Conference Transcript - GH 2026-08-12

Kyle Mixon, Analyst — Canaccord Genuity

Hi, welcome to the Canaccord Genuity Growth Conference. I'm Kyle Mixon. I cover life science, tools, and diagnostics for Canaccord. Really pleased to welcome you to a fireside chat with Garden Health here with us today. The company is a leader in precision oncology diagnostics across screening, MRD, and therapy selection. With us from the company, we have Helmy Latouki, co-CEO, and Amir Ali Talazaz, co-CEO. Thanks, guys, for joining us today. Appreciate it. So let's, yeah, of course, let's start with the 2Q26 earnings recap. You guys had earnings recently. Again, like a really strong quarter, nice beat. raise guidance. Can you just walk through the results from the quarter?

Helmy Eltoukhy, CEO

Yeah, once again, I think it shows a business that's really firing in all cylinders. We have these three overlapping S-curves, very large market opportunities that are all growing very rapidly. We had great growth with Garden360 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. And 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, you know, 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, 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 360 and the strength we have with oncologists. And 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 the volume and revenue point of view. We're seeing, you know, I think 50 percent quarter over quarter growth there and multi-hundred percent, you know, year-over-year growth there. So I think a lot to like about how the year has progressed so far.

Kyle Mixon, Analyst — Canaccord Genuity

Perfect. And then just kind of diving into that, I believe oncology volumes grew like 60% year-over-year. Liquid, I believe, grew like 30% and tissue was above that. And then Reveal, you just said, because we're over 100%. So maybe just Liquid, it's the historical kind of business, 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 shares talked about, just how large, how material is this in terms of moving the needle for you financially?

Helmy Eltoukhy, CEO

On the therapy selection, on the liquid and?

Kyle Mixon, Analyst — Canaccord Genuity

Reveal and G360 tissue.

Helmy Eltoukhy, CEO

Yeah, so those right now are obviously smaller contributors to the overall business compared with the Garden 360, 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 large segment for us as we continue to lean into it. What we're seeing is that that flywheel just takes time to sort of 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. But as physicians start using it, trialing it, sampling it, and then they gain experience with our lower Q and S rates, It's 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 sort of 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. And so we will be probably the company with the most comprehensive offering in oncology in terms of liquid tissue, tumor-informed, tumor-tissue-free. And 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.

Kyle Mixon, Analyst — Canaccord Genuity

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, like, you know, revenue and volume base than these other companies?

Helmy Eltoukhy, CEO

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 hostology 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. And then the other piece is it takes time with diagnostics, you know, to essentially have physicians understand the power of the platform, especially with, you know, all of these apps and with all of these features. It's not like you can order just one test and, you know, immediately experience, you know, all the wonder that is Garden360 Liquid. You have to, you know, see it interact with a particular patient subset that has that mutation or has that sort of feature or that biomarker. And 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.

Kyle Mixon, Analyst — Canaccord Genuity

Yeah, impressive. All right, thanks for that. Amir, Lee, on Shield, it's been a 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 a new volume. You know, 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, you know, what in your mind kind of stands out?

AmirAli Talasaz, CEO

Yeah, we're very excited with what's happening on the SHIELD front, like we're in the second year of launch now. And, you know, it's really, 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 taught, 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 United Health 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. So 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.

Kyle Mixon, Analyst — Canaccord Genuity

Yeah, so on UnitedHealth, I mean, again, very surprising that that occurred. Maybe talk about, I mean, how that came about, you know, And also why we shouldn't expect other large commercial plans to, you know, join suit over the next year or two.

AmirAli Talasaz, CEO

We didn't expect it. Having said that, we were working on it for multiple years. Because of our oncology products, we had multi-year relationship with United Health Group. We've done pilot of S.H.I.E.L.D. 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.

Kyle Mixon, Analyst — Canaccord Genuity

And I guess on the on the ACS guideline front, what's that tailwind sort of look like for you in terms of the 12 states or so that would cover?

AmirAli Talasaz, CEO

So 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 United Health Group. So that was unexpected, and it's a very good and positive surprise for us.

Kyle Mixon, Analyst — Canaccord Genuity

Okay. And then the shield, the new approved workflows that are lower COGS, I believe, I mean, in addition to that type of an improvement, what can you do on the performance side over the next few years? And just give us a flavor for what you're kind of cooking up behind the scenes for Shield.

