Myriad Genetics, Inc. (MYGN) Earnings Call Transcript & Summary
May 9, 2023
Earnings Call Speaker Segments
Derik De Bruin
analystGood afternoon, everyone. I'm Derik De Bruin, the senior life sciences and diagnostics analyst here at Bank of America. Welcome to our 2023 Healthcare Conference and coming to you live from the Encore here in fabulous Las Vegas. It's my great pleasure to welcome Myriad Genetics and Paul Diaz, President and CEO of the company. Paul, thank you for being here.
Paul Diaz
executiveThank you, Derik. Appreciate the opportunity.
Derik De Bruin
analystSo I have a long history with Myriad. I have covered their stock in some form since 2001.
Paul Diaz
executiveWe're quite a different organization these days.
Derik De Bruin
analystSo -- and when you joined this company a few years ago, you initiated a very significant transformation. You started to see some good momentum in the last couple of quarters, particularly in hereditary cancer testing. I mean I watched that business evolve over the years, prenatal. So let's start our discussion there. In hereditary cancer testing, you're seeing really good growth the last couple of quarters in both Women's Health and Oncology businesses. Let's talk about some of the key drivers and sort of like what's changed in that business.
Paul Diaz
executiveYes. It's -- things never move as quickly as you would hope, but I do think that we're getting really great traction with customers and what always has been sort of the market-leading product. And I think we've refined our go-to-market. We've improved our relationships with important influencer communities like genetic counselors. And we've really focused on ease of use, which was really one of the things that as we studied what was not happening and why we were losing share, it wasn't the quality of MyRisk. It was the experience that our customers were having. And we've talked about those changes and those experiences as really the lead driver. I think what continues to excite me, and I think there's some misperceptions in the marketplace is still the lack of penetration here, whether it's on the oncology side for affected patients, there's 300,000 to 500,000 eligible patients not receiving hereditary cancer testing; on the unaffected side in multiple channels, whether it's imaging through our partnership with SimonMed or Women's Health, there's close to 600,000, 800,000, what we look at as, actionable patients that need guidelines and should receive hereditary cancer testing. So we think it's been great to see that turnaround start happening in the third quarter. I think our best days are still ahead of us. It's a high-margin product. We've got good rates and good coverage and definitely can fuel growth over the next few years.
Derik De Bruin
analystSo what has prevented penetration, sort of like, growth in that market? I mean is it just something that you've got to age out some of the physicians that thought about it? I mean I go back and thinking about when I was in grad school and we lived with all the medical students, I mean they have like a week of genetics. Right? And this is in mid-90s. Right? And so...
Paul Diaz
executiveSo I'm on the Board of Johns Hopkins Medicine and Chair Johns Hopkins health plans. And I can tell you that even in that institution, adoption rates are slower than we think. It's 7 years for adoption for best practices clinically. So I really do think and one of the things that drew me to Myriad Genetics is the great foundation of science and quality of products is that they were at the early stages, really here of the opportunity for patients for adoption. And I think that you're seeing, coming out of the pandemic, let's not forget how distracting that's been for the last 3 years, people really starting to focus on preventative care, screening. We saw yesterday an announcement of lowering guidelines to 40 for breast cancer screening. So -- and that's on the heels of other announcements along those lines. So I do think that the next few years, you're going to see younger doctors and organized physician groups really start thinking about this differently. And those are channels that I think we're only just starting to tap into, whether it's urology or imaging and other areas.
Derik De Bruin
analystSo I think I mentioned this before on one of your calls, but I think I never understood why Myriad would not cooperate with ClinVar. And it just didn't make any sense to me, given how irritated you made the clinical geneticists on this one. So can we talk a little about that decision? And also, it's just like, are we done with sort of like the debate about whose database is bigger and better and the business about service?
Paul Diaz
executiveWell, I think that the profession of oncologists and genetic counselors want and rightly expect us all to get better and more transparent with data. I'm only frustrated that it took me so long to overcome internal forces. I mean this company really hurt itself by focusing on price, not service and focusing on IP as opposed to innovation. And that's what we've been focused on. Now the challenging part a little bit is that that's required some investment, I think modest investments across our organization. And as I've talked about, those investments are fully baked in, in terms of our opportunities. And so we have a high degree of confidence that we can grow organically our current products over the next few years at 10-plus-percent, which is what we've shown in these last 2 quarters and the drop-down in our P&L as we manage our OpEx and maintain our 70% gross margins will be pretty compelling for investors.
Derik De Bruin
analystAnd has pricing stabilized? I mean I know you had one competitor that was a little bit irrational in pricing.
