Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

Good morning. We are joined -- really pleased to be joined by Jeff Elliott, the CFO and COO of Exact Sciences. And hopefully, in a few seconds, there we go. We're also joined by Jake Orville who is the SVP of Pipeline at Exact Sciences.

So we just had a great, very nuanced debate on multi-cancer testing. We also talked about Cologuard 2.0 and liquid biopsy there at the end. Maybe just as a kickoff question, we'll start with Jeff. Obviously, the focus today is on liquid biopsy. Just at a high level, can you talk about the learnings from the Cologuard development process? Just what you can -- what you think can be translated over to liquid biopsy? And how you see Cologuard -- how the screening paradigm is going to play out with Cologuard?

Sure. And, Jack, thanks for having us. Really appreciate the time today and the questions. So we've learned a lot over the past 13 years since we first restarted Exact Sciences to bring Cologuard to market. One, I'd say it takes a great team. At Exact, we've got the proven capabilities, not only to launch a test, but also to develop a test and generate the evidence that are so crucial to being successful with the launch. Again, 7,000 employees. We've built that up over years. We've invested significantly in a platform to bring Cologuard to market and layer other products on top of that. That investment, if you would ask this question 10 years ago, I would have thought the investment was far smaller. We probably invested a total of $4 billion when you think of all the commercial awareness and advertising; the 1,000-plus person sales and marketing team; the lab investments; IT. It's a major investment. We're thankful to have that in place now. So as we launch other new products, whether it's Cologuard 2, a colon blood test, MRD, multicancer, those products all layer into this foundation. As an example of how quick this company can move, I would go back to the early days of COVID. Back then, as you well know, there was a lack of COVID testing available. In a matter of about 3 weeks, we've designed a test and quickly brought it to market. We were able to do that because of this foundation. It's very similar to testing for Cologuard, same instruments, same IT platform. Again, we can move quickly because of that foundation we had in place. And going forward, we look forward to demonstrating that with other new products.

Great. Can you maybe just give us a mark-to-market on Cologuard? How deep do you think you are penetrating in the market today? Where do you feel like you are in the S curve? Just what's driving adoption for these noninvasive methods kind of versus colonoscopy?

Look, Jack, I think the S curve is still in front of us. But just starting with what we -- how we define the market, currently, there's about 110 million people in the U.S. who are at average risk for colon cancer. So that is the market. The sad thing is that even though colon cancer is known as the most preventable cancer, it's still the least prevented. It's clearly, we need more and better options, and that's why we invented Cologuard. So today, about 55% of the people in that population are screened. What that means is you have well over 45 million people who aren't due for screening now. Where are we in market share? Our estimate is that our current market share is between 5% and 10%. So still early days. However, when you see the growth here, I'm confident that longer term, we'll get to at least 40% share. What that means is a top line of between $7 billion and $8 billion. Again, longer term, when you look at -- back at third-party data, it typically takes about 17 years from a time a new product is introduced to achieve full adoption. Again, this was a third-party data. They looked at all sorts of different product launches. And while we're 8 years in now with Cologuard, Cologuard was FDA approved back in August of '14. So we think there's a lot of really exciting growth ahead of us.

Great. Let's keep going. It came up toward the end of our last discussion related to Cologuard 2.0. And you, obviously, have this big study underway with BLUE-C. Can you give us an update just how is enrollment tracking with the upsized study? What do you think are going to be kind of the key readouts when we see the data, hopefully, later this year?

Sure, I can address that, Jack. So first, just a reminder to everyone what BLUE-C is, it's our large prospective U.S.-based trial to support our next generation of Cologuard, very similar to what we did in DeeP-C for current Cologuard. We're mirroring and, as you said, upsized for BLUE-C. We stated this before, we're thrilled with the progress that the team has continued to make. We expect to have the number of cancers we need for the study by the end of this summer in stool and then shortly thereafter to support not just our next-generation Cologuard product, but also using the study to support our colon cancer blood product. And we expect to have the number of cancers in blood shortly thereafter.

