Thank you everybody for joining us. I'm here with CEO Kevin Conroy and CEO Everett Cunningham. I'll just start off with saying and I'm David Leckow the diagnostics analyst. So you came up a lot of consecutive beat and raise quarter. Where operating margins frankly probably surprised even you guys. As we approach the tough comps how should we think about the momentum in the business and you know what your potential is to beat expectations? You know, not a lot surprises us about our business anymore, Sarah, for saying. Thanks for having us. We are really happy to be back at the Piper Conference. And, Dave, our business continues to grow. It's a strong business. I t starts with, you know, our lead colon cancer screening opportunity. There are 60 million people in America that aren't up to date with colon cancer. Colon cancer is the number 2 cancer killer in the U.S. Just last week, an old good friend of mine told me he has stage four colon cancer, late 50s. There are just so many people who are not up to date with screening, and they're finding out that they have the disease when it's metastatic. So the opportunity here continues to be one where, you know, we just have a passion. Our mission is to help eradicate this disease, cancer broadly with tests that help prevent it, detect it earlier, and guide treatment. And that's our Cologuard, our screening business on one side. Our precision oncology business with Oncotype DX on the other. And as we look at this business, we see growth this year over last year. We see growth next year. We see growth out into the future. And every January as a team we sit down, we map out our five-year plan, give that to the board of directors. And that's an aggressive exciting path forward for us. Gotcha. How far are we into the rescreening opportunity or are we maybe with penetration rates or percent of tests or however you wanna slice and dice that? Yeah, thanks. Rescreen, which is a big growth lever of Exact Sciences. Just the definition of rescreen: we have those people that take Cologuard and then since it's a three-year interval test when they take it the first time it's that second time we call that the rescreen patient. It's about 20% of our Cologuard revenue this year. In 2025 we look at it to be about 50% of our Cologuard revenue. A big continuing growth lever for us. Commercially of which I lead that commercial organization we have people out every single day helping physicians helping hospitals with their rescreen population. We have the data. We have the lists. We can digitally help them screen those patients. Our marketing campaigns are geared towards that rescreen population. A s that population grows we know exactly by territory by market on where to do that. Lastly around rescreen is we wanna make it easy. We wanna make it easy for our healthcare providers to care for that population. I f a patient goes in and they might not hit their rescreen anniversary we can order Cologuard anyway. We can give that physician the list of their rescreen population. They can cover that order those for the population. Then when their three-year anniversary comes up during that year they get Cologuard. So it's just a way in which we're making it easier to order Cologuard for one of our biggest growth levers. Yeah, yeah, this year in March I was at work and I got a message on my iPhone. It said you have a MyChart message. I went into the MyChart app which is My Health Systems and Epic the app. I went in there and it said Kevin, you're overdue for colon cancer screening which I thought was ironic. So I was able to email directly my healthcare provider who then immediately ordered a Cologuard test for me. It was just a couple of clicks. A week later I had a Cologuard kit at home. I was able to get rescreen then in very short order. That is the power of the IT platform. It's much of a cancer diagnostic company as we are. We're also a very advanced IT company. Those capabilities fuel growth. I think Everett may have said that we'll be 50% rescreen by 2025. We haven't guided as to when that will be. It won't be 2025 quite at 50% that would we if it is everybody here who's long Exact Sciences would be very happy. But we'll we over time we'll we expect that 20% to be 50% which means over half of our Cologuard screening revenue is recurring revenue. That's a really powerful part of the Exact Sciences story. Got it. Very helpful. So let's just talk about the pace of ordering from the 45-49 crowd. Has that been faster than average? And you know has that been feeling some of the recent growth? It has. The 45- to 50-year-old population is a big growth contributor for us. About two and a half years ago they took the screening age from 50 down to 45. So it introduced a new population for us. We look at it like this. Every year there's 4 million people that turn 45. So it's a big opportunity for us. What are some of the things we're doing? Our marketing messages are now geared towards a younger cohort, the 45 to 50-year-old. The way in which we message physicians, we let them know every single day that there's a new screening age of 