Exact Sciences Corp

NASDAQ:EXAS

Earnings Call Transcript 2021-Q2

[Operator]

Good day and thank you for standing by. Welcome to the Exact Sciences Corporation Second Quarter 2021 Earnings Call. [Operator instructions] Please be advised that today's call is being recorded.

I would now like to hand the conference over to your speaker today, Ms. Megan Jones. So please go ahead, ma'am.

[Megan Jones, Investor Relations]

Thank you, Ria. And thanks to all of you for joining us for Exact Sciences' second quarter 2021 conference call. On the call today are Kevin Conroy, the company's Chairman and CEO; and Jeff Elliott, our Chief Financial and Chief Operating Officer and Jake Orville, General Manager of our Pipeline. Exact Sciences issued a news release earlier this afternoon detailing our second quarter financial results.

This news release and today's presentation are available on our website at exactsciences.com. During today's call, we will make forward-looking statements based on current expectations. Our actual results may be materially different from such statements. Reconciliations to GAAP figures are available in our earnings press release, and descriptions of the risks and uncertainties associated with Exact Sciences are included in our SEC filings.

Both can be accessed through our website. It is now my pleasure to introduce the company's Chairman and CEO, Kevin Conroy.

[Kevin Conroy, Chairman and Chief Executive Officer]

Thanks Megan. And thanks to everyone for joining us this afternoon. We tested 850,000 people in the second quarter with Cologuard and Oncotype DX in our COVID test, the Exact Sciences team remained unwavering in their dedication to our mission and delivered record results with Cologuard and Oncotype. The team delivered in spite of limited salesforce, and in person wellness visits due to COVID. Exact Sciences is a leader in advanced cancer diagnostics because of our people, our capabilities, our scientific platform, and our powerful brands. We will transform cancer care with our strong foundation and screening and precision oncology in our pipeline of innovative tests. We have a relentless focus on creating a great company culture with the best team. We are inspired to achieve our mission of cancer eradication. Because of this passion and engagement, Exact Sciences was recently certified as a great place to work for the third year in a row.

Today, we will review our second quarter performance, third quarter and full year guidance and our progress for 2021 priorities. Our CFO and CEO, Jeff Elliott will now review our financial results.

[Jeff Elliott, Chief Financial and Chief Operating Officer]

Thanks Kevin. Good afternoon, second quarter revenue was $435 million, an increase of 62%. Screening revenue was $264 million, an increase of 101%. Screening revenue would have been $276 million but for a one time downward adjustment of $12 million. The downward adjustment was taken because we missed the contractual deadline for submitted insurance claims on a small percentage of previously completed Cologuard tests. The adjustment represents 2% of screen revenue during the relevant time period. We are addressing this by improving our billing systems and processes. And we're confident these enhancements will support a rapid growth in new product launches. Highlights for the second quarter include the highest number of people tested for Cologuard by more than 60,000 tests. A significant increase in the number of lives covered for Cologuard in the 45 to 49 age group.

Solid contributions from three year rescreening, a two point improvement in the Cologuard electronic ordering rate to 45%, and 8,000 new healthcare providers ordered Cologuard during the quarter, and nearly 244,000 of orders since launch. Turning Precision Oncology, second quarter revenue was $138 million, an increase of 34%. Growth was primarily driven by Oncotype DX breast in the US and internationally. COVID testing revenue was $33 million. Second quarter GAAP gross margin was 69%. Non-GAAP gross margin, which excludes amortization of acquired intangibles, was 74%. Sales and Marketing expense was $195 million. The increase was due to investments in our sales and marketing campaigns to support growth. G&A expense was $168 million, including $13 million of acquisition integration costs. R&D expense was $106 million, and then included $33 million for the acquisition of PFS Genomics. Aside from PFS, growth was driven by a multi cancer screening test.

Adjusted EBITDA was a loss of $27 million, and we ended the quarter with cash and securities of $1.3 million. Turning to our 2021 outlook. We now expect revenue between $1.705 billion and $1.745 billion, an increase of $10% million to $15 million for the year, we've slightly lowered our screening revenue assumption, and now expect between $1.1 billion and $1.125 billion. We've increased our Precision Oncology revenue assumption, and now expect between $530 million and $540 million. We've also increased our COVID testing revenue assumption, and now expect between $75 million and $85 million. For the third quarter, we expect revenue between $420 million and $435 million, the system screening revenue of between $285 million to $290 million. Precision Oncology revenue between $130 million and $135 million and COVID testing revenue between $5 million and $10 million.

