Thanks, everyone, for joining us this afternoon. I'm Vijay Kumar, the life science diagnostics and med tech analyst at Evercore. A pleasure to have Exact Sciences with us. We have CFO Jeff Elliott. Jeff, thanks for joining us. Thanks for having me. You guys have had a pretty remarkable past 12-18 months, right? We went from the trough of the fear cycle to some exuberance, if you will. You know, the numbers certainly backed it up, right? Your third quarter numbers came in pretty strong. Cologuard still up, you know, 30%. Maybe just if you can talk about the performance in the quarter. Was it pretty much in line with the expectation? What surprised you? I think in the past, you've given some details about existing versus new prescribers, where the growth came from, small versus health system. Some color on how the quarter progressed. Sure. Thanks, Evercore ISI, for having us here. I really appreciate the time in Miami. We're based in Madison, Wisconsin, which is 15 degrees and cold now, so a little warm weather here is great. Thanks for those of you in the room. For those of you who don't know, Exact Sciences is focused on helping eradicate all the suffering from cancer and really helping prevent it through early detection. It's a mission. It's a bold mission, but one we know that we can win. Third quarter was a really good quarter. We're pleased with the state of the business, the progress we're making. You had mentioned that there's many different growth drivers out there. Today, our flagship product is Cologuard. It's a non-invasive test for colon cancer screening. Part of why this is such an exciting opportunity for us is that there's 60 million people today who need to be screened. 60. Our market share is just 10%, so there's a long way for us to grow. We're fortunate to have a wide variety of different growth drivers, from more doctors ordering Cologuard. On a quarterly basis, about 10,000 new providers are ordering Cologuard every quarter. The bigger opportunity is to get the existing base of ordering doctors to order more. How do we do that? It's through a broad surround sound campaign of marketing direct to consumers. It's through our talented team out in the field, our sales team, client, physician. It's through digital tools that are engaging patients more effectively every year. Perhaps some of the biggest growth drivers we enjoy are health systems, as you mentioned. In this country, about 2/3 of all primary care doctors work for or affiliated with a big health system. Our growth there has been very good. Today, that's over 60% of our revenue. Rescreens, Cologuard rescreens, the guidelines recommend repeating Cologuard every three years. That's almost 20% of Cologuard revenue today and growing. That's been a material driver for us. And lastly, I would say the younger population. 2.5 years ago, guidelines updated to now recommend screening start at age 45. Previously, it had been 50, and the reason being is because incidence has been growing in a younger population. We're not entirely sure why. We believe it's related to diet and lifestyle, but the change to the guidelines added 20 million more people to the screening pool. The team has done a very nice job executing and really penetrating that market. Today, in fact, our penetration rate there is higher than it is in the older population, the 50 and over population. So, we're fortunate again to have many growth drivers and a huge market that we serve. Fantastic. I think, with that as the background, you know, maybe some near-term dynamics here. When I look at your Q4 sequential assumptions here, almost I think it's flattish for Cologuard. Was there any cadence issues, something that got either pulled forward, anything one-off in the third quarter? Well, Q3 to Q4, a normal trend for us is really tied to primary care trends, utilization trends. So I would expect that going forward to be pretty much flat. Really, our business goes through a pretty, pretty steep inflection starting around late August, early September, as people come off of vacations, get back to work, and then primary care visits really pick up. That continues all the way through Thanksgiving, and then things typically slow throughout the holidays. So we're in the midst of that now. And then what that leads to is, from a revenue basis, a pretty sequential flat quarter, Q3 to Q4, in normalized terms. Going forward, I think I would just probably model that. Then when you look ahead into the after the holidays, then the growth really picks up January all the way through summertime at a pretty steep growth trajectory for the business. Earlier this year, Jeff, I think, there was some commentary about, like, reimbursement dynamics having pulled forward revenues. Could you just remind us what it was, and has it any impact for cadence for 2024? So Cologuard is routinely covered as preventative care. Over 95% of our patients pay zero out-of-pocket, which is, that's how it should be. Tests that are validated in guidelines should be covered in full. What's happened here is, the team, our internal team has done a really nice job of executing and making sure we're getting paid fully for all the tests that we perform. So about a year ago, we upgraded our internal billing systems. That allowed us to collect at a higher rate. When we make those upgrades, we also go back in time and try to pull through collections, really get paid for tests that historically maybe we didn't get paid in full on. So what that did is it added some, let's say, above and beyond revenue last year in Q4, and a bit spilled into the first part of this year. Now, on a go-forward basis, I don't expect that to continue. The team is doing a very nice job making sure that we get paid in full. Again, we're paid over 95% for over 95% of our patients, so there's not some big incremental