Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

Thank you both. Kevin, while you're walking up to the podium there, maybe you can talk a little bit about your recent purchase. You bought $1 million worth of stock in the open market. It's a good place to start. Bullish signal.

Well, I've only done this twice now in my 15 years as CEO. The first time was at $5 a share. I thought there was a dislocation. And the second time was last week. And I -- as I was walking out the door in the morning, I said to my wife, Sheila, what do you think about buying more Exact Sciences stock? And she said, go for it. At times, you see this over a long period of time, opportunities. And I looked at this opportunity and just saw the core value of the company that we're building and thought it was an opportune time to do so. So there you go.

Let's talk about guidance. either Aaron or Kevin can take this one. You lowered by $90 million at the midpoint. Obviously, a number of gives and takes here. Do you want to kind of walk through the moving pieces?

Yes. So we took down guidance at midpoint by about $90 million. Roughly 1/3 of that was more onetime in nature. So there's about a $10 million to $20 million impact on our Screening business as it relates to the hurricane, most notably in Florida. And we have seen both orders and results start to rebound in those geographies, but slowly coming back up to levels they were at historically pre-hurricane. The second was a $10 million to $15 million impact. We took our Oncotype DX platform in the U.S. onto our ExactNexus IT platform. And ultimately, the cash collection rate for a short period of time, while we went through that transition, was a little bit below where it had been historically, primarily related to in oncology, there's a lot of billing, paperwork, prior authorizations of note that are required. Good news is that's resolved. We're actually back at the same levels of cash collection rates that we were pre go-live, and would expect that to improve over time. The bigger impacts were on -- there was about a $20 million shortfall from recent sales and marketing investments that we've made earlier in the year. While we have seen a positive signal from those investments, they've been a little bit more gradual than what we had anticipated. The biggest factor is, though, we always see and have historically seen a big ramp in our orders that's directly tied to physician and wellness visits coming out of kind of that late August, early September time period into kind of early November. And that ramp, while we have seen a positive signal during that time, it's been not as great of an increase as what we've seen in the past, and we'll get into why.

Yes. Why don't we actually start with that and talk about why you didn't see the typical seasonality that I think you kind of alluded to, changing consumption patterns for health care earlier in the year, but maybe dive into that a little more.

Yes. And let me take a step back and just -- for those of you who are new to Exact Sciences, our mission is to help eradicate cancer through tests that prevent it, detect it earlier and guide treatment. So you have Cologuard on the Screening side. Cologuard Plus is a new product that will be available next year that will launch. A multi-cancer screening test, Cancerguard, that we haven't announced the launch date of that, but we're starting to offer that as a lab-developed test now. And then also our core Precision Oncology franchise led by Oncotype DX. So you have Cologuard and Oncotype DX, the 2 biggest, strongest brands in cancer diagnostics. Oncotype DX will be supplemented now with OncoDetect, an MRD test in an exciting new growing market. So as a base, our company has this amazing brand of test, and it's built on a platform called the ExactNexus platform that allows physicians to easily order a test, get the tests electronically, do prior authorization electronically, bill electronically, it helps automate this. So if you ask, is Exact Sciences a diagnostic company or a platform company, you can have that debate. It's both. In terms of what we have seen in the short term with Cologuard so let's go back to how we built Cologuard. We had a maniacal focus on making sure that our sales force called on the right physicians with the right materials, the demo kits, the educational materials to get more -- to get new orders to order more frequently. And if you go back over the last couple of years, the truth is we've lost some of that focus. So we had a commercial leadership change middle of this year that gave me an opportunity and our team to dig in, in a deeper way back to looking at Cologuard and how was our sales force deployed? How was it sized? Who were they calling on? And there were some basics that we were getting wrong. And those basics are being fixed. And the reason that we haven't seen the lift that we typically see is because, number one, we weren't calling on the right physicians. So historically, when we get a new physician ordering Cologuard for the first time, we're able to reach out to that physician either on the telephone or live in person with the sales -- one of our sales leaders, and we bring them a demo kit. We bring them the New England Journal of Medicine paper. We're able to educate them. And what you see then is a direct lift. Over the last 3 years, we have not focused on those first-time ordering health care providers like we have historically. That's -- I am accountable for that. The good news is that when we do that, when we focus on those new ordering providers, what we see is month-over-month lift in terms of their frequency of ordering, and it's very predictable. Now if you take a look at the new ordering health care providers over the last 4 years, they represent about 46% of all orders, but a much lower percentage in the 30s in terms of volume. Why? We haven't constantly updated those physicians to be called upon by our sales force. That's like a basic mistake that is being fixed. Every quarter, you want to update your targeted customer list. The other thing that we haven't done as well as we should have is to make sure that, that sales force is deployed in a sensible geographic territory-based approach. And we had moved to a targeted customer list approach, which deincentivized the sales force from converting a whole office. Why? Because you're only incentivized to call on 1 person in that office or maybe 2 people in the office. We're going back to what has allowed us to always grow. And this is actually not the first time that we have ever faced this challenge. If you go back all the way to 2016, there have been multiple times where we have redesigned, redeployed our field force as our base of customers has continued to grow at between 800 and 1,000 new health care providers. So I'll give you a data point. Last week, we added 1,000 new providers ordering Cologuard for the first time, in 1 week. That's -- it usually bounces between 800 and 1,000. Our ability to call on them and drive them up to peak volume ordering is clear. You have to send a salesperson in to talk with them. And when you do that, you drive it up. That is the reason that the back half of this year, the growth isn't there. So I'm glad the commercial changes that are being made are being made now. As of December 1, we will be appropriately sized. The reps will have all of the tools to know who to call on, and they will have the right incentives to make sure that we deliver on those numbers. And maybe, Aaron, you could talk a little bit then about the drivers of growth as you look out through the next several years on top of that core base of growth?

