Guardant Health, Inc. (GH) Earnings Call Transcript & Summary
June 1, 2021
Earnings Call Speaker Segments
Brian Weinstein
analystGood afternoon. My name is Brian Weinstein, and I'm the group head of life sciences here at William Blair, and I am responsible for coverage of Guardant Health. Before we jump into all the fun stuff and get into a good fireside discussion, I am required to inform you that for a complete list of research disclosures or potential conflicts to please visit our website at williamblair.com. Logistically, the format, as I mentioned, is a fireside chat between me and the management team that will last for approximately 30 minutes. We have a set of questions prepared, which we are hoping to get through. [Operator Instructions] We will try and keep an eye out for it but cannot guarantee that we will be able to get to questions given the short time that we have with the management team. With that, let's jump in. We are fortunate to have the company's CEO, Helmy Eltoukhy, here as well as the company's CFO, Mike Bell. Good to see you both. Thank you so much for spending some time with us today.
Helmy Eltoukhy
executiveThanks for having us.
Brian Weinstein
analystOf course. So as this is a growth stock conference and really not a health care specialist conference, I thought we would start by really having you give an overview of the business because we know there's a growing interest in this space and that's bringing new investors to the story who may not fully appreciate what the company is about, the technology you use and sort of where you're applying it. So maybe a 5 to 10-minute Guardant one-on-one, if you will, overview would be appropriate as a way to start out here.
Helmy Eltoukhy
executiveSure, Brian. Yes, happy to do that. So we are really a leader in what's known as a liquid biopsy space in oncology. And liquid biopsy is a very broad term as it's shaping up to be. There are really 3 distinct segments in this space. And if you think about the cancer population and some of the indications that are, I think, most interesting, the first is what's known as therapy selection. That's where you have a late-stage patient, let's say, stage III, stage IV cancer patient, who essentially needs to be matched to the most precise therapies, the whole new class of precision medicine therapies, targeted therapies, immunotherapies. And really, the only way to properly treat these patients is to understand the underlying genomics of the tumor itself, really sequencing the DNA that's there. In that indication, before liquid biopsies really the primary way of getting that information was through a tissue biopsy often surgery. That's -- in lung cancer, just to give you kind of a flavor for how invasive it is, it's about a $14,000 procedure, 19% complication rate and 1% mortality rate. And we launched the first comprehensive liquid biopsy in this space back in 2014. That's called Guardant360. And essentially, the Guardant360 replaces that procedure with a simple blood draw. So a simple tube of blood, and you can get essentially all of the information that's driving the tumor and match that patient to the best effective therapies -- or most effective therapies. And that test works for all solid tumors, breast cancer, lung cancer and so on. So that's that first bucket of advanced cancer patients. The second major indication for liquid biopsies are what's known as the recurrence monitoring or MRD setting, minimal residual disease setting. So these are typically earlier-stage patients, stage I through stage III that are potentially curable through surgery or through some adjuvant chemotherapy. The big question or the big dilemma for those individuals is, was the surgery successful? And is their cancer going to come back? And there are not really good follow-on tests for those patients, those 15 million cancer survivors. So this is -- give you a perspective on the numbers as well, there are about 1 million late-stage patients, 700,000 to 1 million. There are 15 million cancer survivors. So it's a much, much bigger segment of the population. And what technologies like ours can do in this setting is really give a more of a definitive sense of whether the patient's cancer will come back or not. We can essentially use that same liquid biopsy platform, take a test a couple of weeks after surgery and really see -- if we see traces of the cancer there in blood, that patient has nearly 100% chance of recurring. So these are very, very accurate tests and that I think are going to change the nature of how cancer is managed in that setting. And then finally, the last bastion of liquid biopsy or at least the one that multiple companies are developing is screening. So this is the exciting kind of area that applies to everyone who is asymptomatic, has average risk. We're developing a test for colorectal cancer screening initially, will expand to other cancer types. And so we have a 10,000-patient trial that's comparing head-to-head our blood test, our liquid biopsy with a colonoscopy. And if that's successful, our test would potentially be another option for those that are between 45 to 84 to be able to be screened. So that's a population of about 100 million Americans. So we're going for a successive geometric scaling from 1 million to 10 million to 100 million. And we have active programs across all 3, but it's been -- this is an exciting year because all of those areas will either be in late-stage development or commercially launched by end of this year.
