Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

September 9, 2020

NASDAQ US Health Care conference_presentation 48 min

Earnings Call Speaker Segments

Catherine Ramsey

analyst
#1

All right. Hello, everyone. Thank you for joining us today. I'm Catherine Schulte. I cover life sciences and diagnostics here at Baird. So we're very excited to have Exact Sciences presenting here today. And representing the company, we have CFO, Jeff Elliott. So thank you so much for being here with us. As far as the agenda, we're just going to dive straight into Q&A. So if anyone from the audience has any questions, please submit them through the web portal, and we will try to work them in. So welcome, Jeff, and thanks for being here.

Jeffrey Elliott

executive
#2

Hi, Catherine, good to see you again.

Catherine Ramsey

analyst
#3

I guess starting with some obligatory COVID questions before we move on to the bigger picture. On your second quarter call, you talked about seeing Cologuard orders up year-over-year in June and flat in July, very swift recovery after a meaningful pause in April and May. Just any update in terms of trends that you've seen over the last month or so in terms of doc reopening -- doc office reopenings or sales force access?

Jeffrey Elliott

executive
#4

We're very pleased by the strong momentum that Cologuard has. When you think back to what happened during the month of April, Cologuard orders were down over 60% year-on-year. At that point, physician office visits were down meaningfully. People were largely hunkering down and not going out to provide preventative care. But because of the actions our team took, combined with the preventative, accurate, convenient nature of Cologuard, our business recovered meaningfully. And that momentum, I think, going forward will help us accelerate towards our long-term goal of at least 40% market share. So a couple of actions we took include standing up a consumer-initiated ordering portal. That's got some nice early momentum. And our sales force has also made some swift adjustments to adopt to a world where they're seeing providers virtually more than they are in person. So the team responded quickly, and we've got very nice momentum that we're pleased to see, especially relative to colonoscopy, which is the predominant way to test for colon cancer. Colonoscopy volumes are still down by probably at least 30%. Cologuard volumes, we said on our last call, were relatively flat year-on-year in the month of June and July. So relative to colonoscopy, Cologuard is much better off. More recently, we've seen physician office visits continue to recover to. So now I think we're probably down somewhere in the 20% range. So things are recovering. COVID volumes seem to be receding, which is a good thing, and going forward, hopefully, that continues. When you look ahead to next year, I expect a more normal year. I think COVID volumes will continue to decline, and that momentum we have on Cologuard will help us continue to drive very strong growth into '21.

Catherine Ramsey

analyst
#5

Yes. Very helpful. And to your point, on colonoscopy volumes being depressed even lower than what we saw with Cologuard, COVID has created a very meaningful backlog of unscreened patients. We've seen several professional bodies say we need to be using more stool tests and help triage, only the higher-risk patients to go get that colonoscopy. Is this something you started to see play out? Do you think physicians are realizing that they're going need to use more of these at-home tests?

Jeffrey Elliott

executive
#6

Yes. We have, Catherine. This backlog is significant, and the backlog today stands at well over 1 million patients who have either canceled or deferred a colonoscopy. That's in addition to the over 45 million people in this market who are currently unscreened for colon cancer. So this market is massive. There's no lack of opportunity out there. We think this backlog could take years to clear, considering it continues to grow. I mentioned before, total colonoscopies are down pretty significantly still. Screening colonoscopies, which are a subset of that broader pool of colonoscopies, are down more because they typically are deprioritized relative to a more urgent procedure such as somebody with symptoms. So this backlog will continue to grow. We know that Cologuard is helping to alleviate that backlog. And one tidbit is that relative to colonoscopy, as you mentioned, Cologuard is performing much better. Another is that when you ask physicians, how do you see COVID impacting Cologuard ordering and colon cancer screening more broadly? We did a big survey on this. And the vast majority say that they expect to order more Cologuard going forward because of COVID. And we see this playing out in our own numbers. When we look at the ordering trends, historically, doctors who had maybe sporadically ordered Cologuard, ones that ordered, say, every few months, order trends in that group are up -- are actually up year-on-year. There are some more doctors who had ordered more frequently. That's where the order trends are a little bit softer. That's because their patient flow is lower. But when you really dive into the trends, there's some very exciting underlying momentum that will help us accelerate adoption going forward because of COVID.

Catherine Ramsey

analyst
#7

Yes. And to that point, you've talked publicly in the past about thinking COVID could actually accelerate Cologuard adoption by 1 to 2 years. You mentioned the sporadic orderer is now ordering more frequently. What are you doing to really capitalize on that and make sure that those previously sporadic orderers, that will now be a sticky ordering base? And can you just remind us how penetrated you are from an ordering physician perspective and the revenue potential just from penetrating your existing ordering base?

