All right. Good morning, everybody. Thank you for joining us. On behalf of UBS, first off, I'm Doug Schenkel, just in case you don't know, and it's my pleasure on behalf of UBS to welcome Mike Brophy, CFO of Natera. Michael, thank you for being here.
Oh, thanks for having me. Good to see you guys.
Looking around the room, I think most of you know Natera, but I think it's important to just set the stage by acknowledging the journey you've been on, where you guys have just done a remarkable job establishing a leadership position in reproductive health, and then moving into MRD. I mean, there's not too many companies where you say, at least in our space, you did a really good job in one area, and then you go out and dominate with a second act. You guys have done that in MRD, a market we believe could ultimately represent a $15 billion-$30 billion annual revenue opportunity. You're now pursuing additional indications, adjacencies, and moving into new geographies. We'll tackle a little bit of that today.
With that in mind, before we get into it, just to provide a roadmap, there were a few developments last week at the company.
Panorama volumes?
Panorama volumes is where we are going to start. But I definitely want to talk about the CEO announcement, the 2029 framework.
Yeah.
Then we will get into the all-important questions about Signatera, adjacencies, geographies, and CRC screening. We will see what we can cover over the next half hour. Kicking off on the CEO transition.
Yeah.
Maybe tell us about Solomon before we break down how we got here.
Yeah. Solomon is the 40th or 41st employee that joined Natera in 2011. There's probably not one single person that's more responsible for the development of these additional areas of focus, first with Prospera in organ health, and then ultimately with Signatera, making the critical choices around what clinical questions to answer, what clinical trials to run, which KOLs to partner with, every decision around product and product strategy for Signatera. Solomon was really the point person for all of that and is obviously critical in the commercial rollout for Signatera. It was a pleasure to listen to Bhavna do the intro for the conference and to have her mention MRD as an industry vertical.
Doug and I have done these conferences over the last decade where MRD did not exist as an industry vertical. I'm up here trying to convince people that it ought to be, that this ought to work. It's a pleasure to hear it just mentioned as, of course, it's one of these things that are common and rapidly emerging as a standard of care. Solomon's had a huge role in that. He's worked in each kind of area of the business. He's deeply connected to our R&D teams and our sales teams. I think Natera's a little bit unique in the structure of our leadership team in that we've got a bunch of really long-tenured executives. You mentioned my journey. I've been here 11 years, and I'm the newcomer.
Yeah
You take a picture of me around 2011 when I first met the company, if you'd taken a picture of us at that first meeting and taken a picture of us at our board meeting this week, it's really all the same people. It's really the same folks, the same core technology, and it's really the same core strategy. We're just a little bit further along. There's a lot of continuity in the handoff between Steve and Solomon. Another thing that's made it a little bit unusual about us is, we're all really dear friends. I know Steve's excited for Solomon. I'm excited for Solomon, and we know he's ready.
Why so abrupt? At least from the outside, it seems like this came out of nowhere. How'd this happen?
Yeah, no, I understand from the outside it can be perceived that way. If you have got an outgoing CEO and an incoming CEO that has not been part of the enterprise, you need a six-month transition. The new CEO has got to show up. They have got to sit in meetings with the outgoing CEO. They have got to learn all the different people, what is the meeting cadence, what are the different meetings that management even does, what are the decisions, who works where. All those types of questions are absolutely critical for a CEO transition. This is nothing like that. There is really not an important decision or meeting that Solomon is not already either chairing or deeply involved in. For us, a lengthy transition would actually be really kind of dysfunctional and counterproductive.
One of our traditions at Natera is after the earnings call, I will usually do the callbacks, and then I will be heading home at 12:30, half hour past midnight Central Time, and I will call Steve because he is curious about what were the questions, and we kind of kibitz about what did we do well, what did we do poorly, what came across, what do we have got to communicate better. I did my normal call with the guy, as we-
Same as usual.
Yeah, of course, of course. I told him, one of the questions people had was, "Well, why not a six-month CEO transition?" Steve and I both realized for us internally, for him, that had not been something that was really a topic because he knew it just would not work, as good of friends as we all are, for him to be kind of sitting in Solomon's meetings for the next six months. Two friends trying to tiptoe around each other.
Right.
