Going to go ahead and get started. I'm Tycho Peterson from the life science team at Jefferies. It's my pleasure to introduce our first company this morning, Guardant Health. With us, we have Helmy, AmirAli, and Mike Bell. Welcome.
Thanks for having us.
Let's maybe jump in on the core business. Obviously, there's a lot we'll get into on Shield in a minute, but maybe just looking on ASPs, the past couple of quarters, you've really gotten back some exceptional performance on the ASP front. G360 was over $3,000 in the third quarter, up 11% year over year. You've talked about that moderating a little bit in 2025, but maybe just talk about the different levers left to pull to increase G360 ASPs over time.
Yeah, Tycho, I think ASPs on Guardant360 have been a real tailwind for us over the last 12 months or so. It's primarily been driven by, at the start of the year, we got a Medicare increase for Guardant360 LDT from $3,500 to $5,000. And then through the year, we've seen the pull-through of Medicare Advantage. So that's, yeah, led us to reach our $3,000 target, which we had for 2028, sort of four years early. There is still room to go. I think the main area of focus now is on commercial coverage.
We've got very wide-ranging coverage for Guardant360, but with some of the national payers, there's still some gaps in the coverage. So some might cover just the LDT version of the test, some maybe the CDx version of the test, some for just selected cancer types. I think our real focus over the next few years is just to expand that coverage. Yeah, and hopefully over time, we'll see a continual tick up of the ASP. We won't see the big uplift we've seen in the last 12 months, but I think over time, we'll see a nice movement forward.
And where does the incremental growth, I guess, for G360 come from? You've talked about both U.S. and European markets. Given that we're in Europe, maybe just spend a minute on the European uptake. And then where else do you see opportunities for expansion?
Yeah, I mean, certainly internationally is a big, big opportunity for us. There are 10,000,000 cancer patients that unfortunately die and succumb to the disease globally, 600,000 of them in the U.S. And so there's a big expansion opportunity outside of the U.S. Europe, we've had a lot of success, I would say, specifically in the U.K. We essentially helped build a lab with the Royal Marsden just down here in London. They are now testing kind of a large portion of all lung cancer patients in England now with the Guardant360 technology.
And that's likely to be expanded to more lung cancer patients, essentially 100% of lung cancer patients, and a number of other indications. And so that sort of public-private partnership model has been a really nice template for us to essentially build and secure reimbursement, public reimbursement in the sort of European or EU model. We're doing that in Spain, and we just announced a partnership with Gemelli in Rome to serve Italian patients.
We'll continue to essentially syndicate that model across multiple other countries. That's been working really well for us. Japan, obviously, we've talked about. We have PMDA approval there, and we're making some progress. In China, we're serving the needs of both local and global biopharma there. In terms of the U.S., we see sort of a lot of room to grow. We see essentially three main catalysts there. One, it's essentially making sure that liquid biopsy is used in the sort of long tail of cancers.
We have good penetration in lung, breast, and colorectal cancers, but there are 50 other cancer types where I think there's more room left to grow. Secondly, we see these types of therapy selection tests going earlier in the patient journey into the Stage II and adjuvant setting as these targeted therapies and immunotherapies move earlier and earlier in the treatment journey. And then three, essentially moving from one test per patient per lifetime to multiple tests per patient per lifetime.
Why don't we spend a minute on TissueNext, also positioned for an ASP increase? Can you maybe just talk to the response from the upgraded panel and how we should think about adoption there next year?
Yeah, we recently upgraded the panel to 500 genes and saw really good response from the market. One thing we're seeing now, which we really hadn't seen before, hadn't really sort of pushed, is essentially physicians ordering only tissue from us, essentially coming to us for tissue. And that's been really exciting to see. So we're seeing tremendous growth there. And it's a franchise that we're continuing to invest in.
As you alluded to, starting January 1st, we've been able to secure a higher Medicare reimbursement price for TissueNext of $3,500, up from $3,100. So it's going to be, I think, a really strong contributor to our business in the coming years.
Maybe just stepping back on clinical volumes, you effectively blessed 20% clinical volume growth for next year. What are the durable trends you're seeing in the business today that gets you kind of comfortable putting that out for the street at this point? What are kind of the upside, downside risk factors as you think about that number?
