Hey, welcome to the Canaccord Genuity Growth Conference. I'm Kyle Mikson. I cover life science and tools and diagnostics for Canaccord Genuity. Really pleased to welcome you to a fireside chat with Guardant Health here with us today. The company's a leader in precision oncology diagnostics across screening, MRD, and therapy selection. With us from the company, we have Helmy Eltoukhy, Co-CEO, and AmirAli Talasaz, Co-CEO. Thanks, guys, for joining us today. Appreciate it. Yeah. Yeah. Thanks for having us. Yeah, of course. Let's start with the 2Q 2026 earnings recap. You guys had earnings recently. Again, like a really strong quarter, nice beat, raised guidance. Could you just walk through the results, put some takes from the quarter? Yeah. Once again, I think it shows a business that's really firing on all cylinders. We have these three overlapping S-curves, very large market opportunities that are all growing very rapidly. We had great growth with Guardant360 in our oncology business. That's our flagship therapy selection test. We saw over 30% year-over-year growth there. We saw even greater growth for our tissue test. It's really, I think, just the momentum we're seeing with the Smart Platform, this really broad-based genomic, epigenomic platform we launched almost two years ago now, and we're continuing to see sort of that pay dividends in terms of continued volume growth and adoption. We're also seeing very good strength in our MRD business. This is the next market that we're in, the sort of $20 billion recurrence detection market. We have our product Guardant Reveal that has been doing really, really well. It's been growing over 100% year-over-year. We recently launched a new indication for therapy monitoring there in November of last year, and we see really good growth with that market really drafting behind Guardant360 and the strength we have with oncologists. Then finally, with Shield, we're seeing, I think, continued very strong momentum there. One of the, if not the, probably most successful launch in diagnostics from both a volume and revenue point of view. We're seeing I think 50% quarter-over-quarter growth there and multi-100% year-over-year growth there. So, I think a lot to like about how the year has progressed so far. Perfect. I think, then just kind of diving into that, I believe oncology volumes grew like 60% year-over-year. Yeah. Liquid, I believe, grew like 30%, and tissue was above that. Then Reveal, you just said, I think has grown over 100%. Yeah. So maybe just in liquid, that's the historical kind of business, so some catalysts we'll talk about later, but could you maybe just help maybe size the tissue and the reveal kind of opportunity, like revenue or volume streams right now compared to what we've seen with others in the market? Market share is talked about. Just how large, how material is this in terms of moving the needle for you financially? On the therapy selection, on the liquid. Reveal and Guardant360 tissue. Those right now are obviously smaller contributors to the overall business compared with Guardant360, which we launched in 2014. But the fact that those are growing, I think, very rapidly bodes well for the coming years. We think tissue is going to be a pretty large segment for us as we continue to lean into it. What we're seeing is that that flywheel just takes time to gain speed, especially for a product like a tissue product that we have incumbents in there. There's I think legacy products that are out there. As physicians start using it, trialing it, sampling it, and then they gain experience with our lower QNS rates, the comprehensiveness of the test, all the apps that we have on it, we're seeing that momentum build up, and it's something where I think we can continue to take share and build that up into a fairly sizable business. MRD, obviously, I think is still very much in its early innings. That's something where not only do we have, I think, the premier tissue-free MRD franchise right now, we're about to launch, this year, our first tumor-informed offering, Reveal Ultra. We will be probably the company with the most comprehensive offering in oncology in terms of liquid tissue, tumor-informed, tumor tissue-free. We think that will also carry a lot of momentum on its own in terms of, especially at the key account level, in terms of large cancer centers sort of using our portfolio for the bulk of their patients. Perfect. One more on the kind of the quarter and what's currently happening. So on therapy selection liquid, you're growing as fast as some of the competitors, the 30% or so. How are you able to do that with such a larger revenue and volume base than these other companies? Well, I think it goes down to architecture of the technology. It's just head and shoulders above what we see out there. It's the only liquid product that has full comprehensive genomics and epigenomics in terms of methylation. There's now hundreds of thousands of samples that we've used to train these applications that we've launched on that platform. It's allowed us to do things that essentially, I think were once considered science fiction in terms of being able to tell the histology of disease, seeing transitions from non-small cell lung cancer to small cell lung cancer in blood. We have FDA approval now in that platform. So we have just, I think, created both a platform and a moat, frankly, that I think has put us in a really good position. The other piece is it takes time with diagnostics to essentially have physicians understand the power of the platform, especially with all of these apps and with all of these features. It's not like you can order just one test and immediately experience all the wonder that is Guardant360 Liquid CDx. You have to see it interact with a particular patient subset that has that mutation or has that sort of feature or that biomarker. As physicians have continued to use the test, I think they're gaining more and more confidence that this is something that