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On Tuesday, 09 September 2025, Exact Sciences (NASDAQ:EXAS) presented its strategic vision at the Baird Global Healthcare Conference 2025. The company, known for its Cologuard brand, outlined plans to expand into multi-cancer screening and enhance its digital ecosystem. While the focus was on growth and innovation, challenges remain in navigating regulatory landscapes and market competition.
Key Takeaways
- Exact Sciences aims to expand its Cologuard brand and introduce CancerGuard for multi-cancer screening.
- The company is optimizing its commercial organization, achieving a 20% productivity increase.
- Strategic partnerships, such as with Freenome, are crucial for entering the blood-based screening market.
- Care Gap programs have seen explosive growth, with potential revenue of $500 million to $1 billion.
- The company is committed to reducing cancer-related mortality through early detection and treatment guidance.
Financial Results
Exact Sciences reported significant growth in its Cologuard business, with an 18% increase in Q2. Price increases from Cologuard Plus contributed about 200 basis points to this growth. The company anticipates a full-year top-line impact of 200-250 basis points. Care Gap programs generated over $125 million last year, experiencing triple-digit growth.
Operational Updates
The commercial organization has seen a 20% improvement in productivity, driven by territory accountability and AI tools for route optimization. Approximately 800 new healthcare providers are ordering Cologuard each week, with half being nurse practitioners and physician assistants. Care Gap programs, delivering colon cancer screening to patients’ homes, have tripled the return rate compared to FIT tests and are run by all top 10 payers.
Future Outlook
Exact Sciences is prioritizing the launch of Cologuard Plus, CancerGuard, and Oncodetect. Cologuard Plus is expected to replace the original Cologuard, with growth tailwinds anticipated in 2026 and 2027. The collaboration with Freenome focuses on a blood-based test for patients refusing traditional screening methods. CancerGuard, priced under $690, targets consumers over 50 with higher incomes, aiming to reduce cancer mortality by 17%.
Q&A Highlights
The rescreen opportunity is expanding, with 2 million people due this year and 2.6 million next year. The Freenome collaboration has shown promising assay performance. The primary care sales force is pivotal in introducing new tests to physicians, leveraging Exact Sciences’ established network.
For a detailed understanding, readers are encouraged to refer to the full transcript below.
Full transcript - Baird Global Healthcare Conference 2025:
Katherine, Diagnostics at Baird, Baird: Diagnostics here at Baird. We’re very excited to have Exact Sciences here with us today from the company. We have the CEO Kevin Conroy, CFO Aaron Bloomer, and the new Chief Growth Officer, Raj Pudapedi. Thanks everyone for joining us. Kevin’s going to kick us off with a few slides, and then we’ll go into Q&A. If anyone has questions during the session, you can email them to session1@rwbaird.com, and I will pass them along. Kevin?
Kevin Conroy, CEO, Exact Sciences: Thank you, Katherine. It’s really great to be back at the Baird Conference. This may be my 20th year being here, and I look over here to my right and see Quentin Lai, who was the analyst, the very first analyst to cover Exact Sciences when nobody else thought there was any hope. I need to go dig up that initiation report because he wrote it in the month of December and initiated before the end of our first year at Exact Sciences back in 2009, when there wasn’t a lot of money being invested in early-stage companies. Thanks to the whole Baird team for all of the belief and effort that they’ve put into helping us grow as a company. There are some disclosures here. We will be making forward-looking statements.
The value proposition here at Exact Sciences from an investor standpoint is it starts really with the unique science and this robust commercial and technical capability to deliver electronic orders results to physicians and patients that help achieve our goal. Our vision is to help eradicate cancer with tests that prevent it, detect it earlier, and guide treatment. Happy to report that we are still in the early innings of making that vision a reality, and the team is really focused on that. Aaron Bloomer, our Chief Financial Officer, will be available for questions about the tremendous financial profile growth that we have seen, top-line growth and bottom-line growth. One of the things that’s most underappreciated about Exact Sciences and the Cologuard brand, and Cologuard is a test, is the power of that brand. When we all go to the store, buy a box of Kleenex, we buy Kleenex. Why?