opportunity to win new coverage. It really was just about improving the efficiency of our teams and systems. Gotcha. And you did bring up rescreening, 20% of your revenues. But you also cited, like, $50 million of headwind from rescreening. Like, I just walk us through, because when I look at the total number of, you know, rescreened cohorts, 2020 versus 2019 didn't seem like there was any change. So where is this headwind coming from? And what a rescreen is, is that the guidelines recommend you repeat Cologuard every three years. That's because colon cancer can form spontaneously, so you can't just screen once and be done. You've got to screen over the course of your lives. Guidelines typically say 45 to age 85 or so, to continue screening. And that's, you know, that's why we built Cologuard, to get more people screened and keep them screened over time. Cologuard rescreens are about 20% of revenue today. The reason why we face what I've sized as a $50 million headwind this year is because when you look back to early days of the pandemic, Cologuard volumes were depressed in April and May of 2020. So people that didn't get screened then aren't now due for rescreens this year. So if you you size that- Right In rough terms, it's about $50 million. All right. Welcome, everybody. What, just over a third of that hit Q3 of this year, and probably just under a third hit Q2 and Q4. So we're almost done with that $50 million headwind. You know, that should continue or that should end at the end of this year. Looking at the next year now, part of what excites us about next year is that the pool of patients becoming eligible for rescreens grows. This year was 1.2 million people, last year was 1.2 million people, next year now it's 1.6 million people. So the pool of patients coming in for rescreens is growing, and our success rate at getting them to come back to Cologuard on that repeat basis is growing, too. So I expect rescreens to be our perhaps our biggest driver next year, and for many years to come. Over time, if you look out into the future, I think half of Cologuard revenue will come from rescreens. You know, CFO, it's exciting. You start the year, and you have a pretty good sense of where a big chunk of the revenue is coming from. It's also higher margin revenue because these patients come back. When they come back, it requires fewer resources for us to re-engage them. It is a nice, nice gross margin tailwind. It's also a way to help just provide recurring revenue that gives us better visibility and better predictability of in the model. Fantastic. A lot of details there, Jeff. The I guess you did mention the success rate on in rescreens, right? Can you give us some numbers on what those success rates were over the past few quarters or a couple of years, how that's trending? About 50% of patients who come back today, who are eligible for rescreens, come back and eventually do Cologuard. Over time, that number has been growing. It's been growing because our teams out in the field are doing a great job educating doctors on the need for rescreening. Our digital tools are getting better at informing patients of when they're due and, and just really making it easy, taking that friction out of the system. When you think about that success rate relative to other tests out there, it is actually very good. There was a study published based on UnitedHealth data years ago that showed that the FIT test, which is another non-invasive test that's available, it's an at-home test that looks for blood in the stool. That test, which the guidelines recommend doing every year, only about 3 out of 1,000 people do it every year as recommended over a 10-year period. So us getting to even 50% is much better than we see in other non-invasive means. Our goal, though, is to get up to about 70% over time, and I think we'll get there. We'll get there through better execution and better digital tools. And that 50%, Jeff, like, is the implication your 2021 cohort is 1.6 million, so that's a step up of 400,000. Right. So half of those will, you know, get a rescreen test incremental. Is that the right way to look at it? They'll eventually get it. Well, it's really half of the 1.6 million people. Now, they all won't get it next year, because someone who becomes eligible, say, in December, they're not getting tested next year probably. They're more likely to get tested in 2025. Of those that we retest, about half do so within that first, like, calendar year. About half will do it in the second calendar year. So it, it's still look, it's a huge driver for us. It, it is our almost 20% of revenue today. If I look out in a, a few years, this is easily a $500 million business, and eventually it becomes half our revenue. What, where was that number a couple of years ago? Was it 50 or, you know, sub 40? A couple of years ago, yeah, sub-40. It's been steadily working its way higher, and this is. We have obviously great visibility into leading indicators here, and we can watch this closely. So we can run experiments to find out what works, what doesn't works, and use AI tools to continue getting better at this. So that rate has been steadily marching higher. It's been going up a few points every year, and the implication is next year should be in the low 50s, low-to-mid 50s? Let's hope so. Yeah. Look, it, we're, we'll try to get as many people as possible. The goal, again, is to get to at least 70%. That's gonna take some time to get there, but, I'm confident it'll keep marching higher. And that goal of 70%, Jeff, what gives you or what were the assumptions in arriving at 70%, and what gives you the confidence that that's the right number? What tools does Exact have that would allow you to hit those numbers? Yeah, so one way to look at it is to look at breast and cervical cancer screening. Yeah, I