AmirAli Talasaz, CEO

So we are still in 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. So when you're thinking about the Q2 ASP that we reported, the COGS of $400, roughly $400 that we reported in Q2, we're 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. And we expect and continue to be on track that sometime in 2028, at scale, the SHIELD COGS would drop to about $200. So ASP of north of $700 in 2028 and COG's profile of approximately $200 would generate a lot of exciting gross margin profile for us.

Kyle Mixon, Analyst — Canaccord Genuity

All right, maybe just taking a step adjacent to this for a second on Shield. So a competitor today had a breakthrough device designation announced for lung. You guys had the lung kind of indication in the works and the study and so forth. You know, maybe talk about why you guys have this mode and advantage in screening, whether it's for single cancer or multiple cancers.

AmirAli Talasaz, CEO

I believe we got our breakthrough device designation for shield as a panel of 10 cancers where long is part of that 10 cancer probably like two years ago. So I think other competitors in the field are continuing to play some catch up games with us. And this first-mover advantage, which kind of 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. So SHIELD, as a platform, we developed it as a multi-cancer detection platform. It's clinically validated for a panel of 10 cancer types right now, all solid humors. And for one indication, colorectal cancer screening, it's FDA approved. We are also working on FDA approval for lung cancer screening. That's a lung trial that we are doing during the 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. And we continue to expect to finish the follow-up and clinical database lock probably sometime before end of the year or early next year.

Kyle Mixon, Analyst — Canaccord Genuity

All right, excellent. And then on the MCD component, the opt-in, so you've been kind of offering that for some time now, maybe almost a year or a half here. I think the attach rate is pretty strong is what you've said recently. So maybe remind us what you're going to use that data for and have that compared. Like, you know, where does this kind of fall on the whole, like the Vanguard study, for example, and what's the go forward over time with MCED?

AmirAli Talasaz, CEO

So right now, when the patients are going through CRC screening and they're 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 effective, they authorize us so that we can get access to their medical record and we can monitor really the performance of our MCD test. And shortly after launch, we were amazed with the adoption of that opt-in by physicians. And 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 results report. So what that gives us the opportunity is to build this U.S. patient database of the performance of and utility of MSA testing very quickly, powered by the commercial leverage that we have and scale up of CRC screening and this strong opt-in by physician and the patients that we are experiencing. So 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 S.H.I.E.L.D. is really paving the path for us to get to that point in the near future.

Kyle Mixon, Analyst — Canaccord Genuity

All right. And just like for context, the other, you know, MSED FDA submission right now has 175,000 patients in the, maybe even more in the submission. So would your data, would the data points that are included in what you just said basically, like eventually add up something like that or bigger?

AmirAli Talasaz, CEO

I mean, 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. So it's not going to take us long until we get to this point of having a major clinical database in our hand.

Kyle Mixon, Analyst — Canaccord Genuity

Okay. And then on kind of commercialization in Salesforce, so you have, I think, 400 reps right now, plus a DTC effort. Can you talk about the balance between those two functions, basically?

AmirAli Talasaz, CEO

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. So 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 kind of ads. And in terms of the investments, still, majority of our investments are going in the personal promotion on the field force side. But a material fraction is going in DTCs, and we expect that to continue as we go to next year.

Kyle Mixon, Analyst — Canaccord Genuity

All right, perfect. And then maybe help me go back to you on the G360 liquid approval recently. So that's great. I mean, did that impact volumes at all kind of maybe end of 2Q or early, you know, third quarter or so far? And then also what's the path for the ADLT rates and trying to get to the 8,500 rate?

Helmy Eltoukhy, CEO

Yeah, I mean, right now we're phasing the launch. So most of it will be launched really at once we get ADLT designation. But, yeah, you know, and obviously we got it late in Q2. So it really didn't impact sort of the Q2 results. But we're certainly seeing a lot of excitement around that approval. And we're hopeful that that'll be something we can continue to lean into as we sort of make more progress in the field. In terms of ADLT, we've been, I think, positioning it around the sort of first half of 2027 event. And so yeah, we're going through the sort of motions of getting a PLA code and And then, you know, submitting for ADLT, which are the two steps required for that.

Kyle Mixon, Analyst — Canaccord Genuity

And then the ASP for that, you know, therapy selection business could be maybe $5,000 or so in the next, like, maybe year or two. Is that kind of the guidance?

Helmy Eltoukhy, CEO

Yeah, I would say that there are a couple steps along the way. There's first getting Part B Medicare, then Medicare Advantage, and then finally some of the commercial payers. So it's at least probably a 12 to 24-month process to get to something close to what you mentioned.