Yeah, a big part of that is, I think, the confidence we have in the sort of early launch days of our Smart Liquid Biopsy transition for Guardant360. We're seeing that the new test, new Guardant360 LDT, now is 700-plus genes, fastest turnaround time, and really high sensitivity, 10x higher sensitivity for tumor burden detection. And that's just the tip of the iceberg in terms of what's coming in that platform. So we're already seeing a lot of movement away from other products, essentially back to Guardant360.
So we believe both breadth and depth can increase nicely over the coming years with this platform. Obviously, we see potential growth opportunities with the Reveal once we secure surveillance reimbursement and CRC and complete some of the COGS reduction initiatives. And then obviously, we are seeing nice progress, as I said before, with our tissue franchise as well.
You've done really well in biopharma, too. I don't know that you always get enough credit for the volume growth you've had there. Can you maybe just walk through some of the drivers, Infinity Smart Liquid Biopsy, what's going on in China, and some of the potential focus areas for next year?
Yeah, we've been really pleased with the progress we've made in biopharma. Biopharma has been a sort of hard road for, it seems like, many companies in the space, in the tool space. And for us, it's been a really nice bright spot. Obviously, we've grown the volume tremendously this year. We now work with 180 biopharma partners. And what we're seeing is that a lot of them are moving very nicely to our Smart Liquid Biopsy platform, our Infinity product. And so that has been a great catalyst for us.
As you alluded to, I think biopharma needs to see a few things before they sort of really work with a strong partner in the diagnostic space. Clearly, having the competency to bring companion diagnostic products all the way through the process is important, and we've done that many times.
Having robust clinical volume so that when those products are actually approved, essentially physicians are actually ordering that test. And then three, global scale. And we check the boxes across those three categories now. And so we see biopharma also continuing to grow nicely over the next coming year.
Maybe we'll shift to Shield. And I'll start out with kind of the CMS rate $920. How has that helped kind of in conversations around potential adoption?
We are very happy with this Medicare rate that we got from our local Noridian at $920. It was more than what we expected for our test and gives us a bunch of opportunity as we go to 2025. The additional gross profit that we can make before the ADLT pricing gives us some opportunity to optimize the enterprise value by reinvesting on the commercial or not while we are keeping this overall spend under $200 million that we talked about. In terms of adoption, we are in market now for three months.
And really, one of the factors that's important in terms of price and adoption is what's the financial responsibility for the patients at the end of the day. So we are targeting really covered patients at this time, 65 years and above mainly. The out-of-pocket costs for these patients are very minimal for fee-for-service is zero, and for MA plan, based on actually the detailed benefit, it's very, very nominal.
As a result, the experience by both physician and patient has been pretty good. We are very happy with what we are seeing. We are exceeding expectations that we had, but we are in very, very early innings. We'll see how the Q4 will shape.
You said you expect to be, I think, 60% of the market in 2028 with around $500 million in revenues. That points to a market that's just over $800 million. Can you maybe walk through how you expect the expansion to play out over the next couple of years, where you expect competition to start to enter the market as well?
Yeah, sure. So maybe if we just step back and when we just look at the CRC screening market today in the U.S., there are about 50,000,000 unscreened patients for CRC that they should get screened based on guidelines, but they are not doing after having multiple modalities of scoping and stool-based tests in market for some time now. And our test is really very well positioned to bring those patients into the screening journey.
Also, it's a new choice, a great choice for patients who are due for rescreening to consider this choice of blood test when they are going through that conversation with their physician. So I think now when we connect this to our LRP kind of a target that we talked about in our last investor day last fall, we talked about we are going to get to one million annual testing volume in 2028.
Obviously, still, we are forecasting that the exit growth rate would be very high in 30% plus due to the size of this market. And at the time, we assumed there would be more progress by some of our competitors. So we assume in the blood-based colon cancer screening, we would have 60% of the market share.
So that's why we got to $1,500 ASP. On the ASP front, with this Medicare rate that we got, effectively our ASP right now is approximately $500. So we are ahead of the plan. So we feel more comfortable and more confident about the LRP projection that we talked about last fall.
