Next session. Thanks, everyone, for joining us. My name is Mike Ryskin. I'm on the Bank of America Life Science Tools and Diagnostics team, and I'm excited to host for our next session, Exact Sciences. We're joined by Kevin Conroy, Chairman and CEO, and Aaron Bloomer, CFO. Kevin, Aaron, thanks for being here. Thanks, Michael. Great to be here. We'll keep this a fireside chat, but if any of you guys have a burning question, raise your hand, and we'll get a mic to you. Kevin, maybe just to kick things off, you've been busy. You had a very interesting first quarter update a couple of weeks ago, or last week. Maybe you could give us sort of the high points from that. What really stood out to you as the quarter played out? Yeah, and just taking a step back, I believe this is my 15th conference at Exact Sciences, and a lot has changed in 15 years. When we first presented, I think we were a $50- million market cap company with this idea of reinventing colon cancer screening and solving the problem of what was then the number two cancer killer in the U.S. I am so proud of the progress that we've made. The first quarter highlights work that has been done over a very long period of time, we believe, giving us the ability to go solve this, one of the big problems in cancer. Taking another step back, though, what is our bigger purpose, our bigger mission? It's to help eradicate this disease with diagnostic tests and screening tests that help prevent it, like Cologuard does, detect it earlier, like Cologuard. You'll hear about Cancerguard. Both of those tests do. And then help to guide treatment, like our tests, Oncotype DX, OncoExTra, Oncodetect. It's an exciting time because we have built a company that is now a platform company. Scientific platform, which powers just the incredible performance of our tests. Number two is the commercial platform. Nobody has a commercial engine like we do, the ability to reach health systems, healthcare providers, payers, patients, the consumer of healthcare. And then this technology platform that we call Exact Nexus. So that technology platform has multiple benefits. We'll talk a little bit about that today. Those assets that we have, those capabilities we've developed, create a unique competitive ability on our part to address this big need of prevention, earlier detection, and guiding therapy in a way that leads to better outcomes. The first quarter, we had a wonderful first quarter. Maybe Aaron, you can touch upon that. Yeah, so we said back at the beginning of the year that this was going to be the most transformative year in the company, and we kind of outlined three key things. One was going to be momentum and growth back in the core of our business. Second was around new product launches. Third was leveraging the scale and the platform that Kevin talked about to really deliver sustainable profitability and execute against all three of those in the first quarter. If you look at it, we exceeded expectations on the top line, really pleased. I'm sure we'll get into some of the changes we made to the commercial organization that allowed us to beat on the top line and, importantly, raise then, given line of sight that we have already into the second quarter and into the back half of the year. New product launches. We launched two of the three new product launches that we intend to launch here and announce that on the last call. First, Cologuard Plus, and second, our Oncodetect, which is our molecular residual disease test. The third would be around the platform. We grew profitability by more than 60% in the first quarter. 60%. That is on the backs of growing nearly 50% last year. This is all part of, again, us creating scale and leverage for our company moving forward. Great. That's a great intro. Maybe I'll start with that first point, the momentum and the growth in the core. You talked about the commercial organization and how that's gaining traction. Could you expand on that? Sort of how are you seeing the benefits play out? What did you see in the first quarter? What are your expectations for the rest of the year? We made a number of changes as we diagnosed kind of some of the challenges we had last year. First was around making sure that we had the appropriate size organization. Just going back to levels that we had just a few years ago. In the meantime, we've grown Cologuard more than a billion dollars over that period of time. Significant leverage, but resizing that. What that's allowed us to do, and what we talked about on the call, was increase engagement with healthcare providers. We said that that was up more than 30% year- over- year in the first quarter. The second thing we talked about was around going back to geographic territories. Ensuring that we had the right size, every key territory and zip code around the United States had the appropriate rep in that territory and that they owned it. They owned their territory. What that has led to is increased accountability and productivity for the reps. We've talked about not only did we increase engagement with healthcare providers, our reps are more productive. On a per rep, per day basis, calls are up more than 10% year- over- year. Going to the geographic territories has led to increased productivity. Ensuring that we're giving them the right tools for them to be able to be successful. A couple of examples of that. One is we used to have this program we called No Order Left Behind. Where we're seeing the most growth is coming from the newest ordering providers to Cologuard. We've rebuilt our inside sales organization such that when a doc first orders Cologuard, we want to make sure we're reaching them