45. We have to let them aware of that. Interesting, I was out in the field a couple of weeks ago. I was working with one of our colleagues. We had a customer, a physician healthcare provider, that was writing a lot of Cologuard for their 50+ population but wasn't writing any Cologuard for the 45-year population, 45 to 49. So it kind of told us, were they aware of that change, the guideline change. So we're out there every single day messaging that. Last thing I'll say is Cologuard is picture perfect for that 45 to 50-year-old. They're in jobs. They're busy. They have kids. You know, do they really wanna go through all of the process prep for a colonoscopy? Or Or do they want an at-home test, non-invasive, no prep needed, no dietary restrictions? That's where we position Cologuard. It fits perfectly. So maybe we can talk about the 40 maybe like a 40-45 yo potential cohort. I mean, I know, I mean every study I'm seeing you know basically is saying colorectal cancer for some reason or another is starting to happen in an earlier age than we've seen historically. You know is that a possible age group that you know some of the guideline committees or whatnots would look at? Who ultimately decide will decide when to move that? So the question is, will it and when will the age lower from 45 to 40? Is that even possible? It is possible. T he basic dynamic is how many people in that age group get cancer? What's the rate of prevalence of cancer in that age group? And if it keeps growing at the rate that it's growing which is alarming we would expect maybe not in this cycle but then the next cycle that the guideline group USPSTF looks at this. I t may be in the ten-year range before that has changed. But we do expect that another new 20 million Americans will come into the screening population at some point. The calculus is basically what is the cost of screening versus the benefit. They frame it as benefits to harms. And harms being measured as the colonoscopies or the cost of colonoscopies generated in that cohort. If the incidence rate keeps increasing we would expect maybe not in 2026 when the guideline group meets but by 2031. Okay, got it. No, that's helpful. Maybe this one's probably for Everett. What is the strategy around targeting healthcare systems versus just individual docs? Yeah, it's an AND strategy. We target individual doctors with our commercial organization. We have a great sales organization. I'd mentioned districts territories that are really focused on their individual customers. And we also focus on health systems. A couple of years ago when I came on board Kevin and I knew that health systems were critical for us to you know get our Cologuard volume from. So we more than doubled our resources in our health systems. We have more than 100 account managers that are calling on our largest systems. A couple of things that we do with our health systems first of all we need to make it easy for health systems to order Cologuard. So we have a big focus on making sure that we can electronically interface with that health system so they can be in their Epic system. They can order Cologuard. They can get the results back. It makes it easy, and they love that. They're always talking about operational efficiency at the health system. Another thing we do at health systems is we provide the help. Health systems right now are at a capacity for colonoscopies. Not only are we calling on health systems but they're coming to us saying how can you help us with our colorectal cancer screening rate? What they're doing is they're saying not only will we have that capacity for colonoscopies but we can use Cologuard for our average risk patient to make sure that we can get those people screened and get them screened at the appropriate time. That partnership is increasing every single day around our health systems. It will continue to be a big focus of ours moving forward. Gotcha. What's the latest on Cologuard 2.0? Can you talk about the process of raising ASP, what that looks like, how fast that can happen? And then on the cost side of it, can you remind us the COGs differences between Cologuard and Cologuard 2.0 if there are any? Yeah, so the second question first is about a 5% decrease in our COGs, which is about $125 per test, roughly speaking. So there's about a 5% decrease we think over time because it's a more streamlined product with fewer biomarkers that we're targeting that streamlines the workflow in the lab. Cologuard 2.0. What was the goal of that program? It was to improve the performance. And the number one goal with our next generation Cologuard test was to decrease the false positive rate. Feedback from customers said one of the top three reasons primary care physicians chose not to order Cologuard or didn't order it as frequently as we would like them to was because of the false positive rate. The number one goal was to identify all new biomarkers that would improve the performance, maintain or even increase cancer and pre-cancer detection while significantly decreasing the false positive rate, taking that down. And we achieved all of