Y ou want to do it? Terrific. Good morning. Welcome day three of the TD Cowen Global Healthcare Conference, 46th annual. I'm Dan Brennan. Really pleased to be joined with me on stage here, the senior management team of Guardant Health. To my immediate left, we have Helmy Eltoukhy, who is, and to his left, we have Mike Bell, who is the Chief Financial Officer. Gentlemen, thank you for being here. Thanks for having us. Terrific. 2025 was an exceptional year, right? Capped off by a solid 4Q. There's a lot of exciting growth areas to dig into over the discussion. Maybe Helmy and Mike, maybe you can just start off by, you know, telling us a little how you see the year ahead and kinda what makes you excited? Yeah, no, I mean, I think 2025, as you said, was, you know, a really fantastic year and one that sort of wasn't in isolation. Obviously, we've been having this sort of accelerating growth for the last few years. I think we're continuing to lean into it in 2026. I think a lot of things are going right in terms of really a confluence of products that are all sort of really gaining traction in the market, you know, starting with Guardant360. I think we did this transition to the smart liquid biopsy platform and this really broad epigenetic profiling and that is really, I think, paying dividends. We launched it in middle of 2024, and we saw really a fantastic acceleration of the therapy selection business. We're continuing to see that. You know, it's a platform that we thought would sort of drive years of innovation and penetration into the market and market adoption, and one that I think we're seeing play out as we launch, you know, more applications onto that platform. It's driving further and further adoption, further share gains and I think greater depth into our physician user base. I think with MRD, we are the sort of clear leader on the tissue-free side of the picture. I think this year is gonna be an important year where we launch Reveal Ultra and really sort of dip our toes into the water on the tumor-informed side. We think with a test that, you know, will, I think really, move the needle in terms of what's possible, in terms of performance, in the, in the market. Then finally, with SHIELD, obviously, we had a very strong year in 2025 in terms of the first sort of full year, commercial, launch of that test and, we've guided to, you know, a very, very strong year here in 2026 as well. We really have all parts of our business sort of firing on all cylinders. Super exciting. Maybe just starting with G360, I think you came off a year of 25% volume growth, 30% in the back half. Yeah. I think the guide this year is for 20%. Maybe could you just unpack a little bit of kind of the drivers? You mentioned Infinity, you talked about depth. I'd love to hear you unpack a little bit, you know, serial testing, maybe more upfront concurrent testing. We'll dig into Infinity in a moment, but just maybe unpack some of the drivers that got you to that 30% growth. Yes. I think a lot of what you mentioned are things we still have left ahead of us in terms of serial testing at progression, really driving that number from one test per patient to, you know, perhaps two or more. I mean, we think every patient, there are 1 million late-stage patients should be getting at least two Guardant360s, at some point, you know, when they start their sort of therapy journey and when they end it as a sort of, you know, last, you know, sort of resort or last option for them. Clearly, many of them will have, you know, testing opportunities in between that as well with every change of therapy, every time they progress. This is something that's gonna continue to grow as therapies get better, as different lines of treatment become the standard of care in different tumor types. We think this is a market that just continues to grow rapidly. I think the nice thing is we've not even sort of, you know, scratched the surface in terms of that opportunity that's ahead of us. What we've seen, I think to date, has largely been share gains and then deeper penetration, in terms of those patients that are not even getting one test for a lifetime. You know, liquid biopsy is still, I think, you know, in that early S-curve or middle S-curve in terms of adoption. Certainly in tumor types like lung cancer, there's been more penetration because tissue is hard to come by. Y ou know, it's a very easy test. Time to treatment is a critical factor. The speed of a liquid biopsy is really important. You know, there's still, I think, a lot of room to grow in many tumor types outside of lung, breast, and colorectal. That's where we're seeing, you know, I think a good amount of growth. We're seeing good growth in terms of greater penetration in those, you know, first three tumor types I mentioned. You know, and then, you know, greater depth with physicians' share gains from some of the other tests out there. You know, I think the platform we have is, you know, is really a gift that can keep on giving in the sense that, we have dozens of other. We've launched 15 applications. We have dozens of other ones that are frankly even more powerful that are in the queue to be launched later this year and over the coming quarters. What we find is that having a