Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

We'll go ahead and get started. Good afternoon, and welcome to the Jefferies 2023 London Healthcare Conference. I'm Brandon Couillard. I cover life science tools and diagnostics sector here at the firm. It is a great pleasure to have Exact Sciences back at the conference again this year. Joining us for this conversation, CEO, Kevin Conroy; as well as EVP of Human Resources, Sarah Condella. Sarah, Kevin, thanks so much for being here.

Well, Brandon and Jefferies, thank you for having us. It's always one of our favorite conferences to attend, and we really look forward to the conversation.

Maybe just to kick things off, Kevin, I mean, in the third quarter, very solid 23% organic growth. Cologuard up 30% on a 30% comp. You posted positive adjusted EBITDA, again, for the fourth straight quarter. Can you just unpack some of the highlights from the third quarter and how you're feeling about the business moving into year-end?

Well, we're really feeling great about the business. Cologuard is growing this year about $420 million over last year. So it's just a tremendous growth driver, and we're having a big impact in colon cancer. It's becoming a new standard of care that is changing the way people in the U.S. are screened for colon cancer. But let me take a step back and just talk a little bit about Exact Sciences as a company. Our mission is to eradicate -- help eradicate cancer through tests that prevent it, detect it earlier and guide treatment. And I've been with Exact for 14 years. We have worked from being a small one product company to a multiproduct company with a much greater vision. And we believe that we can have this impact because we have been able to recruit, motivate, retain, we believe, the very best people in the field of cancer diagnostics. And that continues to grow as we become a more successful company, even better people want to join and be part of the team. So that flywheel starts with great people, moves to great tests with great clinical evidence, which then generates the ability to get market access, insurance coverage, the ability to penetrate health systems, individual physicians. And that leads to greater ability to generate profit so we can invest in that cycle again. So looking forward to talking about these things today. In terms of the quarter, some of the tailwinds in the quarter was continued growth in 45- to 49-year olds, which is a new category with a lower screening age starting 2 years ago; people who are due for their second Cologuard or even third Cologuard test, what we call rescreens; and then greater adoption by health systems. So those tailwinds, we believe, are tailwinds that will persist for years to come, helping to grow Cologuard from around $2 billion to, we believe, $8 billion over time.

Just looking at the fourth quarter guidance, I mean you guided Screening revenues about flat sequentially. I know the holidays can be a little tricky in terms of like timing for kits coming back in. But with the exception of '21, you've actually posted pretty solid growth sequentially every year since 2017. Can you just unpack some of the puts and takes as you think about the fourth quarter and whether or not there's -- or actually seeing greater seasonality in terms of flu or COVID cases that might push out...

The thing about the fourth quarter is that between Thanksgiving in 1.5 weeks and Christmas is that fewer people go see their primary care physician during that time. So there are fewer orders. Now that impacts next quarter more than this quarter, but it does impact this quarter a little bit. And then also during that time, fewer people return their collection kits. And so that's the dynamic that we see from Q3 to Q4. Last year, we saw a step-up. Why was that? Was some of that pent-up demand because of COVID? Probably. We won't know until we get there during the year, whether people will continue to return Cologuard kits at the same rate they always do. We certainly have gotten more sophisticated about how we reach out to patients to remind them by text, by their MyChart account, all different types of way, calling patients, sending letters to patients. So we'll see how that develops, but that's the way to think about the fourth quarter.

On the EBITDA guide for the fourth quarter, it actually applies a step-down, call it, $30 million or so sequentially even though revenues are about flat. There are some expenses, which have been running about flat year-to-date, OpEx, right? Since the first quarter, ticking up a little bit in the fourth. Can you just unpack how much of that is seasonality, timing, R&D rather than investments coming back into the P&L after being pretty disciplined for the better part of the past year?

