Hello, everyone. This is Rachel Vatnsdal from the Life Science Tools and Diagnostics team. Thank you so much for joining us today. Today we've got Exact Sciences. As a reminder, this will be a 40-minute session. The first 20, give or take, will be a presentation, followed by 20 minutes of Q&A. So with that, I will pass it off to Kevin for the presentation. Kevin? Thank you, Rachel. Thank you, Rachel and JP Morgan. Welcome to all of you. Welcome to those who are listening on the webcast. Our purpose at Exact Sciences is clear and bold. It is to help play a role in the eradication of cancer through tests that prevent it, detect it earlier, and guide treatment. That's who we are. It's what we are. We're a cancer diagnostics company, and we're one that's having an impact. This is our safe harbor statement. We will be making forward-looking statements today. What's next is now. This year, we expect to have the most productive year in the history of Exact Sciences, launching two major, impactful tests. Tests that really will change the practice of medicine. Cologuard Plus, we'll talk about it. OncoDetect in the molecular residual disease field, a tremendous and fast-growing field that's having patient impact, and multi-cancer screening, CancerGuard. We're so excited this year. We're also going to announce data in about the middle of the year in our colon cancer blood program. So it's going to be a really busy year, and we're excited to have you along for the ride. So when we first started Exact Sciences 15 years ago, the whole idea was to eradicate colon cancer by addressing a huge unmet need. Well, since that time, we've become more of a platform company. And how have we done this? Really, three ways. Number one, with our scientific platform, which we'll also talk about. Our commercial engine, best in class, 1,400 people, allowing us to bring innovations to patients and physicians who need them. And then also the Exact Nexus IT platform. These capabilities that we've developed have taken a long time, significant investment. And I think what you'll see over the next several years is the rewards of those investments that we've made over the last 15 years. All of this allows for personalized treatment of cancer, and it also allows for the earlier detection. It's a powerful platform, and it really starts with people. So when you look at our flywheel, the thing that creates momentum at Exact Sciences, it starts really with incredible scientists and the scientific platforms that we've developed. And then with that platform of people and science, we're always developing clinical tests that actually change the practice of medicine. All too often in our field, you see tests that are developed that don't actually change the next step in clinical practice. You know with Cologuard, you know with Oncotype DX, it changes that next step. The next part of the flywheel is so important because it is developing evidence that is rock solid, evidence that you know clinicians, guideline groups, and importantly, payers rely upon to issue coverage decisions, to incorporate it into the standard of care. All too often, companies don't always think about developing robust evidence. Our hallmark at Exact Sciences is ensuring robust clinical studies that help answer the questions, getting these tests into guidelines. And this is the hard work. The right side of the flywheel, it takes a tremendous amount of time and effort. As you get to the bottom of the flywheel, this is where your people, your commercial engine starts to accelerate things. And then the Exact Nexus platform, that customer engagement, healthcare providers, patients, health systems. That's where the acceleration occurs, and you see that with the top-line growth and then also bottom-line growth, allowing us to reinvest back into the business. It's an important part of who we are and how we grow over time in a way to be able to bring a robust pipeline to the physicians and to the patients who need this. We have two units at Exact Sciences, our Screening Business Unit and also our Precision Oncology Business, each anchored by the two most well-known brands in cancer diagnostics, Cologuard and Oncotype DX. On the Screening side, you're going to see a lot of innovation coming through to our customers and having a significant impact in the field. And you're starting to see that too on the precision oncology side. So this is a powerful pipeline that will have an impact not only in 2025, but for years to come. The Exact Nexus platform. This is an incredible, almost magical platform that when we first started out, we were just trying to develop a test that would improve colon cancer screening. And quickly, we realized you really need to build a technology company upon which you bring advanced cancer tests to health systems, to physicians, and importantly, to patients. And how do you do that? And what is Exact Nexus? Well, Exact Nexus is a best in class and incredibly robust IT stack with about 100 applications connected to the Epic EMR system that allows us to connect with 70% of health systems in the U.S. today. That doesn't happen overnight. That is health system by health systems integrating electronically. So a physician within that health system can electronically order a test and get a result of a test, can get prior authorization completed, billing completed, the clinical next step completed. With the power of AI, it will change all of this, making it more seamless. It also powers, for example, our care gap