Great. Thank you. Thanks for being here, Dan Brennan. Day one of the TD Cowen Health Care Conference. Pleased to be joined with me on stage here, senior management team of Exact Sciences. We have Kevin Conroy to my left, CEO and Chairman. To his left, we have Jake Orville, who's the General Manager of Screening, and then to his left, we have Megan Jones, who is the VP, Vice President of Investor Relations. Obviously thank you all for being here. Kevin, you know, last 18 months, a lot has happened. You know, you had the competitive ECLIPSE data come out, Exact pull forward profitability by a year. You know, the Pfizer relationship was terminated, and you took on, you know, 500 or so sales reps. The pipeline is progressing, new opportunities. Stock has reacted. It's one of the best performers recently. It's up, almost doubled, I think, you know, if you go back to the third quarter of last year. Maybe for those investors looking at the stock price and that really big move up that we've seen over the last, call it six months or so, maybe feel that they missed it, kind of, you know. How would, how would you articulate maybe the message here about what the investment thesis is going forward? Well, let me take it. First of all, Dan, thank you for having us here. It's, I've really appreciated our relationship over the years and, getting to know you. Thanks to Cowen for inviting us to present, and, I really look forward to the conversations. Hopefully, we get a chance to answer questions from, the group here. Let's take a step back. Our mission at Exact Sciences is to eradicate cancer through tests that help prevent it, detect it earlier, and to guide treatment. We are at the start of what we think is a golden era of the, of advanced diagnostics in oncology. It starts with risk assessment and then screening and then guiding therapy and detecting recurrence earlier. Over the weekend, we had the Cologuard Classic, which is a senior tour event. At the Pro-Am on Thursday, I had a chance to play golf with 3 survivors. Well, 2 of them are stage 4, and 1 of them, colon cancer, and 1 of them was diagnosed through Cologuard, early stage and was successfully treated. The other 2 patients are in for a very, very difficult future, and they know it. They were detected symptomatically in their 40s. The fact that early detection for this woman, Megan, led to a big, led to a very different outcome and hope for the future, is indicative of what we are trying to do. We believe that there is no therapy that is effective as early detection. The 2 later stage patients are on multiple different rounds of therapies and recurrence. Each of them had, one had, 3 children, one has 5 children. Therapies, as effective as they may be, aren't nearly as effective as screening and early detection, where with stage 1 colon cancer, it's typically treated with surgery and no chemotherapy. Can you hear me in the back of the room clearly? You can. Okay. Thank you. That's our mission, is to do this not only for colon cancer, to do it broadly for cancer with multi-cancer early detection. We believe that because of the work that we've done over the last 14 years of building a platform company with two incredible brands, Cologuard and Oncotype DX. Cologuard in a primary care setting, in some specialties, Oncotype DX, which is standard of care among oncologists in the U.S. We have the ability to bring every new test to the broad array of healthcare providers that need these tests for their patients. It puts us in a unique position as a profitable company, as a company that will see continued growth in a stable, consistent way for a long period of time. We're just excited for the future where we can have a positive impact on outcomes. Great. Maybe hitting on Cologuard, and we'll spend a fair amount of time there, and then we'll get to the pipeline and kind of the profitability. You know, when you think about the fourth quarter was a really strong one for Cologuard, and we'll discuss rescreening 45-49 in a moment. When you think high level, just give us a sense of how much of the strength that you've seen is maybe from a continued catch up as, you know, we come out of COVID and you've had these backlogs. How much of it is due to, you know, maybe some of the success that you've had on some initiatives that have been ongoing in the background for years, electronic ordering, IBNs. Maybe unpack a little bit about what we're seeing on some of these factors that could be driving growth for Cologuard. I think the big thing with Cologuard is as a broad screening test in a primary care setting, it takes a long time to be considered standard of care. What you're seeing is that Cologuard now is considered a frontline screening test, and more doctors are recommending Cologuard, either Cologuard or colonoscopy to their patients. It's come down to that in most offices, either colonoscopy or Cologuard. That's a great thing. It's because we have broad insurance coverage. It's because we're in the American Cancer Society guidelines, the pivot or the gold standard guidelines for the United States Preventive Services Task Force. It's because we have enabled electronic orders. That growth is because now we've seen 20 million more Americans come into the screening population with the lowering of the screening age. We have 110 million Americans in the screening population, 60 million on screen. Guess what? Colonoscopy is not going to get the job done alone. The capacity for colonoscopy is about six million average risk screening