So what we have seen is that over the last 2 years, we've actually seen a decrease year-over-year for 2 years in sales and marketing expense, while Cologuard and Oncotype continue to grow. So that's a great sign for the long-term leverage that we see in our model. We don't expect to be down again next year in terms of sales and marketing. If anything, we'd probably step that up a little bit because we continue to see a return on the number of calls that we make to physicians. So that is something that we're looking at very closely right now. Where we expect to see leverage is in G&A over time. Included in G&A is a very significant IT spend and also our customer service, customer care organization. And over time, each of those investments as a percentage of revenue becomes smaller, and even in absolute dollars, probably over time. In terms of the third and fourth quarter, compared to the first and second quarter of this year, we have done more hiring in the third and fourth quarter. It's really the timing of hiring more than anything else. So there is some of that seasonality. That's not unusual, by the way. People have great hiring plans as they start the new year. Whether leaders execute on that, it usually takes a little bit more time than they planned.

You talked about Cologuard growing revenue base north of $400 million this year. That's despite rescreening actually being a headwind of, I think, you said $50 million. What will be the biggest driver of Cologuard growth in '24?

Biggest driver of Cologuard growth in '24, it's actually broad-based. It's partnering with large health systems who are implementing organized screening. Pushing more screening out in a programmatic way is one, rescreens, and health systems are becoming very sophisticated about getting those people tested a second time with Cologuard. And then also this 45- to 49-year-old group, there are 18 million people in that small age cohort that are not up-to-date with screening. So that's about 1 in 3 people who are not up-to-date in screening are in that 5-year cohort. Let me come back to the health systems and why they -- or how they are doing a better job of screening. So I was sitting in the office in a meeting, and I got an alert from my health system on my iPhone through what's called MyChart, which is an Epic application, and it said, you have a message. So I opened up MyChart and it said, Kevin, you are overdue for colon cancer screening, which I thought was a little ironic. And so I clicked on there, and electronically, I was able to immediately send a message to my primary care physician who responded, do you have any of these symptoms? No. Okay, then I'll send you a Cologuard kit. So that was all done electronically. A year before, that simply wasn't being done. And so when you think about our electronic relationships with 300 large health systems in the U.S., one of the things our 100-person health systems, health IT team is doing is they're going into the health systems on a consulting kind of a project to help them optimize their ability to get more of the member -- their patients that they serve screened for colon cancer. So is that a tailwind, those -- the changing way that health systems engage with their patients? Yes.

Sticking with rescreens, you've talked about this pool being flat this year, call it, 1.2 million year-over-year. Next year, that steps up to 1.6 million eligible patients, eligible for a third year test, rescreen. Is it as simple as that extra 400,000 patients being an incremental contributor next year, assuming the capture rate is kind of the same year-over-year? And what does that capture rate look like today on that population?

So if you take 1.6 million people who are due for their next Cologuard test, people who are given the opportunity who are in that group, about half of them today get screened a second time with Cologuard. And that may take 2 years to get that rescreening done with half of those, so 1/4 overall, screened within the first 90 days. And so yes, over time, we expect to get, of those 400,000, at least 200,000 screened and 100,000 of those within 90 days. So now they come due over the course of the full year. So of course, that doesn't happen on January 1. Over time, we think we can get that 50% rate up to 80%. And for a patient who actually gets a Cologuard test for the second time, their kit return rate is about 80% versus, call it, 65% in their first instance. So once you're a Cologuard user, you tend to repeat at a higher rate. And this is an important part of our mission to go out there and get everybody screened and eradicate this disease.

You've talked a lot about Cologuard 45 to 49. It's been in guidelines for about 2 years now. Where does penetration stand today for that cohort? And how does compliance compare to the over-50 population?

So we have screened just over 1 million people in that age cohort. But that age cohort obviously gets replenished every year. So next year, we expect 18 million, 19 million people still to be due for screening in that age cohort. We target these patients. By the way, the best way to get 45- to 49-year olds to ask their doc about colon cancer screening and Cologuard, in particular, is to reach them digitally or through social media. And we're becoming more adept at that over time. The amazing thing is many primary care physicians still don't know 2 years later that the guideline has changed. We call on -- let's call it about 100,000 primary care physicians out of 350,000 in the U.S. So it's a huge effort to engage with the primary care physicians. Over time, they're going to know and it's going to become more automatic. Today, this age cohort is 20% of revenue. And 20% of the people that we get screened in a year. Over time, that probably grows to 1 out of 3.

