Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

March 8, 2022

NASDAQ US Health Care conference_presentation 30 min

Earnings Call Speaker Segments

Andrew Cooper

analyst
#1

Good afternoon, everybody. Thanks for joining us. I'm Andrew Cooper, the diagnostics analyst here at Raymond James. We're happy to have Exact Sciences here. We've got Jeff Elliott, CFO; we've got Megan in IR in the back as well. I'm going to hand it over to Jeff to give us a quick overview here, and then we'll jump into fireside chat in just a few minutes. So Jeff?

Jeffrey Elliott

executive
#2

Thanks, Andrew, and thanks to all of you. It's great to be back in front of an audience in-person presenting again. Hopefully, we can keep you on this going forward. So we are Exact scientists. We are a leading global advanced cancer diagnostics company. Today, we have about 7,000 employees around the globe. This year, we expect to do about $2 billion of revenue. Our leading products are Cologuard, which is a noninvasive test for colorectal cancer; also Oncotype, which is the primary test there is a test for -- it's a prognostic test for women diagnosed with early-stage breast cancer. The goal of that test is to help eliminate the need for chemo where possible. And lastly, we have a test called OncoMap, which is a test for late-stage cancer patients to help them identify which therapies that can be optimized for their treatments. We have about 450 people in our R&D team. We are a science-based company. We have a commercial foundation of about 1,400 people primarily in sales and marketing. And we have a presence in over 90 countries. Last year, we tested over 4 million people, and we expect continued very strong growth again this year. Over the past 3 years, we've generated compounded revenue growth of over 50% through organic and both inorganic growth. This year, we expect that strong growth to continue. In our Cologuard business, we expect growth of over 20%. We have balanced growth across three major product areas. Over time, this will expand as we bring other new products to market. The three main areas of focus are colorectal cancer screening; multi-cancer screening; and MRD and recurrence monitoring. This is -- we're focused on these areas because we see the biggest patient impact opportunity. We also see these markets as the biggest markets in all diagnostics. Combined, we see a potential TAM of about $60 billion in the U.S. alone. Internationally, these markets are even far bigger. I've been part of Exact Sciences or followed the company for about 10 years now, and we've never had a year [indiscernible] have this year in our pipeline. We see a significant number of new data catalysts coming. This year, we've got 5 additional major data readouts coming. We also have major milestones in terms of launching new tests later this year, and submitted to the FDA later this year and early next year. So this is a very exciting time for our pipeline, unlike any we've ever had in our company's history. So where we're heading as a company? We are heading to be the partner for patients and physicians across the whole cancer care continuum. And what I mean is, if you talk to anybody who's been diagnosed with cancer, it's often a terrible journey to go through. Patients get passed from physician to physician. They often don't know where to turn next. They don't know where to go to get information. They often don't know what their next best action is. Well, we want to solve that. Patients are asking for it. Hospitals and doctors are asking for help, too. So we are bringing a full suite of tests to market all the way from germline testing, hereditary testing and early-detection all the way through late-stage cancer. That way, we can help hold patients' hands across this journey and provide useful insights throughout. We can also partner with physicians who also -- they don't know where to turn. They don't know where to turn as far as what therapies to recommend, which ones to avoid, what next best action to take. We will be that partner as we bring new tests to market and grow our existing tasks. With that, I'd like to sit down for some Q&A.

Andrew Cooper

analyst
#3

Perfect. Thank you for that. I think that's a good kind of start for us. I want to dive first into the Cologuard growth trajectory. And there's a handful of moving parts in 2022 as we think about what that is to build, I think, it's 24% or so at the midpoint. So maybe first to start with rescreening. Last year, you did, I think, you said north of $100 million. We don't know exactly how far north. This year, you're shooting for $220 million or so. So it's a pretty big step-up. By my math, that's about 1/3 of the available patients that you're really capturing there, maybe even less if we think about last year's eligible, potentially still being up for rescreening. So first, is that math more or less right in terms of 1/3? And are we looking for something like 30% to 40% of eligible in this year? And then I have a follow-up after that as well.

