Veracyte, Inc. (NASDAQ:VCYT) Q3 2023 Earnings Call Transcript

We also have an incredibly effective and dedicated sales team. To be honest, I mean, adding a large number of sales reps isn’t what’s been driving this at all. In fact, we’ve been doing this with pretty much a stable sales force and a very strong sales force. So continuing into next year and beyond with these steps, we believe will help drive and fuel further growth. The market is about 50% penetrated today for these kinds of tests. And we’ve always said that we think that could get to 70% or beyond, and we can be the primary driver of that. So, yeah, a lot more of the same quite frankly.

Rebecca Chambers: The other thing I would add is there was also recently, I don’t know if you want to talk about the draft LCD. It’s not necessarily for next year per se, because the timeline of that could be slightly longer. But as we look broadly across both Decipher and Afirma, we obviously are focused not only on penetrating the market as defined today, but also ensuring every appropriate patient can get the appropriate test, and to that end broadening the market. And so I think longer term, as we think about penetrating both Afirma and Decipher, it’s both about doing exactly the things that Marc mentioned, but also broadening the market indications over a multi-year period. And to that end, our managed care team is actively working to do so vis à vis working with MolDX on the draft LCDs that have come out most recently.

Marc Stapley: Yes. And so that’s a great point, Rebecca. And that could add reimbursement for patients in the Bethesda V category, where we do believe there’s a significant clinical utility of our test, and so if that gets passed in a year or so, then we’ll be very pleased about that for patients.

Unidentified Analyst: Got it. Thanks. It sounds like you’re tackling it from all angles. Congrats again.

Marc Stapley: Thank you.

Rebecca Chambers: Thank you.

Operator: Thank you. [Operator Instructions] Our next question comes from Andrew Brackman with William Blair. Your line is now open.

Marc Stapley: Hi, Andrew. We’re not able to hear you.

Operator: All right, we will move to our next question. Please stand by. Our next question comes from Puneet Souda with Leerink. Your line is open.

Puneet Souda: Hey, guys, hopefully you can hear me.

Marc Stapley: Yes.

Puneet Souda: So wondering if you can talk a little bit about the supply chain issues, and what does that mean for the – sort of the fourth quarter, if you can quantify that? And then maybe also it’s good to see that you are addressing this with multiple platforms, but can you maybe talk about the economic agreement there with Illumina, assuming that being a multiplex platform, that you would see more growth there versus sort of the qPCR and nCounter approach?

Marc Stapley: Let me come back to that one in a moment, but on your first question regarding supply chain. So, as you know, I mean, this isn’t the first time that we have dealt with supply chain challenges. We talked a little while ago, a couple of years ago, less than that about what we were dealing with – with Afirma, and this isn’t really that different in regard to every now and then. You end up with a lack of supply of key components or parts or kits, and you have to mitigate that. And so the good news is we were doing our own – we were standing up our own manufacturing for these particular kits for Prosigna in Marseille as part of our IVD strategy anyway. As and we had planned to get that done around the end of this year.

Once we saw this supply chain challenges happening, we were able to accelerate that and are able to accelerate that and are making great progress on being able to launch our own kits to mitigate that supply challenge, which means that our kits supplement the other kits that we have, increasing our available inventory. And so the next thing you do then is you go through a very robust customer allocation process. You don’t want to build inventory at customer sites when that inventory is extremely in short supply, and you want to make sure it’s available for all patients. And so there’s a lot of activity involving our commercial teams to balance that effectively. So I’d say we’re getting through it. We have assessed a potential impact. You saw in our prepared remarks from Rebecca, Q4 product revenue of $2 million to $3 million, which is lower than we’ve been seeing in previous quarters and even lower than we anticipated, because we did anticipate a little bit of an uptick in the fourth quarter.

So hopefully we won’t see that much, but that’s what we’re projecting right now.

Rebecca Chambers: And then, Puneet, could you repeat your question on economics for the Illumina, it wasn’t abundantly clear. Yeah, thank you.

Puneet Souda: Yes. With Illumina, I mean just want to understand, is it an IVD kit that you’ll be manufacturing and it’ll be simply run on 550Dx, or is there some sort of revenue sharing or profit sharing with Illumina structure?

Rebecca Chambers: Got it. Good structure. Thank you.

Marc Stapley: Yes. I mean, the way to think about that is Illumina has this standard open offer clinical agreement. There’s not a lot of room for maneuver in that, and so we’ve been able to adopt that agreement, or at least our version of that and that’s how the economics is going to work. So there’s technology access, there’s milestone payments as you launch a new IVD, and then there’s a royalty based structure. And if you look online, you’ll be able to see how that typically works.

Rebecca Chambers: And just one point is our updated cash guide does contemplate the technology access fee which is contemplated in the open offer, and we’ve absorbed that in our cash guide.

Puneet Souda: Got it. That’s helpful. Rebecca, I’m just wondering, as we think about the Biopharma impact, obviously is happening with some of the biotechs and biotech funding being under pressure. It seems like Decipher is doing well. Afirma continues to gain traction at these penetration levels. So maybe just wondering what can you provide us in terms of sort of 2024 or sort of the right jumping off point and overall just given a number of these moving parts and now supply chain as well sort of mixed into it and as you bring on these other platforms, maybe just if anything you can provide that’d be helpful?

Rebecca Chambers: Yes. Of course, so the other platforms maybe just to hit those first Puneet, those are tied to longer dated catalysts, right? With regard to the Decipher being launched in the back half of 2025 and Nasal Swab in 2026, so that won’t impact 2024 per se. On the product supplier issues that Marc was just highlighting, given we are standing up our own manufacturing, we’re very hopeful that this will not have an impact on 2024 and that it is short-term in duration, especially since we are pulling forward those activities from our previous timelines of roughly around the end of the year. So that it will not necessarily impact 2024 at this point in time, albeit still work, a lot of work for the team to do there. On Biopharma, we aren’t ready to call 2024 at this point.