Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

May 15, 2024

NASDAQ US Health Care conference_presentation 30 min

Earnings Call Speaker Segments

Michael Ryskin

analyst
#1

Thanks. We'll kick off our next session. Thanks, everyone, for joining us. My name is Mike Ryskin. I'm on the Bank of America Life Science Tools and Diagnostics team. And we're excited for our next session, which is Exact Sciences. We're joined by Kevin Conroy, Chairman and CEO. Brian Baranick, General Manager, Precision Oncology; and Aaron Bloomer, CFO. Gentlemen, thanks for joining us.

Kevin Conroy

executive
#2

Thanks, Mike.

Michael Ryskin

analyst
#3

Maybe just to kick things off, Kevin, I don't know if you want to make any opening remarks to get us rolling?

Kevin Conroy

executive
#4

Yes. I want to congratulate Derek on retirement. Congratulations. And Mike, congrats on your new role. Thanks, Derek, for the years and years, just great coverage. You're a gem of a person to work with. This is, I think, our 14th year at the conference. It's really been incredible to watch the growth of BAML during this time period. You could tell me 5% to 7% growth every year, and it's going on in perpetuity. We think you can do more, Mike. We can talk about the drivers of that growth. And it's really been wonderful to be part of this. We started out as a small company trying to solve the problem of colon cancer with a long-term vision to apply our technology platform to many cancers. And we're happy to be where we are today. Our mission is to help eradicate cancer by preventing it, not just colon cancer, cancer by preventing it, detecting it earlier and guiding treatment. So hopefully, we can talk a little bit about this and the open-ended growth story that exists because we're at the -- in the early, early innings of how genomics and the understanding of cancer genomics is going to change how cancer is diagnosed, how it's treated. And when you look at Exact Sciences, it's built on the foundations of Cologuard and Oncotype DX, 2 of the top brands ever in cancer diagnostics and the power of those 2 brands is helping us build a platform company through which other innovative cancer diagnostics will help patients. That's -- you have this growth story we've guided to 15% growth through 2027. We believe that growth will continue for a long period of time and over 20% EBITDA margins by 2027. So we're really excited about what we can deliver in terms of patient impact and also what we can deliver in terms of shareholder value creation. The near-term drivers that we look at are Cologuard growth and also Oncotype growth outside the U.S. to kind of open-ended growth stories and then a pipeline in screening with multiple tests and precision oncology, Brian Baranick, our GM here, we'll talk about that. So it's an exciting time at Exact Sciences, and we look forward to the conversation today, Mike.

Michael Ryskin

analyst
#5

Great. Thanks so much, Kevin. I'll jump right in. You recently reported your first quarter results. You reiterate your fiscal year '24 guide, both on overall revenue and EBITDA and lot of the debate we heard after the print was on the screening number. It was down a little bit sequentially versus 4Q. It was up 7% year-over-year. You just talked about the guide you have for fiscal year '24, which is 16%, 17% screening. So can you walk us through sort of the bridge between what you saw in the first quarter, how that fared relative to your expectations and sort of the ramp as you go through the year for screening?

Kevin Conroy

executive
#6

Sure. And taking a step back, there are about 60 million Americans who are not up to date with colon cancer screening. So there's just a huge number of people to get screened. And what we saw in the first quarter, the comparison to the first quarter of last year, which was our highest dollar growth in percentage -- dollar growth in our history, and it was a 45% growth for a number of reasons. Typically, Q1 has seasonality because of primary care utilization. And so we grew at 7%. That's not what's going to happen for the rest of the year. The comps get easier in the back half. the drivers of growth, typically Q2, the spring into the summer is primary care utilization screening increases at a rapid rate and then usually post summer into the Thanksgiving time period, you see tremendous growth. We are confident in our ability to achieve our second quarter guide, our full year guide. There are 3 major legs of growth is calling on primary care offices. Just like steady, very predictable growth based upon the input of the number of sales calls that you make and visits you make to primary care office. And then secondly, the health and we can talk about that more. And the growth there, it's been really, really exciting to see. And then a new business starting last year is screening in the Medicare Advantage population and also in large health systems that want to do these large, what we call gap closure programs to their screening gaps. So in terms of the year, we're excited about what the rest of the year looks like. I don't know if you want to add anything, Aaron?

Aaron Bloomer

executive
#7

Yes. I would just say that Q1 was in line with expectations and due to some of the onetime impacts that we called out in Q1 of 2023, we think it's informative to look at it on a 2-year stacked basis, in which case screening revenue grew approximately 24% in the first quarter. Q2, the guide is 22% to 23% on a stack basis. And in the back half of the year, very consistent with that as well. So we think it's important to look through kind of the noise of Q1 of last year.