colonoscopies a year in the U.S. There are 60 million people who need to be screened. We're barely scratching the surface. This isn't one quarter or two quarters or three quarters. It's 8.5 years of being available, FDA-approved, Medicare-covered, covered by virtually every payer. We think this, if you look out at the next five or even 10 years, we're gonna see a lot of growth. Are we going to get to 40% of all people getting tested with Cologuard on a regular basis? We believe we're going to see that. We believe the competitive environment favors Exact, and we are the lead innovator. I've been with Exact for 14 years. I look at the next 5-10 years as exciting as the last 14 years have been. The next 5-10 years is going to be even more exciting. If I leave anything out, Jake Orville or Megan will jump in. Yes. Jake, maybe as a general manager of screening, again, there's a lot of things that you've been executing on for a while. There's opportunities ahead, kind of maybe what excites you the most, particularly as we look at maybe the opportunity in 2023 and 2024? Sure, Dan. Our growth accelerants are really kicking in now at a high degree. Kevin mentioned the addition of 19 million new people that are due for screening in that 45-49 category. That's really exciting for us. One, I believe that's a perfect patient for Cologuard. They're busy. Many of them don't have a doctor. If they are seeing a doctor, they wanna do tests at home that are convenient and also highly accurate. That's a perfect Cologuard patient. The other reason 45-49 is great for us is now we have the lifetime value of that patient. We know that if a patient does Cologuard the first time, they're much more likely to do it again, we can continue to screen them. That brings us to our partnerships with health systems. With 19 million more people due for screening, on top of the 40 million that were already due for screening, now the health systems are calling us proactively and saying, "Help. We can't get through this backlog of colonoscopy if we tried. We now need you more than ever. Your product's great for your underpopulation. We know that a positive Cologuard patient, we can then capture their colonoscopy. That's probably where we wanna spend our resources. We know that you'll do a great job with our compliance engine." Remember, we also work hard behind the scenes not just to reach out, but to also make sure that this patient follows up, completes their Cologuard, and then goes on to complete their colonoscopy. The health system partnerships that we now have are marvelous. We've doubled the electronic connection rate before the pandemic to now. We started about 30% electronic connectivity. We're now at 60. We expect that to go up maybe another 5 points this year. The reason that's great is because as we're working with health systems, we can now work with them to optimize their IT systems to identify people that are due for screening. We have a health system recently that called us, and through our collaboration, we identified 5,000 patients that were due for screening just through 1 click of a button. We were able to go then reach out to them. The great thing about that is about 80% of those patients had never been screened before. We're able to do our job, but also help the health systems do their job as well. Maybe just staying on the health system for a moment. I know it's been one of the things of many in terms of these drivers, but it seems like the traction is really starting to pick up. Is it possible again, to give us a sense of kind of the size of that opportunity? Like how many patients are in that ID and opportunity, and like what's been captured today? Just how do we think about the benefit that you've had and what the opportunity is going forward? 60%-70% of all primary care physicians, nurse practitioners work, are employed by a health system. That's been a transformation, as you know, in healthcare, over the last decade or so. That trend continues, and that trend is one that's very favorable for us because those health systems are incented to make sure that their colorectal cancer screening rates are high. They're incented by Medicare Advantage, which pays out bonuses to the health plans, who then share part of that bonus with the health systems. They're driving screening. As Jake mentioned, they're coming to us. There's been a change just in the last 12-18 months now. They're calling us and saying, "Help us with our screening." That allows us to have a conversation with them about Oncotype DX, about our tumor profiling test, OncoExTra, about our multi-cancer test, which is in development, and we'll start clinical trials. It, it allows us to have the broader conversation about our platform. Those conversations weren't happening in a systematic way two years ago. They are now, and they're accelerating. Got it. Okay. You know, the 45-49 you brought up a few times, you know, terrific growth in 2022. Beat your kind of initial guidance. I think you annualize at 8% penetration in the fourth quarter. Where, which it took, I think you're about that penetration overall for the over 50, and it took, I don't know how many, it was 8, 9, 10 years. Where does that go over the next couple of years? Like how much does this momentum that you saw, not that you're still not gonna grow it, but does that momentum slow or could we be sitting here at 15%, 20% penetration in the next 3 years? I'll take the first part of this and then pass it over to Meghan. If you go back to the fact that there are 60 