Guardant Health, Inc. (GH) Earnings Call Transcript & Summary

Great. Welcome, day 1 of the UBS Genomics 2.0 and Medtech Innovations Conference. This is Dan Brennan. I cover tools, diagnostics and pharma services. I'm really pleased to be joined with me here at our 12:00 session with Helmy Eltoukhy, who I'm sure everyone knows very well, CEO of Guardant Health. So Helmy, thank you very much for participating.

Yes. Thank you, Dan, for having me.

That's terrific. Great. So obviously, a lot of great things to talk about. I got a lot of questions, which I'll try, I won't be able to get to all of them. So hopefully, I'll jump around and get the key points. Feel free for those on the phone to shoot me your question, I'll try to get to it, if I can, obviously, but we've got a lot of stuff to get through, but feel free. So maybe just starting off, obviously, the FDA pan-cancer approval, terrific news on that. I know in the past, you've discussed many ways how it's going to help Guardant, commercial reimbursement, penetrate a lot of the smaller customers and also new CDx opportunities. Maybe can you start with -- on the reimbursement front? I think you've discussed kind of a gradual improvement, how this will kind of play into your ASPs. Is it possible there could be an inflection in reimbursement following the FDA approval, maybe not immediately, but like at some point in the next 12, 24 months where we see basically more of a steep acceleration?

Yes. So obviously, we've made a lot of progress in terms of ASP with the reimbursement to date. I think this recent quarter, we are at $2,700, which is in a very good place in terms of this type of testing, especially relatively this early in terms of where we are in terms of coverage. We have about 180 million covered lives now with Guardant360. And a lot of the private payer lives are really only in lung cancer. We're not quite pan-cancer yet. And so there's still a lot of room for improvement. So there's going to be, I would say, a couple of different aspects to the benefits that FDA approval will provide us. In the near term, we'll be able to expand the current Medicare coverage that we have. The label that is associated with our FDA approval does not have the requirement for tissue insufficiency. And so that opens up a certain sliver of Medicare volume, where we're not getting paid right now because of that requirement with the current LCD. Right now, we're getting paid on about 85% of Medicare claims. We think that this FDA approval and being able to qualify under the NCD, national coverage determination, would certainly bring us to at least 90%, and if not, a little bit higher. And so there is, I would say, some near-term upside from an ASP point of view in terms of that Medicare piece. I would say that FDA approval, I think, accelerated adoption, especially from some of the larger payers, some of the intransigents that have been -- continue to be on the sidelines. We've seen that FDA approval is something that many payers take notice of. It helps separate, I would say, the certain players' FDA-approved tests from the sea of many kind of LVTs that are out there. And it's certainly something we've seen in the past has helped move some of those large national payers over the finish line. And then finally, I think it will help accelerate conversion and -- of some of the only lung coverage that we have -- or lung-only coverage that we have with some of the private payers to pan-cancer coverage given the pan-cancer label that we have associated with the approval. So I think those are the main aspects, I think, we'll see. And to your point, I think the private payer side will probably take 12 to 24 months to play itself out.

Got it. Helmy, in terms of the impact on penetration of Guardant360, obviously, you've got varying levels of, I think, penetration between some of the different tumors or cancer types on kind of label now between late-stage lung and CRC. Help us think about the magnitude and timing of kind of penetration for Guardant360 now in the week of FDA?

Yes. I think in kind of broader strokes, I would say one of the challenges for the whole precision oncology field has been the fact that the use of comprehensive profiling, whether tissue or liquid, has really been something that is either a second-line option. It's not really the kind of first thing that is done for the majority of patients out there. And so we think about how do we move the middle majority and the laggards in the market to thinking about comprehensive genomic profiling upfront for all their patients. And we think that FDA approval will certainly help catalyze that conversion. It's important to have clinical evidence. We've invested heavily in clinical evidence. We have 50 clinical outcome studies, 150 peer-reviewed publications and counting. Yet, we don't have the time to go through those publications when we sit down with a physician. You have a few minutes at a time, sometimes a few minutes a quarter with a single physician. And so being able to come in and say, the liquid biopsy, we understand sounds like science fiction being able to reconstruct the tumor through blood, but it's FDA-approved now. And we think that is going to be a big game changer in terms of really seating and moving that adoption more quickly. The other, I think, tailwind that is outside of our approval, are just the growing and the very active drug approval pipeline that's there. I think with some of the recent approvals in breast cancer and prostate cancer and other cancer types, pancreatic cancer, we're really seeing uptake of precision medicine in this type of testing in those cancer types. And so the whole field, I think, is moving in the right direction. And the more there is a need for finding out which biomarkers a physician's patient has, the more it's going to highlight, I think, the ease of use and compatibility of our solution with some of the requirements and practical realities of clinical workflows that are out there, especially during this time of the pandemic as well we think is a silver lining for liquid biopsies, for sure.