Brian Weinstein
analystNo. That's great. And that transitions really nice into kind of a series of questions that we're asking all of the management teams that my team is speaking to this week. And that's around kind of key catalysts for the next 6 to 12 months, so maybe we can get a little bit more granular on those different opportunities that you have and kind of where they all stand over the next 6 to 12 months. And then we'll go into a couple of the other kind of more scripted type of questions before kind of going into some of the other areas.
Helmy Eltoukhy
executiveYes. So I think one catalyst, we're kind of in the midst of with Guardant Reveal. So this is our test for MRD, for cancer occurrence, initially for colorectal cancer patients. That relaunched a couple of months ago. We expect to get Medicare approval by end of the year. So that's going to be a big milestone for that segment. And we're also presenting data at ASCO around bladder and lung cancer from that platform as well. So stay tuned. The second, I think, major milestone for us is completion of the ECLIPSE trial. That's a 10,000-patient trial that I alluded to. We started that in November of 2019, and we expect to remain on track for completing that within the 24 months we outlined. And so certainly, by Q4 of this year, we should finish enrollment. And that's clearly kind of a huge milestone for the company and I think for the industry as well in terms of having such a major trial completed. I would say that the upcoming launch of our tissue test, we're launching a tissue biopsy sequencing test in the -- or comprehensive genomic profiling test in the therapy selection space. We think that's going to go a long way in terms of catalyzing this blood-first paradigm that we've been promoting. This is an idea of rather than wasting and spending a lot of time on shipping tissue back and forth and getting all of these results from an invasive biopsy, start with blood where it's much faster, it's much easier, it's much less invasive. And if you don't get results from that test, then integrate some of the tissue results kind of in the background. And we think that integrated approach is going to go a long way in terms of really moving a lot of those physicians who are still in the sidelines to embracing, really using liquid biopsy and more specifically, Guardant360 on a day in and day out basis. I would say those are the major ones. And we have a lot more work going on in the background and many other programs. But I would say those 3 are probably the biggest ones for '21.
Brian Weinstein
analystWill we hear anything later this year about other areas within screening that you're looking to move into? Will we formally hear what that looks like later this year?
Helmy Eltoukhy
executiveYes. I think by end of this year, that's another good one, Brian, to point out, is we should be able to share, I think, in more detail, some of the plans around expansion of our screening program from colorectal to other cancer types.
Brian Weinstein
analystWill that be in the form of some internal data or just communicating these are our next targets?
Helmy Eltoukhy
executiveI think you can see -- I mean, certainly, the latter for sure. And I think in terms of data, we're dependent on some of our external collaborators. So -- but the data will come at some point.
Brian Weinstein
analystGood. And we're definitely going to delve back into those here in a second. But I wanted to ask another question around kind of the recovery that you guys are seeing in your end markets. As we sit here, somehow already in the early part of June in 2021, the year has really flown by, I'm just wondering if you have any update as to kind of what the trajectory of the business looks like through May, if there's any update that you're we're willing to provide on that? And how -- what you're seeing now is sort of influencing what you're thinking about for the back half of the year?
Helmy Eltoukhy
executiveI think what we're seeing now is really in line with the expectations that we shared at our previous earnings calls. I think it's really heartening and great to see vaccinations working and cases plummeting. And a lot of our forecast was based on same things really return near normal in the second half of this year, and it feels like we're on a glide path towards that actually happening. I would say that the challenges, I think, we saw in the early part of the year was, I think, primarily due to office closures and limited access. We saw about, I guess, 85% of offices closed in January, and we saw that improve to about 65% at the end of the quarter, and you continue to improve now. So we saw weaker January but a very strong March and very strong April. And so I think we're seeing really that kind of office openings really being a leading indicator for kind of how aggressive we can be with the business. And so we feel very happy with how we performed despite those office closures. We, I think, built muscles we didn't have around remote selling and virtual engagement. And I think those aren't going anywhere. I think those are going to be -- I think that channel is going to be one that I think is pursued by us and certainly many in the industry for years to come. So we definitely see a silver lining there. On the pharma side, I think that's an area that I think we continue to see some challenges with COVID, I think. And then the bright side, a lot of the trials that were delayed in -- or paused in the early part of the pandemic came back online certainly by second half of last year. And then we saw essentially that while the trials are on, I think patient enrollments are still depressed, especially in the oncology space because the trial sites tend to be limited in terms of geography, and the willingness and desire of patients to travel a couple of hundred miles is still not quite to pre-COVID levels. I think we also outlined that by second half of this year, we expect that to return to normal. And I think we still expect to see that. That being said, the pipeline is looking very strong. It's never been stronger in terms of what we're seeing with the, I think, 70 pharma partners that we work with now. You can see the development services line in terms of the companion diagnostic work we're doing has really number have been stronger as well. We're seeing continued growth. We're very pleased with the recent companion and diagnostic approvals we had in those last 2 weeks, back-to-back approvals with Amgen's KRAS drug as well as with Janssen's exon-20 insertion drug as well. And so it's very exciting to see that and that's just the beginning in terms of the strong pipeline we've developed there. And we believe that is really a leading indicator in terms of the strength of the pharma business as well.