sort of substantially new future to talk about, to really drive, you know, hope and optionality for patients, driving clinical utility has been a very strong asset for our sales team to be able to sort of continue the conversation, have something new to talk about, and engage physicians to be sort of loyal users of our tests. A lot to unpack. You know, you mentioned a handful of things. You know, one thing that caught our eye and maybe not super well understood is this therapy monitoring protocol. Mm-hmm. Kind of what it can mean for Guardant. Again, I don't think it's that well understood. Our oncologist yesterday on our panel talked about it. Yeah. Kind of the use case. Maybe can you just unpack a little bit what this therapy monitoring opportunity is, where you stand today with it, and kinda what could be the volume implications? Yeah. We're really excited about that 'cause it really is a fruition of, you know, sort of a vision we had for liquid biopsy when we launched really the field's first clinical liquid biopsy in 2014. You know, this idea that we can move from biopsies and scans to just using blood wholesale to truly select treatment and monitor patients through that cycle. The launch of Reveal for therapy monitoring in November that we did last year is really, I think, a major step towards making that vision a reality. I think the cool thing about, like, what we're doing is, you know, these patients will get a Guardant360 upfront, and the next question is: How are they doing? Are they responding? Is the therapy working? By having a test like Reveal that sort of dovetails nicely with 360 and allows them to sort of monitor that patient, and then when the Reveal test, you know, is potentially positive or, you know, starts growing, we know the therapy is not working anymore, that can, like, quickly sort of prompt them to essentially go do another 360 test, and the cycle sort of begins again. There's, you know, there's not another portfolio here where the tests sort of dovetail really nicely as Lego pieces kind of on one another and, you know, one test is prompting the other and vice versa. We, we call this really the platformization of our, of our, you know, testing portfolio. We're going from just individual tests to essentially a platform or a program for essentially, really managing patient care in the oncology sort of ecosystem. We think this creates a much greater user experience, it creates a more holistic view in terms of the patient sort of care paradigm, and frankly creates a lot greater sort of customer lock-in in terms of the ecosystem. Maybe just back to Infinity for a moment. You talked about maybe some more powerful apps coming. Just what's really stood out amongst the 15 apps or so that you have right now? I know there's DPYD gene- Yeah. In terms of, you know, metabolizing chemo is something that's come up a few times. Is there any that's notably been a driver if we look at the 30% growth in the back half or even just the 25% growth for the year, or is it more just a cumulative benefit across all of these? I don't know. It's sort of like, you know, Baskin-Robbins and 31 flavors in some ways. Like, everyone likes, you know, a certain, you know, type of, you know, app. Depending on, yeah, if they're a colorectal doc, they may like some of the pharmacogenomic features. If they're lung cancer, the fact that we can see subtyping of disease in blood. You know, we had a interesting case where a patient was ALK-positive, which means they have non-small cell lung cancer, then they essentially stopped responding. They tested them with 360, and we saw that they had transitioned their disease from non-small cell lung cancer to small cell. There's no test on the planet that could really detect that. I mean, unless you re-biopsy, you know, the patient and so on, it would be very hard to detect that. We were able to see that. The physician changed to, you know, different chemotherapy, and patient had a really good response as a result. You know, just in breast cancer, we have a subtyping app. Cancer of unknown primary, we can tell you what type of tumor type you have to very high specificity. Yeah, there's just that's the beauty of this sort of app, sort of ecosystem we've developed, is the fact that, yeah, there is a flavor for everyone and for every patient that makes a meaningful difference. Maybe just on FDA approval, you know, you've talked about targeting back half of this year. Then, you know, maybe before we get to, you know, the opportunity for ADLT, maybe just speak to the confidence in FDA approval. Like, I don't know what the back and forth has been with FDA and, you know, sometimes things can slip. Then you've also highlighted, you know, the opportunity for TissueNext, in terms of the inability to test in concordance today. Maybe just walk through maybe some of those factors. Yeah. I mean, we're, we've been very pleased with the progress we've made with the FDA around the, you know, the package so far and the submissions we've made. It's you know, a matter of when, not if. You know, so yeah, we think second half of this year, we don't wanna sort of pin it down exactly, but so far so good. Like, no showstoppers. It's all been very positive, I think, conversations. You