Michael Ryskin

analyst
#8

Okay. That's helpful. And then the other bid data, I think really stood out on the call was you had a little bit of this focus that you pulled back spend a little bit too much towards the end of last year and early this year, and you may need to ramp that up a little bit just to reaccelerate. Can you frame the magnitude of that, the timing of it, how it's going to impact your future investment decisions?

Kevin Conroy

executive
#9

Yes. So we spent about $800 million in sales and marketing and the increment in terms of the sales force component of that. We haven't quantified it, but it's relatively small, and it brings our sales force back to the levels that we were at in 2022. Over time, what you'll see is there is a high ROI on investing in additional salespeople, think of it really simply as more salespeople, more sales. The dynamic is that in the last 5 quarters, we've added 80,000 first-time health care provider users in the primary care segment. So that means primary care docs, PAs and nurses. And they -- once they start ordering Cologuard, they order at a predictable and steep curve. Every cohort of is true since we launched Cologuard 10 years ago. They keep ordering at a faster rate. And the more frequently you call on them, the more frequently they order. And you may ask, well, why is that the case? Shouldn't you be able to set up an start just using Cologuard. The problem is if you're a primary care doc today in America, first of all, it's chaos. You have 8 to 12 minutes with a patient, and you may start with obesity. You may start with diabetes, cardiovascular and 20 other things before you get to prevention and colon cancer screening. So what our sales force does is really brings tools, education, motivation to elevate colon cancer screening, and it works. So you see if you call on a Doc on time in a quarter, you get 6 Cologuard tests. If you call on a Doc 6 times in a quarter, you get 24 Cologuard tests. There are just that many people not up-to-date with screening. So that's really the dynamic that we see. So I think there was some confusion about when we decided to make a modest increase in the sales force. We saw some signal in the fall. And in the fourth quarter, we made the decision as a team to increase the size of our sales force. So with our guide this year at beginning of the year, it encapsulated what we expected to do in terms of this modest increase in the size of the sales force. And I think that -- I think I didn't make that particularly clear on the Q1 call.

Michael Ryskin

analyst
#10

Okay. Aaron, maybe let's -- I want to bring you into the conversation a little bit. I think today is your first day as CFO officially. So congrats, thanks for spending it with us. Any initial impressions you want to follow up on? Or maybe just you want to outline your near-term, long-term priorities?

Aaron Bloomer

executive
#11

Yes. Thanks so much. Thrilled to be here. This is my fifth week here now with the company. unbelievable company, great purpose, mission, what we do and the impact that we have on patients and for me, from a priority perspective, it has to start with growth and maintaining the growth engine that we've built out not only on the Cologuard and Oncotype DX, but also, as Kevin talked about, the new product pipeline. And so ensuring that we've got flywheel going from an innovation perspective. So that's number one. I think the second thing be ensuring that we have clear and credible pathway to the adjusted EBITDA goals that we set out. As Kevin mentioned, we have a goal of 20%-plus adjusted EBITDA margins. by 2027. We have very clear incredible path to do that. We hit 9% adjusted EBITDA last year. We will expand over 300 basis points of margin in 2024. And as we look through the P&L, I think, significant opportunities to drive leverage, particularly within G&A. And I'll bring some of the past experiences in that and bring that here to exact. And then the third would be just a focus around cash flow. I think again, exact flipped free cash flow positive. In 2023, a remarkable achievement will have free cash flow growth and positive free cash flow delivery of the next quarters throughout the balance of 2024, and we'll look to further enhance that on a go-forward basis.

Michael Ryskin

analyst
#12

Great. Maybe let's pivot to Cologuard a little bit. You've had a really impressive CAGR over the last couple of years, really impressive growth there. You're guiding to something in the mid-teens in 2024. We talked about first quarter and why you think that's going to ramp through the rest of the year. Is this the number we should be looking at going forward? Just given the size of the base.

