I think we can get started. Kallum Titchmarsh here from the life sciences team at Morgan Stanley. Welcome to day two of the Morgan Stanley Healthcare Conference. Really pleased today to be joined by the team at Guardant Health. We have AmirAli Talasaz, Co-CEO, and Mike Bell, CFO. Thank you both for being here.
Thanks, Kallum.
Thanks for having us.
Before we get started, just for disclosure relating to this discussion, please see morganstanley.com/researchdisclosures. A lot to discuss. We've had quite a bit of recent news since those Q2 results, but maybe we can just rehash that Q2. Very strong performance across the board. Would love a little state of the union on Guardant Health to kick off, and then we can go into some specifics from there.
Yeah, sure. Great to see you guys. Q2 was another fantastic quarter for Guardant Health. The flywheel of Guardant is moving, accelerating, and a bunch of stuff that we work on for a few years, they are all coming to result and contribution for Guardant right now. Overall, we reported greater than 40% revenue growth year-over-year. On the oncology side, volume growth of over 60%. On Shield front, the growth of more than 250%. We reached a point that we are not building CRC screening market with Shield anymore. That category is already out there. We are at the phase of category scaling and developing that market as fast as possible. On oncology side, the smart liquid biopsy and smart platform in general, both on liquid and tissue front, is resonating very well.
It's helping to develop the market and help us with a bunch of market share gain through a bunch of application that it's enabling for the oncologist to provide some additional actionable clinical information. We are very excited of what we reported.
Mike, any standouts from you for the quarter?
I think we just talked about all of the great news on the volume growth, on the revenue growth year-over-year. No, it was just another very strong quarter from Guardant, and yeah, we're really pleased with Q2.
Amazing. Let's maybe dive a little deeper into the oncology business first. You have an increasingly well-established product both in liquid and in tissue. How do you see the Guardant360 Liquid and Tissue working together rather than competing modalities just to make Guardant the top choice for oncology practices?
They are really at large scale complementary to each other. If you look at actually guidelines now for a bunch of cancer types, dual testing with both liquid and tissue is indicated and recommended in those guidelines. What actually the recent FDA approval of Guardant360 Liquid CDx provides us is really simplification of that ordering workflow and making sure that both tissue Guardant360 and our Liquid 360 are orderable and accessible for physician, and they're reimbursable for us. The data that's coming out is also supporting this kind of dual use cases. It's more than really competing position. It's complementing on the data front. Also, having both of these two assays really helping us to really enrich the data platform that we have at Guardant.
When we are looking at, we're literally the only company on the CGP front is providing epigenomic information and capturing that data at scale. There's a lot of apps that we have developed so far and many apps that we have in pipeline enabled with the power of the data that we are capturing.
I think it's just helpful given the growth rates you're putting up to just level set on penetration today, across your liquid and tissue categories, not just in the core indications, but also maybe more broadly into some of the new indications you've been looking into as well.
Yeah. It's a function of different cancer types. But in general, tissue is well penetrated. About 70%, 80% of the market is developed. So really what Guardant360 Tissue with the innovative platform that it has enabling us to do is really the market share gain relative to the competition by providing additional insight to the clinicians. Liquid biopsy still is pretty under-penetrated. When we are thinking about maybe overall, and again, cancer by cancer is different, maybe we have about 40% ± market penetration at this time. For a single time point use case for liquid, there's still a lot of room to grow on single time point, and then on the other dimension of really going toward longitudinal monitoring and providing multiple testing per patients.
Right now, still we are doing 1.2, 1.3 tests per patient in terms of liquid and tissue testing, and that number can grow in a meaningful way. We are also very excited with the recent FDA approval, which really was landmark for liquid biopsy field and especially for Guardant360 platform, to enable longitudinal monitoring of the patients. It's a totally new use case for liquid biopsy testing.
And we get pretty positive feedback just on that genomic plus epigenomic info that you create with the CDx platform. What do you think physicians can do today with that product that they perhaps couldn't do a few years back? Maybe just give some use cases from your experiences.
Yeah. So on the genomic side, it's pretty straightforward that now it has over 700 genes, this CDx versus the prior one was about 10 times smaller. On epigenomic is really where the main differentiation is. I give you maybe an example of an application. So a lung cancer patient who's been diagnosed with non-small cell lung cancer, it's some kind of specific pathway for treatment and management of that disease. We know that some of these patients go from non-small cell cancer type to small cell lung cancer type. At a large scale, this information is hidden to the physician, because in order to get to that information, we need to do rebiopsy of the tissue of the lung, which is not really very typically done. And the treatment paradigm of small cell lung cancer is totally different.