programs, which we'll talk about. It allows population health management. Population health management in the world of screening is how you bridge this gap of 60 million people who aren't up to date for colon cancer screening. This is powerful, and it continues to grow. We brought Oncotype onto this platform this year, this last year, and now we're able to drop new tests into this platform, bringing their impact to patients. I'll give you one stat. When you bring Cologuard into, w hen you bring a new health system into the Exact Nexus platform, you see a step up of 30% more people getting screened with Cologuard because it's easier to order. It's easier to get those results. We don't talk about this enough. You will see the power of it in years to come. Now let's talk about Cologuard. Colon cancer is the number two cancer killer in the U.S., but it's also the most preventable and least preventative of cancers. Screening, actually, with stage one cancer, there's a 98% five-year survival rate. If you find and remove a precancerous polyp, you can actually prevent cancer in the first place. That's the power of Cologuard, and when we first started, I know a lot of people thought there's just no way you're ever going to get millions of people screened. We've had 18 million people screened today with Cologuard. And the power of this is that it's resulted in $22 billion of savings to the U.S. health system because of earlier detection, because of prevention. Last year, so proud that 4 million people were screened with Cologuard. And we're just started. That's about 13% share. We believe over time we have the ability to get to 40% share. And another thing to put in perspective is today in the U.S., there are about 5-6 million people who are screened with screening colonoscopy every year. Cologuard's at 4 million. We will surpass that in the near future. And it only makes sense to have a less expensive, highly accurate way of screening for colon cancer to be adopted. And we see that world where you're at 14 million or more people screened every year. Cologuard remains an open-ended growth story, 21% five-year compounded growth. We have the ability this year to accelerate growth. When you take a look at our rescreens, that's the people who get their second or third Cologuard test. When you look at our care gap programs, combined, that could be 10% base growth right there. Cologuard Plus, another couple points of growth. Then our commercial effectiveness. We have the ability to improve how we reach the physicians who are new to ordering Cologuard. And so this year could be a really special year, and the team is working together in a way to make this happen. Let's focus in on repeat testing or what we call rescreens. Cologuard is indicated by the guideline groups to be used every three years. When you use it every three years, it's the most cost-effective. By getting tested every three years, you can significantly reduce your risk of mortality from colon cancer. And what you see here is in the dark, 1.1 million here, and then the purple, you see the number of people who are due for their first rescreen and their second rescreen. And you see this grow over time, and then third rescreen. And over a long period of time, a tenth Cologuard rescreen. And today, what you see is about 50%-60% of people in any one of these columns gets rescreened within the next two years. We believe we can drive that to 80%-90% by automating this, again, through the Exact Nexus platform, creating incredible customer stickiness. And it's so important to get people tested again and again and again to keep them safe and to actually move towards disease prevention and disease eradication. We know what has happened with cervical cancer in the U.S. Cervical cancer, where you've seen 80%-90% of people screened on a regular basis, you've seen cervical cancer go from the number one cancer killer of women in the 1960s to number 13 today. That's what's going to happen with colon cancer if we keep this up. And it's a powerful story. And there is another driver of growth that we've seen emerge in the last two years. This is care gap programs. When you look at preventative health, Medicare Advantage plans, commercial plans incentivize it. In Medicare Advantage plans alone, we estimate that there is about a million people a year that we can help get Medicare Advantage members tested on a regular basis so that they're up to date with screening. And why does this matter? Because Medicare Advantage plans offer about $12 billion in incentives based upon quality measures, the Stars and the HEDIS quality measure ratings. So in the last couple of years, those plans, we've had deep engagement with them. And I'll give you an example of one of those plans. A Blue Cross Blue Shield plan came to us in one large state and said, "We'd like you to screen 90,000 of our members who have persistently been underscreened." And so through the Exact Nexus platform, we were able to screen those people. Because of the data we have, we were able to inform many of them that they were already up to date, and even the health plan wasn't aware of that. And then ship Cologuard kits and communicate with those members to get them screened. Just last year alone, we had over 250,000 people screened through these care gap programs. Health systems are also doing the same thing. They're coming to us and saying, "Look, these are patients that we haven't seen in three years. Can you help us get them up to date with colorectal