Maybe switching gears before we get into the pipeline. Sarah, you've been at the company for, I think, a decade. I've been following Exact for over a decade. A lot has changed in that period of time. At the Investor Day, as Kevin alluded to, you talked a lot about this flywheel effect with the top of that flywheel being talent. So how do you approach attracting, developing, retaining talent as the organization scales, especially in a place like Madison?

Yes. Well, over time, we've seen 3 really big differentiators. First, as Kevin talked about at the opening, it's the powerful work and the mission, and it's challenging work. These are difficult problems to solve. We're engaging our scientists and doing things that people have never done before, and that's really motivating. And with a portfolio of products, there's more career opportunity, there's more opportunities to solve even bigger problems. The second thing is our culture, and it's a culture of ownership, and we're really focused on being sure that we're a great place to work. So we try to attract the best talent and then retain them through the development opportunities, through making it a great place to work for all. Finally, that piece about ownership is that our incentives are aligned. We want to win. We want to keep driving the growth of the organization. Every employee is a shareholder. And that is really powerful when it comes to what we're trying to deliver and the impact we can have with the incredible mission.

If we focus for a second on sustainability, Exact has actually made a lot of progress on their ESG score, which I think is now A-rated. Can you talk about some of the initiatives underpinning that progress? Does that influence your ability to attract talent? And I guess, how do you think about ESG as an important metric internally?

Yes. Well, first, I want to comment on the progress that you've seen with those ratings. Really, sustainability and good governance have always been embedded within our culture. And we've listened to shareholders to find out what's really important. And I think we've done, over time, a better job on externally communicating those things. So we speak more about our LEED-certified facilities and what we do for recycling and controlling emissions, et cetera. That's what employees care about, too. So that value proposition of the company I want to go work for, I want to see the impact that they're having on the greater good. I mean, again, we want to help eradicate cancer and that we're doing it in a sustainable way. I think the other part of it is just we have really solid independent Board and good governance where we have that oversight on sustainability.

Kevin, switching back to the pipeline. Cologuard 2.0, you'll be submitting to the FDA imminently by the end of the year. Should we view that as perhaps a major catalyst for accelerated growth for Cologuard? Is it that big of a performance difference that can actually drive further adoption? And then second question is I think you've kind of alluded to you're delivering greater value because you're avoiding more false positives, right? So pure colonoscopies, how do you capture that value? And what's the process to maybe get a higher price?

Cologuard 2.0 is an incredible innovation because we've gone from 11 total biomarkers to 4 total biomarkers and improved the performance. In doing so, we've also brought down the cost of delivering a result. Cologuard 2.0 detects 94% of all cancers, up from 92%; 43% of precancerous polyps, up from 42%; 75% of what's called high-grade dysplasia or the last biological step in progression to cancer versus 69%; and the false positive rate fell by 30%. This required a decade's worth of R&D, and that 30% reduction in the false-positive rate will help fuel growth in Cologuard because one of the #1 objections physicians have in ordering Cologuard is, well, there was 13% false-positive rate. And I would rather just send my patient to colonoscopy. Now you're in a position where the specificity is 91% -- actually 93% if you include small pre-cancers as a true positive. And so this is -- the performance of this test is really hard to think about imagining to match that with the noninvasive test. So yes, we think it's going to address squarely an objection that primary care physicians have. And then when it comes to payers, look, they don't want to pay for unnecessary colonoscopies. And so that's a meaningful cost driver that we are taking out and saying to the payer, look, we'll share that savings with you.

Do you have to go payer by payer? Do you go back to CMS to negotiate a higher price? What is that process?

We go back to Medicare and we go back to all of the payers. And so that's what we'll invest a significant amount of time over the next year is engaging with those payers, showing them the value, budget impact models, all of that; health economic model so that we can be in a position to seek and obtain a modest price increase for Cologuard.

There's an FDA panel at the end of the month on multi-cancer early detection that I think is intended to look at study designs and help inform future agency regulatory efforts. Number one, any thoughts on expectations coming out of that panel? And number two, has there been any progress in D.C.? What are you hearing out of D.C. as far as budgetary authority for Medicare to cover multi-cancer?

