Natera Morgan Stanley 24th Annual Global Healthcare Conference
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We're a couple of minutes away, but I think we can get started given there's a lot to cover. I'm Kallum Titchmarsh, the life sciences analyst here at Morgan Stanley. Really pleased today to be joined by the team at Natera. We have Steve Chapman, CEO, and Mike Brophy, CFO. Thanks guys, for being here.
Yeah. Cheers. Thank you. Thanks for having us in.
Just before we get started, for all disclosures relating to this presentation, please see morganstanley.com/researchdisclosures. Now that the fun stuff's out the way, maybe we can start on that Q2. We're expecting strong numbers, but I think even the Q2 came comfortably above our expectations. Just under 40% year-over-year sales growth, record sequential Signatera tests, and then a healthy raise on the back of that. Maybe just stepping back, how has your confidence in the business evolved year to date? Where do you perhaps think investors may still be underestimating that durability of growth?
Yeah. I'd say obviously, very strong quarter and year to date. We've had multiple revenue raises. We've seen acceleration in Signatera volume and really just strength across the business overall. I think in Q2, we had 34,000 quarter-over-quarter growth, which was just an all-time record for Signatera. Super exciting. I would say, the area that I think is maybe most underappreciated is just how big the MRD market opportunity is. When we start to look, drilling into the numbers, looking at territory by territory, each sales rep, and just understanding how much additional opportunity there is, it's really remarkable, and I think we're going to be in this period of very strong growth for a very long time.
You've made some comments pointing to that tipping point underway in MRD adoption. What are you seeing from oncology practices that gives you conviction in that transition?
Yeah. A couple of years ago, we'd go speak to doctors, and they'd really be focused on, "Well, hmm, not sure how the test should be used," or, "I'm not really sure what I should do if I get a positive result. Maybe we may consider using it. We're just sort of waiting for the evidence." I would say now we really don't hear that anymore. We've just had so much peer-reviewed evidence and prospective data, overall survival data, disease-free survival data, that's read out, that doctors, I think now have come to the appreciation that MRD testing and Signatera particularly, has been thoroughly validated, thoroughly proven in the peer-reviewed evidence.
Now it's really about, "Well who do I use it on?" Not "Should I use it?" But, "Who do I use it on and how often?" The discussions now center around putting protocols in place, EMR connectivity, expansion within the practice from, say, CRC and breast to other indications, which is exciting. I think that really means that we've crossed this threshold and are gearing up for a period of very deep growth.
I think the last metric we saw was just over 70 prospective studies in the pipeline, and expectations for a kind of an accelerated pace of readouts now. What evidence do you think being generated today has the chance to most meaningfully impact practice in the near to medium term as we think about that next unlock?
Yeah. So we've published several hundred peer-reviewed papers at this point. As I just mentioned, there's a sense that we've sort of crossed the evidence threshold, especially now with the FDA approval and so forth. But we're not done there. We're continuing to invest in peer-reviewed evidence, really across histologies. So that's going to continue. We have some great readouts coming in the second half of this year and into 2027. Just to give you kind of a flavor, I think there's continued exciting data in CRC, continued exciting data in breast. We've got a big readout in head and neck, gastroesophageal, in lung, several pan-cancer readouts. So we've got a lot to keep the team busy and we're excited about these new readouts coming.
I want to touch on just the FDA approval of CDx in MIBC back in May. Feels a little like a step change in the kind of clinical decisions MRD can inform. Maybe just unpack a little how significant that is for the business and how much that could expand the traditional MRD market that we think of.
Yeah. So achieving FDA approval and then getting NCCN guidelines has really, I think, changed the way doctors think about the test. Now they really are required to have an MRD strategy in their practice. I think that that has sort of put us on a new trajectory. Again, kind of thinking about, "Okay, how do I use the test? Which patient should I use it on?" Versus, "Whether I should use it." There's also some exciting things in the protocol. If you look at the IMvigor protocol, just how the testing is used every 6 weeks, versus maybe traditionally once a quarter or say, twice a year. We're now looking at sort of a 6-week protocol in the IMvigor study, and under the approval. I think that's an exciting opportunity as well. So overall, on the right path.
We now have multiple NCCN guidelines for MRD, not just muscle-invasive bladder, but also lymphoma, Merkel cell. I think that kind of starts this sort of flywheel effect of where we're on this path to, in the future, sort of be deeply penetrated into guidelines, and that will continue to help accelerate volume growth.
When we're seeing Signatera being used more to identify patients for clinical trials and inform those treatment decisions, I think we're getting a lot of questions now on those biopharma relationships. Maybe just talk us through anything you're seeing in the pipeline there and how big of an opportunity that could be.
Yeah. So we're doing exceptionally well in biopharma. That's an area that we've seen very significant increases in interest, really driven by a couple of factors. I think one is this shift towards an MRD-guided strategy for new phase III clinical trials, particularly this concept of ToMR or treatment on molecular recurrence, where big pharma companies are now saying, "We want to be able to move our drugs up in the care paradigm. Rather than waiting for somebody to have a clinical relapse on a scan before we can administer the drug, we want to be able to administer the treatment directly on the molecular relapse itself. Prior to the cancer expanding within the body and becoming stronger, we want to treat on MRD." That's what ToMR stands for, treatment on molecular recurrence or treatment on MRD.
I think just the last year, we've seen three or four phase III trials signed and initiated. We think in the future, if you look five years out, there's going to be several hundred of these. This is going to be one of the biggest trends by far in pharma and diagnostics, and we're right at the center of it. That's kind of one. On the other side of things, I think there's very strong interest in the Signatera genome with phased variants. We've actually just gotten some of the analytical validation data, some of the initial clinical validation data, and it looks incredible. I think pharma, who's seen some of the early data there, is responding very well, and there's, I would say, extreme levels of interest in that product. We expect biopharma to be a major growth driver for the business in the future.
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