Paul Diaz
executiveYes. Well, I came into the industry not really understanding the logic of giving away tests for free to get market share. But if you're a physician and ease of use is that your patients don't have to worry about deductibles and don't have to worry about payments, that's a friction you don't need. So we've tried to solve that to that in more thoughtful ways and ways to not disrupt coverage. So adding more financial systems programs, adding a direct pay option for people to high deductible plans, improving the transparency at the point of care. And as you said, really have focused on the customer, and I would say that, that's been the #1 thing that we've done here is really put the patient and the customers first, and it may seem trite, but it's working and it works and it matters.
Derik De Bruin
analystWhich putting the customer first, it's a great segue into prenatal. So what happened in that market? I mean, you've had regulation in California, you've had changes in the competitive landscape, you've launched new products. Can we just sort of have an overview of that business? 1Q prenatal was up 13%, volumes up 77%, but 12% excluding the SneakPeek. Can we sort of talk about the dynamics going on in the business [indiscernible] introduction?
Paul Diaz
executiveYes, if you recall, last year, when we were here, we talked about leadership changes, turnover of 37% in the sales force in the Women's Health team. And so it was -- it has been quite a year of change there, and we're now just putting some of the technology solutions in place there, our portal. But turnover is down to 8%. So now we have an engaged sales force, good leadership. Prequel Amplify is by far the best product out there in terms of NIPS testing. We have some opportunity to expand the gene panel for Foresight. And as you said, the competitive landscape has been choppy and that's given us an opportunity, as we talked about in the call. We've been winning share and you started to see some of that in the quarter. I think more of that is in front of us here in that the new customers aren't fully onboarded yet. And again, our customer retention and new customer adds are growing even as I was looking at the April numbers. So our momentum in Women's Health, we're quite excited about. The other thing that Bryan and the team deserve a shout out to is that we're making money in our Women's Health prenatal business, having improved the ASP there by $120 per test, right? So we're trying to focus on the unit economics across all our product lines and both in terms of driving double-digit growth, but making sure that we can make a fair margin across our product lines, too.
Derik De Bruin
analystIs there any sort of like concern on the regulatory environment in prenatal? I know there have been some issues.
Paul Diaz
executiveI think that the concerns raised by the New York Times article are pretty much behind us. We certainly didn't fall into that category. You have to opt in for microdeletions for Prequel, we've always taken a more conservative route on giving the providers what they felt they needed, not what we felt they needed. And now I think that we do expect to see guidelines expansion for carrier screening. And there are a few genes in the panel for Foresight that we need to add for the genes that we think are going to be in those expanded panels. And so we're excited about growing that, particularly given the dislocation that we've seen from some of the other competitors here.
Derik De Bruin
analystAnd remind me on the sort of the patent landscape. Are you paying royalties to Illumina and some of these other companies that are sort of doing these, I think Sequenom is one. And do those roll off? So once again the question on, can you get the business more profitable with some of these things?
Paul Diaz
executiveYes, it's like $50 is the royalty among a few organizations. And I think it's more about continued penetration and coverage in terms of driving EPS there. I don't really see a great deal of regulatory issue. And the California challenge, I fully expect that, hopefully, over the next 12 months, we'll be back in the program. And that certainly caused disruption in what I've said is about 8% of our total prenatal book. So it didn't slow us down any in this quarter with the 12% growth. And we're excited about SneakPeek and the attachment rate there as well, and 60% of the SneakPeek customers go on to get NIPS testing. So we're starting to work on that cross-sell as we speak.
Derik De Bruin
analystGot it. Let's move on to GeneSight. Clearly, a need for better targeting for drug-related depression, but I think there still is some controversy around GeneSight so let's talk about the controversy.
Paul Diaz
executiveYes. That seems to be a really dated story.
Derik De Bruin
analystYes. Well, I was going to say, is the PRIME Care study that you did with the VA enough to sort of get the payers over the hump? And so it's basically -- it's sort of like where we are in the -- there was -- you had United update and then nothing. Well, not really nothing, but then the other big players really...
Paul Diaz
executiveNo, no. Advancing medical policy is always a tough chore. The PRIME study has helped a great deal. Having our own specific codes is helping a great deal. And we expect to be able to announce some additional coverage determinations here in the next few months. But I also think that there is some view overhang from back in 2018 about the FDA and safety issues and currently there's nothing to that. I mean the FDA issued a paper on marketing practices for pharmacogenomic companies. There was never any GeneSight-specific concerns. So there's -- we're in Las Vegas. There is some hangover out there about the clinical validation for GeneSight, but 4,000 providers last quarter said they need a GeneSight to care for their patients. And that's been a recurring theme. And so I think the demand transparency around coding, the PRIME study, the conversations we're having, are all moving forward. And we've had a little bit of noise this quarter in terms of some of the transitions to those new codes, which we talked about on the call. I think those are going to already starting to work themselves through. So we fully expect to continue to grow GeneSight and to see ASP stabilize and grow there over the course of the year.
