My name is Mike Riskin. I'm on the Bank of America Life Science Tools and Diagnostics team. I'm excited to host for our next session, Guardant Health. We're joined by, we got Helmy Eltoukhy, Chairman, Co-founder, and CEO, AmirAli Talasaz, Co-founder and Co-CEO, and Mike Bell, Chief Financial Officer. Gentlemen, thanks for being here.
Thanks, Mike.
Thanks for having us.
I mean, maybe to kick things off, I'll just, not my traditional opening question, but Helmy and AmirAli, you guys had suggested travel plans here. You accepted an award yesterday. Maybe you could just talk a little bit about what you've been up to the last 24 hours, and we can frame that into the conversation.
Yeah, sure. Actually, we're honored to be part of the honored list of top 100 Most Influential People in Healthcare last for 2024-2025. That came following Shield to be recognized as one of the Top Innovations by Time in 2024. We're very excited.
That's a perfect intro. Maybe we'll just kick it off right there on Shield. You guys just reported Q1 recently. You did 9,000 tests in the quarter ahead of expectations. Maybe you could talk a little bit about what you've seen since you've rolled it out, sort of what the feedback's been, what do you think is driving adoption?
Yeah, I'm more confident than ever about actually what Shield could do for the patient and for Guardant Health. We continue to see Physicians use this test in a very meaningful way. The feedback continues to be very solid, very strong. When the Doctors are ordering Shield, patients complete the test and do the CRC Screening. It's been amazing when we are looking at higher depth of ordering by the prescribers that have access to Shield now. It gives us a lot of confidence about the durability of the growth that we can have with Shield. The higher productivity per rep relative to the internal expectation that we have gives us a lot of confidence that actually this year could be a fantastic year, and we can have a very strong launch for Shield.
Maybe on that point, you can talk about your updated guide for the year in terms of Shield, sort of what are your new expectations and the roadmap to get there as you go through the year?
Yeah, so we upped actually our volume to 52,000-58,000. It's almost like the whole volume we did in Q1, we almost raised our guide for a whole year by that amount, which is kind of an indication of how well this launch is going for us. We exited Q1 with a very strong momentum, and we continue to see actually good performance. Actually, that gives us confidence of raising the guidance that we have. Still, the guide would be a very thoughtful guide for us, but it's a very reasonable target to have in mind for the performance of this year. Also, earlier this year, actually, we heard about the ADLT status designation and the improved Medicare rates that is in effect actually starting April 1. That additional ASP was also part of increasing our revenue guidance to $40,000,000-$45,000,000 for this year.
This test, with this revenue, could be one of the biggest diagnostic launches ever. We will see maybe if we can make it the biggest launch ever.
Talking about the new guide, the midpoint $55,000 test, $40,000-$45,000,000, you talked a lot about getting reps more productive, widening sort of the funnel. Can you talk us through the pacing through the year as those reps get productive? When should you really see that flow through?
Yeah, sure. Very good question. We launched this test last August with about 50 people in the field. We ended the year with 100 people fully deployed in the field. We are continuing the hiring, onboarding, and the training of the new reps. When you consider the productivity ramp for these newly hired and this new channel that we built, we are expecting our volume to be second half backloaded. That would be some of the trend lines that we are expecting for this year. So far, so good. Like in terms of when we look at our Q1 performance, as I mentioned earlier, the productivities that we are seeing from those 50 people that we started the launch with, or the ones actually we hired after the launch, their performance has been better than our expectation.
Are you assuming in your guide that the remainder of the sales force ramps that same level of productivity on a similar lag?
Yes, but with some assumption that as we also are adding more reps and we are going after more territories, maybe some of the territories are going to have less productivity than our highest tier kind of territories. We are very thoughtful about that reality of going into newer territories. We see how the whole year would pan out for us. As I mentioned, there is a lot of modeling and thoughtfulness that goes into this new guide that we put out there.
Going forward beyond second half of this year, can you talk about maybe need for additional sales force expansion? Sort of how would you tackle the next level of growth?
Yeah. I think still we believe at steady state in order to really have nationwide coverage on the PCP front and health systems, we need to get to about 700 people in the field. We are going to get to that in a step-by-step fashion. The great thing about the sooner than expected ADLT status and higher productivity for the reps that we are seeing, we mentioned that we are expecting now more than about $10 million additional gross profit than our original estimate. We are reinvesting that additional gross profit into more accelerated commercial infrastructure build-out.
