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.
Yeah, thanks for having us.
Maybe let's just set the stage and have you talk about some of the accomplishments of the first half of the year. 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. What do you think are the highlights in your mind and expectations for us here in terms of your guide and any potential catalysts that are upcoming?
No, it's been quite a year for us, really firing all cylinders in terms of the business. We've seen with therapy selection, I think despite some doubts 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. That seems to be a sort of gift that keeps on giving. With the Reveal, we started the year off strong with surveillance reimbursement and CRC. We're seeing a nice accelerating volume there as well. We just got our second publication in breast out this last week. We are hopeful we'll be able to get the breast indication now submitted to Medicare and get that sort of over the finish line.
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. I would say that all three sides of our business are doing extremely well. I do not know if there is anything to add, Mike.
No, I think you covered it.
Okay.
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 three 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, that happened a number of years after approval for some of the historical tests out there. No, this is a huge positive. If you think about NCCN, they are essentially the highest level guideline committee in oncology. What they say matters quite a bit. People look towards them as really the experts in cancer. The fact that we were put at level 2A, which on sort of the first update to the guidelines is very exciting. Our sales force has that now. 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 timeline of getting Shield multi-cancer detection to market? There's any potential benefits to reimbursement down the line?
Yeah, 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. I think when we think about multi-cancer, I think a lot of where our capabilities there are the fact that we're in this Vanguard study with the NCI. 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. 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.
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. I would say that is the piece that I think we're most excited about with multi-cancer and essentially bringing that to market. 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.
Lastly, it was a pretty active ASCO for the diagnostics industry, yourself included. Could you maybe give us sort of your view and summary of the most impactful abstracts presentations that you had at ASCO? Just what should investors really focus on from that?
Yeah, we had a number of really exciting abstracts. We had the largest MRD study to date, N0147, that was presented last Friday, 2,000 patients. We essentially saw six-year outcomes in terms of the fact that Reveal can truly risk stratify patients in that post-surgical pre-adjuvant setting. We think that validates the test really as a decision support tool in the early stage colorectal cancer setting. 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.
When you look at the dynamics of that, essentially, patients were getting a Guardant 360 test every three months in that trial. This is an indication that is something like 80% of breast cancer patients. It is a huge step change, not just for essentially the ESR1 or the SIRT space, but huge for really paradigm shifting the 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. We think this is just the first of, I think, many such drugs and trials of this architecture.
Yeah, 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 Guardant 360. 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?
Yeah, this is massive. I mean, I think in one line, this essentially confers an MRD-like opportunity to G360. That is the potential here. I would say if we historically look back to our first ESR1 CDX a couple of years ago with Orserdu, and you saw what played out there, we essentially saw almost overnight a doubling of our breast cancer volumes with G360 once that was approved. We continue to see huge uplift as a result of that approval in our breast business. Now our breast business is just below lung cancer in terms of volumes for Guardant 360. This is an order of magnitude more testing than that in terms of what potentially this could mean.
Yeah, 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, your competitors are not standing still, but you've seen accelerating volumes for some time. You've been talking about the smart liquid biopsy platform for some time. 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? How does it position Guardant for the future?
Yeah, 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 two or three weeks or four weeks? We're averaging five days with Guardant 360 CDx, five days with Reveal. 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. On those two respects, there's not another liquid biopsy that essentially comes close to performance on those two levels. Then it's everything else that we're adding to the space in terms of this ability to see the true identity of disease, the new features.
We added 11 new applications just a couple of weeks ago to the test. Some of them are things that I think no one really thought was possible in blood. I did not think it was possible 12 years ago when we started, which is called 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 HR positive and so on. 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 is the problem with liquid biopsy. The fact that we can do that definitively now with a 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 cannot be tested with any other means through promoter methylation and some of the other signatures we are seeing. Things like HLA typing, we can see viral load in these patients. 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 are in a physician's office.
These are the features that are making a difference. It is the reason we're seeing the accelerating volume. I think we'll continue to see accelerating volume.
You have built your business so far in therapy selection, mostly in blood, but you just launched your upgraded tissue test, Guardant 360 Tissue. Given your presence in the liquid biopsy market, how can this help you penetrate the tissue market, which is a much more crowded field? What level of differentiation are you bringing to that market? You have dominated the blood, now you are moving to tissue, but tissue is where the competitors already exist. 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?