million people on screen or who are not up to date in their screen. Some of them have never been screened. Some of them are overdue for screening. That's a lot of people. The opportunity for us to go capture half of those patients, people, make them part of our long-term screening approach of making them customers for life. We have a huge opportunity. This is not something that is a quarter or two quarter or one year or even two years. This, we believe is going to continue to build. Meghan may add more color. Like Jake said, I think Cologuard in the 45 to 49 population makes a ton of sense because those people are busy with work. They don't wanna take days off for colonoscopy. They may have kids at home. If you think about where Cologuard started in that age group, you know, it had really high awareness, broad insurance coverage. It had been on market already. It kind of benefits from having that buildup of awareness that Cologuard, you know, in the 50 and over population didn't start with. If I think about, you know, the path forward for Cologuard, the path from 0%-10% market share will be slower than 10%-20% for the overall market. I think 45 to 49 will lead that growth. Because Cologuard is now starting from such a broad base that we didn't have, you know, 8, 9, 10 years ago, I think the path forward will be much faster than what it took to get to 10%. You could be penetrated how much in the 45-49? Okay. You know, rescreening obviously is the other lever which you brought up today, and it was a really strong 2022. The guidance for 2023 suggests north of $300 million. Let's call it, you know, somewhere $320-$325 million, based upon 20% of Cologuard revenues. It implies a, like, a really big, I think, step-up in continued compliance. Just give us a sense of why that compliance has gone up so much. Is the math right? Similarly, I know in the past, I think Jeff has talked a lot about where that could go to. Kevin, I'd love to hear just, you know, where does that settle out in 3 years? Like, what, you know, what kind of rescreen opportunity are we looking at out in 2024, 25? It's one of the areas Jake as GM of the Screening business has done really an amazing job. Why don't I let Jake answer that? I think ultimately about 50% of our revenue will be rescreen. I mean, this will become a recurring revenue stream for us years out. as you mentioned this year, but think about it, closer to 20%. What's exciting is our engagement, our digital engagement. Remember, this is a patient we've already screened before. We know who they are. We know where they live. We have their cell phone number, their email. We can now communicate with them better than we've ever communicated before. We can also understand how they wanna be communicated with. Some people want a text, we can push them a text reminder, "Go talk to your doctor." Some people want an email, that email might say, "Hey, if you don't have a doctor right now or if you've changed health systems, here's a link where you can get a telehealth provider." Some people want a snail mail or a phone call. We now know more about these millions of people that we've screened. We've now screened 10 million people. We know a lot about them. Re-engaging with them allows us to get better at rescreening every time. The other thing is that we also know that if you've done Cologuard once, you're more likely to return that Cologuard kit at a much higher level. We see about 20 point higher return rate for someone that's done Cologuard before. As that return rate continues to grow and the rescreen population continues, now we have a lower cost of acquisition. Now we have a higher gross margin, if you will, on that product because we're working a little less to get them to return that kit, which is why it's a very, very favorable business for us in the future. Not only is that higher margin revenue, but it's more predictable. You know when those patients become due every three years, it's stickier. That makes just overall the model is easier to predict. I'll give you one example of, again, when you've done this a lot, how this works. Not always do you show up at your wellness exam exactly when you're due for rescreen. We can now go to a doctor who has 30 patients due for rescreen that year. We can actually get that order for all 30 in January, load it into our system, and release the kit and a text message that said the kit's coming when they're due for rescreen. We call that advanced order. Just little things like that improve the ability to engage with the doctor. We're using our time with them wisely, and then also improves the engagement with the patient, and now they know what they need to do when they need to do it. If you roll up Cologuard with the 45-49 and the rescreen and then the underlying momentum with electronic and IV and then the base, what kind of growth rate is reasonable to assume for Cologuard looking out? Well, we've said that we expect Cologuard over the long haul to continue to grow in double digits, not less than 15%. Clearly the trajectory that we've been on over the past few quarters implies higher than that. It's, again, take it 60 million patients. There are about 6 million screening colonoscopies a year in the U.S. It'd take 10 years to get through all of those patients with colonoscopy, and then people are due again. It's just not gonna happen. Part of the dynamic is that about 30%-40% of GIs retire over the next 5 years, and they're retiring during and post-COVID that accelerated the dynamic. Hospital staff in the