Guardant Health, Inc. (GH) Earnings Call Transcript & Summary

Good morning, everyone. My name is Matt Sykes, life science tools and diagnostics analyst at Goldman Sachs, and I have the pleasure of being joined by Helmy Eltoukhy, Co-Founder and Co-CEO; and Michael Bell, CFO of Guardant Health. Thank you very much for joining us today.

Yes. Thanks for having us.

Well, maybe let's just set the stage and have you talk about some of the accomplishments of the first half of the year. And there's a lot to talk about, as we were saying before, you've had a lot of news flow lately that's pretty exciting. But sort of what do you think are the highlights in your mind and sort of expectations for the rest of the year in terms of your guide and any potential catalysts that are upcoming?

It's been quite a year for us, really firing on all cylinders in terms of the business. We've seen with therapy selection. I think despite some doubt to the contrary, we've seen really the third quarter of accelerating growth with the G360. A lot of that is propelled by the new features we've added, the new platform we're on with Smart Liquid Biopsy. And that seems to be a sort of gift that keeps on giving. With Reveal, we started the year off strong with surveillance reimbursement in CRC. We're seeing a nice accelerating volume there as well. And we just got our second publication in breast out this last week. And so we're hopeful we'll be able to get the breast indication now submitted to Medicare and get that sort of over the finish line. And then finally, with Shield, we've, I think, started the year off extremely strongly. We are seeing the ADLT status for Shield as well. We moved the reimbursement price from $920 to $1,495. And so yes, I would say that all 3 sides of our business are doing extremely well. I don't know if there's anything to add, Mike.

No, you covered it.

Maybe let's just touch on a couple of the recent pieces of news, starting with the NCCN guidelines for Shield, the updated guidelines with the recommendation for testing every 3 years. Maybe walk us through the potential impact here. How much of a tailwind could this be for adoption and coverage versus sort of your previous expectations?

No, we were super excited when we saw that because that happened much faster than I think any of us expected. Historically, if you had looked at when that happened, it happened a number of years after approval for some of the historical tests out there. And -- no, this is a huge positive. If you think about NCCN, they are essentially the highest level guideline committee on oncology. And what they say matters quite a bit. People look towards them as really the experts in cancer. And the fact that we were put at Level 2A, which on the sort of the first update to the guidelines is very exciting. So our sales force has that now, and we think it's going to be a positive.

Got it. And then additionally, Shield was granted breakthrough device designation for multi-cancer detection by the FDA and building on some of the Vanguard study data that you just presented at ASCO. Can you talk about what this means for the time line of getting Shield multi-cancer detection to market? If there's any potential benefits to reimbursement down the line?

Yes. It certainly helps with the dialogue we can have with the FDA in terms of multi-cancer when you have breakthrough device designation. We're very pleased with that update. But I think when we think about multi-cancer, I think a lot of where we're -- our capabilities there are the fact that, we're in this Vanguard study with the NCI. And that study is a great vehicle for us to sort of move multi-cancer forward in the sense that some of the anxiety with multi-cancer is the fact that physicians often don't know what to do with a positive result with some of these tests. And so what does that diagnostic odyssey look like? With colorectal, it's very clear when you have a positive result, you have a colonoscopy and it definitively ends the diagnostic odyssey. With multi-cancer, it's not as clear, but the beauty of having essentially being one of the participants in this NCI Vanguard study is the fact that they are going to essentially designate what the protocols are for some of these things and what that odyssey and what the end of that odyssey will look like under that protocol. So I would say that is the piece that I think we're most excited about with multi-cancer and essentially bringing that to market. And the nice thing with that study is we'll essentially have the capabilities and the ability to bring that to market anytime we want as soon as that trial is launched within probably the next quarter or so.

And then lastly, it was a pretty active ASCO for the diagnostics industry, yourself included. Can you maybe give us sort of your view and summary of the most impactful abstract presentations that you had at ASCO? Just what should investors really focus on from that?