Jeffrey Elliott

executive
#8

Yes. Take a step back and look at this market. There's over 106 million people who are on label for Cologuard. So it's about 1 out of 3 Americans. It's a huge market. Of those, as I mentioned before, about 46 million are currently unscreened for colon cancer. So the immediately addressable market is enormous. Our longer-term goal is to capture at least 40% of the total market, which equates to about a $14 billion long-term goal. On the physician side, we've captured about 160,000 primary care doctors, meaning 160,000 have ordered at least 1 test. However, most of those ordered at relative low rates. We estimate we've only captured between 5% and 10% of the opportunity within that base. In fact, the opportunity within that base alone, if they all ordered to the maximum, it's probably around $14 billion just for that cohort of doctors that have already ordered. So if we never added another physician, we could grow significantly for many years. So our multipronged sales and marketing strategy involves targeting those physicians, right, the doctors who haven't ordered with TV ads. So we run a robust campaign to raise awareness of Cologuard. That campaign has been on the TV for over 4 years. It is highly effective. Before COVID, we were adding 10,000 new providers per quarter, and the vast majority had never been touched by our sales force. The sales force focuses on the doctors that have the highest potential and those that have previously already ordered Cologuard. That's a big pool there. As we said before, in total, over 200,000 total providers have ordered Cologuard. So it's a big pool. We call on [ dual ] reps, the most high priority physicians. And they -- we try to target them through live visits where they're open, many physicians are still closed down, live visits where we can. We also have virtual selling capabilities that we try to reach out to doctors that way. The team has taken the time during COVID to make sure we do what's called a total office call. And what I mean by that is they -- we call on the office staff and the nurses and the doctors to make sure they're all aware of Cologuard, and they know how to order it and they know how to give a patient a demo. That way, no matter who the patient talks to, they can provide a unified selling effort to Cologuard. And we also can drag that electronic ordering rate higher. We have seen that rate pick up. Today, we're up to about 37% electronic ordering. We've seen meaningful progress there. I would have thought the conversion to electronic ordering would have slowed during COVID. In fact, it has not. It has accelerated during COVID because of the efforts the team has put forth to do that total office call and really taking advantage of that period. It's things like that, that give me confidence when you look ahead that we can accelerate the adoption of Cologuard towards our long-term goal of at least 40% market share.

Catherine Ramsey

analyst
#9

Yes. That's very exciting. And clearly, COVID has increased the value proposition of at-home testing. Do you think that, that could shift that overall kind of long-term market share pie away from colonoscopies? Or do you think that 40% market share number is still good for now?

Jeffrey Elliott

executive
#10

Our goal is to get more people screened, right? And 40% share, that's a $14 billion long-term revenue target. So we'll stick with that one for now. I think the big thing for -- the big advantage of COVID for us is that it helps us accelerate towards that 40% rate. However, I do think that COVID has heightened the people's appreciation for noninvasive, accurate at-home tests specifically because Cologuard and tests like that don't require you to go to a physician. Before Cologuard, we had over 10% of our orders came outside of that face-to-face office visit, meaning they probably -- it was either a phone call or possibly a text message or some sort of e-mail that resulted in the doctor ordering for a patient. Today, that number has ticked up meaningfully because Americans and doctors have adapted to more telehealth-type sales, away from the live patient -- physician to patient visit. So that is a longer-term benefit that I think will stick with us.

Catherine Ramsey

analyst
#11

Yes. All right. That makes sense. And you gave the update on electronic ordering. You've also put a big emphasis on improving that capture rate on the 3-year rescreen opportunity. So any update on what kind of progress you're making there and how the upcoming Epic broader rollout could impact your success there?