Jeffrey Elliott

executive
#4

So your math is pretty good. Our success rate at getting somebody retest is over 35%. Take it a step-back here, part of what's so excited about Cologuard is not only are we getting more people tested, we've tested 8 million people now, about half of whom have never been tested before. So we're getting more people tested we're keeping them screened. With Cologuard, the guidelines for recommended testing is every 3 years. So we can test somebody who's, say, is 45 and keep them tested over the course of their lives, over 30 to 40 years. From a lifetime value standpoint, to us, that is significant. And we also have a chance to really help improve patient outcome. So that is a key part of our business going forward that will continue to rise as a source of revenue. Last year, as you mentioned, we had guided to over $100 million of revenue from rescreens. This year, it's over $220 million. And I feel good about that number. We're off to a good start. Over time, that will keep increasing. Eventually, 3 years of rescreens becomes over half our revenue. And why that's important is it's a source of recurring revenue, which as a CFO, I love hearing that. Recurring revenue is music to my years. Also it's a higher margin source of revenue because the patient who's already done Cologuard, for the most part, those patients are happy. It's easy to reengage those patients and get them to do the test again. I've done Cologuard 4 times, right? Each time we do it, it's easier, right? And our patients are generally very happy. So it's a really attractive source of revenue for the business.

Andrew Cooper

analyst
#5

Perfect. And kind of leads into my next question, which is I agree from the patient side, it seems like they've done it once they understand it, it should be pretty high compliance once it's ordered. So it seems like the reasons you're at 35% is that the doc isn't necessarily reordering it. So what can you do to drive that higher? And why are some of these docs taking a little longer to kind of capture the rescreens that they should be ordering?

Jeffrey Elliott

executive
#6

The pool of patients today who are eligible for repeat testing is over 1 million people, and another 1.2 million people become eligible this year. So it's a huge opportunity. To keep growing this, we need to make sure it's easy for both the patient and physician to first know when they're eligible, when the patient is eligible for a repeat testing, and make it super easy really automatic to place that repeat order. So the biggest reason why is that people -- this is a 3-year interval, which people generally aren't accustomed to. Typically in healthcare, it's a 1-year interval, right? You get screened for a cluster, I'll say, every year or you do a fecal blood test every year. A 3-year interval is unique. It's also very powerful. Getting somebody screen and having that account for 3 years is a huge advantage for us versus other tests that are out there.

Andrew Cooper

analyst
#7

Perfect. And maybe switching gears a little bit to the -- one of the other moving parts, the 45- to 50-year-old group. I think you mentioned it's 19 million-or-so folks and kind of doing the same math from $40 million or north of $40 million last year to a target of north of $122 million. I guess first, how is this group may be different than the more traditional 50-plus demographic? And do they get to the doctor at the same clip? Do they comply similarly? And why might their preferences be a little bit different? And what might you be seeing in the market today?

Jeffrey Elliott

executive
#8

So last year, the key guidelines updated and recommended screening start at age 45 instead of 50. And you know why is that? It's because that over the past 20 years, incidence in the younger population has grown. It grew by over 50%. Incidents in the 50 and over population has come down over time as screener rates have gone up. But in the younger population, likely due to poor diets and poor -- a lack of exercise, screening rates there are just -- are far too low. So we should screen younger. Again, there's 19 million people in that age group. The difference here is that those people, if you're 45, typically busy with work, I'm sure many of you are busy with work, busy with kids, and don't have time to take up 2 days for a colonoscopy, and that's what it takes to because it's a full day for the prep, another full day off of work for the procedure itself. And on average, that costs $2,000. Who really wants to do that? Cologuard offers great value because Cologuard is done without prep. You collect the stool sample in the comfort of your own home. It's a highly accurate test. You send the sample back in. Again, no prep, send it back into our lab, and we can get you tested with an early cancer sensitivity of 94%, which is about where colonoscopy is. So that's why we're taking share. That's why in this younger population, our share is higher than a colonoscopy. Patients who are younger, typically very busy, compare that to somebody who, says, 75, at that age, hopefully, you retired. At that age, you're less concerned about taking time off of work because, again, you're retired. So the relative preference is very strong for Cologuard in the younger age group and the lifetime value, again -- this is an important point. The lifetime value to us is tremendous for somebody we can screen for 30 to 40 years.