within that first week. We're back to the basics of doing that. Giving them the right tools. So that reps, when they're out in the field and they've got maybe a lunch appointment, they've got a free hour or two, helping them prioritize and be able to see right in their app, in the Salesforce app, to be able to see who is the next best doc to call on, sliding that into their schedule and going and making more calls, again, speaking back to the productivity. That said, it's still early. We did increase guidance. We take guidance increases this early in the year with a great degree of caution. At the same time, we were really pleased with the results that we saw in Q1 and the line of sight that we had from those commercial changes in the second quarter. I was going to touch on the guide increase as well. You just kind of touched on it there, Aaron. Like you said, it's not typical to increase the guide this early in the year, and you must have a lot of confidence. Could you break out sort of where that confidence has come from specifically? Is it really tied to the commercial organization changes? Do you expect more benefit from that as the year rolls on? Are there additional changes you're going to be making as the year goes on in terms of refining the GOs or maybe rolling out some additional tools? We will always continue to look to optimize, but all the changes that we made to the organization went into effect last December 1st. We'll continue to monitor it. It is still early. If you look back to the first part of your question, the guide increase, we increased by nearly $40 million. Almost all of that can be attributed to the changes and the benefits we're seeing from the commercial org changes and then the productivity that we're seeing from that. If you take a step back and you look at contribution to growth, that's just one key element that we have. It's maybe part of the element that we didn't necessarily have as much of last year. Rescreens, and I'm sure we'll get into that too, it's a recurring form of revenue. It is the single biggest dollar contributor to our growth this year and will be for years to come. Our Caregap programs, which was up triple digits last year, saw very robust growth again in the first quarter. We have line of sight to even more robust growth in the second quarter. There are many, many elements driving the growth, but the guide increase came from the commercial changes. You just touched on rescreen and Care Gap, so let's go there next. First on rescreen, I mean, it's something you've been talking about for years and years, just given the nature of the business. It seems like you're finally sort of hitting that critical mass, and you're also getting into that, not just that second rescreen, but the third. Can you talk about sort of the attach rate, the capture rate there, and how that's playing out relative to your expectations? What is a rescreen? Cologuard is a test that is indicated every three years. Our goal is to make sure not only that we get somebody into colon cancer screening, but we keep them screened. Because the challenge with colon cancer is it can start at any time, and it starts as a precancerous polyp, and you want to find that. Every three years is a very protective way to ensure that you have the maximum chance of actually preventing the disease by finding and removing a precancerous polyp or finding stage one or two cancer, eminently treatable. Most people may know this, but stage one cancer, 98% survival, five-year survival. Stage four colon cancer, about 8% survival. It is imperative that you keep people screened. As you know, over time, in the first year, we launched Cologuard, we screened 100,000 people. Last year, we screened in the range of four million people. New news is, as of yesterday, we completed our 20 millionth Cologuard test. That represents 17 million unique people. That means three million rescreens. Over time, that builds. It builds in a kind of a quadratic way because you keep adding new layers of growth over time. First time rescreener, second time, now we have third time rescreeners. I'll be on my fifth Cologuard test. That is a very powerful tool for growth. As Aaron mentioned, if you kind of look at the growth drivers out over the next five years, this is just getting started. It's a sizable portion of the total number of tests that patients that we screen. Over time, it will become over half. The capture rate is between about 50%-60% today of the eligible patients. We're making it a lot easier to get patients rescreened with a simple text, answer two questions. If you answer those, if you basically don't have symptoms or a family history, you're eligible for another Cologuard test. That data goes to a telehealth provider who is able to order a test. That's a powerful way to just keep people screened. Our goal is to get people screened. The Salesforce goes out to our nearly 200,000 customers on a quarterly basis and educate them, prompt them to remember Cologuard when a patient comes in. Automate that so you're getting more patients into getting screened with Cologuard. Over time, you're going to see more and more people rescreen. It's an enormous, I mean, it's really exciting to be able to think about this idea of moving to someday 10 million people screened a year and 15 million people screened per year. Rescreening is a big part of that. You just talked about some of the tools that drive rescreening. Can you talk about tying it back to the commercial organization? Sort of what's the commercial energy required for a rescreen test versus a new test? There's education that is required because many primary care