is truly differentiated, which is why we're seeing that acceleration and the momentum. Yeah, impressive. All right, thanks for that. Amir Talasaz, on Shield, it's been very impressive ramp so far. It's been a beat and raise every quarter that you've offered it. I think in terms of the guidance for new volume, it's been well over a year, obviously. What surprised you most about the launch and the adoption so far? It's obviously been very positive and there's been catalysts, but what in your mind stands out? Yeah, we are very excited with what's happening on the Shield front. We're in the second year of launch now, and I think we graduated from category-building phase to really category scaling right now. The amount of market adoption of Shield is obviously way more than what we thought, how fast HCPs and PCPs are using this test, on how many patients they're using this test. The productivity of our reps is way more than what we expected from them. And frankly, most recent development with UnitedHealth Group was fascinating. We didn't expect a major payer, which is typically a lagger in giving coverage to innovative technologies, to act first and provide very broad access to Shield testing to all patients within their plan. In this world of managed care, we believe no payer want to be first, no payer want to be last, and definitely this kind of development is very exciting for us. Yeah. On UnitedHealth, again, very surprising that that occurred. Maybe talk about how that came about, and also why we shouldn't expect other large commercial plans to join suit over the next year or two. We didn't expect it. Having said that, we are working on it for multiple years. Because of our oncology products, we had multi-year relationship with UnitedHealth Group. We've done pilot of Shield within some of the employer base that United was managing their health benefit, and the experience there was also very positive. So after this multi-year conversation and recent guideline inclusion, and lastly, the guideline inclusion by American Cancer Society, that really acted as a closure and the final triggering point for them to give us positive coverage for Shield blood test. In terms of other payers, we don't expect any major payers to give us coverage before end of the year. Having said that, we are having some positive and constructive conversations with several players in the field, and we see what happens. I guess on the ACS guideline front, what's that tailwind look like for you in terms of the 12 states or so that would cover? We knew that American Cancer Society guideline is well-respected in the field. We knew about some state-level mandates that once American Cancer Society recommends a colon cancer screening test, there would be state-level mandates for coverage of that test. What we did not expect is the impact of American Cancer Society guideline in decisions by major payers, including UnitedHealth Group. So that was unexpected, and it's a very good and positive surprise for us. Okay. Then the Shield, the new approved workflows that are lower COGS, I believe. In addition to that type of an improvement, what can you do on the performance side over the next few years? Just give us a flavor for what you're cooking up behind the scenes for Shield. We are in still very early innings of commercialization and scaling within this category of CRC screening. Having said that, the gross margin of Shield is pretty healthy as we speak today. When you are thinking about the Q2 ASP that we reported, the COGS of roughly $400 that we reported in Q2, we are already sitting on a pretty good gross margin there. Having said that, we have a roadmap to reduce our COGS for Shield and improve the scalability of that test within the next two years. We got FDA approval for newly enhanced Shield workflow, which increases the throughput of the Shield and also increases the efficiencies and reduce the cost for us. That should reduce the COGS of Shield by 15% by end of the year. We expect and continue to be on track that sometime in 2028, at scale, the Shield COGS would drop to about $200. ASP of north of $700 in 2028 and COGS profile of approximately $200 would generate a lot of exciting gross margin profile for us. All right. Maybe just taking a step adjacent to this for a second on Shield. A competitor today had a Breakthrough Device designation announced for lung. You guys have the lung indication in the works and the study and so forth. Maybe talk about why you guys have this moat and advantage in screening, whether it is for single cancer or multiple cancers. I believe we got our Breakthrough Device designation for Shield as a panel of 10 cancers, where lung is part of that 10 cancer, probably two years ago. I think other competitors in the field are continuing to play some catch-up games with us. This first-mover advantage, which rooted in working on Shield during the time that there were not many believers this thing would work, is generating a lot of opportunity for us. Shield, as a platform, we developed it as a multi-cancer detection platform. It is clinically validated for a panel of 10 cancer types right now, all solid tumors. For one indication, colorectal cancer screening, it is FDA approved. We are also working on FDA approval for lung cancer screening. That is a long trial that we are doing during last four years. We made very good progress. We finished enrollment. All the patients have finished their clinical follow-up or going through the clinical follow-up. We continue to expect to finish the follow-up and clinical database probably sometime before end of the year or early next year. All right, excellent. On the MCED component, the opt-in, you have been kind of offering that for some time now, maybe almost a year, half year. I think the attach rate is pretty strong, is what you have said recently. Maybe remind us what you are going to use that data for and how that compared. Where does this kind of fall on the whole, like the Vanguard