Yes. We had a number of really exciting abstracts. We had largest MRD study to date, N0147 that was presented last Friday, 2,000 patients. We essentially saw 6-year outcomes in terms of the fact that Reveal can truly risk stratify patients in that postsurgical pre-adjuvant setting. And so we think that validates the test really as a decision support tool in the early-stage colorectal cancer setting. And I think the one that was, I think, very highly anticipated and watched by many is SERENA-6 readout with AstraZeneca. I think when you think about what that potentially means for the space, this would essentially be the first MRD CDx in a way, the first monitoring CDx in the space, if that reads out -- if that obviously gets approved. And when you look at the dynamics of that, essentially, patients were getting a Guardant360 test every 3 months in that trial. And this is an indication that is something like 80% of breast cancer patients. And so it's a huge step change, not just for essentially the ESR1 or the SERD space, but huge really paradigm shifting this space from one test per patient per lifetime to a paradigm where you're adaptively managing patients where you're looking at patients essentially very often for tumor evolution, how their disease is changing and trying to stay one step ahead of their disease by switching therapies appropriately. So we think this is just the first of, I think, many such drugs and trials of this architecture.

Yes. If we can just drill down on SERENA-6 because I do think it is sort of almost paradigm shifting in terms of what it could do to frequency for Guardant360. And so how do you look at this? I know it's still early, but could this potentially change the revenue and volume profile of the test category for Guardant moving forward?

Yes. This is massive. I mean I think in one line, this essentially confers an MRD-like opportunity for G360. That is the potential here. I would say if you historically look back to our first ESR1 CDx a couple of years ago with ORSERDU, and you saw what happened -- what played out there, we essentially saw almost overnight a doubling of our breast cancer volumes with G360 once that was approved. And we continue to see a huge uplift as a result of that approval in our breast business. And now our breast business is just below lung cancer in terms of volumes for Guardant360. And this is an order of magnitude more testing than that in terms of what potentially this could mean. So yes, we think there's a lot of upside in terms of growth potential for G360 over the next few years with this drug specifically -- with this CDx specifically, but with some of the other conversations we're having with potentially other indications that may have a similar switching dynamic.

Maybe staying with therapy selection, it's -- your competitors are not standing still, but you've seen accelerating volumes for some time. And you've talked -- been talking about the Smart Liquid Biopsy platform for some time. And I think that one thing investors struggle to understand is sort of the true competitive differentiation of that platform. Could you maybe help us kind of understand just given the increasing competition, given your lead and given the accelerating volumes, adding the smart liquid biopsy, what does that do, do you think to the competitive landscape? And how does it position Guardant for the future?

Yes. So there's a few things you have to get right with liquid biopsy. It has to be fast because what's the point if it takes 2 or 3 weeks or 4 weeks. And so we're averaging 5 days with Guardant360 CDx, 5 days with Reveal. So that's one to truly fit into how patient care is delivered in terms of clinical practice, it should be really quick. Two, it has to be sensitive. You can't be missing all of the sort of actionable mutations, EGFR and ALK and HER2 and so on. And on those 2 respects, there's not another liquid biopsy that essentially comes close to performance on those 2 levels. And then it's everything else that we're adding to the space in terms of this ability to see the true identity of disease, this -- the new features, we added 11 new applications just a couple of weeks ago to the test. And some of them are things that I think no one really thought was possible in blood. I didn't think it was possible 12 years ago when we started, which is the ability to almost diagnose disease in a tube of blood, the fact that we can see that a patient is transitioning from non-small cell lung cancer to small cell lung cancer, the fact that we can see a patient is triple negative and how triple negative they are versus HER positive and so on. And so this is stuff that is truly revolutionary and actionable. When a physician sees that patient may have an oncogenic mutation but has transitioned in terms of their tumor biology, that is something they can essentially take into their treatment plans and decide what to do. We can do things like tell you that a patient is KRAS wild-type, which is very difficult with liquid biopsy because the absence of evidence is not necessarily evidence of absence, right? That's the problem with liquid biopsy. And the fact that we can do that definitively now with the test is very, very actionable. Things like immune checkpoint inhibitor like efficacy prediction and being able to get patients on to PARP inhibitors that essentially can't be tested with any other means through promoter methylation and some of the other signatures we're seeing things like HLA typing, we can see viral load in these patients. So it's -- there really is something now like probably 15 applications that we can do and that only we can do on this test that are actionable today that will change patients' lives today when they're in a physician's office. And so these are the features that are making a difference. And it's the reason we're seeing accelerating volume. I think we'll continue to see accelerating volume.

