Good day, and welcome to the Exact Sciences second quarter 2022 earnings call. Today's call is being recorded. I would now like to turn the call over to Megan Jones, Senior Director of Investor Relations. Please go ahead. Thanks for joining us for Exact Sciences second quarter 2022 conference call. On the call today are Kevin Conroy, the company's Chairman and CEO, and Jeff Elliott, our Chief Financial Officer and Chief Operating Officer. Everett Cunningham, our Chief Commercial Officer, will also be available for questions. Exact Sciences issued a news release earlier this afternoon detailing our second quarter financial results. This news release and today's presentation are available on our website at exactsciences.com. During today's call, we will make forward-looking statements based on current expectations. Our actual results may have material differences from such statements. Reconciliations to GAAP figures are available in our earnings press release, and descriptions of the risks and uncertainties associated with Exact Sciences are included in our SEC filings. Both can be accessed through our website. I'll now turn the call over to Kevin. Thanks, Megan. During the second quarter, the team made several advancements toward our vision to eradicate cancer through earlier detection and smarter answers for patients and their healthcare providers. Highlights from the quarter include being a great place to work certified for the fourth consecutive year. Screening more than 700,000 people for colon cancer with Cologuard. Securing an improved position in ASCO guidelines for Oncotype DX Breast as the preferred test for early-stage breast cancer patients. Improving our path to profitability and cash liquidity position. Cutting adjusted EBITDA loss in half quarter-over-quarter. Showcasing the breadth of our screening and precision oncology pipeline with 13 abstracts at ASCO. Making progress towards completing BLUE-C, our pivotal study to support our next generation Cologuard and colon cancer blood tests. Publishing evidence for our tumor-naïve minimum residual disease test in colon cancer. Generating additional evidence for our multi-cancer early detection test, which we plan to share at the European Society for Medical Oncology or ESMO Conference in September. Finally, enhancing our sequencing capabilities by partnering with Ultima Genomics. We're focused on executing with our core business of Cologuard and Oncotype DX, prioritizing the highest impact projects to reach profitability and generating high-quality evidence for our pipeline of advanced cancer tests. Jeff will now review our financial results. Thanks, Kevin. Good afternoon. Second quarter revenue was $522 million, an increase of 20% year-over-year or 27% excluding COVID testing. Screening revenue was $354 million, an increase of 34%, including four points from PreventionGenetics. Cologuard growth was driven by improved sales team productivity, our marketing partnership with Katie Couric, three-year rescreens, and use in the 45-49 age group. 9,000 new healthcare providers ordered Cologuard during the quarter, and nearly 282,000 have ordered since launch. Precision oncology revenue was $154 million, an increase of 12% driven by Oncotype DX Breast and therapy selection. Foreign exchange was a $2 million headwind. COVID testing revenue decreased 58% to $14 million. Second quarter GAAP gross margin was 68%. Non-GAAP gross margin, which excludes amortization of acquired intangibles, was 72%. Margins were lower than expected due to inflation, especially shipping and wages. We expect inflation and unfavorable foreign exchange to be about a two-point headwind in the second half of the year compared to our prior guidance of about 73%. We expect margins to expand as we absorb the additional lab capacity brought online for Cologuard and introduce new automation. Sales and marketing expense was $216 million. G&A expense was $182 million, including a $24 million net gain mainly related to Thrive and a $5 million expense from cost reduction activities. R&D expense was $106 million. Net loss was $166 million, and adjusted EBITDA was a loss of $46 million. This improved $76 million from two quarters ago and $44 million from last quarter. We entered the quarter with $728 million. We established an AR securitization facility during the quarter with up to $150 million in borrowing capacity. Per the agreement, we borrowed $50 million under the facility. We also have about $150 million available on a revolving credit facility. This provides total liquidity of almost $1 billion. We're also exploring ways to unlock capital from our real estate facilities. We expect our cash use to be lower in the second half of the year compared to the first half, and we're confident in achieving adjusted EBITDA profitability in 2024 while we continue investing in future growth and efficiencies. For example, we're investing $300 million in IT this year to improve our digital tools and support initiatives like Cologuard rescreens, enhance our customer experience and billing systems, and eliminate redundant costs from legacy IT platforms. Consistent with our guidance, we expect total revenue between $490 million and $505 million during the third quarter, and between $1.98 billion and $2.022 billion for the year. We expect screening revenue between $350 million and $355 million for the third quarter, and between $1.35 billion and $1.372 billion for the year. This includes PreventionGenetics revenue of approximately $10 million during the third quarter and between $40 million and $42 million for the year. We expect precision oncology revenue between $135 million and $140 million for the third quarter and between $580 million and $590 million for the year. Our expectations for global Oncotype DX Breast are unchanged. We're updating our guidance to reflect product portfolio changes and a $4 million incremental FX headwind for the year. We divested our Oncotype DX Genomic Prostate Score test to ensure our team is focused on the highest impact projects in improving our profitability. Certain members of our dedicated urology team will transition to MDxHealth, a commercial-stage precision diagnostics company focused solely on prostate cancer and other urological diseases. We have agreed to provide certain transition services to MDxHealth, including lab services, to ensure a smooth transition for patients. Per the agreement, Exact Sciences received $30 million upfront, including $25 million in cash and $5 million in MDxHealth equity. An additional $70 million is payable to Exact Sciences upon achievement of certain revenue milestones. We expect COVID testing revenue between $5 million and $10 million for the third quarter and between $50 million and $60 million for the year. Moving down facts for the full year, we are lowering our sales and marketing expense by $30 million and now expect between $870 million and $890 million. In the second quarter, we saw improvement in key sales and marketing metrics, such as revenue per sales representative. We expect this to improve further as we grow Cologuard and make more products available. We're also lowering our research and development expense by $5 million and now expect between $425 million and $445 million. Our expectations for G&A, CapEx and intangible amortization remain the same. I'll now turn the call back to Kevin. Thanks, Jeff. A recent study showed that about half of Americans between ages 50 and 75 are not up to date with colon cancer screening. That means as many as 60 million Americans need to be screened. Cologuard is helping to solve this problem. Almost half of first-time Cologuard users are new to screening. The Centers for Medicare and Medicaid Services, or CMS, recently proposed removing a barrier to getting more people screened by eliminating Medicare cost sharing for a follow-up colonoscopy after a positive stool-based screening test. This follows a federal regulation requiring private payers to eliminate cost sharing starting in 2023, addressing a top concern patients and providers have about using Cologuard. Our sales and marketing teams are helping screen more people with Cologuard by using a multi-channel marketing approach to elevate colon cancer screening and Cologuard, investing to support our health system partners' needs, and implementing tools to help people, to help keep people up to date with screening. A powerful data and digital infrastructure is one key to unlocking the full potential of Cologuard, Oncotype DX, and our future tests. We have spent nearly a decade thoughtfully designing and enhancing our IT systems, including a custom-built laboratory information system and installing Epic as the backbone of all processes from ordering to billing. This will power one interface to meet our health system and physician partners' testing needs in hereditary cancer, colon cancer, multi-cancer, cancer prognosis, minimum residual and late-stage therapy selection. Our goal is to make it easy for healthcare providers to order all advanced cancer tests through one partner, making prevention and diagnosis simple and personalized instead of complicated and fragmented. Exact Sciences has the foundation in precision oncology to provide answers to key questions a cancer patient, oncologist, biopharma, or academic partner may have. The Oncotype DX Breast Please stand by. This is the operator. We will reconnect the speaker line. Once again, this is the operator. Please stay on the line. We will reconnect the speaker line. Once again, everyone, this is the operator. We are attempting to reconnect the speaker line. Please stay on. What point? Operator, do we have you? We're on the backup line. Yes, your line is live. Please go ahead. Can you let us know where the line dropped, please? It dropped approximately three minutes ago. To those listening, we apologize for the technical glitch. We don't know exactly where we stopped. For most of my comments, I am going to go back to the start for safety sake and reread them. Thank you, Jeff. A recent study showed that about half of Americans between ages 50 and 75 are not up to date with colon cancer screening. That means as many as 60 million Americans need to be screened. Cologuard is helping to solve this problem. Almost half of first-time Cologuard users are new to screening. The Centers for Medicare and Medicaid Services recently proposed removing a barrier to getting more people screened by eliminating Medicare cost-sharing for a follow-up colonoscopy after a positive stool-based screening test. This follows a federal regulation requiring private payers to eliminate cost-sharings starting in 2023. This addresses the top concern patients and providers have had about using Cologuard. Our sales and marketing teams are helping screen more