Andrew Cooper

analyst
#9

Great. And then maybe the last piece kind of as we move into more of the bread and butter. You launched the new initiative for the unscreened population. Was it this morning, I think?

Jeffrey Elliott

executive
#10

The Katie Couric -- yes.

Andrew Cooper

analyst
#11

Katie Couric. Maybe just give you an opportunity to comment on it. And then how do you think about that 46 million-or-so people in terms of who's not complying with something a doctor is ordering, who's not going to the doctor, and how much of that is really kind of truly capturable out there today?

Jeffrey Elliott

executive
#12

Yes. I mean, The real opportunity here is the 46 million people today who are unscreened for cancer. When you look at colon cancer, overall screen rate is probably about 55%. When you compare that to, say, breast or cervical cancer screening, there they're about 80%. So we've got to close that gap. We and many others out there are targeting, bringing that up from 55% to 80%. How are we going to get there? Cologuard plays a major role there. Now typically, everybody who's 50 and above has been told at least once, get screened, right? It's a no-brainer. Colorectal cancer is called the most preventable but least prevented cancer. Why is it not prevented? It's not prevented because before Cologuard, people often didn't like the screening options that existed. Now with Cologuard, we have more options, and that is getting more people screened. And part of what we announced yesterday was a partnership with Katie Couric. Most of you I'm sure know who Katie Couric is. She is relevant to colon cancer specifically because back in 2000, Katie went on live TV and had a colonoscopy. She did that because her first husband died of colon cancer at an early age. He wasn't screened. So she wants to raise awareness and make sure more people get screened. This led to something called the Katie Couric effect. It led to about a 10-point increase in overall screen rates in this country. Rates have been stagnant for years. Katie comes in, and she's very brave to go on live TV and do this. Anybody here willing to do that? I don't know if I would, but Katie went on live TV and had a colonoscopy. That led to a 10-point improvement. Now she is advocating for Cologuard. So we've launched a brand-new ad campaign, geared at driving urgency. Again, people are generally where you should be screened, even awareness for Cologuard, very high. From an aided awareness standpoint, over 90% of physicians know Cologuard. No surprise, where we've been out there advertising for years, but the urgency of it isn't there. This new ad campaign is about driving urgency in part due to the pandemic. A lot of people pushed off screening in part due to this pool of patients who have been on screen for many years.

Andrew Cooper

analyst
#13

Great. And that's super helpful context. And as we think about that potential for growth and think about 2022, if you just do the math, I think, on the rescreening and the 45 to 50 or 45 to 49 population, it leaves about $100 million of sort of bread and butter growth in the screening segment to get to the midpoint. So it's about the same dollar amount as you had last year. You've got the Pfizer sales force coming in. You've got sales force access improving. So maybe just walk me through how conservative might that growth rate be? Is there upside potential? And how you think about building up to that total number?

Jeffrey Elliott

executive
#14

We're fortunate enough to have multiple different growth drivers. You hit on some main ones here. The 45-year-old population, 3-year rescreens, the sales force. So I'd say, the sales force this year is likely the biggest driver. And I mean that because over the past 2 years with the pandemic, our ability to go out and educate physicians on Cologuard and raise their awareness has been limited. Because of the pandemic, many physicians said, look, please stay out of our office. This was unique to us. This was across all of primary care. Even today, access to physicians, primary care doctors, is about 50% to 60% of what it was before the pandemic started. It is better than what it had been most of last year, but it is still relatively muted compared to before the pandemic. As things open back up, here we are live at a conference as things open up throughout the world, access to doctors will also open up, and that allows us to get back out there. Our reps are huge proponents, huge advocates, getting out there and educating doctors on Cologuard and raising screen rates. And now going forward, they will succeed with that. They are one of the biggest drivers, our reps, of 3 rescreens and the 45. So these drivers all work together. We have been somewhat conservative in guidance around physician office access. Here we are, the pandemic is still here. There could be other waves of it. So early in the year, we can't bake-in a broad quick reopening of doctors' offices. So we have been conservative there. We have said that we expect some improvement, but we don't expect a full normalization in this year.