those goals: higher cancer detection by two points, pre-cancer by one point, and dropping the false positive rate by 30%. That means 30% fewer unnecessary colonoscopies. Colonoscopies are very expensive at about $2,500 per. W e plan and we're working with health systems now to share in those cost savings by increasing the price of Cologuard in a modest way so that we can recoup our R&D costs, our investment here, and we expect Cologuard 2.0 to launch around the first quarter of 2025. Perfect. Can you discuss the key IP around Cologuard? You know, I know you can't talk about legal, i.e., ongoing legal issues. But if you can maybe discuss what you have IP around. Let me start by saying there's in fact I just ran into somebody in the hallway who said Kevin I you know remember you 14 years ago talking about this at-home stool colon cancer screening test? I didn't think it had a prayer of being successful. Y ou know next year we expect it to be over a $2 billion product. We've invested immensely into our research and development efforts. We have found new markers. This has been an enormous amount of effort and cost. W e have secured intellectual property. We have 80 patents in the colon cancer screening field. We have about 80 patents pending. I f companies want to try to copy what we have done they are you know they have to respect our intellectual property. W e've never really had to talk about this. But you know there are some companies that don't respect IP. But there's a reason we have the laws that we do in the U.S. We intend to enforce our intellectual property and expect that to be enforced. Got it. Maybe you can talk about this some of the competition and blood. I don't think I'm gonna get an answer on asking which Freenome, Guardant Shield, or Natera—I mean, Natera I think is gonna have an initial readout, not necessarily a later stage readout. Which of these would concern you? W hy is blood maybe generally not a concern? I'll probably get more of an answer from that there versus a rank order of the competitors. Well, you know, there are a bunch. I wouldn't say there are any competitors. To date, I've been hearing about blood-based colon cancer screening for seven years. And I haven't seen any people tested with an FDA-approved test. And the reason being is yes, there is a need for more different, unique, improved forms of testing. But inferior performance is not progress. And that's what all of us at Exact Sciences has a blood-based screening program. We think there is a niche application for it for people who refuse guideline-recommended forms of screening. There is a need, no doubt. Is FIT like that's the hemoglobin in the stool test is FIT like cancer detection in the 70+% range and with a high false positive rate which some of these blood tests seem to have and no pre-cancer detection? Is that progress? No, no, not really. Will there be a role for it? Yes, but albeit, you know, it'll be a limited role. I think it's easy to talk up a good game. It's really hard to go run a massive prospective screening study and put up good results. And the reason is a biological one. For early stage cancers and pre-cancers very little DNA is being shed into the blood. Many of us in this field have looked for signal from the immune system. We've looked at protein markers, DNA markers, RNA markers, et cetera, et cetera. The challenge you run into is in stage one tumors and pre-cancers, just there's not signal that is reliable from blood. In stool there is because the inner lining of the colon is where the cancer is. Those cells, as soon as you have a pre-cancerous polyp, are being shed at a very high rate directly into the sample that we test. t here isn't the same biological barrier. How we as a field overcome this we don't know that there's a path forward. But we've been hearing about this for. I've been CEO for 14 years. For 14 years we have been hearing that a blood test would take over this market. 14 years later not one person has been tested with an FDA-approved test. That's not true. Epigenomics did. They just went out of business. y ou know the performance wasn't there. t he Epigenomics test never took off. Gotcha. Maybe you can talk about the fact that you're getting operating leverage now. You have a pretty decent balance sheet here. I mean I do think you have $2 billion in debt but with 2025 maturity and that one's closely in the money right now. I don't think there's necessarily any kind of financing overhang on your balance sheet. You know how do you think we should be using that balance sheet in the coming years? Do you see any M&A opportunities? Do you see any holes in your precision oncology business where you think you know you can incorporate new areas testing there? I don't think there's any holes in Cologuard. That's why I'm asking precision oncology. Well, you know, I first of all, in terms of balance sheet, our philosophy has always been the leadership team has to own that balance sheet. The CEO has to own that balance sheet. This isn't something that is delegated. You know, and we've always believed that from day one is make sure