Yes. So as we look into 2025, we believe growth reaccelerates for our Screening business, really driven by a couple of key factors. First is on rescreens. And so rescreens for us is our most predictable recurring form of revenue. And this is a base that's going to continue to grow not only in 2025 but into the future as people become eligible for their second, third, fourth time of rescreen. In fact, the number of patients eligible for a rescreen grows again next year from 1.6 million patients this year to 2 million in 2025, to 2.6 million in 2026. So that alone gets you to mid- to high single-digit growth on the screening side. The second is demand for our care gap programs, and I'm sure we'll dive into a little bit more of what that is, but we're continuing to partner, primarily with payers. But also with health systems, the demand continues to grow rapidly as they're looking to close some of their challenges that they're having meeting -- getting their quality credits. So those two things alone gets you to something that's north of 10% growth in 2025. We're also going to be launching Cologuard Plus, our next-generation Cologuard test with improved performance, and we're seeking a modest 10-plus percent price increase from that. We'll start through the Medicare pathway. And just through the Medicare pathway, we would expect a couple of points of added growth from Cologuard Plus. And so those three things gets you to growth acceleration next year. And then obviously, as Kevin just walked through, there's a number of changes that we've just made to the commercial force that we would expect to be additive in 2025 and beyond as well.

And then any recapture from the hurricane is on top of that, right?

Yes. And we obviously...

You wouldn't recapture some of that?

No. And we've been through hurricanes before. We know what typically happens. Orders are the first things that slows down. And then obviously, people from those impacted areas, the results come back a bit slower as well. We would expect to recapture that through the first half of 2025. Obviously, we don't know what hurricane season will look like in the back half of 2025.

And Kevin, it sounds like you kind of implemented the changes you need to implement. So why did you talk about this kind of lasting a couple of quarters in terms of the sales force transition?

Well, the commercial leadership change occurred in the summer. And quite honestly, it took us time to dig in and really understand the changes that had been made in the prior 2, 2.5 years and time to figure out exactly the best approach to addressing those changes. And what you saw during that 2-year period of time from the end of COVID until now was there were some tailwinds that obscured the underlying rate of our core customer base. Number one, you had a bolus of new patients coming in post COVID. And you also had the 45- to 49-year-old age group that became first-time Cologuard users. So some of that obscured the underlying behavior of those core physicians. But the good news is, again, we've been able to identify the problem, address the problem. It's going to take a little bit of time before you're able to see the signal and the output of that. We're confident. One of the reasons we're confident, Tycho, is as you take a look at these new first-time ordering providers over the last, let's say, 3, 4 years, some of them we do call on. And if you look at the ones that we call on versus the ones we don't call on, you see a significant inflection in terms of the frequency of ordering. If you adjust to the baseline, all of them to the baseline date of 0 and then look at what's the frequency of ordering each subsequent quarter after their first order, you see the ones you call on order at a higher clip as we have always seen when we call on new customers.

