Exact Sciences Q3 2025 Earnings Call - Accelerating Growth Fueled by Cologuard Plus and CancerGuard Launch

Conference Operator: Hello, and welcome to the Exact Sciences third quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session, and if you would like to ask a question, please press star one on your telephone keypad. I would now like to turn the conference over to Derek Leckow. You may begin.

Derek Leckow, Investor Relations, Exact Sciences: Thank you for joining us for Exact Sciences third quarter 2025 conference call today, November 3, 2025. On the call today are Kevin Conroy, the company’s Chairman and CEO, and Aaron Bloomer, our Chief Financial Officer. Earlier this afternoon, Exact Sciences issued a news release detailing our third 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 be materially different from such statements. Discussions of non-GAAP figures and reconciliations to GAAP figures are included 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 will now turn the call over to Kevin.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks, Derek. The Exact Sciences team delivered record results in the third quarter. Thanks to the team’s execution, we’re raising our full-year 2025 revenue and adjusted EBITDA guidance. A few highlights from the quarter include growing revenue 20% to $851 million, the highest quarterly growth rate in over two years. This was driven by Cologuard’s strong brand awareness, inspiring commercial execution, accelerating health systems integrations, and a record number of ordering providers. Screening a quarter of a million more people in the third quarter versus last year, deepening our relationships with payers and health systems by helping close gaps in guideline-recommended cancer screening, and launching CancerGuard, our multi-cancer early detection test. Our team is focused on continued commercial effectiveness, expanding access to Cologuard Plus, and driving adoption of our new test to close a strong year. I will now pass the call to Aaron to discuss our financial results.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Thanks, Kevin, and good afternoon, everyone. Total revenue grew 20% year over year to $851 million, $43 million above the midpoint of our guidance. Growth was led by screening, which increased 22% year over year to $666 million. We saw broad-based Cologuard growth, led by strong execution from the commercial organization, care gap programs, and rescreens. Precision oncology revenue increased 12% year over year on a core basis to $183 million. Growth was led by continued Oncotype DX expansion internationally, U.S. Oncotype DX volumes, and partner revenues. We generated $135 million in adjusted EBITDA, an increase of $37 million, or 37% year over year. Adjusted EBITDA margins expanded 200 basis points to 16%. Driven by continued efficiency efforts across our lab, supply chain, G&A, and support functions. Non-GAAP gross margins were 71%, down 100 basis points versus last year.

The reduction was driven by record care gap shipments, which can cause a temporary timing difference between cost of goods and revenue. Free cash flow was $190 million during the quarter, an increase of $77 million. This was driven by increased receivables collections following the Cologuard Plus launch and continued working capital improvements. Year-to-date free cash flow is $236 million, an increase of $173 million, or 270% year over year. We ended the quarter with cash and securities of just over $1 billion. Turning to guidance, we are raising total full-year revenue to between $3.22 billion and $3.235 billion, an increase of $78 million at midpoint. This includes screening revenue between $2.51 billion and $2.52 billion, or 20% growth at midpoint, and precision oncology revenue between $710 million and $715 million, or 9% growth at midpoint.

We are raising our adjusted EBITDA guidance to between $470 million and $480 million for the full year, or 14.7% adjusted EBITDA margins at midpoint. Guidance at midpoint implies more than 47% adjusted EBITDA growth, or about 300 basis points of adjusted EBITDA margin expansion. As stated on our last call, our adjusted EBITDA guidance does not reflect any potential impact from the Freedom licensing agreement. The upfront payment of $75 million will be expensed to R&D upon clearance of HSR, and it will not be an add-back to adjusted EBITDA. Overall, this quarter marks an inflection point in our business. Momentum is building across the company, operating leverage is expanding, and cash generation continues to strengthen. We are well-positioned to achieve our 2027 financial targets and create long-term value. Back to you, Kevin.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks, Aaron. Strong Cologuard performance was driven by the trust patients, healthcare providers, and health systems have in the Cologuard brand and our commercial organization. The iconic Cologuard brand is recognized by more than 90% of consumers. This brand awareness is driving increased adoption of Cologuard among the 55 million Americans who are not up to date with colorectal cancer screening. To have a trusted diagnostics brand, you need to have best-in-class performance. Cologuard Plus raised the bar for non-invasive CRC screening tests, demonstrating 95% sensitivity and 94% specificity. This performance leads to a 40% reduction in false positives compared to the original Cologuard. A recent modeling study published in the Journal of the National Cancer Institute showed that Cologuard Plus was the only non-invasive screening option shown to be efficient at guideline-recommended intervals and age ranges.

We continue to make progress expanding patient access to Cologuard Plus, including positive coverage decisions from each of the top 10 payers. In the third quarter, we also signed contracts with Aetna and Highmark to bring the added value of Cologuard Plus to their members. Backing the Cologuard brand is our patient-centered technology platform, Exact Nexus. We’ve spent over a decade building a platform that is deeply integrated within primary care workflows. Our platform connects tens of millions of patient records and integrates access and awareness to accelerate adoption of new tests. Broad insurance coverage, deep provider engagement, health system integrations, and proven product quality allow us to deliver innovative diagnostics efficiently and at scale. The power of the Cologuard brand and our Exact Nexus platform is driving triple-digit growth in a new patient demographic, customer-initiated orders, or CIO.