We are going to go after this build-out to 700 people based on the gross profit that we are going to generate throughout the next few years and meeting some additional milestones that we are going to have in terms of commercial attraction and the revenues that we are going to have with Shield.
Talking about the Gross Profit Dollars, can you talk about cost reduction and other factors in the Gross Profit Line?
Yeah, on the Shield side, we've made very good progress on the reduction of the cost per test. Before we launched the FDA-approved version of the test, cost per test was over $1,000. Now we've reduced that to below $600, and we actually now have in Q1 a gross margin positive test. There's still plenty of room for that cost per test to reduce. Volume is going to be a driver. That's been the driver to date. Making efficiencies to the workflow, we're going to have a step down in cost per test. That's more likely in 2026. We're also investing a lot on the automation side. We want to take out as much labor cost from running the test as possible. When we implement that, it's probably 2026, 2027 timeline. We'll have another step down there.
I think we feel very confident with all of the initiatives we're taking and the growing volume that will eventually, by the time we're at a million samples a year, we'll have cost per test of $200.
$200. Okay. Maybe we can talk about Shield v2. So just give us your latest thoughts on that. What are you most excited about?
Yeah, maybe for some of you guys who may be newer to this story, we got the first generation of Shield. We took it to the finish line, got FDA approval, CMS coverage, and we're very excited with its performance. That would not be the best thing that liquid biopsy and Shield can do. We are working on a pipeline of activities to make Shield a better test. One is around improvement on Colorectal Cancer and AA potentially, and on the other side is adding additional cancer to the same test. Now this Shield v2 is a newly developed algorithm that we have. It's more sensitive. Looks like it can detect Colorectal Cancers at the levels which are about two times lower than the previous limit of detection that we have. We have to see analytically, we know this test is more sensitive.
Clinically, still, we don't know. During the last few months, we had very constructive conversations with the FDA. We know what they want to see for validation of this test. We continue to be on track. We expect to get to the readout of this Shield v2, and if the data is positive, submission to agency and hopefully approval, a launch of this test before the end of the year. We'll see how it goes.
How should we think about expansion of the indication? What are the criteria you're looking at in terms of wording next?
That's the part that actually I'm even more excited about the future of Shield. When we go back a few years ago, we built Shield as a multicancer detection platform technology. We are looking at many, many epigenomics features in genome that not only it's relevant to looking at Colorectal Cancer, but they are relevant for a bunch of other cancer types and even potentially other diseases outside cancer. Step at a time. CRC was our lead indication to have basically a pathway for reimbursement and FDA approval. Now that we reached this milestone, we are envisioning a day not far from today that when a patient is getting tested for CRC Screening, the patient can also see if they have any indication of other cancer types.
We are very excited that we got selected by the National Cancer Institute as one of the technologies that they are going to use in their Multicancer Detection Trial. That trial is actually going to start very soon. It's imminent. Once that trial starts, since it's an interventional study, effectively, we are going to have this multicancer detection feature of Shield be operationally and clinically ready for patient management. We are very excited to get to that milestone.
Can you talk about some of the costs associated with taking it through that stage and how that would compare to Shield v1?
Yeah, sure. The beauty is since we've developed Shield as a Multicancer Detection Platform, when we are talking about costs of Shield of today, effectively, the Shield, which can also look at multicancer features, it's the same cost because it's the same panel, same sequencing, same data. When we are looking at that sequencing data, not only are we seeing the signatures associated with Colorectal Cancer Disease, but also we are seeing the signatures associated with other diseases. Since it's just an algorithm, it's effectively the same cost for profile.
Let's move on to Reveal. You talked about how performance in Q1 was driven by G360 and Reveal. Can you talk about relative contribution, how Reveal played out in the Q1 ? What are your expectations for the rest of 2025?
No, we were very pleased with the performance of both tests. With Reveal, I think we were very pleased with the reimbursement decision in terms of CRC Surveillance for that test that happened very early in the year, which was great. Really getting the sales team to sort of fire on all cylinders in terms of really pushing out the new patient starts as well as starting to build the adherence and compliance engine around subsequent test orders. We are seeing acceleration in volumes in both tests in 360 and Reveal. We are seeing, I think, really strong momentum and new patient starts after that reimbursement decision. Now it is about pull-through in terms of just execution in terms of the subsequent test orders.
I can tell you that there's sort of a latent demand or latent sort of test order that's out there from the existing patients that would be a huge, huge step up from where we are today. I think when we look at the back half of the year, we expect to see, I think, a pretty strong inflection in terms of Reveal volume as those volumes sort of pull through.