The organization really needed clarity around who is in charge and who is making the core decisions. We do have a very amicable transition in place with Steve, which is, we have got a lengthy transition agreement with him. As I mentioned, I was chatting with him, so we have him anytime we need. There is going to be some of that. There is going to be questions, recollection of who made what decision, and just clarification. He is available to us, and we all remain friends. I think in spirit, what investors rightly want is they want there to be a warm handoff. They do not want there to be dropped balls or missed opportunities,
Right
because of a transition, and we absolutely have that covered. We have got continual dialogue between Steve and Solomon, Steve and me, and the rest of the organization.
Yeah, that takes me to what was going to be my next question, which is roles and responsibilities. How much changes here? It sounds like, the way you described it, not a lot.
Not a big change.
Okay.
Honestly, I think that kind of speaks to, one, the type of leader that Steve has been for us, and that he's been a very collaborative one. Our history was our Chairman and Co-Founder, Matt Rabinowitz, as many of you will recall, was the CEO from
Right
the time of the IPO until 2019. There was a group of us, kind of a motley group of people. We used to be the younger management team at the time, and now absolutely no one refers to us as the younger management team, which is slightly depressing.
You guys look great.
Yeah. There's a group of us, it was a really diverse group. On the face of it wouldn't look like a lot of us have much in common, but the one thing we have in common is that we're the type of people that like working for Matt. Matt, for whatever reason, can have a reputation as being a guy that can be hard-charging or difficult to work for. What I found out is that he just wants you to be half as good as him and care half as much as he does, and then he's an unbelievably wonderful guy to work for. So, Matt had, consciously or not, kind of gathered a bunch of people, like-minded people in the leadership team, and that has really infused our culture. Okay? This management team has always gotten along really well.
When Matt took a step back from the CEO role and we elevated Steve accomplished a really difficult leadership feat, which he became the CEO, but he remained our friend and our colleague, and his leadership style remained very collaborative, both in tone, but also in decision-making.
Yeah.
Really, there wasn't not a critical decision where one might imagine in many organizations that there's a huge differential between the CEO, particularly someone who's like a chairman and a CEO, making decisions, and everyone else was kind of an order taker. On the contrary, this was always a collaborative organization where we fight with each other and argue, and then we kind of come to a consensus. Solomon is going to do the same thing, and we're all ready for that.
Last one from me on this topic. You and I have talked about this a couple of times since last week. For whatever my opinion's worth, I'm comfortable. I would say if there's one thing, as I was thinking about it over the weekend, that I'm a little fuzzy on, it's arguably right now, science is always going to be the most important thing. Solomon, he's done a lot, but if you were going to pick one thing, I think he's the person who embodies the science. But there's a balance at this point on where we are in the MRD rollout, where it is, I think, almost as important to be dominant from an execution and from a commercial standpoint. So, you still have the great science person. I think we all thought of Steve as just being this commercial animal.
Yeah.
Why shouldn't we be at least a little bit concerned about the loss of somebody who is so good commercially?
Yeah. Well, I love the question because all of our long tenure sales leadership, when I get that question, I am sending little texts on Friday saying, "Hey, everyone thinks it was just Steve, completely up to Steve that grew the organization and is able to deliver excellent customer service. I did not know that. I thought you had something to do with it.
Yeah.
You are not really getting a lot of credit out here.
Yeah.
There is a little friendly banter and competitive spirit about that. It just cannot be true that in an organization where you do $3 billion in revenues and you serve over 3 million patients, that one person is responsible for the commercial execution. I think I am very grateful to Steve because, back to these kind of collaborative meeting structures we have had, I have sat in these meetings over the last decade as we have built the oncology commercial effort, really person by person. And we have landed on, through trial and error, the right meeting cadence, data and analytics cadence, how to cut a territory, how to expand a territory, how to pay people, how to promote people, how to bring people into the organization. We are now, for the overall org, we are 15, 16 years into that.
When I go to sales meetings, for a lot of these people, I am still the new guy. And one of the things that has been, I think, a hallmark and perhaps has been unusual about Natera is, I think in a lot of organizations, particularly ones in tech or biotech where the CEO is a technologist or a scientist or something like that, there is a tendency to have a little remove to the commercial team, and the commercial team does not have quite the influence in the decision-making flow that the scientists do. And I was really struck when I first came to Natera that if a sales rep had a complaint or they had a user experience problem, this was a real problem. This was all hands on deck, and we had to fix this.