Andrew Cooper

analyst
#15

And I know it's only been, I think, a couple of weeks since earnings and since you sort of talked about it. But in terms of that physician office access, has it continued to improve through the back end of February, start of March? Do you have anything you can sort of update us with?

Jeffrey Elliott

executive
#16

The big improvement is on case counts. As case counts drop, that's fewer people getting sick, which is great for all of us. It's also great for doctors who are fewer doctors who getting sick, fewer nurses getting sick, and fewer patients are getting sick, which means that they can get back in there, you're seeing wellness visits improve, access to doctors is improving because, again, fewer people are getting sick. So that's been the biggest change in recent weeks.

Andrew Cooper

analyst
#17

Okay. Great. And shifting gears a little bit. I think I look back to when I was launching coverage and doing the work, and you guys stopped giving price and volume separate, you said, hey, the growth is really volume-driven. That's why we're able to do that. And for the first time in a while, on the most recent earnings call, you talked about ASP potentially as rising and as a tailwind. So what's changed there? And how do we think about that path to go from, call it, the $480s up to, I think you said, $500, $515 is kind of the target?

Jeffrey Elliott

executive
#18

Yes. The big change is investments we're making in our billing systems and revenue cycle systems that will allow us to capture more fully what we're contractually owed. There's times where something as simple as -- my legal name is Jeffrey, but I go by Jeff. Something as simply submitting Jeff at a bill as opposed to Jeffrey can lead to a claim getting tagged. So our billing systems are being enhanced, which will allow us again to raise that ASP or that revenue per test. The goal here is to get to at least $500 per test for Cologuard. Now why we're confident is that when you look at our overall contracted rates, they're above $500, probably in the $515 to $520 range. What that means is that when we collect $480, we're leaving $30 a test on average on the table. Through enhancements to the billing systems, we can collect more of that. And the beauty of that is that's pure margin that drops straight through that we can reinvest in growth or let fall through for all of you.

Andrew Cooper

analyst
#19

Perfect. And don't worry, we'll get to margins a little bit later. But maybe now transitioning to 2.0 -- Cologuard 2.0. You had the data at ASCO GI. You showed the nice uptick in precancer and in specificity that you were shooting for, but on the specificity side, I get the sense, sometimes folks are too focused on sensitivity and don't realize what that impact really is. So maybe just lay out what does going from 87% to 90% do. And how does that stack up for something like FIT versus some of what may be coming to market in the future as well?

Jeffrey Elliott

executive
#20

Yes. Specificity is important because in a screening test, that affects more patients than sensitivity, right? You're trying to make sure that people who are healthy, you're accurately calling as healthy. That is incredibly important. When you look at all the feedback we get from doctors, to the extent there's any clinical pushback on Cologuard, it's typically around two things: one is the precancer performance rate, and precancer is incredibly important for doctors; and the others run the false positive rate, which is really specificity. Those two things are what we're attacking with Cologuard 2.0. Now the data we shared back in January shows that with some enhancements we're making to the test, we believe we can improve both. On the false positive rate, we think we can reduce that rate by 30% or about 3 points, which will have a huge impact on patient outcomes and at least to overall better value for the system. What that means for the finance types is it's also very important. The NPV of this program is over $1 billion. Now how do you get there? A lower false positive rate means that fewer patients we send unnecessary to a colonoscopy. Let's say, it's a 3-point improvement. That's 3% patients. Every time you run Cologuard, there's 3% more that we keep, we can rescan them over time. There's also some operational efficiencies that we're baking into Cologuard 2.0. This should reduce the cost of goods over 5%. Again, that should fall through as better margins on the test. Over time, again, that's a $1 billion NPV. We're very confident in that. We expect to read out additional data on that on -- the prospective data later this year and then submit to the FDA in the first half of next year.