And so you've built your business so far in therapy selection, mostly in blood, but you just launched your upgraded tissue test, Guardant360 tissue. Just given your presence in the liquid biopsy market, how can this help you penetrate the tissue market, which is a much more crowded field and what level of differentiation are you bringing to that market, meaning you've dominated the blood, now you're moving to tissue, but tissue is where the competitors already exist. So how do you leverage either your blood franchise into tissue? Or what is it about your tissue test that you believe will be a differentiator in that market?

Yes, that's a great question. So we were told for many years that we love your liquid test. If you had a similarly great tissue test, we'd move our volumes to you. A lot of oncologists have told us this. And so over the years, we've worked on essentially really listening to the market, really trying to understand what are the pain points that continue to exist in tissue. And this recent launch just a few weeks ago, Guardant360 tissue is really the culmination of that. So we not only have all of the biomarkers that are necessary in terms of very comprehensive DNA testing, comprehensive RNA testing. But we have this sort of genome-wide methylation backbone that's there that is really the common thread between all our products between Shield, between Reveal, between Guardant360 liquid now and now tissue. And then we've heard that IHC is important. We have the broadest menu of IHC. We have germline testing. And so we really brought -- essentially, we kitchen sink the tissue test, and it's been resonating really, really well. And the nice thing about this common thread we have with methylation is that all these applications that I just talked about on the liquid side, will also be populated on the tissue side. So there'll be a common visual language, a common sort of application framework essentially between all of our tests in our ecosystem. And I think the one last piece I'll mention is that we're a very science first, very patient-driven company. And I think sometimes what gets lost is how excellent our commercial team is in terms of this space. We've been #1 share of voice, #1 effectiveness, #1 perceived utility of essentially any oncology sales team for the last 4 years every quarter after quarter. And so when you have that combined with best-in-class products, we believe we're sort of very strong team to contend with.

Shifting to MRD to your Reveal test. You highlighted the early momentum that you're seeing on your most recent earnings call. Can you maybe talk about where you're seeing most of your early success? Is this with patients, whether it's near term or longer term? I mean, I do think that there is a certain market for it where the tissue sample might be inaccessible. Also for longer-dated patients, you might develop additional somatic mutations. Could you just talk about where you're currently resonating in terms of your volumes of what patient population? And how do you expand that out?

With Reveal?

Yes, with Reveal.

Yes. So you're right. There is, I would say, 3 classes of segments of the patient population where Reveal wins pretty handedly. Patients that are further out from surgery where there's a worry that there may be some tumor evolution or what was taken out doesn't necessarily reflect what's still left. It's -- actually an interesting one is right at the first time point, we have a very strong sort of selling proposition, a value proposition and the fact that many of these tumor-informed tests, despite claims to the contrary, still take 4 weeks, 6 weeks, 8 weeks. And that is -- there's a lot of anxiety there from the patient perspective at that first time point. These patients know that they're being drawn for a ctDNA test to understand if the disease is still there or not. And so then waiting 8 weeks sometimes to get a result is not very pleasant. And because we're averaging 5 days, it's a very, very high value proposition to have a quick test that can give patients that peace of mind. And then yes, to your point, there are anywhere from 10% to even 40% of patients that either don't have tissue available or where tissue is inaccessible or hard to reach. And then finally, the neoadjuvant setting as well. We had some great neoadjuvant data in the publication that came out in breast cancer. And so there are very sizable patient populations here that really a tissue-free MRD test is either the better or the only options for patients.

Got it. I want to move over to Shield screening for a bit. It's gotten off to a really strong start. You've obviously had some very positive pricing developments, raised your volume guide for 2025. Maybe just talk about the potential penetration you think you can achieve in the next few years prior to seeing increased competition in the space. I mean we do see a first-mover advantage. I think a lot of people talk about competition prior to them even getting on to the market, yet you're there and selling into that market. How do you think about the importance of driving penetration in the near to medium term prior to potential competition coming on? And how can you drive that with your commercial team as you build that out?