Our culture is to presume that the sales rep is right if they have a problem, and we work for them. We have to solve that because by extension, we are keeping in mind that we work for the patients. That is not something that walks out the door when one person leaves.
Right.
We have an unbelievably deep bench of very accomplished people who are all still in their roles, who this morning are just doing the exact same thing they were doing yesterday, who know Solomon extremely well and trust him deeply. There is a huge amount of continuity associated with elevating Solomon to this role.
The $6 billion 2029 revenue target. I think you talked a little bit about this on the call, and then we certainly talked about it after the call. One of the key messages, other than that is a big number, is that there is multiple ways you can get there. Is that the right takeaway?
Yeah. Thank you for teeing that up like that. What a commercial guy you are, Doug. That is exactly kind of the thought, the cadence of thinking that we were hoping to inspire with that number. We would like to have had the first reaction be, "Gosh, that is a pretty bold step." We are just crossing over $3 billion, and here we are planting our flag saying three years hence, we are going to double the revenues. So at first, gosh, that is a big number.
But then what I hope would happen is that it would inspire investors to actually, "Well, let's put pen to paper and let's just see how doable it is." And then I hope you come away with that thinking, "Actually, this is pretty doable." So, it was important to note that we didn't really Just in terms of building the model, it's not necessary to hit any of the other long-term targets that we've already set out in order to get to this interim step of getting to $6 billion in revenues. For example, I still feel great about our ability to eventually get Signatera ASPs to $2,000. Our contracted rates are in the mid $3,000s. Our ASPs, as you know, are about $1,290 right now. So what's the difference?
The difference is that there's a set of tumor types for which we're not yet reimbursed by Medicare, and there's a broad swath of commercial patients who don't yet have coverage for Signatera. To do those things, the pathway's pretty straightforward. Step one is we've got to send a bunch of submissions into MolDX to get additional tumor types covered. Now, we have all the major ones covered, but as Signatera has evolved from being something that you would use in a targeted setting for colorectal cancer and breast cancer and evolved to more of a liquid CT scan, our tumor mix in our volumes has broadened accordingly. It looks much more like the SEER data than it did five years ago. Okay?
So that requires us to go and no one tumor type that's outstanding has more than 3%-4% of the volumes, but in aggregate, that can be about a third of the volume where we just need to establish the Medicare reimbursed beachhead like you've seen us do time and time again over the last five years. So that, I feel like investors ought to have a good amount of confidence in. Reality is, if we just do that and we continue to make our standard steady progress with biomarker states and just achieving compliance for reimbursement for already covered services with our Medicare Advantage partners, that ought to be more than enough to carry you to this indicative ASP of $1,450 that I tossed out there
Right
on the call. Now, of course, you can get to a revenue number on a lower ASP or higher ASP, a lower set of volumes, higher set of volumes. I throw out the $1,450 not because I have some, that's a magical number for 2029. We could blow well past that by 2029. I put that out there because I feel like most investors, that ought to strike them as something that would require good execution, but is also eminently achievable. Now, armed with that ASP, the volumes are a compounding metric, so it's harder for me to give you one number around the volume assumption. But I think that you could easily kind of back into any set of permutations around how you grow volumes between here and 2029 that does not require heroic accelerating growth rates on the Signatera business. It requires good execution.
It requires a continued compounding of repeat testing with our existing installed base of patients. It requires us to grow new patients at a healthy, but certainly a sustainable clip. Again, it is a good goal. It ought to hit you all as being eminently achievable. The last thing I will say is that, as many of you know, we do not love to put out these long-term targets. We would rather just not. We would rather under-promise and over-deliver. We would rather just keep our head down and let investors figure out what the numbers are going to be. We did this once before in 2022, the last time I was really in trouble. We burned $100 million in cash in a quarter. I am kidding about the trouble part, by the way. We burned $100 million in a quarter in cash, okay?