endoscopy suite got this challenge. They have the same labor shortage that exists throughout healthcare. There's a limitation on the number of patients who are gonna go in for a screening colonoscopy. It happens to be at a time when a lot of innovations are coming to the GI suite, where there's higher value procedures to be done. All of those, there are so many tailwinds where people say, "Why is Cologuard doing well?" Well, it's not because of one or two or three reasons, it's because of 12 reasons. As a result of that, we feel confident over a very long period of time about the impact that we can have. Back to the story of this woman, Megan, who was diagnosed early stage. There are 52,000 Americans every year for the last decade that have died from colon cancer. This is a preventable disease. It can be treated when detected early. Outcomes can be changed. The thing that inspires us is take a look at what happened to cervical cancer in the U.S. Most people forget that cervical cancer was the number 1 cause of cancer death among women, as recently as the early 1970s. What happened was the Pap smear came into being. The Pap smear, the goal of the Pap smear wasn't to find cancer, it was to find the precursor lesions so you could ablate them and prevent disease. You've gone from 45,000 cervical cancer deaths in the U.S. to 4,500. It's just... That's what we believe we're gonna do this with colon cancer. The neat thing is you're seeing it in the data. The data that came out last week showed a rise in the incidence for early onset colon cancer below age 50. It showed a significant decrease in people age 65 and older. Those are the people when we first launched Cologuard 8 years ago, were the first people to get Cologuard because Medicare covered it. We know we're having an impact here. That drop isn't all because of colonoscopy. Colonoscopy's been flat for two decades. Maybe moving over to blood. When you think about where blood will stand over the next year or 2, you know, after, you know, a competitor goes through FDA, and then eventually you're gonna have your data later this year, and then you'll seek approval. Kind of what are the guideposts you think in terms of what's like the best case in terms of blood actually has a meaningful impact and, define meaningful and, what's the, what's the downside case where maybe it, you know, is really limited? Just, you know, whether you wanna talk through the outcomes on FDA or just, you know, how you see the data for your competitor and your own, pivotal trial playing out? All right. You're talking about a blood-based-. Yep. screening test. Yeah. In colon cancer, what kind of who influences colon cancer screening? It's the guideline groups, it's the payers, it's Medicare, and of course, it's the healthcare provider. Healthcare providers have looked at colonoscopy as the leading screening method because it has a high detection rate for cancer, about 95%. Cologuard detects 92%. I'm not quite sure how many precancerous polyps it defines, but let's assume that it's probably in the 50% to 75% to 80% of precancerous polyps. It's, it's a high quality test. Then you have Cologuard, which detects 42% of all precancerous polyps. The way the screening group looks at this is, okay, if you, if you put those accuracy data through the model, how many lives do you save? How many life years gain do you get compared to how many unnecessary colonoscopies you do? Those are the two factors. Benefit, life years gained, harm, unnecessary colonoscopies, which is kind of a proxy for cost. You compare that to the FIT test, the fecal immunochemical test, which misses a lot of stage one cancers. It detects about 24% of precancerous polyps. You do that test every year and it models out pretty well, in part because it detects 24% of precancerous polyps. If you have 10-15 years to find a polyp and remove it models out really well. In the real world, nobody does the FIT test every year. Like, nobody does it every year. 3 in 1,000 people do it every year. When you pump it through the model, it models out really well. Those are the three tests that make it into the guidelines. The problem with the blood test is the cancer detection is, let's call it, in the low 80s, and pre-cancer detection is in the low teens. It models very poorly. It doesn't model in a way that even gets it into the guidelines. What happens if you have a screening test that has lower, worse performance than even a $16 FIT test? Is there room for it? Probably. Does it make it into the guidelines? Nah, probably not. Does it make it into the quality measures? Docs are driven by, do they get a quality check if they run the test? They do for FIT, they do for Cologuard, they do for colonoscopy. Will they for a blood test? Probably not. We tried to offer Cologuard before we got into the quality measures. It was really hard. Somebody just sent me a photo of our kinda whiteboard all-employee update from 2016. 