Great. So once you have the headline results, what's going to happen next? Like how quickly do you think there will be an update for investors? Have you thought about just the way you kind of roll out the data for people to review?

Sure, Jack. We'll follow the same playbook that we did with Cologuard. And that is that we will press release the top line data. I mean by that overall sensitivity and specificity as well as precancer performance. And then, of course, we will look to publish the entire data set in a leading scientific medical publication.

Perfect. And maybe just talk about -- just like what's the pathway once you have -- so you have the data. You'll publish it in a journal. What comes next? So you go through the FDA. What's the reimbursement pathway look? Can you talk about things like coding and pricing for a test like this?

Jack, I think, it's a little too early to get into the coding, some of those details. But I would say the foundation that we built for Cologuard is largely the same foundation that we'll use for Cologuard 2. So again, lab, sales force, kind of the brand name, we can leverage all that. Cologuard 2 provides even greater value. We can talk more about that, but the goal of Cologuard 2 is a lower false positive rate and higher precancer sensitivity. That's more value for the system, more value for patients. So there could be a chance for higher pricing. We need to look through all that. But again, it's greater value. We think the pricing should reflect the value. The evidence that we've established for Cologuard 1 and Cologuard 2 will meaningfully help payer coverage, guideline inclusion, all that. So we expect a very smooth transition between the two.

Great. Yes, and I want to talk a little bit more about the data, but I might weave that into our next discussion on liquid biopsy and just how these things stack up against one another. Well, actually, maybe let's move into that. So obviously, there's a number of companies that are approaching the liquid biopsy world. What do you think Exact -- sets Exact apart in terms of maybe capabilities, expertise, just the experience? Talk about that.

Yes. Well, sure. First, I think, Jeff mentioned this at the opening. The experience that we've developed with Cologuard, the market discovery process, the product development process and the commercialization process, that entire experience is transferable and translatable into how we're approaching liquid biopsies. So we're not new with this. In fact, Jeff mentioned it that we've been at this for the last 13 years in partnership with our collaborator, Mayo Clinic. To your point, Jack, I think there are 3 things that stand out for what we're doing. The first is how we go through the market discovery process. The second is the evidence generation. And then the third is the portfolio view. So I'll touch just briefly on all three. We've been looking at deep sequencing of tissue samples for the last 13 years. Tissue samples, the source, and we're looking at deep sequencing to identify those needles in a haystack as compared to healthy or normal tissue. Now you and others may know us most notably through the Cologuard markers that we've discovered, developed and commercialized the performance. But it's the same process that we've been following over that 13-year period. That discovery process is the same. This time, obviously, we're looking for those needles in a haystack or those methylation markers in blood to be translatable in our liquid biopsy program. So not only is it translatable, but it's the same process. And I think that really helps us. We've been at this for a while. The second is our evidence generation approach. Remember, we're after making the biggest impact in the patient care that we know these tests can have. And to do that, we need broad-based adoption. In order to achieve broad-based adoption, we have to have guideline inclusion, and we have to have payer coverage. For that to occur, we've got to generate the evidence of these tests in the intended use population where they're meant to serve. That's not easy. That takes time and that's, obviously, expensive, as Jeff had indicated. If you look at how we've approached evidence generation first in Cologuard, you look at DeeP-C, pivotal study, large that supported guideline inclusion and FDA approval in Cologuard, And then if you look at our Oncotype suite of tests, you look at a 10-year outcome-based study, I think, Jack, there are 6 New England Journal studies that support our current on-market products. So that's the bar we set, and that's the bar that we will continue to achieve.