know it's women versus both men and women, but in breast and cervical, you see screening rates 75, 80%. And this is You know, it's been out there for a long time. You know, women have been educated for a long time, like, "Get a mammography." And so those rates are pretty high. So there's precedent to say that you can get up to that high. We say we'll get to at least 70%, knowing that, I'll speak on behalf of men out there, men typically aren't quite as compliant as women on this stuff. From a blended basis, our goal is to get to at least 70%. Gotcha. If I just stop, maybe I'm not doing the math correctly here, Jeff, but if I look at the rescreening revenues in fiscal 2023 Seems like it grew 50% year-over-year, despite the headwind. Do I have those numbers right, that the rescreening num- or revenues are? Yeah, we had guided to last year at least $220 million of revenue. We had said before that we beat that. This year we guided to about 20%, which implies somewhere around $350 million of revenue. So yeah, going from $220+ million to $350 million, yeah, I mean, that's 50% or so growth. Now, I've called out this headwind of $50 million. This team did a really good job of offsetting that, so that while the headwind exists, all else equal, through better execution, we've offset that, you know, a big part of that headwind. And that, that still feels like a pretty big step up from 220 to 350, Jeff. And was this some new capabilities, you know, that allowed you to, you know, reach these patients? Yeah. I think it's improved access from the teams in the field. It's improved capabilities. I'll give you an example of one. About a year ago, we launched the ability to do what we call an advanced order. What that allows is that, yeah, if you go back to your doctor, let's say it's been 2 years and 6 months since your last Cologuard, you're technically not due yet. Well, odds are you're not gonna come back again in 6 months. You may wait for a whole another year for your next physical. Well, we allow that doctor to submit an order up to a year in advance of that patient actually being eligible. We then hold that order up until the time the patient is due, and then we send the collection kit out. The patient then collects, and then we report the result and record revenue. That advanced order workflow gives the physician comfort that they can order the Cologuard test whenever, and then we take care of making sure the patient's screened at the right time. So it's capabilities like that. I talked about digital tools. These digital tools are allowing the frictions to come out of the process and allow us to increase that success rate. Another dynamic here I'd point out is that Cologuard was first FDA approved back in 2014. You do that math, nine years. We're nine years into it, which means that some patients are coming back for their third Cologuard now. When you come back for your third Cologuard I've done Cologuard five times, so I may be a little biased here, but each time you do it, like, your, the compliance rate gets higher, it's easier to do. When people come back for their third or fourth Cologuard, the success rate there continues to climb higher. So that's a newer dynamic, but it's one that will really start to play out in a major way in coming years. Gotcha. And, and do you have any more tools which could, you know, further take you down this journey of converting those rescreening patients and improving those compliance rates? We do, and I'll give you one more example here. I don't want to share too many secrets, but another one is that we allow patients to go to our website. Again, we wanna make it super easy for patients to get screened. If they don't have a physician right there that they can readily access, they can go onto our website and ask a physician using telehealth, submit the key questions on Cologuard to make sure that you're on label, and have a physician through telehealth order the test for them, all from. You can do it right now if you're on your laptop. Go to Cologuard.com and request the Cologuard's ordered for you. If you haven't been screened, please do. It's colon cancer is the most preventable but least prevented cancer out there. So you can go right to our website, order Cologuard that way. Again, it's a whole suite of digital tools to make it even more convenient to order. Gotcha. And then switching to the 45-49 age group, why did that group adopt so quickly? Was it the pandemic effect, or did Exact approach that cohort slightly differently? Did you use more DTC campaign? Yeah, so, what happened 2.5 years ago, the key guidelines here updated to lower the age from 50 to 45, at which we should start screening. That brought in almost 20 million people new unscreened to the recommended colon cancer screening. And in that age group, many of you are. I'm in that age group, I'm 46. In that age group, people are typically really busy with kids, and work, and other activities. They don't have time or they don't wanna take off two days for a colonoscopy, so, Cologuard really fits into their lifestyle. Also, some of the digital tools we have, I think, really appeal to the younger audience. And if you're in this age group, many of us, myself included, have heard of friends or know people that have gotten colon cancer younger, so it, it's scary. It's again, it's one of the most preventable, if, you know, maybe the most preventable cancer. So people, I think, in this group just readily said, "Hey, I want this new technology that I can do. It fits in my lifestyle." You know, we've been educating the market for many, many years on Cologuard and the brand name, and so the brand name wasn't new, it was just the guidelines changed. So we saw rapid adoption, and we went to 11% penetration today in an age group in just 2.5 years. Our penetration rate there