Yes. Look, it's -- the first-mover advantage we know in the health care space is extremely important. There have been a lot of studies in terms of what sort of long-term advantages that confers to a franchise. And we're very cognizant of that, which is why I think we're being aggressive in terms of investing appropriately. Obviously, with the constraints we've mentioned in terms of a net burn of $200 million for the screening business. But -- we have a lot of levers now with ADLT status at $1,495. We have good gross profits now that we brought the COGS down significantly over the last few quarters. And so I think we have the ability to sort of reinvest into sales and marketing. We're seeing great dynamics in terms of the tests, the depth of ordering from physicians compared to some of the precedents in the market. So I think we have a lot going for us to really leverage this first-mover advantage that we have of 2.5 years or so.

And you and AmirAli have talked in the past about the importance of HEDIS quality scores for screening. Could you maybe talk about how we should think about the time line for Shield getting quality scores? Is this a gating factor until that happens? Is there a potential for getting into that? And what do you do as an organization to drive that?

I think even before that, obviously, we're seeing great traction. There's a large segment of the market that is accessible today without those quality scores. But there's no doubt that's a huge driver and a huge uplift potentially when that happens. It typically happened after USPSTF guidelines, and that's probably the base case. But we have some levers and we have some activities that could potentially accelerate that.

Okay. And you showed some pretty impressive pan-cancer data recently for the Shield platform in your last quarterly call. I realize Shield was always designed ultimately to be a pan-cancer platform. But we kind of really appreciate your strategy of a single cancer at a time. So I guess, could you maybe talk about how this early data informs your longer-term strategy as you move into additional indications? Will you take some of those better-performing cancer types and put them in? Will it shift the priorities of where you're doing R&D? Just how strategically do you see Shield evolving into that pan-cancer type test?

Yes. I would say there's sort of 2 parallel paths. There's the capabilities of Shield as an LDT test in the market. And that's, I think, where multi-cancer potentially sits today. And then there will be sort of FDA-approved indications that will be layered in, CRC being the first one, lung potentially being the second one and so on. So you could think of these as 2 parallel pathways and ability for us to make sure that we're squeezing all the value that we can squeeze out of Shield in terms of helping patients and detecting cancer earlier in a way that I think leverages kind of the nuances of the sort of regulatory system.

And maybe, Mike, I'm not going to let you off the hook here. Shifting over to you, just broadly on ASPs across the portfolio. You talked about Reveal around $600, Guardant360 in the $3,000 to $3,100 range, so closer to $800 realized near term. But maybe just talk about the overall impact on revenue growth from the different product ASPs. And how should we think about where you'll see the largest ASP impact over the next year plus from ASPs across your portfolio?

Yes. I mean I think over the last 18 months or so, we've seen good traction on all the products on our ASPs. I mean, starting with Guardant360, 18 months ago, that ASP was $2,700. Now we're in the range, $3,000 to $3,100. So a significant uplift there with tissue. At the start of the year, we had a Medicare increase. So we went from $3,140 to $3,500. So that's a nice uplift. And I think the overall ASP for tissue is going to continue to tick up over time. Shield, again, when we had our Investor Day a couple of years ago, our assumption of an ASP was around $500, and we assumed the Medicare rate would be $920. So our Medicare rate is significantly higher than that now with ADLT. It's $1,495. And again, Matt, you mentioned it, our ASP that we're expecting for the remainder of this year is going to be around the $800 mark. I think ASPs across all those 3 products are pretty -- going to be pretty steady now for the next couple of years. We'll probably get some uplift on Guardant360 liquid and tissue. And Shield is going to -- the overall ASP is going to depend on the mix between Medicare and Medicare Advantage and commercial. But I think the levels they are now, we're feeling very good about. Where we're going to get the biggest uplift over the next couple of years is going to be with Reveal. We saw with getting the MolDX coverage for CRC surveillance at the start of the year, and that CRC rate now has ticked up over $600. We had good news this morning, actually, we press released that we had breast data published in ESMO open. That opens the door for us now to submit to MolDX for breast reimbursement for Reveal. And breast is quite a significant portion of our Reveal volume. CRC is the highest, but then breast coming very sort of quickly behind. And so if we can get that reimbursement, that will have a significant impact. We're expecting a publication in therapy monitoring coming soon, and that's going to open the door for MolDx submission for that in Reveal. And of course, we're in the process of ADLT for Reveal as well, which hopefully, we'll know about that in Q3. And so I think we're targeting an ASP for Reveal over the next few years of going from the $600 level to $1,000. So I think that's where we can get the most revenue uplift from ASPs over the next couple of years.