This enables individuals to easily request tests ordered online by a telehealth provider. Directly from their phones. Exact Nexus is eliminating friction points for individuals who know they want to get screened with Cologuard. Our commercial engine continues to deliver strong results. The sales team is energized by territory realignments, AI-powered efficiency tools, and new products, Cologuard Plus and CancerGuard. The changes we made are working. In the third quarter, we had over 12,000 providers order a Cologuard test for the first time, the greatest number in over five years. We also saw the number of active ordering providers climb to over 200,000, a new record. Our commercial team is firing on all cylinders, and they’re just getting started. All these efforts will have a lasting impact and fuel momentum in Cologuard rescreens.

Rescreens represent the growing base of patients that rely on Cologuard every three years to stay up to date on colon cancer screening. Today, these patients make up more than a quarter of our total screening volume. In the third quarter, we launched CancerGuard, our multi-cancer early detection test. With a blood draw, CancerGuard screens for more than 50 cancer types and subtypes. This launch is a major step forward in our mission to help eradicate cancer through earlier detection. Today, only 14% of cancers are found through screening. CancerGuard will help address this problem. We are bringing CancerGuard to patients through many channels to maximize patient adoption, including primary care physicians, health systems, concierge practices, and our CIO platform. We are leveraging our large sales force to educate providers about CancerGuard. In the third quarter, we trained the first group of sales reps on CancerGuard.

We plan to train our entire screening and precision oncology commercial teams in the U.S. by the end of the year. On October 1, we launched our consumer-initiated ordering platform that allows people to request a CancerGuard test directly from our website and builds on the learnings of Cologuard’s CIO capability. Starting in the fourth quarter, we are investing in direct-to-consumer marketing, including social media campaigns to drive awareness of CancerGuard. Drawing on a decade of consumer marketing experience with Cologuard, these efforts leverage our trusted brand with the message that CancerGuard comes from the makers of Cologuard. We are excited about the launch, and we look forward to sharing more over the next few quarters. Our precision oncology team continues to be a global platform for growth. Oncotype DX delivered solid order growth globally in the third quarter.

The strong summer was supported by effective commercial execution and the recent expansion in screening guidelines to include younger age groups. We are seeing positive momentum across our precision oncology portfolio, including OncoExTra, RiskGuard, and our recently launched MRD test, OncoDetect. The OncoDetect launch is progressing well. We’re seeing encouraging utilization in colorectal cancer and meaningful traction in breast cancer, driven by synergies with Oncotype DX. Turning to our pipeline, one of our guiding R&D principles is to invest in areas where we can help patients the most. We have broad technological capabilities through our multi-omic platform, including our proprietary PCR and also deep next-generation sequencing capabilities. These technologies form the backbone of our novel tests. Our platform allows us to advance multiple single cancer screening tests in areas of significant need, such as liver, esophageal, and endometrial cancers. Current screening methods for these cancers are outdated and lack effectiveness.

Next week at the liver meeting, the flagship international congress hosted by the American Association for the Study of Liver Diseases, we will present Oncoguard Liver data from the ALTUS study, ALTUS. This readout underscores the test’s potential to transform liver cancer surveillance for at-risk populations. During the fourth quarter, we will share data supporting OncoDetect’s use in triple-negative breast cancer. In 2026, we also look forward to sharing clinical validation data and launching the next-generation version of OncoDetect that leverages our Maestro technology. We are investing in MRD evidence generation to support reimbursement and adoption. We have over 10 clinical validation studies planned over the next few years, including four key studies in breast cancer, colorectal cancer, and pan-tumor indications. I’m very proud of the strong third quarter the Exact Sciences team delivered.

Our best-in-class products, trusted brands, patient-centered platform, and commercial execution provide a foundation for long-term growth as we continue to make transformative new tests available to physicians and their patients who need them. We’re now happy to answer your questions.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again. We ask that you please limit yourself to one question. Thank you. Your first question comes from Vijay Kumar with Evercore ISI. Your line is open.

Hi, Kevin. Thanks for taking my question and congrats on a nice spring here. My one question is on just the performance in the third quarter. Quite remarkable here for screening. Can you talk about what drove the speed? Was this care gap versus rescreens versus first-time rescreens? Related to that, I think that Street’s looking at like 14% screening growth for 2026. You guys have done 20% year-to-date. I’m curious on how any early comments on 2026. Thank you.

Kevin Conroy, Chairman and CEO, Exact Sciences: Sure. Thank you, Vijay. I’ll let Aaron take the second part of that. The first part, let’s go back a year ago when we had a challenging quarter. The team really came together. I’m incredibly proud of the work that they did to deepen our relationships with health systems, to design territories, allowing us to have total ownership of those territories, making more calls with better targeting, stronger messaging, so that you could really bring the Cologuard brand, which is known for its high, strong test performance, sensitivity, and specificity, through our Exact Nexus platform, and then also bringing new products. This was a total commitment on the part of leadership, really more so on the part of our frontline sales force, our team members who are out there every day doing important work. That’s both on the screening side and the precision oncology side.