people with Cologuard by, one, using a multi-channel marketing approach to elevate colon cancer screening and Cologuard. Two, investing to support our health systems partners' needs. Three, implementing tools to help keep people up to date with screening. A powerful data and digital infrastructure is one key to unlocking the full potential of Cologuard, Oncotype DX, and our future tests. We have spent nearly a decade thoughtfully designing and enhancing our IT systems, including a custom-built laboratory information system, installing Epic as the backbone of all processes from ordering to billing. This powers one interface to meet our health systems' and physician partners' testing needs in hereditary cancer, colon cancer, multi-cancer, prognosis, minimum residual disease, and late-stage therapy selection, all of these tests. Our goal is to make it easier for healthcare providers to order all advanced cancer tests through one partner, making prevention and diagnosis simple and personalized instead of complicated and fragmented. Exact Sciences has the foundation in precision oncology to provide answers to key questions a cancer patient, oncologist, biopharma, or academic may have. The Oncotype DX Breast test is now the most strongly recommended in NCCN guidelines, with the highest evidence quality of all multi-gene tests. To expand our precision oncology test offering, we're developing a minimum residual disease test, enhancing our therapy selection test, and partnering with biopharma companies to help identify and develop better therapies for patients. In therapy selection, we're taking aspects from our current tests, OncoExTra, to bring one market-leading comprehensive test to patients. PreventionGenetics recently received approval for the first FDA-authorized Class Two molecular companion diagnostic device developed in collaboration with Rhythm Pharmaceuticals. With 40 biopharma partnerships, the PreventionGenetics team provides invaluable relationships to build upon for future diagnostics. The team is also planning a focused pilot launch of hereditary cancer testing later this year to help breast cancer patients make better treatment decisions based on the genetic makeup of their tumor. In the next 12 months, we plan to deliver evidence supporting three of the most important diagnostic advancements for patients: colon cancer screening, multi-cancer early detection, and minimum residual disease testing. We displayed the breadth and depth of our pipeline at ASCO with 13 abstracts. In our prospective BLUE-C trial, which is supporting our colon cancer screening program, we're happy to announce that we've enrolled the number of cancers necessary to power an FDA submission for our next-generation Cologuard test. We will continue enrollment to ensure we have enough cancer cases to support our colon cancer blood test. In multi-cancer early detection, we plan to share data at ESMO in September that demonstrates the power of our multi-marker approach. In minimum residual disease, we published evidence supporting our tumor-naive panel in colon cancer at ASCO. We also initiated a study with the Women's Study Group to validate our tumor-informed approach in breast cancer and expect to have additional data in colon cancer later this year. We want to provide patients better information before diagnosis and across all stages of cancer treatment. We have a team with expertise across many technologies and biomarker types. This provides flexibility to deliver the best test on the right platform for each question we're answering before and throughout a cancer diagnosis. Our development work with Ultima Genomics and Singular Genomics may provide future access to a differentiated and affordable sequencing technology and another tool to help deliver the best outcome for patients. We're now happy to take your questions. Thank you. If you would like to ask a question on the phone lines today, you can press star one on your telephone keypad. Please limit yourself to one question to allow everyone an opportunity to ask. If you have additional questions, please reenter the queue. We'll take our first question from Derik De Bruin with Bank of America. Hi, good afternoon. Thank you for taking my question. I guess to start off, I mean, you know, there was a $12 million beat on Cologuard relative to consensus and our estimates on the quarter, yet you're still maintaining the full year guide. I guess why the conservatism for the second half of the year, given, you know, you should have a number of tailwinds that are sort of there, given the sales force and less COVID? I guess initial thoughts on how we should think about Cologuard for 2023. Well, let me start and then hand that over to Jeff as well. Let's start by saying we are guiding to 22% growth in the back half of the year. Taking a step back, Cologuard has a tremendously long runway ahead of it. There are between 45-60 million unscreened people who need to be screened. The people 45-49 are starting to be screened at an increasing clip. The environment for access to physicians has not changed. It has been essentially flat over the first half of the year. We expected that to increase. Eventually it will again. What we're seeing is that we moved from a period where access was limited because of COVID to now access being more limited because of office staff shortages. All of those things are temporary