Yes. Yes, I think, it helps to -- there's hundred liquid biopsy companies which have come out over the last couple of years. I don't think everybody has the same skill set that you guys have built over the past decade or so. Speaking of deep sequencing of samples, one question I've now gone five times in the chat and via e-mail is your announcement this morning with Ultima, about the investment in the company and the long-term supply agreement. Can you just talk about maybe the background with the company? How this relationship came together? And what do you plan to use to work with them on? Is this primarily liquid biopsy, multicancer? What other tests could work -- could you work with them on?

Well, first of all, we're thrilled to announce this partnership today. What we announced was that we had invested in Ultima and also signed a long-term supply agreement that will involve working together to develop at least one of our tests onto their platform. So some background here. As you know, Jack, our philosophy is always the right tool for the right job. So we're always scanning the universe for new and upcoming technologies that we can incorporate into any of our tests. And so we've been going through a long-term process evaluating different sequencing platforms. We've looked at all different platforms out there. And what really struck us about Ultima was the high-throughput capability, the ability to scale, low cost and, eventually, get to a very high level of accuracy. When you look at the key markets that we're entering, multicancer, MRD, even colon cancer. We see opportunities across all of those in addition to some of our on-market products like therapy selection. We're already a big user of sequencing technology. I think, over time, we'll be a much, much bigger user. And Ultima, I think there's a very good place in the world for Ultima to come in and help with many of our different tests.

Interesting. So I guess now let's turn to the data. I think over the years, and like -- it's obviously heated up a bit as we get closer to the ECLIPSE results. You've got -- you've been very consistent. You think the liquid biopsy performance is going to be closer to fit than Cologuard. We've seen several of Guardant's case cohort studies would seem to suggest the opposite. So just has your opinion changed at all? What do you make of kind of where the bar is here?

No, our opinion hasn't changed at all. We know how these studies should be designed. We understand the degradation of performance over time. And remember, when you enrich for a sample population, of course, you're going to see better results. But, Jack, I'd like to just step back for a minute and just remind everyone the value of a screening program so as guidelines so as modeling and so as the providers are to detect early-stage cancer and in particular, pre-cancer. That's where the value, that's where we're going to have the biggest impact in a screening program. For colon cancer, the colon does a really good job of what it's intended to do. There's a biological barrier that keeps things in the colon and out of the bloodstream. Early-stage cancer and, in particular, pre-cancers, they begin to form on the inner wall of the colon. And so measuring performance in early stage in pre-cancer in blood is going to be incredibly challenging. I think the studies that you mentioned actually support this, 10%, 20% pre-cancer performance compared to, in a pivotal study, 42% with Cologuard measured in stool. So if you look at the value of the screening program and you understand where the focus should be, I think we're confident that precancer performance is going to matter. And then as a result, Cologuard will continue to be a superior product compared to blood.

Can you maybe just build on that, so this precancer detection, and this would maybe be a good time to weave in some of the data from Cologuard 2.0 earlier this year. Like if you have something that's in the 40% range or better for advanced adenoma detection versus 20% or so, and we'll see what the final data shows, just like what does that mean maybe, through the eyes of the USPSTF? And what gives you so much confidence kind of in that relative value where that -- why that's so important?

Well, Jack, this is Jeff. So what USPSTF and other guideline groups often look at is the benefits to harms by any different screening modality, and they'll evaluate those modalities across different intervals, starting ages and stopping ages. And so what's clear is that if you look back to the 2016 update, Cologuard provided the best ratio of benefits to harms and also it was a very convenient sample type and with that home collection. And so Cologuard was included in the guidelines. One thing they said at the time is that the best test is the one that gets done. And if you look at real-world evidence, Cologuard's adherence rate or compliance rate is the best of any test out there. Over time, I think it will continue to climb as we enhance our program and add in additional 3-year rescreening. That's the framework in which they look at it. We've generated additional models that show -- that looked at a range of different outcomes for whether it's stool or blood. We've also looked at a range of different adherence rates. And it's clear that Cologuard, when compared to any likely scenario for blood, generates a meaningfully higher life years gained and the overall ratio of benefits to harms. In fact, we published this data at ASCO. We looked at 20% precancer sensitivity for blood and then we looked at 74% sensitivity for overall cancer and 90% specificity. Think of that as the Medicare minimums. These are at 100% compliance rate, which we all know won't happen. In the real world, blood typically maxes out around 70%. If we assumed 100% compliance rate, that test meaningfully underperforms Cologuard. So we've looked at this thoroughly, precancer matters. It drives over half of the life years gained benefit. So you have to be able to find precancer. Precancer goes a long way towards determining your test interval, but also because of that, it helps determine your price of your ultimate product. With all that evidence we've looked at, and we've looked at this for a long time, we're very confident that a blood-based test is almost certainly going to be a 1-year interval test.