Andrew Cooper

analyst
#21

Great. And I'm going to tack-on to the end of that net 5%. And so when we think about the cost of goods benefit you'll get there and we think about, and we'll touch more on this in a little bit as well, the profitability target that you laid out for 2024, how much of that is contingent on Cologuard 2.0 and making the transition from Cologuard to 2.0?

Jeffrey Elliott

executive
#22

Well, I'm comfortable we can get there even without 2.0. I do expect 2.0 to be on the market within the timeframe. But we have not baked in incremental revenue or growth from pipeline tests in that target. And what I mean there is we can get to profitability, full year adjusted EBITDA profitability in '24. That is the goal. We will get there with Cologuard and Oncotype, I'm not counting on multi-cancer, I'm not counting on MRD, I'm not counting on [indiscernible] blood. And 2.0, like there may be a small contribution, but we would get there even without 2.0.

Andrew Cooper

analyst
#23

But to be clear, you're counting the spend towards all of those things?

Jeffrey Elliott

executive
#24

Correct. Yes, good point. We are counting on the investment. Look, this year, we're planning to invest over $400 million. The bulk of that is on the 3 big focus areas I mentioned in my presentation: multicancer; colorectal cancer; and MRD. Those 3 programs are about 80% of our total R&D. I'm not counting on any benefits in terms of revenue from any of those in the '24 horizon.

Andrew Cooper

analyst
#25

Okay. Perfect. And then just on the precancer sensitivity piece. You go back to the start of the year, you guys had a survey saying doctors found this very impactful. Future competitor had a survey that kind of said the opposite. So it feels like they've softened their stance a little bit as the weeks and months have gone on since then. But I guess what kind of struck me is that tells us that there's going to be a need to educate physicians on, hey, here's the differences in this and here's why Cologuard is going to be the right choice or Cologuard 2.0. So I guess, at a high level, GPs are busy. What are the things you do to make that front and center when there's a lot -- that they're already thinking about in terms of blood or stool or colonoscopy or FIT? How do you rise that to the top?

Jeffrey Elliott

executive
#26

Well, I mean, GPs looking at more than just colon cancer. They look at heart disease, mental health, they look at everything, right? So they are very busy. The important thing is here, GPs want -- they want accuracy for both cancer and precancer even today. Precancer sensitivity is one of the most important things that they look at in the quality of the test. Precancer is also important in that it informs the test interval, the more accurate your test is for precancer, the longer the test interval. And if you can test somebody like Cologuard every 3 years, that's a big win for patients and physicians. On the flip side, if you have to run a test every year because your precancer sensitivity is lower, that's a bigger deal, that requires more work from a physician. So part of how Cologuard has succeeded is we've made things easy for doctors, easy all the way from things like electronic ordering. Today, 50% of Cologuard orders coming up electronically. 3-year horizon gives a long test interval for doctors, again, making a lot easier. Over time, with Cologuard 2.0, we plan to raise the bar on precancer, which will increase the significance or increase the importance they put upon that will do the same thing. We'll educate doctors more on the importance of that, and they will care more about it. But already, it is very important. It also informs reimbursement. The rate that a test gets from payers and insurance companies is really informed in [indiscernible] because of your precancer sensitivity.

Andrew Cooper

analyst
#27

That makes sense. I think the cost saving piece for them is the important part there. Obviously, we can't talk about CRC screening without talking about blood at least a little bit. So I won't drag on too long. But I think we sliced and diced it every way we could pretty much. So maybe just for folks that are a little bit newer to the story. You're working on your own blood-based assay as well. Talk about how you see that fitting into the market if it takes share, how much and where do you think it takes it from in terms of driving to that 80% you referenced earlier?

