Hello. Thank you everyone for coming today. It's my pleasure to introduce Exact Sciences. Today we'll be joined by Kevin Conroy, who's the Chairman and CEO of the company, who will be providing the presentation. Then we will also be joined by Jeff Elliott, who is the CFO and COO, and Everett Cunningham, who's the Chief Commercial Officer for Q&A. Handing it over. Thank you. Thank you, Zach. Thanks, JP Morgan, for having us attend and present, to all those on the webcast and here, thanks for joining. We will be making forward-looking statements. This is our safe harbor statement. Remember these numbers one, five, seven, nine, 14, and $10 million. In 2009, I had a meeting that changed everything. I got a call from the Exact Sciences board. They were looking for a CEO to effectively restart the company and develop a non-invasive colon cancer screening test. The only problem is they had no R&D team left after a decade of work and no real proof of concept. They suggested that I go meet Dr. David Ahlquist, here on the left, who, a renowned gastroenterologist, researcher, scientist at the Mayo Clinic, who is focused on the early detection and prevention of colon cancer. I left that meeting knowing that I would join the Exact Sciences team, we would partner with Mayo Clinic, and we would go about developing what became Cologuard. The first thing that we did was hire Graham Lidgard, who you see here on the right, and he is a legendary molecular scientist who built the team of research and development scientists, biostatisticians, clinical affairs team, a lab team, automation team to develop Cologuard and bring it into a lab environment. It was an arduous process. Highly difficult to detect colon cancer from a stool sample because you have to get that DNA out of that sample. For five years, so five years from that one-day meeting it took to get FDA approval, it took seven years to get into the main guidelines, it took nine years from that one-day meeting to get full commercial insurance coverage. Here we are 14 years later, and Cologuard, that test that Graham and Dave and the team developed, has now started to change the standard of care. We're proud in November that we achieved our 10 millionth Cologuard test. 14 years to $10 million. My friend Dave, I promised I wouldn't do this, passed away from ALS two years ago. He left us with this incredible mission, which was the focus on early detection and prevention to eradicate colon cancer and to expand that beyond colon cancer. As he said, "Look, if you're under age 85, the number one cause of mortality is cancer." Most people in this room are under age 85. Number one thing you have to worry about is cancer. The way, I mean, there are brilliant therapies being developed. Every year you see more and more. The way to really impact this problem, those therapies need to be coupled with earlier detection. The University of Chicago just came out with a study that said only 14% of cancers are found through screening. If you find a cancer that's not through screening, it's typically symptomatic, which means it's typically later stage, which means it has spread, which means that you're dealing with a much more complex problem. On the strength of our Cologuard test and also our Oncotype test, our breast cancer test, we are able to invest heavily in making Dave's mission become reality. When you look at where we are building a company around a full range of tests, this is where things get exciting. We know that this is so critical for us to innovate in a way that we help people determine what their predisposition to cancer is, their genetic risk. New screening tests to help detect cancer earlier. New tests that help diagnose and prognosticate what the outcome of that cancer is gonna be, like the Oncotype test. You have to deliver this in a frictionless environment, and a technology that makes it really easy to identify a patient who is going to benefit from a test to ordering a test electronically, to providing a surround sound, we call it our compliance engine, that helps people complete a test, to a test result and the billing associated with the test. All of that takes an immense lift and deep technological capabilities because the goal is to make sure that physicians are able to spend more time with their patients and less time with the complexities of precision medicine. Let's talk about our Screening team. the focus has been colon cancer to date, and it's a big problem. Colon cancer is the number two cancer killer in the U.S. 150,000 new cases last year. 53,000 deaths. Unfortunately, about half of people who are in the screening age 45 to 85, are not up to date with screening. Please, if you're in that age group, make sure you get screened, either a colonoscopy or Cologuard, the most sensitive way to detect either cancer or pre-cancer. We know that earlier detection matters. If you're diagnosed with Stage I or II cancer, nine out of 10 people survive five years or more. If diagnosed with Stage IV colon cancer, one out of 10 people survive. That's the difference. Early detection really matters. The goal here is to go and get these 60 million people screened, and we're doing that. Cologuard, you know, it's a travesty