We could not be more proud of the work that is done. We think that this sets us up for lasting growth and a flywheel effect so we can get those 50 million Americans who are not up to date with screening screened.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Vijay, specific to your comment on 2026, I think it’s important to keep in mind the long-term guide that we have sitting out there, which is a 15% compound annual growth rate from 2022 through 2027. As you referenced, we’re obviously accelerating in growth here through the back half of the year. The full-year guide for screening is at 20%. The back half of the year is obviously even north of that. We’re pacing ahead of our long-term goal, but it’s important to note our normal practice would be to provide our 2026 guidance at our next earnings call as we review the fourth quarter and look ahead to next year. As Kevin alluded to, really pleased with the progress on the commercial side, the momentum that we have with care gaps.

There’s a lot of work we have to do in the coming months on Cologuard Plus contracting as well.

The next question comes from Tycho Peterson with Jefferies. Your line is open.

Hey, thanks. Two hopefully quick ones. Aaron, maybe just on the care gap strength, how should we think about that continuing and then impact on margins going forward? For Kevin, can you just talk a little bit more about the CancerGuard strategy with payers and how you’re thinking about reimbursement? Obviously, one of your competitors has a CRC first path on MSED reimbursement. How do you kind of think about that as an approach where you’re headed?

On the first part, Tycho, we had a record quarter in terms of our care gap business. We had our largest orders go out in the third quarter. How we’re thinking about this is we’re really investing in our care gap program. Obviously, it’s slightly lower gross margins, but highly accretive to the total bottom line. This is really giving us an opportunity to partner with payers, helping them achieve their quality measures. It’s also really helping us with patients, getting more and more of that 50 to 55 million patients out there and get them up to date with screening. We view this as an investment that’s really bringing accelerated growth here in the back half of the year that obviously has both near-term as well as long-term patient and financial impact.

As it relates to the gross margins, we would expect to see an uptick in the fourth quarter as we would have less care gap shipments go out in the fourth quarter relative to Q3. Again, as a reminder, these are typically back half weighted. I think we’ve said in the past, more than two-thirds of the revenue kind of comes in the back half of the year.

Kevin Conroy, Chairman and CEO, Exact Sciences: Yeah. As for the second question, as we’ve talked about with CancerGuard, CancerGuard is priced at $689. Distinct from other Medicare-covered tests. We think the approach is being taken by others. It’s an interesting approach. I think the more sustainable approach, given the regulatory context and compliance context, is to keep those two tests separate in the Medicare population. In terms of the playbook to get coverage across Medicare and commercial payers, we think that that is a long-term game. We think that the work that is being done in this field by Grail, by Exact, by others, is work that will eventually captivate the payers to recognize the positive impact that screening can have. That’s the way that we look at this space.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Patrick Donnelly with Citi. Your line is open.

Hey, guys. Thank you for taking the question. Kevin, maybe to stay on the screening side, can you just update us the latest on the timelines around Freedom? I know V2 is looming. The FDA would love just an update on some of those timelines. On that same topic, just how you’re thinking about your internal program. I know you’re kind of keeping it going. Maybe just an update on how you’re thinking about the two combined there. I appreciate it.

Kevin Conroy, Chairman and CEO, Exact Sciences: Really, thanks for the question. Really, no changes there at all in terms of the Freedom V2 timelines. We expect that data to be presented in conjunction with a scientific conference sometime in the next few months. In terms of our internal program, yes, that continues. We haven’t given more of an update there other than to say the Freedom test is now the Exact test. We’re really looking forward to making that available to physicians and patients through our deep network of providers that we have a relationship with, over 200,000 ordering in the last quarter, over 250,000 total, and our incredible commercial reach. We’re excited about bringing our blood test, subject to regulatory approvals, to clinicians and to patients.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Brad Cole with Mizuho. Your line is open.

Hi, there. Thanks for taking the question. Just wanted to hear about kind of the Cologuard, the Cologuard Plus sunset plan. Would imagine it sounds like you’re more aligned with payers than ever. Payers would want to have their members on the better test. Just wanted to kind of hear about how you’re thinking of pacing. Thank you.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks for the question. Yes, the Sunset plan is in the works. I have not provided public details of that. At the appropriate time, we will. What is important is what you pointed out, that Cologuard Plus is a better test. There is no screening test that we are aware of that has 95% sensitivity and 94% specificity, no non-invasive test. As a result, we are in active discussions with payers. The top 10 payers, we are proud to report, have all covered Cologuard. They have issued a positive policy decision that Cologuard Plus is covered. Now we are in discussions with six of the remaining 10 to contract. Four are contracted, six remain. There is a long list of additional smaller payers that we are focused on as well.

At some point next year, we will sunset Cologuard so that Cologuard Plus will be the test available to all patients. We think that is the right thing to do. It is incredible technology. It is differentiated. It is good for patients.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Catherine Schulte with Baird. Your line is open.

