projects we have been working on. Nicole Lambert, our Chief Operating Officer, will speak about our new Lab of the Future and our more customer-focused operations. And Mark Verratti, our Chief Commercial Officer, will talk about replicating our commercial success with GeneSight across the rest of the business. Bryan Riggsbee, our Chief Financial Officer, will give more color and transparency into our financial performance and our short-term and long-term guidance. All of these things and much more to come next week, and we look forward to seeing you all there. Finally, our focus and goal will continue to be to accelerate growth through the remainder of this year going into 2023, as we also invest for the future, elevate our products to their full potential and introduce new innovative offerings. We look forward to a bright future ahead for Myriad Genetics as we continue to work to better serve our patients and customers and deliver sustainable growth and profitability for our shareholders. I'll now turn it back to Foster for the Q&A.

Thanks, Paul. 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 financial guidance can be found under the Investor Relations section of our website. Now we're ready to begin our Q&A session. [Operator Instructions]. Operator, we are now ready for our Q&A.

[Operator Instructions]. And the first question is from the line of Dan Brennan.

This is Kyle on for Dan. How's it going? I want to start with GeneSight, if we could. Could you provide any more color on what your expectations are for the impact of the PRIME study on GeneSight volumes? And maybe attached to that, what percentage of the addressable GeneSight opportunity today isn't really accessible now due to reimbursement limitations?

Well, we think the PRIME study was a very positive development, particularly given it was published in JAMA in a very highly respected piece. The initial feedback has been quite positive. As we said at the time of the announcement, we think that this really enables us to sustain the trajectory of the growth as we look to expand coverage and get more adopters both on the health care practitioner and psychiatric side. One physician we talked to sort of said it best. We think that the treatments that we do to reduce symptoms, where speed of recovery are measured in days, and GeneSight helps to do that measured in weeks and months. And so that's really what this is all about is improving access is something that helps get patients on the right medication to reduce their symptoms and get people back to productive lives. So we've seen great adoption. And again, while it's early innings, most of the feedback we've gotten is pretty positive from the clinician and health care practitioner community.

Great. And then just on the OpEx side, you raised total OpEx guidance for 2022. Can you just -- what exactly are you seeing is the best opportunity in the market for opportunistic investments? And what could this mean for the growth trajectory over sort of the next 12 to 18 months?

Yes. Thanks, Kyle. I think in terms of the operating expense investments that we've made and plan to make going forward, I think -- we believe there's been, as you've seen, quite a bit of disruption in the marketplace. And as we noted in our commentary, we believe there's the opportunity to retake market share and really position the business for growth in 2023 and beyond. And so as we look at things like sales and marketing, investments in technology, those are the incremental things that are -- I think, are going to really support growth in the coming period. And we just felt like now is a great time and a great opportunity to put a little capital behind that in order to really drive growth in the upcoming year.

Yes. And I'll just add, we began to make those investments this quarter, first, because we saw that we were getting traction on these investments, and the marketplace was reacting well to them. As we'll speak more -- in more detail at our Investor Day, these are still large, underpenetrated markets. But what we also feel is that the competitive landscape has been leveled, at the same time that we've been improving the quality of our products, expanding genes from myRisk and improving the ease of use. So we've been on a path the last 18 months to, quite frankly, manage costs better so we can reinvest in growth. And this is just a continuation of that, but an acceleration of some of the commercial investments that we've made in GeneSight that we think will prove successful in our other businesses, and to get behind the launch of Precise Liquid and accelerate the potential launch, hopefully next year, of MRD for research and that quickly to be followed with MRD for commercial use. So we're pretty bullish. And ultimately, we hope that this pushes us to the high end of our long-term growth range of 9% to 12% to 12% and beyond.

And the next question comes from the line of Derik De Bruin with Bank of America.

This is [indiscernible] for Derik. I wanted to start -- to start off, so 2 straight quarters of sales beats, you guys reiterated the guidance here again on the top line. Are you expecting some sort of headwinds in the back half here? Or is it just the kind of seasonality again?

I mean third quarter is always seasonally slow. And we continue to see the ups and downs of COVID in terms of restrictions in offices. We're getting better, just like everybody, on adjusting to what is the new normal. Again, the rollout of our digital tools and portals. We'll be rolling out the portal for Women's Health in the third quarter. All of that won't materialize in terms of use as we train people into the fourth quarter. These are all the things to sort of try to take that volatility out of access in terms of physician offices. But again, this is the final year of our transformation of putting these capabilities in place. And this summer, we're retraining sales forces and redeploying our efforts. And so it's really about -- as Bryan talked about, really picking up steam in the fourth quarter, which is usually our strongest, going into 2023 and '24, where we expect, again, to drive growth to the higher end of our long-term guidance.

Got it. That makes sense. And then just one more quick one. Were there any benefits from catch-up payments in the quarter?

Yes, that was in our slide deck. It was $11.7 million in the quarter, and that compared with $13.3 million in the prior year same quarter. So it was down, and then it was down from the first quarter as well, where I think we had $12.4 million.

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

So on GeneSight and the PRIME Care study, I know you guys are excited about the results, but some of the leading KOLs have voiced their opinion, which is given the lack of blinding, the remission benefit may have been driven entirely by the placebo effect. I'd be curious to get your take or response to that.

We disagree with you, Jack, on that point. And we'll be in a position to spend a lot more time at that at our Investor Day next week. That is not how the folks that we've been talking to have responded to that, and be happy to get into that in more detail next week. But we met the 2 primary endpoints. And we think it's just part of an increasing body of evidence to support GeneSight and the clinical utility. And most importantly, clinicians are embracing GeneSight because it's helping manage patients. It's helping reduce medication errors. It's getting people on the right treatment. And so we're continuing to do more clinical validation work, both retrospective tests and future tests. But we think this result of an independent 2,000-person, VA-led, unfunded-by-us study is incredibly supportive of the GeneSight value proposition. And the general response has been quite positive. Again, happy to get into it in more detail with our scientific crew next week at our Investor Day.

Looking forward to it. And then on Hereditary Cancer testing, I was curious to get your thoughts on the Medicare coding. So it looks like there might be some transition that's going to take place. Could you just walk us through the timing on that and within guidance, what you're assuming in terms of a potential financial impact?

Yes. And Jack, well, I think, first of all, the transition -- the coding transition is sort of been well known. I mean that process started last year. And so we had built that into our guidance for the current year. And I think it's something that's been well known by us. The other thing that I think is important from us to note is that over time, a lot of the ordering clinicians have moved to the CDx test, which is unaffected. So there is no -- that will still utilize the same coding as the same 81162 code. So again, it's contemplated -- it was contemplated in our guidance at the beginning of the year and still is contemplated.

Jack, that's the same question, the same answer we gave you last time you asked. So I'm not sure if you're expecting a different answer.

Well, the announcement only came out at the end of May. So this is fairly new. Do you know when it goes effective with Noridian for Utah?

I'll have to get the specific date for you on that, Jack.

We'll follow up at our Investor Day with that specific question, Jack.

And there are no further questions at this time.

Well, great. We want to thank you guys all for participating today. And again, we are really pleased about the progress in the quarter. We are still in our transformation journey and are excited about the continued progress, hopefully, in the back half of this year and mostly the trajectory going into '23. So thank you all for your time today, and we look forward to seeing many of you at our Investor Day next week. Foster?

And lastly, a replay of this call will be available via webcast on our website for 1 week following the call. Thank you.

Thank you.

Thanks, everyone.

That does conclude today's conference. We thank you for your participation and ask that you please disconnect your line.