that we're not getting more people screened. Cologuard is part of the solution, a big part of the solution. One of the most important features of Cologuard is it detects 94% of Stage I and II cancers. No other non-invasive test comes close. It also detects 42% of precancerous polyps, including the small ones, and it detects 70% of the largest, most advanced precancers. If you find and remove a precancerous polyp, you actually can prevent the disease. Cologuard being an at-home test that's easy to use, highly sensitive with 24/7 support, is a test that is now really starting to take off and make a difference. People who are reluctant to get screened are getting screened. This is one of our customers who happens to be a physician. Here's his story. As a physician, I recommended getting screened for colon cancer, but for myself, work was busy. I thought, "I'll do it later. He was a few years overdue with his colonoscopy. When he heard about Cologuard, I was like, "Hey, you don't have to waste a day. Just do it." The Cologuard test found something. Reading the pathology report with my name on it was just surreal. "Cancer. You have cancer. He had no symptoms at all. Thankfully, they caught it just on the cusp of it getting into lymph nodes. Stage one, they got it all. I'm thankful that my husband's here for sure. This has rejuvenated me. He uses this story at work in various presentations. Numerous people reached out and said, "Thank you, I've been putting it off." It's made me see the impact I can have as a physician. I can create urgency about screening. It's pretty cool. It's powerful. We want to make sure that all people get access to Cologuard. Like Dr. Fenton, it's changing. In fact, it's life-changing. When you look at now the adoption of Cologuard eight years after launch, we saw a little blip there during COVID, we have seen renewed strength. This momentum amounts to 66% compounded growth since we launched in 2015. We're more confident than ever that Cologuard is going to become part of the solution to go get those 60 million people screened. Cologuard is recommended to be used every three years, so there is a recurring element to Cologuard, which is a powerful one. Now let's talk about our breast cancer and our Precision Oncology team. In 2019, we acquired Genomic Health. They developed an amazing test called Oncotype DX. What Oncotype DX does for an early-stage breast cancer patient is it examines the tissue and it looks at certain genes and how they're expressing the RNA. From that, they can do a calculation that answers two really important questions. The first question is, will the patient actually benefit from chemotherapy? 80% of patients early stage don't. 80% don't. Challenge is you didn't know who would benefit and who would for sure, until Oncotype came along. The second question that it answers is an also an important one. What is your% likelihood risk of recurrence? Those patients can be treated more aggressively. These two questions, because they've been answered with randomized controlled studies, multiple studies, it is now tier one recommendation. There is no peer, nobody has invested in those studies to generate that level of confidence. Well, here's an oncologist who really truly believes in Oncotype, because at age 41, Dr. Hala harvi was diagnosed with early-stage breast cancer. She knew that she was facing the same decision that her patients were facing, lumpectomy, mastectomy, chemotherapy or not. She knew that she needed an Oncotype test. Her test score came back at 18. 25 or below, virtually no benefit from chemotherapy, she could confidently make the decision to forgo chemotherapy. Well, we know chemotherapy can cause other cancers. We know that it has lifelong implications. She was able to avoid chemotherapy. That's a powerful testament to what Oncotype has become. When you look at what this team has done, when we first acquired Genomic Health, it was a $400 million business in 2018 with 20% EBITDA margins. Today, it's a $600 million business with 40% EBITDA margins. The investment is making a difference in people's lives, this emanates from a culture that we have developed at Exact Sciences that starts with great people and through developing incredible tests and bringing them to patients and physicians who need them, ultimately driving profitable revenue that you can invest part back into the business. It truly does start with the people. We have a culture of Exact Sciences that starts with great science and great scientists, and we know that we're on this mission to deliver something that changes the lives of people. When you look at how this culture has, through constant small solving complex problems one at a time over a period of 14 years, we've grown from a handful of people to 6,500 people who are focused on this mission. A special call-out to our frontline team members who delivered last year coming out of the pandemic. Our field team, our marketing team, our ops team, our lab team, our customer support team, and the list goes on, our finance team, they delivered. It was the front line that delivered, and that's where the culture starts. We've been certified as a great place to work four years in a row. It's