Now with this Guardant360 Liquid through epigenomic data that we have and the application that we enable, the doctor can look at this transition very easily. Another kind of story that in fact in this trip I just heard is some of the patient who have CUP cancers, through epigenomics, we can figure out where is this site of the tumor. Sometimes actually for this specific patient that I heard is, it was not a CUP cancer patient, but really the oncologists were concerned if the diagnosis was accurate or not. Guardant360 Liquid in fact showed that what was considered breast cancer patient was in fact had a totally different cancer type, and the treatment of that patient got changed in a very meaningful way.
Mike, just on the ASP going up to the ADLT price, I think just under $8,500.
Maybe just talk to us around your confidence in that pricing outcome, and just the math we should be doing on that conversion over from the current price up to the ADLT price.
Yeah. We're very confident with the ADLT process. We've gone through this twice before now, first of all with the old Guardant360 CDx back in 2021 and two years ago with Shield. Both of those have gone through the ADLT status after receiving FDA approval and Medicare coverage. It's a relatively straightforward process. If you're FDA approved and Medicare covered, then you qualify for ADLT status. So, this is the same now for Guardant360 Liquid CDx. We're in the process, in the ADLT process, so we expect that to come in the first half of next year. So, very confident on that. Obviously, once we get that, you mentioned the ADLT price will be $8,455, so an increase from $5,000. Then over time, we would expect an increase in the overall ASP for Guardant360.
It is around $3,000 now, compared to a Medicare rate of $5,000. Something like a 60% realization of the Medicare price overall when you include all the Medicare Advantage and the commercial payers and the Medicaid and some of the zeros. I think it is reasonable to assume that over time, and we think this will take sort of 18 to 24 months for all of the payers to sort of change their prices, but it is reasonable to assume we will sort of realize something like 60% of $8,455, which is around $5,000. I think we look at that in 2028 as being sort of our target ASP for Guardant360.
Great. One of the newer updates since Q2 results, SERENA-6, camizestrant as well, approval there. SERENA-4 not working out as the trial had planned. Talk to us about what that means for Guardant specifically and the use cases there, because I think it could unlock this new meaningful opportunity for the test.
It is very exciting. It is the first FDA approval in an indication of longitudinal testing using Guardant360 and general liquid biopsy. It is a new clinical paradigm, and that is why even I think contributing the fact that FDA went through ADCOM process for this drug. Now it is proven actually after three failures, not just by AstraZeneca, but by other oral SERD, that using that drug as a frontline, a firstline, is not going to work. You really need this biomarker stratification monitoring this emergence of ESR1 mutation to use this drug on the right subset of patient population. This really emphasize the value of liquid biopsy and Guardant360 is the only FDA-approved CDx. In terms of the size of the opportunity, we estimate about 37,000 breast cancer patients to fall under the indication use of this drug.
In the trial, those patients needed to get tested every three months, so it is about maybe 150,000 annual testing opportunity. Obviously we have work in front of us. We need to see how the drug launch goes by our partners in AstraZeneca in terms of the adoption. In order to fully realize that opportunity, we have some work to do on the reimbursement front on changing the 90.2 NCD, which right now doesn't allow Medicare payment for longitudinal testing. That conversation has been ongoing, and we are working on it with CMS.
Any rough timelines you would put on that?
Probably maybe we are one year away from that.
Okay. Helpful. Reveal as well, I think was a standout for the second quarter. Some really strong sequential volumes there. Could you maybe just unpack where that success is coming from, whether they are existing MRD users that have switched over to Reveal, or whether these are new MRD users coming to the table? Maybe just a little bit of color on that success would be really helpful.
The Reveal MRD was getting used by a fraction of the oncology base that we have in terms of ordering physician. What this Reveal treatment monitoring is enabling, it went actually much better than what we expected. We just finished the second full quarter of the launch with that product now. Effectively, all Guardant360 user base, which is vast majority of the oncologists, when they are considering CGP for profiling, now they have an option to bundle a treatment monitoring post 360 if they are interested. It has a very nice synergy, same call point, same kind of channel that we have. We have some work to do on the reimbursement front. We have some kind of applications in front of MolDX work, like two major indications of chemo and IO.
But the adoption has been very great, which is really an endorsement of the brand value that Guardant360 has in front of oncologists and to some extent, the Reveal franchise.