Hey, guys. Thanks for the question. Maybe just on your overall portfolio. You have some new products now with OncoDetect now covered by Medicare and CancerGuard launching. Are either of those material contributors in 2025? How should we think about measurements for success as those ramp in 2026? Thanks.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks, Catherine. We do have these wonderful new products, as we’ve said from the beginning of the year. We don’t expect them to be material in terms of the overall mix of revenues. Over time, we expect them to be very material. Those are big markets. They take time to penetrate. We are pleased in terms of how they are progressing. CancerGuard, of course, just launched within the last couple of months. As a result, that’s nascent. We’re excited about what we’re seeing and the growth that we have seen, not only week over week, but day over day. We have big expectations there.

With OncoDetect, and I’m sure there will be more questions more in depth there, we are doing all of the things you need to do in terms of getting the scientific evidence to secure a broad base of coverage so that we can go out there and serve patients in this large and growing opportunity. We’re excited about it.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Brandon Couillard with Wells Fargo. Your line is open.

Thanks. Good afternoon. Aaron, could you give us a sense of what Cologuard Plus contributed to screening growth in the quarter and where you see that mix exiting the year? Kevin, it’d be great to get an update just on care gap compliance and how that’s playing out and if you’ve been able to move the needle a little more using your compliance engine, maybe relative to where you were 12 months ago. Thanks.

Hey, Brandon. Thanks for the questions. On the first part, as it relates to Cologuard Plus. When we originally did the guide for the year, we expected a couple of points in terms of contribution to growth coming from Cologuard Plus pricing and mix. What we saw in the third quarter, just given some of the progress we had made and updated everybody on the last call with Medicare and two of the top 10 payers, we were kind of in the 2-300 basis points range in terms of price impact on overall screening growth rates. With now having four of the top 10 plus Medicare, we would expect kind of in the 3-400 basis points impact on growth in terms of the fourth quarter. You kind of package that all together.

Those four payers plus Medicare represent approximately 30% of our volume, which is where we will be exiting then as we head into 2026. As Kevin alluded to earlier, obviously in active discussions with the remaining top payers as well.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks, Brandon. In terms of care gap compliance, let me first just remind folks what care gap is. Care gap is what we refer to. Payers who are approaching us to help them improve their CRC screening rates within their membership. Unfortunately, again, about half of the population in the US eligible for colon cancer screening is not up to date. Payers care about it. Health systems also care deeply about getting more of their members screened. Capacity is limited with GIs having pretty much full capacity across the country. What is occurring is they’re approaching us to help get an order initiated, prescribed by a physician so that the patient gets a Cologuard kit. In terms of compliance, we see room for improvement there, Brandon. In terms of total volumes, we’re seeing a significant year-over-year increase.

As you may know, FIT programs, care gap programs started about 20 years ago. That has been the predominant way to fill those care gaps. Many payers and now health systems are converting to Cologuard because they see an opportunity to secure a longer duration of somebody being screened and therefore getting three years of credit versus one year of credit. They have fallen in love with our compliance engine, our ability to engage with patients. The patients that we get are typically people who have refused screening over and over again. I think it’s just going to take more work for us to get the uplift we know we can with care gap compliance. We’re pleased with the volume increase in the people we’re getting screened, that this over time, we think can be even more impactful.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Puneet Souda with Leerink Partners. Your line is open.

Conference Operator: Yeah. Hi, guys. Thanks for taking my questions. First one, just wanted to understand. The six commercial payers that are not in, paying for Cologuard under the contracted rate, when do you think they will be contracted? If you can provide some timeline on that. Just wondering, Kevin, on CRC blood, how are you thinking about pricing? If the data was positive for V2, how are you thinking about pricing there? Thank you.

Kevin Conroy, Chairman and CEO, Exact Sciences: In terms of the contracting for Cologuard Plus with the remaining top 10, all I can say, Puneet, is that we continue to work with those payers. Eventually, we will sunset Cologuard and move all payers. Really move all patients to the newer and better tests. We have great relationships with the payers. We have high hopes for getting that done sooner rather than later. We will not be providing timelines there, but we are making strong progress. In terms of CRC blood pricing, we have not decided that yet. Our philosophy around how we price our test is to secure the broadest access and impact. If you look at the effectiveness of a screening program, it equals the sensitivity of a test times the access that people have for the test and compliance. Those factors are the factors that impact screening. Access is so important.

Commercial payers are sensitive to price, and they look at the performance of a test as part of that mix. That has been our philosophy. How we end up pricing a blood test is probably going to be within our greater philosophy of bringing value to patients and to payers in the greater healthcare ecosystem. We think it is one of the reasons Cologuard has been such a wonderful success, because of where we priced it relative to colonoscopy.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Jack Meehan with Nephron Research. Your line is open.

