Thanks. We'll kick off our next session. Thanks, everyone, for joining us. My name is Michael Ryskin. I'm on the Bank of America Life Science Tools and Diagnostics team, and we're excited for our next session, which is Exact Sciences. We're joined by Kevin Conroy, Chairman and CEO, Brian Baranick, General Manager, Precision Oncology, and Aaron Bloomer, CFO. Gentlemen, thanks for joining us. Thanks, Mike. Maybe just to kick things off, Kevin, I don't know if you wanna make any opening remarks to get us rolling? Yeah. I want to congratulate, Derek, on retirement. Congratulations. And Mike, congrats on your new role. Thanks, Derek, for the years, and years of just great coverage and, you're a gem of a person to work with. This is, I think, our fourteenth year at the conference, and, it's really been incredible to watch the growth of BAML during this time period. You tell me 5%-7% growth every year, and it's going on in perpetuity. We think you can do more, Mike. So, we can talk about the drivers of that growth. And, but it's really been, wonderful to be part of this. We started out as a small, company trying to solve, the problem of colon cancer, with a long-term vision to apply our technology platform to many cancers. We're so happy to be where we are today. Our mission is to help eradicate cancer by preventing it, not just colon cancer, cancer, by preventing it, detecting it earlier and guiding treatment. Hopefully, we can talk a little bit about this and the open-ended growth story that exists because we're in the early, early innings of how genomics and the understanding of cancer genomics is going to change how cancer is diagnosed, how it's treated. When you look at Exact Sciences, it's built on the foundations of Cologuard and Oncotype DX, two of the top brands ever in cancer diagnostics, and the power of those two brands is helping us build a platform company through which other innovative cancer diagnostics will help patients. That's. You have this growth story we've guided to 15% growth through 2027. We believe that growth will continue for a long period of time, and over 20% EBITDA margins by 2027. So we're really excited about what we can deliver in terms of patient impact and also what we can deliver in terms of shareholder value creation. The near-term drivers that we look at are Cologuard growth and also Oncotype growth outside the U.S., two kind of open-ended growth stories, and then a pipeline in screening with multiple tests and precision oncology. Brian Baranick, our GM here, well, will talk about that. So it's an exciting time at Exact Sciences, and we look forward to the conversation today, Mike. Great. Thanks so much, Kev. I'll jump right in. You know, you recently reported your first quarter results. You reiterated your fiscal year 2024 guide, both on overall revenue and EBITDA. A lot of the debate we heard after the print was on the screening number. You know, it was down a little bit sequentially versus 4Q. It was up 7% year- over- year. You know, you just talked about the guide you had for fiscal year 2024, which is 16%-17% screening. So, can you walk us through sort of the bridge between what you saw in the first quarter, how that fared relative to your expectations, and sort of the ramp as you go through the year for screening? Sure. And taking a step back, there are about 60 million Americans who are not up to date with colon cancer screening, so there's just a huge number of people to get screened. And what we saw in the first quarter, the comparison to the first quarter of last year, which was our highest dollar growth and percentage, dollar growth in our history, and it was a 45% growth for a number of reasons. Typically, Q1 has seasonality because of primary care utilization, and so we grew at 7%. That's not what's gonna happen for the rest of the year. The comps get easier in the back half. The drivers of growth, typically, Q2, the spring, into the summer, it is primary care utilization, screening increases at a rapid rate, and then usually post-summer, into the Thanksgiving time period, you see tremendous growth. We are confident in our ability to achieve our second quarter guide, our full year guide. There are three major legs of growth. It's calling on primary care offices, that's just like steady, very predictable growth based upon the input of the number of sales calls that you make and visits you make to primary care office. And then secondly, the health systems, and we can talk about that more, and the growth there, it's been really, really exciting to see. Then, a new business starting last year is screening in the Medicare Advantage population and also in large health systems that wanna do these large, what we call gap closure programs, to close their screening gaps. In terms of the year, we're excited about what the rest of the year looks like. I don't know if you want to add anything, Aaron? Yeah, I would just say that Q1 was in line with expectations, and due to some of the one-time impacts that we called out in Q1 of 2023, we think it's informative to look at it on a two-year stacked basis, in which case, screening revenue grew approximately 24% in the first quarter. Q2, the guide is 22%-23% on a stacked basis, and in the back half of the year, very consistent with that as well. So we think it's important to look through kind of the noise of Q1 of last year. Okay, that's helpful. And then the other bit that, I think really stood out on the call was, you had a little