There are two main pandemic related dynamics impacting the screen business, reduced physician offices access for our field teams, and fewer in person wellness visit. Since their last earnings call, we have not seen as much improvement in these two factors as previously expected. This is in part due to the recent uptick in COVID cases from the highly contagious Delta variant. Starting with field team access, it is very promotionally sensitive. The more times we talk to a physician about Cologuard, the more tests they order. In person sales costs have been gradually improving, but they're still well below pre COVID levels. 55% of primary care physicians are not allowing sales representatives into their office according to a recent survey we conducted. In offices where we have physician access, we're seeing fast in Cologuard orders. Secondly, in person wellness visits are limited. Cancer screening and conversations and Cologuard orders typically occur during a routine wellness visit. That's different from most advanced diagnostics, which are ordered outside of wellness visits. Our survey showed 44% of primary care doctors are doing fewer in person wellness visits, when compared to pre COVID levels.

Turning to operating expense; for the full year we expect sales -- of $800 million to $$850 million. For G&A, we are raising our guidance to $600 million to $625 million, excluding integration costs. The increase is mainly due to investments in our IT and customer service teams to support our continued growth. For R&D, we expect $410 million to $435 million. The acquisition of PFS Genomics was expensive in the second quarter, adding in $33 million in R&D costs not contemplated in prior guidance. We continue to expect around $95 million for tangible amortization and CapEx of around $125 million.

I will now turn the call back to Kevin.

[Kevin Conroy, Chairman and Chief Executive Officer]

Thanks Jeff. Exact Sciences is focused on three priorities this year, getting more people tested, enhancing our customer experience and advancing new solutions. Starting with our first priority, Cologuard was designed to help screen more people for colorectal cancer and find it earlier when it is curable. According to recent CDC data between 2015 and 2018 Cologuard helped improve screening rates for Americans 50 and older by four percentage points. Our survey data show nearly half of Cologuard users have never been screened for colorectal cancer. Since Cologuard was made available, we estimate it is helped precancerous polyps in more than 200,000 people and early stage treatable cancer in more than 30,000 people. Cologuard is especially well positioned to help screen the 19 million Americans ages 45 to 49. The final USPS recommendations expanded the screening population by lowering the starting age from 50 to 45. Colon cancer incidence in this age group has increased more than 50% since the mid 1990s. People in their late 40s typically lead busy lives and Cologuard accuracy, and convenience makes it an ideal option to keep them screen for decades.

A recent study published in Cancer Prevention Research showed that Cologuard specificity is greater than 95% in this age group. This means that fewer than one people will receive an unnecessary colonoscopy following Cologuard helping screen many people without pressuring colonoscopy capacity. Since the guidelines were finalized, we've seen a significant increase in Cologuard coverage for 45 to 49 year olds. We recently launched a national Cologuard television, digital and social media advertising campaign aimed at educating 45 to 49 year olds about the importance of screening and the benefits of Cologuard, we're making it easier for people to stay up to date with screening after an initial Cologuard test. The number of rescreen eligible patients is growing. This year, more than 600,000 people will become eligible for another Cologuard test. Next year, more than 1 million people become eligible. We're investing in technology to stay connected with our customers and make ordering easier. This gives us confidence we can help keep people screen with Cologuard for years to come.

Our Precision Oncology team is providing better information to guide patients in their cancer treatment decisions. We have established deep relationships with oncologists, pathologists and surgeons. Nearly half of our oncology sales representatives have been educating physicians about our Oncotype test for at least nine years, creating strong brand recognition. Following our acquisitions of Paradigm and Ashion, we're now offering therapy selection tests for patients with advanced cancer providing even more value to oncologists, researchers and pharma partners. Our international team and the powerful evidence backing our Oncotype DX breast test are enabling new areas of growth around the globe. Supported by the TAILORx and RxPONDER studies, our Oncotype DX breast test was recently approved for national reimbursement in Italy. This makes Oncotype accessible to nearly 25,000 breast cancer patients in Italy.

