Guardant Health, Inc. (NASDAQ:GH) Q3 2023 Earnings Call Transcript

Jack Meehan: Thank you. Good afternoon. For Helmy. A couple of questions on the G360 volumes. First is with breast cancer. This dynamic you called out. I was curious, do you think this sequentially continues to taper in 4Q? Or is that bolus normalized at this point? And second, volumes are obviously pretty strong. I was just curious with the dynamic backdrop we’re seeing, are you seeing any changes in market share versus tissue or other liquid players? Thanks.

Helmy Eltoukhy: Yes. No. As I said, there was a sort of warehousing effect that happened where you had this pent-up demand for everyone that wanted to get on the drug. And so we had a huge jump up and we believe we’ve completely worked through that bolus. And now we’re just continuing on a very nice trajectory. And I want to highlight that we’re still extremely elevated levels of breast cancer testing than we were a year ago. I think year-over-year, we’re over 100% growth. And so we’re very excited in terms of where we are with breast cancer. And I think now on kind of the right trajectory here, now that we’ve worked our way through that bolus. Yes, in terms of sort of competition, I think we’re seeing a lot of the kind of same dynamics play out, ebbs and flows, the usual suspects out there.

But we continue to be the leader – undisputed leader in terms of liquid biopsy, especially in therapy selection. So we’re just chugging away. And obviously, as we said, we have all these catalysts coming up in terms of really working at a really much closer level with a lot of the important oncology practices around either through EMR or other sort of center-wide arrangement. And so, we’re very excited about what this sort of next phase bodes for Guardant360 testing and Reveal testing.

Jack Meehan: Great. And one question for Mike. With the pricing improvement for G360 that you’re seeing. I was curious if there’s any flag you’re willing to put in the ground for cash burn in 2024? Just with the trajectory you’re on with that improvement? What’s a good landing spot for next year?

Michael Bell: I mean I think if you look at our Investor Day slides, we said this year was a year of reduction of cash burn. Next year will be to — we said over the next five years, we expect the cash burn to come down each year. Although I want to sort of — cut that because it is a year of launch within screening. We’re still making investments on MRD. We will definitely see therapy selection flip to generating positive cash flow. So I think it will be a little bit lower than this year, but not too much lower because, again, we need to invest in the launch. But yes, just to reiterate, we’ll end the year with $1 billion in cash, and we still see that as being able to get us through to cash flow breakeven in the five-year time line we pointed out at the Investor Day.

Operator: Thank you. Our next question comes from Dan Brennan from TD Cowen. Please go ahead.

Dan Brennan: Hi, thanks for – thanks for the questions. Congrats on the quarter. Maybe the first one just on Reveal. Could you just kind of walk us through the road map forward in terms of how we should think about filing for expanded coverage both in CRC and then also be interested to hear about what expectations should be for the upcoming data at San Antonio Breast and how that could play into your Medicare filing plans in breast?

Helmy Eltoukhy: Yes. So as we speak, we’re putting, I think, some of the Kosmos data for colon cancer, getting it ready for publication and so hopefully, once that’s published, that is something that would really make up the majority of our submission to MolDx for the expanded surveillance CRC indication. As we speak, we’re seeing a lot of, I think, good breast cancer data internally. We’ve also made a lot of good progress on lung cancer as well. And so we’re hopeful that — we’ll be able to have something out there certainly, hopefully published sometime in ’24 and have that submitted as well to MolDx. So we think – we’re laser-focused on breast, colon and lung cancers. We have obviously multiple other cancers in the pipeline as well, but we think those 3 indications would get us really a long ways of the way we need to be to have a reasonably reimbursed product for Reveal.

Dan Brennan: And with the data at San Antonio Breast, that will be a piece of the larger filing package, Helmy for breast?

Helmy Eltoukhy: Yes. I mean we continue to have data we had data at ESMO that was a very compelling in breast. I think we’ll have some additional data in San Antonio. But we have some other studies as well that may make up the bulk of the submission. So yes, we have sort of multiple shots on goal. I won’t be reliant on this one study.

Operator: Thank you. Our next question comes from Patrick Donnelly from Citi. Please go ahead.

Patrick Donnelly: Hi guys. Thanks for the question. Help me maybe just on kind of the core business. It sounded like breast, had the backlog had some benefit from the pent-up demand early in the year, normalized a bit in 3Q. Can you just talk about, I guess, the trends you’re seeing there? It sounds like maybe the backlog you had you worked through and now it’s just kind of executing on the healthy backdrop, but I would be curious just a little more on the moving pieces there and the right way to think about that going forward?

Helmy Eltoukhy: Yes. I think now we’re sort of at normalized rates. And now it’s just a matter of getting additional patients tested. One thing — we see a lot of room to grow even for ESR1 and for breast cancer testing, we’re seeing data out there that despite our, I think, very large increase in volume of breast testing, and a lot of patients are still being tested by tissue or by other methods to try to assess ESR1. It’s very important that physicians know that — it’s very unlikely to detect ESR1 mutation since there are often emergent mutations or distance mutations through our archival tissue biopsy. And so there’s obviously, more work to do, but that is a, I think, opportunity for us to continue to increase volumes, I think, considerably.

And obviously, in the other cancer types outside of lung and breast I think there’s still a lot more room to grow. So CGP, I think, is still not top of mind for many patients. And yes, we’re continuing to see, I think, that can be considerable growth for years to come.

Patrick Donnelly: Okay. That’s helpful. And then maybe just another quick one on Reveal. It sounds like smart liquid biopsy upgrade is on track for the end of the year. Can you just talk through, I guess, the impact there, what we should be thinking as that rolls out?

Helmy Eltoukhy: Yes. We’re very excited to move to that platform, obviously, as even better performance than where we are now from a sensitivity and specificity point of view, but I think more so, the types of capabilities that assay will be able to provide in terms of not just telling the sort of the what in terms of as the cancer there or not. But what’s happening with the cancer or where is the cancer. And so while the transition initially may be somewhat invisible or very low impact, we think, over time, as we start layering in these new futures, it will be really exciting in terms of where the MRD space goes and really using this tool as a sort of blood-based equivalent of a CT scan. I think it’s going to be really exciting for the oncology space.

Operator: Thank you. The next question comes from Derik De Bruin from Bank of America. Please go ahead.

Derik De Bruin: Hi. Thanks for taking my questions. Two questions. First, just on the — going back to V2 on Shield, can you explain why the AA detection didn’t go up even though the sensitivity increased pretty significantly between B1 and B2. But just wanting to get my head around that. And then second question would be, any comments on volumes that you’re thinking about for 2024 and you still expecting something in the 30s percent growth rate for next year?