bit of this focus that, you know, you, you pulled back, spend a little bit too much, towards the end of last year and early this year, and you may need to ramp that up a little bit, just to re-accelerate. Can you, can you frame the magnitude of that, you know, the timing of it, you know, how it's gonna impact your future investment decisions? Yeah. So we spent about $800 million in sales and marketing, and the increment in terms of the sales force is a modest component of that. We haven't quantified it, but it's relatively small, and it brings our sales force back to the levels that we were at in 2022. Over time, what you'll see is there's a high ROI on investing in additional sales people. Think of it really simply as more salespeople, more sales. The dynamic is that in the last five quarters, we've added 50,000 first-time healthcare provider users in the Primary Care segment. So that means primary care docs, PAs, and nurses. And they once they start ordering Cologuard, they order at a predictable and pretty steep curve. Every cohort of docs is true since we launched Cologuard 10 years ago. They keep ordering at a faster rate. And the more frequently you call on them, the more frequently they order. And you may ask: Well, why is that the case? Shouldn't you be able to set up an office and they start just using Cologuard? The problem is, if you're a primary care doc today in America, first of all, it's chaos. You have eight to 12 minutes with a patient, and you may start with obesity, you may start with diabetes, cardiovascular, and 20 other things before you get into prevention and colon cancer screening. So what our sales force does is really brings tools, education, motivation to elevate colon cancer screening, and it works. So you see, if you call on a doc one time in a quarter, you get six Cologuard tests. If you call on a doc six times in a quarter, you get 24 Cologuard tests. There are just that many people not up to date with screening. So that's really, the dynamic that we see. So, I think there was some confusion about when we decided to make a modest increase in the sales force. We saw some signal in the fall, and in the fourth quarter, we made the decision as a team to increase the size of our sales force. So with our guide of this year, at beginning of the year, it encapsulated what we expected to do in terms of this modest increase in the size of the sales force. And I think that-- I think I didn't make that perfectly clear on the Q1 call. Okay. Aaron, maybe let's, I wanna bring you into the conversation a little bit. I think today is your first day as CFO officially, so congrats. Thanks for spending it with us. Any initial impressions you wanna follow up on or maybe just, you know, you wanna outline your near-term, long-term priorities? Yeah, thanks so much. Thrilled to be here. This is my, my fifth week here now with the company. Unbelievable company, great purpose, mission, what we do, and the impact that we have on patients. And for me, from a priority perspective, it has to start with, with growth and maintaining the growth engine that we've built out, not only on the Cologuard and the Oncotype DX, but also, as Kevin talked about, the new product pipeline, and so ensuring that we've got that flywheel going from an innovation perspective. So that's number one. I think the second thing would be ensuring that we have clear and credible pathway to the adjusted EBITDA goals that we set out. As Kevin mentioned, we have a goal of 20%+ adjusted EBITDA margins by 2027. We have very clear and credible paths to do that. We hit 9% adjusted EBITDA last year. We will expand over 300 basis points of margin in 2024. As we look through the P&L, I think significant opportunities to drive leverage, particularly within G&A, and I'll bring some of the past experiences in that, and bring that here to Exact. And then the third would be just a focus around cash flow. And I think, again, Exact flipped free cash flow positive in 2023, a remarkable achievement. We'll have free cash flow growth and positive free cash flow delivery each of the next quarters throughout the balance of 2024, and we'll look to further enhance that on a go-forward basis. Great. Maybe let's pivot to Cologuard a little bit. You know, you, you've had a really impressive CAGR over the last couple of years, really impressive growth there. You know, you're guiding to something in the mid-teens in 2024. You know, we talked about first quarter and why you think that's gonna ramp through the rest of the year. Is this, is this the number we should be looking at going forward, just, you know, given the, the size of the base? If you look at our guide through 2027, embedded in there is 17%, yeah, Cologuard growth. So, we have a clear path to doing that, and what we're seeing is opportunities to enhance the utilization of Cologuard as a frontline screening test. It's taken a long time, really, to get build the brand, build the platform, the commercial team, and very importantly, the IT capability, the ability to do electronic ordering, right from embedded within the physician's electronic medical record. This is what we call Exact Nexus, our platform built on Epic with over 100 other applications that surround it. We're able to do electronic ordering, resulting prior authorization, reimbursement, and so you get a huge amount of leverage, customer satisfaction, by being able to deliver this incredibly customer-friendly ecosystem that makes their life easy. If