Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

Okay. I think we're good to go here. I'm Tycho Peterson from the Jefferies Life Science team. It's my pleasure to introduce our next company, Exact Sciences. We've got Kevin and Aaron with us today.

Kevin, maybe kick it off, we'll start with the base business and the strength you're seeing in screening. Obviously, a number of pieces here between care gap, rescreens. Just talk about kind of the durability, the momentum you're seeing, sustainability of some of the trends we've seen this year.

Yes, it's been exciting. A year ago, we were in a totally different place, weren't we, Tycho. It was -- what we have seen over the course of the last 12 months is tremendous commercial execution in a durable way that is deepening our connectivity with large health systems, with health care providers and with consumers. So we're kind of firing on all cylinders, incredibly proud of the team. What's driving that. You're looking at revenue -- this recurring revenue, this recurring testing model of making sure that people get screened, they stay screened. That is -- that will continue to build over time, care gap testing. And if you take a step back, what you're seeing is this incredible brand of Cologuard and Cologuard Plus, the new and improved version of Cologuard is addressing the needs of 50 million people in the U.S. who are not up to date with screening. And over time, we'll be able to extend that. The Precision Oncology business is also growing at a nice clip, 12% in the last quarter. So on all cylinders, team Exact is firing and that bodes well for the future as we launch this suite of new tests.

And maybe touch on the sales channel. If we go back a year ago, you're obviously dealing with some changes there. Talk a little bit about the influx of new commercial hires, how quickly they've come up to productivity and how you think about contributions from that next year.

We've done a few things. Number one, we increased the size of the sales force back to the size that we were at in 2023. We went back to the way -- when we first built the Cologuard commercial organization, we had 2 choices. We could go through Quest and Labcorp, which was not very attractive to us or we could build a primary care sales force, which was less attractive to us. It was a really difficult dilemma. We chose the less attractive model of going direct. And what that has given us is this unbelievable engine to now launch new tests into. And we built that organization in a very careful and thoughtful way with the design. We got away from that as we brought in some different commercial leadership in 2023. We got back to it on December 1 of last year. That means every rep has their own territory. They own everything that happens in that territory. We provide incredible data. We have a massive store of data and AI tools to tell them what's the next best physician health care provider to call on. Coupled with just the Cologuard Plus message of 95% cancer detection, it's returned us right back to the growth. And you could see that happening in middle of December, a few weeks into our launch of this robust sales force. We're proud of this team, of what they've done, but put that aside, what they can do now with Cancerguard in their bag, our multi-cancer screening test is -- this is going to be fun to watch.

Any lingering messages you want to leave with us coming out of 3Q. Obviously, a nice beat also an EBITDA beat I note. So maybe just talk a little bit about some of the takeaways from 3Q.

Third quarter was our highest growth rate that we've seen in over 2 years. So total company growth was 20%. Screening accelerated. There was a step change up to 22%, a lot of the key drivers that Kevin alluded to, and that obviously flowed through in a pretty meaningful way then to the bottom line. We saw an inflection up in free cash generation in particular. Through 3 quarters of the year now, we've generated more than triple the amount of free cash that we generated all of last year. I think the one double-click on the revenue side, Tycho, just as analysts are starting to model out 2026 would just be around care gap. And care gap has some seasonality to it. It's a relatively new business for us. We've been doing it about 2.5 years. And just a reminder, what is care gap. For largely the payers, but also the health systems, they try to close gaps in care. And it's been something that they've been doing with the FIT program for over 2 decades. And what they've started to come to us to help with this problem is we're able to deliver a ninefold impact relative to what they've gotten with the FIT program. So we drive a 3x improvement in the adherence rates, so the number of tests that get completed. And then because of the performance of Cologuard and Cologuard Plus, we give them 3 years' worth of quality credit. And so this is still a new business. We said last year, it was more than $125 million, growing triple digits. It's meaningfully contributing to growth in the back half of the year. So think like adding mid-single digits to our top line growth. And in Q1, we would not expect to have as meaningful of care gaps, and that's just because we ship very few care gaps out in the first quarter. It's pacing similar to what it was last year, 2/3 of the revenue in the back half of the year.

Another driver has obviously been rescreens, 25% of total screening volumes. I think you've talked about maybe getting to penetration closer to 75%. Talk about some of the initiatives there around kind of automation. And then why is this expansive to the TAM as opposed to something that gets used up once a rescreen is completed?

