Good afternoon, everybody. Luke Serga, I cover life science, tools, and diagnostics here at Barclays. With me, I have Amir Ali Pelesos, co-CEO, and Michael Bell, CFO of Garden Health. I told you I wasn't going to try your last name, but I did it anyway. Thanks again for making it. For having us. Yeah, this is great. I think that I just wanted to come off the jump. I mean, there's a couple of conversations that we've been having around Serena 6, right? A couple of fierce biotech or fierce articles out there around really the kind of the protocol design, et cetera. But in the articles and in the conversations, they've talked about, like, the clinical utility of discovering the ESR1 mutation. And it's a broader kind of clinical utility question on the liquid biopsy side anyway. But I think that can you just kind of walk through where you see the clear clinical utility and the benefit to the patients in getting the test and making that switch without having to talk about the drug itself or anything like that?
Yeah, sure. So maybe for some of the people who could be near to the story at Garden, we have three major actually business drivers and brands around treatment selection, MRD, and screening. All of them are giving us opportunities for hypergrowth. And the question about Serena 6, one of the growth drivers for Garden360, our liquid CGP test for treatment selection, is making the liquid testing also a monitoring tool while the patients are going through the treatment selection phase. We got ESR1 approval from FDA a couple years ago. in breast cancer for treatment selection. And what happened right after that FDA approval, the volume of our breast cancer testing in a matter of very few weeks doubled up. It's an emerging mutation that happens as a mechanism of resistance to response and then it's activating some other kind of opportunities for treatment for patients. Now, within the Serena 6 trial, our pharma partner AstraZeneca this time is monitoring the patient to figure out when ESR1 is getting detected in blood and using that as a surrogate for changing the decision on the treatment and starting a different kind of therapy. And that trial readout actually has been very interesting. It's got discussed in ASCO, and the expected decision by FDA for FDA approval is in near future, in the first half of this year. Now, it's a biomarker that uniquely can just be detected for liquid biopsy. It takes our liquid biopsy at a single time point testing at each round of progression to multiple time points of testing, initially for breast cancer for this ESR1, but it could open up the utility over time to similar kind of studies and similar kind of biomarker testing in monitor setting. The utility of this drug actually is pretty interesting. When you are looking at the response rate, it's pretty strong. Our pharma partner, AstraZeneca, it looks like they are very bullish about the opportunity with this drug. They are getting ready to launch this test. And there is an outcome to talk about the drug actually in late May. What we do know is whenever FDA want to approve something which could be paradigm change in clinical decision making, it could be a big event, they want to actually call for outcomes and get some opinions from KOLs. That's actually, we experienced that with some other brands at Garden ourselves. And for Serena 6, since the patients are not first line or second line they're falling kind of between these two it's an interesting new paradigm for oncology management so it makes sense for FDA to go through this process and we are very positive and hopeful
that would go smoothly and I guess just on the whole the third space we have a Roche readout also come through I assume that you guys are involved across the board on the indication and as you think about that like what that means for the the particular biomarker within the franchise and I know you guys don't have it in your 26 guide but as we think about 27 and 28 how how a how instrumental is this approval or if the drug comes on like what can that do to the
overall outlook it's a very good growth driver actually for garden 360 there are 40,000 breast cancer patients who are candidates for this kind of monitoring if this drug gets approved for this indication and you know three four time points of testing per year for this kind of patients and And, you know, if the patients actually, you know, still continue to be SR1 negative, the testing would continue in the second year. But we expect, on average, maybe three to four testing per year. It's a very interesting growth driver for us. It's not part of our guide in 2026. We want to wait for FDA approval to secure that. And then we see actually what happens to our breast volume post-approval. It could be something very interesting for us.
Would this be included on the companion side, or is this just the HER2, the HER2, whatever the indication is for the 40,000 breast cancer patients, it's associated with Astra's drug, right?
It's going to be a new CDX for Garden 360, and it's going to be the first monitoring CDX for Garden 360. We already have 25 approvals for 360, but all of them are companion to drug specifically for treatment decision-making at a single time point. But this one would be in monitoring CDS. Yeah, like you said, first of its kind.