We don’t want rough tissue paper. We don’t want to risk it. We keep buying Kleenex. Healthcare brands take a long time to build because trust takes forever. We all know that Institute of Medicine’s report that says it takes about 10 years to change the practice of physicians. That’s been true with Cologuard, but now we’re hitting that point where you have over 90% brand awareness. About 95% of people, when prompted, say, "Oh yeah, Cologuard, that’s the colon cancer screening test." What’s even more impressive is when you leave that open-ended blank, what is the most, what is the way you’d get screened for colon cancer? Fill in the blank. More people now say Cologuard than colonoscopy. Something has changed. 11 years of marketing to physicians and patients has changed everything.
The power of a healthcare brand is that there is a trust because your life may depend upon the quality behind that. With Cologuard, 95% sensitive, 94% specific, doctors do not want to recommend. They recommend either Cologuard or colonoscopy. Across the country, that is what is happening, and it is having a huge impact. We have estimated that we have helped detect over 100,000 patients with early-stage treatable cancer and over 600,000 people with precancerous polyps. There is a power here that is built into that trust in the quality, but also all of the service elements that we will talk about today during the presentation. That translates into loyalty, and it is loyalty that you can then leverage into other tests that also have a positive impact on life.
This is all able to be delivered because of a very thoughtful construction of a digital ecosystem that ties together payers, providers, patients, large health systems to eliminate the terrible amount of friction that exists in getting people screened and up to date with colon cancer screening. There are 50 million people out there that today in the U.S. are not up to date with screening. This ecosystem is helping us get more and more of those people screened. Some of it is the data that we have now in 30 million unique patients in this database. That gives us the ability to reach people, empower them to not only get screened in the first place, to allow them to stay up to date with their screening, what we will call rescreens.
That is a recurring part of the business model that is transforming the way we are screening people in the U.S. The commercial organization is a big part of this. It took a long time for us. In the first couple of years of launching Cologuard, we had 80 reps. I remember thinking, Maneesh Arora, our Chief Commercial Officer at the time, said, "What do you think? Can we go with 50?" I said, "It is going to freak out Wall Street. Let’s go with 80." We are now up to a field force. When you are calling on a universe of potentially 600,000 ordering healthcare providers, physicians, nurse practitioners, PAs, you need a large sales force, and you need to know who to call on.
That is part of the capability that we built that Raj Pudapedi, our leader overseeing marketing international and the Cologuard brand, will talk about today. What is the output of all of this? The 11 years of painstakingly building, bringing quality to physicians and patients. One of the most exciting things, if you go up to COVID, you saw a nice slope of the line there. Since COVID, and you look out over the last couple of quarters, you see an inflection. That inflection comes right back to the brand, the commercial engine, the digital reminder capabilities. What we’ll talk about is the Care Gap programs with payers and large health systems where they’re highly incented to make sure that their patients who are recalcitrant to get screened get screened. This is exciting. There’s a lot of growth. Where does this take us in our screening business?
You have Cologuard, now Cologuard Plus, which has fueled our ability to deliver a message to patients. Cologuard first, colonoscopy is needed. CancerGuard, our multi-cancer screening test, which Raj is responsible for launching in the U.S. and globally. That launch occurs this month. We’re excited. A CRC blood test that is targeted towards patients who are unique. They are those people who refuse colonoscopy or Cologuard. We know who they are. We have the capabilities to identify them and help them get screened. Other new tests as we move forward. This all powers an incredible engine, and that engine will help bring CancerGuard to patients who need it. CancerGuard is a one blood draw, most cancers. It’s a powerful test, and it’s from the makers of the people who brought you Cologuard. That’s the message we’re delivering in the U.S. Raj is also focused on launching outside of the U.S.
CancerGuard is undergoing multiple clinical trials right now, and we will launch it as a lab-developed test. Awfully exciting times at Exact Sciences. The financial profile of the company is also exciting. With the top-line growth, with the discipline on costs, we are seeing an inflection not only on the top line, the bottom line, and Aaron will be happy to answer those questions today. Thank you, Katherine, and look forward to the conversations throughout the day.