Yeah, that's a great question. 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. 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. This recent launch just a few weeks ago of Guardant 360 Tissue is really the culmination of that. 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 Guardant 360 Liquid now and now Tissue.
We have heard that IHC is important. We have the broadest menu of IHC. We have germline testing. We really brought essentially, we kitchen sink the tissue test. It has been resonating really, really well. 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. There will be a common visual language, a common sort of application framework essentially between all of our tests and our ecosystem. I think the one last piece I will mention is that we are a very science-first, very patient-driven company. I think sometimes what gets lost is how excellent our commercial team is in terms of this space.
have been number one share of voice, number one effectiveness, number one perceived utility of essentially any oncology sales team for the last four years, every quarter after quarter. When you have that combined with best-in-class products, we believe we are a 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. Could 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 with what patient population? How do you expand that out?
With Reveal?
Yeah, with Reveal, yeah.
Yeah, so you're right. There is, I would say, three classes of segments of the patient population where Reveal wins pretty handedly. It's 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. Actually, an interesting one is right at the first time point, we have a very strong sort of selling proposition, value proposition, and the fact that many of these tumor-informed tests, despite claims to the contrary, still take four weeks, six weeks, eight weeks. 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. Then waiting eight weeks sometimes to get a result is not very pleasant.
Because we're averaging five days, it's a very, very high value proposition to have a quick test that can give patients that peace of mind. Yeah, 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. Finally, the new adjuvant setting as well. We had some great new adjuvant data in the publication that came out in breast cancer. 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, to 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 this space. I mean, we do see a first-mover advantage. I think a lot of people talk about competition prior to them even getting onto the market. Yet you're there and selling into that market. How do you think about the importance of driving penetration near to medium term prior to potential competition coming on? How can you drive that with your commercial team as you build that out?
Yeah, look, the first-mover advantage we know in the healthcare space is extremely important. There have been a lot of studies in terms of what sort of long-term advantage is that confers to a franchise. 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 net burn of $200 million for the screening business. 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. 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.
I think we have a lot going for us to really leverage this first-mover advantage that we have of two and a half years or so.
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 timeline for Shield getting the quality scores? Is it a gating factor until that happens? Is there a potential for getting into that? 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. There's no doubt that's a huge driver and a huge uplift potentially when that happens. It's typically happened after USPSTF guidelines, and that's probably the base case. We have some levers, and we have some activities that could potentially accelerate that.
Okay. 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. 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?
Yeah, I would say there's sort of two parallel paths. There's the capabilities of Shield as an LDT test in the market. And that's, I think, where multicancer potentially sits today. Then there'll 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. You could think of these as two 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 cancers earlier in a way that I think leverages kind of the nuances of the sort of regulatory system.
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, Guardant 360 in the $3,000-$3,100 range, Shield closer to $800 realized near-term. Maybe just talk about the overall impact on revenue growth from the different product ASPs. How should we think about where you'll see the largest ASP impact over the next year plus from ASPs across your portfolio?
Yeah, 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 Guardant 360, 18 months ago, that ASP was $2,700. Now we're in the range $3,000-$3,100. A significant uplift there. With tissue, at the start of the year, we had a Medicare increase. We went from $3,140 to $3,500. That's a nice uplift. 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. Our Medicare rate is significantly higher than that. Now with ADLT, it's $1,495.
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 three products are going to be pretty steady now for the next couple of years. We'll probably get some uplift on Guardant 360 liquid and tissue. Shield's going to, the overall ASP is going to depend on the mix between Medicare and Medicare Advantage and commercial. 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, that CRC rate now has ticked up over $600. We had good news this morning, actually.
We pressed release 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. If we can get that reimbursement, that'll 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. That and Reveal. Of course, we're in the process of ADLT for Reveal as well, which hopefully we'll know about that in Q3. I think we're targeting an ASP for Reveal over the next few years of going from the $600 level to $1,000.
I think that's where we can get the most revenue uplift from ASPs over the next couple of years.
Is breast currently being reimbursed at all, or is that sort of a cost right now for you guys?