cancer screening?" And when you think about it, it's the logical way to screen people over time. You know when a patient comes in to see their primary care doc and they have eight minutes, colon cancer screening a lot of times doesn't make the top 15 items. This is a way to automate it at a societal level. And it's working. It's having a big impact on patients. Now, this is my favorite part of the presentation. This is Tim from Massachusetts. We're going to share his story in his own words. My grandma lived next door to us for most of our lives. He's my first grandson, so he was very important to us. I'm a fifth generation union painter. We didn't always have a ton of money, so he worked a lot. He'd do anything to take care of us. I went for my yearly physical. My doctor said to me, "They just lowered the age of having a colonoscopy to 45." I was 46 at the time. I went. Then he said, "There's a Cologuard test. Do it at home. Send it in." And then he called me and said, "Hey, there was a positive result. Let's just get a colonoscopy." I woke up from the anesthesia and he said, "You have colon cancer." That was really scary. It was completely out of my control. I had an appointment to go see the surgeon, and I was like, "Man, I might leave here today and never come back." They removed part of my colon. It ended up being stage three. It was frightening. My grandma, she sent me this picture. Oh, I love that picture so much. You were scared to jump off the wall. I promised you I'd be there. I'd be there, and I am. I know you are. I love you too. After I'd started chemo, my oldest daughter, Taylor, she surprised us one day, told us she was pregnant. It was like, "This kid can't grow up without me." I don't know how I can love somebody so much that I never even saw yet. We did chemo for six months. Everything worked out good. No evidence of disease. Oh, it's such a relief. My grandson came along. He just is everything we needed at that moment. I can't be more grateful that I did Cologuard. It is unbelievable that I can see my grandson become a grandfather with his own little grandson. Yeah, that's why we come to work every day. I am so proud of the team that has made this possible. And last year, screening 4 million people is just the start. We estimate over time that there have been 86,000 people like Tim who've been diagnosed with early stage treatable colon cancer because of Cologuard. There have also been 500,000 people who have had precancerous polyps removed, leading to disease prevention. And as you can see here, the impact that we can have, the real impact that we can have is generational. And we're not going to stop. The precision oncology team is doing work that is equally as impactful. Oncotype DX has changed everything, really, in advanced cancer diagnostics. Oncotype DX answers really important questions for patients with early stage HR-positive, HER2-negative breast cancer. That's about 70% of patients diagnosed with breast cancer in the U.S. And before it came along, you had this real challenge, like, how do you decide whether a patient should get chemotherapy? Only 20% benefit, but you don't know which should get it. Oncotype DX answers that question. And it's backed by evidence with 100,000 patients in studies. It's become a standard of care. Because it's become a standard of care, patients, 2 million patients have benefited around the world. And this patient here who got a score of 13, what does that mean? That means only 1% chance of recurrence and virtually no benefit from chemotherapy. Can safely avoid chemotherapy. The precision oncology team really delivered last year, $655 million in revenue based on the strength of Oncotype DX. And this is the business. This is the team that is delivering on OncoDetect, which is going to impact patient care all over the world. And we're so excited because the strength of our relationships with oncologists, 98% of oncologists in the U.S. have ordered at least one Oncotype DX. We have 90% share. That's the base of relationships and customers, which will grow our precision oncology team. So let's now talk about the pipeline. The pipeline is driven by our insights and our unique capabilities in DNA, RNA, proteins, this multi-omics. And just a ton of technologies. We have two incredible R&D teams, one in Madison, Wisconsin, one in San Diego. These teams are focused on next-generation sequencing and our TARDIS technology platform that delivers the power of Cologuard Plus. This capability, the scientific capability, will fuel us for years to come. Cologuard Plus, amazing new technology. With only three biomarkers, we're able to detect 95% of colon cancers from a stool sample with only a 6% false positive rate. That's a reduction in the false positive rate of 40% relative to Cologuard. It's been recognized, New England Journal of Medicine publication last year, FDA approval last year. Importantly, at the end of last year, Medicare announced pricing for Cologuard Plus, recognizing this improved value of Cologuard, fewer false positives, less wasted costs on unnecessary colonoscopies, increasing the relative value to Cologuard by 16%. Proud of the scientific work that has led to that. Large payers are already starting to cover Cologuard Plus. We've been told by the guideline or by the HEDIS group that it will be included in the quality measures and CMS that it will be loaded into their system, so we'll be ready to launch at the beginning of the second quarter. OncoDetect. Okay, so for patients