Natera, Inc. (NTRA) Earnings Call Transcript & Summary

Well, good morning, everyone. Thanks for joining us. I'm Andrew Cooper. I cover diagnostics here at Raymond James and happy to have Mike Brophy, CFO from Natera with me this morning. We're going to do a little fireside chat. So I'll just kick it right off. Maybe to start us off, Mike, just give us a little bit of the history and background of who Natera is for folks that maybe aren't as familiar and what sets you apart from some of the other players in the space that we think about.

Yes. Thanks for having me. It's always great to be here. So Natera is obviously publicly traded diagnostics company based in Austin, Texas. It's a blood-based diagnostics company. It's about a $20 billion market cap. 2025 is actually a exciting year for us because it marks the 10-year anniversary for us as a public company. So I was just looking back at what the results were for 2015 and we did $190 million in revenue that year at a 40% gross margin. Year-ended ' 24, which we just reported last week, we did $1.7 billion in revenue at a 60% gross margin. So we've made a little bit of progress over the intervening decade. Substantially, all that growth has been driven by -- driven organically from our core technology. So our core technology is really an innovative approach to PCR chemistries and associated algorithms that allow us to make very, very precise measurements of DNA that's freely circulating in your bloodstream down to kind of single molecule in a tube of blood sensitivity for DNA that's in your bloodstream. And we exploit that to generate important kind of time-sensitive readouts for patients in various settings. The first major application for that technology was noninvasive prenatal testing, where we launched in 2013 as a fourth market player and very rapidly moved to the #1 position. Today, we serve something like 1/3 or more of pregnant women in the United States with our noninvasive prenatal test and this is now broadly enshrined as the standard of care in the United States. I think that launch of that playbook of NIPT is instructive to see how we operate in the other areas of our business today. So how did we go from #4 to #1? Well, one, we think the technology, which is superior, just delivered better results. Then we backed that up with a massive commitment to generating best-in-class, what we think is best-in-class prospective clinical trial data. So we've got a 20,000-patient, 7-year prospective clinical trial to evaluate our performance in NIPT in another disease state called 22q that will just never be replicated in the field. We paired that with a relentless commitment to commercial execution and patient and physician experience, led by our CEO, Steve Chapman, who is actually the first commercial employee that was ever hired here back in 2011 or 2012. Steve has built the commercial operation here at Natera person by person over that time period and still is obviously heavily involved in the sales and marketing effort. Today, every sales leader that we have in the company is somebody that Steve probably hired at some point over the last decade and we've got a very long tenured team kind of across the business. So that was kind of the first leg of growth, NIPT. We rapidly scaled that business and we started generating kind of sustainable cash flows from NIPT and women's health in 2019. It's been sustainable since then. So we were able to kind of get into a very competitive high-volume market and achieve that kind of scale and margin profile required to kind of deliver sustainable cash flows. And so there's a lot of lessons that we've derived from that, that we've now applied in the launch of our organ health business and crucially in the oncology business. So organ health, very similar kind of technology approach that we deployed in NIPT. We screen patients using cell-free DNA that have been recently transplanted, for example, for a kidney transplant to see if they are experiencing an acute rejection of their kidney noninvasively. So that meets a critical unmet need that we've grown that from 0 to that -- the overall organ health business is something like $100 million in revenue in 2014. And we've grown that from 2017 to now has kind of gone 0 to $100 million. So that's been an important contributor and very proud of the -- of our ability to affect patient care in that setting. The third area where we've deployed this core technology and this kind of core execution learnings is in a product called Signatera. So we created a new category of cancer care for solid tumors called minimal residual disease and recurrence monitoring. So it's very heartening to come to academic conferences or investor conferences and MRD and recurrence monitoring is like an industry vertical now. And I feel like we made that up -- we made those terms up on a whiteboard in 2015. So it's important to understand we have this core technology. We have this kind of key set of principles around commercializing. What we did not do is hire McKinsey to tell us what are the big markets in oncology and then kind of retrofit our technology to that. Instead, we sat around the room with the people that were already at Natera, the scientists, the core technology and we said what's an unmet need in oncology that we could solve with our core technology where we would be better than anyone else at solving this problem. And that's how we came up with this concept of monitoring people immediately postsurgery to see if there's still cell-free DNA from their tumor in their bloodstream. That has incredibly important implications for whether or not you should get chemotherapy. And then once you're in remission, whether or not your cancer is returning. So that's been a real sea change in the care for patients in cancer in the United States. So that's gone from 0 to north of $600 million in revenues over a very short period of time. And that's a addressable market. Estimates will vary but that's something between $15 billion and $30 billion market opportunity. We're currently -- we probably have north of 95% market share just because we're the leader and this has proven to be very difficult to do. We've deployed all of these kind of core lessons that I talked about within NIPT. We replay that here in oncology. So one, because we're playing the home game on the technology front, we feel like our ability to deliver a high-quality test and then importantly, continue to iterate and continue to improve that test over time is very difficult to replicate. We've been incredibly focused on delivering excellent and ever longer-dated and larger prospective data sets tumor type by tumor type to prove out the clinical utility and the use case for Signatera. And finally, there's an enormous customer experience and commercial execution component to getting this right. This is a repeat monitoring test. You have an ongoing relationship with the patient and the physician. You must design for each patient an assay that is personalized to their tumor and then help them stay with them through the course of their journey. And so we've built the commercial operation and the UX operation piece by piece since 2020. We're now at a point where we started enrolling clinical trials in 2019 and 2020 and we're reading out data sets that are 5 years in the making with 3-year overall survival data that is very difficult to replicate and at least takes a long time for others to replicate. So we feel like we're in a very good position going into '25. Maybe just a quick summary since we just reported the full year '24. We had an excellent 2024. We grew revenues from $1.3 billion to about $1.7 billion over the course of the year. Gross margins moved from the low 50s into the like low 60s, so massive move on the gross margin front. And we grew revenues really kind of just across the board. The guide for 2025 implies more of the same that we just -- we continue this momentum that we're on and we're very excited about a range of clinical trial readouts we've just had and a lot of great news to share. So that's a quick summary. I'm happy to give any more.