Great. I don't know if this is something you guys have discussed, but is -- in terms of the volumes today, when a doctor is ordering Guardant360 and they're making a call, how much of that is -- how much of that has been related to non-small cell lung cancer? And how much of it is related to these other tumors that are now going to be covered?

Yes. So lung cancer, even though it's the area we focused on initially, and certainly, the area with the initial -- initially had the greatest clinical utility, it's about a little over 40% of our volume. It fluctuates between 40% and 45%. And so the majority of our volume is actually outside of lung in terms of absolute numbers. But we're certainly seeing uptake and very strong growth in breast cancer and prostate cancer and so on, really in line with some of these recent approvals for PIK3CA or for the PARPs in prostate cancer. And so as the pharma companies bring their drugs and their targeted therapies over the finish line, we're beneficiaries even if we're not an official companion diagnostic for those drugs.

Got it. Okay. And then maybe just one more question back to reimbursement. Is there a difference between the price for Medicare that you're in at and versus some of your private payer club? Presumably with PAMA, there's no motivation to go in anywhere below Medicare. But I'm just wondering if that's been disclosed at all since I had a question on that and just to kind of round out the reimbursement discussion.

Yes. So our pricing with private payers is all higher than $3,500. So there is an opportunity with PAMA to slowly move that up given that it will be priced at the median of the private payer-contracted rent.

Got it. Okay. And then kind of on your biopharma business, it seems like the pace of that could accelerate given what you just mentioned, obviously, on kind of the targeted therapies, in particular, in I-O that are still pretty early on. Like, how do we think about the growth in the biopharma business, if you look out, like you've been putting up really good numbers. But if you look out over the next X number of years, like, how quickly could that business grow? And like what would you point to as the key drivers of that?

Yes. I think there's still huge opportunity there. We pegged that market at, at least $2 billion in the total addressable size just for the late-stage piece. And that doesn't include some of the new offerings we have, which is a GuardantINFORM in terms of the data piece. And we estimate that GuardantINFORM by itself could add another kind of $800 million of annual kind of market potential in the field as well. And so we're -- there's a lot of opportunities. There's 130,000 patients who should be enrolled in the trials every year. And so we're clearly doing -- testing a very small percentage of those individuals to date. I would say that there's still -- we're still in the early days of adoption of liquid biopsy for a lot of these trials. I would say that tissue is still the dominant modality for enrollment, for screening of patients and so on and for testing of patients in these trials. The companies that have adopted liquid have been big beneficiaries. We've now had multiple studies and publications that have come out, one from Merck and one from the work we're doing in Japan with the GOZILA program, where we showed that we essentially had multifold increases in enrollment and reducing the time that it took to find patients from when you actually screen them to when they actually enroll in the trial. And so in almost every dimension and every metric, we blew away any kind of tissue-based modality for finding these patients. And so we're seeing very good trends out there. We're seeing essentially this -- the pendulum swing from immunotherapies back to targeted therapies in terms of the pipeline, just much higher success rate with targeted therapies and some of these immunotherapy kind of programs that are extremely expensive and often don't make it over the finish line, especially in terms of where the top players are with Merck and BMS. And so you're seeing, I think, a lot more investment dollars go into targeted therapies. And our solutions, we believe, are really second to none in terms of finding patients, testing them, the sensitivity, the performance. And then ultimately, working with us for -- when these drugs make it over the finish line, so that these pharma companies can get a running start. You don't want to go -- have to go and launch a new companion diagnostic that no one's ever used to -- and that will just slow down the uptake of your drug versus if you can piggyback on an existing testing modality, and simply elevate 1 marker that's already on that test to something that's a companion diagnostic. That's the best kind of running start any pharma partner could hope for. And so yes, we're seeing a lot of, I think, promise, in terms of the pipeline, the engagement we have, we think the FDA approval is going to be a catalyst on the biopharma side in terms of it's -- there's always skepticism before you've actually achieved it. And I there's skepticism whether a liquid biopsy could make it over the finish line in terms of FDA approval, and now that is behind us. We see a lot of those conversations really continuing to develop, and we think that's going to be an important driver of our development services revenue, and certainly, our pharma business in the years to come.