So one of the wonderful things about what we're building here is the capability to get somebody screened in the first place and then keep them screened for the rest of their lives. So Cologuard is indicated recommended every 3 years as a screening tool versus colonoscopy, which is recommended every 10 years. On every 3-year basis, we have the ability to go back to that patient and get them rescreened, either they can initiate it themselves through our website or they can go back to their doc and have their doc order the test for them. We also go back to the health system, and they can do this at a population level or to the individual doc where we use digital tools to help automate the process of getting that test order up to 12 months before a test is due. And there are about 2 million opportunities just this year to get people rescreened. And as you can imagine, as this occurs over time, this opportunity grows and grows and grows. And it's a deep relationship that you have with the patient that also allows you over time to start to have a real engagement, a conversation with the patient about the need for other types of screening, including multi-cancer screening. So this is an opportunity for us to have this recurring testing relationship with patients. It is working. It continues to get better every year. It's just one data point. For somebody who's due for their third Cologuard test, when we get them a kit, 90% of them return it. These are wonderful relationships. The goal over time is to have somebody do their 10th Cologuard test.

Maybe we can double-click on EBITDA margins. I mentioned a minute ago. Aaron, you've got a good cost-out program, I think, $50 million this year, $150 million next year. Talk a little bit about the path to the 20% EBITDA margins you've laid out. How do we think about out-year CapEx? And how are you balancing kind of the growth expansion with cost-outs?

2025, if you look at our guidance, will mark the second consecutive year of nearly 50% profit growth. So it's just this really remarkable engine that Kevin talked about and the platform that we're now able to leverage throughout the P&L. And then the cost-out productivity program that we outlined a quarter ago really just layers in on top of that. And so if you look at the back half of the year margins, we're at between 16% and 17%. As a reminder, our long-term margin goal, which is out through 2027 is to deliver 20% plus EBITDA margins. So we're already kind of within striking distance. This productivity program will layer in on top of that. We would start to expect to see leverage not only through G&A, but also in sales and marketing. One of the beauties is we have Cologuard, we have Oncotype. And now as we layer in tests like Oncodetect and Cancerguard, we don't need to necessarily add more salespeople to go sell those tests. It will be around marketing investments. And so you'll start to see leverage kind of across the P&L.

You mentioned DTC on the 3Q call. Any way to kind of talk about the magnitude of that type of program? Or is it too early?

It's early. What we did say was we expected to see a pretty meaningful step-up in terms of sales and marketing spend sequentially from 3Q to 4Q, I think in the range of $30 million to $40 million, and that's what's embedded in our guide. That's not all Cancerguard, though. Keep in mind, DTC spend in general, even on core Cologuard tends to step up in the fourth quarter tied to things like football season, et cetera.

We started off talking about the core business. I want to go back to that. I guess, Cologuard Plus, you've got 4 of the top 10 commercial payers on board. Maybe Kevin, talk a little bit about what it takes to get the remaining 6 insurers. And how large a lift would this be on mix. You're expected to exit this year at about 30%.

So we have -- out of the top 10 payers, which represent north of 60% of all lives in the U.S. We have 10 out of 10 with positive coverage decisions. That's the starting point then for contract discussions. We have others in the pipeline where we're close to agreement on contracting. And we suspect, if you look into next year, we'll really start to phase out Cologuard and move to Cologuard Plus. Look, the patients deserve the best test and Cologuard Plus is just a better test. Yes, it's a little bit more expensive. We haven't had a price increase in 11 years. This is the first increase, and it's modest at 16%. So we expect to be able to have contracting done by the end of next year and earlier if we continue to execute well.

And from a pacing perspective, Tycho, next year, we'll be able to give more color when we give 2026 guidance in February as to how these contracts pace because, as you said, we're exiting at 30%. How many more contracts we get signed between now and February will be a big indicator of what that means in terms of a tailwind to growth next year.

And just thinking about some of the pricing drivers, Medicare fee-for-service expected to add, I think, a 4% pricing increase here in the back half of the year. How do we think about Medicare Advantage, Medicaid and then remaining commercial adoption over the next year.

For Cologuard Plus?

Correct.