in nature, and the need for colon cancer screening is persistent. We're seeing a fundamental shift. That is that Cologuard is becoming more commonly accepted within large health systems, among primary care physicians, importantly among patients, as a great way to get screened. It's just becoming more common, and the data back that up, Jeff, on some of those aspects of ordering behaviors. The positive note is the upside is tremendous, and we continue to expect to meet or beat our 40% long-term market share goal with Cologuard. Derik, this is Jeff. As Kevin talked about, we're guiding to 22% growth in the back half this year for Cologuard. That's $120 million of incremental revenue. I mean, keep in mind, Cologuard, as you know, is a billion-dollar-plus product. It's profitable today. We're emphasizing profitable growth going forward. Want to make sure what we've built here is sustainable and generates consistent growth and cash flow. We'll guide to next year as we look to do, likely on our fourth quarter call. There is a ton to be excited about, as Kevin talked about that. You know, he mentioned the efficiency of things we're doing with health systems. We're up to 50% now electronic ordering. That number will continue to climb higher with the backlog of systems that are signing up, just really waiting to convert to electronic ordering. When you do that, you see a nice lift in orders. I feel good progress is made on growth. Today, we have about three and a half months left in the year from a Cologuard order perspective. Recall things really slowed down for us. Our ability to turn orders into revenue really goes down after Thanksgiving. Here today, about three and a half months left in the year. We will try to do everything we can, but you should think of the midpoint of guidance for the year as the most likely outcome. We'll take our next question from Brandon Couillard with Jefferies. Hey, thanks. Two-part question for Jeff. First, a $1 billion reduction in sales and marketing. I can elaborate on the driver for that. On G&A. I think there was a $25 million gain in the second quarter, but your spending outlook unchanged. Is that right? Yes. Two-part question, Brandon. The first one I'll start on the sales side, and then maybe Everett can chime in too, if he's got something to add. On sales, I think what you're seeing here is an emphasis on prioritization in investing in the highest return areas of growth. Everett and team have done a very nice job making sure we're targeting the right doctors, targeting the right territories, always looking at marketing spend closely. What I'm really pleased to see the improvement that we saw when you look at the sequentials here. Sequential up growth of 7%, a sequential decline in sales and marketing of 7%. This is some really nice efficiencies we're getting. I mentioned in my remarks we're seeing improved efficiency of our sales team. You know, this is part of the plan that we kicked off early this year to improve the productivity there. Everett chimes in on this. We had in the last two quarters a $5 million gain. Really, this relates to the earn-out for the Thrive position. The only thing that really happened as interest rates go up, the math around the accretion on that says that we've got a bigger gain. That's really the dynamic here. That could happen again in the future. I'm not counting on it, but it could happen again as interest rates fluctuate. You know, that's the change there. As far as the G&A in the back half, we're continuing to invest in things like IT. That's likely to step up in the back half. You know, IT is a crucial driver for, you know, for the efficiencies that we expect over time. I think those investments make a ton of sense. Everett, anything to add on the sales and marketing line? Jeff, just around optimal deployment. You know, we've taken a look at putting our resources toward those largest opportunities that we have. I like and I'm excited about where we've invested in our commercial organization. We've invested in our health systems organization. We know that health systems have been important and will be more important as the year goes on, as we go into 2024. That investment in health systems has allowed us to really develop some deep partnerships, making sure that Cologuard is a major choice for those large systems. We'll take our next question from Brian Weinstein, William Blair. Hey, guys. Thanks for taking the question. Not really thrilled that you brought up three and a half months to Thanksgiving. It's 55 and sunny in Chicago today, and I don't want to think about that yet, so not cool at all. You guys divested an asset this quarter. You're clearly looking at what makes sense. Maybe or Everett, if you talk about the portfolio more broadly. Any thoughts about the right time to potentially add to the bag to maximize kind of sales more broadly and even potentially Cologuard? Like even in precision oncology, you've been an acquirer. Should we expect that to continue? The reason I'm asking is obviously just strict intent, but also just wondering how M&A or other types of opportunities to add to help Cologuard potentially, how that factors into kind of comments you've made in the past about not raising equity, of course, and then also seeing profitability. Kind of a bunch of stuff bundled up there. Hopefully that made sense. Yeah. Thanks, Brian. It's Kevin. If