No, that's perfect. You hit on a lot of things that I want to dive a little bit deeper on. I had, thinking through this, look back in the past and I think I always started with reproductive health and I'm not going to this year, which I think tells us a little something about kind of how things have gone. So maybe just thinking about Signatera, the last number you gave was over 40% of oncologists have ordered. How is that number trending? Like can you give us an update for kind of where it is now? And how do you think about that, whether it's the end of '25 or long term and where that could and should be?

Yes, that just continues to grind up. I mean we feel very strongly that just given that the clinical trial results seem to be remarkably similar across tumor types and the use case is quite compelling in many, many solid tumor types such that you can very reliably take costs out of the system while also improving outcomes for patients that this -- the MRD and recurrence monitoring technologies are going to be just the standard of care really for cancer care in the United States and beyond really. So I think that will kind of grind to 90% over time. The trend has been quite linear. I mean we've just been able to kind of step that up into the 40s. Every quarter, there's a few percentage points of growth there. There's really 2 components to that. I mean what that number captures, I think, is indicative because it's just like, hey, what fraction of U.S. oncologists ordered a single -- at least one test in the prior quarter. But there's a massive penetration opportunity to be had within our existing customer base. Oftentimes, the way that physicians start with Signatera is that they solve a frustrating corner case. They'll have a Stage III patient that they feel like they really ought to get chemotherapy but is not tolerating it well. The patient knows that the surgery is great and that the surgery actually cures most people and they've got to get back to work. They have care to give to their loved ones and they're just -- they can't tolerate it and so they're going to skip the chemotherapy. The community oncologist is a busy person. They've got 10 other patients coming in that day. They can't make people do these things. But that's -- and they agree that the odds are kind of in the favor of the patient but that's still -- that's on her mind. Like I need that -- I wish that person would just stick with me on the chemotherapy. So they've heard that a colleague has had a very good experience with Signatera. They've seen the interesting data at ASCO GI, haven't had time to kind of change her own practice but I'm going to try it for this patient. Patient reads out positive on the Signatera, meaning that we're finding cell-free DNA from the tumor still in that patient's bloodstream. Okay, nowt patient, you got to work with me. Let's try a different cocktail. Let's figure something out. You've got to stay with me on this regimen because you still have cell-free DNA from your tumor in your bloodstream, patient complies, physician feels good about that, better outcome for the patient. Now you find more -- there's more and more use cases as you get accustomed to how easy it is to order, how thoughtful it is and how much it helps your patients. So there's that -- there's a time on task element to penetrating by volume much more rapidly within our existing base as well as kind of adding the just absolute number of oncologists who ordered a test last quarter.