know, it's a huge catalyst for the business in the sense that it really simplifies the portfolio. There's frankly, you know, a little bit of confusion now with having two liquid biopsy tests and one that's FDA approved and one that's an LDT. It's not the most straightforward thing for, you know, a sales team to manage, and not the most straightforward thing for our customers to kind of keep track of. By consolidating into a single FDA-approved sort of flagship product, it's gonna really simplify things. To your point, it's ironically gonna be, you know, a big boost for our tissue business because it also simplifies how that test is ordered in conjunction with our liquid test. It's gonna be a major catalyst for both liquid and tissue in our, in our portfolio. You know, it also paves the way for a sort of new ADLT rate in 2027 as well, which could be obviously a major sort of boost in both top line and bottom line, sort of which is upside to the LRP we presented in our investor day. Is there any way to frame the tissue volume opportunity? You know, I don't think we wanna sort of like paint it in sort of like too much detail and so on. you know, right now, you know, clearly having an attachment rate is a sort of very strong feature, very strong asset for, you know, companies in our space. right now we have, you know, zero ability to attach to the, you know, flagship liquid biopsy right now. If you imagine going from zero to, you know, substantial attachment rate, there's, you know, could be a. We think it's gonna be, you know, a major boost in tissue volume for sure. Maybe final one here, just on the ADLT kinda rate, like how do you think about the value of that G360 assay and kind of what, you know, what's the opportunity? You know, I think Caris leads the field right now with their, you know, 8,500 plus or minus rate. Just kinda where do you think you can kinda land? Look, I don't wanna sort of, put something, you know, out there prematurely, you know, we're doing the analysis of really what is the health economic value that, you know, these tests provide and sort of guiding philosophy of the company is to always price lower than the health economic value we provide. We're trying to build a generational company, you know, one that is a net positive for healthcare outcomes as well as the health economics of this country. Right now I think too much money is spent on too many interventions and sort of, you know, some misutilization of, you know, therapies and interventions and so on. We wanna be part of the sort of, you know, the sort of positive force in right sizing, you know, some of these things. We think more testing is a net positive. In most fields, you know, certainly most people in the finance space and tech space pay for data, and they measure twice and cut once. I think we have a healthcare, you know, industry that, you know, basically cuts three times and doesn't measure. We think we can certainly, no matter where we price it, we, I think we'll be hugely net positive for the space. Maybe just shifting to Reveal. You know, volumes grew over, I think, 80% in the back half of 2025. You know, I think consensus has it volume somewhere in the 50% range for 2026 ±. A, I guess, do you think 50% is a reasonable volume outlook? B, can you just speak to, you know, some of the new applications that you have pending? We talked about therapy selection. Yeah. You know, you've got breast cancer surveillance, chemo monitoring, immuno-oncology. Yeah. Just how do those factor into the growth? Like, are those in the guide for 2026? You just like to put the Guardant or? Well, are you mean, you asked about the growth rate? You know, we're not sort of saying exactly what it is gonna be in 2026. Albeit to say that it's gonna be, it continues to be the fastest growing product in the oncology portfolio. You know, we have high hopes for Reveal in 2026, and we think it's gonna be a very strong grower. I think, you know, we've talked about the potential upside drivers to volume. You know, we're still in some way gating volume with Reveal for breast, and it's quite a substantial proportion of total Reveal volume now. CRC is still around 50%, closely followed by breast. We're not covered by Medicare for Reveal breast yet, I think when we get that's gonna allow us to really push on that volume. We see that as a real catalyst for us. Again, you know, Helmy was talking before about the therapy response monitoring with IO and chemo, when that reimbursement comes again, I think that's gonna be a very positive catalyst for us. We're excited about Reveal for 2026. Maybe Helmy, you touched upon in the opening remarks about your tumor-informed approach with Ultra. Yeah. You haven't shared much yet. You've kind of teased out excitement, enthusiasm. Yeah ... highly differentiated, kinda what is it about the profile that excites you or should invite patients, investors, and how different can it be? Yeah, it's, you know, just like you've seen with our other products, we don't build things in isolation. We think about how they work with the entire portfolio. I think there's gonna be really an exciting aspect of that where it sort of dovetails into our other tests in a way that, you know, is currently not available right