Sticking in G360, the recent liquid approval marries really well with the tissue side. And I think that there's a little bit of an unappreciated understanding of how these two are going to be married together. and kind of offered it for a bundling opportunity. Can you talk about that?
Actually, very recently, I think maybe what you're referring to, is the CRC approval that 360 got. In January, we got the first approval for 360 in CRC indication. It's new for us. And the utility of CGP and CRC is well established, but always there are some physicians that once the test is indicated, for specific FDA-approved indication, actually the level of confidence even goes higher and the level of utilization goes higher. So that could have some kind of interesting impact. It also drives some kind of new conversation with commercial players to fill some of the gaps that still we have on the coverage side. After 10 years, we are in a very good position with 360 reimbursement, But there are still some cases that we are not getting good payment from the payers. And our experience has shown that once we get actually FDA approval, our conversation with commercial payers for those specific indications becomes even much more solid. So that could have some kind of a tailwind for us on the coverage and ASP front. But it's going to take some time.
Yeah, I'll take time to build that out for that to build. So as you think about the platform itself, you guys really made your bet on the methylation with Infinity a long time ago. But as we see the sequencing costs come down and the elasticity pickup of the amount of data you can put out, talk about the platform strategy and layering on more of multi-omics, or are you guys kind of just continuing and adding indications for your existing technology?
So this is really the data mode that we have in Garden's story, the flywheel of data at Garden. When we are looking at, you know, one million patient data that we have on the genomic side, that's very deep. When we are looking at the epigenomics side, that's something that internally we even call it a dark matter of biology and our understanding of cancer. we have many hundreds of thousands of patients that we have actually full epigenomic data in them that's a treasure that's already paying some dividend for us in terms of technology development application development for us like you know what we are doing on 360 franchise based on this epigenomic data just to give you some example we developed some smart apps that is generating some kind of clinical information for physician for first first time like subtyping
the patient has been enabled by this database and is one of our smart apps, just as an example.
We are adding some other kind of layers to our data step by step. We talked about our recent metaside acquisition, which is generating a new layer of complementary technology for us. And that would potentially take us to even beyond ctDNA analysis, genomic epigenomic analysis and give us a new layer of information which has potential for improvements of our
product across the whole portfolio. Great. And then let's shift gears, I guess, from when you talk about Reveal. So this is the fastest growing test in your portfolio. We have you somewhere around 60,000 tests. It'd be great to know if I'm in the right ballpark there. But outside of that, as you continue to land, you know, obviously it's really early in the launch so most of these i assume are on the adjuvant side but how are you guys thinking about the screen the the actual the the surveillance portion um you know it was promised or not promised but the idea was that surveillance would include like three or four tests a year and that's quickly been kind of walked back to one or two so walk me through kind of that waterfall and how you
think it builds yeah um i mean first of all we don't we don't break out our reveal volumes but I think the number, you said 60,000. I mean, it's broadly in the right ballpark. And, yeah, it's been our fastest-growing oncology product by volume for the last few years. And we expect it's going to continue to be so this year. We're very bullish on Reveal for 2026. You know, on the adjuvant surveillance side, we're not sort of breaking that out. But what I would say is that on the CRC side, where we're now reimbursed for our CRC surveillance since roughly 12 months ago, yeah, I mean, we're seeing good traction there. We're seeing good pull through. I think there's been a focus from our commercial operations to really focus on the surveillance aspect and making sure that we've got the mechanisms in there to pull through the patient for the second, third, you know, further test. So it's definitely an opportunity for us. It's somewhere that I'd say we're improving, and that sort of test for patient is getting better. And so, yeah, again, reveal in both the adjuvant and the surveillance setting for us is very important.
And as you think about the, you know, submitted breast, submitted IO, they're both of them all DX. How does the actual treatment paradigm change versus CRC with breast or immuno-oncology? The reason I ask is because, like, with CRC, if you come back, you're starting to see the signal again. and then you can go back in and identify and cut that out. But with breast, you've already probably done the double mastectomy, or it's more about a treatment and a clinical utility question there associated with those. So how does that paradigm change as you're rolling out on these new indications? Is that way off?