Perfect. And maybe just give us a little framing. I mean you have coverage in, I think, what, 5 indications at this point, I mean in Medicare.

Probably more than that. I mean I don't have the exact count. But it's a -- the majority of our volume that is Medicare falls under kind of a Medicare reimbursed coverage policy.

Can you break that down a little bit just in terms of the volumes, whether it's of Medicare? Obviously, CRC is when we see a lot of data, hear a lot of conversations about -- you have breast, you most recently have lung. What is kind of the mix there?

Yes. So just first, just by payer type, I mean, the Signatera volume is something like 1/3 of that volume, very roughly speaking, is Medicare volume, something like 10% is Medicaid volume. And then the balance, a little more than half is commercial volume. Now cutting it by tumor type, a little more than half of the volume is colorectal cancer. I mean you've got 25% or so is breast cancer. Immunotherapy response monitoring, which is kind of a pan-tumor application but it just monitors how patients are responding to their checkpoint inhibitor, for example, is 10% to 15%. You've got several other tumor types, muscle invasive bladder, other GI cancers, ovarian and melanoma, these kind of bleed from the double digits into the single digits and then there's like a -- there's a longer tail. But we have Medicare reimbursement for most of those and working to obviously broaden the commercial reimbursement as well.

What's been the ordering pattern for lung in particular, given you just got the Medicare coverage, a lot of use of those checkpoint inhibitors and those types of drugs where you would use the immunotherapy monitoring -- in the adjuvant window, you just got the recurrence coverage. How do we think about kind of how behavior might change now with that coverage?

Well, I don't think that -- this is an interesting topic and I suppose people have different perspectives on this. I don't think the physicians are really up at night worrying about like which indications might are covered by Medicare. They're just dealing with their patients. So I don't think it really changes ordering patterns all that much. It is helpful to us, obviously, because we're doing a good service in the adjuvant setting for these patients that are receiving an immunotherapy. And the majority of those patients are lung cancer patients just because that's where immunotherapies have found one of their initial ports of call has been in lung cancer. So we've had the experience of monitoring a patient while they're on immunotherapy, they go into remission. And of course, they continue to use Signatera to monitor whether or not their cancer is coming back. And on those, we would not be getting reimbursed because we don't have a lung-specific recurrence monitoring coverage policy. And that was the spirit behind why we applied for that from Medicare and we're very glad to have that. So incremental reimbursement on the existing volumes. I think there's also a case we made that we could -- with some of the additional effort we're making on our kind of commercial operation, there are verticals even within the community of physicians that specialize more in lung cancer that we could cover with more intensity and more thoughtfulness that we're going to try and do this year. So there's a potential to grow volumes because of that effort.

Okay. Helpful. Maybe jumping to NCCN guidelines a little bit, been a big topic. You had some really good signs of acceptance in the most recent update in CRC. You've got pretty kind of full recommendation in terms of Merkel cell carcinoma, a little bit smaller indication. But you guys have said the CRC updates are positive. I tend to agree. I think there's a little bit of noise there on prognostic but not predictive and on surveillance not being recommended. Just help us think about what that journey from here looks like.