The environment had gone from very permissive to very grumpy about the cash burn topic, just for the industry coming out of the pandemic. We knew that we had to put a line in the sand. We did that. We said, "Hey, look, we are going to get to cash flow break even in a quarter in 2024." We hit that exactly. What I had not anticipated when we set that line in the sand By the way, you had to make a lot more challenging assumptions to get to that metric than the $6 billion. In my view,
Yeah
that was a much lower probability of success, but I thought that we could do it. What was unanticipated from my perspective is what a rallying cry it became for the employees. We came up on the town halls, we said, "Hey, we got to do this. This is what we said to our shareholders." Then I am in the lab just minding my own business, and people are coming up to me and talking to me about this and talking about what efficiency they came up with. We included all the employees in that goal. We try to treat everyone like partners in the business, but when you include them in a tangible goal, that gives them the opportunity to really show that. Okay? Friday morning, Solomon is on our usual town hall, same meeting cadence. He knows all about town halls.
Everyone in the company knows Solomon, and he is planting his flag and saying, "Hey, look, we just did $3 billion. Now we are going to double our revenues to $6 billion, and here is what we need from you in order to get there." A secondary benefit to a goal like that is it does become a rallying cry for the organization, and it is a team that we are really proud of, and we are going to need their help to get there.
How penetrative do you think MRD is right now?
I still think we're early days.
Yeah.
I really do. If you think about, you mentioned that the MRD market is something like a $15 billion-$30 billion kind of annual revenue TAM. I think that's right. I think my estimate would be right in the midpoint of that zone. I think there's Signatera is going to be something that does a little over $1 billion in revenue this year, so that ought to give you a sense
Yeah
of how early we are, single-digit kind of penetration. So, I'm so excited about that because it just puts into perspective the amount of good that we can do for patients. Every single person in this room and every single person listening to this webcast is going to either be personally affected in their cancer care by Signatera, or they're going to have a loved one whose lives are improved because they have access to Signatera, whereas a few years ago, this thing just didn't exist. One other comment about TAMs is that we're not done. We're in a really, really interesting position now in early cancer detection, and you just saw kind of a glimmer of the scale of the impact we can have there with the Breakthrough Device designations.
Yeah
we got beyond colorectal cancer. If you just take a conservative sum of the number of patients we can impact annually with an early cancer detection screen in colorectal cancer and in these additional high-risk populations that were included in that Breakthrough Device designation win, that addressable market is the same size as this MRD market. Just as we are going to be hitting our stride with Signatera in the latter part of this decade, we are going to be doubling the addressable market and the number of patients that can benefit from a test from us in each year. We are really, really just getting started, and I think that is quite unusual for a business to get to our scale with our growth trajectory in a core area and then still just be on the cusp of doubling the TAM once again.
A model question. You guys did, was it 32,000, 33,000 more tests sequentially?
Yeah, 33,000 , 113,000 annual growth, which was a record by more than 10,000 units.
And that, [inaudible] I know how you tell us to look at the trailing four quarters.
Yeah
to model from there, but is there anything that I heard you say suggests that things are starting to hit a ceiling in terms of quarterly growth.
No, absolutely not. I do think that we are at a scale now where the year-on-year comparison is really the rational way to evaluate the business. You mentioned that 33,000 sequential growth units over Q2. The business did 318,000 units in the quarter. So, I had this conversation a couple times with a few of our shareholders. ± 3,000 units on that 33,000, I think if we'd have done 30 or 36, I think people's perceptions might have been a little different.
Yeah.
It's like a half hour.
Yeah
in the accessioning lab, the difference between these numbers. I think that the sequential is now, it's just too fine of a distinction to really deliver the same explanatory power that it once gave you three, four years ago. I do think that rolling four quarters average is something to look at, but the reason why we included a different slide in the deck is that I think that year-on-year volume growth number, now you're talking about, hey, 113,000 growth units over 100,000 growth units, roughly in that zone. I don't have the numbers in front of me. But that gives you kind of a more robust way to measure the acceleration we're seeing in the business. And if you do that year-on-year volume comparison, the chart looks like very clear acceleration, and that's how we're evaluating it internally.
And you're going to keep investing in commercial, right? Earlier in the year, you talked about a 300+ person oncology sales force being at the scale you needed.
Yeah.
But it sounds like you're going to go further now.