Katherine, Diagnostics at Baird, Baird: All right, let’s go quick. Thank you, Kevin. A great overview. Maybe just first, as we talk about Cologuard and kind of building the long-term growth of that franchise and why it might be different than what goes on in other diagnostics, it seems like the base of that growth is really rescreens. Then there’s penetrating docs more deeply, and there’s going after new docs. Maybe starting on that rescreen piece, can you just talk a little bit about how you’re executing on that today and what that looks like from a long-term perspective?
Kevin Conroy, CEO, Exact Sciences: Yeah, the rescreen opportunity is that every three years, patients are recommended to get their next test. Last year, we had 1.6 million people who were due for their rescreen test. This year, it’s 2 million. Next year, it’s 2.6 million. That growth is additive because you have first time, second time, third time, even fourth time rescreeners. Because of that curve that you saw, you’re getting more and more people into the funnel. With 5 million people or thereabouts that will get screened this year, three years from now, think about 70% of those people will be eligible for a rescreen, maybe 75%. That drives a recurring business, a recurring revenue business model that helps us get people screened and keep them screened.
Katherine, Diagnostics at Baird, Baird: Over the past few quarters, you’ve had core Cologuard improvements, largely been driven by some of the commercial changes you made towards the end of last year. Can you just walk through kind of some of those changes? What do you think has been most impactful when it comes to getting Cologuard back on the right trajectory? What is there going forward?
Kevin Conroy, CEO, Exact Sciences: You know, it was really about going back to the same approach that we took when we built Cologuard. That was giving reps accountability and ownership for their territory and making sure that we covered every zip code in the country, number one. What we’re seeing is about 20% improvement in productivity. Half of that is because reps get credit for everything in their territory. That’s the way we built the sales force. There was a change under prior commercial leadership about three years ago. We’re back to the way that we’ve done things historically. You’re seeing, of that 20% productivity gain, about half of that is just giving people their own territory. The other half of it is giving them automated AI tools.
With the click of a button, when I wake up in the morning and I’m a rep and I want to know who am I going to visit today, Raj and his team have stratified all the docs, fed it into a large language model, which analyzes all of that data and recommends a route. It also looks at traffic and creates a route for a rep to call on a dozen physicians in a day. Go visit a dozen offices. If there’s a gap in the day, boom, you click the button again and you get a list of 10 new docs and you drag those docs over that you want to go see in the extra hour that you have. If there’s a cancellation, boom, automatically, you couldn’t do that before this year. That’s another 10% of the power.
As a result, now that productivity, as you saw in Q1 and Q2, you saw a really nice response to that. We’re pleased. We’re not done. Much more improvement to do. We believe that there’s a sustainability to this.
Katherine, Diagnostics at Baird, Baird: As you mentioned in your prepared remarks, this is something that takes a large sales force to go after primary care. How do you feel about the size of your sales force as it is today? Does that change your needs at all with CancerGuard or the blood test opportunity?
Kevin Conroy, CEO, Exact Sciences: You know, I’ll never forget about 14 years ago, as we were thinking about launching Cologuard, maybe 13 years ago, we thought we would partner with one of the large labs. We met with one of the large labs and they said, "Look, here are all the reasons you don’t want to partner with us. It’ll be painful for you. We won’t really promote your product. We’ll take most of the economics." I still thank that individual at one of the two largest labs in the U.S. for just being truthful with us. On the other side of the equation, we had hired one of the top consulting firms in America that gave us the analysis. Whatever you do, do not launch in primary care. You can’t make the numbers work. They were right. We didn’t have a better alternative, so we launched.
It’s taken a decade, but we’ve hit this escape velocity. The message is it’s hard to build primary care sales force because there are six or seven hundred thousand prospective customers to go after, and they only have eight minutes with their patients. You’ve got to get them to promote, to elevate colon cancer screening, which usually is not in the top dozen things they want to talk to a patient about. We’ve been able to do that. We’re thankful for that because now that is an asset that allows us to bring other life-saving tests to that same group of physicians.