For Cologuard Plus, I think those contracting discussions we go into with their full book of business. So Medicare Advantage, Medicaid, commercial. And so that is typically all decided. It's almost always decided in one fell swoop. So we don't negotiate each of those plans separately. We do it all at one time. And each of the top 10 typically have a mix in their book. Humana is an exception where it's mostly Medicare Advantage. Centene is more Medicaid plans and Medicare Advantage. And both of those, we have signed contracts with.

Maybe we can spend a minute on blood. Obviously, a lot of debate on size of the market, how quickly that market can evolve. I guess, what are your thoughts on competitive advantage and opportunities initially?

So CRC blood.

Yes.

So for colon cancer screening, what's recommended today is colonoscopy, Cologuard and the FIT test. That's recommended by the USPSTF, which is the main guideline group. There's this nascent area of testing with blood-based testing, the challenge with blood-based testing, there's both a challenge and an opportunity. The challenge is that performance is not as good as Cologuard or colonoscopy. The opportunity is there are some people who won't get a colonoscopy or won't get a Cologuard test, and there are 50 million people out there. It's hard to say. The uptake so far has been small despite a pretty big push. And -- but what is happening out there in the market is that we think there are about 400 sales reps out there promoting blood testing. Cologuard is getting a lot of the benefit from that because the more attention that there is on the subject of colon cancer screening, which is typically ranked about #13. When you go in to visit your doc, after 12 other things they talk to you about, they get to colon cancer screening. The more promotional activity there is in colon cancer screening, the more Cologuard tests are ordered. And we see that in the data that we are getting coming from the docs who are starting to adopt CRC blood. Our CRC blood test, we expect to be in market middle of next year. And the advantage that we have with our test is that we're incredibly trusted by 250,000 health care providers that use Cologuard this year. They trust us. And we also have the data to show them this is the cohort of patients that is unique and distinct. There are people who refuse colonoscopy and they refuse Cologuard. And we can get those people screened. And so that's the goal is to get people screened with either a really effective test like colonoscopy or Cologuard, and if not a blood test. Why not a blood test? Blood tests are pretty much blind to precancerous polyps, and they miss far too many Stage 1 cancers, the very cancers that are -- if you find and remove those cancers, there's a 98% 5-year survival rate. So we think that this is going to be, call it, 5% of the overall market, maybe 10% of the overall market. And in the meantime, more attention inures to the benefit of Cologuard and colonoscopy.

Is the experience with Cologuard pre-guideline pre-USPSTF at all a good proxy. I think you scaled to 40,000 tests or so in the first year?

Well, we only had 80 reps. So you have to remember the work that we did, I think it was 40,000 tests in the first year and 100,000 tests in year 2. So that would have been 2015 and '16. We only had 80 sales reps. We had good data. We had a really good test in Cologuard that was a game changer. And so that data matters. We're out there shaping the market to educate our customer base, and it's easy for us to do that. And with blood-based testing, I think the opportunity we have is we have about 10 million people in our database who we have sent one or more Cologuard kits to them, they haven't returned them. So we start with those 10 million people and we can market directly to them and through their physicians to go get them screened with the CRC blood test. We haven't named our test yet, but we'll do that again and launch in the middle of next year. And we think that's a big opportunity, but nowhere near as big as Cologuard and Cologuard Plus.

Tycho, one of the other things we have now that we wouldn't have had a decade ago when we launched Cologuard is EMR connectivity. And so we just connected in the last quarter with our 500th large health system in the country. And what we see when we flip those on is it makes ordering so much easier for the physician. We typically see about an immediate 30% pop in terms of order rate once we connect electronically. And that's not something that's very easy to do. It's taken us 8 years and having a very relevant test that you get prioritized from the health system, their CIO, their lab director, et cetera.

Yes, to do that connectivity, it's 500 health systems. That's about 700,000 primary care health care providers. You need to get the sign-off of the Head of GI, the Head of Internal Medicine, the CIO, the lab director and frequently population health. And to do that, you've got to do it one by one. And then you need to do the IT work. So we started at this a long time ago. We now have the ability to extend that capability into other tests like we have with Oncotype DX, and we will with Cancerguard, Oncodetect, our other tests that -- are we a cancer diagnostic company or a technology company, you can have that debate. What you see is the combination of great tests and this incredible technology platform that not only allows you to electronically receive an order, provide a result, but it helps with prior authorizations, billing, collections. It's a supercharger to this capability that we have to go out there and execute on the bigger vision which is cancer eradication with tests that prevent it like Cologuard, detect it earlier like Cancerguard or guide treatment like Oncotype DX and Oncodetect. You need that technology platform to be able to achieve those goals.