Brian Weinstein
analystYes, absolutely. Going back to the catalyst side. Is there anything on the -- from a companion diagnostics perspective that we should be thinking about in the back half of the year? Are there more that are more near-term that might be coming here for you?
Helmy Eltoukhy
executiveYes. I think we've announced, I think, collaborations with Daichi and Radius and so on. But those tend to be on kind of their own time line. So we don't have a lot of insight in terms of -- we have the broad strokes but not a lot of insight in terms of exact timing. But we're certainly very happy to have these latest 2 under our belts now in the last 2 weeks.
Brian Weinstein
analystGood. Maybe taking a bit of a diversion for a question that you may not get asked all that often, but I am curious about anything with the supply chain that you're seeing right now. Obviously, we see reports every day or every week about some other industry that's impacted by something you never would have thought of being impacted just a couple of months ago. So anything from your standpoint on supply chain that's sort of raising a yellow flag to you? And is a corollary there? Are you seeing any pricing pressure coming to you as far as input costs going up? Any kind of inflationary pressures that you are seeing on your business at this point?
Helmy Eltoukhy
executiveI don't know. Mike, is going to...
Michael Bell
executiveYes. No, I would say, first of all, Brian, we're not really seeing any supply chain impacts in the business. I mean, we manage that very carefully and very closely. And I think we've done a very good job over the last 12 months or so. From an inflationary perspective, well, I mean, first of all, we are rapidly growing, so that's giving us a lot of ability to negotiate with suppliers. I think also, we've got some very good long-term supply agreements in place with defined price increases throughout the contract. So we're not really looking at these inflationary pressures really changing our perspective on the business or the products that we're producing.
Brian Weinstein
analystI appreciate it. Another topic you may not get asked all that often but it's becoming an increasingly important factor for many investors is ESG. It hasn't really received a ton of attention, I think, in the sector yet, but clearly, the appetite for investing in companies that have strong ESG policies is increasing. So we wanted to give management teams an opportunity this year at the growth stock conference to highlight anything that they are doing with ESG in terms of actions or activities. And then we'll check in with you on it occasionally and certainly every year at the growth stock conference. But I guess if I just through the topic, ESG, how would you answer it as it relates to the Guardant?
Helmy Eltoukhy
executiveYou want to scratch, Mike?
Michael Bell
executiveYes. I mean, firstly, of course, the mission of the company is focused on improving patient outcomes. and so we're very patient focused. And we believe that everything that we're doing is really working to an important benefit for society. And as a company, again, we're really committed to being very socially and environmentally responsible. There's things that we definitely focus on internally, safety and efficacy of the products and services that we produce. We're in a highly regulated industry and we need to follow all the guidelines there. And from a marketing perspective, we definitely make sure that all of our marketing is ethically proper and that we're giving accurate and truthful information. I think one area that we realized that we can improve on is definitely the disclosures that we put out. We do a lot internally, but we can't really talk about it. And I think as investors are looking inwards now at the company, I think if we start to update those disclosures and really show what we're doing can have a bigger impact to the investors that are really concerned about that area.
Helmy Eltoukhy
executiveYes. I mean, one thing I'll add is, I think we're pretty committed to very diverse and inclusive workplace. We have very good gender kind of the equality and balance in the company throughout -- even at the Board level, we've made a lot of strides there. So yes, this is something we're very committed to, and I agree with Mike we'll, certainly, I think, disclose more of the good work that we're doing internally as well.
Brian Weinstein
analystGood. I look forward to hearing about that for sure. Wanted to go back to a couple of the products that you were talking about. We'll start with kind of Reveal and what's going on there. So as you mentioned that product is for residual and recurrent disease detection. But it's got a bit of a different approach to than some of the others that are in the space. So can you talk about your approach, your tumor-naive approach versus a tumor-informed approach? And for people who, again, may not be as in the weeds on this as you and I are, kind of what that means? And what -- not just what it means in words, but why you decided to go with the approach that you did and what it means clinically to use one or the other?
Helmy Eltoukhy
executiveYes. We prefer tumor independent versus dependent, but...