Katherine, Diagnostics at Baird, Baird: Maybe talk about Cologuard Plus, how that helps you from a competitive standpoint. Aaron, maybe you can chime in on kind of what pricing contribution was in the quarter, what you expect for this year. Given just the timing of how those contracts come into place, is that an even bigger dynamic as you get into 2026 and 2027?
Aaron Bloomer, CFO, Exact Sciences: Just from a pacing perspective, what we saw in the second quarter was about a 200 basis point positive impact. We grew our Cologuard business 18% in the second quarter, a significant kind of step up and acceleration. That’s what we’ve guided to in the back half of the year as well. About 200 basis points came from price, 16 points from volume. In terms of what we saw in Q2, it was still just Medicare fee for service. What we were excited to announce on our earnings call was that due to the brand of Cologuard, the quality credit that we’re getting to these payers through our Care Gap programs, the conversations we’re having now on the contracting side have been very productive. We were able to secure two of the top 10 payers already, Humana and Centene, which are going live here later this year.
In terms of full year, what’s embedded in our guide is about 200 to 250 basis points in terms of top-line impact. As we continue now the contracting process through the back half of this year, at some point we’re going to reach the point where we’ll sunset Cologuard. Cologuard Plus is a much better test. We want to get that in the hands of patients as soon as possible. We’re working on contracting discussions here as we close out this year, and we would expect that to be a tailwind to growth in 2026 and 2027. How much of that sort of inures to the benefit of 2026 versus 2027, we’ll update you all on our February earnings call when we give 2026 guidance.
Katherine, Diagnostics at Baird, Baird: Great. Maybe on Care Gap programs, which you mentioned as well, Kevin, what’s the opportunity there? How big could those become over time as a growth driver for Cologuard as you become more of a partner with these payers and systems?
Kevin Conroy, CEO, Exact Sciences: It’s a huge opportunity. Let me take a step back. What is a Care Gap program? There are about 30 quality measures that commercial payers and Medicare Advantage payers are measured on in terms of achieving certain star levels as they are rated by how good they are at preventive medicine. The whole goal is to bend the cost curve by taking care of people, including cancer screening. That measurement for colon cancer screening is a really important one because most health plans and most health systems aren’t great at colon cancer, keeping 90% of their patients, even 80% of their patients, screened. The payers and the health systems come to us to say, can you partner with us to deliver colon cancer screening to our patients in the privacy of their own home? We’ll give you a list of 100,000 patients that are not up to date.
You ship them collection kits. You take the risk. We’re willing to take the risk. We follow up with those patients to get them to return the kit. That’s a Care Gap program. What we have seen is explosive growth over the last two and a half years. Why? Care Gap programs and colon cancer screening for a long, long time has been shipping FIT tests to 100,000 patients and getting 8,000 or 9,000 of those kits back and getting one year of quality credit, which means the next year you have to do it all over again. By the way, the health systems and payers had to pay for that FIT kit to be sent off. We come in and deliver a totally different value proposition, which is we’ll triple the return rate into the 25% to 30% range, and you get three years of quality credit.
That delta is 9x altogether. As Aaron Bloomer said, we have 10 of the top 10 payers who’ve run these Care Gap programs, which is helping us in the contracting discussions we’re having with them because they really see the value to their Medicare Advantage, their STARS ratings, and their commercial HEDIS ratings. This program has grown. It’s going to keep growing. You take rescreens and Care Gaps and what we call new to point of care, so new customer growth in that point of care setting, and what we’re seeing there too is strong. We’re also continuing to see about 800 new first-time ordering healthcare providers every single week. We thought five, six years ago that that would abate and decline over time. It’s not. About half of those healthcare providers that are new to ordering Cologuard are nurse practitioners and physician assistants.
That’s about half of the new ordering providers, which means we’re seeping into new parts of the healthcare primary care ecosystem, helping us fuel growth not only for Cologuard, but for CancerGuard and other tests down the road.