I guess how about the legacy customers? One of the concerns being you're more -- maybe more penetrated than people realize on the legacy business and you need care gap, you need rescreens to kind of maintain the...

Well, I think what we see there is that we can probably not call on them as frequently. That too has been a core part of how we have deployed our sales force. We've just never had to really dig into these details. But in the past, as you get an ordering physician up to kind of 12 to 16 Cologuard tests per quarter, you don't have to call on them as frequently. There is a real durability and a real stickiness to that ordering. Coupled on top of this, what we call our care gap programs. So in the U.S., we have this system where health providers and health payers are highly incented to get their -- to practice preventive medicine, especially when it comes to cancer screening. So every health system, every payer, every Medicare Advantage plan is measured based on these scores. And colon cancer screening is one of those scores. And by the way, the bar is getting higher there. So last year, it would -- you had to get to 71% to be a 4 out of 5-star plan. Today, you need to get to 75%. The only way to do that is with Cologuard. You can't -- with colonoscopy, you only can screen 6 million people a year in the U.S. There are 45 million insured patients who are not up to date with screening. Let me say that again, there are 45 million not up to date, 6 million colonoscopy capacity. We have basically an unlimited Cologuard capacity, which is now why payers are coming to us in droves saying, "screen with Cologuard." And you get a 3-year quality credit with Cologuard versus the FIT test, which is not a very accurate test, you only get 1 year of credit. So the payers are coming to us and now the large health systems that also care about their quality measure, they're coming to us as well. This is a large business. It's growing this year at -- in triple digits. Next year, it's going to likely grow in the high double digits, and we're excited about that for years to come.

Let's talk about Cologuard Plus. I mean, a number of kind of moving pieces here. I guess one question we get a lot is where do you set price, right? And I know you've talked about 10% being a bar that you'd maybe be happy with, but why couldn't you go to the cash pay rate for Cologuard, for example, which would be quite a bit higher. Are you automatically grandfathered into USPSTF? And then I know some of your legacy contracts include next-gen testing in them. So how do we think about that dynamic?

So the way to think about pricing, Tycho, is that we would expect at the end of the day, so if you go out 2 to 3 years, when you take into account all of the different classes of payers, Medicare, fee-for-service, Medicare Advantage and commercial, that would -- we would be at -- at least 10% price increase, taking all of those into account. So that would start probably with a slightly higher increase for Medicare and then you work your way through this over a couple of years as you change those contracts out and move Cologuard into Cologuard Plus in those contracts, we would expect to net out at about 10%. So initially, it could be a little bit higher than that. Our list price for Cologuard today is $690. Typically, under this pathway to get a price increase for a new test, you would start with that list price. Our negotiated price today is $508 with virtually all of the payers.

You've got data coming next year. Maybe we can just spend a minute on the MRD data. You pushed out the release of the data. You didn't push out the launch time line. So maybe just talk about that dynamic and how we should think about the data.

Yes. So first of all, let me come back to Cologuard Plus real quick because that data, we haven't -- Cologuard Plus is a big deal. We're not asked about it a ton, but the sensitivity for Cologuard Plus is 95%. The specificity is 94%. That's a 40% improvement in the false negative rate. It's a 40% improvement in the false positive rate. It's a big deal. MRD, molecular residual disease is an amazing new class of tests that allows a patient who's been diagnosed with cancer, who's going on therapy to get -- examine their tissue, find mutations and then go into the patient's blood and look for those mutations following initial treatment. And what happens is you divide the patients into 2 cohorts. Those who still have circulating tumor DNA in their blood, those patients are highly likely to recur. Patients with no circulating tumor DNA in their blood are not likely to recur, say, after 3 years. So our test is a test that will help answer the question, is a patient likely to recur? And therefore, what therapy should they be on? We expect to show our data in January. We already have data. It's been submitted for publication, expect it to be published in January and a second set of data, which will be coming around the same time. So we're excited about this. It's a fast-growing market, and we expect to be able to reach our core base of oncology customers who utilize Oncotype DX, which has 90% market share in that class of testing to same -- think the same customer base, a community or academic-oriented oncologists who we know well and have known well for 20 years.