Well, we are. One of the interesting dynamics about Signatera and the MRD market is how scalable it is relative to other diagnostics markets I've ever been a part of, and this is like year 20 for me in the molecular diagnostics space, because you do have this compounding effect. It is a repeat monitoring test for patients. So, our aspiration was to get to 300, 400 people in the commercial organization for Signatera. That's very similarly sized to most other specialty diagnostics labs, so there seems to be some magic around that number.
Yep.
Given that there are about 11,000 oncologists in the U.S., there is a natural ceiling to this. It probably does not make sense to have 2,000
Right
people in the commercial operation. They'd just be stepping all over each other. So, I think that should give some comfort to investors that are thinking, "Well, do these guys, does Natera, do they scale the business? Do they really end up generating lots of EBITDA, lots of EPS?" Obviously, with Natera, I think the answer is yes. That doesn't require you to believe something special about my point of view on profitability. That's just a natural consequence of how large the addressable market is relative to the commercial team that's required to execute. Okay? So we're at scale. We're at that level now. You mentioned, "Hey, are we going to keep growing?" I think you should expect us to continue to look for ways to grow and iterate and change. Again, this is something that we all learn together, including Steve. How do you iterate?
How do you figure out what is the right commercial structure? Well, we just try stuff. It's really not that hard.
Yeah.
We run experiments, and we screw up, and then we fix it quickly, and we learn from that. The cadre of people that have all of the wounds and battle scars from all the mistakes we've made over the last 10 years, I know that's not very evident to investors because it looks like it's a pristine record. Underneath the surface, we've made all kinds of mistakes, and we've fixed them quickly, and we've measured them quickly, and we've learned. All of us, particularly Solomon, have a deep kind of Rolodex of lessons in mind for how do you expand the team. We're going to continue to try and be aggressive there. I do think that the thrust of the investments for Signatera is going to continue to be on the R&D side, particularly in clinical trials.
You've talked about next year being another investment year.
Yeah.
I think of this as you describe R&D, where you're continuing to support Signatera. You're continuing to move into other areas like CRC screening. You're boosting the sales force next year. I think we have OpEx going up like 12% next year. You have the line in the sand for 2029 at the top line?
Yep.
What about below the top line? Is there anything we should be thinking about as we think about 2028 and 2029 from a margin perspective?
Yeah. I think it's really important to peel back the onion on where the investments are going even today. If we just had this core set of businesses, women's health, organ health and MRD, the $6 billion in revenue would come attached with it, significant EBITDA margins as well. Just hearkening back to the point I was making around scaling is, we won't have 2,000 sales reps in 2029. We might have modestly a few more compared to what we have today. The question will be, I would love to be taking that EBITDA and reinvesting it into a couple of these early cancer detection trials in high-risk populations. We don't have to do that. We can all look at that together based on the results at the time and decide what is the high ROIC investment there
Yeah
what's best for patients at that time. If you take a look at the Not to give you guys homework, but just go back and look at this last earnings call deck. There's a slide in the back in the finance section. I know that's a boring part of the deck, but there's a stacked column chart for SG&A spend and a stacked column chart for R&D spend. You can look at where, by high-level category, where that spend is going. The bulk of the growth in OpEx both this year and for next year is going to be in the R&D organization. I think if you look at that stack, you look at where things are going, I made the comment on the call that we could probably cut something like 70% of that investment, and it would not affect us for the next two years.
We would just continue to
Right
roll on. About $100 million in a $900 million-$950 million R&D budget this year, north of that really, is going to colorectal cancer and early cancer detection, which delivers nothing to the top line right now.
That is a complete boat anchor. And if you just screen us on your Bloomberg terminal, it looks like, "Oh, these guys, they can never make money." The reality is that that is going to be the first data readout next year that then opens up an ability for us to double our TAM. So we're going to go from getting zero leverage, 100% EPS dilution on our early cancer detection investment to going to a place where we're launching a test, we'll have reimbursements. There are 13 million people a year that need that test. And we're going to be ramping it, going once again from zero to millions of tests like we've done before.
Can you talk about the sequence from here when it comes to CRC data generation, including FIND, and then going beyond that to FDA, and then how do we think about your MCED strategy?
Well, so I think we're very excited about the FIND study readout. I expect that next year.
Probably back half, right?