is now actually higher in the younger age group than it is in the 50 and over age group. So the team's done a nice job here. I think over time, this will still be one of our key sources of growth. Now, the beauty of getting somebody who's 45 tested is that through rescreens, we could have that patient for 30 to 40 years. So that's a, when you think of lifetime value of customers, we'll take anybody, but, like, that, that's a really valuable customer for us. In that cohort, Jeff, I think revenues were almost up like triple digits, right? year-on-year, 2023 versus 2022. Do I have the numbers right? It is approaching 20% revenue, not quite there yet. It's approaching. You think back a few years ago, before the guidelines updated, it was maybe 1% of revenue. Now it's almost 20. So the team did a really nice job of executing there. Look, this is gonna be a big source of growth for many years to come. In that cohort, is a colonoscopy indicated, or is that not part of the guidelines? And is that- It is. The recommended modalities are the same, for 45 to 49 as they are 50 and above. I would think, like, that patient population is a little bit hesitant to perhaps go for a colon Look, we've got in this country, we've got a capacity constraint on the number of total colonoscopies that can be done. Not many new GIs are graduating and wanting to go out and do colonoscopies, so the capacity is relatively fixed. Whereas, when the guidelines changed, that expanded the people. It actually grew the people needing to be screened by 50%. Cologuard capacities can ramp quickly. You know, we've got capacity to do 10 million tests per year, and we're just under four now. So we can absorb the incremental capacity, where screening colonoscopies are really maxed out around five or six million per year. So we've got a big problem in this country. Even if you, if you wanted to screen everybody who's due now with a colonoscopy, and let's assume nobody else came into the pool needing to be screened, it would take 10 years to screen everybody. That's just. We can't do that. And remember, new people are coming in every day. On a daily basis, 10,000 new people come in, into the screening age pool, and people who had been screened, say, five, 10 years ago with other, other means, come back and are eligible again. So we're capacity constrained with colonoscopy. Cologuard can really help fill that void. I think you called out a tailwind from this capacity issue. There's been some debate, Jeff, on whether that's one time or is that sustainable. Can you talk about what the tailwind was? There really should be no debate. It's not one time, it is sustaining. We see it in the numbers. I think you saw a shift probably a year and a half ago. I think part of the reason for the shift was the pandemic. The pandemic led to more people, or I'll say fewer people getting screened temporarily that created this backlog. But other sources have since come in, like lowering the screening age to 45. That added 20 million more people. And so when you add that on top of this backlog that started with the pandemic, the problem's getting worse. When you look ahead, other factors are coming now, too. The need for payers and health systems to achieve their quality metrics, Stars and HEDIS, is getting harder. Starting next year, there's a full audit of all the beneficiaries on those plans. Historically, it had been a partial audit, a small sampling. So Exact Sciences is well positioned to help out, providing data on millions of people, who's been screened, and who hasn't. So the payers are increasingly turning to us as a partner to help them screen more people and provide that valuable information. So the problem's getting harder, not easier, and Exact is uniquely positioned to help solve it. Or maybe I'm confusing this with, I think what you called out as care gap program, Jeff. Can you just remind us what care gap program was, and was that, like, one time, or should that be recurring? Yeah. What we call Care Gap or our Gap Closure Program, there's really two flavors of it. One is a health system, one is on the payer side. So in either case, what this is, is a concerted effort to screen a bulk number of patients who are historically reluctant to be screened. So an example here could be, let's say, a health system comes to us and says, "We've got these 10,000 people. We've been trying to get screened for years. We've been unable to so far. Can we partner?" And so they could submit an order where we provide all these digital tools around helping get these people screened, reach out through email, text, even phone calls, and try to bring them in. In many cases, we're able to get a lot of these people screened that historically, again, hadn't been. This is a big opportunity, one that I think we're pretty early on, but over time, you can imagine there's millions of these tests done per year, at least attempted to be done per year. Cologuard, I think, is well positioned to screen the masses because, again, it's an at-home convenient test, where capacity is not really a rate limiter for us. It you know, we can get three years of quality credit for a payer or health system, and many times, if you're a big payer, oftentimes they get scored on these. It could be, you know, $ billions of credit from the government for achieving quality scores on Medicare Advantage plans. Cologuard can help get many people screened. Again, three years of credit is a differentiator. The FIT test that's often used today in these programs only gets one year of credit. So that differentiator is really helping Cologuard start to succeed in some of these care gap programs. Gotcha. And so this is definitely, it feels like it's sustainable. It's not a one-off, fair statement? That is, and look it's, it's relatively small in terms of revenue