Interesting. So it sounds like the answer to this next question will be a lot given what you just discussed, but I had kind of written down, it was a question like, what percent of targeted therapies across the market is Guardant involved with today? And how -- of the market -- of the total market like how much could you address, do you think?

So I'll answer -- the second one, we can address. I would say the majority of the market, especially with GuardantOMNI. It was designed in conjunction with dozens of pharma partners in terms of asking them what their wish list in terms of different biomarkers to screen for what they had in their early drug development pipelines. And so GuardantOMNI, I would say, covers the vast, vast majority of the pipeline. And Guardant360 covers most of it as well, especially in the later-stage side of the picture. In terms of the percent of the market we have, I would say it's still much lower than it could be. I would say that typically, when we lose, it's either priced or the sense that liquid is kind of a nice to have but not a necessary component of their programs that really stick with kind of simple tissue testing. That's really the primary, I think, competitive pressure we have in the market is fighting the perception that tissue is really what is necessary, and often, they believe is sufficient for their programs. And so I think it's these types of stories as they come out in terms of what have we been able to provide, how we can find more patients faster for them, where I think the pendulum will swing towards more and more inclusion of liquid biopsy modality into these trials.

Are there any more head-to-head versus tissue? Obviously, you've already got one really important study. And I'm sure there's been many others that I haven't read about, but are there any other big ones in the works to kind of further validate this kind of liquid-first or -- kind of approach?

Yes. We've had studies now in, I think, some of the largest studies in lung and breast and colorectal. And so we have most of the major cancer types, I would say, covered. But we're always working with KOLs and different principal investigators on these types of studies and often smaller ones, but what we see is there are many cancer types where liquid is just better at picking up gastric cancer, for instance. There's a lot of heterogeneity that's there that a single tissue biopsy often misses in terms of some important biomarkers that are driving the tumor. And so there are a number of cancer types where counterintuitively, liquid does a much, much better job in terms of picking up the totality of the disease in these cancer patients. And I think the other piece where we're starting to see a lot of engagement and a lot of research is really in the monitoring aspect. The fact that liquid can pick up treatment response and it's treatment response that's often better correlated with overall survival than even response rates from CT scans. And so that, I think, is very exciting for opening up a new chapter where tissue just can't compete by definition. And so it's really thinking about the temporal dimension, the heterogeneity, the resistance mutations, that is going to open up a much, much bigger opportunity that is a true advantage of liquid. I would say everything we've been doing now, most of what we've been doing now in the treatment selection side has been the 0 to 1 chapter of liquid biopsy. Liquid biopsy is just trying to stand shoulder-to-shoulder with tissue biopsy approaches, which is fine. We find more patients. It's an easier modality, but the true benefits of liquid is in the monitoring aspect, the fact that you can keep coming in and seeing that temporal evolution as well as a special evolution of the disease. And that's what's exciting now, and it's starting to open up.

Interesting. It's a great segue. So in terms of LUNAR-1, I know you've talked about the importance of not just finding cancer but proving there's a mortality benefit via testing, an intervention rather than just watchful waiting. So in terms of like what's your confidence level in kind of CRC for MRD being effective in this regard? Like how long will this take?

So we have a number of studies that we've announced and other studies we're working on. Certainly, COBRA and our Stand Up To Cancer studies. COBRA is a randomized controlled trial, which is really the highest level of evidence, 1,400 patients. It's something that very excited about in terms of really trying to establish clinical utility in this setting. And so it's been now established in multiple cancer types, and we've shown it in colorectal and lung, and we have data in other cancer types as well that when you detect tumor DNA, tumor signals in the blood shortly after surgery, those patients have nearly 100% probability of recurring. And so the clinical validity has been shown by us and by many other groups. The question is, does it actually make a difference in terms of outcomes of those patients? Is it just lead time bias? Would you have found the same outcomes by just doing a CT scan 6 months later? And so that's still an open question for most of these cancer types, which is why we're investing in these types of studies. It's why we're working with a number of pharma companies as well on their drug studies. And so we think by taking as many shots on goal in terms of how this valid clinical diagnostic information marries up to the right kind of treatment modality, and at the marriage of the 2, the combination of the 2 can lead to better outcomes, that's what it's going to take to get over the finish line. You may get some wins with Medicare or some early payers. But to really get the -- to really realize the enormous TAMs that exist in this market, we're going to need to get, I would say, seminal clinical utility information out there to really get these payers over the finish line. Many of these payers still don't pay for comprehensive genomic profiling in tissue in late-stage patients, where the clinical utility is self-evident and abundant. And so it's -- I would say it's a bit foolhardy to think that we'll be able to realize and get all these payers on board, realize this big TAM and get all these payers on board without that clinical utility. And so that's why we're investing now in many of these studies, but we'll continue to be aggressive. And obviously, if the market takes shape and there's a lot of engagement around this setting, we do have a clear approved test in our LUNAR-1 assay that we could launch very quickly.