Jeffrey Elliott

executive
#12

The 3-year rescreening is a huge opportunity for us. It already is a material part of our revenue. Going forward, when you model this out long term, I think that this could be over half of our revenue because that pool of patients that need to be screened again continues to grow. There's over 370,000 patients this year alone who become eligible for their 3-year repeat test. Last year, it was 160,000. So that number continues to grow. On top of that, our capture rate of those patients continues to grow, too, because of the actions we've taken both with patients and physicians. With patients, we have new tools we've put in place to heighten their awareness to make sure they know that, that 3-year interval is there for screening again. On the physician side, this is where we've made the biggest advancements. We now have tools in place through our web portal. When a physician logs in, they can see a list of all the patients they have that are eligible for 3-year retesting. And once they verified those patients are still indicated for Cologuard, they can click a button and reorder Cologuard for all those patients. We can also deliver that list via either a fax or an e-mail if the physician wants that, so -- to help drive awareness on who is due for a 3-year retesting. So our efforts there are leading to a much bigger capture of that 3-year rate. And going forward, with these tools, as you mentioned, with the broader Epic rollout, I expect that rate to go higher. Coming up in the fourth quarter, Epic, who is our EHR partner, our Electronic Health Record partner, Epic has a major upgrade coming in the fourth quarter. What this upgrade will do, it will embed Cologuard ordering, electronic ordering, in that base software such that anybody who uses Epic's software can order Cologuard through the click of a button. Why this is important is because 45% of primary care physicians use Epic. It is the dominant EHR platform out there. It is particularly big in the health systems, where our penetration rate is relatively lower than it is in the independent doctor group. So I think it will help us advance our penetration in the big health systems. And converting from a faxed order, which today is over 60% of our orders, to an electronic order helps drive incremental utilization. Doctors that order via Epic order over 50% more than when they order via fax. It's easier. If you're seeing a physician, if they can just click a drop-down without changing the screen, they're going to -- they're more likely to order it. Instead, today, what they often have to do is log into a portal or fill out a fax form and send it in separately. That's a more cumbersome process. So getting Cologuard embedded, while it drives incremental utilization, it made Cologuard a stickier product for the long term. So that's a big win that we have with Epic in the fourth quarter. Now when Epic makes that software available, it can take up to 2 quarters for all the health systems to adopt it. So it will take a little bit of time for that to get rolled out and then us to get pull-through. But this is one of the big tailwinds we expect next year.

Catherine Ramsey

analyst
#13

Yes. That makes sense. Another big opportunity is the 45- to 49-year-old bucket. We could potentially have a new USPSTF draft recommendation coming up soon. They stated in their research plan that they'll look at the 45 to 49 age group. I guess what are your expectations for if we might see the age lowered in USPSTF? And any general comments on how you feel you're positioned in the upcoming update?

Jeffrey Elliott

executive
#14

We need to screen earlier in this country. That 45- to 49-year-old age group is seeing rapid growth in colon cancer rates mortality. So that is the one age group we really should change our perspective on. You saw 2 years ago, the American Cancer Society lowered its recommendation to age 45 based on the rise and incidents that we've seen. USPSTF, as you mentioned, is looking at that. Clinically speaking, we think we should screen earlier in this country. In that age group alone, there are 19 million people who are average risk for colon cancer. And effectively, all of them are due right now for screening. Cologuard fits well into that lifestyle. 45- to 49-year-olds are likely to be working. There's a very good chance that they have kids, and they have a busy lifestyle. So Cologuard can fit right in there. It's different than somebody who is, say, 70 and retired. They may have more time on their hands than a 45-year-old. So Cologuard fits in well. And a customer who's 45, we have multiple chances to retest that patient over the course of their life. So it's a really attractive customer base where Cologuard can really make a meaningful difference. So as far as expectations, we know that USPSTF is looking at that. We think the clinical evidence supports lowering the age. We don't know what that group will do. We will keep working, though, to drive adoption in that group. What we've seen from a commercial uptake standpoint is we've seen much faster adoption in that age group than in the 50 and over group from a low base, but we've seen much faster adoption there. From a coverage standpoint, which is really important for longer-term growth, the coverage of Cologuard in that age group is much better than we expected. When we submit a claim to a payer, over 80% are paid in full today. So the majority are paid in full. However, we want to make sure that all the payers have, all the major payers have the coverage policy that says, "Cologuard is covered as a preventative benefit." So that is the goal we are working towards. However, we do see a reasonably good coverage already before USPSTF even updates their guidelines.

Catherine Ramsey

analyst
#15

Yes. All right. Awesome. Maybe one last question on Cologuard before we shift to the pipeline. We have one from the audience. And I think going back to the acquisition, you did have Genomic Health. Part of the rationale was getting that international infrastructure. So the question is, what's your current thinking around capturing the OUS opportunity for Cologuard?

Jeffrey Elliott

executive
#16

Yes. The OUS opportunity is significant. When you look at Europe relative to the U.S., there's much higher incidence rates. There's higher mortality rates. We think that Cologuard would fit better in that market. Unfortunately, in Europe, it's a tough market. We did try to enter the international market years back. The adoption was relatively slow because much of Europe, not only do they not want to use colonoscopy, they're stuck on the FOBT test, which is a test that's probably been around 50 years, because it's a relatively inexpensive test. It may cost EUR 5 instead of EUR 15, like a FIT test. So FOBT is still the broadest, the most widely used test in Europe. Colonoscopy is generally reimbursed around EUR 250. So it's a more challenging market. It's something that I would -- near term, I don't expect Cologuard to see meaningful adoption there. However, our colon blood product is something that we could consider for international markets. And our other pipeline tests, which I think we'll get to in a moment, with our liver cancer test, those products, I think, will be well suited for not only Europe but also the Asian markets.