Conference Operator: Thank you. And good afternoon. Just had a couple of financial ones I wanted to ask. First is just more color on the $150 million cost savings program you’ve talked about in the past. Just how’s that progressing and how you think that steps up into 2026? And then last quarter, you had the accounts receivable stepped up because of the timing of the Cologuard Plus payments. I was just wondering if you were fully caught up on that. It looked like yes, but wanted confirmation. Thank you.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Hey, Jack. On the first piece around the productivity program, really pleased with the progress that we’ve made. Just as a reminder, what we committed to was to deliver $150 million in savings in 2026, which would be about $100 million year-over-year impact. We’re progressing very nicely against that. The actions that we need to take to deliver against that have been taken. If you think about the other component to that, it is the one-time expenses. Last quarter, we guided to kind of $90-$95 million in 2025 and then $105-$120 million in total. We’re going to come in a little bit lighter on that, which is a good thing. We now expect approximately $85 million in terms of one-time expenses for this year. Making good progress, and the team is executing against that nicely.

As it pertains to the AR, yes, all of the AR from Q2 related to Cologuard Plus has now been collected on in the third quarter. Maybe just take a step back on the progress that the teams have made across Exact to really lean in and deliver record amounts of free cash flow for the company. On a year-to-date basis, we’re at $236 million. Obviously, the strength in the third quarter came from collecting on the Cologuard Plus claims, but also all of the progress that the teams have made in terms of working capital improvements. Inventory optimization as well as renegotiation of payment terms with suppliers. Really, really pleased with the progress that the team has made across the company.

The next question comes from Dan Brennan with Talon. Your line is open.

Conference Operator: Great. Thanks for the questions. Congrats on the quarter. Maybe just one. I know, Aaron, in the past, you’ve typically updated in terms of the contribution within the screening guide between the different buckets, whether it’s first-time users or care gap or rescreening. You’ve given some color when if you can disaggregate that, how you’re thinking about that for the year and maybe for the fourth quarter. Just any comment on OpEx? Sales and marketing kind of was below our expectation, R&D was above. Just wondering kind of moving forward as we head into the fourth quarter, how we think about the different buckets within OpEx. Thank you.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Thanks, Dan. We saw broad growth in the third quarter really across all lines of business. No matter which way you cut it, 50 plus, 45-49. Rescreens, care gaps, CIO, all elements of the business were growing north of double digits. Really pleased with the progress. All of the commercial improvements that Kevin alluded to earlier, we’re really seeing that flow through, not only in the leading indicators and the sales rep productivity, but now obviously also into volumes. We talked at length already about care gap and the record amount of volume that we’re seeing there as well. Just in terms of some of the OpEx items, yes, R&D spend did step up a little bit in Q3. We would expect similar levels of spending in Q4.

A lot of that is tied to all of the clinical evidence generation and the work we’re doing to continue to improve our OncoDetect test and get additional cancer indications on that into the future. In terms of sales and marketing, Kevin talked about that earlier as well, but we would expect and are investing in our CancerGuard launch, particularly as it pertains to marketing. You’ll probably start to see, whether you’re watching on YouTube or Netflix or any of the other social channels, you’ll start to see some CancerGuard ads start to take flight here as soon as this week.

The next question comes from Doug Shankle with Wolfe Research. Your line is open.

Hey, good afternoon, guys. Just a couple of quick questions. First on seasonality. The fourth quarter has typically been a seasonally weaker quarter due to the holiday season. Obviously, your guidance implies this is not the case this year. Some of that, I think, is just the assumption that ASPs are going to increase sequentially. I think the balance of that is care gap. Do I have that right? If so, is that probably the right way to think about your business moving forward, meaning not just this year? My second question is on CRC blood. It may be too early, but I’ll ask anyway. I’m just wondering if you have a good handle on how to manage that launch in a way where there’s no channel conflict.

As we think about the P&L, at least in terms of gross profit per test, is there a way to price that test in a way where we’re going to see the same level of gross profitability, whether it’s stool or blood? Again, it’s early, but just curious if you guys have given any thought to that that you’d be willing to share. Thank you.

I’ll start maybe on the first piece there, Doug, just on the seasonality. Care gaps obviously are just with the tremendous demand that we’re seeing from payers that are becoming a larger part of our business. Again, given the lumpy nature that those programs have, i.e., they’re back-end loaded, that certainly would distort some of the more traditional seasonality trends that we had in our business. I would just flag in particular, if you think about this Q4 guide and then what that implies for a typical Q4 to Q1 step down in terms of sequential growth as we head into 2026. Again, all driven by the strength and demand in our care gap programs. You did hit on pricing. Pricing will be up slightly sequentially from 3Q to 4Q, but that’s really only about 100 basis points in terms of the overall uplift.

Kevin Conroy, Chairman and CEO, Exact Sciences: For the second part of the question, Doug, around CRC blood and our launch of the CRC blood test with license from Freenome, we will take lessons from the launch of Cologuard and the launch of Cologuard Plus and our unbelievable analytics around what patients have refused Cologuard or even colonoscopy over time so that we can get the right test to the right patient at the right time. That right test may be a blood test for a patient who has consistently refused colonoscopy or a stool test. That is important. There are a huge number of people that are in that refuser camp, and getting them tested with a test that has lower performance is better than no test at all, for sure. We will price that in a way so that we can maintain margins as much as possible.