something that the team takes great pride in, so everybody has ownership. That ownership then ends up helping us develop great tests through great science. That's what our commitment is. Don't cut any corners. Do the hard work. Not everybody does it. You do the hard work on the science, and then you are able to address big problems. Colon cancer. Our Cologuard 2.0 program. Our colon cancer blood program will have readouts this year. We're excited about that. Our multi-cancer program, the idea of one blood draw, most cancers. This idea of minimum residual disease testing. If you've been diagnosed with cancer, today frequently the answer is, "Go home. If you're not feeling well, come back after your treatment." Now, today, by doing a bespoke test, you can do a blood draw and separate the world between people who are likely to recur and those not likely to recur. It's gonna be game changing. Here's the important part. You have a great test. Many innovators forget that the next most important part is to do the hard study. In the case of Cologuard, a 10,000-patient study comparing Cologuard to the current standards of care. People thought that was insane when we did that. It ended up in The New England Journal of Medicine. Genomic Health before us, randomized studies, five different The New England Journal of Medicine publications, Tier 1 evidence. You've got to do the studies that may... If they don't turn out your way, you don't have a product. You've wasted a lot of time maybe, but you've got to do those studies regardless because that leads to commercial insurance coverage and the ability to change practice. What you see here is our incredible field team at a national sales meeting, and they're able to convince physicians to change the way they've been practicing medicine for a long time because of the evidence that exists. That's part of this flywheel that keeps rolling. This is the best, most trained, most motivated, most experienced sales team that exists in diagnostics. There isn't anything close. Everett's gonna will be happy to answer questions about this incredible team. Then this customer experience grounded in our IT infrastructure that we built that is second to none based on the Epic EMR system. The ability with all of the different tools to prompt a physician to order a test when a patient needs one, and then also makes the experience incredibly easy all the way from order to result and to billing. This has taken an enormous investment, but that's part of what you're seeing flow through in the operating results of the company. When you see this, each one of these stars represents a health system to which, through our instance of our Epic EMR, is integrated. That means there are hundreds or even thousands of physicians can order a Cologuard test electronically. It's powerful. It's taken us eight years to get to about 300 systems. We have another 500 to go. You can't just replicate that overnight. That is something that is unique to Exact. It means we can drop additional tests into this ecosystem and deliver an incredible experience to physicians, to patients, and automate things in the future, like prior authorizations. We're really proud of our partnership with Epic and what that is doing for patients and outcomes. Now, we announced results yesterday, and Jeff is gonna wanna make sure that I read all of this accurately. I'm not gonna freelance. We're tremendously proud of what the frontline team members achieved in the fourth quarter and for the full year. It starts with growth. You can see here that the total revenue, excluding COVID testing, grew 28%. The Screening team drove a 45% growth quarter over the last year's quarter or 2021. The Precision Oncology team, they faced two things. Number one, we divested our prostate cancer test. We also faced FX headwinds. We expect that the Precision Oncology team to grow Oncotype from $600 million to about $1 billion. There's plenty of room to grow there. We added $119 million in revenue year-over-year in the fourth quarter, the largest dollar amount to date, and $120 million in incremental profitability. The flow-through was over 100%. It was tremendous. We believe that this growth and the momentum is sustainable for many years because of the strong base of leading diagnostics that we have in our bringing. We about $2 billion in revenue last year, a little bit more, and about $1.5 billion in gross profit. For 2023, analysts consensus is $2,267,000,000, and we think that's the right way to think about this year. With the platform that we built and the new tests that are coming, we believe that we can continue to see this momentum grow and this big base of predictable revenue helps fuel the company. Now, one of the things that we're proud of is a year ago, we said that we will become profitable full year 2024. Not only were we profitable on an adjusted EBITDA basis in the fourth quarter, we will be profitable on an adjusted EBITDA basis for the full year 2023. The team you've seen is making steady progress, and this was a team effort. This is a result of our IT systems, our lab infrastructure, our commercial channel, all working together to make sure that we sustain growth and are very disciplined