As we think about the ADLT process, can you maybe just talk about the mechanics of going through that, what we should be paying attention to from the outside, and where ultimately you hope Shield pricing lands?
Yeah, so actually for an unmet need, as long as the lab-developed test has FDA approval, it qualifies for the ADLT process. So there are different ways that you can go through that Medicare process. The path that we chose was first getting our PLA code and then submitting our ADLT application for that specific code, which is unique to Shield, and activate the ADLT pricing. So we are in the first phase of it in terms of securing and getting our PLA code.
And once we have it, then we apply for ADLT. We expect this ADLT status to be designated to Shield sometime in 2025. And then that would enable getting even more favorable Medicare pricing, which is going to be at $1,495 at that time.
And then I think people are starting to focus a little more on version two. As we think about that, can you remind us of the timelines of bringing version two to market and how the reimbursement process will work for the second version? And do you plug directly into version one, or will this need to go through its own ADLT process?
Yeah. So maybe I just step back and just give a kind of a very high-level overview for some of the people who are maybe newer to this story. So at Guardant, we've been working on liquid biopsy technology since 2012 and specifically for screening-related liquid biopsy technology since 2015. And we are sitting here with the first FDA-approved Medicare liquid biopsy test for cancer screening as a result of all the learnings and insight that we got throughout all these kind of years of R&D work.
We are proud of what we achieved with our first version of Shield after all these years. But what we've seen is probably not going to be the best and the last performance that a blood-based cancer screening test can do. So we talked about Shield v2. We had some kind of early-stage R&D data in terms of case control data that we shared last fall. That looks like the performance of that test, at least in the case control setting, was better than v1. And we need to now go through clinical validation of that v2.
So now that we have v1 FDA-approved, we took it to the finish line. We are in conversations with the agency to coordinate and align on a specific plan for clinical validation. We expect to execute that and submit the data as long as it's positive to the agency for consideration of approval. And we expect all this to happen in 2025.
Great. And then maybe one for Mike again on cash burn. You've been clear about ring-fencing the spend for Shield, $200 million a year. Current Shield ASP, $500 a test, and COGS have come down significantly as the test continues to scale. Do you see any pathway to lower the burn moving forward? Can you walk through what needs to play out in the next several years to get Shield to profitability?
Yeah, you know I mean, we've said that we'd expect Shield on its own to get to profitability one to two years after being in guidelines. So really, when we're at a level of scale that's going to allow us to be break-even and profitable, and some of the assumptions we've mapped out there around having at scale an ASP of $500, potentially with an ADLT rate now that we could get of $1,495, we could potentially have a higher ASP that could get us to gross margins in excess of the 60% gross margin targets that we'd set.
So potentially, we could be generating more gross profit over the next few years. We're committed to building out the sales force over the next few years. And that's part of this $200 million net burn. But once we get to a sales force of around 700 people, then we'll really be able to start leveraging the infrastructure, the commercial infrastructure that we've built. So I think we're still committed to a break-even, again, one to two years post USPSTF guidelines.
But I think with the way that ASPs are going and potentially the traction that we can have on the commercial side, we feel even more confident than we were a year ago when we had our investor day. And maybe just another thing on the cash burn. I think what's often missed is therapy selection now, our core business, is now profitable and generating positive cash flow. And MRD is on the cusp of an inflection where we now start to generate positive gross margins. And that's then going to drive to break-even.
So I think even though we'll have a net burn over the next two, three years for screening of $200,000,000 , the rest of the business is going to be generating positive cash. And so again, we're targeting a company-wide break-even of 2028. And potentially, that could come in a little bit. We've said, again, the positivity we've had on ASPs in the core business could potentially bring that 2028 target forward by maybe one year.
Got it. Maybe we can shift over to Reveal then. And I think on the data generation side, we're expecting to see data on breast this year and lung, potentially pancreatic in the first half. Can you maybe talk about the process of data generation, getting expanded indications for Reveal? And when could we realistically see an indication for pancreatic?
Yeah, I mean, right now, I think we're really focused on obviously getting CRC surveillance under our belt. That, along with our COGS reduction initiative, will be sort of two triggers that will essentially allow us to get to positive gross margins on the test and really inflect volumes in terms of the demand that we're seeing and really serve that demand. Breast is obviously the next indication. We believe breast and CRC alone can really make this a very solid franchise that is really an exciting business.