today. Thematically, it's very important. Over time, I think it could be a pretty big part of our business. So when, when I, roll all of these, you know, three elements together, Jeff, between health systems, you know, 45 to 49 rescreen, or just let's look at that 45 to 49 and, and rescreening. Numbers I have, maybe $600+ million of revenues in fiscal 2023 from those two buckets, and a slightly north of $300 million the year prior. So year-on-year, we're looking at a $300 million step-up in 2023. And when you think about those two buckets, should we be looking at a similar $300 million step-up? Is the growth rate the right way to model these, opportunities, or on a dollar basis, like, what's the right way to think about them? We've been giving guidance for next year. Like I've said before, that in a couple of years, I could see those two combined being over $1 billion. So we expect a lot of growth. And I mentioned before, long-term, rescreens are half the revenue or more. So there's clearly a long runway ahead. The pool of patients is growing. You're seeing more and more people come back at a higher rate on rescreens. 45, you know, our goal there, it's we've got about 11% penetration now. The goal there is to get to over 40. I could see that one being closer to 50, long term. So a long runway in both of those at the head. Gotcha. And so when you look at the, I guess, penetration within the 50-plus age bucket, right? I mean, that group feels like it's been growing, like double digits, low double digits. Is there anything that you could do to accelerate, you know, compliance adoption rates in that group? I mean, there, there's a lot. That's where the teams out in the field really come into play. We hired a new chief commercial officer two years ago, Everett Cunningham. Everett's done a really nice job getting the teams focused on the initiatives that matter the most, helping draw clear lines of accountability. And so what we saw last quarter is the highest productivity we've ever seen out of our sales team, so I think that will continue. I could see a multiple expansion of our sales rep productivity over time. A big effort we have, you talked about health systems. Well, one of the key steps there to really unlocking a health system is electronic ordering. Today, we're up to about 70% of Cologuard orders come in electronic. What that means, though, is that 30% of orders still come in through a fax. I don't know how many people in here use a fax every day. I use one maybe once a year, and it's typically, like, some random healthcare thing. But so we've got to get more and more ordering through digital tools. When you do that, when you make it easier and make it where it's look, you, you're sitting down, you're looking at your Epic healthcare record, doctor, patient. The doctor can just click one button, that easy button, and order the test. You see a step up in adoption. In fact, when we see a health system convert fax to electronic, you see at least a 30% increase in orders, and that is sustainable. So, getting more and more systems to order electronically is a big push. Before the pandemic, so-called 3.5 years ago, our electronic ordering rate was only 30%, so it's been going up almost 10 points a year for a while. Each year, it gets harder to keep driving that number higher, but that is a big effort, again, because you see such a big lift in orders. The beauty of that, once you've created that electronic connection, us, our lab, to the health system, we can leverage that for other tests. So imagine dropping in our colon blood product or MRD products into that same foundation. That gives us a massive advantage, that creates really good scale and, again, ease of ordering for everybody. I think part of this electronic prescription is your connectivity to EHRs, and Epic was a big part. Like, are you now connected with all major EMR vendors, or are there still certain vendors you need to connect Cologuard prescription? You know, athenahealth's been we've been electronic there for a long time, Practice Fusion, eClinicalWorks, so we do have other electronic connections. You know, what's unique about Epic is that we are on Epic internally. We are a healthcare provider, so we run Epic, and essentially, all the big health systems out there run Epic as well. So Epic, they're right in our backyard. They're a great partner. They created a new ordering functionality called Aura. It used to stand for Orders and Results Anywhere. They've kind of renamed it, but Epic Aura, what that allows is any other health system on Epic can create a direct connection right to us and place an order without having to take any special steps. So it's a quick way to create that electronic connectivity to other Epic health systems. If you're talking about Cerner or Allscripts, some of the other ones, we can create the electronic connection. It takes more work on both ends to create an HL7 interface between our lab and that health system, so we can do it. We've done it. It just takes longer, more steps than it does to create that connection with an Epic user. Gotcha. And so this 70% of prescriptions coming in electronically, is that should that still be going up next year or It better, Everett, if you're listening, it should go up next year. Yeah, it will. You know, I'm confident. There's a pretty massive backlog of systems waiting to connect. What this requires is a little bit of work on both sides. The health system IT team, our IT team, we can do it in a matter of weeks, and once you do it again, you unlock higher order rates. Gotcha. I know, like, when you said 70% of prescriptions are coming in, they're electronic. But from a number of healthcare provider perspective, like, how many of those healthcare providers have access to these electronic prescription? Well, they all technically have