Brian Weinstein
analystThat's fair.
Helmy Eltoukhy
executiveNo, it's -- the reason that we went with this approach is it really has all of the advantages and none of the disadvantages. So we -- the approach that we have is very different than what's out there. What's out there is, essentially, you look at the tumor, you find a few mutations -- single point mutations that are driving the tumor. And then you kind of create these simple assays just to monitor that over time. And so you're looking at a handful of mutations that may or may not be present in kind of new tumors that form or may only be present in part of the tumor. So there's some limitations in terms of the technology and the technique. What our technology does is rather than just looking at a handful, a dozen or a couple of dozen spots, we're looking at basically tens of thousands of different regions. And both in the genomic areas, the areas that tend to be frequently mutated in these types of cancers as well as what we call epigenomic regions. And so these are essentially changes in the genome that aren't reflected in the sequence itself, in the 4 letters ACGTs. These are chemical modifications of the DNA itself. And these chemical modifications are what make your liver cells different than your lung cells different than your skin cells, and cancer cells largely different than normal cells. And they're very sensitive, and they tend to be very well preserved if you have enough data and you capture enough of these regions. And so we looked at how much does this improve if you were to sequence the associated tissue. And the answer is, not very much. And so that's really the beauty of this approach is that you get potentially higher sensitivity without needing the need for a tissue biopsy. And so we see this as really the first true liquid biopsy in this space where you're not dependent on tissue. This opens up a lot of opportunities having an approach like this. Logistically, a lot simpler, 7-day turnaround time versus weeks and weeks and weeks for a tissue-dependent approach. It enables really democratization and access to every individual, even those that may be moved away from the site that they had their biopsy or had their surgery, or maybe years out from essentially when they've had a curative resection where the tissue block is not found. So it really opens up the patient population. And then finally, we're not subject to -- these tumors are constantly evolving. A lot of times the initial tumor's taken out and there may be secondary sites that cause the recurrence. And so the fact that this is agnostic to the specific tissue allows us to really keep up with the cancer and potentially truly find those recurrences. And that's why I think we're seeing a very high sensitivity with this test. The last thing I would say is if you look at a lot of the companies that are going towards screening, many of them have converged to kind of the approach we have taken, which is looking at these epigenomic signatures. And it's thought that these epigenomic signatures really are more sensitive because they're maybe not confined to the tumor itself, they may pervade the tumor microenvironment and so on. And I think that's why there tends to be higher sensitivity in early-stage disease with these approaches.
Brian Weinstein
analystAnd we'll transition -- certainly with a couple of minutes remaining, we'll transition to that in a second because I think going into that screening is important to kind of talk about here in a minute. But as it relates to Reveal, obviously, some news over the last 10 days or so, litigation that you guys filed. Can you just talk about the basis of that litigation that you filed with Natera? And any thoughts on the response that they had, and sort of next steps here?
Helmy Eltoukhy
executiveYes. We can't really comment on ongoing litigation at this point. Needless to say, I think we stand behind the performance of our products and all marketing and sales efforts that we've had as a company. We've always taken kind of the high road as we speak, and we've always tried to maintain truthful and honest information about our products. We think it's a duty for every company in the health care space to both highlight the good and the bad, where the tests should be used and where it shouldn't be used. That's something that we've been committed to from day 1. We have over 200 peer-reviewed publications in our technology. And that's something that we're going to continue to maintain, really providing that very accurate information about all of our projects, and we expect other companies to do the same.
Brian Weinstein
analystUnderstood. Okay. Transitioning to screening for a second, just focusing on colorectal cancer because it's the most near-term opportunity for you. You recently showed data on a case-control sample set that was a large data set that did include asymptomatic patients. But can you go over that data with us and talk to us about what you think that means sort of big picture? What did you learn about your product after seeing that data?