Our international presence will accelerate the availability of future advanced cancer tests all around the world. Moving to our next priority, Exact Sciences plans to transform cancer care by providing patients valuable insights at every step of their diagnosis and treatment. We are working to build the best digital infrastructure and diagnostics. Our vision has two main elements first, enabling patients to take a more proactive role in their care. Second, making it easy for physicians to order tests, interpret results, and personalized medicine by applying real world evidence and guideline recommendations. Imagine a world where a patient uses an interface on their phone to interact with a physician for cancer prevention, diagnosis and follow up. They complete an Exact Sciences multi cancer screening testing and can monitor the status of their results virtually. If the test result is positive, a support system can help schedule a PET CT to confirm their diagnosis. If cancer is found an Oncotype tests may be offered to help determine disease and aggressiveness and treatment options.

In the coming years, we'll remind the patient to complete testing periodically through that same interface monitoring for residual disease and cancer recurrence. If the cancer returns after initial treatment, Oncotype MAP can be ordered to help quickly guide them to potential treatments. Our powerful IT systems will make working with Exact Sciences in easy decision. The information collected across a patient's health record will automatically translate into actionable options for physicians; we will help provide the right test at the right time partnering with providers to help bring guideline recommendations to life within their native electronic medical record system.

Turning into our next priority. Over the next 24 months, we're planning several key milestones to bring six innovative cancer diagnostics, from our pipeline to patients in need. This is a combination of more than a decade of work by the Exact Sciences team and our partners including the Mayo Clinic, Johns Hopkins and now City of Hope. Starting with multi cancer, next year, we expect to share case control data demonstrating the power of combining methylation, mutation and protein marker classes. We also plan to initiate a prospective interventional randomized trial for FDA registration.

Moving to Cologuard 2.0, we plan to share additional case control data, supporting our goal to improve specificity of Cologuard while maintaining sensitivity. For colon cancer blood testing, we plan to share case control data, providing an initial look at test performance. For Cologuard 2.0 in colon cancer blood we plan to announce top line results from our perspective BLUE-C study to support FDA approval of both tests and help cement our leadership in colon cancer screening. In the area of minimum residual disease testing, we expect to generate clinical validation data for tumor informed liquid biopsy test. In therapy selection, we plan to release clinical validation data supporting a blood based version test, Oncotype MAP.

Finally, we expect our Oncoguard Liver manuscript to be published in a peer reviewed journal. This publication will support a Medicare reimbursement submission and future guideline inclusion. We're excited about the depth and breadth of our pipeline. Our scientific capabilities combined with our commercial scale, will help us provide several new life changing cancer solutions to patients in need. The Exact Sciences team is energized to continue growing Cologuard and Oncotype and bring new innovative tests to patients throughout their diagnosis and treatment. Our capabilities, relationships and foundation will help us achieve our mission of eradicating cancer through the power of advanced analytics. We're now happy to take your questions.

[Operator]

[Operator Instructions]

And your first question comes from the line of Brandon Couillard from Jefferies.

[BrandonCouillard]

Thanks, good afternoon. Jeff, in terms of the screening guidance for the back half of the year, it would imply that 4Q growth sequentially steps up to something like 11%, despite what is typically weaker seasonality. Can you just talk about kind of what went into your assumptions for 3Q and 4Q and your level of comfort with that scenario and kind of what it contemplates in terms of access and maybe an uptick in wellness visits?

[JeffElliott]

Yes, first starting on the guidance adjustment for the second half of the year. This is an overall $25 million adjustment for screening, about half that relates to the $12 million one time adjustment, we took in the quarter. And the other half really relates to some pandemic related factors that we believe are temporary, namely physician office access and wellness visit, that's your question, Brandon, on assumption, for the back half of the year what we're assuming is that we see continued modest improvement to physician offices, and overall wellness visits. And we know that when our reps get into a doctor's office, they're very good at educating a doctor. And the more times we call a doctor, the more they order that correlation is true today. It has been historically. Again, it is true today, where we can see a physician. What we're seeing right now, though, is that 55% of physicians, we surveyed aren't allowing reps in, again, assume modest continued improvement in these trends. I also assumed that the strong momentum we had in the second quarter, again, this was a record quarter by more than 60,000 people over any other prior quarter. I assume that underlying momentum continues. So things like three year rescreening, we're making very good progress there. Things are on track for the guidance we outlined previously with rescreen call it 45. We've got very good limits in there. I expect that to continue to the rest of the year. And overall there are a lot of reasons to be excited in the back half, think the implied growth rate for Q4 is fairly similar to the rates we've seen in other years. So I am confident that we can -- we will achieve these numbers that are in planning guidance.