who are diagnosed with cancer, current treatment is you treat the patient, you hope that you got it all, but you don't really know, and then maybe you do PET scans down the road. The future is to look into that individual patient through a blood draw and look for even tiny fragments of residual tumor. So you have the tissue, you can find the mutations, look for those mutations in blood. So you can answer the question, did you get it all? Has the cancer come back? There are studies showing that there's an ability to detect recurrence a year sooner through a blood draw than even the most sensitive imaging PET scans. This is a powerful technology. This field is growing. It's about a $500 million market, only 5% penetration today. OncoDetect, we expect, will be launched in the second quarter with Medicare coverage in the colon cancer space, and we expect to expand from there. Our technology and our unique approach is today looking at between 50 and 200 mutations, and in the future, looking for 2-5,000 mutations. That's our unique scientific advantage, launching this through the precision oncology team. Let me see here. Okay, so I may have messed up the slide there. Let's move on to CancerGuard, our multi-cancer screening test, one blood draw, most cancers. We've been working on this for a very long time, almost a full 15 years since I've been with Exact Sciences. Second half of this year, we launched it. Why would anybody want to get one blood draw to detect most cancers? Because 70% of cancers aren't screened for. There's only five cancers that are recommended in screening, leading to only 14% of people diagnosed with cancer being found through screening when you're detecting earlier. To really bend the cost curve, this is how you do it. Initially, we'll launch into patients at a reasonable price point, out of pocket pay, right out of the flexible spending account or the health savings account, and we believe this can have significant impact. Performance in 2024, we delivered, and this is new news. We issued a press release yesterday, $2.76 billion in revenue. We provided guidance in the last quarter call of $350 million of adjusted EBITDA. We expect to be at least at that level, which is 44% year-over-year improvement. Again, we expect our Cologuard screening business to accelerate leading into 2025. I just want to emphasize that we are comfortable with current analysts' expectations around 2025 total revenue. We're also well on track to delivering on our five-year financial targets of 15% compounded growth and at least 20% adjusted EBITDA margins. 2025, our team is hyper-focused, accelerating core growth, launching new advanced cancer tests, and extending and leveraging the Exact Nexus platform. What's next is now. Can't wait to take your questions. Perfect. Thank you, Kevin. So maybe first up, just question. Can you explain what the QR code is behind us? Sure. How many of you in this room are over? Show of hands. Over 45 or over. Okay. Put your hand down. Keep them up, if you would, for a minute. How many? Drop your hand if you're not up to date with colon cancer screening. All the people who dropped their hands, this QR code, in three minutes, you can have a Cologuard kit being shipped to your home. Answer some questions, put in your name and address, put in your insurance information, and you'll get a Cologuard test at your home. So the power of the digital platform that we're delivering is shown by this. It also, over time, will be used to automate rescreens. It's really exciting. Perfect. Thank you for that. And maybe I just wanted to dig into 4Q. So you guys pre-announced yesterday or earlier today with the solid announcement. Can you just kind of walk us through what were some of the drivers of growth within that fourth quarter? Yeah, so we're pleased with how we ended up finishing the fourth quarter, about $20 million above where our guidance expectation was at the midpoint. And the growth was really driven by Cologuard. Okay, and within Cologuard, there were kind of two key factors. First, from the care gap programs that Kevin has talked about, and the momentum around our care gap program just continues to build. And that was ahead of our expectations. The second, one area we called out on our call was the impact from the hurricanes, most notably in the Florida region. Those orders started to come back a bit better than anticipated as we closed the fourth quarter. And then within our precision oncology business, we're pleased with where the cash collection rate of our Oncotype DX business finished within the fourth quarter, setting us up for even better cash collections in that business heading into 2025. And as Kevin alluded to, we are comfortable with where 2025 analysts' expectations are right now, and that would imply accelerated growth for all the reasons and the drivers Kevin hit on in his presentation. Perfect. We'll dig into 2025 in a minute, but first, I just wanted to ask about Cologuard Plus. You recently secured pricing there. You plan to launch the product in a few months. So how should investors be thinking about the benefit they're translating to your P&L? And really, when will those be realized? Well, we'll start to launch in the second quarter and first into the Medicare population where we have coverage. And then over time, commercial patients will get access to that. That's probably at least an 18-month transition until we decommission Cologuard and make Cologuard Plus. One of the things Cologuard Plus will do