Catherine Ramsey

analyst
#17

Yes. So as you mentioned there, there's a lot of innovation going on, including by you, to try to develop a blood test for colorectal cancer. So I'd like to focus on your efforts there for a moment. I guess first, just how long have you been working on development of this test? And while you haven't shared any data, how do you feel like your test will stack up versus the competition?

Jeffrey Elliott

executive
#18

Well, when you think back to when our CEO, Kevin Conroy, joined Exact Sciences 11.5 years ago, he initially came to develop a blood-based test. However, as soon as he started to look at the science and the biological barriers to an accurate blood-based test, they pivoted at that time to a stool-based test. And we still believe that all the signs we've seen point to a biological limitation on accurately detecting pre-cancer and early-stage cancer to the blood. We still think that is the case. Nothing has changed there. However, as we look at this market, we think there is a niche of the market where a blood-based test could be well suited to help increase screening rates up to 80% or higher. We don't think that overlaps with the Cologuard portion of the market. We think most patients and physicians want an accurate test. All the survey work we've done supports that, and the simple fact that most patients, the most common test out there today, is a colonoscopy, which is anything but convenient, it is an accurate test. That just shows you how much people want accuracy. Only Cologuard and colonoscopy are proven through a prospective study to offer high levels of accuracy, 90% or higher. So we think that, that will be -- those 2 methods will be the dominant ways to screen for colorectal cancer for the long term. We think that fecal blood tests and the blood tests will help us drive that adoption rate from, let's say, 80% to 90% or higher, colon cancer screening overall. The blood-based test, though, they all suffer not only from lower accuracy, but in a COVID environment, there are some challenges with -- you have to have patients come in to the physician's office to get a blood draw. And in this environment, with office visits down, there are some challenges there. And we know that the price point here is going to matter significantly. The price point here, because these tests will all model up to be an annual test. We've done the modeling work on this. We've been looking at this for years. They typically all model out to be a 1-year interval, which means from a reimbursement perspective, you're likely thinking of something in the range of $150 to $200 per year. For that to work, financially, you have to have a cost per test below $100. So as we've approached this market, we've approached this with a cost profile that is below $100 per test, such that when the guideline committees determine the interval, we are prepared to have a test that is a 1-year interval test and, financially, it can make sense. We think we're best positioned to succeed in this market given all the work we've done to lay out this commercial infrastructure, right? We've talked about this before. For Cologuard alone, we've invested almost $1.3 billion since 2009 and building up that foundation. From an IT perspective, we're approaching $400 million. That gives us a robust foundation to grow from. But it will be very difficult for somebody else to come in and replicate that, which they would have to. We have the lab capacity. We have the know-how to succeed in blood. We continue to make progress there. We've run hundreds of samples through our assay. We've done multiple case-control studies. We are seeing progress there, and we are currently running our pivotal study called BLUE-C. It's for Cologuard 2.0, which we can talk about. That's an enhanced version of Cologuard and our colon blood product. As we enroll those patients, we're banking those samples, and we ultimately intend to use those samples for FDA approval. So we are moving forward here. We think we're best positioned to succeed. Of the data we've seen, which has been pretty minimal out there, of the data we've seen, our test is at least as accurate as anybody else's out there. And with all that commercial interest we have, we're confident that we can be the leader in the colon liquid biopsy space.

Catherine Ramsey

analyst
#19

Yes. So given the performance that you expect from your own tests, as you envision that long-term market share pie, Cologuard 40%, what portion of the market do you think could shift towards a blood test? How do all those different buckets fit together?

Jeffrey Elliott

executive
#20

It's probably in the 10% to 15% range, Catherine. So when you look -- colonoscopy today is around 50% of the market, Cologuard in the 5% range, going to 40% or higher. And if you look at total screening rates, we think they can get to 80%, maybe a bit higher. So that speaks to colonoscopy in the 40% range, Cologuard in the 40% range, with FIT and the fecal blood test, and going after the last, call it, 10% to 15%. There will always be a portion who refuses to get screened. You see that across all leading cancer types. So we think it's the last 10% to 15%, and that's what the survey work supports. When you ask doctors about the -- who would you use a given test for? Only the minority would say that they'd be willing to sacrifice accuracy for arguably better convenience. Most say, "Look, we want accuracy and convenience." Cologuard offers that. But colon blood tests, the accuracy will be lower.