you make colon cancer screening easy, it's super powerful. We've invested about $1 billion in that platform. We've also invested in the brand, and importantly, in making sure that Cologuard is part of the quality measures, which is a long, arduous process. Because we're in the quality measures now, we can help health systems and health plans increase their Star Ratings, and the goal is to be a four out of five or greater in a rated system or plan in order to get the quality bonuses, which are absolutely key to the success of the systems and plans. So there are so many drivers here. It's exciting how we think we can help solve the problem of colon cancer. It's the number two cancer killer. It kills 50,000 people a year, 130,000 new cases in a year. I would suspect there are people 45 and older in this room who are not up to date with colon cancer screening. You can go to the cologuard.com website, and you can have a kit delivered to your home within a week. You go there, you enter your insurance information, name, address, family history, et cetera. We are making this easy, so we can go get 60 million people screened. And one of the great dynamics is that we're serving the need that colonoscopy can't even fill. So there's a capacity for colonoscopies in the U.S. of around 12 million. Half of them are screening colonoscopies; the rest are diagnostic colonoscopies. The U.S. isn't making more GIs. We're about 600 a year and about 600 retirements, so it's just flat. The capacity is not there. And Cologuard is just helping meet the needs of health systems, of primary care physicians, and now even GIs get more people screened. Kev, you touched on a lot of different levers there, you know, commercial team, electronic ordering, things like that. And, I mean, there's others in terms of rescreening, in terms of age group expansion. So how do you think about pulling on all those levers? Maybe this kind of goes back to that initial point on sales force expansion. You know, could you push on it even more? And sort of like, which levers do you see as most attractive? Yeah, I mean, you can always push on it more. Now that you're a profitable company, you have to balance this, this investment in IT, which allows you to push it more, investment in the growth of your sales force, which allows you to push it more, and that's good. But this consistent pushing is what makes a difference. By investing in IT solutions, you're able to screen America in these large programmatic orders. So as an example, you have health plan A that comes to us and says, "We have 100,000 people who are persistently under-screened for colon cancer. Can you help us screen them?" You bet. We look at their list of 100 patients, we clean... help them clean up all the data. It goes into our system, and what we do is then ship 100,000 collection kits out. We follow up with texts, letters, emails, telephone calls, to inform that member of the health plan why this kit is coming to their house. We get about 20%-40% of those people to complete a test, and these are the people who had been immune to screening for a decade or more. So, the levers of growth, when you think about rescreening, what does that mean? Well, it's just a recurring part of our screening opportunity. So Cologuard is indicated as a test that should be performed every three years by the main guideline group and by the quality measure group. So on your third-year anniversary of your last Cologuard test, for me, I just got a digital reminder by my health system, University of Wisconsin Health System, that I was overdue for colon cancer screening. I thought that was ironic last year when that happened, but with a quick message to my primary care doc from within my chart, I was able to get a Cologuard kit within a week and return the collection kit. It came back normal. I was good to go. That's what we are doing. So re-screening eventually will be over half of our revenue. Today, let's say it's in the mid-twenties. That's pretty exciting because every time you get a new customer, healthcare provider, patient, what you do is you have a lifetime relationship with each. And so there is this additive effect. If you take a look at last two 2 years, because of the COVID year, we are now starting to lap that. two years in a row, we had 1.2 million people eligible for a rescreen. This year, it's 1.6 million. Three years ago, the screening age was lowered to 45. That's 20 million new prospective customers. The group that got Cologuard in that 45-49 age group three years ago are due for a rescreen this year. We want them to be happy customers of Cologuard for the next 30 years or more. Can we talk about Cologuard Plus? You know, in terms of timing for approval, your expectations, and just sort of, you know, how that fits into the story you were just painting in terms of accelerating uptake and compliance. So Cologuard Plus is the next generation version of Cologuard, and it's an amazing innovation of 10 years of research development clinical trials. It improved the performance across the board. Specificity, it improved by 30%, so a 30% lower false positive rate. It improved cancer detection, pre-cancer detection. Docs tell us with the lower false positive rate alone, two-thirds of docs say they will order more Cologuard just because of that one element alone. We continually invest in our Cologuard program, so we're already working on the next version of Cologuard to drive the performance even higher. So