access. Anybody, any doctor can order. We've got a web portal anyone can use, any healthcare provider can use. Some still, maybe they're not-- they don't know about it, or they're-- they just love sending faxes for some reason. Not everybody is using it yet, so part of this is on the reps to go out there and make sure doctors, health systems know about the electronic connections. And they're doing that, look, by going up 10 points a year for This is our fourth year at that pace. That's pretty rapid adoption. I don't know if that'll keep up with that pace next year, but part of it is awareness, part of it is just getting in line, getting through the IT workflow at the health system and making sure that we're connected. What is Everett focused on right now when he's thinking about fiscal 2024? Is that mostly on health systems, large health systems? Boy, I think it's all of the above. Everett's got a great team below and around him. You know, he oversees all of the Cologuard sales team. He oversees our sales, our marketing efforts, you know, our overall customer experience, so I think all three get a lot of focus from him. But again, he's got a good team around him. The sales team, specifically, health systems are a big part of it. They, you know, that's over 60% of revenue. Making sure that the doctors all know what the guideline change. Our best estimate is that maybe 50% of doctors know that the guidelines now say order or, you know, start a screen at age 45. So we've got to change that. We know in this country, screening saves lives. We have to get more people screened. The majority of colon cancers that happen, happen in people who are unscreened. I think it's 75% happen in somebody who's unscreened. So again, if you haven't been screened, please get screened. Yes, Everett is making sure that doctors know about these guidelines, making sure the digital tools we have are used, electronic ordering happens. Where is that number coming from, Jeff? 50% awareness among docs that the screening guidelines have changed. Well, that's it, it's an internal number. You know, anecdote from the field, some survey work we've done. And obviously, we know we can quickly tell through our ordering systems. If a doctor's ordering a high a month for ages 50 and above, but not for younger, that's a pretty good tell that they, they're just not aware of the guideline change. So, we can quickly go out and make sure that doctor is aware. Gotcha. Then maybe switching on to Cologuard 2.0. You know, we saw the data, pretty impressive data, both in terms of sensitivity, specificity. I think the submission was by year-end. Has it been submitted to the FDA? Yeah, first on, the final submission will go in this month, actually December, early December. It's a rolling submission, so there's multiple parts to it, so it has started, it's just not done yet. And then think of it as a year or so for FDA to work through the process. So we're assuming we launch in early 2025. First time, what Cologuard is, Cologuard two is, it's an enhanced version of already a very good test. The reason why Cologuard two came to be was because there are some doctors who pushed back clinically on Cologuard one, because what they say is the false positive rate, which per the FDA is 13%, they say that's too high. Look, a false positive, it's not the best outcome for the patient. That's the patient who goes to a colonoscopy unnecessarily. So, Cologuard 2.0, the goal of that was to improve the false positive rate and also, and add some operational enhancements to the test. Vijay mentioned we shared some data over the summer, showing that we had improved that false positive rate by 30%. We had 30% fewer people going to a colonoscopy unnecessarily. That helps in patient experience, that helps in health economics, it also helps in our financials significantly because that's more patients that stay in our re-screen pool over time. We also added in some enhancements to our, our lab workflow to improve the efficiency there. So we expect Cologuard 2.0, once it's FDA approved, to improve our cost of goods by at least 5%. So it's a pretty major impact on margins. Over time, perhaps the biggest driver of growth will be going back to the doctors, and we know who they are, back to the doctors that historically wouldn't order Cologuard or wouldn't order as much because of that false positive rate. Everyone in the team knows who they are. We can go back and target those doctors directly, and we expected a nice step up in orders because of that. Do you have any sense on what percentage of docs had this resistance or inertia, if you will, due to false positive rate? Internally, we know who they are. We haven't shared that number, but we're excited to get the new product out there. Look, Cologuard 1's an awesome test. It's included in the guidelines. It's FDA approved. We've now screened over 13 million people. I think we can help save even more lives with Cologuard 2, both in terms of getting more people screened and getting them screened more accurately. Any sense, like, is it, like, low single digits of, like a prescriber base? Stay tuned, Vijay, on that one. Look, we invested over $100 million in Cologuard 2 because we know the impact it can have on patient outcomes, and we know the size of the opportunity. That's helpful. That's another way to size it. I guess the one year for FDA approval, because it's a rolling submission, like, my understanding is when you have these rolling submissions, you have constant back and forth. FDA is familiar with it. It should be a faster, quicker process. The FDA has been a fantastic partner for Exact Sciences across a wide variety of different tests that we work with them on. Cologuard 1 took almost 16 months for approval. Part of that was it was a new modality. Part of it was they asked for an outside