Helmy Eltoukhy
executiveYes. So these successive data sets we've presented outside of ECLIPSE. What we've been trying to do them is -- do with them is really be our own worst critic. Really say, okay, if things were to go wrong or if ECLIPSE didn't go over to the finish line, why would that be the case? And with this cohort that we're presenting in ASCO, we really try to assess 2 things. One, really upsize the number of positive colorectal cases, really by a significant number. We have 434 CRC positives in this study, which is, I think, at least 4x bigger than most other studies, at least in the positive CRC side. And what we tried to do there is just really get -- ensure that we're not overfitting, have enough diversity of cohorts and so on to really understand the -- test kind of the limits of performance of the test. And that I think -- so that we accomplished that with this. And obviously, we maintained really a similar performance as we've shown before. The second aim, as you alluded to, was asymptomatic versus symptomatic. And the hypothesis there was, you tend to see performance decline in some of these prospective studies. And is it because you're finding earlier-stage patients, patients where disease was really not apparent? And so these may be harder to detect by some of these assays. And it was really encouraging that we saw very little performance degradation between the 2. The asymptomatic cohort did almost as well as the symptomatic one. But I think what is more -- even more intriguing was that there were biological differences between the 2 samples. We saw much lower signal levels in the asymptomatic individuals. And so I think the hypothesis was sort of a valid one and maybe one that's been borne out by other assays where they saw difference in performance. But the fact that the LUNAR-2 assay was sensitive enough to really maintain comparable performance was very encouraging to see.
Brian Weinstein
analystSo as then we think about ECLIPSE, what would your expectations be for a successful clinical trial there?
Helmy Eltoukhy
executiveYes. I think for us, it's -- we are hopeful that we'll see performance that's largely in line with where we've presented in these other cohorts. Certainly, the red line that we can't cross is the NCD specifications in terms of 74% sensitivity, 90% specificity. And I think there's a lot of margin in between those 2 goalposts. So we're feeling very good that we can hopefully end up in a place that I think is very positive for patients. It's getting over that goalpost and getting into the Task Force kind of good graces in terms of the positive recommendations that we think are going to be the major success drivers for an assay in this space.
Brian Weinstein
analystAnd obviously, Task Force just wrapped up. You can't really communicate with them, but what's the expectation you have about the opportunity for you to be able to get into Task Force maybe sooner than what has been a 5-year sort of interval on things. Do you think there's an opportunity for that to shrink? And what informs that?
Helmy Eltoukhy
executiveI think there's potential opportunity. I mean, if you look at the current landscape, there are 30 million to 40 million Americans who aren't being screened who should. So there's a great need for technologies that can really chip away that compliance issue that continues to remain. We think that if the results are as compelling as they are with ECLIPSE with some of these earlier cohorts we presented, then I think there should be a good basis for that. There are I think some other initiatives that are ongoing as well legislatively, too, that I think are trying to hopefully give the Task Force maybe some more funding so that they could have -- really, I think, impedance match their process to the significant investment that's happening in the screening space today. This is -- it's just historically unprecedented. So yes, we're very hopeful. But our base case is kind of the current review cycle. And that's something that's still a great outlook for us.
Brian Weinstein
analystYes, understood. And then the last thing that I'll ask you guys about today is on that product, what do you think reasonable assumptions should be as we're thinking about modeling this out on pricing? We've heard other companies talk about $150 million to $200 million but being very clear that they think that's going to be an annual test. I'm going to put words in your mouth intentionally, and correct me if I'm wrong, but I don't think that you think your test will be an annual test at the performance you're expecting. You're expecting it to be -- every 3-year type of a test, similar to what I'd say, Cologuard has, right? So...
Helmy Eltoukhy
executiveYes, that's what our baseline is. Yes. Let's say, $500 every 3 years.
Brian Weinstein
analystYes. Okay. So that's your expectation. So if you saw degradation in the data for whatever reason, and this became more of an annual test, will you be able to support -- if the pricing for the industry kind of comes in $150 to $200 for annual test, will you be able to support a product in that price range?
Helmy Eltoukhy
executiveYes, I think that remains to be seen in terms of the -- I think we feel pretty confident that we could have the performance that would be commensurate to a test that's every 3 years, and at the current benchmark that's there, I think the NCD itself, I think, is written largely towards every 3-year cycle, and that's for blood-based screening at 74% sensitivity, 90% specificity. So I think there's good support for our base case.
Brian Weinstein
analystUnderstood. Okay. Well, we're already a minute over. It's amazing how quickly these things go. I have pages of other questions I'd love to ask you guys. But unfortunately, we're out of time. So Helmy, Mike, as always, thank you so much for spending time with us today. We look forward to connecting with you guys in the future.
Helmy Eltoukhy
executiveYes, thanks for having us, Brian. Take care.
Michael Bell
executiveThanks, Brian.
Brian Weinstein
analystTake care.
Read the full transcript via the API
You're viewing the first half of this call. Get the complete Guardant Health, Inc. transcript — plus 251,000+ transcripts from 12,000+ companies, speaker segments, AI summaries and full-text search — through the EarningsCalls.dev API.
Get the API View API docs →This call discussed
For developers and AI pipelines
Programmatic access to Guardant Health, Inc. earnings transcripts and 251,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.