Derik De Bruin
analystGot it. Oncology, so Prolaris doing well, double-digit growth, sort of some additional color on your prostate cancer test and the growth there. And also since Exact got rid of their Genomic Health prostate test, do you see any sort of like benefits from that?
Paul Diaz
executiveI haven't heard anything directly there, Derik. We match up against one of our other esteemed competitors. And the market is only 25% penetrated. So here, again, is like hereditary cancer, there's a lot of white space to grow. We grew 16% in Q4, 22% this quarter. We've got great coverage there, and it's a high-margin product. And like we're trying to do in the rest of our Oncology business, there's a great demand for many urologists to also order myChoice and our hereditary cancer testing. So the attachment rate is pretty high. We launched what we call the UroSuite of services in the urology channel and we're starting to see some of that happening. So when we think about our oncology products and we think about the different channels, the opportunity to leverage the FDA-approved HRD myChoice and the best hereditary cancer product out there MyRisk along with the Prolaris is pretty powerful across these different channels.
Derik De Bruin
analystSo maybe you can talk about some of your expansions into therapy selection and MRD and some of those initiatives and where you're going with that? And I guess what is differentiated about your approach because it's very -- there's a lot of people that are sort of going after that? I mean you've got a great channel. Is that your major franchise?
Paul Diaz
executiveI think that sensitivity and accuracy based on the analytical validation work we've done already is as high if not higher than anybody and we've shared some of that at a prior one of your competitors' conference. We'll be announcing clinical validation studies with an academic medical center here shortly. But all the samples that we're running right now, we think we're going to have a highly sensitive accurate test that's tumor informed. The other 2 things that I would point to why we are excited to be a fast follower, let's say, in MRD is that we can stand this up in our labs today with the technologies we have with Prequel and myChoice. So operationalizing this in the labs and then putting it into our commercial channel are things that we can do. And there was a recent transaction, somebody valued a company at $300 million, maybe $400 million. Based on what I've seen, we are as good as that assay and have a lot more to build on. They don't have any of the capabilities we do to actually commercialize this and grow. So I think right now you're sort of getting MRD for free with Myriad Genetics or at least option value there that isn't being recognized.
Derik De Bruin
analystGot it. And what are you doing in -- you have this relationship with Illumina, you're doing something there. Can you remind us what that is and sort of Intermountain relationship as well?
Paul Diaz
executiveYes. So we've started talking about this a little bit more, Derik. We have a growing biopharma business, which has helped fuel innovation into companion diagnostics which is now an $80 million business. What we're excited about is that over the last couple of quarters, the interest in us doing more research work for pharma partners like AstraZeneca and Merck and others has increased. There's a great deal of interest in working with them on MRD as well. And then the Illumina partnership, which has a couple of different components, it is putting myChoice ARD into their TSO 500 kit and it also allows us to work with some of these pharma partners to advance the expansion of clinical indications for myChoice. myChoice is only ovarian right now and the biggest white space is prostate and breast for us. So we see this as an emerging business line on a couple of different levels and we get paid so it's 100% pay. We don't have a no pay issue with our pharma partners. Always good to get paid.
Derik De Bruin
analystAnybody have any questions from the audience? I think they're going to bring a microphone around, one second.
Unknown Attendee
analystAre you going to have to do any clinical trials? And then can you talk about what Intermountain is doing to help you there?
Paul Diaz
executiveYes. So Intermountain is part of the trial work we're doing. But again we're working through the bureaucracy of other big institutions in terms of running samples and doing the MRD clinical validation work with 2 other institutions. So we've gotten great responses based on the analytical validation stuff that we have showed and the samples that we have run. And again I'm hopeful and pushing hard to see if we can announce something here in the next month or 2, but we're very close and are really quite excited about it as I said. I think that MRD is going to be a huge opportunity for patients and for the oncologists to treat them. I would say that I'm excited about the coverage determinations that have happened. I'm a little surprised, quite frankly, because I don't think we've done enough work yet on the clinical utility and how is this going to be used in practice and how does it really change the course of treatment. I'm a health service guy so I kind of think about those things a lot. But the good news is we have some really big customers that we are talking about not only doing the academic research; but putting it in their clinics, running it in their clinics, working with their docs to figure out how we're actually going to use MRD and then God forbid actually talking to payers about this as well as part of the work we're doing. So the bigger semantic for me, Derik, is that doing the clinical validation work is not enough. I think this industry has to do a lot more about how the science can be adopted in practice, how it changes the course of treatment and how does it change the cost curve for payers. And those are things that I think we need to spend more time and energy on and that we're pretty focused on at Myriad.
Derik De Bruin
analystWhenever I've locked horns with my bankers, it's often because I actually talk about things like reimbursement and utility and how you get this stuff done as opposed to this sounds great, let's push it out like this. And we sort of get to the point like a lot of these assays tend to take longer and cost more than anybody thought. How much of a burden is this on your P&L right now?