docs, when they first order Cologuard, they don't know what the guideline says about rescreening. Heck, a quarter of docs don't know that the screening age lowered from age 50 to 45. There is a ton of education that is required because of the nature of the primary care setting, which is chaos. Our job is to bring clarity to that chaos, simplicity, repeatability to say, here's how you order a Cologuard test. Here's how simple we make it. A rep comes into an office with their Viva iPad, and the rep can see that, say, that individual physician has 12 patients who are due for a rescreen test in the next 12 months. Doc, I'm going to click on this, send you an email. You will be able to see who those 12 patients are. You or your staff can go in, check the medical records of those patients, call the patient, however you handle your practice, and order a rescreen test for all of them. Today, about 40% of all of our rescreen tests come from that pre-ordering because a prescription is good for one year. You can order that test for up to a year before you actually send that test out. It is wonderful. That rate will grow over time. The technology platform enables that. We have made major investments, over $1 billion of investments into the tech platform. Because of those investments, we can power rescreens at a much more efficient clip. Is there also an angle of sort of the DTC side of things going straight to the patient, straight to the consumer that, again, might be more fruitful with a rescreen than with the new patient? Yeah. If you were due for a rescreen test, you're too young, far, far too young for that. You would get a text or an email or both saying, okay, it's time for a rescreen. Here are two questions to answer. You answer those questions. Again, that data goes directly to a telehealth provider who's then able to see. It's pretty basic. If you're not up to date with screening and you don't have symptoms or family history or you haven't recently had cancer, et cetera, then you're eligible for your next Cologuard test. We are able with the Exact Nexus platform to go into the cloud and look up your insurance plan. We weren't able to do that five years ago. We needed you to enter that. Imagine what the falloff rate was in the completion of that rescreen order, a consumer-initiated order. Same thing. We know who your health plan is. We can populate it for you, and then you can confirm. Are we a tech company or are we a diagnostic company? We can have that debate. You can't do one without the other. When we started 11 years ago when we launched Cologuard, 100% of our Cologuard orders came in by fax. Today, a much smaller, a small fraction come in by fax. Electronic ordering, electronic resulting leads to about a 30% step increase in a physician's willingness and frequency of ordering Cologuard. We have integrated with about 400 health systems with our Exact Nexus platform. We still have about 300 to go to cover the country. We are so far ahead of anybody else in the field. We have been at it for eight years. That requires work on both sides. Education with every office. How do you order Cologuard within the Epic environment? How do you do it within the Athena environment? What we have built is a powerful tool that will lead to this incredible recurring testing, keeping people up to date with screening, leading to better outcome, also recurring revenue. Maybe just tying the last few questions and answers together. You hit on DTC. One of the things that's so exciting being a CFO here at Exact is we have so many ways to get net new patients screened. You talked about DTC and customer-initiated ordering. We highlighted that on our call for the first time just a few weeks ago, which was that that was up triple digits. It's still small, but it's something that we're trying to meet patients where they are. To the younger patient population who might not be going in and seeing a physician, we now are able to leverage our platform that we've built out to be able to engage with them in a really, really simple way. Answer a couple of questions. We'll get you a kit. We've talked about Care Gap programs. We've talked about our Salesforce. All of these are ways to drive net new patient growth. Then once you've got that patient, you have the opportunity to have them for life, right? The recurring revenue stream. This whole flywheel just builds on each other. It's fantastic and very powerful. We've seen screening rates jump 11 percentage points nationwide in the last decade. That's almost solely attributable to Cologuard. Now with Cologuard Plus, which we can talk about at some point, it's another, we believe, another step function increase in the ability to go get the unscreened people screened or people who've done colonoscopy once and don't want to do it again, screened with another highly sensitive, highly specific method. Okay. You just touched on Cologuard Plus. Kevin, let's go there. What's been the market reaction since launch? What's really stood out to you in terms of the doc and the HCP reaction? Yeah, the HCP reaction has been phenomenal. Cologuard detects 92% of cancers with a 90% specificity or a 10% false positive rate. Cologuard Plus detects 95% of cancers with a 94% specificity, so a 6% false positive rate. That is a 40% reduction in false positives. Why does that matter? You do not want people to unnecessarily get a Cologuard result and have to go get a colonoscopy. That has value to the patient, obviously, and to the provider and to the overall cost of the ecosystem. If you look at all screening tests, mammography, pap smear, PSA tests, Cologuard, there is no other cancer screening test that