All right, let's get started. Good afternoon, everybody. My name's Luke Sergott. I cover the life sciences here at Barclays. With me I have AmirAli Talasaz, the CEO of Guardant Health, and Mike Bell, the CFO. Thank you guys for making it down. First time meeting you and doing this fireside, hopefully not the last, right?
Thanks for inviting us. Great to be here.
Great. Let's start off with the topical news, the ADLT that you guys just received. Walk through how that matched up with what you were expecting from a timing perspective. The reimbursement rate is in line, I'd say. From a broader question, it's more on, as Shield continues to ramp, and this obviously doesn't mandate a certain volume uptick, talk about how you're able to use the ADLT status to kind of drive your commercialization or to pull some of those levers to get more volumes out of Shield.
Yeah, we are very excited with this new development. It's something that actually we expected. This test is addressing a big unmet need. It's FDA approved, so it's qualified to be an advanced diagnostic laboratory test for people who are newer to this story and actually what this means. This enables a pathway to get a more favorable Medicare pricing for innovative tests and services. Actually, the pricing would be matched with the market-based pricing. We are very excited that we got to this news. Now the Medicare rate for Shield is going to go to about $1,500 starting April 1. It gives us a lot of actually opportunities. This was something that we didn't expect to get it this early in the year. It was not part of our guide.
I asked Mike to go into some of the details of financial impact momentarily, but at a high level, what it would enable us to do is a bunch of this additional gross profit that we are going to have with this more favorable pricing, which gives us the opportunity to bring this innovative solution to the patient coast to coast more aggressively to maximize the benefit of this test. Effectively, we can be more aggressive in build-out of our commercial infrastructure. That in turn, as we go to 2026 and beyond, this additional investment and more accelerated build-out would give us upside in the outer years.
Yeah, maybe just how this impacts our guide. At the start of the year when we put our guide out, we were confident that we would get ADLT. We just did not know the timing, so our guidance excluded that. Now we have it. We can quantify the impact. Our assumption for our ASPs for Shield for the year in our initial guide was approximately $600 per test, and that is what we had seen in Q4. As we look out now with this new ADLT rate starting the 1st of April, we expect to get something like a $200 increase in the ASP from the 1st of April. Our ASP is going to move to something like $800 per test. Obviously, throughout the year following that, it is going to be dependent on the mix between Medicare Fee-for-Service, Medicare Advantage, and commercial payers.
Yeah, we're very confident that ASP will be in the $800 range. As AmirAli mentioned, that's going to add to the top line, add to our gross profit, and we can reinvest that back into the SG&A line.
Gotcha. As you think about the ASP and kind of the approach here from commercialization, obviously the blend between the different type of coverage that you guys are getting. Talk about between going for the fee for service on the Medicare versus the big commercial and how the progress there and really how that kind of fit into with your to blend it on the $800 now that you're talking about.
We are very excited with actually the very early innings of launch of Shield post-FDA approval. You may remember that before FDA approval, we had Shield in the market for some experience with market shaping activity as a lab developed test. During those days, Medicare patients were a minority of the volume that we were processing. There are a lot more opportunities in the younger patient population. What we decided to do after we got FDA approval and we got this Medicare coverage was really try to target the patients that would have coverage for this test.
Through some of the workflow adjustments that we made in terms of the ordering process and educating the physician, educating the patient about do you have coverage, you don't have coverage, effectively what we saw in the first full quarter of the launch of the test, which was Q4 of last year, we saw a vast majority of the reported Shield volume became samples for patients who are Medicare beneficiaries, both Part B and Part D in terms of fee for service or MA. The way we achieved that is through a bunch of, again, education. The physician knows where the coverage is for this test. The patient knows that if they're a younger patient, they may have financial responsibility.
That suppression of the demand and volume of younger patient population gave us this opportunity that even in the first full quarter of the launch, we had Shield with break-even gross margin. We expected for this year for gross margin to be positive, and now with this ADLT designation, in fact, we would be even in a better shape. We are very excited about the early data of how this targeting is effectively working for us.