Study, for example, and what is the go forward over time with MCED? Mm-hmm. Right now, when the patients are going through CRC screening and they are eligible for CRC screening, patient has a choice. If they are interested, they can opt in and receive the information about nine other cancer types. As long as the patient participate in our data initiative program that we have, effectively they authorize us so that we can get access to their medical record, and we can monitor really the performance of our MCED test. Shortly after launch, we were amazed with the adoption of that opt-in by physicians. We reported in our Q2 earning call that now majority of PCPs who are prescribing Shield are in fact opting in to receive that multi-cancer detection result report. What that gives us the opportunity is to build this U.S. patient database of the performance of and utility of MCED testing very quickly, powered by the commercial leverage that we have and scale up of CRC screening, and the strong opt-in by physician and the patients that we are experiencing. We are not far away from having a database which is going to be powered enough that could be the main backbone of our submission to FDA for indication expansion of this test from CRC screening to multi-cancer detection. Still, there are some work for us to do on that front, but the commercial scale of Shield is really paving the path for us to get to that point in near future. All right. Just for context, the other MCED FDA submission right now has 175,000 patients, maybe even more, in the submission. Would the data points that are included in what you just said basically eventually add up to something like that or bigger? If you just look at even the guidance for our CRC testing this year of 270,000 to 285,000 testing this year, you can get a sense of the commercial scale that we are talking about. It's not going to take us long till we get to this point of having a major clinical database in our hand. Okay. On commercialization in Salesforce, you have I think 400 reps right now, plus a DTC effort. Can you talk about the balance between those two functions, basically? We have a skilled commercial infrastructure right now. More than 400 reps in the field, which at steady state, we are going to scale it to 600 to 700. We made significant progress and dramatically actually build that commercial infrastructure. Our national DTCs and influencer campaigns are live at national level. Maybe some of you guys have seen those kinds of ads. In terms of the investment, still majority of our investments are going in the personal promotion on the field force side. A material fraction is going in DTCs, and we expect that to continue as we go to next year. All right, perfect. Helmy, going back to you on the Guardant360 Liquid CDx approval recently. That is great. Did that impact volumes at all, maybe end of Q2 or early third quarter so far? What is the path for the ADLT raise in trying to get to the $8,500 rate? Yeah, right now we are phasing the launch, so most of it will be launched really once we get ADLT designation. We got it late in Q2, so it really did not impact the Q2 results. We are certainly seeing a lot of excitement around that approval and we are hopeful that that will be something we can continue to lean into as we sort of make more progress in the field. In terms of ADLT, we have been, I think, positioning it around the sort of first half of 2027 event. We are going through the sort of motions of getting a PLA code and then submitting for ADLT, which are the two steps required for that. Yeah. The ASP for that therapy selection business could be maybe $5,000 or so in the next maybe year or two. Is that kind of the guidance? Yeah, I would say that there are a couple steps along the way. There is first getting Medicare Part B, then Medicare Advantage, and then finally some of the commercial payers. So it is at least probably 12-24 month process to get to something close to what you mentioned. Okay. On the ADLT notes, do you still plan on trying to get Reveal ADLT status from payment, right? Yeah, I think all our products long-term, our intention is to get to ADLT status. With Reveal, we still have some irons around the novelty pathway, but I think we have a full plan B around FDA approval, so we're working on some of that. The same thing with tissue. We see that getting ADLT at some point as well. Perfect. Sticking with Reveal, so you're trying to get coverage from MolDX for breast cancer and therapy monitoring, and the volume for those indications has been growing really fast, obviously. Once MolDX turns that coverage on, what could that mean in terms of that revenue stream for you? Yeah. I think the exciting thing is just how much demand we're seeing in the market right now ahead of reimbursement. I think that really is a leading indicator for really the fact that we have product market fit with these products out there. There's a lot of people who love using them and really the next shoe to drop is just getting reimbursement and getting the ASP up for those products. I think we're also excited about expanding indications beyond those as well. We have a lot of work we've done in terms of expanding the platform beyond just breast, lung, and colorectal cancers and therapy monitoring. We see a lot of opportunity there over the coming years for increased expansion, increased volume as well, and then obviously Reveal Ultra as well. Yeah, and Guardant Reveal Ultra, I was going to say like that's reimbursement at some point in the next year or so. How important is it to really round out the Guardant Reveal portfolio in order to compete? Because I feel like that's kind of the name of the game in MRD, it's kind of having like a portfolio of products. It's very obvious what you're doing on the therapy selection side. Yeah. Shield side, but Guardant Reveal's a little bit more behind the scenes almost. What's your take on that? Yeah. We think the market will be similar to how