Natera, Inc. (NASDAQ:NTRA) Q3 2023 Earnings Call Transcript

Q – Puneet Souda: Hi, guys. Thanks for taking the question here. So first one on ASP, then I have a follow-up on guidelines — on ASP, I mean it’s good to see the improvement. And I appreciate you giving the details on Signatera. But could you talk about what — how much was the ASP improvement on the Panorama and Horizon side? And sort of what should we expect there. And then on Signatera, could you outline what’s the ceiling here, given the ADLT rate you have the reimbursement, the indication expansions that you’re seeing and potentially guideline and inclusion ahead as well, which could help with commercial payers. So maybe just talk about ASP.

Michael Brophy: Thanks, Puneet. I appreciate the question. So yes, first on the ASPs, we saw in addition to continued pretty rapid improvement in the Signatera ASPs, which we covered. We also saw some very encouraging improvement in the women’s health, ASPs. I mean I think and that’s both for Panorama and for carrier screening. You may recall that earlier in the year, we actually guided assuming some erosion in the ASPs in that category. And at the time, I said, look it’s not because we’re seeing it but it’s kind of more of a focal point. And frankly, we haven’t seen that erosion. And indeed we’ve seen some, we’ve actually seen some improvement. Now where does that improvement come from? It really comes from a variety of sources and it’s small contributions from a range of the efforts that we’ve been we’ve been really making over the last year, and Steve covered in some detail on the call.

So, leading the guidelines aside, which I think could be very impactful, I’m actually quite encouraged about the trajectory that we’re seeing right now on ASPs in women’s health, I have to say nothing of the rapid improvement we’ve seen in the signatory ASPs, which we did expect. Second question, can you just remind you again, just give me a follow-up again one more time.

Q – Puneet Souda: Yes. Just what is the ceiling for Signatera, and how you think about that with the ADLT indication expansions?

Michael Brophy: Yes. So I think Solomon covered it in the prepared remarks that just based on what we’re seeing right now just on the current coverage dynamics that we have on our current tumor types we feel like there’s a path beyond $1000 just through kind of grinding and blocking and tackling and making sure that we get paid for covered services. And we clear all of the myriad kind of administrative hurdles that one typically encounters in this space. So that’s a lot of room to run from where we are now. I wouldn’t put a ceiling on that per se. I mean I think at about the time that we’re reaching those levels we’re going to have more data. We’re going to have feedback from NCCN and then also we’ll have prospective randomized data we’ll have data in a number of different sources.

Steve touched also on the biomarker legislation. So there’s some other potential catalysts that are going to hit roughly contemporaneously. So I would expect kind of a fairly smooth trajectory to say the areas piece which is really encouraging.

Steve Chapman: Yes. I’ll just add too. I think one of the things that is really exciting is as we’re looking now at this very clear path to cash flow breakeven in 2024 and a very strong revenue growth ahead that we’re not really incorporating any of the upside opportunity from guideline changes, things like in 22q, or any of the upside opportunity from biomarker legislation, which was just asked about a minute ago. So, the model that we’re looking at really just includes sort of status quo and blocking and tackling and billing operations improvements, but all of those other things are really upside, potentially very significant upside that we just don’t need to get to cash flow breakeven and have another good year.

Puneet Souda: Got it. Super helpful. And then on guidelines, wondering maybe a part A and B to this question. Could you clarify on the women’s health side, Mike, did you say you’re expecting to see 22q guideline update in early 2024? I just wasn’t sure if I heard that correctly. And then on the NCCN for the Signatera side, could you maybe elaborate — given the number of data sets that you have already with ALTAIR and treat ctDNA coming up. I guess the question is when does this translate into NCCN guideline inclusion? What that guideline inclusion can look like? If you could — if maybe Alex or Solomon can elaborate on that. thank you.

Steve Chapman: Yes. First, let me just talk about women’s health. So, of course, we don’t have any information on exactly what happened and so forth. But we do know that there was a guideline committee meeting, I think in September from ACOG. And if you start to think about just sort of the timeline that you might see the results from that, I think that could be in Q1. We don’t know either way whether things will be positive or negative, but we feel really strong about the fundamentals behind 22q testing that are outlined in the SMART study and behind the fundamentals of expanded carrier screening. So, we’ll just have to stay tuned and see what happens there. From the NCCN side of things, when you look at kind of the — I think there was a meeting in August, we’re expecting to kind of hear an outcome from that maybe later this year or early next year.

We do know that the CIRCULATE 18-month data was included in the review because it was submitted in time. But of course we don’t know the outcome. Now, the great thing for Natera is because we started working on randomized controlled trials in the escalation setting for example, ALTAIR, more than five years ago. In 2024, we will actually have the results — initial results from ALTAIR reading out. So, regardless of what the guideline committee says this year with respect to the CIRCULATE study, next year the ALTAIR results will be out. And so it’s just really a matter of time assuming the trial reads out positively and that’s why we feel very positive about things. And when you look at what setting is ALTAIR. I think it has sort of two settings.