around expenses. This preserves our balance sheet, which we expect to finish 2022 at about $630 million of cash on the balance sheet. This puts our team in a tremendous position to bring innovations to physicians and patients. What started with one day meeting with Dave Ahlquist turned into 10 million people screened. Now by 2027, so four years from now, we expect that to turn into a total of 30 million people. We're on a trajectory, and we're doing all of the small right things to continue that trajectory, to make earlier detection of cancer a routine part of medical care. That takes more than a great test. It takes a team, it takes this amazing surround sound. There's still a huge amount of work in front of us. Dave used to say all the time, "If we can, we must." I miss Dave. Thank you. Thank you, Kevin, for that remarkable presentation. I'm gonna kick off one question, and then we're gonna open up to the audience. Don't be shy. I think we have a mic running around. Tish is gonna be there. Kevin, you kinda touched about this in your presentation a little bit, but can you just talk about the key drivers in Q4? Well, there, let me start, then I'll pass it to Everett and Jeff. Much of the strength in Q4 comes not from Q4, but investments that we have made over a long period of time. The three things that come to mind is brand awareness, the quality of the test, the performance of the test, the commercial team, this field team is really humming. Then all of the small, the prompts, the digital experience, the text, the reminders, those things led to, are leading to growth. Let me pass it over to Everett. I'll mention a couple of things. I spent a lot of time in the field with our internal team and with customers over the last couple of quarters. People are accepting Cologuard as a first-line treatment for colorectal cancer screening. It's no longer a novelty. People know about it. I would say that our surround sound has really taken hold, meaning our field is out there. We're better deployed. We have better tools. Jeff's team has equipped us not just with data nationally, but data at the market level, so we know exactly which target to call on and when. Our marketing team, the marketing campaigns that we put in place throughout the entire year is really starting to take hold, we're really focused on campaigns for the 45 to 49 cohort. You, as Kevin said, nine out of 10 adults over the age of 45 are seeing a marketing campaign every single day, which is phenomenal. Lastly, just that surround sound that we get help with IT, making it easier to prescribe Cologuard every single day because we're electronically interfaced. The focus and help that we get, from our operations team, making it easier, for us to get to our targets, that momentum, that discipline in the commercial organization, we put in place at the beginning of the year, and you're just seeing it just gain momentum throughout the year. What really excites me about this is the sustainability of the growth. You know, Kevin talked about the size of these markets. There's a lot of people out there, 60 million right now who are unscreened. There's years and years of growth ahead for Cologuard, and that gets even more exciting. This platform we've developed gets even more exciting as we drop new products in. We've built a power of accessioning here that keeps getting better with time. That flywheel Kevin showed, sustainability of growth, that will be a hallmark of Exact for years to come. Does anyone have any questions or? I can restate. You mentioned the Cologuard test. I was wondering if you have secure timelines on launch with that and, could you comment on the challenges and timelines getting that into. The question is around the multi-cancer test. What's the timeline to launch, and also what are the challenges around reimbursement? Let's first talk about what a multi-cancer test is and what the goal is. A blood-based multi-cancer test, interestingly, in 2009, the second part of the day with Dave Ahlquist of the Mayo Clinic was he had this crazy notion that you would do a blood draw and look at methylation markers to detect all cancers. I thought that was insanity. I mean, that was so far out there. Grail and other companies really started doing good work to evaluate whether it's achievable. In fact, it is. You can detect most cancers through a blood draw. Now, not all cancers, but most types of cancers and maybe ultimately half of cancers through a blood draw. What does that do? At a population level, if you wanna take the number one killer for people under age 85, start to screen them because 2% of them are walking around with cancer and don't know it. If you can shift detection from Stage III to Stage I half the time, or Stage II half the time, you all of a sudden change outcomes in a massive way and in a way that you can't do with therapies alone. What are the timelines? There's a lot unknown about what the timelines look like because you have to run large prospective studies, you have to secure FDA approval, and ultimately, get Congress to allow Medicare to pay for a new test, which we think is achievable. Then also you need to get into guidelines. The guideline groups have never looked