Kyle Mixon, Analyst — Canaccord Genuity

Okay. And then on the ADLT notes, do you still plan on trying to get, reveal ADLT status and payment rate?

Helmy Eltoukhy, CEO

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, you know, I think we have a full plan B around FDA approval. And so we're working on some of that. And then the same thing with tissue. We see that getting ADLT at some point as well.

Kyle Mixon, Analyst — Canaccord Genuity

And then sitting with the reveal, you're trying to get coverage from Moldex for breast cancer and therapy monitoring. And the volume for those indications has been growing really fast, obviously. So once Moldex turns that coverage on, what could that mean in terms of that revenue stream for you?

Helmy Eltoukhy, CEO

Yeah, I think the exciting thing is just how much demand we're seeing in the market right now ahead of reimbursement. And so 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, you know, really the next shoe to drop is just getting reimbursement and getting the ASP up for those products. You know, 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 improving the, expanding the platform beyond just breast, lung, and colorectal cancers and therapy monitoring. And so 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.

Kyle Mixon, Analyst — Canaccord Genuity

Yeah, Reveal Ultra, I was going to say, like that's, you know, reimbursement at some point in the next year or so. So how important is it to really round out the 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, shield side, but Reveal is a little bit more behind the scenes almost. So what's your take on that?

Helmy Eltoukhy, CEO

Yeah, so 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, very deep. And so we think there's, but, you know, those tests tend to be slower and more narrow in terms of what they detect. And so, you know, I think there is really a place for both in the large, you know, 18 million sort of patient population that is part of the MRD market. And I think, you know, the eventual winner, I think, will have best-in-class products on both sides.

Kyle Mixon, Analyst — Canaccord Genuity

All right. And, I mean, there's been a lot of kind of consolidation in the MRD space recently, the past few months. What's your thoughts on, you know, maybe a bolt on giving all your cash to enhance that portfolio?

Helmy Eltoukhy, CEO

We look, 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 Garden, a lot of great product trajectories. But when we find things that make sense, we execute on them. And we had a small tuck-in late last year with MediSight. 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.

Kyle Mixon, Analyst — Canaccord Genuity

Yeah. And so it feels like your epigenomics and your multi-omics kind of platform can enable you to break into a multi-disease market, $300 billion is the TAM basically. But also acquisition can help as well. What I mean, what's kind of like a good way to think about the timing regarding to break into something outside of oncology?

AmirAli Talasaz, CEO

So 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 in Alzheimer or 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 see what happens all right it's exciting but 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 what you're like the way you do in oncology yeah I mean 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 like 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, you know, like 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.

Kyle Mixon, Analyst — Canaccord Genuity

All right, awesome. And then maybe merely just sticking with you on S.H.I.E.L.D. again, just thinking about the path forward, It's just been, it's been so, so strong, so impressive, you know, it's not, it's still inflecting, basically, and it's got, you know, United Health Coverage and ACS. But what, how could that product really, like, you know, surprise investors, let's say, maybe next year going forward? I mean, USPSTF could be a factor. What else could, you know, we should be looking forward to?

AmirAli Talasaz, CEO

Well, if I tell you the surprises, it's not going to be a surprise. Stay tuned.

Kyle Mixon, Analyst — Canaccord Genuity

But I guess on that note, though, what is your thoughts on guideline inclusion in the next couple of years? It's been very volatile in that group.

AmirAli Talasaz, CEO

Yeah, I mean, the reality is there's a bunch of uncertainty there. Like 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. So still task force, we are considering it maybe late 27, 28 kind of time frame. 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, potentially with the new membership. But the field has changed. Again, look at some of the commercial payer actions that we are seeing. So other players are well aware of what's happening. And I think some decision makers and stakeholders are not going to wait for USPSCF's decision. But we'll see how it goes.

Kyle Mixon, Analyst — Canaccord Genuity

All right. And then one kind of interesting question I get sometimes is like, you know, why order the single cancer screening test when I can have one for 50 cancers or maybe 10? But 10 isn't offered by you guys just yet, basically, right? FDA approved. So why choose SHIELD rather than the one I just referenced?

AmirAli Talasaz, CEO

So 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. Like 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 so 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.

Kyle Mixon, Analyst — Canaccord Genuity

Awesome. Okay, thanks Amirly and Helmy.

AmirAli Talasaz, CEO

Yeah, thank you very Appreciate it for having us.