We just do not see a conflict here because we will be out there educating physicians, clinicians, PAs, nurses about what patient population is appropriate for each test. We think of this as expansive. The way we think about this program is expansive to where we are today with growth. Because of the fact there are 50 million people not up to date with screening, there is plenty of room for growth. Significant growth with Cologuard and with our CRC blood test.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: The next question comes from Andrew Bracknen with William Blair. Your line is open.

Conference Operator: Hi, guys. Good afternoon. Thanks for taking the question. Kevin, I think you made a comment that you’re seeing encouraging signals with the MRD launch and in particular in the breast indications. Anything more you can share with respect to how you’re sort of thinking about the halo effect that Oncotype brings to that indication in particular? Any signals or colors that you can provide there? Thanks.

Kevin Conroy, Chairman and CEO, Exact Sciences: Yeah, thanks, Andrew. It’s been 21 years of Oncotype depth among oncologists, surgical oncologists, pathologists. The customer trusts us with that tissue block. They trust us in the breast cancer space. As you think about the adoption curve in breast cancer, we think that is a natural starting point for us. Also, our strength in colon cancer is also a natural starting point. The studies that we are doing in breast cancer include what we call the ExactDNA003 test, which is a study enrolling over 1,800 participants in conjunction with NSABP. Also, we are enrolling a pan-tumor study that has enrolled across 10 different tumor types, including lung cancer. The evidence is going to mature. As we get breast cancer coverage, we expect to be able to really start to more deeply penetrate that customer base. We’re excited about the ability to do that.

The other thing that will unlock value is the Maestro technology, which is the whole genome approach for our next version. We expect that to launch in 2026. It would be used to support other indications. It’s important to start with breast. The ability to look broadly across these thousands of different mutations while reducing the sequencing depth and achieving this ultra-low limit of detection, potentially below one part per million at an attractive cost point, is a differentiator. That is work to be done. It’s a huge market. It’s growing. It’s under-penetrated at the current time. We think that our commercial organization and reputation among oncologists will be a great starting point.

Conference Operator: The next question comes from Dan Arias with Stifel. Your line is open.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: Good afternoon, guys. Thanks. Aaron, maybe just following up on rescreening, what percentage penetration are you assuming that you’ll be able to achieve there this year? I know you were thinking mid-50% as a percent back in the starting at the start of the year. That feels a little light just given the strength here, but we’d love to know just what an updated view would be and whether you think that number should move higher next year.

Rescreens continue to kind of be in that mid-50s to high 50s. We’ve continued to make progress on that throughout the year, Dan. I think if you take a step back, one of the things that we’re really trying to do is automate the rescreen process. There’s a number of different things that we have in flight to be able to do that. What we have said is that over time, we think that we can get that up into 70% or 75%. The reason for that is because we know that the key to getting people rescreened is getting that prescription. Once we get the prescription and ship the kit back to that patient, we know that the compliance rate is anywhere from 80% to 95%. That’s what we’re laser-focused on right now. No more to update on that.

We’ll keep you all posted as to what that means for future financial guidance.

Derek Leckow, Investor Relations, Exact Sciences: Yeah, the goal really is to automate the screening process so that people get screened and stay screened throughout the duration of the recommended screening time period. That’s important. It’s one of the unique things that we can do with Cologuard and the Exact Nexus platform that we have invested so heavily in over the last decade.

Conference Operator: The next question comes from Bill Bonello with Craig Hallum. Your line is open.

Hey, guys. Thanks a lot. I wanted to follow up on the telehealth comment that you made that consumers or patients being able to order directly. Can you just talk a little bit about how that then integrates with a primary care physician if you have that information or are able to get that information? Does that information get channeled back to the PCP? Would the PCP still get quality credit for that patient being screened? Is there any potential conflict there if the test is ordered via you rather than being prescribed by their PCP? How do we think about that?

Derek Leckow, Investor Relations, Exact Sciences: Thank you, Bill. Yes, that’s something that we’re really sensitive to as we rolled out not only CIO, this customer-initiated ordering, but also rescreen and care gap programs. One of the beautiful things about the Exact Nexus platform and the power, which is powered by Epic, is that the MyChart account gets integrated ultimately. That may take the next couple of years to really bring that to its maximum impact. That allows patients and physicians to see any type of test that is performed anywhere ultimately gets back into one single electronic medical record. That then enables a physician to get full credit for all of the screening, regardless of whether they initiated it, and allows payers, which are moving to the payer platform, to see that as well. It’s a powerful tool.

Us being on Epic, one of the nodes of Epic, really creates the ability for us to do some pretty unique things in terms of managing the health at a population level. This is one of those really positive stories.

Conference Operator: The next question comes from Mike Riskin with Bank of America. Your line is open.