Yes. So there's been a lot of back and forth between Exact and Guardant kind of on this point of the interval length. When I read the Medicare NCD, at least as it's written, it's pretty clear that it's 3 years. I guess we can debate what happens down the line with USPSTF. But is that also your expectation is at least right out of the gate, it should be 3 years? Or is there some way maybe that changes?

I guess, Jack, let's be clear on what Medicare said. They said that they would only reimburse that test that met those performance criteria, 74% sensitivity for cancer, 90% specificity. They said they would only reimburse that once every 3 years. It doesn't mean it needs to be run every 3 years. They would only reimburse it once every 3 years. What they did has effectively reduced the size of that market by 2/3, right? So that's a major impediment that I haven't or anybody find a way around right now. Again, these tests, when you model them out, what the guideline groups almost certainly going to say is that blood needs to be run every year. So imagine that landscape. A test that has to be run every year to keep that person's screens, but Medicare is only going to pay for it every 3 years. That's a major obstacle that, again, we have to overcome that too. Now what Medicare did say, if you read further down in the NCD, they'd be willing to revisit the interval upon data. Okay, well, I think the likely source of data there is USPSTF. Then I think you've got to ask the question, when is USPSTF likely to update their guidelines? I imagine we'll get into this, but the likely timing based on historical precedent is 2026. So we've got a period here where Medicare may say, "Hey, we'll pay for once every 3 years, but it needs to be done every year." That's going to be a hard obstacle to overcome.

Yes. So the other, I feel like, point that's been debated back and forth is kind of this topic of adherence. Obviously, it seems like the USPSTF cares when they went through the review a few years ago to include Cologuard. But it would be great to get your perspective on that. Do you think they care, maybe the modeling group doesn't? Like how is this all going to play out?

Well, Jack, if you read what they wrote in 2016, I think they've repeated it since then. They said the best test is the one that gets done. In my view, that is adherence is a priority for them, or if you look at the modeling criteria, the modeling group, what they look at is they assume 100% adherence, which is a repeat test over a period of time. Think of that as 30 years over your screening interval. You do that test every time when you do. Now in the real world, that never happens. So we've been asking this group, pleading with them for years, please change that, please use real-world adherence. Because in a real-world scenario, Cologuard is even better. Again, this is the modeling that we've shared at ASCO and other conferences. Cologuard is even better when you use real-world inputs. But they still -- they've been sticking to the 100% model, which we'll deal with that. Even with that model, Cologuard performs well and has been included in the guidelines. But at 100% adherence, that hurts Cologuard relative to real world and relative to a colonoscopy.

Great. A few follow-up questions that have come in via e-mail and also the chat. One is just, I think, a clarification on your statement. Looking at the precancer sensitivity, 20%, 74% for overall cancer, 90% specificity, I think the comment was even at 100% compliance, it meaningfully underperforms Cologuard. Was that an annual test that lost to Cologuard? Or was that referring to 3 year?

That was an annual test, Jack. That was -- and this is in the post we published at ASCO.

Got it. And then one was on Ultima. Just can you confirm is that a new investment that you made today or announced today? Were you previously an investor in them?

That's a new investment.