[Operator]

And your next question comes from the line of Derik De Bruin.

[DerikBruin]

Okay. Hi, good afternoon. So just can you talk a little bit about the Precision medicine franchise? How much of that was Oncotype? And how much of that is sort of like some contributed for some of the acquired products you've had? And can you also talk a little bit about the competitive landscape there? There's been some chatter from some private companies about some potential share shifts in that market, can you sort of highlight and update us on what's going on in the Oncotype business? Thanks.

[JeffElliott]

The Oncotype business globally had a very, very strong quarter, again, a record quarter for the organic business. There was a small saturation, non material, but there was a small contribution from acquisitions. And the overall though constant currency growth is north of 30%, I feel very good about the status business. And what it really boils down to Derek is the strong evidence, the unmatched evidence out there, from both the TAILORx study and RxPONDER studies, this gives the teams in the field, robust evidence to talk to physicians about and an Oncotype DX is really the standard of care. So no change to that I feel very good about the state of business. And it provides a very robust foundation for us to grow from, whether it's the Oncotype MAP business that we launched, just in May, that is now launched on to the entire salesforce, or the GEM ExTra product that we acquired, last quarter, the GEM ExTra product is off to a very good start, but most of the growth here was organic, and that franchise is in very good shape.

[Operator]

And your next question comes from the line of Brian Weinstein with William Blair.

[BrianWeinstein]

Hey, guys, thanks for taking the question. With Jake, on the call here, I think it's a good opportunity to at least ask him for his thoughts about that long list of things that that Kevin, that you highlighted as far as what that pipeline really looks like, and really starting to round into shape here. So question for you, Jake, is what are you most excited about here in the pipeline, and why? And then I'm also curious, your view about sort of challenges that you guys face from a technology standpoint, as you look to develop these products? Thanks.

[JakeOrville]

Sure, Brian, I mean, what excites me is really the themes you've already heard from Kevin and Jeff, we're just so unique in the both the breadth and the depth of our pipeline now, we have a full portfolio of high impact tests across the entire cancer care continuum, screening, prognosis, minimal residual disease, recurrence, therapy selection, it just really means a lot that we're going to continue to be the trusted source for innovation, with both patients and providers across that care continuum. Brian, in addition to the portfolio, we now have the team, the talent, and the scientific expertise that gets -- we're not just going to have eight portfolios, but we're going have a portfolio of the best tests. And we know in the long run, the best test always wins. We're going to continue to bring these tests to market the right way with the right evidence. So strong portfolio, strong talent, wonderful expertise, gives us confidence, one of the best test, and we're going to support the evidence to make sure that we demonstrate their utility. What really excites me at this stage is the fact that now we can also innovate at scale. So all of these solutions are now completely turnkey and seamless as they transition into our lab infrastructure. We leverage our IT connectivity. And as we bring these to our industry leading commercial team, and that's not just the United States, Brian, that's globally we already operate in 90 countries. So I feel great about how the pipeline can now truly make a huge impact into patient care. And that's --

[Operator]

And your next question comes from the line of Doug Schenkel from Cowen.

[DougSchenkel]

Okay. Hi, everybody, problems with the mute button. I just want to talk a little bit more of a Cologuard. So first off, question screening revenue grew, I think it was around 10% sequentially, based on your commentary, and just doing some quick math. Jeff, it seems like volume growth sequentially was 15% to 20%. I just want to make sure I have that right. And then higher level but bigger maybe more of question, I think we all appreciate the dynamic associated with lack of access to physician offices, especially given mostly the reality that things seem to be trending in the wrong direction in the United States when it comes to COVID. That being said, one might think that things like increased Cologuard and its efforts, the repeat testing opportunity, a backup colonoscopy, infrastructure, amongst other things, some of which you cited in your prepared remarks would all be positive offsets. Especially given the need for more screening and low market penetration. So, it really and my questions are, are you fully confident there's nothing hindering there -- physician practice access? And we don't hear similar commentary from peers over the course of earning season would--change? And do you have any concern that some of your efforts to make Cologuard less dependent longer term on physician detailing may not be proceeding as quickly as you hoped? Thank you.