Kevin Conroy

executive
#13

If you look at our guide through 2027 embedded in there is 17% Cologuard growth. So we have a clear path to doing that. And what we're seeing is opportunities to enhance the utilization of Cologuard as a frontline screening test. It's taken a long time really to get -- build the brand, build the platform, the commercial team and very importantly, the IT capability, the ability to do electronic ordering, right from embedded within the physicians' electronic medical record. This is what we call exact Nexus. Our platform built on Epic with over 100 other applications that surround it. We're able to do electronic ordering, resulting prior authorization, reimbursement. And so you get a huge amount of leverage customer satisfaction by being able to deliver this incredibly customer-friendly ecosystem that makes their life easy. If you make colon cancer screening easy, it's super powerful. We've invested about $1 billion in that platform. We've also invested in the brand and importantly, in making sure that Cologuard is part of the quality measures, which is a long, arduous process because we're in the quality measures now we can help health systems and health plans increase their star ratings. And the goal is to be a 4 out of 5 or greater rated system or plan in order to get the quality bonuses, which are absolutely key to the success of the systems and plans. So there are so many drivers here. It's exciting how we think we can help solve the problem of colon cancer. It's the #2 cancer killer. It kills 50,000 people a year, 130,000 new cases in a year. I would suspect there are people 45 and older in this room who haven't who are not up to date with colon cancer screening. You can go to the cologuard.com website, and you can have a kit delivered to your home within a week. You go there, you enter your insurance information, name, address, family history, et cetera, we are making this easy so we can go get 60 million people screened. And one of the great dynamics is that we're serving the need that colonoscopy can't even fill. So there's capacity for colonoscopies in the U.S. of around 12 million. Half of them are screening colonoscopies. The rest are diagnostic colonoscopies. The U.S. isn't making more GIs. We've about 600 a year and about 600 retirements. So it's just flat. The capacity is not there. And Cologuard is just helping meet the needs of health systems of primary care physicians and now even GIs get more people screened.

Michael Ryskin

analyst
#14

And Kevin, you touched on a lot of different levers there. Commercial team are trying to order and things like that. I mean there's others in terms of rescreening in terms of rate of expansion. So how do you think about pulling on all those levers. Maybe this kind of goes back to that initial point on sales force expansion, could you push on it even more sort of like which levers do you see as most attractive?

Kevin Conroy

executive
#15

Yes. I mean you can always push on it more now that you're a profitable company, you have to balance this investment in IT, which allows you to push it more investment in the growth of your sales force allows you to push it more. And that's good. But this consistent pushing is what makes a difference by investing in IT solutions, you're able to screen America in these large programmatic orders. So as an example, you have health plan A that comes to us and says, we have 100,000 people who are persistently under screen for colon cancer. Can you help us screen them? You bet. We look at their list of 100 patients. We help them clean up all the data. It goes into our system and what we do is then ship 100,000 collection kits out. We followed up with text, letters, e-mails, telephone calls to inform that member of the health plan, why this kit is coming to their house. We get about 20% to 40% of those people to complete a test. And these are the people who have been immune to screening for a decade or more. So the levers of growth when you think about rescreening, what does that mean? Well, it's just a recurring part of our screening opportunity. So Cologuard is indicated as a test that should be performed every 3 years by the main guideline group and by the quality measure group. So on your third year anniversary of your last Cologuard test, for me, I just got a digital reminder by my health system, University of Wisconsin Health System, that I was overdue for colon cancer screening. I thought that was ironic last year when that happened. But with a quick message to my primary care from within my chart, I was able to get a Cologuard kit within a week and return the collection kit. It came back I was good to go. That's what we are doing. So rescreening eventually will be over half of our revenue today, let's say it's in the mid-20s. That's pretty exciting because every time you get a new customer, health care provider, patient, what you do is you have a lifetime relationship with each. And so there is this additive effect. And if you take a look at the last 2 years because of the COVID year, we are now starting to lap that. 2 years in a row, we had 1.2 million people eligible for a rescreen. This year, it's 1.6 million. And 3 years ago, the screening age was lowered to 45. That's 20 million new prospective customers. The group that got Cologuard in that 45 to 49 age group in about 3 years ago, are due for rescreen this year. We want them to be happy customers of Cologuard for the next 30 years or more.

Michael Ryskin

analyst
#16

Can we talk -- can you talk about Cologuard Plus in terms of timing for approval, your expectations? And then just sort of how that fits into the story you were just painting in terms of accelerating uptake in compliance.