So I think typically post-MRD testing, the next step for a patient is to do radiographic imaging to find, you know, where that site of residual disease is or then make some kind of treatment decision just based on that MRD finding. But what you're pointing out actually generates some kind of interesting opportunity, which could be actually a paradigm shift there in the field of MRD. Just imagine a day that a patient was going through MRD testing. Not only you can figure out if the patient is MRD positive or negative but also where the site of residual disease is through the same these are some of the application or opportunities that platform technologies that we have has potential to deliver versus just a yes no quantification level of residual disease in body so we are very excited to potentially see those kind of future opportunities in the field of mrd yeah so that's
mounting application almost like tissue of origin like you've seen with some of the msd side there are potential for yeah is that a big technology lift or is that just
looks like you know the science of it like already when for instance we have blood tests for multi-cancer detection that we do that has clinic cancer site of origin and part of it there's some aspects of science and technology and understanding that we have we are also capturing some additional layers of the data. What I'm talking about is not, you know, in terms of prime time, but really like, you know, figuring out and seeing a vision for future where we could be, right, that in this field of MRD, not only we find it, but we can also locate it and characterize it and provide additional information about that residual disease.
Gotcha. And then I guess I'm sticking with Reveal here with the Reveal Ultra Launch. um you know you don't have this in the guide walk us through like i guess why not include it in the guide and i understand that there's a healthy dose of conservatism and uncertainty with how this kind of paces out but you already have kind of the sales force in place ready to build this out and so early feedback from physicians and then you know timing of when we could start seeing
this? So we are maybe just some background, maybe for some of the people who are nearer to this story. We are already a leader in the tumor naive MRD side. And now we mentioned that we are going to get into a tumor informed MRD testing with Reveal Ultra. It's a new technology stack that we built ground up. We believe it's going to be the best in class technology when we launched it. It's on track to get launched later this year. Now in terms of the guide it's a product that still we haven't launched and when we launch it we are going to have the data but probably no reimbursement right off the bat so we are not counting either as a revenue contributor in 2026 but it's definitely an interesting development for us as we go to 2027. Right and then from a
reimbursement perspective kind of gives a specific number you're targeting or is it going to be
similar to what reveal is? Is it going to change at all? I think that's to be determined that, you know, CRC, we're reimbursed at 1644. Our sort of base case assumption is that the reimbursement would be in that ballpark. But I think, you know, we'll have to see as we go through the moldyx process there'll have to be sort of discussions on that and we'll see we'll see where we uh see where we come out but yeah i mean we're hopeful for uh reimbursement as soon as possible and we're hoping for you know the right the right reimbursement level all right
and then last year here on on on ultra i mean what really stood out was the the limited detection to us like how did you get it so well i mean how deep are you sequencing is it is it just a matter of just brute force or is there something more elegant? I think
by now we should have developed this confidence at Garnet. We really have very strong muscle power in innovation and going after hard problems, which if we can solve it would be a major contribution to the field. We've shown it across multiple products and now Reveal Ultra would be the newest example. We haven't disclosed details about the technology stack, but we are not far away from the launch when we get there. We are going to have some interesting conversations.
Fair enough. All right. And then I guess moving through the portfolio, we talk about screening. We talked about GARDEN even back in the day, 2016 and 17. This was it. This was this big opportunity, and now it's here. You have g360 still going strong and you have reveal on the mrd right so a lot broader portfolio but as you think about the screening and the ramp here that you've seen a little bit more mature market how much of the adoption you've seen how much of that is closing the care gap from those that haven't had some prior screening technology and just don't want to get colonoscopy or uses tool-based tests.
Maybe I just make a general comment about the whole portfolio, and then maybe I go through the SHIELD specifically on the Care Gap question. So to your point, look, like we've done several things at Garden during the last few years that all of them became kind of, got ready almost at the same time to really contribute in a very meaningful growth driver. We are very excited, confident, and bullish about continuity of garden 360 growth powered by small platforms of the new indications and you know going to early stage bunch of growth drivers that we are seeing on 360 that gives us a lot of confidence there mrd we talked about it earlier and shield this is probably the biggest diagnostic brand ever in the first full year of launch we made it outside covid testing the best diagnostic launch It's really an endorsement of the unmet need, which is out there. And we have a blood test that this time we are really messaging for unscreened patient population to get tested in PCPs. That's the biggest piece of untapped opportunity, 54 million patient opportunity there. And what we've seen in some of the latest data that I've seen is about 90% of the patients who've been tested by S.H.I.E.L.D., They haven't been screened during the last five years based on their medical information that we have. Which means really our messaging is working and we are filling the gap of really bringing on-screened patient population around the table. At the end, it's a simple routine blood test that 90% of the patients age 50 and above do it on an annual basis. And SHIELD is just getting added in. We are very excited of what's happening there.