When you talk about the weight and demand from existing orders, are you talking about orders you already saw, or are you talking about?
Yeah, if you think about it, we have a bunch of new patients already in the system. We were not necessarily pulling through those subsequent orders with very high rigor. Now we are turning all of that machinery on in terms of going to patients, going to physicians, pulling that. That just takes implementing the right systems, processes, Offsite Phlebotomy, and so on. All of that is being put into motion in terms of the last few weeks, a few months. It has been good. We are seeing returns on that investment. It is like a snowball that is beginning to sort of ramp up and grow.
Mike, maybe for you, you talked about Reveal is also now gross margin positive. Can you talk about the contribution there and some more of your comments on Shield, how you expect that to ramp?
Yeah. Again, Q1 was a great quarter for us in that Reveal flipped from being a gross margin negative test to gross margin positive. In fact, again, last year, before we implemented these workflow efficiencies with Reveal, the cost per test was over $1,000. Running that test with the reimbursement where it was sort of between $400-$500, it was a cash burn for us, a significant cash burn. Now that that's flipped, we've got the CRC surveillance reimbursement. Our CRC Reveal ASP now is over $600. Reveal COGS around $500. It is gross margin positive. There is room for that cost per test and gross margin to continue to improve. Cost per test going forward is really going to be driven. The reduction is going to be driven by continued volume.
There is the opportunity for us to take the automation that we're building for Shield and also put that onto Reveal. In a couple of years' time, there could be another step down in Reveal cost per test. Of course, we're focused on additional reimbursement for Reveal. We're pursuing the ADLT route for CRC. Hopefully, we'll be able to submit to MOLDI-X for breast reimbursement soon. We see potential increases in ASP, continued improvement in cost per test. Gross margins continue to expand from now onwards.
Can you talk a little bit more about the timelines for those reimbursement decisions and potential ASP Uplift?
Yeah. I think most likely within the next quarter, we should be ready to submit for breast and potentially IO Therapy Monitoring. Maybe end of the year is when we would, at the earliest, potentially be over the finish line from a Medicare reimbursement decision, hopefully a positive one. That might move into the beginning of next year. Yeah, we're very encouraged by the data, by the performance we're seeing from the tests. When you think about those three indications, CRC, breast, and IO monitoring, those three make up the largest of the MRD indications and would then provide a very strong base for that franchise for us.
Okay. You touched on some of your ongoing studies. You've got some longer-term studies in progress as well. Can you just give us an update on how you think about data readouts and that as a Catalyst path?
Yeah. So those are the three that are nearest term, but we have something like 10 or 11 other indications we're working on. We have something like 20,000 patients and 80,000 samples that are queued on MRD over the next few years. Some of the biggest studies we have are the TRACC study, which is an interventional clinical utility study in colorectal. That will take a couple more years to read out. I think we should have some other readouts potentially in the coming quarters as well and some smaller clinical utility studies. It is going to be a steady drumbeat in the coming quarters and years in terms of additional data readouts on Reveal. Like I said, those three sort of give us a solid base, and everything else would just be additional ASP over time.
Maybe let's pivot to Therapy Selection, G360. You talked about accelerated growth again in the first quarter. I think it was the 2nd or 3rd consecutive quarter of accelerating growth. Can you talk about the factors that are driving that? Sort of what did you see in that business?
Yeah, it's a Q3 of accelerating growth, but who's counting? It's one that is very exciting. When you look at the volume for 360 and you break that out over the last four or five years in our business, we're seeing one of the fastest ramp rates we've seen in 360 in that time period over the last three or four quarters, really coincident with the launch of our Smart Liquid Biopsy Platform. It's really telling us there's a market preference, there's a product-market fit that we've unlocked with this new test. It's very exciting because we really haven't sort of unleashed all of the power and promise of this platform yet. We have a major launch of many new applications that will be added in the coming months and quarters to this platform that will be even more exciting.
We're essentially creating all these features that provide additional clinical utility around IO therapy, around PARP inhibitors, around tumor biology, around transitions of disease, subtyping of disease, essentially seeing cancer at its fundamental level at much higher resolution than has been possible through either tissue or liquid. It is very exciting as we start sort of launching these features. Essentially, we're creating a whole new visual language by which to essentially understand disease, understand a specific patient's disease. That is going to carry through to all of our products on the oncology side or tissue products with this new launch that we have. We'll have all of those features as well over time. The ones that apply will also apply to Reveal as well.