we've set this bar that starts to roll in next year. We will be looking for a modest price increase. We haven't taken a price increase in 10 years, so we'll be looking for a modest price increase that will roll in over a couple of year period of time. And because the false positive rate is lower, that means 30% fewer people going off to colonoscopy, remaining within the Cologuard screening family. We like that. So that's the benefit. Oh, the other thing is that Cologuard Plus has 5%-7% lower COGS, so our margins expand. And this is a great opportunity for the commercial organization to continue to deliver only the best to the physicians that need to get their patients screened. Brian, maybe let's pivot to you real quick on precision oncology. I mean, any remarks you want to make real quick about Oncotype DX? And then I want to follow up with MRD. Sure. I can maybe set some context. I think it'll help clarify our right to play in MRD. So just for context, we celebrated our 20th anniversary with Oncotype here in the U.S., which is an amazing milestone. And we over that time, we've built up what we think is arguably the best commercial capabilities in diagnostics and oncology. We also have amazing infrastructure, which I'll come back to. Kevin touched on it, $1 billion cumulative investment into that infrastructure, and I can touch on why that matters with respect to MRD and other products in a moment or two, if asked. And then thirdly, it's around quality of the science and the clinical evidence wrapped around it. In the case of Oncotype, we've got 12-year outcomes data, and we continue to accumulate evidence in and around that. So the business unit, the legacy Genomic Health Infrastructure that we acquired several years ago, it's just deeply rooted in being patient, customer-centric, and building quality products and quality evidence around those products. And then, yeah, and then on MRD? Sure. So I think the question we typically get asked in MRD is: "You're not first. How are you gonna catch up?" A couple of things. I've been a student of diagnostics for just shy of 20 years now, and I've never seen a market that I can point to that's kind of developing as fast as MRD is. A lot of enthusiasm from patients, physicians, et cetera. Real, real hitting a real clinical unmet need, and we're really excited about the opportunity to participate there. But I'll come back to those exact three things I just talked about that drove the success of Oncotype. We have world-class commercial capabilities. I'm out in the field regularly, and I'm amazed. You'll go out with reps, and they've been in their territories 15, 17, 18 years they've been with the company. They know their physicians, and they know how to sell and get access. So I think we'll be in a really good position when we launch in colorectal next year, to be able to leverage those relationships in the field. So that's one. Two, the Nexus platform that Kevin talked to. Again, in the field regularly, this may not seem sexy to some of you in the room who study stocks and build models, but if you're living the day-to-day life of a community oncologist or an oncologist, and you have patient flow and churn, just step back and think about the cost of doing a prior authorization in those clinics. They often spend 20-25 minutes, not the physician, but a delegate. Could be a nurse, physician assistant, getting through the prior authorization. We're solving that. They, they often require three to four outreaches between a company like Exact or another company to help them sort through that prior authorization to get that test into the hands of their patient efficiently. We can shave that down, so shave meaningful steps and minutes off of that with the infrastructure that we're building. And then thirdly, evidence and, and test. We've been partnering with, with companies like the West German Study Group, NSABP, et cetera, to build out the evidence around our, our, our test, which we think is also gonna be a better performing test. We measure more mutations in the blood than some of the first mover companies in this space, and so we think we'll have a better performing product along with best-in-class evidence. And you'll hear more about both of those, the performance of the assay and the evidence and the studies that we have in flight, in the back half of this year. Any questions from the audience real quick? All right. Can we talk about blood-based screening assays? You know, you've got Cologuard Blood you're pursuing, but it's a pretty crowded marketplace, potentially a crowded marketplace. You know, what do you see as the use case, and, and what's your latest view on sort of what you've seen from some of the potential market entrants? Sure. So the idea of blood-based colon cancer screening is a great idea in concept. Back in 2009, when I joined Exact Sciences, I called Bert Vogelstein, who is the most preeminent researcher in the field, and asked if I could come visit him and talk to him about the blood test we wanted to develop. And Bert said, "Kevin, did you read my 2005 paper?" And I said, "No, I didn't, Bert," and kind of sheepishly, and he said, "Well, you should." And what that paper said is what was very predictable for all of us who are developing blood tests, which is detecting precancerous polyps, looking for circulating tumor DNA. Good luck. You can't find what's not there. That the colon is really well designed to keep bugs out of the blood supply, and it's really