It's a cost. Overall, Reveal, when you look at all the products and the blended ASP, it's gross margin positive. That's allowing us to put the foot on the gas for volume across all of the portfolio. Breast, no, we're not getting reimbursed for that at the moment. When we get Medicare reimbursement for that, it's going to have a significant impact for us.
Got it. 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 timeline in your mind?
Yeah, I mean, we set our target break-even 2028, and we're committed to reducing the cash burn every year from now to then. We've made good progress over the last couple of years reducing that cash burn each year. I think the risk, I mean, 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. A lot of those have come from the ASP increases that I mentioned. I think we're doing better than expected on ASPs. I think the two significant milestones that we've seen this year is really both Reveal and Shield becoming gross margin positive.
With Reveal turning gross margin positive as well as allowing us to drive the top line, that is going to significantly reduce our cash burn over the next couple of years. We have had actually significant cash burn in the last couple of years on Reveal as we have been doing volume, but having a negative gross margin. I think getting to gross margin positive is going to drive the Reveal burn down significantly. Helmy was mentioning it with Shield, now that that is gross margin positive, it means that we can continue to heavily invest on the sales and marketing side. Taking that incremental gross profit and putting that in the sales and marketing line means our cash burn on screening is not going to increase, and we can stay within this $200 million for the next couple of years.
I think, again, a lot of this is in our control, and we're making very good progress. We're very confident about getting to break-even in 2028.
Just on gross margins, you reported around 65% gross margin for the first quarter. You're guiding to 62-63% 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?
Yeah, I mean, long term for all of our products, we target at least 60% gross margins. With Guardant 360, we're already high 60s for Guardant 360. There's possibilities for us to continue to chip away at the cost of Guardant 360 and continue to improve the ASP. I think high 60s, 70% gross margins for G360 is our target. Our biopharma business, where we do sample testing, gross margins are already in the 70s. Biopharma is a very profitable business for us. Yeah, 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. I think that's a reasonable target.
With Shield, again, at our Investor Day, we set an expectation or a target of 60% gross margins by 2028 when we're doing a 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. 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 very likely. With Shield, gross margins of at least 60%. We feel good where we are with all the portfolio and moving up the gross margins specifically on Reveal and Shield over the next few years.
I want to come back, Helmy and you, in a second on the biopharma business. Before I do, Mike, just on COGS specifically, so much of the improvement I assume is going to come from scale. What other things can you do prior to that scale leverage to reduce COGS further? Is there more room to go on that?
There is across all of the portfolio. Again, with Guardant 360, I think there's the opportunity for us to reduce sequencing costs. We can move Guardant 360 over to NovaSeq X. I think that'll reduce the sequencing costs. With Reveal, it's primarily going to be volume-driven. As that volume increases, the cost per test is going to reduce. I think with Shield, we've seen nice reduction over the last six months or so since we got FDA approval, or nine months. That's been volume-driven. Volume's going to continue to drive Shield cost per test down. Also, we're looking at workflow efficiencies. That needs to go through an FDA process. 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. Also, when that goes live, it's probably 2027. We'll see another significant step down in cost per test. I think those two initiatives, as well as volume, are going to drive Shield from this $500 level today to $200 in the next couple of years.
Got it. Helmy, on biopharma, I mean, Mike mentioned the 70%+ 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 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? How do you continue driving that growth? I mean, these aren't the easiest customers in the world, I'm sure, to deal with. 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.
Yeah, in some ways, they're the most discerning customers, most demanding in the space. 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. It's a bunch of things. 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. Yet we're the ones seeing this traction with methylation and some of that analysis we're doing. 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. Finally, having the capabilities of essentially going from essentially a cradle to commercialization, going through having so many SPMAs 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.
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 require a lot of follow-up and support. 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?
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 the lingua franca of blood. It's something that's very seamless and integrates well with the current healthcare system. I think that's obviously directional in terms of where we see things now. Yeah, 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 are coming on, the data sets you release, some of the news flow and catalysts you've got upcoming, that I'm sure there's 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 a stellar story on its own. 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. I do think it's a sum of the parts seem smaller than the individual pieces.
Got it. All right, thank you very much, Mike, Helmy. Appreciate it.
Thanks.