And tell me, I forgot, have you laid out beyond the initial -- the Stand Up and the COBRA study in CRC, have you laid out kind of -- even though those are critical and important and those are going to take time, like as we think about MRD, kind of what's even next beyond that in terms of timetables with some of the trials either working in the background or things you're planning to do?

Yes, we haven't disclosed some of the other trials we're working on, but we are working on a number of different studies and several different cancer types as well outside of CRC.

Got it. Okay. Maybe just one question on kind of business trends before we kind of move over to LUNAR-2, if you don't mind. So I know your guidance for Q3, I think, indicates volumes are going to be up from the first quarter's clinical volumes. And you said you exited Q2 with volumes in line with mid-March. And if we think about it in different terms, like how far back to normal would you say the cancer market is in terms of volumes? And how do you see that progressing over the second half?

I think one of the challenges that even though patient volumes thinking at the top of the funnel in terms of patients actually coming into physician offices or oncology offices, even though that's come back pretty sharply and pretty nicely, it's still not at the level of where it was pre-COVID estimates are. It's maybe come back 90%, but there's still some ways to go in terms of coming fully back. And one of the challenges with advanced cancer patients is that there's about a 30% mortality rate from COVID in that population, in that patient group. And so there's justified fear in terms of trying to protect these patients as much from exposure to the disease. And so that is swinging the pendulum towards telemedicine, towards virtual visits, towards less physical one-on-one follow-up, which, by its very nature, reduces the number of touch points, reduces the number of opportunities that diagnostics and pharma companies have in terms of engaging with this patient group and with the physician group. We're also seeing physicians' offices open up and then close back as the pandemic rages on in certain regions and as kind of new precautions kind of crop up in terms of where the disease is and where the infection rates are in a certain region. And so we think that this is going to be a headwind for some time to come in terms of the impact of COVID. That said, I think we're very pleased with the progress we've made in terms of fully getting back to pre-COVID levels despite all of that happening around us. And we think some of the benefits of liquid biopsy, the fact that it doesn't need coordination with multiple medical professionals in terms of the pathologists or interventional radiologists or surgical oncologists that can be done simply in the physician's office with a simple blood test. Obviously, we have mobile phlebotomy, which helps those segment of patients that can't come into the physician's office. But we've also launched in early March, very quickly, really the ability for completely virtual engagement, whether it's our sales team, our medical affairs team that can follow up on every report in terms of interpretation, our physician education programs where we've seen as many as 40 or 50 physicians on a single call in terms of learning about liquid biopsy, so -- and then a financial assistance program that we launched around COVID. And so we think that the suite of services that we launched within kind of almost in the same week as these shelter-in-place orders came into effect, I think, really strengthened our relationship with the oncology community as a whole. And so I think we're seeing some of the benefits of that. But that said, we are seeing kind of regional hotspots occur where things close down and volume is impacted on a kind of a regional basis. And so we think that's going to continue for a number of quarters, obviously, until there's a vaccine or the numbers go down dramatically in terms of new cases.

Excellent. Maybe shifting over to LUNAR-2. I think I may have written down something here on that question. But nonetheless, I know you've talked about, to mitigate the impact of COVID, you guys have expanded the number of sites enrolling to 150, and you've expressed confidence in hitting your original time line for the study for completion. And I wrote down November 2022, but I think you've talked about, what, 18 to 24 months, which would be back half of '21, right? Because you started in the back half of '19, right?

Yes, that's true. That's true.

Right. Right. So is that right, are we thinking like kind of somewhere middle to back half of '21 is kind of that's consistent with kind of what you've said?

Yes. Certainly, that 24 months, we feel very confident that we should be able to hit that time line. As we said on the call, June and then July were both record months in terms of enrollment. And so we are really chugging away. The engine is really running, I think, full steam. And that's not a position we thought we'd be in, in March or April. And so the fact that it's come back so quickly that we were able to leverage some of the downtime of this -- of these sites to sign on many, many more sites and get to -- in the next few months, we'll get to 150 sites that are fully engaged, and these are, I think, tremendous sites that we've been able to contract with. We feel that we're in a very good position in terms of being able to execute quickly and execute in a way that, I think, it kind of preserves hopefully a leadership position in terms of that aspect of the screening space, the blood-based modality and colorectal screening.