[KevinConroy]

I will take that. The reason that we're tremendously excited about Cologuard and where we are in delivering this record quarter is driven by the fact that there are so many primary care physicians and nurses. And when you look at the base of who's ordering, and just to give more details on this, the healthcare providers who typically have ordered the least are ordering at a higher rate than previously and especially compared to historically are most frequently ordering positions. And what this tells you is that, yes, our Cologuard is always going to be sensitive to two visits by our field force. And that's because of the nature of the patient. The patient here is a patient who comes in who isn't sick. And in a time like this, there's a triage occurring in the primary care setting, focusing on problems with diabetes and obesity, and high blood pressure and other serious conditions that physicians and nurses are triaging. And so they get around to prevention and screening after all of that. And what this tells you the net of this is that there's tremendous strength in Cologuard, and that strength is a broadening and deepening. And we know as these offices start to reopen, and as we see more of the appropriate wellness visit patients into the offices, that we will see even stronger growth, because again, it's the best customers are the ones who aren't growing at the pace that you would expect to maybe Jeff could add to that.

[JeffElliott]

Yes, just add to that, the data Kevin referred to as we look at different quintiles of doctors, and what we see is very, very encouraging. The bottom 60% of doctors based on pre COVID ordering levels. When you look back at them over time, they continue to ramp throughout the COVID pandemic. In fact, in second quarter, the order rates are the highest of event, that group is driving the growth. And these are the physicians who had not previously fully adopted Cologuard, where we see a slightly different dynamic is the top 40%. These are the true believers and they are some of the strongest physicians, their orders are down at average about 15%. And why that is because their wellness visit volumes are down probably somewhere in that range. And recall Cologuard is ordered primarily during a wellness visit. One difference between Cologuard and most other diagnostics out there is that Cologuard is ordered for the asymptomatic averages. These are people who think they're healthy; we're trying to help them find cancer early. Typically in diagnostics, you're ordering it as for somebody who's already sick, or they've already been diagnosed with something so Cologuard is unique. The top 40% of doctors, they will come back, this is a temporary dynamic, they'll come back as wellness return and office access improves. So I am confident that will happen where it is happening where our reps can get back in there. This correlation we've talked about for many years, the more times you call a doctor, the more the order that is returning. So we're very optimistic that things open up, Cologuard robust growth will continue.

[Operator]

And your next question comes from the line of Catherine Schulte from Baird.

[CatherineSchulte]

Hey, guys, thanks for the questions. Towards the beginning of the year you talked about expecting t least $40 million from 45 to 49 and over $100 million from rescreen. How are those two drivers progressing relative to your expectations? And related to that, I believe we should be getting the technical update for next year's HEDIS measures pretty soon. What are your expectations around 45 to 49? Getting included in those following the USPS PF update, and how big of an impact would that have next year?

[JeffElliott]

Sure. This is Jeff. On rescreening, it's a very exciting opportunity. There's a lot of good news there, I am very confident that we will achieve at least $100 million of revenue this year and for Cologuard. In next year, that number will continue to grow. As you know, next year, over a 1 million more people become eligible for rescreening. On top of them were, why we feel so excited if those patients that get a rescreen order comply at a much higher rate over 10 points higher than the first time screening. And the team we have dedicated is doing a fantastic job at going out and getting more people retested. Cologuard 45 off to another very good start, and why this is so exciting. There are 19 million people, ages 45 to 49 essentially, they're all in screen. And we believe Cologuard is the ideal test for that age group. Things are off to a very good start there. In fact, if you compare the initial trajectory of the adoption for that age group, it is pacing above the trajectory that Cologuard had in the 50 and over age group when it was first launched. So things are off to a very good start there. And I am -- at least $40 million for that age group.

[Operator]

And your next question comes from the line of Dan Arias with Stifel.

[DanArias]

Good afternoon, guys, thanks for the questions. Kevin or Jeff, I know the situation is fluid. And so confidence around a number is certainly not 100%. But can you just give us a sense of how in your mind you're thinking about salesforce activity and the rebound, just through the end of the year when it comes to the screening outlook. I mean you are assuming that you're back to three quarters strength by 3Q or by year end? I mean what's the base case right now?