is it will re-energize the conversations that we're having with healthcare providers on a regular basis because it gives something new for the salesforce to really talk with those offices about, and it's really the patient impact, the sensitivity of the test, and the improvement there and the lowered false positive rate. And then just in terms of timing and when we would expect, this is going to lead to growth acceleration for the next several years, as well as margin expansion, and so what we've outlined is that we would expect, just based off of the Medicare fee-for-service population at launch and a launch in Q2, this will add a couple of points of growth in 2025. Most notably, though, it will be in the back half of the year with a launch in Q2 and about a 30-45-day time lag between when we ship a kit and when we get the kit back. We would expect that contribution to be in the back half of the year. And then on the margin side, it's a 16% increased value that we have with Cologuard Plus. And so we would expect to be able to see meaningful several hundred basis points of margin expansion over the next couple of years. Perfect. Maybe as a follow-up on that, just on Cologuard Plus, can you talk about, do you expect that to be covered by Medicare? And also, do you expect it to be included in quality measures as well? Yes, as I mentioned, the quality measure group has already indicated that they consider Cologuard Plus to be just a modification of Cologuard in terms of how they think in the quality measures, so that will be included. Medicare, the national coverage group, has indicated to us that there will not need to be a modification to the national coverage decision, and we, again, are starting to see large national payers just routinely now cover Cologuard and also start to take the code for Cologuard that the AMA issued and start to load it into their systems. Perfect. Maybe shifting over then just to MRD. I think this is an area that a lot of investors are interested in, just given the size and the speed that this market's growing at. So can you spend a minute talking about how is Exact differentiated across the competitive landscape in MRD? Yeah, well, let's take a step back first. This is such a wonderful story for our industry and our field because this nascent technology has been applied by doing the right clinical studies to prove that the patient impact and the ability to detect recurrence sooner, and so you can either have greater intensive therapy or potentially de-escalate therapy over time, and we have two things that really stand out with OncoDetect. First of all, we're looking for more mutations, and you take a disease like breast cancer. Breast cancer doesn't shed a lot of DNA into the blood. The ability to detect that by looking for thousands of mutations confers, we believe, an advantage that over time will allow us to get more people tested with OncoDetect, and today, the current version is 50-200 mutations, so that's an advantage. But also, look, we have deep relationships with virtually every health system in the U.S. because of Oncotype DX. Not only in the U.S., but there's about 25% adoption internationally, and that continues to grow. So we have a platform that we can deliver this to, electronic ordering, electronic resulting. Also, that Exact Nexus platform enables prior authorization through Epic's Payer Connect platform that we have unique ability to help those patients get access because of the platform. And so those are some of the advantages I think that we have as we enter this field. Perfect. Maybe shifting over then to multi-cancer. So can you talk to us about your strategy there? When should we expect revenue? You talked today about launching that product in 2025. So walk us through some of the color there. Yeah, it's interesting. We've already had a couple of large health systems approach us about adopting CancerGuard. Obviously, this is a field that is emerging. And our advantage is that we have a highly accurate test with a cost structure, a unit cost structure that makes a lot of sense so that we can price this at a price point that it's accessible to patients that ultimately we believe payers will be willing to pay because of the health economics. And we can deliver this through our commercial organization that is already serving all the same customers with Cologuard. It'll also give that commercial team something new to talk about with their providers, creating energy in that salesforce. Again, this is a second half of the year launch. We don't expect commercial insurance coverage this year, so it's largely going to be out of pocket pay. If you're 50 or older and you haven't been tested with a multi-cancer screening test, this is your opportunity. We'll get another QR code for you so that you'll be able to do it. So we wouldn't expect material contribution in terms of revenue for this in 2025, some in the back half of the year, but really excited to be able to drop this into the commercial organization, the technology platform that we have, and excited for what that means for revenue contribution over the next few years. Maybe going off of that, just sticking on the topic of your commercial organization, you guys have made some recent improvements there. So can you spend a minute discussing those changes and when we should expect to see that impact? Yeah, we're excited about changes we made in the fourth quarter. We expanded the size of the team. We gave every sales rep who carries Cologuard