you go look back to 2016, I think we generated $99 million of revenue, and this year we're guiding to $2 billion. The company has been transformed, and an important part of that transformation was joining forces with Genomic Health and building what we believe is the best reach from all the way from primary care, GI, OBGYN, other specialties, all the way to oncology. If you then look at what is our portfolio strategy, you have two of the we think the best brands in cancer testing, Cologuard and Oncotype DX Breast, which are anchors to our long-term growth. Now looking at our pipeline, we have multiple early detection testing. Really an amazing opportunity to access 135 million Americans on a regular basis and transform cancer care by making detection earlier. Two, our colon cancer next generation test and colon cancer blood programs, minimum residual disease. Those three group products access a total combined TAM of about $60 billion, and we are the company that can deliver. One of the reasons we can deliver it is because we have this amazing IT platform that is suited from the time a doc learns about a test, they order it, they get a result, all the way to billing. The investment there is huge. We believe the best commercial organization, not only in cancer diagnostics, but in diagnostics. This is an incredible team of professionals that engages deep capabilities in the lab, in clinical, in regulatory. This allows us to take new products and drop them in to this portfolio. Our M&A philosophy is driven by, will the product or the technology contribute to this long-term strategy that I just articulated? Is it the right culture fit? Does it create shareholder value? When it comes to our Oncotype DX Prostate test, it's a great test. I know people personally who have benefited greatly from the information that that test delivers. MDxHealth is a, we know the leadership of the company well. It's a very strong company, totally focused on urology. We will be one of the important shareholders of the company. We want to support and help them be successful. We believe that this is the right home for Oncotype DX Prostate. We'll continue. Everett, I don't know if you have anything to add there. Yeah. Kevin, I will just add one thing. I've been out in the field over the last month and a half talking to large health systems about this portfolio approach to our cancer continuum. The response that the health systems are giving us, the CEOs, the CMOs, they're saying if you can simplify the number of lab partners that we have to deal with, and you have the back-end support of all your IT solutions to help our workflow, they're gonna partner with us. We're gonna move from selling individual products to being their, you know, cancer continuum partner. That's what health systems are looking for. That's what I've seen over the last month and a half that I've been in the field. It's inspiring. Thanks, Everett. We'll take our next question from Catherine Schulte with Baird. Hey, guys. Thanks for the questions. Yes. First, in the past, you've talked about the group of docs that had represented the top 40% of our orders pre-COVID, you know, is still down while the bottom group is ordering much more than they did pre-pandemic. Did that trend continue in the second quarter? You know, how long do you think it takes for that top tier of orders to come back? Hey. Hey, Catherine, this is Jeff. This is a really exciting part of the business, something I know Kevin and I and Everett look at closely, and we're really excited about the future here. That trend, it actually accelerated in the quarter relative to prior quarters. We saw those doctors that order historically had ordered most recently, they improved. Their, you know, their orders now are down just under 10% relative to the start of the pandemic. Again, that's in an environment of more limited access. That compares to about down 15% in the first quarter. Again, improvement sequentially. These are doctors that are the true believers. They order still at a higher rate. The patient flow is ticking back up. As access improves, they will come back even more and expand from their current levels. The doctors who historically had only dabbled ordered infrequently, oftentimes we didn't even call on them, this part of the business tremendously exciting. Those doctors have essentially doubled their order rate relative to the start of the pandemic. Continues to improve. Last quarter, I think, was up 60%. Now it's close to 100% improvement since the start of the pandemic. This provides a huge growth opportunity for us for years to come. We can selectively call on the most promising doctors in this group. We're seeing this broadening of the ordering base. That really bodes well not only for Cologuard, also other products like hereditary cancer and multi-cancer. As we launch them, we'll have a broader base of physicians to launch them through. We'll take our next question from Dan Brennan with Cowen. Great. Thanks, guys. Thanks for the question. Kevin, I thought I'd just ask you about with ECLIPSE coming, obviously, you've spoken, you know, pretty prominently on expectations. Net-net, you know, by the time we get to the next call, you know, the data could be out. Just wondering if you can update us anything incremental and kind of how you're thinking about, you know, the different scenarios and kind of how Exact we'll