And then I guess with Reveal Ultra coming by the end of the year, I believe-
Yes.
Just how are you thinking about that kind of tumor-informed versus tumor-naive trade-off in MRD? And I guess what is your expectation longer term of the relative adoption of both products?
So we wanted to make sure our bag is complete. There are some doctors that really they prefer tumor-informed MRD versus tumor-naive MRD. So we were leading the tumor-naive side, but that was a gap that we had in our pipeline and our bag of commercial team, and now they're going to have it by end of the year. Unlike many players in the field of tiMRD, that it's kind of their platform or their offering is kind of, at least on the technology side, looks kind of me too. Reveal Ultra is pretty differentiated. We are very excited to talk about it when we release the product. We are on track to launch it before end of the year. I think it's going to be a fantastic contributor to the whole field of MRD and Guardant oncology brands that we have.
In terms of use cases, it is not a replacement of Reveal. It is really for some doctors, for some patients, they prefer tumor-informed when the tumor is an option. For some patients, the convenience or the faster turnaround time or lack of tissue really provides a better fit for just liquid-only Reveal to be used. I think it is just going to give optionalities to the oncologist.
You said it is just some internal validation work that is holding back the Ultra launch. That is the only remaining step, right?
We are almost done. Stay tuned. It is going to come out before end of the year.
Amazing. Given your scale, I think increasing in MRD, having that very established CGP franchise, how does that kind of full suite solution resonate with the physician versus incumbents that perhaps are under index to one of those product types?
Yeah, I think Guardant is not like a holding company of few business units, frankly. All these assets that we have are really working together and give us leverage and new commercial opportunities. I think on Guardant Reveal and Guardant360 are very clear. We talked about Guardant360, connecting it with Guardant Reveal for treatment monitoring, and then when the treatment is not working, again, the profiling is going to be indicated, so another Guardant360. Even the MRD in early stage, monitoring those patients with Guardant Reveal, and at the time that Guardant Reveal is finding something, then typically those patient needs to go through profiling, and it reflects to Guardant360 would be indicated in those patients. There are some subset of the market that they really value single-stop shop or the convenience of the ordering.
These kind of portfolios that we have give a lot of ease and connectivity of offering and the data for busy oncologists in the marketplace. Even on the Shield front, what we are seeing is even connecting Shield to our oncology brands on both sides are giving some commercial benefit. Just imagine down the road when a good fraction of CRC patients are going to get initially diagnosed through screening done through Shield. Right now, when we are talking with some accounts, they're interested to know that we have some screening solutions in terms of a complete portfolio. Nobody else. Guardant is the only company who has offerings across screening MRD and CGP testing right now. On the other side, on Shield front, we are getting the benefit from established brand of liquid biopsy pioneers and trusted vendor when we are talking to primary care physician.
That's been helping, too.
Amazing.
See this market adoption that we are experiencing.
It's a good segue probably onto Shield. I would say another couple of very good updates there on the commercial side since those second quarter results. We had Carelon on and then eviCore yesterday. Just unpack a little what that means for the Shield commercial program and maybe some numbers as well on just the covered lives now and then how rapidly you can go after that opportunity.
Yeah. I think the flywheel of Shield is moving very fast. Literally, it was about a year ago that I think the conversation was, would the patient and physician use a blood-based colorectal cancer screening? Does this category even exist? Do unscreened patients get tested with a blood test? Now, just in a short time of about a year, we are in a category scaling phase. About 80% of all eligible patients have coverage for Shield. 94 million people with multiple successes that we had and wins that we had during last few months, few weeks. Now 80% of people have coverage for Shield. Dramatically changed. It just gives us opportunity to provide more equitable access to this test and continue to drive commercialization scale-up of this brand.
Is there anything holding back the momentum that you can go for, just given the commercial coverage is there now, well, will be coming and evolving. But is there anything just holding back the rate of uptake that you could perhaps push out into the market? Or do you feel like you have the capabilities, supply chain infrastructure to service that demand?
We are moving as fast as, Guardant is a fast-moving company, and for Shield, we are doing as fast as we can in terms of scale-up. Dramatically, the size of sales team has increased. We mentioned that we started this year with more than 300 people in the field in terms of commercial field force. In Q2 earning, we said at that time, we had more than 400 people in the field. Our DTC campaigns went from nothing last year to some pilot phase earlier this year, and now really at a very scaled DTC campaigns right now. In terms of lab, we bring forward some of the capacity that we are planning to build down the road. We moved it forward, so we are very excited with those kind of progress that we are seeing.