Does higher adherence with blood potentially change the equation with payers if they can show 95% adherence. I mean you mentioned the number of Cologuard kits that don't get returned.

So you see some of these numbers out there about adherence being in the 90s with blood tests. That is -- if you're calling on an office that has a phlebotomist in the office, you can probably get 95% of the people to walk from the exam room to the phlebotomist. But as soon as the patient has to walk to the second floor of the building from the fifth floor or worse they need to go to a -- in other words, you're calling less than half of doctors' offices today having a phlebotomist. You don't really need one anymore because Quest or Labcorp, they have one for you down the street. The problem with that is and you can see this, there are papers out there written about this, the compliance for blood testing is about 60%, 65%. So as soon as you put any friction into that system, it's -- the compliance falls. And I think that's what you'll see with our blood test eventually is similar compliance from a prescription or a test order to an actual blood draw, there's that falloff that's hard to deal with. With Cologuard, at least you can send the kit directly to a patient's home and they can, through a very simple app or telephone call, schedule UPS to come pick up the kit.

Maybe last one on this. Aaron, when do you think we'll learn more about COGS for your test? And any reason you'd be vastly different than some of the other NGS-based tests, $500 or so?

We wouldn't expect to be any different at launch. In fact, we have an agreed-upon pricing schedule with Freenome in the early days. One of the things that we want to do, though, is get this transferred into our lab in Madison, Wisconsin. And we've got a deep understanding of the cost structure. And obviously, overhead is a key component of that. We don't have to build out a new lab. We're going to be able to drop that right into, again, our lab in Madison, Wisconsin and look forward to being able to do that and drive the cost meaningfully below that $500 number you cited.

I want to make sure we hit on MRD as well. Oncodetect, you got Medicare coverage in July. Talk a little bit about early adoption. What gives you the right to win in this market.

So we're pleased with the start and what gives us the right to win over the long haul is in our Redwood City lab for Oncotype DX, we see about 50% of all of the breast cancer tissue blocks in the U.S. So Oncotype DX has been available and widely used and clearly the leading breast cancer therapy determination test. And because of that deep trust that oncologists, community oncologists, academic oncologists have with us and then the pathologists actually sending us the whole tissue block. That gives us the ability for the 20%, 25% of patients who are at a high risk of recurrence per the Oncotype DX score to actually then get an MRD test, Oncodetect. We are running studies in breast cancer, in colon cancer, pan-cancer, altogether about 10 studies that will help provide the fuel for us to leverage this great capability that we have with oncologists and extend that deep into MRD. We're already seeing that today as we see not just colon cancer tissue samples that we're getting, but also patients with -- in fact, there are more patients with other types of solid tumors than colon cancer and colon cancer is the one type that we have Medicare coverage for today. We expect that to rapidly change. We also believe that over time, that there will just be a broad-based coverage for all solid tumors. We think that should be the case because of just how prognostic MRD testing is for predicting whether a patient is likely to recur and then allowing oncologists to treat differentially based upon that test result.

We've got 1.5 minutes. I'm going to go rapid fire on MCED. And just thinking about Cancerguard, you've got an FSA, an eligible price of $6.89. How did you arrive there? And then talk about the decision to go with a broader panel approach as opposed to indication by indication.

The broader panel approach is, that's what makes the most sense. If you want to screen a whole person with a blood test, you do it looking at 50 different types and subtypes of cancer. So there's that. And at $6.89, we see the most -- that's where people are most likely to come out of pocket out of a flexible spending account or a health savings account to pay for a MCED test. And so Cancerguard is our MCED test, it's Cancerguard from the Cologuard. We love what we're seeing in the first 45 days. We can't wait to head into next year with more marketing behind us and also a plan to bring Cancerguard to our customer base globally. So we're excited about the capabilities that, that commercial organization that we started this discussion about can deliver with a multi-cancer screening test. If you haven't tried it, go online, cancerguard.com, if you're not from the U.S. and next time you're in the U.S., you can just go to a blood draw. Quest blood draw collection place and get the test done. $6.89, we think it's well worth it. .

There you go. We'll leave it at that. Thanks, guys.

Thanks so much. Tycho. .