100,000 Cologuard tests. I mean, you do more than that in 2 weeks today. That's because we are in all of those things. We're covered, we're in guidelines, we're in quality measures. Any one of those falls short, you know, a blood test is gonna be challenged. The data is gonna be about the data. It's hard to detect pre-cancers from blood. There's a barrier between that pre-cancer and the blood supply. We know that. Stage 1 cancers, very hard to find because half of them are truly small and there's a physical biological barrier between that tumor and the blood supply. It's hard to find what's not present if you're looking for circulating tumor DNA. Is there going to be a role? Yes, because back to the 60 million. Is the compliance going to be 90% with a blood test? No. Can you show that if you offered a blood test to all comers, what percentage of people go to get a blood test after their doc tells them, you know, 'Go to Quest or Labcorp?' Maybe two-thirds. Jake worked at Quest for, sold his company to Quest. What was the compliance rate? Yeah. The compliance rate, to Kevin's point, you know, 60%-70% for routine blood testing. For specialized testing, maybe 50%. It's not easy. Just think, you know, the data says 20%-30% of patients don't pick up their medicines. Just think about what we're not talking about this room. We're talking about the population that we're trying to get screened. The only way to get to 90% compliance is to offer the test for free and only offer it in offices that don't care about HEDIS scores. You can do that like in an OBGYN office, and offer it only in offices where they have a phlebotomist on site. Can you get to 90% then? Yeah, maybe. Can you get to it in a real world? No way. There is no magic solution to colon cancer screening. The benefit of Cologuard is highly accurate. You can do it in the friendly confines of your own home, and even then it's not perfect. You combine colonoscopy and Cologuard, and we think over time, that's how you move to disease eradication. We have about five minutes left. Maybe let's move to the pipeline, and then we'll go to the cash flow and margins, which are, I think, a, you know, really important part of the story. 2.0 data is mid-year. You discussed on the 4Q call, you know, obviously specificity improvement is the key focus here. You showed great AA improvement in some of your case control. I'm just wondering, you also did talk about maybe sensitivity degrading a bit. Just talk through how we should be thinking about the 2.0 data and kinda what it's gonna mean? Cologuard Plus is the next generation version of Cologuard. It has more accurate DNA markers in it. We know that. We've done two case control head-to-head studies, Cologuard, next generation against Cologuard. It's a better test. Better sensitivity, better specificity. The main goal of this study is to reduce the false positive rate and see the cancer detection rate and the pre-cancer detection rate at least be no worse. That's what we would expect to happen. Of course, you never know in a big prospective study. We expect to see that data out around mid-year or to complete that study mid-year and then present the top line data, et cetera. You asked about cash flow. I don't wanna lose this opportunity with just a few minutes left. What you saw at the end of last year, we became profitable from an adjusted EBITDA standpoint in the fourth quarter, well ahead of when we guided to. There's operational discipline combined with top line growth, combined with strong gross margins. We expect to have growth in OPEX in the low single digits. There has been, you know, this platform that we've invested in for years. Now you're starting to see with continued revenue growth, the fall through to profitability is really strong. We expect that to continue. We're excited about that and that what that helps fund then is the pipeline. The two things that you mentioned, molecular residual disease testing, helping us detect recurrence in metastatic patients, earlier or even stage 2 or 3 patients where you think you've gotten all the cancer, that's a very important program. Also, our multi-cancer early detection test, which could be a lot bigger even than Cologuard. Our teams are hyper-focused on these three big opportunities: colon cancer, MRD, multi-cancer, top line growth, generating cash. We're excited about where we start this year. On the margins, we have a few minutes left. It's I think it's probably difficult for a lot of us to think through when a company turns profitable, you know, kinda how quickly can those margins, you know, kind of expand further. When you punch in flat OPEX growth, sometimes it seems like, you know, how long can that be sustained for? Sort of when we think through the level of expansion, how we should think about it, I think you're gonna host an investor day later this year. Just any initial thinking about the pace of margin expansion. You know, Jeff talked about best in class margins, which I assume is, you know, 30% plus operating margin. Just how do we think about the profile, the margin profile of Exact as we look out? Yeah. If we look at kind of the base business today made up mostly of Cologuard and Oncotype DX. Oncotype DX already has 80%+ gross margins, and we see a path to get Cologuard there as well. If I think about the broader business, the pipeline is a little bit harder to predict, like things like the multi-cancer early detection tests. Before you have an assay finalized, it's kinda hard to predict where the margins are gonna be. The base business today, 80% gross margins shooting for 40% adjusted EBITDA margin, margins over time. The way you get there, Dan, is about 20% of revenue would be on sales and marketing, 18%-20%. About 10-12 in G&A, then about 8-10 longer term in R&D. Is there like a revenue base that kinda gets you there? We haven't been more specific there other than it's a longer term target, we're obviously heading in that direction quickly. Great. Well, I think with that, we're out of time. Thank you, Kevin, Jake, and Megan for being here, and thanks all for being in the room. Thank you all.