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

One is treatment escalation. But then the other is a treatment on molecular recurrence components where patients from the VEGA study that are initially negative are being monitored with ctDNA. And when they screen positive, they flip over into the Altera Arm and are randomized at that time. And then are either treated or not treated. So we’re excited about that treatment on molecular recurrence readout as well which we think — I think is another reason why Surveillance Testing is important. So look forward to having both of those read out. Alex or Solomon, would you like to add anything else or? Yeah. Okay.

Solomon Moshkevich: No.

Operator: Your next question is from the line of Catherine Schulte with Baird.

Catherine Schulte: Hey guys congrats on the quarter. And thanks for the questions. I guess, first, Steve, I think you mentioned planning to launch some new MRD products next year. Could you give any additional details on that? Will that be additional indications? Or are you more referencing a new platform like the potential for a Liquid Exome or Tumor-Naïve kind of off-the-shelf version?

Steve Chapma: Yeah. So we’re going to have multiple new things that are coming out, not just in MRD but across the business. And we’ve been investing heavily in research and development and innovation really the entire history of the company, but particularly over the last couple of years. And I think that’s now going to start to bear fruit as we have a significant number of product launches and updates next year. So on the MRD side, I would expect to hear multiple different opportunities both new products and product updates.

Catherine Schulte: Okay. Great. And then you mentioned validating Signatera and NIPT on an alternative NGS provider. Any additional color you can give there? What’s the timeline to rolling out NIPT on the alternative sequence here in your central lab? And is the plan to switch all of your volumes over.

Steve Chapma: Yeah. So I think you guys sort of know the history here of the evolution of sequencing. And really over the last several years, we’ve seen the market open up quite a bit. And now we’ve done work on multiple different instruments. And we think there’s, many different groups out there. So it’s great that we’ve been able to meet regulatory milestones. And in collaboration with pharma partners validate Signatera and independently now validate NIPT on these alternative platforms. We’re focusing on reducing our COGS and getting to cash flow breakeven. And so we’re going to make the best decision for Natera on what provider we use, based on the service level, the price and the quality.

Operator: Your next question is from the line of Rachel Vatnsdal from JPMorgan.

Rachel Vatnsdal: Great. Thank you for taking my questions and congrats on the quarter you guys. So first off, nice to see the coverage of the FoundationOne Tracker in the US last month. Can you just kind of walk us through how should we size that opportunity? And then, how quickly can it become a meaningful contributor here.

Steve Chapma: Yeah, Solomon, why don’t you take that?

Solomon Moshkevich: Sure. Yeah. Thank you for the question. We were very excited about getting that coverage for Medicare. And we thought it was appropriate given the great data that’s already been generated to support the tests. FoundationOne Tracker is very well positioned, for patients in the advanced cancer study who are already getting a FoundationOne CDx test and want to monitor response to immunotherapy without needing to send another tissue sample for development of Signatera and that’s especially useful for patients where tissue might be scarce already exhausted after the first analysis for genomic profiling. So that’s exciting and we look forward to rolling that out that commercialization being led by Foundation Medicine, and helping a lot of patients.

Rachel Vatnsdal: Great. And then my follow-up, I just want to ask about the pending lawsuits that you guys have with Rabgen in the upcoming trial in early next year. You have one peer that had to pay out in the high $200 million range but other peers have settled out of court. You had one peer earlier this week flagged that their payout is going to be in that like $30 million range all in. So, can you just walk us through what are the potential range of outcomes that we could see for tissue? And any color on dates leading up to that trial? Thank you.

Michael Brophy: Hey, Rachel. Thanks for the question. So just like all the intending litigation unfortunately I just can’t get into a lot of details on ongoing litigations — we clearly believe we don’t infringe. We don’t think the patents are valid and we feel that we’ve got some very strong defenses. And that’s kind of where we’ve got to leave it for now. But we look forward to providing more updates as they become available.

Operator: Your next question is from the line of Dan Brennan with TD Cowen.

Dan Brennan: Great. Thanks for the question. Maybe the first one Mike you talked about some of the screening data that’s coming out later this year and early next year and you talked about if the data looks very strong you would evaluate and move forward only excellent results. Can you give us a sense of what we expect to see here coming up in these two studies? And just any more color around the level of evidence you would need in order to push ahead?

Steve Chapman: Yes. So, this is Steve. I’ll take that. So we’ve said before we have a case-controlled study that’s coming out probably at the end of this year maybe in early January. And then we’re following that up with an additional study looking at advanced cetinoma. And once we have both of those in hand we’re going to sort of see how we measure up to others that are out there. And I think there’s sort of two decision points there. There’s — how do we compare to the competition and where are we on our trajectory to cash flow breakeven and how do the financials look. And we’re not going to do anything at all that’s going to impact our ability to get to cash flow breakeven. So we think we’re taking the right unmeasured approach and phase-gated approach where we’re waiting to hit key milestones before we decide whether we’re moving the ball forward or not.