Jeffrey Elliott

executive
#28

The goal here is to get more people screened. I said before that colorectal cancer is the least prevented but most preventable test. And the only way we solve that, the only way we prevent the 50,000 people who die each year in the U.S. alone, from dying is getting more rescreens. So to do that, we need more options. That's why Cologuard was invented. That's why we're investing heavily in Cologuard 2 and our own colon blood program. More options is a win for patients. There is room for all these tests on the market. The target market here, it's 110 million people. It's hard to put that in perspective, like that's like the size of the smartphone market. It's a huge market. So there -- clearly, there's going to be more than one test that succeeds here. Today, you've got colonoscopy, Cologuard, a fecal blood test all in the market down the road, blood test so likely is room for them to come over the next 5 or 6 years. Where do we think this shakes out? Well, when you look at patients today, they have bifurcated this market on two main criteria: accuracy of a test 'and convenience of the test. Now accuracy typically wins. That's why colonoscopy today is used. It's the leading test used out there. It's used by about 45% of people in this market because people really want accuracy. And up until Cologuard, the only -- all the real action was a fecal blood test. The accuracy is lower. It is fairly convenient. You can do it in the comfort of your home, but accuracy is lower, which means that only about 10% of people in this market use that test. Cologuard has taken share broadly, 50% of our customers had never been screened 40% are coming from colonoscopy, and 10% coming from the FIT tests. So we're taking share broadly because Cologuard is both accurate and convenient. The blood test where they're likely to shake out is accuracy close to the FIT test, The convenience we could debate, but the accuracy wins out here. Accuracy closer to the fit test means that their addressable portion of the market is about 10% to 15%. And look, 10% to 15% of 110 million people is still a major market that we are investing in, but it's a different segment of the market primarily than Cologuard competes in.

Andrew Cooper

analyst
#29

Perfect. And just for the sake of time, we're going to move to multi-cancer because I want to make sure we hit a couple of different things. But you've talked about some data coming out around midyear. I guess, remind folks what that data set is. And then can you give a flavor for how many cancers you might include in that data set and what we should really be looking for as that starts to get closer?

Jeffrey Elliott

executive
#30

So we expect two major data rates this year in our multi-cancer program. The first, which is midyear is a macro selection study. So we're looking at least 5 different classes of markers. And we're evaluating which ones should be included, which ones maybe could be excluded from the test. So the study this year, which we'll publish. We'll have hundreds and hundreds of different cancers in that to make sure we accurately inform, again, which marker classes to remove and which ones to include. Later this year, then we expect to finalize the test, finalize the test to do a final validation study, which we'll publish at some point of this year. We'll use that then to move on to our prospective pivotal study and launch a lab-developed test version of this. Those two things will happen no later this year or early next year.

Andrew Cooper

analyst
#31

And on that, on the LVT version, ahead of FDA approval. It's a little bit kind of strange of a situation, right? I think there's no way to kind of get around that. But when we think about that launch, what will your sales force be doing in terms of detailing GPs, or is it more of a top-down to health systems and payers kind of what's the approach or employers? What's the approach as you think about that LDT relative to the eventual approach with FDA approval?

Jeffrey Elliott

executive
#32

It is unique, but there's a big difference here. With a test like Cologuard and a colon blood test, you're launching into a world where FDA-approved tests already in the market. A multi-cancer test, that market doesn't exist today. We are working with others to try to create this market, which is why we're eager to get that test onto the market. The goal of that was to be to help build the market and generate additional evidence that down the road can help lead to the eventual full commercial launch. Next year, the plan will be to work with the key health systems. They are asking for it. They really want this test to come on to the market because health systems want to find these patients early. If you find a cancer patient early, that can significantly improve outcomes. Also, the health systems, they want to make sure those patients come to them. They want them to come for the surgery, the chemo, whatever therapies they may have, and again, the earlier find those patients, the better. So we'll likely target the big health systems and also leverage the sales force we have. We have about a 1,000-person sales force out there promoting Cologuard today. We'll likely start with the pilot launch of multicancer, but eventually, roll out to the broader team, again, who's eager, they're in place, they're going to have new products, and we can leverage the foundation we have in place to leverage the foundation across IT and lab. That's important because when you launch a new test, it's very difficult to launch for the facts. Back when we launched Cologuard back in 2014, almost all of our orders came in through a fax. I don't know if you all use fax that often, but we -- still, to this day, we get over 40,000 faxes per week for Cologuard. We're working to rapidly convert that to electronic ordering. As we do that then, we create a foundation for other future tests that we can launch right into the electronic network.