react depending upon the scenario and kind of how Cologuard will be positioned versus those scenarios. Well, let me remind you, there are many challenges in bringing a blood colon cancer blood test to market as a leading way to screen people for cancer. There are five main reasons. Number one is that any of the blood tests, the data that we've seen, are less accurate than Cologuard and colonoscopy and other established screening approaches. Equivalent FDA approval and claim language is unlikely. That's a challenge when it comes to introducing a new test into the, you know, awfully challenging and complicated screening paradigm. The bar for guideline inclusion, which drives commercial coverage, is very high. Pricing is likely to be some $200. There's the question of where does a blood test fit given that you have tremendous performance with, in terms of efficacy with colonoscopy and Cologuard. You know, I think the market is challenged. Our view hasn't changed here. We have a blood test that we expect to be priced appropriately. We have a commercial team, a lab infrastructure, an IT system where we will be able to drop our blood test into that ecosystem, making it really easy for docs to order and patients to use a test if for any reason they opt not to get a Cologuard test. That's our view of this in terms of data. Data is step one. There's FDA approval, there's getting claim language, Medicare coverage, et cetera, that will take most likely multiple years. USPSTF's next output is probably three to four years away. Our next question comes from Vijay Kumar with Evercore ISI. Hey guys, congrats on the print, and thanks for taking my question. I had one on this path to profitability. Jeff, it looks like your gross margin assumptions changed. I heard some comments on inflation. What's your updated free cash flow burn rate for the year? You know, when you think about the 2024 adjusted EBITDA path to profitability, assuming revenues to grow teens, gross margins are consistent, I mean, your OpEx has to grow low singles over the next two years. Are those assumptions reasonable? Do they make sense to you given we're looking at you know Exact being at the high end of your peer group growth set? Thanks, Vijay. This is Jeff. I just wanna say it again, I know we've said this before, but we are firmly committed to adjusted EBITDA profitability for the full year of 2024, and we made great progress towards it. This team pulled together, came up with just awesome and new ideas on how to get more and more efficient as we grow. Going forward, you know, it will start with revenue growth, and Everett and team are doing a nice job growing the top line. I do expect some gross margin improvement over that period. You know, inflation here in the near term is what I pointed to. Shipping and wage inflation are an incremental headwind relative to our last update. We have significant lab automation projects in flight now that'll help us drive improvement on top of leveraging the fixed cost of our labs. I do expect some gross margin improvement. Then you're seeing the OpEx discipline. It's starting with the sales and marketing line. You'll get even more of that in G&A in the coming years. I feel very good about the path from here to 2024. We'll take our next question from Dan Arias with Stifel. Good afternoon, guys. Thanks. Kevin, maybe a couple on the pipeline. Starting with Cologuard 2.0, is a 2023 commercial launch for that assay in the picture at all, just given the current submission timeline expectations? Maybe on MRD and the dual approach that you have there, I mean, obviously, there's a need for data generation. It sounds like there's some data on the way. How are you thinking about the timelines that those tests are on? Should they more or less arrive together, or is the development path just not something that's gonna allow that to happen? Thanks. Cologuard 2.0, or what we call next generation Cologuard, will 2023 is a possibility. We have not yet made a determination internally as to when that test will be launched. It will obviously depend upon the test performance. Then there are a whole bunch of things you need to do to make that flow. We may or may not need a new CPT code. That will affect the launch timing and then Medicare coverage and insurance coverage. You wanna make sure all of that is locked so that when you flip the switch, you have a very smooth billing process and patient experience process. In terms of MRD, we have access to a couple of important sample sets that will allow us to seek an LDT status and then work towards getting inclusion as one of the reimbursed tests. We see this space is developing very nicely. It's setting us up for a product launch in MRD not this year on a reimbursed basis, most likely next year. We'll take our next question from Matt Sykes with Goldman Sachs. Hey, guys. This is Dave on for Matt. Congrats on the strong print. Could you tell us, I hate to ask about physician office access for the millionth time in the past two years, but any comments on the percent of pre-pandemic office access your sales reps are getting in in person and any directionality there? Yeah, this is Jeff. I'll take that one. So we've talked about access being relatively unchanged since our last call. You know, one of the newer dynamics, and this is, this isn't just us, you, I'm sure you've heard other companies talk about this, is