Nice. Okay. And then -- yes, so the Medicare bar is 74-90 for reimbursement every 3 years. Do you have a sense like for where is the threshold where it becomes 1 year versus 3 years? Is it -- do you have a view? Like is there some line as you do the modeling related to the advanced adenoma detection or early-stage sensitivity? Like what matters most that's going to push it to 1 year versus 3 years?

What matters most, Jake commented earlier, is precancer sensitivity. That drives over half of the life years gained benefit in a screening setting. When you look at why, if you look at the DeeP-C data, which was for Cologuard 1, in that population, over 7% of people had precancer and only about 65 basis points worth of people had cancer. And most of those, 75% of those, had at early stage. So if you look at the number of people impacted by detecting a precancer, it's far bigger than there are people impacted by finding a cancer. Again, if you find precancer, you can snip it out. And that person, they've got a bad couple of days and they tend to take off for work. But you've actually prevented the cancer from happening. So the benefit is far bigger with precancer. Where does it tip over? I mean I would point to Cologuard, right? At Cologuard, it's very clearly a 3-year interval. You'd have to approach or, if not, achieve Cologuard-like performance in order to get a 3-year interval. Fed, as you know, is 24% sensitive for precancer, 74% sensitive for all cancer at 95% specificity. Again, that's a 1-year interval. Now for blood, I think having -- achieving similar levels of performance would be a good outcome for blood, and that's very clearly a 1-year interval.

Got it. Okay. The debate -- yes, very helpful. I'm sure we'll debate in the next panel as well with Guardant. So I appreciate your perspectives. We have about 15 minutes left. I want to turn next to multicancer, either for you or for Jake, just it would be great to get an update on the progress the Thrive team is making toward locking in the final assay.

Sure. Well, first, Jack, I couldn't think of a more impactful test category, at least in my lifetime, than multicancer. Start with the why. I think everyone knows, 70% of those diagnosed with cancer this year do not have a routine standard-of-care screening option. And so we've got a lot of people to screen, if we can, to determine if they have cancer outside of those 5 predominant standard-of-care screening modalities. So we're really excited about being in the space and excited about the progress that the team is making. As Jeff mentioned, I think, already, we did present data at AACR earlier this year, taking our methylation approach in combination with proteins and publish that data. We're pleased with those results. And we've got 2 readouts coming up still later this year to lock down that assay and the test performance prior to kicking off what will be a large prospective interventional study early next year.

Great. So GRAIL was first to market in the category with their LDT. They're having some level of success in the market. Just any thoughts as to how your test is going to stack up versus theirs? Like what sort of differentiation you're trying to drive?

Well, I think, it starts first with the size of the impact that we can have. I think it's about 130 million people just in the U.S. alone that could be screened for multicancer. So we think multicancer is a good thing for all patients, and there's certainly an urgent need to detect cancer earlier, right? Bert Vogelstein from Hopkins has the famous quote. There's still no therapy as good as early detection. So we're focused on that. To create such a large class in such a new environment of testing in multicancer, it's going to need multiple partners. It's going to need an ecosystem. And we're actually going to hold hands together with industry to make sure that we can support this new approach of multicancer. This is the only test, Jack, that I'm working on that I know needs an active Congress to make sure that Medicare [indiscernible]. So we have our work cut out for us. We need to make sure we're focused not just on test performance, but also on what it means in such a big new modality. Now that said, compared to GRAIL, we're very comfortable in our approach in a multi-omic fashion. We want to look at multiple market classes that we can select the best class of markers that have the best performance. And again, we're going to emphasize as much as possible early stage. So we think multi-omics certainly matters and FDA approval is crucial, which is why we're investing in such a large pivotal interventional study that I mentioned will kick off here soon.

Nice. So maybe just elaborate a little bit more on some of the work you're doing, need a bunch of partnerships, both with government agencies, other organizations to bring something like this to market. Can you talk about the work NCI is doing? We saw a recent update around, I guess, their Vanguard study. Is that something you expect to participate with? How does that compare to the pivotal work you're doing?