On the workflow, we got FDA approval for a more scalable workflow for Shield very recently, so that would really help with the scale-up and also reducing the COGS of Shield in a meaningful way, even before end of the year. In general, we are moving as fast as possible.
Mike maybe hit on that cost reduction for Shield. I think it was a pretty interesting evolution there we've seen.
Yeah. We know we had a very nice reduction in cost per test recently. I think, we've been mentioning for a long time that really we've got three main drivers of cost reduction over the next couple of years to get us from over $1,000 per test when we launched, and we're targeting a $200 test, when we're at scale. We've made really good progress, scaling our lab, getting a lot of efficiencies. Volume, of course, has been a driver to date of bringing the cost per test down, and in Q2, it was just over $400 per test. But recently, we got an FDA approval for changes to the workflow. So we've taken out a lot of analysis that was unnecessary. That needed to go through an FDA sPMA process just to prove equivalency with the original test.
But we were very successful in doing that, so that's now gone live in the lab. We expect that by the end of the year, we'll realize something like a 15% reduction on that $400 COGS that we had in Q2. So we think we'll exit the year with a cost per test of $350. We've still got work to do. We've been investing heavily in automation. Our plan is to take out as much labor cost as possible in the lab, where we're processing Shield. So that work's ongoing. That will again need to go through an FDA approval process. But when we come out of that, and we expect sometime probably late 2027, we'll see another significant step down in cost per test, and then continuing to drive efficiencies and with additional volume, that's going to get us to $200.
I think we're well on the way with the target that we set, and we're really pleased with the results.
With these new commercial wins, could you maybe just unpack what that means for ASPs and what those different rates look like perhaps across the different plans?
Yeah. Obviously, getting coverage on the commercial side is very positive, and it's going to have an improvement on what we get paid by the commercial base. Just as a reminder, we've got the Medicare ADLT rate, $1,495. That's been in place now for two years, and that's a well-established rate. Over the last two years, we've seen very strong payment from Medicare Advantage payers, and so we're getting very good reimbursement on that side. Where we've lacked to date is, has been on the commercial side, and with no coverage, we've effectively been getting zero paid. So we've been managing our ASP. We've primarily been focused on the over 65s, where we do get paid.
As we've got into guidelines with ACS and now with these commercial coverage decisions, we'll start to open up to more and more under 65s. So that'll have two impacts in the near term. Obviously, for the payers where we're covered, we'll start to get paid. We'll have to see what that is, and we'll have to see what decisions we want to make about contracting with those payers. But those zeros will start to transform into paid tests. But we'll still have some zeros from all of the other commercial payers. I think with our ASP, it's going to depend a lot on the mix over the next couple of years. We know that percentage of commercials and potentially the percentage of zeros in the short term is going to increase. So we had, for the last couple of quarters, an ASP in the $800 range.
We've guided for the remainder of the year at $770, so a little bit of a dip. There might be a further dip as we have more and more zeros when we open it wider to commercial payers. But obviously, this flywheel that AmirAli mentioned on commercial reimbursement, that's going to drive ultimately the ASP back up. We're very confident that we'll have a strong ASP in the medium to long term.
Great. AmirAli, just on the ramp, any seasonality we should be thinking about for the third quarter? I realize, again, it's still early on, and so that ramp probably still looks pretty aggressive. But anything you're seeing out there in the market?
So, just as a commercial organization on PCP front, still, we don't have a lot of history data to rely on. But we have some, and we are looking at a lot of other kind of external data. Like in Q3, what we talked about is there are some seasonality in patient foot traffic in PCP offices during the summer days. In Q4, typically, you see some kind of weather events. These are in terms of some of the dynamics of quarter-over-quarter, and we consider it when we set our guidance for second half of the year in our Q2 earning call. Besides that, nothing else to call out.
Then maybe one for both of you, but just thinking about the level of investment going in behind Shield now, DTC spend and the reps, how should we be thinking about the direction of travel for both of those in the years ahead?
You want to take that? I think we've consistently said that as Shield continues to progress and volumes increase and revenue increases, we'll be investing any incremental gross profit back into the sales and marketing line, basically, to drive the commercial scale-up for screening as quickly as possible. So we've been doing that. Obviously, getting commercial coverage, being able to reduce our COGS is going to just allow us to reinvest more gross profit back into the line. So, I think over the short term, we should just expect that investment to continue to ramp. We want to get to a place where we've got 600, 700 reps and a very strong DTC level of spend as soon as possible. We're scaling as quickly. So you should expect that in the near term to continue.