Right. And then I know you just recently put up some new data, which was an update from last year's data, 90% sensitivity at 97% specificity. I guess what changed from last year, when you think you had 64% stage 1 and 82% stage 2, what changed from last year to this year in terms of the performance improvement?

Yes. I think those numbers are actually our lung numbers and...

Really? Okay.

Yes. I was looking at them in the...

It wasn't CRC?

Yes, it wasn't. And CRC, I think, what we presented last year was top line numbers that were similar. It was about 88% sensitivity with 94% specificity. The stage 1, stage 2 was at low 80s. I think in this cohort, we are just about 89%, 90% in the earlier-stage disease. And so we definitely did see improvement from last year, but maybe more modest than what you initially said. So we certainly saw -- fairly significant improvement on the specificity side by zeroing in on colonoscopy screen negatives, which is what the ECLIPSE trial would be composed of and consist of in terms of the negatives. So that made us feel, obviously, even more optimistic in terms of where we were. But in terms of what's changed, the assay is fairly the same. I would say there was a lot more fine-tuning on the bioinformatics side, on the epigenomics portion of the classifier that we've developed. And so that's really where I think we saw improvement, especially on the early-stage detection side. And so, yes, the epigenomics and the kind of -- I think about methylation and then the fragmentomics and so on, there is a lot of headroom there that we have yet to explore. We're just seeing the -- its ability to help us pick up earlier-stage cancers is really unmatched on the genomic side of the picture. And so it's a very important component that, obviously, it's early days in terms of our experience compared to the genomics side of the house, which we've been working on for 8 years. And so we see a lot more headroom potentially down the road, especially as we expand to other cancer types in the future.

But now you're running -- so for ECLIPSE right now, is the assay still being optimized before you run these samples? Or what you presented with this recent improvement, is that what's moving forward for the -- for testing for ECLIPSE?

So as I said, we're happy with the performances from a technical point of view. What's being improved is really the rigor of the assay, having something that can be run in at, I would say, kind of FDA-approved in vitro diagnostics grade level. So our guard-banding studies, thinking about the supply chain, the reagents that are there, making sure it can be run at extremely high volume, cost efficiently. So there is certainly sort of locking down of the assay aspect that we're working on now.

Got it. And in terms of like, the question we get is kind of in a controlled study, how much changes -- in asymptomatic large pivotal study, how do you answer that? Like how do we think about -- well, we don't know until we see the data, but how do you think about from what you've shown versus what ultimately could transpire? Is there a natural degradation because of the more average-risk larger patient population? Or is that not the right way to think about it?

Yes. That's always a concern that a number of individuals have. What we've tried to do to address that is really test independent sample sets really collected in kind of different fashions and really tried to sort of diversify and guard against some of those potential risks in as much of a way as possible. But when you're doing case-control studies, they're always different than the final collection mechanism you may have in a registrational study like ECLIPSE. And so there's always that risk, frankly, that we acknowledge that there could be degradation or differences in performance. But that's why I think when we moved from self-reported healthy normals to colonoscopy-screened negatives and actually saw an improvement in performance, I think we're very happy with that. And so I think we feel increasingly more and more confident as we publish these new data sets that the data and the performance seems to be recapitulated every time and around the same levels. And so there's always non-zero risk of failure with any large study. And so we don't want to discount that fact. But if anything, I think we're much more bullish than we were 12 months ago, 18 months ago. It's one of the reasons we did this follow-on offering recently was that we're starting to think about commercialization of the assay and building that large commercial channel in the primary care space. And it's something that obviously is going to take a good amount of capital to do it the right way, but something that -- as we are void by these new results, we feel kind of very confident in times of forward investing in some of those activities.

And maybe just one more on this maybe to move off. But in terms of -- I know you've been asked this before, but just to level set that, what do you feel is like the bar at which the test would be "successful" in your mind commercially in terms of, I guess, early-stage sensitivity, I guess, is probably the best metric to look at?