Great. Thanks, Bruce, for the end. I want to follow up on a couple of points you guys touched on earlier. I mean, first, the gross margin you called out, I think 100% headwind, I think kind of tied it to the record care gap strength. Just to make sure, just relatively speaking, talking about care gap being strong in 4Q, is that relatively the same impact that you’d expect then? Just to make sure I got it right, reverses in 1Q and 2Q just from the seasonality. I just want to make sure I got the moving pieces right there. I will throw on the follow-up at the same time. I want to bridge the revenue raised to EBITDA, really solid beat, obviously, a nice phrase, but EBITDA did not come up quite as much. Is that the gross margin impact that’s different there?

Or maybe some of the incremental R&D investments we were talking about earlier, I think when Dan Brennan was asking about OpEx, just kind of talk about the lines between GM and EBITDA. Thanks.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: There’s a lot of questions there, Mike. I’m going to do my best to unpack all of those. On the gross margin piece that we saw in the third quarter, yes, it was exclusively limited to just kind of the record demand that we saw within our care gap programs. We would actually expect 4Q gross margins to step up. If you look at kind of where consensus gross margins are in the fourth quarter, it does imply a step up, and we certainly would expect that as well. The reason for that is because we do not actually ship as many care gap programs out in the fourth quarter as we do in the third quarter or the second quarter.

The reason for that is because the payers, again, really want to try to get patients screened through their PCP early on in the year and then kind of turn to these larger care gap programs that you get in the middle part of the year if they want to ensure that they achieve their quality score. We would expect an uplift in 4Q as well as then in 1Q of 2026. On your question as it relates to the flow-through and the EBITDA guide, I think it’s an important point too to just kind of take a step back, which is this is going to be our second consecutive year with nearly 50% adjusted EBITDA growth. Margins in the back half of the year are going to be in the 16-17% range and well on our way to achieving the long-term goal that we have of 20%.

If you look kind of down the P&L line, where we’re seeing the most amount of leverage right now continues to be from G&A. We’ve talked about the productivity plan. G&A, as it stands already right now, will be down about 700 basis points on an adjusted basis versus where we were two years ago. We have said that this year was going to be a year of investment. On the R&D side, Kevin just talked about some of the areas we’re investing as it pertains to MRD and the clinical evidence generation that we want to generate in that very, very large under-penetrated market. In the back half of the year, really on sales and marketing expenses, specifically marketing for CancerGuard. Again, very, very large market. We do not have to add salespeople to be able to get after that.

We really want to tap into this large market that exists. We’re putting our full back behind that and look forward to sharing updates in coming quarters and years on how that launch is progressing.

Conference Operator: The next question comes from Subu Nambi with Guggenheim. Your line is open.

Hey, guys. A couple of model cleanup questions and then one topic on CancerGuard. What were the Cologuard AFTs this quarter? Were they up quarter over quarter? Did I hear you right? The Cologuard volumes grew 250,000 tests year over year. That’s one. On the topic of CancerGuard, you have an unparalleled PCP commercial infrastructure. That said, given this is largely a cash-pay market at this point, I’m curious how impactful do you expect the PCP commercial infrastructure advantage to be?

Aaron Bloomer, Chief Financial Officer, Exact Sciences: On your first point, Subu, AFPs were up sequentially from Q3 versus Q2, and we would expect them to be up sequentially again in Q4 versus Q3. Yes, we screened more than a quarter million people more this quarter than we did a year ago at this time. Let me say that again. We screened in this quarter more than 250,000 more patients than we did a year ago. Yes, those are the modeling questions that you had. Kevin, maybe you want to take the CancerGuard question.

Kevin Conroy, Chairman and CEO, Exact Sciences: Yeah, I think it’s a good question, Subu, as I’ve been out talking with our field reps. One of the things they’re acutely aware of is which offices in their territories have patients that would be willing to pay for a CancerGuard test. That will become an important part of our salesforce’s conversations. It will get them more access. We believe we’re seeing that happen already. You’re bringing up a good point. It’s not easy in the US health system to get people to pay out of pocket for a novel technology. Something as important as a multi-cancer screening test, we believe we will see uptake here. It will take some time, just like Cologuard did.

We’re pleased here in the early month or two, the early days of this launch, and we think that a significant advantage will not only be our frontline sales reps, but also the relationships that we have with health systems. We’re trusted because they trust us with the quality of the tests that we develop and bring to them, the ability to electronically order and get resulted for a test, our customer service. They know that they can call us anytime, day or night, and get an answer that is needed. All of this ecosystem, our human capability, our systems capabilities, are important. Another part of our company that is important is, do you remember back when we acquired Genomic Health, one of the three things we said that was important that we loved about Genomic Health was their international reach?

Cologuard has much broader applicability outside the US than even inside the US, which is pretty significant in the US. The team, we just got back from our international headquarters where the team laid out their plans for launching Cologuard around the world. They’re revving up their teams to be able to deliver this, and we’re excited about that. That aspect of the platform, the Exact Sciences platform as well.

Conference Operator: The next question comes from Mark Massaro with BTIG. Your line is open.