Kevin Conroy

executive
#17

So Cologuard Plus is the next-generation version of Cologuard, and it's an amazing innovation of 10 years of research development clinical trials. It improved the performance across the board. -- specificity, it improved by 30%. So about 30% lower false positive rate. It improved cancer detection, precancer detection. Docs tell us with the lower false positive rate alone, 2/3 of Docs say they will order more Cologuard just because of that 1 element alone. We continually invest in our Cologuard program. So we're already working on the next version of Cologuard to drive the performance even higher. So we've set this bar that starts to roll in next year. We will be looking for a modest price increase. We haven't taken a price increase in 10 years. So we'll be looking for a modest price increase that will roll in over a couple of year period of time. And because the false positive rate is lower, that means 30% fewer people going off to colonoscopy remaining within the Cologuard screening family. We like that. So that's -- the benefit -- the other thing is that Cologuard Plus has 5% to 7% lower COGS. So our margins expand. And this is a great opportunity for the commercial organization to continue to deliver only the best to the physicians that need to get their patients greed.

Michael Ryskin

analyst
#18

Brian, maybe let's pivot to you real quick on Precision Oncology. I mean any remarks you want to make Rock about Oncotype DX? And then I want to follow up with MRD.

Brian Baranick

executive
#19

Sure. I can maybe set some context. I think it will help clarify our right to play in MRD. So just for context, we celebrated our 20th anniversary with Oncotype here in the U.S., which is an amazing milestone. And we -- over that time, we've built up what we think is arguably the best commercial capabilities in diagnostics and oncology. We also have amazing infrastructure, which I'll come back to. Kevin touched on at $1 billion cumulative investment into that infrastructure, and I can touch on why that matters, with respect to MRD and other products in a moment or 2, if asked. And then thirdly, it's around quality of the science and the clinical evidence wrapped around it. In the case of Oncotype, we've got 12-year outcomes data, and we continue to accumulate evidence in and around that. So the business unit, the legacy genomic health infrastructure that we acquired several years ago, it's just deeply rooted in being patient customer-centric and building quality products and quality evidence around those products.

Michael Ryskin

analyst
#20

And then yes, and then on MRD.

Brian Baranick

executive
#21

Sure. So I think the question we typically get asked at MRD is you're not first, how are you going to catch up? A couple of things. I've been a student of diagnostics for just shy of 20 years now, and I've never seen a market that I can point to that's kind of developing as fast as MRD is. A lot of enthusiasm from patients, physicians, et cetera. Real -- hitting a real clinical unmet need, and we're really excited about the opportunity to participate there. But I'll come back to those exact 3 things I just talked about that drove the success of Oncotype. We have world-class commercial capabilities. I'm out in the field regularly. And I'm amazed, you'll go out with reps and they've been in their territories, 15, 17, 18 years, they've been with the company. They know physicians, and they know how to sell and get access. So I think we'll be in a really good position when we launch in colorectal next year to be able to leverage those relationships in the field. So that's one. Two, the Nexus platform that Kevin talked to again, in the field regularly. This may not seem sexy to some of you in the room who study stocks and build models. But if you're living the day-to-day life of a community oncologist or an oncologist, then you have patient flow and churn just step back and think about the cost of doing a prior authorization in those clinics, they often spend 20, 25 minutes, not the physician, but a delegate could be a nurse, physician assistant, getting through the prior authorization. We're solving that. they often require 3 to 4 outreaches between a company like Exact or another company to help them sort through that prior authorization to get that test into the hands of their patient efficiently. We can shape that down. So shape meaningful steps and minutes off of that with the infrastructure that we're building. And then thirdly, evidence and test. We've been partnering with companies like the West German Study Group, NSABP, et cetera, to build out the evidence around our test, which we think is also going to be a better performing test. We measure more mutations in the blood than some of the first-mover companies in this space. And so we think we'll have a better performing product along with best-in-class evidence. And you'll hear more about both of those, the performance of the assay and the evidence and the studies that we have in flight in the back half of this year.

Michael Ryskin

analyst
#22

Any questions from the audience real quick? All right. Can we talk about base screening assets. You've got Cologuard blood you're pursuing, but it's a pretty crowded marketplace, potentially a crowded marketplace. What do you see as the use case? And what's your latest view on sort of what you've seen from some of the potential market entrants?