Paul Diaz
executiveWell, I mean look, there's no doubt that we've had an enormous tech deficit and deficit the investments in the commercial tools to really compete. Those tools have been built and are being rolled out now. So we feel really good about whether it's R&D or our new commercial capabilities and how we execute now, we think that that is fully embedded in our OpEx guidance. Certainly ran a little heavy the last couple of quarters as we saw some opportunities here to get after some share. But as we talked about on the call, we expect and we'll see that moderate just like our CapEx. Our Lab of the Future are done. We're starting to move in and we have to move the actual labs in and transition the products, but June 1 is kind of certificate of occupancy for both the new labs. So the majority of that CapEx, 95% of that CapEx is behind us. So I think you're going to see a lot more leverage in the operating model on the top end and then ultimately to free cash flow and EPS in the back half of this year.
Derik De Bruin
analystGreat. And returning to profitability?
Paul Diaz
executiveBy fourth quarter. I mean we fully expect that Q3 is seasonally pretty soft. Again I think you'll see moderation in CapEx and OpEx spending, but the real trajectory just historically for us is Q4. We have a great strong start to the year and April has continued to be a very strong month so we're feeling really good about Q2 as well as kind of the momentum going into Q3. But clearly we've put the stake in the ground about being profitable and generating cash flow in Q4, which is why we are comfortable that with our cash balance we have on the books now and the secured credit facility that we expect to finalize here in the next couple of months that we're going to have plenty of liquidity to run the company and grow the company.
Derik De Bruin
analystGot it. I mean since you mentioned liquidity and cash, I mean you seem to be doing a lot of this organically. You haven't done a lot of M&A, a lot of tuck-ins and I think you did Gateway, but you haven't really done much beyond that. I mean is there anything that you feel like you need to add incremental to the portfolio?
Paul Diaz
executiveWe got a lot on our plate. I mean I would say the product -- I mean here's the funny thing too. For a products company, we had no product management people or skills so nobody was thinking about go-to-market, no one was testing markets, no one was thinking about how we position products. And so it's a learning process and what we have learned and Bain Consulting has helped us about our new product management team. We're constantly refining how we go to market and look at the opportunities for our core products. And I'm really focused on getting our core products to their full potential because that's the greatest return on invested capital for our shareholders and the best thing for our patients. And so that's hereditary cancer, that's our prenatal products, that's GeneSight and Prolaris. So we have a great portfolio of products. Now we still have to continue to tinker with them. So I mentioned Foresight, we need to expand that panel. But those are all high returns, if you will. So to me those are low risk, high returned investments of OpEx, in some cases small CapEx. So I'm not really feeling the pressure to go out and buy stuff, it's not proven. I think as we go into '24 and '25 and some of the lunacy comes out of the marketplace, we may see some tuck-ins that are worth considering. But I think right now we're just focused on getting to profitability and generating free cash flow before we step into any acquisitions.
Derik De Bruin
analystSo can you talk a little bit about how you have reinvigorated the R&D organization? Because you're right, I mean there was a stretch there that was underinvested.
Paul Diaz
executiveFor a biotech company, we weren't investing in the technology to enable the science either whether it was in the lab or commercially. And I will tell you the labs in my old hospitals were nicer than the labs that we've been running MyRisk at. So we really needed to invest in our people, we really needed to invest in our labs. Those investments have been made and it's creating a lot of energy in the company both in R&D and we're going to open our innovation center in South San Francisco. I can't wait to show it to you and show it to others and the automation that we've built there. And that's the other thing that in order to sustain the 68%, 70% gross margins that we believe we can maintain, automation is going to be part of that and that's been part of that investment as well. So yes, I just think we're going to just stay focused right now and down the road, there may be some tuck-in opportunities. But we've invested a lot in R&D and tech to the tune of probably $60 million, $70 million and a lot of that was just tech deficit, things like EMR that are contributing and just in the labs as well.
Derik De Bruin
analystAny incremental questions? So Paul, I think we're coming towards the end. My standard closing question is always what's underappreciated about Myriad?
Paul Diaz
executiveWell, I think as we've talked about; I think the people, the team, its experience, the depth of our science. We talk about MRD for example, like the leading MRD company right now outsources everything. So to be able to stand this up on technology that's running in our labs and to be able to operationalize this and then commercialize it, those are the capabilities that I think are underappreciated of the company. So everything from our regulatory teams to our payer markets teams to our customer service, R&D, standing this up in labs that are FDA approved and CLIA certified and New York certified. Some of the emerging companies go to do this, I think they're going to have a harder time than they think. So it's complicated and difficult and takes time and takes money.
Derik De Bruin
analystI don't disagree with that. So well, thank you.
Paul Diaz
executiveThank you. Appreciate the opportunity to be here. Thank you all for attending.
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