Hey, guys. Congrats on the strong 22% growth in screening this quarter. I wanted to ask about the OncoDetect MRD test. I appreciate the commentary about the meaningful lift in breast cancer and the encouraging utilization in CRC. Kevin, I’m just curious, do you think that OncoDetect could become at least a material contributor to your precision oncology business in 2026? You did put up double-digit or 12% growth in PO. I’m just trying to figure out how much of that strong growth this quarter came from OncoExTra versus OncoDetect, and any thoughts about 2026? Thank you.

Kevin Conroy, Chairman and CEO, Exact Sciences: Mark, it’s too early, really, to give much color in terms of 2026. And as we said, OncoDetect is not material to this year’s revenue, but over the long haul, and we really tried to. It’s been quarter who we are thinking about the long term. When we developed Cologuard, when we developed Genomic Health, developed Oncotype, those were long-term investments that over time you’re able to win because you do things the right way. I’m proud that the team is doing things the right way in terms of gaining the evidence needed to then go to the customers, show them that evidence, and convince them that our test is the best test for their patient. We love what we’re seeing so far, and we expect to be able to demonstrate that quantitatively in the future.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: In terms of then within the third quarter, obviously, we are really pleased with what the PO team delivered in the third quarter as well. Double-digit growth in our precision oncology business. That did not come from OncoDetect. As Kevin said, it is still early days. It does speak to the strength of Oncotype DX. Oncotype DX continues to expand and penetrate in international markets. We also saw a nice uptick in volume in Oncotype DX in the US as well.

Conference Operator: The next question comes from Luke Sergot with Barclays. Your line is open.

Great. Thanks for the questions here. Just a quick cleanup on the Freedom Simple screen with the FDA. Jumped on here a little late. I don’t know if you guys gave an update of when you expect the FDA to kind of give you any feedback there or any type of feedback you’ve gotten and types of updates you guys need to do. I guess, more longer term, as you think about the launch of that Simple screen within that market, I mean, you guys have a massive CRC screening database. For whatever reason or not, whether it’s a failed or a Cologuard test or just shipping tests out, realizing patients don’t want to do that, that seems like a pretty low-hanging fruit to me as you kind of launch and think about commercializing this test. Can you use that also as you think about MSED going forward too?

Kevin Conroy, Chairman and CEO, Exact Sciences: Thanks, Luke. Yeah, to that last question, yes. Our relationship with over 30 million patients and more than 250,000 primary care physicians and then oncologists and beyond. You have GIs and OB-GYNs. We’re a source of trust in terms of our CRC blood test that we plan to bring to clinicians and to patients. We have the ability to meet what the NCCN and who else was it? ASGE.

Aaron Bloomer, Chief Financial Officer, Exact Sciences: AGA.

Kevin Conroy, Chairman and CEO, Exact Sciences: AGA recommended in terms of. The blood tests are, look, they’re not as effective as Cologuard, Cologuard Plus, or colonoscopy. They’re just not. The right test for the right patient at the right time. Somebody who doesn’t get screened at all for colon cancer, we know who 10 million of those people are because we’ve sent them a Cologuard kit, and they haven’t returned it. Now, that’s over 11 years, and over time, that base of customers builds. So we’re able to work hand in glove with health systems to identify patients who would be appropriate for a blood test if that patient comes into the office. Okay. They’ve tried to get a colonoscopy order. They have tried to get a Cologuard test. Now, how about a blood test?

We are in a unique position there to help that patient get screened, and nothing is more important than getting patients screened.

Conference Operator: The next question comes from Kyle Stacey with Canaccord. Your line is open.

Hey, guys. Thanks for the questions. Congrats on the quarter. On the CRC blood partnership, just a couple on that. On the data that’s due early next year, is that the V2 data that will ultimately trigger the $100 million opt-in payment upon FDA approval, or is that data set related to that payment coming later in the year, later in 2026? Secondly, something that’s kind of come up in my conversations, for example, is how do you prevent the partner from gaining access to your accounts in certain scenarios, such as if the provider opts in for the FDM set version and the ownership of the customer kind of switches to the partner? Thanks.

Kevin Conroy, Chairman and CEO, Exact Sciences: In terms of the Freedom V2 data, let’s be clear about this. There is data that is kind of concept data, and then there is a pivotal study that will be underway. The initial data is the data that will be forthcoming sometime in the next few months. The pivotal data is data that would come next year. We don’t know exactly when that data would come next year, but it’s the pivotal data that will be used to submit to the FDA, and that’s the important thing. In terms of FDA approval, that will be on the V1 data, which was submitted in August, and it takes about a year. In terms of any confusion about who gets the credit for CRC screening, we have the exclusive right to market CRC screening test. Freedom intends to launch a lung screening test and eventually a multi-cancer screening test.

The CRC blood screening test is ours exclusively to market.

Conference Operator: This concludes the question and answer session. I’ll turn the call to Kevin Conroy for closing remarks.

Kevin Conroy, Chairman and CEO, Exact Sciences: Thank you all for joining today and to the Exact Sciences dedicated team for their commitment to deliver on our mission of eradicating cancer. Thank you.

Conference Operator: This concludes today’s conference call. Thank you for joining. You may now disconnect.