Aaron Bloomer, CFO, Exact Sciences: Just sizing the Care Gap and the overall opportunity longer term, what we’ve said was last year we did more than $125 million in revenue. It was growing triple digits. This year, what we’re seeing, as Kevin mentioned, is explosive growth in that part of the business as well. It’s a meaningful contributor to growth through the first half of the year and embedded in our guide as well. What we’ve said is over time in the Medicare Advantage population alone, we see this becoming a $500 million opportunity. We’re well on our way towards that trajectory. If we’re able to improve the adherence, much like we’re trying to do on rescreens as well, you could double that business then overnight from a $500 million to a $1 billion opportunity longer term.
Katherine, Diagnostics at Baird, Baird: All right, very helpful. I wanted to move to blood. You know, your initial internal data came in below expectations, but you coupled that with the Freenome licensing agreement. I guess, do you feel on the internal side, do you have a clear path forward for that program? Maybe when could we learn more on that side?
Kevin Conroy, CEO, Exact Sciences: All we’ve said there, Katherine, is that testing continues. We continue to work with that. We haven’t yet submitted data to the FDA. We’re just not going to be talking about that topic more. The Freenome test is now the Exact Sciences test, and it’s a high-quality test. We have confidence in the ability to get that through the regulatory processes. We need to get it through the FDA process in collaboration with Freenome. We like the data that we’ve seen. It’s a very clean submission, and the data are strong and very similar to the other aspiring entrants into this field. How we are going to use that test, I think, is the important question. There’s this distinct patient population. We know them because we have 10 million people out of the 30 million who’ve had Cologuard orders over time, 10 million people who haven’t returned a Cologuard kit.
That’s a really good starting point. There are three guideline groups out there: ASGE, a GI society; AGA, the leading GI society; and the Cancer Guidelines, NCCN. They’ve all said, look, there’s a distinct use case for an inferior blood test. It’s for patients who refuse colonoscopy or Cologuard. We’re uniquely able to work with physicians and health systems to be able to ship a patient a blood collection kit that they would then take and get their blood drawn with and then return that to our labs. We have a unique ability to help get more people screened. I think that’s what Freenome saw was our reach. What we see is the appropriate use for a test, which is it doesn’t see precancerous polyps. It is not as strong at stage one detection as Cologuard, but there is a use case for it.
Medicare is willing to pay for this test. Commercial payers, not so much. We’ll be able to make sure it’s kind of the appropriate patient, and the hope is in the future, you get that patient to switch over to a Cologuard test, which has higher efficacy.
Katherine, Diagnostics at Baird, Baird: I want to dig a little more into the Freenome side, but maybe just to close the loop on the internal program, you obviously had a different marker set that you had previewed at ESMO last year. You say testing continues. I guess, if you were to have a different assay, do you have the samples you would need to run such an assay? If not, how long would it take you to procure those?
Kevin Conroy, CEO, Exact Sciences: You know, in that whole topic, we’re just not really going to talk a lot about it in terms because we haven’t sat down and engaged with the FDA. If there’s one thing that I have learned over the last 20 years, talk to the FDA first before you talk to Wall Street. We need to have those conversations. I would just refer back to the Freenome test as our blood test. We’re excited about it. We believe that we can bring it to patients and physicians who need it sooner than we would have been able to bring our own test anyway. There’s a real thoughtful approach to what we’ve done here with Freenome.
Katherine, Diagnostics at Baird, Baird: Yeah, on Freenome’s test, it sounds like they have their own V2 data on hand. You know, any details on when we could see that? Is that something that you guys have already seen?
Kevin Conroy, CEO, Exact Sciences: We saw their V2 assay tested on a cohort of patients that will not be part of the ultimate pivotal study. However, they were patients that were enrolled in the same fashion, and it’s a part of that pivotal study enrollment. We have seen V2 performance in patients with adenomas and normal patients, which gives us, you know, it was interesting, intriguing data. One thing that we have learned is it’s a lot harder to detect precancerous polyps from blood than you ever thought it would be. I think you saw that last night with another company’s data that came out. It’s just, it’s hard. You can look as hard as you want for fragmented circulating tumor DNA. If it’s not there, you can’t detect it. That’s the fundamental challenge with detecting precancerous polyps or even stage one cancers from a blood draw.
Looking for DNA, if it’s not there, you can’t detect it.