ownership of a territory. So they now get credit for all that is going on within their territory, giving them the incentive to make an impact and own that territory. We've also given them the data and analytics and even AI tools to direct them to who the most likely to prescribe healthcare providers are. And the frequency will be tailored. Group A, Group B, Group C of healthcare providers allows us to help them become more successful by calling on the physicians who are most likely to utilize Cologuard within their practice. And so we expect that some of those changes that we've made to start to have an impact a couple of quarters from now. Perfect. Maybe a financial one. Just in terms of the progress that you guys have made on profitability, can you talk about the drivers there and kind of what's the trajectory that we can look at going forward? Yeah, so first of all, we didn't disclose just yet where we finished the year in terms of our adjusted EBITDA or profitability, but it will be another record year of profitability for Exact Sciences. As Kevin alluded to earlier, it would be up 44%, 44% at the midpoint. That's what we would expect, at least the amount of profit growth last year. That's nearly 300 basis points of margin expansion. So we're really pleased with the progress. We're well on our way to getting to that 20% plus that we've outlined by 2027, and the exciting thing is there's several levers that we have at our disposal in order to get there. It starts with growth and fixed cost leverage that we have in our lab, in our supply chain across G&A. And as we outlined, we expect growth to re-accelerate in 2025. The second is productivity. There are a number of opportunities that we have to take costs out of our lab, our supply chain, some of our enabling functions. Really pleased with the progress, but excited for what's ahead in the coming years. Third is Cologuard Plus. We outlined the 16% increased value that we're seeing now through Medicare. We would expect a large portion of that to drop through to the bottom line and will be a meaningful contribution to margin expansion in the coming years. And then lastly is G&A optimization. And so the team has done a lot of work on that, but there's more to come. There's more that we can do within G&A, and we're excited about what that means. We delivered more than 300 basis points of margin expansion just through G&A in 2025. Perfect. Helpful. Then just I wanted to ask on, given your guys' free cash flow and also your strong balance sheet, how should investors be thinking about capital deployment going forward for Exact? Yeah, so again, we've not yet disclosed what our 2024 free cash flow is, but just where we were tracking to, it will be another record year of free cash flow. And it puts us in a unique position amongst our peers in diagnostics. We are generating sustainable free cash flow, and that's obviously coming through our profit expansion, but also through a number of different working capital initiatives that we have. And we're excited about what that means in the coming years as well. Just in terms of capital allocation then, our priority will continue to remain reinvesting back in growth in the business. 2025 is set to be the most productive year at Exact Sciences, and we want to make sure we're putting the full force of our balance sheet behind supporting those three new innovative tests that we have. Second priority will continue to take a disciplined approach to M&A. We've been very active in the past. We have a very disciplined approach to how we think about M&A, and we want to make sure anything that we would do would be accretive to growth and fit within Exact. The last area, which will be a new opportunity for us heading in the future as we continue to generate sustainable cash, we now have the optionality to start to offset dilution moving forward as well. Helpful. Then how are you guys thinking about the capital structure of Exact Sciences going forward as well? Yeah, so traditionally we've funded Exact Sciences' growth largely through the convertible market. And we announced this morning a revolving credit facility of about $500 million. Really pleased to get that put in place. That's part of the continued evolution that we have of our capital structure. We do not have any plans to draw on that. But what it does do is it increases our liquidity by 50%. So we have a strong balance sheet already. We closed the year with more than $1 billion in cash and marketable securities, and we're going to increase that with this transaction by more than 50%. Perfect. Then maybe last question. Looks like we have just over or just under a minute left here. I guess you've talked about how you're comfortable with some of the sell-side estimates on 2025. So what are you guys most excited about when we look towards this year? You know, it's an exciting year because we have the ability to enhance growth through rescreening, automating rescreening, commercial effectiveness. And then we're launching Cologuard Plus. You know, it took 10 years to develop and bring Cologuard Plus all the way through to where it is today on the precipice of launch, OncoDetect, CancerGuard, and continuing to invest in more innovation. It's all fueled by our people. We can't wait for the year to get started. We can't wait. Perfect. And with that, we are unfortunately out of time. So thank you both of you for joining us today. Thank you for everyone in the room.
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