Well, I think it's very complementary. I mean the fact that NCI is looking at this just, I think, speaks volumes into that everyone is interested in this working and the momentum that's building behind this new category of multicancer. So we're in conversation with NCI and others. And we want to make sure that whatever study we design is in concert with other efforts that are undertaking. So -- again, I think it's going to be a partnership. And I think the work we do in DC and with NCI matters.

Yes. I'm going to skip ahead to a question for Jeff and then bring it back. One is, obviously, we've all been watching the capital markets as of late. The stock market has been pretty choppy. When you think about running a large-scale study such as this, just like how does the volatility in the markets? Does it influence your plans at all? Just if so, how?

Jack, our plans haven't changed on the major growth drivers. You look at the on-market products of Cologuard and Oncotype, I think the best way to fund our company is really to drive growth there. This year, we'll generate about $2 billion of revenue, call it over $1.4 billion of gross profit, that's great funding right there, nondilutive capital, right? We're funding our growth not only in those 2 products, but also the pipeline that Jake helps oversee. So it's the best source. In the meantime, we're making sure we're prioritizing the highest impact pipeline opportunities. We have evaluated, and we think that MRD [ NSAID ] and our colon cancer franchise are the biggest, highest impact area. So we're making sure that they get the right investments. There may be some areas that we slow down in this environment without affecting growth, things that maybe we're going to start to generate revenue later this decade, maybe push those off or put them on hold for a while. But I don't think we'll make any big changes here. I think we've got a strong plan, and we're going to stick to it.

Great. And then just back to the multicancer work. Are there rough parameters you're thinking about for the potential size and cost of a study? Are there any creative ways to structure a trial to help manage that cost burden?

Yes. I can start and maybe Jake can chime in then. Jake talked about some of the big studies we've done before. I mean we could spend a whole conference, I think, talking about those; DeeP-C, BLUE-C, TAILORx, Responder. So this team has extensive experience -- proven experience, delivering high-quality studies, high-quality publications and an effective rate. So yes, there are things we are incorporating. The size of the study will be the biggest study we've ever run and perhaps the biggest study ever run in this space, likely 100,000 people, again, fully prospective. It's an interventional study. We want to make sure that we study this in the appropriate end market. These are [ averages ] people out there, right? People who think they're healthy, we're trying to help them detect cancer early. So it will be a large study. When you compare that to BLUE-C, which is, let's call it, roughly 20,000 people, 5x the size. Only, if you look on a per patient basis, far more efficient. Again, this is where we're incorporating the learnings to get even more efficient as we grow, far more efficient. It will be an expensive study. It will be north of $100 million, but it's spread out over multiple years.

Great. We're seeing the regulatory landscape change a little bit. I feel like something else we could have talked about for decades is LDT regulation. We finally see the VALID Act making some progress through Congress. Just how does this influence your launch strategy plans? Do you think LDT is viable? Or is FDA key?

Well, Jack for screening test, it's clear that longer term to be successful, you need FDA approval. The FDA has been a great partner for us. We've got deep connections there that we've developed over years, first, with Cologuard and now we've had plenty of conversations with them on our multicancer approach. So great relationship there. We look forward to that continuing. It's clear, though, you need an FDA approval, because the goal here isn't just to get a test onto the market. The goal here is to be successful out there and really bend that cost curve down and bend the rate of death down from cancer. So we'll partner with the FDA. We'll generate the necessary evidence to get through the FDA and also to work with the payers and key guidelines to make sure that we're successful. So can you be successful with LDT? Sure, in certain areas. I would point to Oncotype DX, right? That product, we'll do over $500 million of revenue this year. That is an LDT, highly successful. Certain markets, the LDT environment works, ability approach. Others like screening is cleared. FDA is the right way to go.