[KevinConroy]

Well, I don't think it's going to be at that level before the end of the year, it's taking a step back with the uptick in COVID over the last month. And we expect that to accelerate it just like we've seen it previously. We expect that offices are going to continue to be conservative. We don't have greater visibility into this than probably what you have, which is this is an important driver long term. And also long term, keep in mind that we -- there are 45 million Americans that remained unscreened. Cologuard is a perfect solution to catch up on the backlog to capture the 45 to 49 population. When things do start to open up, we believe that we will -- that will ramp up our growth beyond even what it is today. So we don't have visibility into how these offices are going to open up. We just told people go out and get vaccinated. And that's our message and it's our message to our employees and to their families. It's -- that is the solution. And once that starts to occur, we will all be in a better place.

[Operator]

And your next question comes from the line of Vijay Kumar with Evercore ISI.

[VijayKumar]

Hey, guys, thanks for taking my question. Jeff, one on the guidance here. If I understood you correctly, the $12 million reduction in the quarter that's just under reimbursements side right, one off, ex which revenues would have been basically in place, your volumes were pretty strong in the quarter. So I don't understand I guess the back half, when you are saying there's another $30 million reduction. Is that a reimbursement issue or you're just being cautious on the volume side of the equation?

[JeffElliott]

Thanks Vijay. The overall guidance suggested of $25 million, half that is related to the $12 million one time adjustment in Q2. The other half call it about $13 million is based on our updated look at the back half of the year. So what Kevin just talked about salesforce access out in the field and wellness visits given the recent spike in COVID cases, things are not improving at the pace we have previously expected, so we continue to expect growth in the back half. Just we don't expect as much growth as previously based on this recent spike in COVID.

[Operator]

Next question comes from the line of Andrew Cooper from Raymond James.

[AndrewCooper]

Hi, everyone. Thanks for the question. Maybe just to take a little bit different angle on some of the same topics, the Precision Oncology space was strong, you talked about Oncotype DX breast. And a lot of that volume comes from screenings that needed to occur, kind of flowing through the pipeline. So maybe just walk us through why is it that business is coming back stronger verse, you're getting more cautious on the screening side? Is there timing dynamic we should be thinking about in terms of just flowing through that funnel or anything else we should think about in terms of why one, working through the backlog might be happening a little bit faster, and one, maybe a little bit slower in terms of getting back into the wellness swing I think.

[JeffElliott]

Yes, this is Jeff. There are different businesses, the Precision Oncology business is more heavily dependent on mammograms, which are largely back to normal did return to normal earlier in the year. So that's a different dynamic. Also, you have the fact that around 40% of breast cancer diagnoses in this country started at home through a self exam or pain, which is different than colon cancer. Colon cancer overall, is still muted in this country, it has been and so that's the backlog Kevin reference continues to grow. Cologuard is a solution here. Cologuard has been growing year-on-year since June of a year ago. So Cologuard is helping address this problem. But it is a different animal. The headwinds that we are up against in Cologuard are wellness visit decline and salesforce access decline again, both temporary that seems to do a nice job in overcoming those.

[KevinConroy]

And I think, this is Kevin, I think it really highlights the strength of the Oncotype DX brand for somebody who has been diagnosed with early stage breast cancer, a friend of mine was recently diagnosed with an early stage breast cancer and Oncotype was just automatically ordered, in that case, by the surgeon. And it's different because that patient who was diagnosed versus an onscreen healthy patient, many of whom are going back in into a physician's office. And we think that we are being greatly realistic about those two dynamics, offices opening and patient's willingness to go back into a primary care setting, and especially older patients, which comprise a significant percentage of our screening population.

[Operator]

And your next question comes from the line of Matt Sykes from Goldman Sachs.

[MatthewSykes]

Yes. Thanks very much for the question. This on the Pfizer salesforce, they've been a little bit more conservative, in the past about returning back to the field is that, are they still back deployed? And if we get resurgence may they pull back? And then secondly, are you seeing any correlation? And originally, there have been a lot of differences in terms of vaccination rates? Do you see any correlation between access to doctors' offices and wellness visits in areas that have higher rates of vaccination, so we can kind of extrapolate that as we see vaccination rates rise.

[KevinConroy]

Our partner Pfizer has been our great partner; they have an amazing field force with an average like 14 years of experience in a primary care setting. They've been an amazing partner; they did come back to the field in late May. Truthfully, that's later than we would have hoped. But we understand every company has to make their own decisions. And that certainly is the dynamic because it takes time for them to then to have that have an impact on people whose tests get completed, there's obviously a lag between the time the test is ordered and the time that a test is completed. Pfizer helps us reach more physicians. And we're always evaluating ways to make that partnership better and stronger. And we think that their team will deliver good results this year.