now with other tests. I mean, I think from a performance point of view, we think it's gonna move the needle in terms of, I guess, people are talking about like even PPB now, parts per billion, or everyone throws out different numbers. In terms of meaningful performance and real samples, I think we'll be really unmatched. You know, some of the other features like, you know, how does it work with 360, how does it work with Reveal and so on. I think there's an interesting, I think, triangle that you can build when these tests sort of work together in an interesting way where you can substantially improve patient care and result generation and time to results and so on. You know, it's all been a long time coming. We've tuned our tissue test now for a number of years. We can use very small sample inputs. We can return results really, really quickly. That was a good sort of first step that we had to go through with a lot of learnings to get to this point where with tumor-informed, we can take very small sample amounts, neoadjuvant sort of like biopsies and use that to generate robust results out of that. It's, it's really like a coming together of all of these building blocks we've built over the years, and I think it's gonna be, you know, I think it's gonna be pretty exciting when we sort of reveal what Reveal can do, Reveal can do. All right. Well, we'll shift to SHIELD. Only 10 minutes left, and I haven't even got there yet, but a lot to talk about. You know, can you give a little color? Obviously, the guide was impressive, more than double 2025 levels in terms of volume. Just, you know, can you give a little flavor, the number of doctors you're reaching, repeat ordering, just kind of anything in the field that you're seeing that would kinda support, you know, kinda how you're thinking about this really strong volume outlook for 2026? Yeah. I think what we're seeing is really good both breadth of ordering and depth of ordering. You know, throughout last year, we increased the sales force. We went from, you know, roughly 100 in the field to around 300 at the end of the year. We're gonna continue to add to that in 2026. The sales reps are doing a great job at bringing on new accounts, really driving the breadth of ordering. One thing that's sort of surpassed our expectations is the depth of ordering at those accounts. Once, you know, a doctor starts using SHIELD, sees the ease of use for the patient, sees the pull through, the compliance of the patient getting the blood drawn, then the, you know, the account sort of buys in, and we're seeing really good depth of ordering. That's again, that's surpassed what we thought where we would be at this stage. I think that just sets us up really well. Of course, in 2026, you know, we have our Quest partnership that's gonna go live this quarter. Having that instant EMR connectivity of something like 650,000 accounts, having that phlebotomy and logistics network in place, and then also utilizing the Quest sales reps to open up accounts for us to allow our sales reps to go in, I think is gonna be another really strong driver of volume in 2026. Yeah, we're pleased with the guide, and we're feeling very confident about it as we say it today. Have you grown? Yeah, 'cause at the Investor Day, you announced the Quest partnership, and it sounded like it was really something, and I felt maybe it just got drowned out that day. There was a lot going on, right? Yes. I mean, as you've kind of been in the background planning for this, have you become more positive on what that could mean, or is it, you know, consistently since you signed it, now we're just hearing more about it? Yeah, no, we were really pleased with that we could announce it, and we did it on the Investor Day. You're right. It got a little bit lost. You know, that was sort of six months ago. In the background, there's been a lot of planning. It's been a great collaboration with Quest where, you know, we're really impressed in how they've taken this on, you know, their focus on that. Again, we're ready to go live this quarter. Yeah, we're feeling very bullish. You know, we've done a lot of work training the Quest reps, and we feel that, you know, when this is launched, it's got the potential to be very successful. Have you said how many salespeople you'll end the year with on the Guardant team from 300? No, we haven't. You know, we said, our plan by 2028 is to be at sort of 600-700. Effectively doubling from where we are, at the end of the year. Obviously, we're gonna be adding people through 2026. I don't think we wanna be giving a sort of a blow-by-blow account of how many we're gonna be adding. Suffice to say, I think we've done a great job. We've been hiring in waves throughout 2025 and bringing on a, you know, substantial number of people at a time, getting them trained, we've got a really great training program, and then getting, out in the field. Again, yeah, we'll be doing the same in 2026. I mean, ACS, you know, they had that meeting in November, I think it was, and I think folks were hoping maybe we'd heard something already. It's, you know, early March. Just what are thoughts around ACS and whether or not they will endorse SHIELD? If they do, you know, Helmy, we ran some math with you, and