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

Marc Stapley: Yes. And remember, I think a couple of factors at play here. One is, as we talked about last time, the incidence of prostate cancer is growing. You can see that it was around 7% growth. And that’s partially driving the whole market to be larger. In terms of the 25% penetration, that was our rough math at the end of last year. So, not as tough to update that when not everybody gives you numbers, and it’s hard to tell. But I would say, clearly, we’re continuing to take share when — as Rebecca just mentioned, this business grew in the mid-40s quarter-over-quarter. It certainly feels like that represents some share gains as well as taking share and growing the overall market.

Matt Sykes: Got it. And if I could just ask one last, just clarification question. Because I think you talked about in your prepared remarks, but just remind me on the ramp in Europe for the IVDs. You obviously have Prosigna. Is it Envisia, Decipher Prostate, than Percepta in sort of like 2024-2025 time period, or could you just maybe help me outline that a little bit better?

Marc Stapley: Yeah. So yeah, thanks for the question. In this year, so starting with Prosigna, which is on market today and actually had a good quarter, and we talked about the growth there and how well that test is so far with close to 3,000 in the quarter which is actually a record quarter for that product, which is great news. And then Envisia, we submitted in December last year, a little ahead of schedule. And as I mentioned in the beginning of the call, we’re dealing with comments from the notified body, which is a normal part of the process, what we expected and the back and forth there. And I still can’t give us a sense of time on when that will be approved as the IVDR process is so untried and tested still at this point. We’re going to submit — you’ve got the timing right there. We’re going to submit decipher prostate in 2024, and we’re going to submit nasal swab in 2025, and then they’ll go through a very similar review and response process.

Matt Sykes: Great. Thanks for clearing that up. I appreciate it, Mark. And congrats again.

Operator: All right. Thank you. One moment for our next question. Our next question comes from the line of Andrew Brackmann of William Blair. Your line is open.

Andrew Brackmann: Hi. Good afternoon. And thank you for taking questions. A lot has been asked already, but maybe if I could just do a housekeeping question here. Can you just sort of reiterate or remind us around time line for the NIGHTINGALE study is it on track to finish enrollment later this year? And how should we be thinking about a potential readout? Thanks.

Marc Stapley: Yeah. Thanks for the question there. And NIGHTINGALE, yes, actually, the progress has been really good in terms of signing up new sites. And our clinical team has done an excellent job of contracting and getting those going and with patients starting to enroll in those sites, we’re starting to see some nice uptick here still expecting around the end of the year to pull through the last patient in the trial. In terms of the readout, that’s where there’s a lot of variability because as I think I’ve talked about before, we’re going to take a few bites to the apple here in terms of looking at some short-term analysis. And clearly, how well we — how much we can use that to drive the appropriate clinical utility conversations for reimbursement will depend on the results of that analysis.

So there’s a couple of pathways there that we’re pursuing in order to move as quickly as possible to reimbursement. But ultimately, as we’ve said before, we’ve got to get the clinical utility data published, which is — takes time, and then that drives the reimbursement conversation, which also takes time.

Rebecca Chambers: Yeah. And just one thing to add there is the guidelines point to a two-year follow-up and we hope that we’ll be able to effectively do a shorter follow-up than that. But the longest follow-up that would be required before we go through the publication or early readout would be up to two years.

Andrew Brackmann: Okay. Thanks. And then Rebecca, I’ve got a boring modeling question for you. I think you mentioned the sequential step down in gross margin. Can you just maybe give a little bit more color around what’s driving that? Thanks.

Rebecca Chambers: Absolutely. I’d be happy to. So obviously, we were very pleased with our gross margin this quarter, and especially the testing gross margin line. But overall, we really did benefit from fixed cost absorption, both on the labor and overhead side this quarter, the benefit of mix as well as the benefit of the $2 million of higher period collections flowing down at 100%. If you look forward with the sequential impact you cited, we will not necessarily have that benefit of the prior period collections, and so that will be a headwind sequentially. And we have been running incredibly lean in the lab. A couple of hundred basis points with the majority of that coming from labor absorption is not a sustainable business model.

And so, we will be to ensure — to ensure the ability to continue to grow at increased volume levels we’re seeing, we are going to have to staff up in the lab, which will also impact gross margins on a sequential basis. In addition to that, we are expanding our laboratory here in San Diego to take into account the growth of the Decipher franchise. We will be buying instruments. We’ll see taking on the incremental space. All that also will impact margins. So, it’s a good new story in the end, because we’re growing a little bit faster than we had expected. But obviously, we need to invest in that growth. And even a mid-60s margin is a pretty solid one. And so even though it’s a slight sequential step down, I’ll take it all day long for the growth we’re seeing.

Andrew Brackmann: Okay. Great to hear. Thanks.

Operator: Thank you. One moment for our next question. Our next question comes from Mike Matson of Needham & Company. Your line is open.

Unidentified Analyst: Hi guys. This is Joseph on for Mike. Maybe another question on Afirma. Now that teratessin has been added. Maybe looking back to when, I guess, Xpression Atlas was introduced from test. I guess I’m assuming that Xpression Atlas is probably ordered or will be ordered a lot more. But in terms of your sales force and productivity, maybe when that add-on was introduced, did you see a large uptick in interest from new physicians or what have you? And maybe you kind of expecting a similar thing going forward with the testing? Thank you.

Marc Stapley: Yes. No, I wouldn’t — the way I would look at it is, as I said earlier, the third testing, it’s really important for some of our physicians because it’s important to some of our patients that we’re able to provide a readout on to. But it gives the sales team a really good reason to go and have the conversation with the physician about the enhancements to the product. And I’d say would have done the same thing. And now, we’re making this kind of more of a blended product sale. The salesperson is speaking to the physician about Afirma as a as a group of products, which includes Afirma, it includes the genomics as well as Teri you check that box, and so it’s actually just a very more straightforward conversation at this point.

I wouldn’t look necessarily to drive, as Rebecca said earlier, in terms of the ordering patterns for significant incremental sales on its own, but I just think it helps to continuously enhance the product and make sure that we’re providing physicians what they need to be able to deliver the insights to patients.