Yeah, it's probably back half. It's hard to put perfect visibility on that. I mean, one of the hard challenges we had to get through was get the study fully enrolled, and we've done that. I mean, we were able to get that done ahead of schedule, so that's one of the potential risks to timeline that I think we've de-risked at this point. We had excellent data out of our preliminary prospective PROCEED study on 2,000 patients. From there, we learned a lot, and we're in flight on a bunch of development on what will be the final assay. We're going to want to make sure that we're really ready to go with a locked assay when we finally accession all those tests in the door next year and run the study.
When that reads out, the reason why you run the big study is that you don't know what the results are, right? You got to read out the study and find out what the results are. I think at this point, my expectation is that those are going to be quite good. We'll have to see. From there, then you've got to submit to FDA. That's usually about a nine-month process, thereabouts. On the back of the FDA approval, we'd be ready to launch in the United States, so that puts you somewhere back half of 2028, early 2029 for a launch.
MCED?
Yeah, I mean, MCED just drafts right off of that. I mean, I think we're going to learn a lot between now and the FIND data readout. That's step one, and I think the plan for MCED is quite path dependent from there. But in concept, we ought to be able to take a lot of the technology development, assay development, and rapidly apply all of that that we learned in the CRC development process to the MCED product. Again, I'm as excited about this as I was about Signatera back in 2018 and 2019, around our ability to just massively impact a huge number of patients, people that do have a high risk for cancer, that do objectively need a screen. You can run an efficient study in these populations. You can get a high PPV in these populations.
You can show very clean health economics, where you're repeating the key objective that I think has made us successful over time, which is we're trying to offer tests that are time sensitive, that are clearly needed right now by the patient, that offer obvious clinical utility over the standard of care, and at the same time, take costs out of the system. We're poised to do that again, both with CRC, early cancer detection, and then with MCED.
It's interesting, maybe to state the obvious, but given the timelines we talked about, those aren't going to be big components of this 2029 target, but they're also very timely when we think about FDA and when CMS would be ready to actually reimburse things, especially on the MCED side.
Yeah, the 2029 target is just a way station.
Yeah.
It's just a point in time. I shared with investors on the call in the Q&A, there's a certain amount of symmetry. I mentioned the employees, and I do have the employees in mind when we set a goal like that, and there's a certain amount of symmetry around, well, doubling the revenues and then what's a reasonable amount of time to get there, difficult but achievable amount of time to get there. But I think that's merely a way station. It does not assume some heroic contribution from a piece of the organization that's not generating revenue today.
Japan. You've suggested Japan could adopt Signatera as fast or faster than the U.S. What comes next in Japan?
Well, there's a lot of excitement internally about Japan because we are getting close to launch, so we expect to get pricing between now and, say, JP Morgan. I'd like to be talking about it at the JP Morgan Conference in January. Obviously, we don't totally control that, so we'll have to see what we get. But cautiously optimistic on that milestone, and with that, I think we'll be in position to launch. Huge amount of enthusiasm both in Japan and within Natera for offering this incredibly large unmet need in Japan. I mentioned Solomon as being one of the people that is kind of uniquely responsible for the existence of Signatera. I think if you're making a list, you've got to include a few Japanese KOLs
Right
who were willing to include us in the CIRCULATE study when Signatera truly was a nascent technology, where MRD and solid tumors really was a new concept that we were pioneering. A lot of our most impressive outcomes data, long-term outcomes data in colorectal cancer is actually Japanese data. They already have a tremendous guideline in support of colorectal cancer MRD in Japan. I think the stage is set for that to be an outstanding contribution that we can make to the world and also a contribution to our business. Having said all that, as I've said to many investors here in the room individually and a lot of you guys on the webcast, it's going to be new. I mean, this is a new market. I don't think there's massive numbers associated with Japan contribution for 2027 per se, and I think that's appropriate.
We're excited to get in there and learn and help patients as quickly as we can. If you look out a couple of years, I think it's going to be, it's an effective doubling of the number of patients we can help in colorectal cancer when you add the U.S. and Japan.
All right. Well, that was great, and you've given me enough homework, so I think we should stop now. We really appreciate you joining us and going through all these great opportunities. Thank you.
Thanks for the time, Doug. Good to see you all. Cheers.