that you're adequately capitalized. We took a range of, I think, 2025, 2027, 2028 converts and pushed those out to 2030. We have a small tranche of 2025s that are 2025s that are still due, very manageable with the current cash that we have on our balance sheet. Over this time we'll generate a lot of cash be able to pay off those instruments refinance them. We have tons of different options there. In terms of how we think about M&A it hasn't changed. There are a lot of seemingly cheap assets out there. A week doesn't go by that somebody doesn't approach us about something interesting that they have. And we have a robust business development team and an advanced technology group that helps us take a look at opportunities. But you know we look at number one is there the right mission fit? Do they help us in those three areas: prevention, earlier detection, guiding therapy for precision oncology? And that's one is it a right culture fit? C an this be fast-growing and profitable? So those are the things that we look at. T here are some interesting companies out there. You just have to make sure that the science is really strong. You need to make sure in the precision oncology field that a path towards very broad-based reimbursement is strong. The secret to Exact Sciences is, look at our brands, our two leading brands Cologuard and Oncotype, strong gross margin profiles, deep brand awareness [among] primary care physicians [and] oncologists for Oncotype DX, international capabilities. That has provided real strength to this company. We compare those opportunities to the internal programs that we're funding, and those external opportunities have to be better than the best thing that we have internally to fund. Got it. No, that's actually a great segment 'cause I'm gonna ask you about your MCED business. It's clearly a cash burn here. I mean generally speaking right now we're seeing a lot of move from investors outside from higher cash burning large TAMs into more you know tangible cash flow positive like Cologuard you know honestly. Any thoughts to reducing activity in that business whether it be spending on R&D or any kind of other overhead or allocations? The MCED business refers to multi-cancer early detection or one blood draw most cancers. It's really an amazing technology that works. We have data that we've released showing 60% cancer detection with only a 1.5%-2% false positive rate. It's remarkable. If you screen a whole population you're gonna on average shift the stage of detection by one full stage. There is no therapy as effective as earlier detection. We acquired Thrive. We added our own technology DNA methylation technology to the effort. We're seeing great sensitivity and specificity performance with the R&D team. The caveat is that Congress still hasn't given Medicare the authority to pay for a test that detects more than one cancer at a time. We're we have there is a bill pending. We have been working with the American Cancer Society and other advocacy groups. There's a bill pending that has over 50% of Congress as co-sponsor. You would think that would lead to legislation that gets signed into law. But that is not the case. If that legislation doesn't pass next year we will bring down our spend not eliminate it. It'll still be a strong investment in the field. And we would run the pivotal clinical study after we see movement within Congress. W e think that's a good plan. That allows us to let some of those profits flow through and then also make investments into other high ROI programs internally. Gotcha. And then maybe just on the blood test, the not MCED blood test the For colon cancer. For colon cancer. What are the latest timelines on that? And what are the puts and takes to make it shorter or longer than your? The first question is why would we have a blood-based program if the performance isn't there? Well, we know that there's about one in three patients who get a Cologuard test that never return it, just like there's about one in three people who don't show up for a colonoscopy. Many of those people get a Cologuard test. Many of those people don't return the Cologuard test. We know who these people are. We have a direct ability to work with their healthcare provider to get them tested. We can reach out to the individual directly. We can reach out to their physician. Medicare has provided a pathway for reimbursement with those patients. We expect our blood-based colon cancer screening test to have data from our large pivotal study, the Blue-C study, in the middle of next year, followed by a submission to the FDA and approval probably within about a 12-month time frame. Gotcha. Perfect. With 22 seconds left, what's faster, your marathon time or Everett's fastball? Oh my goodness. Not a close call. Marathon time probably. Your marathon. Well, I did shatter the 5-hour mark by a minute and 10 seconds. Everett's fastball, I guarantee you, is faster than that. It was so fast. I'm sitting up here talking to you guys so. There you go. Thank you guys. Thanks. Thanks Dave. Thanks Dave. Thank you. I would have let it go over but I'm.