The FDA's decision to have a panel meeting was a little bit of a surprise to us, and we think it's just a fantastic thing because it's a public discussion around multi-cancer from the FDA. We -- multiple companies have been having conversations with the FDA. And I think the FDA genuinely wants to get public input and also start to share publicly their thought processes around multi-cancer screening. And so we think -- we've had a lot of discussions, so we know generally what their hot button issues are and that they generally want to find a way to approve a class of new tests. When it comes to Congress giving Medicare the authority to create a new benefit category for multi-cancer screening, it remains to be seen. American Cancer Society has made this one of their major priorities. We clearly have -- GRAIL has done a tremendous job of creating awareness in D.C. We don't know where that is going to come out. We will clearly moderate our investment based upon Congress' willingness to reimburse for this. So it's a hugely impactful new field of screening. It may take longer to play out than we initially anticipate, but we'll see.

The next or first 2, I guess, pipeline tests that are launching, you've got both MRD, right? One for colon soon, one for breast shortly thereafter. You talked about presenting data next year. What would that data look like? What does good data look like for those MRD tests? How do you show clinical utility for that type of test?

So what is MRD testing? It's called molecular residual disease testing. And it's this -- it could be one of the most innovative, impactful new test in cancer care. So for a patient who is diagnosed with cancer, is treated, the first application of the MRD test is to answer the question, did they get all the cancer? So they -- you take the tissue sample, look for mutations, develop a bespoke blood test and go do a blood draw. So a friend of mine who, 2 years ago, was diagnosed with late-stage kidney cancer had a Natera -- Signatera test. I actually connected her with Natera and said, make sure you get this test. And she has had 6 or 8 negative blood-based tests over the last 2 years being on KEYTRUDA. So at some point, can she deescalate therapy? There's no evidence of disease. The mets that they saw are no longer there. So at some point, can she back off of treatment? Well, so it's the initial is, did you get it all? And over time, is it recurring? So if you keep getting that test, you can see the cancer recurrence up to a year before you can see it on a PET scan, the most sensitive form of imaging. And it's one test, whether it's for breast or whether it's for colon or whether it's for lung. And Natera is really -- I'm talking of a competitive company. Natera has done a really tremendous job of creating this field, doing the right studies. And now there are dozens of clinical trials that are being run by oncologists all over the world. We're participating in 2 of these studies: one in colon cancer, one in breast cancer. These will inform our ability to bring our test to patients. And we, as a company, because of our Oncotype DX Breast test, see 50% of all breast cancer patients in the U.S. tissue and about probably 20% of those patients in Europe. So we're -- we have that starting point is tissue, then blood, and that's a great starting point for us to develop a presence in MRD.

I do want to touch on blood in the time we have left. Now that you've -- on the cusp of submitting Cologuard 2.0, you collected blood samples as part of that large trial. You do have a couple of competitors that are aiming to get in front of the USPSTF in the next window. Is your expectation you'll be there, too, even though you haven't presented any data, you haven't run any samples, but that you'll also be part of that review process with your own blood version for colorectal?

Well, we'll definitely be part of that review process, but the modeling is pretty clear that blood-based tests probably don't get an A or B rating by USPSTF. And the main reason for that is twofold: number one, they don't detect enough precancerous polyps; number two, the false positive rate is too high. So if you do that test every year, you end up sending almost everybody to a colonoscopy every decade. So you -- number one, if you don't pick advanced adenomas, you don't get the life-years gain benefit. That's not good. And if there's a 10% false positive rate and you do that test every year, odds are you get a colonoscopy every year, which leads to too many unnecessary colonoscopies. And those are the 2 criteria that USPSTF looks at. So we believe that there is an appropriate use of blood-based colon cancer screening test, and it's for people who you can't get screened with the guideline included tests like Cologuard or colonoscopy or even a FIT test. And so we know who those patients are and we can help get them screened because too many people are dying of colon cancer, even with the colonoscopy that they didn't go to or a Cologuard kit in their closet. And we want to make sure that everybody gets screened. So we think it's probably a multi-hundred-million dollar market opportunity for us. But without guideline inclusion, you're not in the quality measures. Without being in the quality measures, docs don't want to use your test. It counts against them.

Great. Unfortunately, we're out of time, so we'll have to leave it there. Kevin, Sarah, thanks so much for being here. Great to see you, guys.

Thank you.

Thanks, Brandon.