I think we're in the same zip code. Like, how do we think about the potential impact either on just awareness volumes or even just more so kinda commercial payment? Yeah. I mean, we've had a lot of conversations, positive conversations with ACS. You know, we still believe the guidelines are gonna be positive for us and that they're coming soon. We know that ACS has done all of its review work, and so we're just waiting for the guidelines to be published. Yeah, we're still confident that that will come soon. Yeah, I mean, I think we feel it's gonna have a very positive impact for us on volume, certainly. You know, first of all, being in ACS guidelines alongside NCCN guidelines is gonna be a very positive just overall for the field and nationally. In those sort of, 10-15 states where commercial pay is mandated to follow ACS guidelines, then there's gonna be a real opportunity for us. You know, we've been sort of putting a lot of friction in the system, really focused on the, on the over 65s reimbursable tests. In those states, those ACS states, once the guidelines are in place, yeah, we'll really open up to the under 65s. We think there could be, you know, potential, nice volume uptick. From a reimbursement point of view, we know it's gonna take time for the commercial payers in those states to sort of get on board. You know, it could take something like 12 months before we're sort of getting regularly paid, and we can be recognizing the revenue. The revenue impact might not come immediately, but we'll certainly be pushing on the volume, getting ready for when that reimbursement starts to come in. Maybe can you flip and just talk a little bit about, you know, lung cancer for SHIELD? Can you review the strategy there and the timing? I know you basically said you've already said in the study you found, you know, the requisite number of cancers. When do we learn more? Yeah. I think this year we're, we already, as you said, found the hidden enrollment sort of numbers in terms of number of patients. We're waiting for some of the follow-up, which should, you know, happen, which will conclude maybe end of this year. Yeah, probably sometime in 2027, we run the samples and, you know, and have that study read out. Would you share ahead of that? Like, I think we spoke a little bit last night. Yeah. What are you actually targeting with the test? Is it similar to the SHIELD profile? Is it more like some other players are looking for high negative predictive value, so they, you know, lower the specificity? Just, like, what's the target profile of the, of the type of patient you're gonna screen for? Yeah, we haven't shared, you know, what it is. It's a different approach than, you know, some of the other companies are taking, one that I think we'll talk about more as we get closer to the, to the read out. Should we be excited about the lung cancer opportunity as we are about the colon cancer opportunity? Yeah, it's a huge opportunity. It's, you know, there's a huge number of, you know, millions and millions of high-risk patients out there, and it's potential annual testing. That is, I think, the interesting part is it sort of gets SHIELD and a subset of patients into a sort of annual testing framework. Maybe just MRD. You know, you had some news obviously from the key player in the market that had a, you know, disappointing study but still had some positive signs. Just maybe kinda where do we stand with your MRD strategy? You know, you're accruing all these samples. You've got the Vanguard Study. Like, what's the pathway forward in MRD for Guardant, and, you know, how will you share that in, you know, kind of the strategy visibility? Yeah, look, we feel, I think, very pleased with the approach that we took, really, focusing on CRC as a sort of entry point into the screening market where there was a lot less sort of, up in the air in terms of regulatory risk and reimbursement risk, and so on. We're building a very solid business on that very strong foundation. You know, I think for us, it's a very low marginal cost for us to develop the amount of evidence that's gonna be required for MSI-H. One, we always knew early-stage sensitivity was very important when you think about, you know, these types of MSI-H tests. That's what we focused on from a technology point of view. You can see that with CRC and some of the performance we've shown in other cancer types. Two, I think, you know, with these studies where there aren't predicates in terms of, you know, some of these cancer types from a screening point of view, is it lead time bias? Is it, you know, truly providing utility? That's why we're doing it in this cost-efficient manner that we're doing it, where if we need it to be a few 100,000 patients or 500,000 patients or so on, we can do that on the back of SHIELD in a very, very sort of capital efficient manner. That's the beauty of our approach is we can let the data mature at its own time. We don't have to force the force things like, you know, some of the other companies have done. Well, fantastic. I think we're just at time. Helmy and Mike, thank you so much for being here, and have a great rest of the conference. Awesome. Thank you. Thank you. Thanks, Dan. Thanks. Thanks a lot. Thanks. Appreciate it.