at anything like this. We're talking about a number of years before this market develops. We don't believe that a lab-developed test without FDA approval and without reimbursement is the way that we'll probably think about making the test available. More like Cologuard, do the years of work and the clinical work, and ultimately then payers will see, oh, if we can do stage shifting from Stage III, where we're spending $300,000 on a patient, to Stage I, where we can do surgery with curative intent, changes everything. More to come. Hopefully this year, Congress passes a law giving Medicare the authority. There's over half of Congress, Democrats and Republican, equal number, are co-sponsors. Let's see if we can get the bill passed. I guess I have another question then as well. You know, you mentioned great progress on reaching profitability, ahead of schedule and everything. What do you think is driving that progress? Well, Jeff, why don't you take this one? Kevin talked about the years of focus in building up the two big brands, the two biggest brands of all of diagnostics, you're seeing that momentum continue. The growth we delivered in Q4 is sustainable. If you look at what's driving it, there's not just one thing. It's the sales force, it's Cologuard rescreens, as Kevin talked about. You repeat Cologuard every three years. It's an expanded population. This younger population now indicated for screening ages 40, 45 to 49. It's all those things, plus combined with the platform we have. By platform, it's this Epic foundation that's so powerful, allows us to engage with patients and do it efficiently. It's our sales force that every self build out, 1,000 people out in the field educating doctors, growing the business. That going forward doesn't really change much, right? You look at last year in 2022, our sales and marketing expense was actually down versus 2021. In 2023, we expect it to be flat to down again while we continue very robust top-line growth. That foundation allows us to scale efficiently. Kevin talked about some numbers in Q4. Our Q4 incremental adjusted EBITDA margin was over 100%. Now, we're not gonna get that level every quarter, but you can see how this business was built to scale with an ultimate goal of generating sustainable top-line growth, margin improvement and cash flow. I guess another question building off of that. You know, you mentioned, you dove really well into that. You know, when you think about growth and profitability in this environment, you know, how do you kind of weigh that trade-off and, you know, what do you think is gonna be more important going forward? We have made investments over a long period of time, and I think investors have been incredibly patient, and they were asking themselves a question, "Hey, look, do you need to spend $1 in sales and marketing to create $1 of revenue?" It wasn't entirely intuitive because you'd never seen a diagnostic like Cologuard launched into primary care. A primary care launch is like a jumbo jet taking off. It takes a long time, but once it gets airborne, there's momentum to it. We have already invested in a meaningful way, and looking forward, I think what you'll see is more flattish sales and marketing expense. Everett, maybe you can touch upon how and why. Yeah. I look at it as a change of mix, especially when it comes from commercial. We invested in 2022 in our health systems team. We knew that we were gonna get a lot of growth from our top 250 health systems. At the beginning of the year, I took a lot of resources from part of our organization and really invested in health systems. What we've done in health systems has been amazing. We've developed different partnerships, not just at the physician level, but we're calling now on IT to making sure that we can get electronically interfaced. We're calling on quality measure leaders at the health systems. They have a goal and quality measure to hit with colorectal cancer screening. Now they're coming to us saying, "How can we use Cologuard to hit that growth? Not only hit the growth, but get patients to use our back end to be adherent to the test?" So that's a great example of just not just, reducing costs, but changing the mix of costs to get more growth, better return, and, set us up for the future. We've got a question right here. Hi there. Thanks. You mentioned during the presentation that you expect the Oncotype DX program or product to grow from $600 million- $1 billion in revenue. You also doubled margins from 20%-40%. Could you give a little bit more color about the plan to achieve that growth and the timeline, what drivers were in the margin increase? Sure. Why don't, I'll start with the top-line growth and pass it over to Jeff. Oncotype in the U.S. is used by about 70% of HR-positive, HER2-negative Stage I, II breast cancer patients. It's about 70% of those patients get one of get this class of tests, and Oncotype has about 90% share. Outside the U.S., in major markets, penetration is class penetration is only about 25%. There's huge growth outside of the U.S. Today, you know, that's approaching a $150 million business. That's where we see most of our growth. Japan will come online this year. There are things