[JeffElliott]

Matt, this is Jeff. I'll take other part of the question, which I believe is on vaccination rates and the impact, yes, the correlation really comes down to where you have high vaccination rates. You have lower or I'll say fewer new cases being diagnosed. And when you see hotspots formed, and we've seen this over the whole course of the pandemic, where hotspots arise. That's behavior change both, behavior in terms of physicians being more cautious in terms of letting salesforce representatives into their office -- physicians are also far more cautious than going out and getting a wellness visit. If you're think you're healthy, you're not worried about anything right now. And there's a COVID spike, you're less likely to go out there and get a physical. So yes, there is a strong correlation between vaccination rates and COVID and our ability to go out and educate doctors.

[Operator]

And your next question comes from the line of Patrick Donnelly from Citi.

[PatrickDonnelly]

Thanks guys. Maybe just following up on an earlier one, Jeff, on the rescreening opportunity, can you just talk about how momentum is building there, how you've refined your message to increase kind of a capture compliance rate there and keep it as close to the three year mark as possible. And then secondarily, just on electronic ordering, how you're progressing there, and again, trying to push volumes at that direction.

[JeffElliott]

Patrick, I've never been more excited about rescreening. This is a hugely important part of our business. Our goal is to get more people screened, and keep them screened over the course of their lives. And we are getting more successful, really, by the weekend doing just that. As you know, over 600,000 more people become eligible this year. So it's something we've invested in and we're seeing improvement. And what it boils down to is that when a patient gets their rescreen order, they comply at a very, very high rate for our communication with patients has been exceptional. Where we've seen even more improvement as of late is our communication to physicians. The goal here is to make rescreening or reordering if you will, automatic, you want to make it exceptionally easy for physician to identify who needs to be tested again, and for them to place that repeat order. So that's where the effort had been. And I'm really proud of what this team has accomplished. There's even more in store. With next year, over a million more people becoming eligible, this team is going to get it right. And we're also seeing the time after they become eligible, the time to them actually completed the test is improving. So there's a lot of good news to report on rescreening.

[Operator]

And your next question comes from the line of Dan Leonard with Wells Fargo.

[DanLeonard]

Great, thank you. Just two quick ones for me. One, Jeff, would you say that your guidance is de risked at this point? If we were to have a real flu season in the fourth quarter as it looks like we might? Or is that still something which could impact access? And then secondarily how sensitive do you think your clinical trial and clinical research timelines would be to the current case rates? Are you able to manage with the current infection rates? Are you envisioning that there's some correlation between case grades and your ability to enroll in your studies? Thank you.

[JeffElliott]

Dan, on the first one, guidance speaks and everything we know as of today, clearly in the middle of a pandemic with more hesitates than we could probably count right now. There's a lot of uncertainty out there. So we've created everything we know now. I can't predict what's going to happen with flu or COVID months from now. So we are facing everything that's out there in the news that you and I can both see. On the case rates, those can impact enrollment. You recall last year, as we were trying to enroll our BLUE-C study, which again is for Cologuard 2.0, and a colon blood product we did pause BLUE-C for about five months last year, because of this massive spike in cases so it can impact and if we do see a big spike, it will continue to impact enrollments and some of our case studies.

[Operator]

And your next question comes from the line of Mark Massaro from BTIG.

[MarkMassaro]

Hey, guys, thanks for taking the question. I wanted to ask maybe a two parter, I guess. The first is obviously, there's a lot of investor interest in the MRD space. You acquired via Ashion some extra test. I'm curious how that integration is going. I believe you're trying to merge that into the TARDIS technology. And so I guess, can you maybe comment about timing of data, or potential submission to [Moldex]? And then another question I had is, can you just over the years, you've been certainly looking at a lot of assets last two years, you've been pretty highly acquisitive, can you just give us a sense for bids dove and just looking at other assets would be super helpful. Thanks.