Okay, that makes sense. Sticking with Shield, you guys targeted 45,000 to 55,000 for volumes for the year. I'd say the biggest pushback that we've gotten is that you had Cologuard, if you kind of match up to where they were ahead of the USPSTF, they were doing, they finished somewhere around like 135,000, and you guys are targeting 45,000 to 55,000. What led you to settle out on that level? What is an internal metric for you guys as like, hey, this is actually accelerating better than what we were expecting?
Yeah, sure. Actually, the Q4 data that we reported was much better than what internally we expected, the 6,400 reported case last quarter. There are multiple elements that were considered when we put our guidance out there for Shield. This is the first guidance that we are putting for a full year, and we wanted to be very thoughtful about it. On the other side, I think this is a number which is very reasonable, and it's not very conservative because of the following. This is a brand new market. It's not that PCPs know about Shield and the promise of blood-based CRC screening. The demand is a function of investment in the S&M and the number of people that we are going to have in the field.
When we look at the number of people that we have when we launched the test, our hiring plans that we had late last quarter and throughout 2025, and what the other competitor had in their first full year, it's almost like we are going to have about half the size of the team throughout the whole year. We are mindful of the reality of the size of the team that we are going to put, that we are going to have in the field. The other element is quality score, and quality metrics HEDIS score is a real consideration for a good fraction of the market. We are very excited with how progressive CMS has been in making sure patients would get access to Shield. Today, it's not a HEDIS score qualifier.
The way quality scores are entrenched in the health system now is much deeper than the way it was 10 years ago. We are very thoughtful about the potential impact of this quality score. On the other side, there are many things which are very good with blood testing. There are 50 million unscreened patients. When we activate an account, we are seeing higher depth of ordering for Shield versus what historically has been seen for stool-based testing. When the physicians are ordering the test, 94% of the patients are completing that test. S&M efficiency is pretty high too. When we balance all these factors, we came up with this guidance of 45,000-50,000 versus what stool competitor did, about 100,000 in their first full year launch.
As you, oh, sorry. Did you have something else or?
No, that's it.
Okay. As version two comes on, what's the update that is the material update from version one to version two? How does this help with what you've talked about as like the back half weighted ramp with the launch? Outside of that, as you build out the sales force, how much education still needs to be done within that PCP market for the liquid biopsy on the CRC screening?
We are very excited about the potential of the pipeline activities that we have at Guardant. We've shown it already for other brands, Guardant 360, then Reveal, and now most recently Shield. I think just over time, Shield is just going to get better and better. That's probably what we should assume. Like 360 got better about 10 times throughout the last 10-year cycle that it had in the market. Shield is IVD; the bar of evidence is higher, so we should not expect like once a year kind of adjustment, but we are going to update its performance. We are going to try to update the performance around CRC indication and also other cancer types. Shield has been built as a multicancer detection device right off the bat.
For Shield V2, what we are expecting is to generate that data, submit to FDA if the data is positive to hopefully get to that upgrade and launch it by end of the year. It is an active program for us right now. In terms of product market fit, based on what we've seen, we are very confident that the current version of Shield is more than enough to really support the demand and really support the penetration of screening unscreened patient population in the market. Why we are doing Shield V2 and adding other cancer types in the same test is to continue to make it just even a better test. Mainly some of it is just competitively, we want to make sure we have the best test in the market.
We are going to continue to leverage the data advantage that we have, two and a half years' time advantage that we have to make sure Shield remains best in the class. It is the back half loaded component of our volume expectation. It is not because of Shield V2; it is really based on the productivity expectation of the newly hired reps that we added really late Q4 of last year.
On that productivity ramp, I mean, how are those reps that you've added? I know it's only March right now, but give an update on how that productivity has ramped from are you guys measuring this in number of docs reach per rep, or is it test per rep? What are the internal metrics there as you track their productivity and push them?
Something that we learned as this investment that we did with Shield LDT to be in market for two years is a bunch of these infrastructure and KPIs that we have developed in terms of registering, activating doctors, the churn rate, and actually what we are going to hear and how many samples we can expect from new accounts and so forth. We effectively have a productivity curve for newly hired rep, which is variable as a function of the productivity of each territory that we are adding the new rep, which is effectively part of our commercial operation and forecasting. Standard stuff, but it just got learned throughout two to two and a half years of commercial data that we captured. There is a productivity curve we expect initially in diagnostics within the first three months post-hiring. You can't really count on any contribution.