And you're exiting the year with 300 reps. You guys are guiding 150% volume growth. Do you have ACS and EDIS and USPSTF baked in? Just walk through the assumptions there on this growth, and is it more about just increased productivity on your existing reps?
Effectively, that's right, Luke. We've not included being in ACS guidelines in our guidance. neither being in quality metrics or USPSTF. And we look at ACS guidelines as being in the relatively near future, and so that would be an upside. The main driver is just going to continue to be execution on the commercial side. We ended last year with 300 sales reps. We're going to add to that this year, But those 300, the productivity is going to be increasing throughout the year. We'll bring on new reps. We'll put them into new territories. So I think the field sales is going to be a main driver of that. You know, we've started now a DTC campaign. We're very hopeful for that. The early days look very promising. So we think that's going to be a driver of growth. So we announced yesterday a partnership with Quest. You know, that gets us really to fast track our EMR connectivity. So we're assuming that that's also going to be a driver and that's in our guidance. What we haven't included from the Quest partnership is, you know, the reps are going to be calling on their accounts to educate them about Shield. We're going to be able to utilize that to send in our reps as well and drive volume into those accounts. We haven't baked that into our guidance. If that's successful and it works well, I think that could be a potential upside on what we've guided to. So, you know, we think we've got a lot of drivers already in that guidance, but, you know, we've left ourselves some room for potential upside.
Yeah, I mean, that makes sense.
You guys haven't worked with them before,
so you don't really know how that's going to play out. But from a coverage perspective on those 300 reps and maybe adding a few more, but how do you guys have that structured? How is that? Because there's a lot of PCPs out there and a lot of them are, let's say, not as conducive to growth as some might others be. So like how are you guys kind of segmenting the market and going after it versus boiling of the ocean, I would say?
It launched in a very targeted way. We have targeted the people who have experience with non-invasive CRC screening. In the early days, we really targeted people who are super users of non-invasive CRC screening, have a good volume of Medicare beneficiaries, since that's the reimbursement that we had at the time of launch. Now with this 300 and continuing to increase reps, we have a nationwide coverage. But still, there are 250,000 potential PCPs who have experience with CRC screening, and we are just scratching the surface. We are just opening up this opportunity, and there is a lot of room of potential growth is left, obviously. So, but in terms of coverage now, we have nationwide coverage.
And I guess as from your thinking about building up the next year or two of the business, it's more focusing on those patients that are non-compliant, right? Or are you starting to go into the hand-to-hand combat with some of the stool-based testing?
No, not yet. I think obviously our coverage is broad. Our indication in terms of FDA approval is first line, it's broad. But, you know, we are after screening unscreened patient population. That's the biggest untapped opportunity. But we are already seeing, although we are not promoting it, we are seeing actually cases in some accounts that they have some other interesting use cases. For instance, we are seeing when the patient is due for re-screening, some of the patients are really opting out of continuing with the previous modality. And blood is a great opportunity for that. some patients are getting tested between two interval of colonoscopy. There are some incidental CRCs that we know are getting diagnosed as interval CRCs. So there are some interesting cases that we are seeing in terms of market adoption, but we are focused on the
screen patient population. All right. And I know we're over time, but on the DTC side, so if I went on and tried to go get screened, could I just log in and just get one sentence to me? Or is this more about just educating the consumer so that they can go to their PCP and
get it? You're targeting 45 and above and double indexing on 65 and above. I just hit it earlier in the month. I'm ready. But yeah, I think you're seeing some heavy kind of presence in the digital side, some presence on TV. But still, we are not doing full force DTC campaigns. But step by step, we are pleased with what we are seeing. Great. All right. Thank you. Thank you.