Veracyte, Inc. (NASDAQ:VCYT) Q1 2023 Earnings Call Transcript

Unidentified Analyst: Okay. Thanks for the color on that. Maybe a question on encounter. Just looking at the installed base, maybe without getting into the numbers, in Europe, just looking where these machines are installed, whether hospital labs or clinical labs, maybe that versus academic institutions or pharma. If you have an idea on the split there and maybe the same question for the US installed base?

Marc Stapley: I think — I don’t really think about it in terms of the nature of the installed base. I think if you think about Europe, we have to go — once we get the regulatory approval for a new test to add to the encounter menu, which is obviously the strategy here, we have to go — even if we get the regulatory approval, we have to go country by country to drive reimbursement. And then once you’ve got that reimbursement decision in the country, you go lab by lab to drive placements. Now the placements could be in academic, last, it could be in smaller clinical labs. It’s really going to be driven by the menu and the flow-through of patients in those facilities. And so — and it’s not really about the current installed base because we’re also going to have to place new instruments in order to drive that.

And to do that, we need to have the menu on the platform, hence the strategy. So I think about it more in terms of going country by country, and that’s the important way to focus on it, including in the US as well.

A – Rebecca Chambers: Yes. The only thing I would add is — we obviously are selling Prosigna in the US. It is, I would say, the vast majority of revenue is actually outside the US. I think that is where we put the majority of our investment to develop out those US markets. So just something to keep in mind.

Unidentified Analyst: Yes. Okay. That makes sense. And then maybe just one last one. In terms of the biopharma revenue, you had mentioned in your prepared remarks that not only from IVD development that you’re seeing some pullback but as well as some of the, I guess, earlier stage services or clinical trial services that you guys do. Has there been any effect in terms of maybe licensing revenue from the Decipher GRID database or you guys as other databases? Maybe how has that trended here in 2022 and the start of 2023

A – Marc Stapley: Yes. Just maybe a reminder, the majority of our biopharma revenue is coming from our immuno-oncology business, which itself stems from the HalioDx acquisition. And a lot of it is outside of Europe also the US. There is a little bit of US related revenue that is associated with kind of the former Veracyte Decipher businesses. But the majority of the impact we’re seeing in the decline is on that immuno-oncology side. And so that’s where we’re seeing the effect. And that’s a bit that’s involved in the very early biomarker development work where you’re more likely to see that impact. So no, I’d say there’s no read-through there in terms of the Decipher GRID-related activity. There’s a lot of interest in that. But yes, I wouldn’t say that’s the biggest driver.

Unidentified Analyst: Okay. Great. Makes sense. Thank you very much for taking the questions.

Operator: Thank you. One moment for our next question. Okay. Our next question comes from the line of Tejas Savant of Morgan Stanley. Your line is now open.

Q – Tejas Savant: Hi, guys. Greetings. So maybe I’ll talk about the real simple one for you, Rebecca. Is it fair to assume that in terms of those out-of-period collections that you called out a $2 million impact here in the first quarter, there’s — you’re essentially zeroing it out in the guide for the rest of the year?

A – Rebecca Chambers: Yes, that’s fair.

Q – Tejas Savant: Okay. Perfect. And then, Mark, a big picture one for you on biopharma. I know you called out sort of the sizable customers are pulling back on spend, et cetera. But — as you look to the next sort of three years or so, are there any key missing pieces in your offering that will make it sort of really step up here in terms of the traction and help better sites sort of participate more substantively in that opportunity?

Marc Stapley: Yes. It’s a great question. I don’t think that there are. And to the extent there are — we’re working on developing those. But the biggest of which is our biopharma Atlas, because we believe that there’s a really interesting market demand for that. And so that’s what we’re working on, because that’s one of the things we think is going to drive revenue growth in this business. But I think we have most of what we need today. I mean, we have custom assays, whether they be, in Immunohistochemistry or Proteins or we have RNA expression-based assays multiple versions of that. We have DNA, that we can do in our lab in Marseille and also here. So we’ve got the capabilities and we got plus, of course, AI capabilities on top of that, which is a lot of what’s behind the Atlas work.

So we’ve got the capabilities. We’ve got the assays. We’ve got the lab. We’ve got the people. We just need to drive more success on the selling side and bring more of those biopharma customers in, in the current macro environment. That’s a more difficult conversation. I don’t expect that current macro environment that lasts for the next three years, I would certainly hope not. So we’re starting to get traction, and we’ll see how that pans out. We’re — in our guide we’re being a little bit more bearish on this side of the business right now, given some of the trends that we’ve seen.

Q – Tejas Savant: Got it. Makes sense. And then on the nCounter Menu, marc, I think you pointed to decide for prostate in 2024 is a particularly important submission. Is there anything you can do that’s within your control to pull it forward? I mean obviously, the approval time lines and then the reimbursement time lines by country are sort of largely out of your control. But — in terms of the submission itself to the Europeans, anything you can do to accelerate it?

Marc Stapley: No, it already has been. I mean, relative to the original timeline that we looked at for all of these products on the platform. We pulled it through — pulled it forward substantially. It’s not happening in series. I think that’s an important point to make. We don’t work on Envisia then start work on Decipher and then start work on Percepta. All three have been happening in parallel, but they were just at different stages of development. So the work to bridge over the Decipher or the nCounter platform has been progressing very well, and we’ve made good progress there. We’re moving to the next stage of that. So it’s going to go as fast as it can go with our current plan and roadmap, and that’s not really much we can do.

The most important thing we can do to speed things up is on the notified body review and making sure that what we submit is a very thorough and detailed dossier. The work that we’re doing on Envisia and we always thought it would be this way is kind of like a pilot for us. It’s giving us some of that sense of what the notified — the new notified body under the new IVDR process is looking for that might be different from what it used to be. Our team has got 15 years of experience in doing this, but the regulatory process is new, as you know. And so, there’s, a lot of learnings for the notified body and anyone who’s submitted. So that should help hopefully see Decipher so long and make it a little bit smoother. The other thing is we can point to the extensive evidence that we have for the Decipher test in the U.S. and outside the U.S. And — and hopefully, that drives the notified bodies accordingly, because there are patients at the end of this that need this test in Europe.

So, more will come on that, but yeah, we’re going to go as fast as we can.

Q – Tejas Savant: Got it. That’s helpful. And then, one final one for me on M&A, I mean, Marc, in the past, you’ve talked about sort of staying away from the cash strugglers in the space, so to speak, either in cancer screening or perhaps even in the Metastatic setting via MRD, et cetera. Is that sort of a red line for you as you think about the M&A opportunities in the pipeline? I mean, obviously, I’m assuming seller willingness here has gotten a little bit better following the regional banking crisis. So could we, at some point, sort of see you dabble in that space, or is that just sort of off limits in terms of how you think about it philosophically.

Marc Stapley: I’m currently seeing no change in our philosophy around M&A. So I’ve said it before, we we’ll obviously not be blind to opportunities. We’ll keep our eyes open to things that make sense, but the bar is very, very high for us. In terms of the care continuum itself, yes, we’re not necessarily looking to enter that healthy screening area because there’s a lot of people doing that, and it’s a significantly heavy investment. But as far as dealing with cancer patients or patients who are suspected of having cancer, that’s right in our sweet spot, all the way across the care continuum, once you’ve been identified as a patient, and that’s where you’re going to see us always continue to focus.

Tejas Savant: Fair Enough. Thank you, guys. Appreciate the time.

Operator: Thank you. One moment for our next question. Our next question comes from Sung Ji Nam of Scotiabank. Your line is open.