Kevin Conroy

executive
#23

Sure. So the idea of blood-based colon cancer screening is a great idea in concept. Back in 2009, when I joined Exact Sciences, I called Vogelstein, who is the most preeminent researcher in the field asked if I could come visit them and talk to them about the blood test we wanted to develop. And Bert said, Kevin, did you read my 2005 paper. And I said, No, I didn't, Bert, kind of sheepishly. And he said, "Well, you should." and what that paper said is what was very predictable for all of us who are developing blood test, which is detecting precancerous polyps looking for circulating tumor DNA, good luck. You can't find what's not there, that the colon is really well designed to keep bugs out of the blood supply, and it's really well designed to keep precancerous lesions, which are just in it's they haven't invaded yet to where the blood supply is out of the blood. So you said, you can't find what's not there. If you can't do that , you don't really have a colon cancer screening test. That was Bert's main message. That main message hasn't changed and that research hasn't changed in about 20 years. And it's because biology hasn't changed during that time period. So is there a role for blood-based screening? Yes. And we firmly believe there is a role for us in blood-based screening. Is it the main role no, because the real power of colon cancer screening, everybody should know this, is finding and removing precancerous pilot which prevents colon cancer. The goal is not to find Stage 1 disease. The goal is to stop Stage 1 disease. Now if you find Stage 1 disease, there's 90% cure rate within 5 years, I mean you cure 98% of the cancers. But the goal is to find the precancerous polyps and these blood tests don't do it, which means these blood tests are highly unlikely to get in the guidelines. They're highly unlikely to get into the quality measures. Medicare did say, we'll pay for them for fee-for-service Medicare, we'll be able to -- there's a market there, especially for people that we know refused colon cancer screening, either colonoscopy through our partnerships with health systems. And also because of the 6 million people who haven't returned a Cologuard collection kit. And I know people who have had bad outcomes because they didn't get screened and they -- some of them had a Cologuard kit in their home or they skip their colonoscopy. So there is a need for that. But it's more of a niche. And commercial payers probably aren't going to be excited about paying for something that's not in the quality measures. Now the earliest we'll know about the quality measures is 2028, 2029 in that time frame. And so there's a lot of work to do to evolve this market. Always people ask, "is blood testing going to reduce the impact of Cologuard?" And the answer is, not anywhere in the near term. The other I think important thing to note is the United States Preventive Services Task Force, the main guideline group meets every 5 to 8 years on colon cancer screening, not before then. It's like 6 years, 6 years, 6 years, 8 years, 5 years, and we think, again, 6 years. And then if you get into the guidelines like we did with Cologuard, then it's a couple of years to get into the quality measures. So if you're in the audience, you're worried, what's going to happen with blood-based testing. There's a panel meeting next week on blood-based testing. It's -- we expect 2 or 3 blood tests, including ours, will get approved. Getting broad insurance coverage, getting into the guidelines and the quality measures, a whole different story. That's going to be a march over a number of years.

Michael Ryskin

analyst
#24

So having said everything you just laid out, I mean a lot of that is really consistent with what you had in the past and it makes sense. But how do you put this debate to bed? How do you finally answer that? Because I mean, if it's going to be there until 2027, '28, '29, is that going to be at least a sentiment overhang for some time?

Kevin Conroy

executive
#25

No, I don't think so because I think what is going to happen is you'll see blood test get approved, and you will see Cologuard continue to grow. And let me say, look, the more ways to screen for colon cancer is good. However, you want to get screened with a test that is the most effective test and it's colonoscopy or Cologuard, and so is there going to be a debate among a very niche portion of the overall population. There won't be much of a debate among primary care physicians, GIs. The GI societies came out with a note a couple of months ago, which basically said with the current performance of the blood-based test, we do not recommend a frontline screening claim. We'll see what the FDA does. But no, I don't think -- I think the growth of Cologuard over a long period of time is the thing that will excite investors, and I don't believe that there will be much of a debate about that as you go forward.

Michael Ryskin

analyst
#26

Okay. All right. 30 minutes goes by really fast. We're almost out of time. Kevin, Aaron, Brian, any concluding remarks or sort of our usual closing question is, what do you think is most underappreciated or misunderstood about Exact.

Kevin Conroy

executive
#27

Aaron, you've been here for 5 weeks, what do you see?

Aaron Bloomer

executive
#28

I would say our pipeline. One of the things that's been really exciting to me and even just since sitting in meetings is I would say 90% of the questions plus has been about Cologuard, what's happening with blood, what's happening with potential other aspiring entrants we're slated to launch a number of new products over the course of the next few years. And we've spent many years developing them. And I don't think that's well appreciated more broadly as to the impact that's going to have on patients, the impact that's going to have on our revenue and growth profile as well as in our margins. And I think it's a diversification play then as well. We're excited about the mid-teens growth in Cologuard. And we're going to get MRD and a number of these other new products that were slated to launch. It's a really, really exciting time to be at Exact Sciences.

Michael Ryskin

analyst
#29

Great. Thanks so much. And with that, thanks, everyone.

Kevin Conroy

executive
#30

Thank you.

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