Katherine, Diagnostics at Baird, Baird: Yeah, and maybe one more before we move on to multi-cancer is just assuming FDA approval for Freenome’s test. How do you position that within your primary care sales force, and whether that’s incentives or messaging versus Cologuard?
Kevin Conroy, CEO, Exact Sciences: It’s about caring for these patients. It’s making sure that those refusers are identified and are reached out to about a potential blood draw. The appropriate patient should get this test. Over the last 10 years, with this ramp-up, it’s growing every year, the number of patients who don’t return a Cologuard kit in a year. Maybe it’s a year or 18 months after we have done our full 21 touch points that Raj is responsible for, among other things, to maybe we ship them that blood test. We’ll work with the offices to identify those patients and serve them.
Katherine, Diagnostics at Baird, Baird: On multicancer, I think online ordering became available late last month. You’ve priced the test at just under $690. You’ve mentioned you trained a little over 200 reps on the test, and you expect to have your entire sales force selling that in the first quarter. How do you position that initially? Who’s the target patient or physician base?
Kevin Conroy, CEO, Exact Sciences: Let me take that at a high level and pass it to Raj, who owns the CancerGuard business. This is the test again, one blood draw, most cancer types, the cumulative prevalence of cancer in a population is what a blood test can help go identify those patients, pull one stage earlier. Raj, maybe you can talk about how you’re thinking about the opportunity to serve patients.
Raj Pudapedi, Chief Growth Officer, Exact Sciences: Of course. Thanks, Kevin. Look, 80% of cancer diagnosis in the U.S. don’t have a standard of screening. There are only four cancers for which there is a standard of screening. You’ve got breast cancer, colorectal cancer, lung cancer, and cervical cancer. The remaining 80% of the 612,000 deaths and the 2 million diagnoses that happen in the U.S. don’t have a standard of screening. The best way to kind of think about a standard of screening supplement at scale is a multi-cancer blood test. Think about this, right? If you had to find one ovarian cancer, you’ve got to go to 1,000 patients before you find one. If you accumulate cancers, all of the cancers, and start to detect, you could actually just need to go to about 35 to 40 people before you can start to kind of detect the cancer.
The power of this cancer is it actually enables us to screen and find cancer early when it actually is treatable and it makes sense. The second piece is the size of the market. We think there are about 110 million consumers in the U.S. who could benefit from this test. We think the size of the market is about $25 billion. Remember, this is just in the U.S. There is no reason to believe that folks outside the U.S. won’t be as keen to kind of get to this cancer test as anybody else, right? For those of us who are asking this question, right, hey, would people pay $700 for a cancer screening test? What I tell you is think about this, right? The last company I used to work for is Align Technology.
You know, the cost of Invisalign, you know, kind of clear aligners to straighten your teeth, is $5,500 in the U.S. It’s $10,000 in some other markets globally. The question is, can we actually, to your question, frame the value of this test to this consumer such that the consumer sees the importance of this test? Look, we’re going to only 50 plus consumers who have a higher income. The way I look at it is, this is a marketer’s dream, right? How do you actually take a life-saving test and get people to use it so that we can detect cancer earlier and save lives? We presented some data, just so you know, at ESMO. Our modeling indicates we can cut cancer-related mortality by 17% if we can scale this test. Now, show me one more test in the world that could do that.
Katherine, Diagnostics at Baird, Baird: Yeah, I think we’re about out of time. Kevin, maybe just to end things here, as you look over the next year, what are the two biggest opportunities that you see for Exact Sciences?
Kevin Conroy, CEO, Exact Sciences: In addition to Cologuard Plus, you have CancerGuard and Oncodetect, which is our MRD test, leveraging off of Oncotype DX, which has 90% share in breast cancer. We’re excited about CancerGuard and Oncodetect and can’t wait to really continue to lever off of this incredible network that we built, our Exact Nexus network. Looking forward to future conversations on those topics.
Katherine, Diagnostics at Baird, Baird: All right, great. With that, we’ll leave it there. Thanks, everyone, for joining. Kevin, Aaron, Raj, thanks so much for being here.
Kevin Conroy, CEO, Exact Sciences: Thank you.
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