It takes maybe six to nine months for material contribution, and it takes like 12 to 18 months to get to the productivity you have in mind. Our productivity curve is respecting what historically has been seen in diagnostics as well.
Okay. As you continue to add from your reps from Q4, and you can build out to, I guess, 150 by the end of the year, you guys are talking about, are you seeing or expecting any of that productivity time to reaching that material ramp to improve and take your learnings from what you got from your reps in the Q4? I mean, it's just like the natural learning curve there should be pretty acute.
Some of the stuff which we are getting over time is, for instance, our training programs just based on it's a feedback cycle of what's working, what's not working, and it's just getting better. We are very proud of what we've built, and hopefully it will show its result in how fast maybe some of these new reps are going to become productive in the market. It's always continuous improvement, continuous kind of adjustment based on what we learn, but so far, so good so far. We are happy with what we did in Q4. We see how Q1 would shape, and we are very excited about what we can do in 2025.
Okay. I guess from a cost and OpEx perspective, you guys have been sticking to from your OpEx needs there. Update us on how that path and investment continues to go, especially ahead of USPSTF and ACS expected this year as well.
Yeah. We've always said that really on the screening side, the main investment that we need to make now over the next few years is on the commercial side and the commercial ramp. Even as far back as two years ago when we had our investor day, or 18 months ago, we said that that commercial ramp, that increase in commercial spend would be gated on milestones. The first one being FDA approval. At that point, then we sort of over the next few months doubled the field sales team. The next milestone we talked about was getting ADLT status. We've got that now, and that's again with the additional gross margin allowing us to ramp up further our commercial spend. I think we'll continue to do that.
Getting into ACS guidelines will be a next milestone, and we will continue to build the team then until we get to a USPSTF timeline. We aim to have a field sales team of around 700 people. Over time, we are going to be increasing that and investing. That is the real focus of the investment, of course. We still in the OpEx line have a healthy R&D line on Shield. It is focused on multicancer, focused on V2 and CRC, but also on just improving our workflow and our automation. I think we are making all of the right investments on the screening side, but at the right pace as well.
Great. I guess if we shift gears quickly here on the last third, let's talk about the MRD and Reveal. This has had really good momentum, and you've talked about kind of keeping the reins on the commercial force until you get gross margin breakeven and then also your ADLT there. There's been some pushback whether or not you can get the ADLT given that there's already MRD test. I guess the real question is, is that gating that you guys are thinking about from pushing the commercial, is that just an internal thing for ADLT? Because you're already pretty close to gross margin breakeven for Reveal as it is. Is it something that has to have that ADLT, or once you hit that, can you just kind of let the reins go?
2025 is an inflection year for Reveal. In fact, we're very excited about 2025 because a bunch of stuff we've done historically, all of them are coming to the harvesting period now in 2025. For Reveal, 2024, we had a gross margin negative test. We ended the year and started this year with a Reveal that the cost of goods reduced by 50%. We got expanded Medicare coverage by getting the CRC surveillance favorable MolDX decision, which we're very excited about. Effectively today, Reveal is now in the territory of being gross margin positive for us. The capping that we've done and engineering the volume that we've done, we effectively uncapped it. We are not waiting for any other catalysts to really drive the growth of Reveal.
Even if we try to cap the growth just based on the momentum in the MRD market, Reveal was the fastest growing oncology product that we had in terms of year-over-year growth. This year, we are expecting that to even be more accelerated, and we are excited to see what we can do in 2025. Mike, do you want to add anything?
No, I think that's fair enough.
Yeah.
I guess when you're thinking about the Reveal and the ASP, again, gross margin breakeven, pretty close to it, you guys are going to be above that there this year. Talk about kind of the levers that you guys have to pull from a coverage perspective. It's kind of the same question from Shield and the rest of the test, right, depending on your coverage mix. As this continues to ramp and you build that momentum, how's that going?