Yes. We've been told that if we have anywhere close to the data that we've shown, that it's a game changer in the field. I think there's a lot of reading the tea leaves or hand wringing that's done in terms of 1% differences in terms of some of these data sets and whether it's 91% or 92% or so on sensitivity. And the fact of the matter is we've done fairly extensive market research. And first, scientifically, the confidence intervals are much larger than the 1% to 2% differences. So you don't make -- they're not very meaningful. But then two, what we found is, I would say, modality in terms of blood versus stool versus colonoscopy is a much more important factor than 1% or 2% changes. If you look at Forrest ranking, blood versus stool is more like a 5% to 10% difference in terms of performance, in terms of some of the qualitative research that we have done with primary care physicians. And so we think that there is a large opportunity for a much easier modality that puts most of the control into the hands of the physician that requires very little patient participation in terms of addressing the 30 million to 40 million Americans who should be screened that aren't screened today. And the fact of the matter is, too, that today FIT is the lion's share of the market. That's, I think, 10 million FITs performed annually. And every other modality fails in comparison in terms of numbers, and FIT is around 65%, 70% sensitivity with maybe 94% specificity in that range. And so we're very confident we can beat that, and obviously, have something that is extremely high performing. And so we are, certainly, very bullish in terms of the data that we've seen, the data that we've shown, and really, the feedback we've gotten now from hundreds of primary care physicians and dozens of gastroenterologists and so on in terms of where we need to be to really make a difference in this space.

Excellent. And actually, I can see one more in, if you don't mind, before we move on. In terms of pre-cancer side, normally is that important in an exact way to point out, it has to be, they're 42%, FIT's 24%, someone of those, if got, if I remember correctly. I didn't have it written down, but I'm wondering, is that something you've shown before? Or is that something you need to be at least as good as FIT? How do you think about that?

Yes. We haven't publicly presented data yet. It's something that we definitely have researched around and are working on. It's -- I think the science is a little bit circumspect there, only about 5% of these advanced adenomas ever become malignant tumors. And so really, the -- given the biology of a lot of these advanced adenomas is not necessarily consistent with colorectal cancers and so on. But it's certainly something that, from a perception point of view, in the field is extremely important, and certainly, something that we intend to address with our assay.

Got it. Then maybe just switching over to COVID. So you talked optimistically about like the need to ramp testing, lack of PCR capacity and the success you've had in your own workforce. I think you talked about, what, 10,000 tests a day you could do with 1 day to 1.5 days turnaround. So maybe -- just maybe just give a high-level view, I know you just had the call on that recently. But like how would that pricing for this compared to PCR test? And given how important turnaround is, maybe just work through exactly how this would kind of actually play out in the real world?

Yes. So I mean, as you kind of alluded to, we're actually probably one of the first companies to start weekly testing of our employee base. We've started that maybe now, I think, sometime in March, actually, so 12, 13 weeks ago. And what we found was extremely important in terms of gaining confidence in the workplace, and frankly, averting a lot of hairy situations that could ensue in terms of outbreaks and that kind of sign. And we're an essential service. We need to provide our testing to cancer patients globally, and we maintain kind of uninterrupted operations as well as record turnaround time during that period. And so I think testing was a key component of that. And then about probably 7 weeks ago, we switched from a third-party test to our in-house test. And our in-house test is one, as we've mentioned, is fairly orthogonal to the existing supply chain, has sequencing as a readout mechanism, has about 24- to 30-hour turnaround time. And what we found it has about 50 to 70x of sensitivity of a lot of the other tests that are out there and some of these PCR tests that are out there. And so we're able to detect, I think, infection very early in kind of the disease progression, which is very important in terms of trying to prevent these kind of outbreaks. And it's -- and in terms of competitive pricing, it will be highly competitive in terms of -- with PCR test, this is something that we could price, frankly, lower than a lot of the PCR tests. They're priced their -- despite it being sequencing on the back end. I think right now, we're in the middle of potential discussions in terms of partnerships, both with local kind of municipalities, states as well as many other employers as well. And so we're seeing the pendulum swinging back towards need for testing. There was a trough of disillusionment, I think, from the testing side where people thought that maybe testing wasn't needed, maybe we've got over the hump, so to speak. And now there's a lot more engagement in terms of those conversations. And so if we decide to scale things up, we'll certainly keep everyone posted in terms of how aggressively we come into that space.

Maybe just before I let you go because we're just -- we're kind of done. Any sense, I mean, you can't call when you get back from FDA, but what's the normal time frame at which point you think just...

For the EUA? Yes. I mean we submitted it about 5 or 6 weeks ago. So should be getting close to hearing back.

Great. Okay. Well, Helmy, we're at -- we're 15 minutes probably out. Thank you very much for participating in today's event.

Thank you.

Happy rest of the day. And thank you all for being on the phone. Bye-bye.