And in terms of investments around the launch, you've talked about the fact you've got a good sales channel already. You don't need significant incremental investments there.

So we'll probably make some modest investments. You're launching a new product. So you're going to have added marketing investments, maybe modest sales investments. But the goal is to go to that customer base that knows and loves us because of our leadership position in oncology and really be able to leverage the ExactNexus platform. We move that whole Precision Oncology business on to this IT platform that allows us to readily engage with oncologists all over the country, and eventually all over the world because Oncotype DX is utilized in 99 countries. It is standard of care without question, and we see an opportunity to grow that business not only in the U.S. but globally. So this is a long-term growth trajectory back to your first question. Why did I think that $50 a share was a dislocated price. Because you take a look at all of these drivers, not just the quarter that we're in.

Let's spend a minute on blood then, too. Obviously, case control data was strong. Attenuation is probably the #1 question we get there, right? And what level of degradation would you feel comfortable with? I mean, how do we think about degradation on pivotal readout?

Yes. So as we said in our press release, when we released that data, we expect there to be degradation. The question is how much. There always is in colon cancer screening when you -- or any type of screening, when you go from what's called a case-control study to a prospective study, you are going to see lessened performance. In this case, we announced a case-control performance that was really good, 88% cancer detection, 31% pre-cancer detection at a 10% false positive rate. So nowhere near as good as our multi-target stool DNA test, Cologuard Plus, but still pretty darn good for a blood test. Where do we expect that to be in a prospective setting? So some of that -- the 11% that others in this field have shown and the 31% that this case control study. But I don't know where that's going to be. Our Chief Science Officer doesn't know where that is going to be. If we knew that, you wouldn't run this study. So we just don't know. And there have been people who have been [ chirping ] competitors. And I want you to know that chirping started the day before we even released the data. And the press release was already drafted already in the hands of reporters. And in that press release, it said we expect to see degradation. Now the difference between Exact Sciences and others, not only do we know this, we've been doing this for 15 years. We've seen degradation over and over and over again. We are also transparent enough to tell you to expect to see degradation. So expect to see degradation there. The real question is, where is blood testing going to fit? And the challenge with blood testing is at the current performance levels, it's highly unlikely to get into the guidelines. And the Guideline Group has published the main modelers who informed the Guideline Group, they have published a paper on this topic. And that paper says, "Hey, look, this level of performance of 11% or 13% or 15% precancer detection is nowhere in the guidelines. If you don't get it in the guidelines, you don't get it into the quality measures. If you don't get it in the quality measures, payers won't pay for the test. The reason Cologuard has been successful is because we got into the guidelines and we got into the quality measures and because we built the commercial organization. Now is there a role for blood testing? Yes, if a patient refuses every other form of testing is a blood test, even though the data are much worse, the test doesn't perform at the same level, it is better than not getting screened. So we think we'll take a leadership position. And one thing to know about our technology is the cost of goods. We've designed the test at high performance at a low cost of goods, allowing us to deploy this at a price point that makes sense, not at $1,000, not at $1,500 like someone in this field would wish that payers would pay for.

Great. We've got a minute left. Aaron, I wanted to maybe just touch on margins, thinking a little bit about like care gap being lower margin. Do we have to think differently about the longer-term margin profile of the business?

Yes. We've made steady progress on margins overall. So we'll have expanded nearly 300 basis points on our adjusted EBITDA margins, approaching 12%. Steady progress well on the path to getting to the 20% plus that is in our long-term guidance by 2027. On the gross margin specifically, we have seen some degradation in our gross margins in 2024. Some of that is related to care gaps. So our adherence rate or the amount of number of kits we get back on these care gap programs is roughly 1 in 5 versus the roughly 2 in 3 on the rest of our business. We've been through this before. We know what to do to be able to drive that adherence up. So we would expect that to improve over time. The other thing and bigger impact that will impact our gross margins positively heading into '25 and '26 is the launch of Cologuard Plus, benefit from our boosted ASP as well as then a lower cost of goods per unit.

Great. I think we're out of time. We'll leave it at that. Thank you.

Thank you.

Thank you.