is 95% sensitive, 94% specific. It detects 75% of what is called high-grade dysplasia, which is a step before cancer. It is powerful, and it is driven by the scientific platform. Now the field is saying, hey, look, it's a heck of a lot easier to get time with a doc. HCPs in the primary care setting are busy. Now they're saying, look, it's just easier for us to get that access as we review the New England Journal of Medicine paper publication that covers Cologuard Plus, to take them through the package insert and the training materials. We're excited right now. Cologuard Plus is covered by Medicare at a step up in value at $592 a test. Over time, we believe that payers will also, commercial payers will pay that same rate. That is the rate that we offer to the largest plans. Over time, with coverage, coding, contracting, kind of over the next 24 months, we will eventually sunset Cologuard and make Cologuard Plus the single test that we run. It's better for patients. It's better for the economics of the health system. It will change outcomes. You mentioned Medicare versus commercial payers. Where's the commercial payment level now? And sort of what needs to happen to get that there to that $592 rate? The first step is coverage. Right now, the medical policy groups, which only update medical policies once a year, are reviewing all of the data around Cologuard Plus. It's better than Cologuard. We don't expect problems there. We expect that to be very smooth in terms of adoption. You have a handful of plans, United, some of the blue plans that have already issued positive coverage decisions. It's not going to be, we think that will take time, but it will occur. There is coding, and then there is contracting. We're starting to have some of those contracting discussions. We'll talk about that more over the coming quarters and into next year. What we have guided is don't expect much this year at all in terms of commercial plans and more next year. That's where we are. They are excited because, look, that lower false positive rate means less colonoscopy, follow-up colonoscopy expense to them, and also a better experience for their member, which they care about. What's in the guide this year, just to build on what Kevin said, is just the Medicare Part B, which is already covered at the $592 level. That's what's embedded in the guide. We started resulting Cologuard Plus tests now. Very proud of the work from our laboratorians to be able to do that in the second quarter. We'll start to see that uplift from that portion of the business. That's about 14%-15% of our total volume. Okay. So any commercial payer move this year would be upside to the guide at this point? Yes. Yeah. You're not expecting it. Okay. Can you talk about. One other quick thing about Cologuard Plus is, in screening, everything comes back to a group called USPSTF and the modeling that they do to determine whether a service should be admitted. It is basically cost-effectiveness modeling. Do you gain life years with this method? Does it cost you more? Cologuard Plus pushed the FIT test off of what is called the efficient frontier. There are two tests now that are deemed efficient in screening: Cologuard Plus and colonoscopy. That gives us the ability to confidently say Cologuard first. The message from the commercial organization is, look, we all know that there is a three- to six-month backlog around the country for a screening colonoscopy, and some places more. The message is Cologuard first. You get your patient screened now. If your patient has cancer, why would you want to wait six months? Makes no sense when you have a test that's 95% sensitive, 94% specific. Colonoscopy in these models assumes 95% sensitivity. That performance is the only performance difference is around precancers. That's why you do Cologuard every three years and colonoscopy every 10. We couldn't be more excited about what Cologuard Plus means for the long term. I mean, taking that question, taking the comment, as you transition the mix from Cologuard to Cologuard Plus, you've previously given an LRP, and we've sort of gotten used to how to think about Cologuard, both seasonality, quarter-over-quarter growth, year-over-year growth. Does Cologuard Plus change that dynamic at all in terms of having the higher sensitivity specificity? Just in terms of as that becomes a bigger part of your mix, how should we think about pacing through the year? You mean in terms of adoption or the transition from Cologuard Plus to? Both. Both. Both. Both. We flipped a switch, and now Medicare Part B patients effective in this quarter get Cologuard Plus. Other patients get Cologuard. Until new plans start to get implemented, the kit comes to the lab, we can look up and see for every individual patient what test they have access to and give them Cologuard Plus if their health plan has access to it. Again, think about Cologuard Plus and that 14%-15% of the population that is Medicare Part B. We wouldn't expect it to shift normal seasonality. Normal seasonality is what it is. Yeah, we'll keep everybody updated on contracting and more to come in the future. Okay. We've got a couple of minutes left. I want to touch on a couple of other points. One is you also mentioned Oncodetect earlier. Could you just give us some quick points on sort of feedback, expectations for the product, Medicare reimbursement? Oncodetect is a molecular residual disease test. It really helps answer the question of what is the likelihood that a patient is to recur. Our data around Oncodetect in the Alpha-CORRECT study showed that a patient with a positive Oncodetect result was 50 times more likely to recur