Andrew Cooper

analyst
#33

Great. And I want to make sure we hit on the Precision Oncology business since we spent so much time on screening. So maybe just first, in terms of the base, it's been really impressive that Oncotype has maintained this dominant positioning for some time, even though we've seen some competitors try to enter and try to carve into that, what is the biggest reason that you think that Oncotype DX Breast business has been so resilient in the U.S. despite increasing competition?

Jeffrey Elliott

executive
#34

Yes. I'm glad you mentioned. Precision Oncology for us is about a $600 million business. It's a very high-margin business. Gross margin is there, probably north of 80%. It picks up a lot of free cash that we can reuse to reinvest in the business and eventually fall through for all of you. Part of why Oncotype -- while there are competitors in the market, part of why the share there has been so high today, over 70% of women who have early-stage breast cancer in this indication, use this test is because of the quality of the evidence. We've run multiple longitudinal studies showing that Oncotype can safely predict which one will benefit from chemo and which ones are better off avoiding it. And also, we can accurately predict their prognosis, which put yourself in the shoes of a woman diagnosed with early-stage breast cancer. You don't want to use chemo if you can avoid it. Chemo itself can suppress your immune system. Chemo can cost cancers. Chemo can make you lose your hair. That's a bad outcome. But look, if you can benefit from chemo, by all means use it. If you're not, if you're unlike to pursue, 80% of women are unlikely to benefit from chemo, then why bother going on it. Over the test live, we think we've helped over 1 million women avoid the ravages of chemo. So again, the quality of the evidence here is key. We've had 5 studies published in the New Journal Medicine, that is the permanent Medical Journal out there. That evidence is helping us grow the business in the U.S. and internationally. This year, we expect over 20% growth outside the U.S., again, thanks to the evidence. That is helping not only penetrate existing markets further but also open up new markets, a big new one coming online this year, midyear is Japan. Japan is one of the -- maybe the biggest market outside the U.S. And now over 15 years after the launch of this test, we can finally get reimbursement in Japan.

Andrew Cooper

analyst
#35

Perfect. And just for the sake of time, I'm going to skip a couple of other things that I wanted to hit, and I said we'd talk about profitability. So the goal of 2024, it's a pretty big improvement from where you are today. Maybe just give a sense of some of the levers that, in your view, are higher risk or harder to achieve versus what's maybe a little bit more of the low-hanging fruit and the execution bit by bit.

Jeffrey Elliott

executive
#36

The biggest lever to get to our target in '24 is growth. We'll get there because we've invested heavily in this foundation. The foundation of labs, sales force, IT that we can leverage over time. So again, we are a growth company, we'll continue to grow in that top line. And that would generate a lot of gross profit that we can reinvest in the business and by '24, let that start to fall through. Also our sales and marketing are in line. You're starting to see leverage right away in sales and marketing. If you look at the Q4 run rate of sales and marketing, we're actually taking a step-down from there for this entire year. Even with growth in the -- even with Cologuard growing 24% this year, you're seeing leverage start in that sales and marketing line. G&A, we're making a large investment here because it's the right thing to do for the long term. I don't want to just get to profitability. When I get there, punch through. They keep generating improving margins, increasing cash flow each year. And to do that, we've pulled ahead investments in things like IT in the billing systems that will allow us to operate even more efficiently over time. So we are very confident in getting profitability in '24, and we will make sure that we get there.

Andrew Cooper

analyst
#37

Great. Well, I probably have hours of things we could talk about, but we're out of time. So please join us in the breakout down in [ Amarante 2 ]. But thank you very much.

Jeffrey Elliott

executive
#38

Thanks, Andrew.

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