And then, yeah, we'll see essentially other indications. We're working on pancreatic and gastric and bladder and other cancer types as well. So as those come online, those will essentially be sort of gravy on top in terms of this franchise.
Should we expect data on pancreatic next year? Is that something that's in the plan?
Yeah, we have a cohort that is pretty close to completion. I think it's a good likelihood we'd have some data next year in pancreatic and gastric.
Great. CRC surveillance reimbursements obviously have been submitted. It's expected next year. Can you maybe just talk about the upside to the Reveal franchise from the new reimbursement? And where's the no-pay rate for Reveal today? Where do you see that going?
Right now, we essentially only have less than half of our CRC samples reimbursed in the adjuvant setting from Medicare, at least the Medicare portion of samples. So CRC surveillance, which is probably the single biggest, I would say, sort of subtype of disease that our patients that we're testing right now would be a big inflection point for us.
It would be a nice step up in terms of ASP once we get surveillance under our belt. And because that is an indication where essentially every test can be paid for separately, it's one that is a potentially big driver for Reveal going forward. I don't know if Mike, you want to.
I'm out. I don't think there's anything else.
I mean, I guess, how do you think about that opportunity emerging around surveillance? I think people have asked if you just flip a switch. I mean, how quickly can you scale that opportunity?
We think pretty quickly. If you think about it, we're actually touching a fairly large number of patients right now from new patients' chart perspective. But essentially, because we're sort of confined to that sort of one-year window or that adjuvant setting initially, at least the start of the testing, we're not necessarily getting the annuity that comes with those new patient starts over time. So once we get surveillance, that is a big driver where we get this sort of compounding in terms of volume potentially.
It also allows us to essentially submit for ADLT status as well. And so that's a potential another step up. So it's a double or triple whammy for our Reveal business getting that sort of surveillance time point reimbursed. I would say the last point is that a sort of tissue-free solution really shines in the surveillance setting. If you think about essentially the 15,000,000 cancer survivors in the United States, 12,000,000 of them are more than five years out from their surgery or surgical resection.
And so there's a really, really large population of patients that essentially where it may be difficult to find tissue or the tissue may not be relevant. If you survey physicians and ask them, what are you more confident using a couple of years out from surgery, they'll say that essentially they'd rather have a tissue-free solution because what may come back at that point may not be what was taken out. So that's essentially where we think this is a sort of really major driver and catalyst for our business going forward.
And then, can you comment on the no-pay rate for Reveal, where you see that going, I guess, over time?
I mean, at the moment, the no-pay rate's pretty high because we're only reimbursed really by Medicare in the adjuvant setting. We do have some commercial reimbursement. So in any way, the only way this can go is to improve. And I think, yes, CRC surveillance from Medicare is going to improve that. Breast reimbursement will improve that. So I think it's probably as low as it could be. And it's just going to get better over the next few years.
Maybe just thinking about competition as more tests come to the market, how do you think about your positioning and the role of tumor-naive in the broader MRD testing landscape longer term?
Yeah, like I mentioned, we think ultimately it's the bigger market opportunity. I think we've seen really nice growth, obviously, in the adjuvant setting with the tissue-informed tests out there. But as I said, there's 12,000,000 cancer patients, cancer survivors that are many, many years out from surgery. We think that tumor-naive or tissue-free test is most likely the right product-market fit for that large, large population of patients. And so, yeah, it's really a matter of getting the surveillance reimbursement under our belt.
I would say the other thing, too, is our platform is extremely data-rich. We've only turned on the idea of being able to monitor disease burden with the test. But we can do some really nice things with the platform in terms of really detect potentially the site of metastases, look at other properties of the disease, subtypes, and so on in terms of what's coming back. And it fits really nicely with our therapy selection paradigm.
Essentially, you can imagine going in a sort of nice continuous loop from essentially 360 to Reveal and kind of vice versa. And we don't think there's another technology out there that can do that.
Great. I think we're basically at time. We'll leave it at that. Thank you.
Thank you.
Thank you.