than somebody with a negative result. You're a patient with apparently well-treated stage three or stage two colon cancer, and you want to understand what's the likelihood of recurrence as soon as possible so you can be aggressive in treating it or de-escalating treatment. Oncodetect can answer that question. It's a long-term investment. It's highly sensitive and specific. It is delivered through that same Exact Nexus capability and also our commercial organization that has brought Oncotype DX to about 90% of patients who get tested in the breast cancer space for chemotherapy guidance and the prognostic, how likely are you to recur? We have about 90% market share in that segment. Oncologists know Exact Sciences incredibly well. We will leverage that incredible Oncotype DX brand to extend into the molecular residual disease space. That is going to take time. It is going to take a number of years, we think, but this is a market that is less than 10% penetrated. We believe that due to the strengths that we have as a company, we will be able to have a significant presence in that and impact in that space. Let's touch on CG Blood, top-line results from Blue Sea midsummer. There's been a lot of questions on exactly what does midsummer mean? Anything you can tell us in terms of progress, expectations? Summer starts June 21st. It ends September 21st. Midsummer would be midsummer. There is no change at all. The team that developed Cologuard, the team that developed Cologuard Plus, and many people who developed a cervical cancer screening test at a company I was involved with previously 20 years ago, this is the same team. For many of them, it will be their fourth PMA cancer screening test. Those people do not exist out there. What they have done to develop a robust test, we have taken the time to do this the right way. It has caused some people, I think, on the street to be frustrated. Is it June or is it midsummer? Here is the answer. I do not care. Go to the science team and ask them, what is the right thing to do? They say, give us all the time to perfect this because we have one shot at 15,000 samples. Their level of confidence is high. We believe that we will have a test that is competitive, that has strong relative to the other blood tests, cancer detection, hopefully better precancer detection. It is a clinical trial, so anything can happen. I am so proud of the work that this team has done to lock down the algorithm, to do all of the work around manufacturing and quality and software validation and lab training, et cetera, et cetera, to put ourselves in the best position for success. This is not our first rodeo. There is a way we do things. I think that we are in a good position. Taking a step back, let's all understand that if you are given a choice between colonoscopy or Cologuard and a blood test, please choose colonoscopy, Cologuard, because the performance difference is significant. These blood tests don't detect very many precancerous polyps. And I'm looking around this audience at your age, your risk of cancer is still pretty darn low. Your risk of a precancerous polyp is not. And a precancerous polyp takes 10 to 15 years to progress to cancer, best they can tell. You want to find that, intervene, and remove it, and prevent the disease. And so that's why we believe colonoscopy and Cologuard. And why is Cologuard performing so much better? It's because cancer starts on the inner lining of the colon and the mucosal layer, and those cells shed, it's called hyperexfoliation. They shed at a super high rate. They break open, and the DNA is accessible. Even for a one-centimeter small precancerous polyp, we find those. You do that every three years. The goal is not to get cancer. The goal is to find and remove a precancerous polyp and make it a procedure that is part of the colonoscopy procedure. Done. We are excited about the ability to have both because there is a role for blood testing. The role for blood testing is for people who refuse every other guideline-recommended test. We are excited. We're in a good position. We're bringing the best of our science through our scientists through this endeavor. We think it's going to be part of the long-term growth story on the Exact Nexus platform with our commercial team. We're pretty much out of time, but I'm going to squeeze in one more question, Aaron, just so I want to make sure we get to it. EBITDA, positive EBITDA, something you've been talking about for a while, really important. As you're sort of right there, can you talk about prioritizing spend going forward versus driving more profitability? You've got a lot of commercial initiatives, got a lot of R&D initiatives. Just sort of walk us through the various buckets. You bet. Even in a year of investment, I would just ask how many companies are out there that are at scale, right? We will be approaching $3 billion of revenue, still sustaining high double-digit growth rates and grow profits by 60%. That is in a year of investment. We are prioritizing investments in sales and marketing right now. That is paying immediate dividends on our screening side. We have talked about that at length. We are also making meaningful investments in R&D and sales and marketing towards the launch of Oncodetect, which we believe is a long-term investment. To fuel that and fund that, we have got gross margin expansion, which we have talked about, and we lowered G&A by nearly 500 basis points with more to come here in the future. A long runway for us to be able to continue to expand margins over time. Great. And with that, we're going to have to end it there. Thanks for joining us. Thank you. Aaron, thank you.