well designed to keep precancerous lesions, which are just in... They haven't invaded yet to where the blood supply is out of the blood. So he said, "You can't find what's not there. If you can't detect precancerous, you don't really have a colon cancer screening test." That was Bert's main message. That main message hasn't changed, and that research hasn't changed in 20 years, and it's because biology hasn't changed during that time period. So is there a role for blood-based screening? Yes, and we firmly believe there is a role for us in blood-based screening. Is it the main role? No, because the real power of colon cancer screening, and everybody should know this, is finding and removing precancerous polyps, which prevents colon cancer. The goal is not to find stage one disease. The goal is to stop stage one disease. Now, if you find stage one disease, there's a 90% cure rate within five years. I mean, you cure 98% of the cancers. But the goal is to find the precancerous polyps, and these blood tests don't do it, which means these blood tests are highly unlikely to get in the guidelines. They're highly unlikely to get into the quality measures. Medicare did say, "We'll pay for them." For fee-for-service Medicare will be able to. There's a market there, especially for people that we know refused colon cancer screening, either colonoscopy through our partnerships with health systems and also because of the six million people who haven't returned a Cologuard collection kit. And I know people who have had bad outcomes because they didn't get screened, and they, some of them had a Cologuard kit in their home, or they skipped their colonoscopy. So there is a need for that, but it's more of a niche, and commercial payers probably aren't going to be excited about paying for something that's not in the quality measures. Now, the earliest we'll know about the quality measures is 2028, 2029, in that timeframe. And, so there's a lot of work to do to evolve this market. Always, people ask, "Is blood testing going to reduce the impact of Cologuard?" And the answer is not anywhere in the near term. The other, I think, important thing to note is the United States Preventive Services Task Force, the main guideline group, meets every five to eight years on colon cancer screening, not before then. There's like six years, six years, six years, eight years, five years, and we think again, six years. And then if you get into the guidelines like we did with Cologuard, then it's a couple of years to get into the quality measures. So if you're in the audience, you're worried, what's gonna happen with blood-based testing? There's a panel meeting next week on blood-based testing. It's. We expect blood, two or three blood, tests, including ours, will get approved. Getting broad insurance coverage, getting into the guidelines and the quality measures, whole different story. That's gonna be a march over a number of years. So having said everything you just laid out, I mean, a lot of that's really consistent with what you had in the past, and it makes sense, but how do you put this debate to bed? How do you finally answer that? Because if it, I mean, if it is gonna be there until 2027, 2028, 2029, is that gonna be at least a sentiment overhang for some time? No, I don't think so because I think what is gonna happen is you'll see blood tests get approved, and you will see Cologuard continue to grow. And let me say, look, the more ways to screen for colon cancer is good. However, you wanna get screened with a test that is the most effective test, and that's colonoscopy or Cologuard. And so is there gonna be a debate among a very niche portion of the overall population? There won't be much of a debate among primary care physicians, GIs. The GI societies came out with a note a couple of months ago, which basically said, "With the current performance of the blood-based tests, we do not recommend a frontline screening claim." We'll see what the FDA does. But no, I don't think... I think the growth of Cologuard over a long period of time is the thing that will excite investors, and I don't believe that there will be much of a debate about that as you go forward. Okay. All right. 30 minutes goes by really fast. We're almost out of time. Kevin, Aaron, Brian, any concluding remarks or sort of our usual closing question is, what do you think is most underappreciated or misunderstood about Exact? Aaron, you've been here for five weeks. What do you say? I would say our pipeline. One of the things that's been really exciting to me, and even just in sitting in meetings, is I would say 90% of the questions plus has been about Cologuard, what's happening with blood, what's happening with potential other aspiring entrants. We're slated to launch a number of new products over the course of the next few years, and we've spent many years developing them. And I don't think it's well appreciated more broadly as to the impact that's going to have on patients, the impact that's gonna have on our revenue and growth profile, as well as on our margins, and I think it, it's a diversification play then as well. We're excited about the mid-teens growth in Cologuard, and we're gonna get MRD and a number of these other new products that we're slated to launch. It's a really, really exciting time to be at Exact Sciences. Great. Thanks so much. With that, thanks, everyone. Thanks, Mike. Thank you. Thank you. Thank you.
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