Great. Just on competition, obviously an evolving market, more people coming into the fray. What do you think are the components of Shield that make it stand out as the preferred go-to screening test here? How are you thinking about that market evolution over time, what that rough share perhaps could look like five years from now?
I'm very confident about the position that we are in now. Still today, Shield has the best CRC detection readout of any other kind of technology out there. So we are still the best in terms of CRC detection. It's the most clinically validated test when you're thinking about the experience with way over 200,000 physician testing, real-world adherence, a bunch of randomized studies that we've done in different health systems or settings to show the overall rate of screening can go up significantly. Publications that we have behind Shield, in general, it's the most clinically validated platform. We also have the network and infrastructure that we built at Guardant during last decade. I think some elements looks kind of maybe simple, but in reality, it's a major infrastructure build-out that takes time. For instance, blood draw, phlebotomy networks.
At Guardant now, we are working with tens of thousands of contracted phlebotomists that help across our brands. That's not easy to build in a regional setting, at the national scale. So I don't think a bunch of this competition, which is going to come to the market, have anything on that front. We have first-mover advantage with a commercial team, which is really focused on this blood-based CRC screening. I think some of the competition is going to have hard time with the positioning of maybe stool test versus blood-based test. Lastly, over time, this MCD opt-in is going to show powerful contribution in the values that we are going to offer to the physician versus CRC-only assay.
Yeah, maybe we can hit on the MCD opt-in. We obviously have an outcome for a competing MCD test next week. How are you thinking about that category? What's the physician feedback been? I think you said the majority have opted in for the MCD feature. Maybe just talk through the evolution you're seeing there.
Yeah, I think still we are in relatively early innings of this MCD opt-in and offering in the marketplace, and majority of physicians are using Shield now as a multi-cancer detection test, the way that actually we built this platform. We were not sure if PCPs in general, that sometimes you look at as maybe they are not the most sophisticated physicians out there, they would adopt this in such a fast phase. It's the broadest way of offering MCD in terms of accessibility. As long as the patient is indicated for colorectal cancer screening, which is 90% of the patient age 45 and above, if their doctor is interested and the patient is interested, they can opt in to receive multi-cancer detection. That's very different than maybe some of the competitors offering that's. It's not broadly accessible for everybody.
It requires very high out-of-pocket payments in order to get access to this kind of innovations. We never believe that's the best way to really make sure the innovative test needs to get offered. So we are very excited, and I think over time, we are going to continue to see that this was the best way to make MCD available in the marketplace. We wish our other players with their outcome best of luck. It would be good for field to move forward if that outcome goes well. But that would not give them really a broad reimbursement pathway versus the pathway that we have, which it's very unique to us.
Anything from the data you're seeing on the MCD side thus far that surprised you or interested you?
Still, it's early days. I think the adoption has been pretty good. We are happy with the rate of data that we get access to on the patient side in terms of patient authorization. It's going pretty smoothly, and it's continuing to trend in the right direction. In terms of performance and sensitivity, it's too early. We do not have data after we opened up this MCD opt-in.
Got it.
We need to be more patient.
A couple of minutes left, so maybe we can just quickly hit on biopharma. I think growth shaping up relatively in line with expectations so far this year. But maybe just speak about the pipeline that's evolving with those biopharma relationships and any assumptions we should have multi-year horizon on that business.
Yeah, no, biopharma continues to be a very strong engine for us. Not only with our pharma partnerships, but of course, it's a leading indicator on the clinical side. Again, all of the work that we did with AstraZeneca on SERENA-6 now comes through to drive the clinical oncology business. So it's a strong contributor to Guardant Health. I think you've seen over the last 12, 18 months, we've had multiple CDx approvals. We've announced multiple strategic partnerships with big pharma. So we're being more and more integrated into the whole clinical development process with them, and Guardant360 is being a key element of that. So yeah, we look at that to continue. We think those pharma partnerships are incredibly important for the whole of the business. Things are going well.
On a long-term basis, we've guided for in 2028 for our biopharma business to be roughly $300 million, which infers a roughly a 10%-15% annual growth rate, which is roughly in line with the market. So we're very confident about that, yeah, and hopefully, some of these strategic partnerships that we've signed can help us accelerate from that.
Amazing. Well, AmirAli, Mike, thank you so much.
Thank you.
Thank you