Yes. So a couple of different things there. So just on the NCCN guidelines, I mean, on balance, I think it was a very positive update. I mean, previously, the wording referenced cell-free DNA in this -- using cell-free DNA in the setting as an emerging prognostic biomarker and that word emerging was kind of removed. It's now kind of a prognostic biomarker. I think the recurrence monitoring language is actually essentially the same as it had been. It's just that the wording got moved to a different part of the document. So it's tempting to kind of read in the summary and then miss the language kind of further in the guideline. When we speak qualitatively to physicians, there's not a perception that there's some huge difference in terms of the recurrence monitoring recommendation and the work in the adjuvant setting, I think, is starting to bear a little bit of fruit with NCCN. So I mean, I think on balance, that's helpful. What we've learned in this oncology journey that we've been on is that the prospective clinical trial data tends to really speak for itself. And oncologists are very accustomed to monitoring the new data that comes out, they've got to. I mean the standard of care changes so rapidly in oncology and they're dealing with very sick patients, they need to be on top of it. And so our ability to deliver really excellent clinical -- prospective clinical results that have been years in the making have been the major driver. There's less of a need to just reference explicitly like to the letter what NCCN says or doesn't say just yet. And you see that in the volumes and the adoption.

Maybe just last on guidelines. Timing means they didn't look at the 702 study. I know you're really excited about the 702 study. Is there a potential for that to happen before the August meeting in kind of early next year's update on the usual cycle? And what happens if that doesn't get you in the guidelines? Does the playbook change at all?

No, playbook doesn't change at all. And I mean, our perspective on guidelines is that -- we obviously, we don't have any input on them. The job that we have is to produce excellent clinical trial results. And if you do that, over time the guidelines will inevitably come. I don't think it really has a big -- it matters much to the business, honestly, the specific timing of a more specific guideline inclusion just given the volume trajectory that we've been on. And importantly, the reimbursement trajectory that we've been on. We've continued to kind of grow the ASPs as we've been able to expand just the number -- the volume of the tumors, the percentage of the tumors that we've been able to get covered via Medicare and Medicare Advantage. And we now have another journey to go on, on the reimbursement via state biomarker laws. So about half the U.S. population lives in a state where there's a state law that requires commercial payers to offer the same level of care as Medicare does. And there's some important caveats to that and these things are never 100%. But as we talked about on the -- I think on the Q3 call last year, I'd love to be making enough progress in those states with commercial reimbursement such that second half of this year, maybe the November call, we could be pointing to some initial green shoots in terms of actual pull-through to ASP. So that's going to be a journey and we're happy to go on that. I think that the unit economics of the business right now support the level of investment we need to make this a multibillion-dollar franchise and to really change the way that cancer is treated in the U.S.

And maybe just stepping back and thinking about competition, right? It's going to come at some point. You've done a good job of protecting your IP to date. I think you had a press release this morning on some new IP as well. But as that competition comes, I think back to something you said on reproductive health, you were fourth in the market and you're the big kind of gorilla in the room now. Now that you're in kind of that leading position, how do you compare and contrast? And what did you learn from going from fourth to first that helps you stay in the lead longer in MRD?

Yes. I mean it's amazing how similar the playbook is because it's not really -- if you just don't worry about the kind of the commercial -- the market share dynamics and you just work backward from what patients and physicians need, that will put you in a pretty good position. So what patients and physicians need is excellent customer service, excellent commercial execution, best-in-class, long-dated prospective data sets and a relentless commitment to continue to improve the technology, okay? So whether you start at #4 or #1, it's critically important that you do those things. I would still say, in NIPT, the first-mover advantage is still, a decade later, it's very, very noticeable in the space. So the first player in that space was a company called Sequenom, which was subsequently acquired by a large reference lab. They still have a huge chunk of market share really by dent of the fact that they acquired the first mover. And a lot of those accounts have just never switched from Sequenom ever. So there's an enormous advantage in any market, particularly in diagnostics associated with being the first but that's obviously -- you can't just rest on your laurels. We try to have a funeral for Signatera every 2 weeks when our management team meets. I mean one of the fun things about having -- now this is like our 10th year as a public company, NASDAQ is actually going to invite us back to ring the bell in July, like, kind of like on the anniversary. If you took a picture of us at that Q4 2015 earnings call and took a picture of us this July, it's the same people. So we've kind of lived through these -- all of these hard lessons and we know how important it is to serve these patients in the best way we possibly can. And so that informs the strategy #4, #1 really doesn't matter.