Catherine Ramsey

analyst
#21

And I want to make sure we spend a little bit of time on your liver test and other tests in your pipeline. You talked about launching your liver test next year. Can you just remind us the size of that market and also the size of kind of the target ordering base you're going after? You both had about a 60-person GI team. So just curious how quickly you think you can penetrate that market.

Jeffrey Elliott

executive
#22

The liver test, we're really excited about this because this liver test will be a proof point of taking the R&D work that we had done, we've been doing at Exact Sciences, combining that with the lab that we acquired, the Redwood City, California lab that we acquired through Genomic Health, and bringing all these things together, IT platforms, the know-how, the sales team, bringing this all together and delivering upon the promise of our pipeline. So we're very excited about that launch. The target market here in the U.S., to start with, is the 3 million people who have advanced liver disease. That generally means cirrhosis or hepatitis B. Globally, the market is even bigger, considering hepatitis rates are far bigger in Asia, specifically, than they are here, but 3 million people in the U.S. who are generally recommended to get tested every 6 to 12 months. The reason why you test this cohort is because over 90% of liver cancers happen in this population. It's different than colon cancer. In colon, you screen the masses because that's where most cancer happens. In liver cancer, it's a targeted market that needs better alternatives. Today, fewer than 1 out of 3 people are screened for the guideline recommendations. And we know that screening matters here. When you use those tests, which have poor accuracy, the current test, screening with them or testing with them, can double the 3-year survival rate. So the goal here is to provide a test that is more routinely adopted and better -- more accurate than the current blood test, which is called the AFP. So we think we're positioned to do that. Our plan is to launch that test next year. We plan to launch that through our GI sales force, which we've built last year for Cologuard, which is a 60-person team. The initial target market will be hepatologists, which is a couple of thousand doctors in the U.S. alone. However, over time, we think this test has room to launch in the primary care sales force because in the primary care team, there are physicians out there who see people who are at advanced risk of liver cancer.

Catherine Ramsey

analyst
#23

And what's the expected time line to get Medicare coverage for that test? You mentioned launching out of the Genomic Health lab. Is your plan to pursue an LCD? And have you gone ahead and initiated that process?

Jeffrey Elliott

executive
#24

Yes. So the goal of the launch next year is really to generate additional evidence that can be used for guideline inclusion and reimbursement and, ultimately, adoption. So that is the plan. We've had some conversations with MolDx. However, that process, it's truly to give a time frame for when an LCD could be issued. We're still in early discussions and planning for that process.

Catherine Ramsey

analyst
#25

Okay. And if I step back and look at the bigger picture, by next year, you'll have multiple early detection tests with Cologuard and your liver test. You'll have treatment selections, your Paradigm, prognostics and chemo benefit through Genomic Health. As you envision this company 5 years from now, how do you view your portfolio evolving? Are there different areas in the cancer care continuum you'd be interested in? And how much of that comes from internal innovation versus potential M&A?

Jeffrey Elliott

executive
#26

Yes. I mean, the focus here is on driving Cologuard and Oncotype, the current portfolio of tests. That is the primary goal, and there's a long runway ahead. As we've talked with Cologuard, the current share is 5%. Our goal is to get that product to $7 billion or more of revenue. Oncotype's global share is 15%. So there's a long runway ahead on those products. Over time, though, the vision is, is to be the leader in the whole cancer diagnostics spectrum, as you mentioned, from screening, all the way to late-stage cancer therapy selection. And we hope to introduce tests across the whole continuum. So with the Mayo Clinic as our R&D partner, we've discovered markers -- biomarkers in the blood are highly accurate, discriminating healthy tissue from cancer, that we've discovered markers across the top 15 cancers. We are working on converting those into products. The first one of those you'll see is our liver cancer test. We have tests in development for Barrett's esophagus, for pancreatic cancer, for bladder cancer. It's a robust portfolio. We expect to launch a new test every year or 2 after the liver cancer test. So it's a robust suite of tests that will come to market, leveraging this platform we developed for Cologuard and Oncotype. So you've got the primary care sales team. You've got the GI sales team. We have an oncology sales team, a urology sales team. All told, we have over 1,000 people in our commercial organization that we plan to leverage as we bring new tests to market.

Catherine Ramsey

analyst
#27

All right. Very good. Well with that, we are out of time. But Jeff, thanks so much for joining us. And thanks, everyone, for tuning in and hope you have a great rest of the conference.

Jeffrey Elliott

executive
#28

You, too. Thanks, Catherine.

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