It's going to be a really exciting Ecosystem that is all sort of buoyed up by this epigenetic backbone that is this common string across our portfolio.
Okay. You mentioned G360 Tissue. I want to touch on that in a sec, but briefly on G360 ASPs, you saw a little bit of an uptick this quarter. Can you talk about conversations you're having with payers? How much more progress do you think you could have there?
Yeah. I mean, I think there's still room to continue to grow that Guardant 360 ASP. We made significant improvements last year, taking it from something like $2,700 to $3,000. In Q1, we're in this range now, $3,000-$3,100. There's been a few things. One was getting the Medicare LDT rate to $5,000 at the start of 2024. We've seen the pull-through with Medicare Advantage payers. I think we've sort of got through to the end of that pull-through now. We've reached a nice steady state on Medicare Advantage. The opportunity for us to further expand the ASP really now comes on the commercial side. Whilst we've got very wide coverage for Guardant360, there are still gaps.
There are gaps with a lot of the national payers who maybe cover LDT and not the CDX version, or they cover certain indications like lung and breast. I think we have a very strong team. They are continuing all the time to talk to those payers. We are looking to push as hard as we can to expand coverage. We think there is at least another couple of hundred dollars over the next two or three years that we can further expand the ASP.
Okay. On G360 Tissue, what's been the response to that so far? A little bit more recent launch.
Yeah, look, we've had a lot of success with our tissue product over the years. We've essentially had Tissue Next. We saw when we expanded it to 500 genes, we saw a really nice uptick in terms of volumes. What we started seeing was a lot of physicians coming to us, and especially when we had those 500 genes, and only ordering tissue from us. Physicians that weren't ordering liquid products were starting to order tissue from us. We call these standalone orders. That was a really sort of nice kind of response from the market. What we've been hearing from some of our liquid customers was, "Add RNA-tiered Tissue Tests, and we'll switch our volume over to you." We knew there were a lot of buying signals out there.
When we built this new product, Tissue 2.0, we really took all the market feedback, everything that was sort of a pain point with tissue today, and everything that we knew that could enhance the clinical actionability of these tissue tests. That is essentially what our Tissue 2.0 or our Guardant360 Tissue represents, is all of that feedback put into one product. We can use essentially much smaller samples than the other products out there, 40% less tissue, which is one of the pain points that are there. It's fast turnaround time, which is another pain point.
More importantly, we scour essentially that piece of tissue across a trifecta of biomarkers, DNA, RNA, and methylation, essentially Genome-wide Signals where we can essentially make sure that no biomarker is sort of like unturned in terms of being able to find a potential option for patients. So much broader DNA analysis, RNA analysis. Then with Methylation, we bring all of the features of Smart Liquid Biopsy to the Tissue Platform, seeing potentially PARP Inhibitors, IO Options. There are many clinical trials now that require promoter methylation, for instance. No other test out there today on the tissue side provides that information. I can tell you that when we launched this now just nine, ten days ago, our sales team has never been more excited for any product we've ever launched than this launch here.
It's a really important sort of final piece of the Oncology Portfolio, at least in terms of the major product categories.
Okay. You just walked through a lot of it, Helmy, but I want to kind of wrap it together. On the tissue side, it feels like it's a little bit more of a competitive marketplace. You've got a number of players that have been established there for a while. You touched on the epigenomics. You touched on the faster turnaround time, the 40% less tissue. Do you think those differentiators are enough to let you really gain share here versus Caris, Foundation Medicine, Tempus?
Yeah. You know, when we look at it, there are entrenched incumbents there. We know the bar is very high in terms of being able to switch patients from one provider to another. I think one of the advantages we have going for us over sort of a new entrant in the space is that we've built a lot of trust with oncologists already. We have something like 10,000 oncologists that have ordered our products over the last 12 months. There is built-in trust on the liquid side. They know what it's like to work with Guardant. They know that we give them white-glove service. They know the quality of our medical affairs personnel and so on. I do not think the bar is very high for Guardant specifically in terms of driving that switch.
That being said, we are very confident with this sort of product profile that for every 100 patients a physician tests, that we would provide more actionable insights than the next test out there.
I want to talk a little bit about the breadth of the portfolio and, again, bring it all together. When we talk to docs or KOLs in the space, they all tend to identify sort of one leader in blood, one leader in MRD, one leader in tissue. There really hasn't been a player out there that's really managed to sort of emerge that brings it all together into one umbrella. As you look at Shield, Reveal, G360, G360 Tissue, do you think that having all that under one roof can really change the conversation with Oncologists in terms of Guardant's positioning in the market?