Yeah. I mean, now we've got CRC surveillance coverage. Really, the drive for us and the push is going to be on the covered test and that CRC, so we cover by Medicare in the adjuvant setting and the surveillance setting. I think there's the opportunity for us to really drive CRC. If we can make that a higher proportion of the overall test volume, then that can also help the ASP, can help the gross margin. Again, we can look to reinvest that. Also, we have available breast and lung. We look at breast, which is the biggest piece of the pie after CRC in the mix. We look at that as being the next up for reimbursement. We've submitted data for publication. Once that's published, it's going to allow us to submit to MolDX.
Hopefully the processes can be relatively streamlined given that we've got CRC. That will give us another lever to really push hard on breast volume. It'll give us an increase in ASP and can help again drive the whole MRD franchise for us.
I guess as that MRD market evolves and you're seeing the CRCs, like you talked about the market that's now breast coming online, talk about what you're seeing from an actual surveillance versus the adjuvant and the volume there. Depending on the checks and kind of the assumptions, it ranges anywhere from you could be doing three tests a year per surveillance patient versus one. What are you guys seeing there from your side? If you're even seeing the surveillance starting to become a material driver yet.
The reality of the MRD market is there are more in continuing testing the same patient versus getting new patients tested just based on the way the guidelines are written, multiple time points in the early years for testing. We did not have surveillance coverage. In fact, any kind of surveillance testing for us would be a negative contributor right off the bat. As a result, we really tried to suppress the amount of surveillance testing that we were doing. Having said that, there were a material fraction of our CRC volume that we were doing with Reveal. That was just a strong pull from the market that we were seeing. Now, again, as I mentioned, that kind of issue is gone.
We uncapped it, and we are very optimistic of bringing new patients into the pipeline of Reveal testing, but also getting the annuity of the patients that are already in that journey by getting them tested multiple time points in their journey.
How are you thinking about that multiple test time point? I mean, when you guys think about this market shaking out, like from a volume, is it going to be twice a year, three times a year? Just as we think about building that waterfall from your adjuvant, moving into surveillance.
Based on guidelines, actually in initial years, sometimes you need to test these patients three to four times, and then over time the frequency drops. In some of the market comparable, it is sometimes getting to about four, four and a half tests per patient when the patients are getting tested by MRD. For us, it was just a little bit north of one test per patient. That was again based on this lack of reimbursement for surveillance and the way we were managing our MRD demand. We are very excited about what we can do with Reveal, and that gave us confidence in the guidance that we put out there that everything, including Reveal, is going to see an accelerated growth in 2025.
Okay. That's fair. From the ASP driver there on Reveal itself, kind of talked about the coverage. As breast comes on and you're thinking about that CRC market, what are differences in how you're going to approach the breast market? Because that's a different treatment paradigm from breast cancer than you actually have from CRC, right? I mean, it's a different call point for you as well. Talk about developing that market and how you see it playing out.
The good thing because of Guardant 360 brand, we have a very deep nationwide commercial channel that's addressing all the oncologists across the United States. Already we have that channel, which we are leveraging for Reveal. We have all those oncologists in our call point and community breast and CRC are overlapping, but even within the specialized kind of academic centers, we have a very high usage of Guardant 360 in the breast indication. Now is offering, we are going to actually offer Reveal breast to them. It's already in market for them, but definitely again, we are trying to manage how much Reveal breast is getting utilized before we get the coverage.
Yeah. That's fair. I guess here the last 30 seconds, I mean, you've talked about it earlier. 2025 definitely feels like an inflection year for you guys. You guys have a lot of moving pieces, a lot of momentum building. As this continues to go, talk about how things are progressing versus your internal plans and if they're kind of coming, you're seeing a little bit more levers that you can pull to kind of accelerate that even more from what you guys were expecting to exit from 2025.
We are super excited. I think we had a blockbuster 2024. We were firing in all cylinders across everything that we were doing. I believe 2025 would be even a better year for us. Let's see what happens. We're very excited.
Great. All right. Thank you, guys.
Thanks for having us.