a critical staffing shortage that you're seeing in the healthcare provider setting. So that has the effect of kind of limiting access further. So, you know, I would say where is it relative to pre-pandemic? You know, probably somewhere 50%-60% of pre-pandemic levels. That's what we talked about on our last call. Everett and team are getting really creative at finding ways around that and making sure that we are a good partner to health systems and other providers, and that's what's helped us deliver upon the growth and, you know, including 22% growth in the second half of the year. We'll take our next question from Patrick Donnelly with Citi. Hey, Jeff. Thanks. Maybe following up on that one there in terms of kind of the improvement in the second half. I think the Cologuard guidance is basically implying kind of flat to down sequentially from what you did in 2Q. You know, typically, 3Q seasonality is a little bit better. Obviously, a few factors kind of working your way, as you've talked about in terms of building the momentum. Is that just conservatism baked into that 3Q number you discussed? Just trying to figure out the moving pieces why that number 3Q would be better than 2Q sequentially on Cologuard specifically. Thanks. Yeah. Patrick, this is Jeff. You know, like I would just say the guidance is the likely view of where we'll end the year based on everything we've seen. You know, access is part of that. You know, there's other trends out there too, but I'd say stick to the guidance that, you know, it's likely where we land. You know, historically, you know, you look back at the last couple of calls, I've talked about the seasonal trends of Cologuard. As the base of this business continues to grow, you're gonna see the seasonal pattern shift a little bit. I think that's what a lot of the Street has missed. I think it's between that and just, you know, access historically or in prior quarters, we had assumed access would improve gradually over the course of this year. Now we're saying it's likely to be flat over the balance of this year. We're just guiding to what we see right now. Maybe it improves, maybe it doesn't. We're baking in no change to access for the rest of the year. We'll take our next question from Jack Meehan with Nephron Research. Thank you. Good afternoon. Kevin, one of your, or maybe for Everett as well, one of your competitors launched a colorectal cancer liquid biopsy test as an LDT back in May. Obviously, very super early days, but was wondering if you saw any impact at certain accounts and what you may or may not be seeing about the interplay between Cologuard and liquid biopsy in the field? We saw zero impact from any other aspiring entrants into colon cancer screening during the quarter. We're unlikely to see any impact because tests that aren't reimbursed, that aren't in guidelines, that don't count towards a quality measure credit just don't. It's challenging to conceive of a way that there would be significant uptake there that could impact that. We screened over 700,000 people in the quarter. We expect that to continue to grow throughout you know the next several years and beyond. No. Really, you know, again, blood tests have a role in colon cancer screening if they achieve at least the same level of cancer sensitivity as a FIT test and better advanced adenoma pre-cancer detection than we have seen from case-control studies. If so, there is widespread reimbursement and validation of these tests, we think that they will have a role just not in the near term. We'll take our next question from Mark Massaro with BTIG. Hey, guys. Thanks for taking the question. Maybe a two-parter. Jeff, the first one is for you on Oncotype Prostate. You lowered the guidance by $15 million-$20 million for the year. Just wanted to confirm that the rough GPS revenue run rate was around $30 million-$40 million. Then secondly, you know, I wanted to follow up on the profitability topic. Clearly you have significant investment to come in multi-cancer early detection, significant investment in MRD. I understand that you divested Oncotype Prostate, a small part of your business. I guess I could use some help as to how you expect to achieve adjusted EBITDA profitability in 2024, when you have the investments that I laid out. What I wanna maybe clarify is, you know, Do you expect to continue investing in DTC? 'Cause obviously that's a pretty significant line item. Then I'd also be, you know, since you're divesting the prostate sales force, any comments on your GI sales force? Mark, this is Jeff. On the first one, I think you're in the right ballpark there. We typically don't break that out, but you're in the right range. On the second one, look, I mean, we are, again, we are very committed to being profitable in 2024. Our mantra internally is to keep saving so we can invest in the highest impact priorities and keep growing this business and serving more patients. You know, I'm confident we can invest in those three key things. Kevin touched on them. You know, obviously it's our colon cancer business, it's MRD and multi-cancer. We benefit from having a strong foundation from which to grow. We've got this foundation of lab, IT, sales forces that we don't have to invest incrementally as we bring these new products to market. The incremental profitability gets even better. I'm confident. I'm happy to spend some time offline on