advisory panel to review the test. I'm not sure if that'll happen for Cologuard 2, but they've been a good partner. We've had a good relationship there, and I expect an approval to eventually come. But the FDA is busy. We're not the only ones working on this, and the FDA, you know, has limited resources. So, we're just trying to estimate based on historical experience, that it'll take about a year. If it comes faster, great. We want to get it out there as soon as possible. Is it a supplemental PMA or a new, new- No, it's a new PMA. It's- It's a branded product. Okay. Okay. And you did mention the 5% reduction in COGS. Are you gonna let all of that drop down to the bottom line, or will there be some reinvestments? We will likely let a lot of it drop through. We've put out long-term margin targets. Cologuard two is a part of how we'll get there. The margin targets are at least 20% Adjusted EBITDA in 2027. Again, it's at least. We'll try to get to as high as possible. But to get from here to there, we're at more like a 9% margin this year, so we'll have to let some of it drop through. But we wanna make sure that we're balancing kind of near term and long term in everything that we do. That means that we'll continue to invest in growing our top line, invest in key R&D programs. Cologuard 2 and our, you know, the other R&D products we have will help us do both of those, grow the top line and, and drive better margins. And will, once you launch the new test, Jeff, is that gonna be run in the same facility, or will you be offering both tests, or is there a transition period? Yeah, there will be some overlap. And yes, the same facility. Anybody who would like to come to Madison, Wisconsin, and see our lab, you're welcome to. It's a highly automated lab. That team does an amazing job. But they'll both be run simultaneously for a time, because when we ship a Cologuard kit out, that patient has up to a year to return it. So, today, there's kits out in the field that will come back, let's say, next year. So you know, if assuming we launch Cologuard 2.0 in early 2025, there'll be 6-12 months of Cologuard one kits out there that we'll still-- obviously, we'll still serve those. From a marketing standpoint, though, I don't think we'll continue to keep marketing Cologuard one, but we'll obviously process the tests that are still out there. Gotcha. And because you'll be running two tests, Jeff, does it have any gross margin implications, or are these, like, similar lines, similar- What it—I guess what it means is the, the benefits on gross margin from Cologuard two, the full benefit will take, call it a year, to really phase in. Gotcha. Because we obviously recognize revenue on the test that we process. So some of the workflow advantages of Cologuard 2.0, you'll see a partial impact, and that will build over time, and about a year after launch, you'll see the full impact. Gotcha. And on competition, I think like 12 months ago, there was a lot of fear. We went through the fear cycle, but there still seems to be on and off noise. I think one of your competitors, or potential competitors, I should say, they presented a 2.0 data, and it wasn't clear if it was a formal trial. Have you guys given any thought on in a competition for these blood-based tests? Look, I mean, I've been studying this space or working in it for over 10 years, and you hear about companies trying to get in. I get why. You know, there's over 50,000 people die per year from a very preventable disease. So it's a big problem, one that we are, I think, well-positioned to help address today and for many years to come. But most of these companies that have tried have failed. You know, Cologuard's the only, let's say, the only new game in town, and Cologuard was first FDA-approved nine years ago. On the market today, you have a colonoscopy, which has been on the market for 25 years. People who are willing to do it, it's maybe 40%-50% of people are willing to do that. There's also a fecal blood test on the market. It looks for blood in the stool. They've been on the market for decades, and they've got about 10% share. Beyond that, you know, others are trying to come in, but it's a tough market to get into. You first have to do things the right way, you know, develop a test that is based on sound science, run a high-quality study, work with the FDA, work through the guideline groups, work through the quality measures and the payers, build up a sales and marketing team. You know, this we've invested $ billions in Cologuard, to a point now where we've got good momentum. We're seeing good margins fall through. I get why others are trying to get in, but, yeah, I think it's, it's a long road ahead, and it's a long road. We have a blood test that we'll share data on middle of next summer. I think there's a role for blood. Again, there's 110 million people total in this market. There's a role for blood. It's, it's more of a niche test than anything, though. Gotcha. Anything in the pipeline? I think you've spoken about launching Oncotype in Japan. There is an MRD test, a therapy selection test, and I don't think I've heard much about your MCD test, where we are on the validation. So which of these could be meaningful or could be opportunities in 2024, and which could be in 2025 and beyond? Multi-cancer, from a revenue standpoint, is beyond 25, I would say. The reason being is because that test, before it gets real material adoption, would need FDA approval and guidelines. So that's an active program. It's one of our big three investment areas for the future. And look, what multi-cancer is, it has the potential, in our view, to have the greatest impact on human health outcomes of any test out there, even greater than Cologuard. Because for the majority of cancers out there, there is no effective screening modality. This