Perfect. I'm going to shift gears, just looking at the time now and want to spend at least a minute on reproductive health. You mentioned some of the data you generated, some of the potential for guideline changes there, is where we get a lot of conversation but I want to tie that to sort of the P&L. And you guys have, I think, rightfully so, invested a lot to maintain and build these leads we've talked about. If you do get 22q or expanded carrier screening guideline changes, how do we think about that dropping through? Is there investment that you'd like to make that, that would enable? Or do we start seeing that really flow through to the bottom line and to cash flows if that kind of flip gets switched -- switch gets flipped?

Well, one of the reasons why our Chairman, Matt Rabinowitz started this company, I mean he was already a -- he was a aeronautics professor at Stanford and a very successful technology executive. He started the company with the mission of delivering a technology that could actually reliably measure 22q early in the pregnancy because he had a loved one that was affected by a 22q pregnancy and that was very shocking for the family. So believe me when I tell you, we've made enormous investments in expanding awareness of 22q and screening very reliably for 22q. So the investments are really there. And so it would be a welcome change to actually get reimbursed for this important service that we provide. It used to be kind of existential to the P&L and now it would be -- it's more incremental just given all of the -- all the growth that we've had. It's a similar answer on the carrier screening side. I mean I think it's just a recognition of the fact that expanded carrier -- expanded prenatal carrier screening really ought to be enshrined as part of the standard of care. If you poll most physicians, they would agree with that. They might be even surprised if the ACOG guideline doesn't more fully support at a level where payers will just reimburse you. So I think those things will be -- can be extremely valuable to the P&L and just consistent with the kind of the mission that we've been pursuing over the last decade.

All right. And sticking with some of the financial side of things, you guys, like I said, are doing a lot of, I think, rightful investment there. When you think long term about that sales and marketing line in particular, how do you -- when do you reach that point of scale? We look at somebody like an Exact Sciences who's here today, who is spending almost $1 billion on sales and marketing. You're calling on at least a somewhat smaller kind of opportunity set from the number of clinicians. How do you think about that growth there given your SG&A at least is at -- approaching those levels but again, with the G&A included there?

Yes. I mean I think that -- look, it's -- we -- I think we've demonstrated over the last decade under Steve's leadership that we have a good handle on how to execute commercially. And that does require investments to make sure that the service that you have in the field is really excellent. I do think one of the underrated kind of business aspects of Natera is the efficiency of the sales model. So we've gone for years in the women's health business where we haven't really meaningfully expanded sales rep counts or things like that, that would obviously drive volume growth and yet the volumes have continued to grow because of the data, because of the service, because of the quality of the reps in the field and how long dated they are. We've done that with Signatera as well, just so a couple of case studies. I mean, in 2023, we actually held expenses completely flat and grew revenues 31%. We had to do that because those were the market requirements at the time. The reason why we are expanding the investments now is that we're seeing very, very high returns and high efficiency from the commercial channel. And it's -- given the size of the market, it's time to expand it. What that means, though, is that these are investments in kind of in a service platform that generate returns forever. These are not Super Bowl ads. These are not kind of onetime expenditures that you have to keep doing in order to maintain a certain level of volume. We could cut expenses in '25 and '26, it wouldn't change the revenues at all. So the investments we make today are things that are designed to make sure that the platform can accommodate much, much higher volumes in '27, '28 and beyond.