things have evolved on the therapy selection side of things, where there is a need for both products, both liquid products and tissue products. We think there are two, I think, very large market opportunities around tumor-informed and tissue-free. I think with tissue-free, you get results much faster, you have a wider catchment in terms of detecting disease that may not be the same as what was taken out with surgery. And then obviously with some of the sort of ultra- sensitive tumor-informed approaches, you can go very deep. But those tests tend to be slower and more narrow in terms of what they detect. I think there's really a place for both in the large 18 million sort of patient population that is part of the MRD market. I think the eventual winner, I think, will have best-in-class products on both sides. All right. There's been a lot of kind of consolidation in the MRD space recently, past few months. What's your thoughts on maybe a bolt-on, given all your cash, to enhance that portfolio? We have a very, I would say, active corporate development group. We want to do things that are sort of meaningful in terms of the pipeline that we have. Obviously, we have a very robust pipeline, a lot of innovation that's happening inside of Guardant, a lot of great product trajectories. But when we find things that make sense, we execute on them. We had a small tuck-in late last year with MetaSight, but there's hardly a deal that sort of happens that we haven't sort of at least looked at and kicked the tires on. Yeah. It feels like your epigenomics and your multi-omics kind of platform can enable you to break into multi-disease market, $300 billion is the TAM basically. But also acquisition could help as well. What's kind of like a good way to think about the timing for Guardant to break into something outside of oncology? For some indications already we have some proof of concept data, so let us make more progress on those matters and we will talk about it more firmly in terms of timeline. But definitely we are seeing some exciting matters when you're thinking about these very wide, highly sensitive epigenomic technologies that we have. We are finding abnormalities in body, which is the source of it could be way beyond oncology when we are talking about organ health monitoring, when we are talking about fatty liver, when we are talking about neurodegenerative diseases like Alzheimer's disease dementia. For some of these, actually, we have proof of concept that looks like during the early phases of developing that disease, we can find some signatures in their blood. So we are very excited with it. Early days, let us make more progress and we'll see what happens. All right. It's exciting. Generally the strategy might be to piggyback off of the personalized medicine or the precision medicine kind of market in different diseases perhaps. Is that kind of like the way you do in oncology? Yeah. When you look at actually even the concept of screening MRD treatment management, that's just not specific to oncology. Oncology was one of the leading disease areas, but just look at neurology, even the last panel that you had, the progress that's happening there with multiple therapeutic opportunities. Patients need to get monitored about the activity of disease similar to MRD, and then we need to find some early development of some of these diseases in patients who have symptoms or even average-risk people. Effectively, the continuum of care scenario that we have for oncology is replicatable in other diseases. All right, awesome. Kyle Mikson, just sticking with you on Shield again, just thinking about the path forward, it's been so strong, so impressive. It's still inflecting basically, and it's got UnitedHealth Group coverage and American Cancer Society. How could that product really surprise investors, let's say maybe next year going forward? USPSTF could be a factor. What else we should be looking forward to? Well, if I tell you the surprises, it's not going to be a surprise. So stay tuned. Yeah. Walked into that one. I guess on that note, though, what is your thoughts on guideline inclusion in the next couple of years? It's been very volatile, that group. Yeah. The reality is there's a bunch of uncertainty there. We are taking our position that based on some of the activity that's happening, we are not changing our projection of bringing any timeline forward. Still task force, we are considering it maybe late 2027, 2028 kind of timeframe. Having said that, it's kind of interesting that finally they're going to meet sometime this quarter after one and a half years of not meeting. Yeah. Potentially with the new membership. The field has changed. Again, look at some of the commercial payer actions that we are seeing. Other players are well aware of what's happening, and I think some decision makers and stakeholders are not going to wait for USPSTF's decision, but we'll see how it goes. All right. Then one kind of interesting question I get sometimes is like why order the single cancer screening test when I can have one for 50 cancers or maybe 10, but 10 isn't offered by U.S. just yet basically, FDA approved. So why choose Shield rather than the one I just referenced? Shield is multi-cancer detection. I think that there is some minimum performances that you need to hit for some specific single cancer type in order to be considered even as a screening test. Some of the multi-cancer detection technologies which are out there, they are not going to qualify as a CRC screening test. They are not meeting those bars. They don't have the clinical evidence to support that. These are two different kind of categories. You need to have high performance in order to qualify for screening, which Shield is, and also we can do multi-cancer detection. I think future for this kind of a pathway that we pick for our Shield platform is very bright. Awesome. Thanks, AmirAli Talasaz and Helmy. Yeah, thank you very much. Much appreciate it. Thanks for having me.