could be a way to help find more cancers earlier and help shift that to where perhaps surgery could remove it, rather than having to go on chemo and other advanced therapies. So it could have a huge impact. We are invested in it. You know, no change to the timing here, that one of the key things where we're looking at is: Will Medicare have a pathway to reimburse the test? Today, they do not. We are hoping and, and waiting for Congress to act to create this pathway. If Congress doesn't, then we're less likely to invest the dollars in the pivotal study to bring it through the FDA. And we need a, we need a clear line of sight to that return on investment before we spend several hundred. So it's an important program, one that I think eventually Congress will create that pathway. There's a little uncertainty on it right now. Understood. And on Oncotype Japan and MRD test? Yeah. So Oncotype, global test, been on the market over 15 years, helps answer two k ey questions for women diagnosed with early-stage breast cancer. 1, what's my risk of recurrence? two, will I benefit from chemo? It's the only test validated to do both those. It has five million internal publications. It really is the standard of care in the U.S. Internationally, it has only about 25% share. One of the key areas of incremental growth is Japan. Finally, Japan reimbursement just came online in September, so that launch is starting. The potential there is huge. The potential is the biggest market outside of the U.S., so it could be a big growth driver for that business. The exciting part of our international business, which this year is about $150 million, the really exciting part is we've got a great team there, a great team that can serve as the foundation for other product launches. So you can imagine a world down the road where we have MRD, therapy selection, multi-cancer, perhaps colon cancer screening, all outside the U.S., built right into this existing platform. How like, have you sized Japan? Like, how big from a dollar perspective Japan could be? Japan could be north of 25 million. Yeah, I think it's early there still, but it could be a big growth driver in the next few years. Gotcha. And on therapy selection and MRD, could they be meaningful next year? MRD, I think the, the real you know, look, on a base of revenue of close to $2.5 billion this year, for something to be material, it, it, it takes some time, right, to get there. MRD, we expect reimbursement to start likely, the back half of next year. So I think the, the real contribution from a top-line perspective is probably more likely 2025. But we're excited about MRD. MRD is - you know, we see as the, the potential to be over a billion-dollar franchise for us. It fits right into our, our sales and marketing team. It fits right into our labs and, you know, we-- in many cases, at least when you look at breast cancer, we're already touching those patients. At least 50% of all the breast cancer tissue in this country already comes to our lab. We can take that same block of tissue. Today, they answer that key question for Oncotype. In the future, it can answer a question around residual disease, recurrent disease, possibly therapy monitoring, all, you know, starting with that same block of tissue. So that sample synergy, that engagement with the patient, we're well positioned to move forward on. Gotcha. You know, here in the closing last few minutes here, Jeff, anything else from a macro perspective for 2024 plus or minuses we should be thinking of? Yeah. Well, like, you know, this is a healthcare group. Let's say that, we're not exposed to many of the pitfalls you see out there in healthcare, whether it's GLP-1s or vial production or, you know, slowdown in China. Exact in many ways, we control our own destiny. We've got a strong balance sheet with over $700 million of cash. We've got massive markets that we serve today. Core growth, on market products, that is the top priority. I I would say our number two priority is R&D. The next couple of years will be exciting times for our pipeline. We plan to make our first MRD test available still this quarter, and next year with, reimbursement coming online. We'll share data next year on our colon blood program, and Cologuard two, we expect approval and launch in early 2025. So it's an exciting few years. You know, I think that these are huge markets, and I think we've got a great team inside that can help execute on the opportunity. Maybe a last question here on margins. Jeff, you've, you've laid out a 20% Adjusted EBITDA margin target. Gross margins will be part of the thesis. But when I look at your G&A, that's, that's the highest spot. Why is G&A so high, and when, when do you start leveraging G&A? Yeah, G&A is an area I think going forward will be our biggest area of incremental leverage from here. This year, we're getting. If you look at an adjusted basis, we're getting about 3 points of leverage this year. So it is starting. Granted, it is I'll say G&A is too high, both in as a percent of revenue and in absolute terms. What's in G&A? The biggest areas now are IT, building out some of these digital tools we've talked about. Our customer care team and customer care engine are in there. So there are ways that we can continue to automate more and more of that. But over time, my goal is not only to bring it down as a percent of revenue, down towards the 10%-12% range, but actually start to bring it down in absolute terms. It's gonna take some time to get there, but I think the efforts have started to help leverage that, the G&A line. Fantastic. I think, with that, we're almost at the end of time. Last few seconds, any closing comments, Jeff? Thank you, Vijay. 45 minutes is a long fireside chat, but thank you very much, and thanks to everybody in the room. Fantastic. Thanks, Jeff. See you.