that we're doing in India, other major markets, Brazil, to get much greater uptake. Since it's practice-changing, it's life-changing, we know that we can do this. We're gonna keep investing internationally. There's still some growth in the U.S., but you're starting to see peak adoption in the U.S. The exciting part about the growth going forward is that the foundation is already there. When you look at the international markets, which will drive most of the Oncotype growth going forward, we're global. We already do business in over 90 countries, either direct or through distributors, but that foundation is there. As we scale and get broader reimbursement and launch in new countries, the margins fall through at a higher rate. I feel good about it. Japan could be our biggest market outside the U.S. It's been a long time in the works. I'm confident that will launch this year. The other exciting part about this business is the foundation that it provides for other products that we launch. Kevin talked in his remarks about MRD. All right, well, MRD, when we launch an MRD test, which we will before it's too long, that drops right into the commercial channel we already have. Over 98% of all U.S. oncologists are ordering or have ordered Oncotype DX. Great. We're already touching at least 50% of the breast cancer tissue in this country. Add an MRD test on top, strong foundation. IT systems, best in class already. You get really good incremental margins as we grow both Oncotype and then as we drop in other new products. You mentioned complex problems solved one at a time, and you sort of touched on that just now. I was just wondering, what is your imagined, what is your envisioned pathway towards that unfolding and rolling out one step at a time with future new additions to platform? The question is around complex problems being solved one at a time. How are we looking at doing that with the platform? The answer is. Is the question more around products or the ecosystem? Products. I'm saying, you know. Tests. When you start expanding, what is the vision towards that? The vision towards that from a test perspective is first, focus on the core, colon cancer, no matter what. I mean, if we invest $100 million a year of R&D for what will become shortly a $2 billion brand, that is a no-brainer. Keep making it easier. Get the insights from patients. Like, here's one insight: Women don't like the larger box to return it to UPS, and they don't like to leave it on their front stoop either. It's a headwind to getting more people screened. Okay. We have a team of people working on a smaller collection kit. We don't talk about that much, but like, you see dozens of these improvements. We're gonna keep investing in the core colon cancer. Colon cancer blood program, we've talked about that a lot. We see that more as a niche for people who refuse colonoscopy or Cologuard because the performance is just nowhere close. But that's an important program, and that test will drop right into this platform. Secondly, minimal residual disease testing. 3% market adoption penetration today. Natera has done an amazing job. It's really a terrific company that has led the way here. Well, we have an advantage because as Jeff said, half of all breast cancer patients in the U.S., their tissue comes to our lab in Redwood City. We know which ones are at the highest likely risk of recurrence. If you're at a high risk of recurrence as an early-stage breast cancer, the next test you wanna get is, do you still have some circulating tumor in your blood? We launched that MRD program second. Maybe you invest $50 million a year for a period of time to access a $15 billion opportunity. Finally, MCED measured because it's a swing for the fences. It's a number of years. That's kind of the third big program. We have a small program around liver cancer, one around esophageal cancer, and one around uterine cancer, all from the same core technology that Graham and Dave and team developed a decade ago. You can leverage that with our lab capability, our team capability, and it really... There has to be discipline there. It has to be the core part of our mission. We're passionate about it. The team is focused on doing it, and it's a financial driver. That's how we look at Exact Sciences. We got time for one more question, so I'm just gonna leave it to you. You know, what are people missing on Exact Sciences? You know, how do you wanna... people remember this? I think the fact that there are 60 million people out there that are not up to date in their screening, we're gonna go get those people screened. It's gonna take time, but what you're gonna see is consistent growth to what we believe eventually Cologuard will be a $7 billion test. That's what we believe. More importantly, we think that if you look out 10 years from now, you can write this down. I think that 53,000 people comes down to 25,000 people. When you drive screening from half the population to 80% of the population, it changes everything. That's the path we're on. I wanna say we truly appreciate the support of investors. This has been a long journey, it's because of your support that we're able to invest. Thank you very much. Thank you, everyone.