And is breast currently being reimbursed at all? Or is that sort of a cost right now for you?

It's a cost. So overall, Reveal, when you look at all the products and the blended ASP, it's gross margin positive. And so that's allowing us to put the foot on the gas for volume across all of the portfolio. But breast, no, we're not getting reimbursed for that at the moment. And so when we get Medicare reimbursement for that, it's going to have a significant impact for us.

Got it. And Mike, just on the balance sheet, you pushed out some of your converts to later maturities. You have significant cash remaining on the balance sheet, but also have a significant amount of spend needs for a number of new products that you have. Maybe just frame for us the path to profitability, any upside or downside risks to that time line in your mind?

Yes. I mean we set our target breakeven 2028, and we're committed to reducing the cash burn every year from now to then. And we've made good progress over the last couple of years reducing that cash burn each year. I think the risk -- I mean, this -- most of this is in our control. It's in our control on how we spend. I think we've seen some very good upsides against our projections over the last 18 months. And a lot of those have come from the ASP increases that I mentioned. I think we're doing better than expected on ASPs. And then I think the 2 significant milestones that we've seen this year is really both Reveal and Shield becoming gross margin positive. And with Reveal turning gross margin positive as well as allowing us to drive the top line, that's going to significantly reduce our cash burn over the next couple of years. So we've had actually significant cash burn in the last couple of years on Reveal as we've been doing volume, but having a negative gross margin. So I think getting to gross margin positive is going to drive the Reveal burn down significantly. And then Helmy was mentioning it with Shield, now that, that's gross margin positive, it means that we can continue to heavily invest on the sales and marketing side, but taking that incremental gross profit and putting that in the sales and marketing line means our cash burn on screening isn't going to increase, and we can stay within this $200 million for the next couple of years. So I think, again, a lot of this is in our control, and we're making very good progress. And so we're very confident about getting to breakeven in 2028.

And then just on gross margins, you reported around 65% gross margin for the first quarter. You're guiding to 62% to 63% for the full year. Now you have, as you mentioned, Reveal and Shield are both gross margin positive and volume growth will likely probably improve that dynamic. Could you maybe talk about where you see gross margins longer term as you continue to reduce COGS, drive ASPs and volume growth?

Yes. I mean, long term for all of our products, we target at least 60% gross margins. And with Guardant360, we're already high 60s for Guardant360. And there's possibilities for us to continue to chip away at the cost of Guardant360 and continue to improve the ASP. So I think high 60s, 70% gross margins for G360 is our target. And our biopharma business, where we do sample testing, gross margins are already in the 70s. Biopharma is a very profitable business for us. And yes, with Reveal, again, the target there is 60%. We expect to get ASPs, I just mentioned of $1,000. We can continue to further reduce the cost per test there. It's around $500 now. We can get it to $400 or below. So I think that's a reasonable target. And with Shield, again, at our Investor Day, we set an expectation or a target of 60% gross margins by 2028 when we're doing 1 million tests a year. That assumed an ASP of $500 and a cost per test of $200. I think on the cost per test, we're making really good progress, and we're very confident on getting that to $200. And with the ASP, I think with ADLT where it is now, and I just mentioned, I think the ability for us to have a long-term ASP above $500 is likely. And so again, with Shield, gross margins of at least 60%. So we feel good about where we are with all the portfolio and moving up the gross margin, specifically on Reveal and Shield over the next few years.

And I want to come back, Helmy, to you in a second on the biopharma business. But before I do, Mike, just on COGS specifically, so much of the improvement, I assume, is going to come from scale. But what other things can you do prior to that scale leverage to reduce COGS further? And is there more room to go on that?