Okay. Helpful. And maybe just shifting to kind of guidance a little bit. One thing that kind of sticks in my mind from the 3Q call was, hey, we'd like to grow volumes on a unit basis just like we did in '24 when we think about '25. What's assumed in the guide there? And maybe talk about some of the kind of potential upside kickers if things go right?

Yes. I mean I think it's kind of -- I think that's a rough and ready kind of decent framework. I mean people will ask like, well, should we grow at the same growth rate percentage. And the way that we think about it in the business and you think about the way an actual sales rep thinks about it is, they just think about absolute units. I mean they're not responsible for the denominator from last year but they are responsible for growing absolute units versus last year. So adding growth units and maintaining a book of business. And then the way that we forecast the business, we've been really successful with kind of guiding with a high level of accuracy over the last decade and that's because we work intensively to build that up bottoms up. And so we think about it the same way that a sales rep would think about it. And so that's why we tend to cast our comments in terms of absolute unit growth versus percentage terms and that's worked out fine. The guide for this year presumes continued excellent execution on volume growth across the board. Maybe one just to -- I know we're running short of time, so I'll just focus on Signatera. I mean, historically, investors would ask, hey, like what's a good kind of sequential volume growth kind of metric, kind of baseline. And we would say 8,000 to 10,000 units. On the Q4 call last week, we just acknowledged that we're just at a acceleration level where 8,000 to 10,000 units is probably no longer the right kind of baseline. It's probably modestly higher than that as a baseline and certainly will exceed that but there will be kind of volatility quarter-to-quarter just based on the number of receiving days and things like that. So you see that kind of baseline acceleration happening in the business, as you would expect from a repeat monitoring test that continues to fill the pipeline with new customers and then patients stay with us over time to get the repeat test.

And then maybe the last question we have time for up here. Gross margins have been a huge part of the story, like you mentioned early on, reaching kind of north of 60%, guided to 60% to 64%. When we think about that journey, I think a lot of it was Signatera kind of reaching more of a level of scale and getting some reimbursement there. But how do we think about the drivers of that in '25 in terms of ASP versus COGS? You've had a lot of projects kind of in flight on the COGS side. So just help us think about those 2 coming together. And is 60% to 64% a success? Or is there a lot more room to go from there?

There's a lot more room to go from there over time. I think it would represent objectively a great success for '25, just given that, ex true-ups we ended Q4 at 59%. So just to even get it in the range, you've got to expand 100 basis points on gross margins. I mean one part of the kind of the history of Natera that I kind of glossed over is part of this relentless execution on the commercial operations has also been on reducing cost of goods sold. So just every moment that you have, every dollar that you have that can reduce the cost of goods sold makes you more robust and more resilient as a business. And we've certainly deployed that playbook, both in Signatera, both in Panorama NIPT COGS over time, are less than half of what they were back in 2015 probably. And the Signatera COGS are likely circa less than half of what they were when we launched that product, right? So I think going forward, I still -- this is not an explicit guide. This is just kind of my opinion. I think that if you're asking me what's possible, I certainly think that 70% gross margins over time are possible. And that's a function of, yes, kind of continued kind of linear reductions in COGS per unit. But probably more impactful is just the growth in the ASP that we can derive. I mean I talked about the one underrated aspect of the business is just the efficiency of the sales model, where we've shown time and time again that we can grow volumes on constant rep counts. I think the other aspect that gets underrated is just the embedded earnings power of the business just based on the existing volumes that we run today, okay? So unit economics in Signatera are sustainable and allow us to invest. But we still are not getting paid on the vast bulk of our commercial volume. So our CEO, Steve Chapman, just referenced on our call -- on the Q4 call, we think that we could effectively double the revenues in the business if we could just get theoretically paid every time on the volumes that we run today. And will you get paid every time? You probably never get paid almost every time but that is kind of a idea of what's possible. It's important to do that math as you kind of do your diligence on Natera.

Perfect. Well, we are over time, so we'll call it there and head down to Amarante 1 for the breakout. Thank you.

Thank you.