Look, I think I'll speak for the oncology side where that's a single call point. It's attended 12,000 or 14,000 Oncologists that are out there. Yeah, absolutely, that's increasingly becoming an important selection criteria. Can I simplify my life? Can I simplify my ordering process? Can I use one portal, one EMR to order all of the products that I need for making diagnostic decisions on a patient? Yeah, I think that is where the bar is moving. We are, I think, one of the first companies to really sort of really populate the whole portfolio across the board. I think longer term, I think you're going to see crossover between the primary care channel and the oncology channel. The fact that MRD patients, cancer survivors, 12 million of them are more than five years out from surgery.
Many of them are in the primary care channel, and that's where it's easier to access them. Having access to a primary care channel is going to be a huge strength. I think there are high-risk patients in the oncology channel where having a sort of version of Shield, for instance, that can address that population is going to be really important. Yeah, we see that together, we can serve the entire market in terms of the cancer care continuum much more effectively than companies that are sort of piecemeal or only in one segment.
Talking about the Cancer Care Continuum, you've talked about this a number of times in the past where you sort of do see it as a journey with a patient where there is a G360 test, then there's a therapy, and then there's an MRD, and then there's repeat screening. Again, you're now sort of getting to that point where you're able to provide all of that. Can you talk about potentially the uplift that could get from just having that patient travel through that journey, whether you want to talk about it in terms of tests per patient, however you want to address it?
Yeah, you're seeing that kind of all roads are leading to sort of more and more tests per patient. We have things like the Serena 6 trial we're doing with AstraZeneca where you're seeing the emergence of this new paradigm in terms of molecular progression, essentially testing the patient at multiple time points and looking for the earliest signs of emergence of a resistance marker. You can switch that therapy when the cancer is as small as possible and as easy to fight as possible. That is going to be the future of all of sort of disease intervention, finding it as early as possible and intervening as quickly as possible. That is where I think having a continuum of testing where you can have one data stream that allows you to track that patient from beginning to end is going to be really important.
That's why I think one of the sort of hidden important features of our portfolio is the fact that it's all built on the same technology stack. The fact that I can essentially take a patient, I can understand exactly what tumor level, what disease markers are there, whether they're in the screening segment, MRD segment, therapy selection segment. We haven't built a Frankenstein portfolio of pieces we've sort of inorganically acquired and stuck together. These are all built from the ground up with the intention of spanning this continuum from essentially when we started the company.
Okay. That's a good point. Mike, I want to make sure I touch on the financial profile and profitability. I talked a little bit about some of the individual products this year, but could you bring it all together in terms of ramp and profitability, even a margin positive, free cash flow positive?
Yeah. I think we sort of look at the business in two sections. One is screening. If you look at that, obviously, that's not profitable now. That's because we're ramping up the commercial infrastructure. We're sort of committed to this, managing the net burn on screening at the $200 million level for this year and next year. We envisage at some point soon after that, we'll start to get to a level of scale that that burn will start to come down significantly quickly. That's screening. The rest of the business, I think the profile is very strong there. Therapy selection, Guardant 360, that's already profitable. A biopharma business is a profitable business. We're significantly reducing the cash burn on Reveal now that it's gross margin positive.
If you take all of the rest of the business excluding screening together, that is heading for being break-even by the end of this year. We are absolutely committed to that. I think then if you put the two together with a screening business that will burn $200 million over the next couple of years, but then quickly get to break-even and a profitable business excluding screening over the next couple of years, we are on track to hit our target of company-wide break-even by 2028. That was our target. Potentially earlier, we have seen a lot of tailwinds across the business. I think the path that we are on to that profitability is a very strong course.
Okay. We're out of time, but I'll squeeze in my ROAS closing question. Whoever wants to take it. What do you feel is most underappreciated or misunderstood about Guardant?
I think maybe there are several points too. Like earlier, what Helmy mentioned, Guardant is truly the only company right now who has great offerings across screening, MRD, and treatment selection. When you see MRD companies are trying to get to screening or screening companies are trying to get to MRD, this is also an indication that other people are trying to catch up since they see that strategic value of being a player at the continuum of care. Since this was our vision from the beginning, we got there much earlier. I think the value of this over time will just show itself more and more in the quarters and years to come.
Great. Thank you.
Thanks, everyone. Thanks for joining.
Thank you.