the math, but I look forward to, you know, driving continued leverage of our sales and marketing team and the G&A going forward. I think G&A will be a big area of improvement in the coming years. Then on DTC, yes, we will continue to invest in that. We'll continue making these investments because the return is very good. The GI sales team is a crucial part of the business going forward, you know, today for Cologuard, in the future for a whole series of other products. Take our next question from Puneet Souda with SVB Securities. Yeah, hi, Kevin, Jeff. Thanks for taking the question, and two simple ones for me. First one on CMS coverage of diagnostic colonoscopy. I mean, wondering if there is any change in the marketing approach among the sales force as a result of this for full coverage of follow-on colonoscopy. Can you remind us how wide is the coverage of follow-on colonoscopy by commercial payers? Just one for Jeff on PreventionGenetics. You know, we've seen a disruption from one of the competitors in the marketplace. A hereditary diagnostic peer is reducing their workforce by a third. Just wondering in terms of share taking perspective and opportunity to gain talent. Thank you. For CMS coverage for diagnostic colonoscopies, that's pretty uniform today. The proposed CMS rule is a change that says when a patient has a positive stool test, so either a FIT test or a Cologuard test, a follow-on colonoscopy should be deemed a screening colonoscopy because it completes that patient's screening journey. As such, there should be no cost-sharing. Today, there's about a 20% cost share for that. This rule, if finalized, won't go into effect until next year. No, today we're not out marketing this, but in the future, we will. Yep. Just to add some color to that one, you asked on the commercial side of that. The CMS update also follows the Department of Labor regulation that applies to commercial plans. This is essentially universal starting in January that diagnostic follow-up colonoscopy will be without any cost-sharing to the patient. Big win, something we've advocated for a long time. On your second question on PreventionGenetics, we're really pleased with the growth in the quarter and the amount of opportunities that Exact has. We highlighted the Biofrontera partnership there. Just couldn't be happier with this new acquisition and all the capabilities there. This does serve as the foundation for future entrants into hereditary cancer testing. The longer term goal is to really grow the pie, especially in the primary care channel. Obviously, we've got a strong foundation there with Cologuard today and future products over time. We do plan a kind of an early access type launch later this year in oncology. I think this is a perfect opportunity for us to build upon the relationships we've established over the past 15+ years with the Oncotype DX Breast test. Really pleased about the future opportunity here. I think it's primarily about growing the pie and getting more women, men and women access to this innovative technology. We'll take our next question from Kyle Mikson with Canaccord. Hey, guys. Thanks for the questions. Just want to talk about BLUE-C. You enrolled enough Cologuard 2.0 patients to power the FDA submission. I think that was expected, but you're gonna continue to enroll for the blood arm. I guess, how long will that take? Then just maybe remind us of the path forward there and any timelines for the CRC blood assay. Thanks. This is Kevin. It's not a separate blood arm. Unfortunately, about 10%-20% of people who are willing to get a stool test don't complete a blood draw. That's probably because that requires a special trip to a blood collection center or because they don't like needles. That's why we continue the entire study. As we have more patients in the study, it just increases the powering of the study, which is great. That's probably for a few more months. We haven't determined when we will finally lock the study. We're just thrilled that we are in a position that if we wanted to shut down the study for Cologuard next generation Cologuard, we could do that today. We're ultimately excited about the opportunities that both tests afford to patients. We'll take our next question from Alex Nowak with Craig-Hallum Capital Group. Great. Good afternoon, everyone. Going back to the portfolio strategy, one of the things that Exact Sciences doesn't have is what I'd call bread and butter, old school cancer testing like FISH, flow, pathology, cytogenetics. Do you need to own a broader testing menus to succeed with that portfolio strategy? Or do you eventually see those relatively commodity-like tests getting ultimately phased out or replaced with newer modalities that Exact would have? We don't think that those tests will be replaced by molecular tests. Rather, molecular tests are answering new and different questions that those tissue tests don't always answer. Do we need a flow business or FISH business to be successful? The answer is no. We don't need that business to be successful over time. We've kind of laid out what our strategic plan is. We're excited about that strategic plan, and we're gonna execute that plan like our lives depend upon it because it's the right thing to do for patients. Thank you, and this does conclude today's presentation. Thank you for your participation. You may now disconnect.
Loading workspace