There is across all of the portfolio. Again, with Guardant360, I think there's the opportunity for us to reduce sequencing costs. We can move Guardant360 over to NovaSeq X. I think that will reduce the sequencing cost. With Reveal, it's primarily going to be volume driven unless that volume increases, the cost per test is going to reduce. I think with Shield, we've seen nice reduction over the last 6 months or so since we got FDA approval or 9 months, and that's been volume driven. So volume is going to continue to drive Shield cost per test down. But also we're looking at workflow efficiencies. That needs to go through an FDA process. But once we can put those workflow efficiencies through, we'll have a significant step down in cost per test. We're also investing heavily on automation and looking at taking as much of the direct labor costs out of the lab operations for Shield. And also when that goes live, probably '27, we'll see another significant step down in cost per test. So I think those 2 initiatives as well as volume is going to drive Shield from this $500 level today to $200 in the next couple of years.

Got it. And Helmy, on biopharma, I mean, Mike mentioned the 70% plus gross margins, obviously an attractive business. For whatever reason, your peers seem to struggle in this area. Yet Guardant, while it's lumpy at times, has been quite successful. What is it about what you're -- how you're approaching the customers, the data that you have or the other services that you attach to it that has made you successful? And how do you continue driving that growth? I mean these aren't the easiest customers in the world, I'm sure, to deal with, but it's just -- it's been really fascinating watching you be able to have that business take off and everyone else seems to have not figured it out yet.

Yes. In some ways, they're the most discerning customers, most demanding in the space, and we feel very pleased with the fact that we're able to win so many of them over. I think we're over 180 pharma companies that use us now. And it's a bunch of things. So I think smart liquid biopsy has been a big driver really going towards methylation because that is truly providing value. Look, people have had RNA-Seq, they've had whole exome for a decade. And yet we're the ones seeing this traction with methylation and some of that analysis we're doing. So I think we're seeing differentiated results that are really important for some of these early programs. I think monitoring is starting to be a really important aspect for a lot of these trials in terms of these sort of internal surrogate endpoints of being able to understand if the drug is working or not. And then finally, having the capabilities of essentially going from essentially cradle to commercialization going through having so many SPNAs under our belt, so many approvals, worldwide approvals, Pharma needs a partner they can depend on, that's not going to be a stumbling block in terms of getting to approval and then getting to sort of worldwide distribution. The fact that we're one of the few that has reach in most of the world, including China, is a very attractive future in terms of working with Guardant.

And then you have a long-term goal of getting to about 750 sales reps for the Shield franchise longer term. I've always felt that given the high levels of adherence, and maybe these aren't commercial folks, maybe it's more support, but it wouldn't require as large of an infrastructure as maybe some of your peers that will require a lot of follow-up and support. So do you think 750 is still -- I know it's early, but do you think 750 is still the right number? Or do you think adherence will actually help you create a much more efficient sales process and commercial organization as you move forward?

Yes. Look, I mean I think from what we're monitoring so far, we're very pleased with the productivity per rep. I mean I think we're ahead of our expectations. I think we're ahead of sort of the industry precedents in terms of what's required to actually move tests. We think this is a test that resonates with how care is delivered, with how essentially tests are performed through [indiscernible] blood. It's something that's very seamless and integrates well with the current health care system. I think that's obviously directional in terms of where we see things now. But yes, we're very hopeful that we can drive, I think, significantly higher scale with the same number of reps as some of our peers have.

Okay. We've got about 30 seconds left. So I'm going to ask the usual conference question at the end about what do you believe is underappreciated about Guardant? I mean, given the durability of your growth, the new products you're coming on, the data sets you released, some of the news flow and catalysts you've got upcoming that I'm sure they're still in your mind areas where you feel investors might not be fully understanding the franchise.

I think each one of the areas that we've been doing really well could be like stellar story on its own. And I think what's hard is when you put them all together, sort of keeping track of the true value of each one of them. So I do think it's a -- some of the parts seem smaller than the individual pieces.

Got it. All right. Thank you very much, Mike, Helmy. Appreciate it.

Thanks.