Great. Maybe my last multicancer question for either you or for Jake. Just talk about like once you get through the Medicare coverage pathway, can you just talk about like how you overcome some of the other hurdles that come with multicancer test? Just the follow-up for positive results, some of the interventions like what are some of the things you need to overcome? And how do you address that?

I mean yes, yes, yes and yes. Those are all the issues that we think about all the time. And I want to go back to -- remember, we want to introduce a new class of testing but we also don't want to interrupt the current standard-of-care screening. We feel strongly about that, so does the FDA and other agencies. There's been a lot of work to progress standard care screening that this will sit next to. I think the way to do that, and we've done this before, is the generation of real-world evidence with key partners. Those include health systems. Those include federally qualified health care facilities, where we know we can have the most impact. And so alongside of that large pivotal interventional study that Jeff mentioned, we also want to create that product, put it into a real-world setting and generate not just the data, but also how it's being utilized, what is the next step, how are the clinicians and patients using this for shared decision-making. And then the most important thing is that we not just get people screened, but they follow through with the process. So you just articulate all the work, Jack, that needs to be done in order for this to actually get the fruit of its labor.

Yes. Makes sense. A lot of work ahead. So under like, I guess, some more operational points, back to Jeff, so we talked about -- a little bit about the recent volatile capital markets. I feel like Kevin was relatively clear with earnings. The plan no more equity raises needed. Can you just talk about like the path to cash flow breakeven in 2024? Just how much of this improvement you expect to come from gross margins versus OpEx? Some of the steps you're taking to deliver on that message?

Look, Jack, this has been a huge area of focus, not only for me, but whole leadership team, the whole company. It starts with growth. We are a growth company. So it starts with growing Cologuard and Oncotype. I do expect some gross margin improvement. However, to your question, more of the path forward between here and '24 comes from OpEx leverage and OpEx reductions. It's starting already. If you look at sales and marketing, what I guided to for the year actually implies a step down from the Q4 level of sales and marketing. So you're seeing some leverage there. We've done a great job of building out a national sales team to make sure we're calling on the most impactful doctors. And over time, we're going to see significant leverage there. Then G&A, another huge area of focus. Over the years, as you know, we've acquired companies, we've grown quickly. We've been making the investments to make sure that foundation is strong. We are pulling in some investments in our IT platforms, in our billing systems to drive additional efficiencies. You'll start to see that later this year and even more so next year and beyond. Then R&D, we constantly scrutinize all the major R&D investments to make sure we're only investing in the highest ROI items. I think Jake has done a great job of doing that. So I'm committed to this. Kevin is committed to make sure that in '24, full year adjusted EBITDA profitability, perhaps even sooner, you may see us turn there in the back half of next year. At the same time, we're looking at ways to bolster the balance sheet. As you know, last quarter, we ended with over $800 million of cash on hand. On top of that, we had $150 million available credit facility. We're getting ready to put in place additional nondilutive financing, likely another credit facility, to give us a longer runway, but I feel very good about the path forward.

Excellent. And as maybe like the final question, let's round it all up. So if you look out 10 years, how do you think the marketplace looks for cancer screening? How does -- where does Cologuard fit versus the colo blood test? Where is multicancer at, at this point? Just what are we going to be talking about at the Nephron 2032 Liquid Biopsy Symposium?

I think you need to think about it as the power of the portfolio. Customers, patients, providers, health systems don't want to see us as products. They want to see us as a partner. And I think the fact that we have a portfolio, and you know this is a banner year for all the evidence that we're releasing across that portfolio, really matters. When you talk to health systems, which we do, because they're our partners, we work with them, we're connected. They say we want one partner, one send-out lab, one patient portal, one seamless experience. And so the fact that we have this portfolio and we already have the deep relationships, especially with the health systems, I think that's what we're going to talk about, is how seamless that experience is, how perfect can the journey be to actually help get more people screened, not a test-by-test, episodic approach but a continuous experience. I think that's what excites us the most with our portfolio and the power of that portfolio approach.

Excellent.