[KevinConroy]

Sure, thanks Mark. So with minimum residual disease testing, we are focused on delivering the very best test for patients and we love how we're positioned from a scientific expertise and technology standpoint, the combination of Ashion and the TARDIS technology with the proven evidence generation capability and the deep commercial relationships that we exist. So the next steps then would be to optimize the test, generate validation data, prepared to make that test available to patients. It's a natural fit with our breast cancer capabilities, Oncotype DX; we're seeing about half of all breast cancer patients' tissue samples, the tumor informed approach, it starts with that tissue. The deep relationships we have with oncologists. And then TARDIS, so TARDIS is a really powerful targeted sequencing chemistry. And we believe it'll allow us to achieve the highest level of sensitivity without sacrificing specificity. And then as Ashion has its proven ability to do this difficult sequencing, it's not just the sequencing capabilities, it's the bioinformatics and this is a well oiled machine. Our partnership with City of Hope and other teams around the country are important. And we have already signed partnerships relating to multiple studies to prove out the capability that we have with TARDIS and Ashion, it's important, it's about a $15 billion total available market. And today, the class is less than 1% penetrated, it's going to change the way that cancer is treated, is after treatment. And we plan to play a very important role in how these technologies are adopted, both in the US and globally.

[Operator]

And your next question comes from the line of Jack Meehan from Nephron Research.

[JackMeehan]

Thank you. Good afternoon, I was hoping you could give us some updates on Oncotype MAP, whether covered lives, and how much revenue MAP contributed, you have to do may launch. And then also, I know it's going through the code pricing process. Now at CMS, any sort of bogey, you're thinking about where that can shake out in terms of pricing?

[JeffElliott]

Jack, this is Jeff, I'll take that one. Oncotype MAP is off to a very, very good start, you'll recall that the two key differentiators for that product are one the turnaround time, the majority of our tests are reported result within three to five working days, so a very quick turnaround time. And the sample input requirement for the test is very low, which allows us to report a result out on a very high percent of patients. You think about the average person who uses this test, they have late stage cancer, they need an accurate result quickly, and we can help play a very important role in that decision. Coverage off to a very good start here, we've had multiple large payers started covering the test. It is also covered by Medicare already. This really speaks to the power of the Exact Sciences platform here. We've got deeper relationships with payers, when you think about the Cologuard business, Oncotype DX breast, prostate, and now MAP, the broad and deep relationships we have allow us to achieve a high level of coverage as we bring new products to market. So things are off to a very good start with MAP. In the May time frame that has not been launched to the entire Precision Oncology salesforce, for about 100 reps. As Kevin talked in his remarks, these are very experienced reps, and they are hungry for new products. So I know this team is going to do a very good job in launching that test.

[Operator]

And your next question comes from the line of Puneet Souda from SVB Leerink.

[PuneetSouda]

Great. Thanks. And Kevin and Jeff, two parts question here. I think you're saying that there are obviously a number of drivers and we all recognize that I mean, the first 45 year old coming into the next three years reorders, there is electronic ordering, there is greater recognition for Cologuard so but despite all that the rep access is low and I appreciate your details on the lowering of the guidance in the second half for Cologuard. But we're seeing that sure there is some hesitancy for the oncology reps to enter clinics because there are these patients are immuno compromised, but primary care practices are just trying to open more broadly. They're trying to get back to normal. And Jeff I think talked about maybe I think it's a last call that you are heading closer to, in a sort of 50% sales reps are doing in person. So just trying to understand if you play that out, maybe second half doesn't recover 100% maybe it gets to 70% to 80%. But and I appreciate your survey, and I appreciate the Delta variances are so out there, but why access to primary care practices would continue to sort of decline in the second half. And then just a quick clarification on the clinical data for the blood base, the CRC?

[KevinConroy]

Can you -- let's take this one at a time. So we are to make it clear, we are not projecting the access declines in the second half, it's not increasing at the rate that we would have expected to, largely because of the current situation with the pandemic.

[JeffElliott]

Correct, and Puneet, I think, to put some numbers behind it. The data we had set it on prior calls was the total number of face to face details in primary care. That did improve modestly during the second quarter, to Kevin's point I expected to improve in the back half of the year. This is with the rise in Delta, and this huge spike in case counts. And what we're seeing just for their own data, I don't expect you to improve it as much as we previously thought.

[KevinConroy]

I wanted to make sure we get that question, Puneet, before we took the second one. To the person who -- would you let Puneet finish his second question since I rudely interrupted?

[PuneetSouda]

Yes. Hey, guys. Sorry. And thank you, Kevin, for setting me back. And just a quick clarification on the data for the blood based CRC screening study in the second half. Is that -- just wanted to get that sort of the timing on that? And is that something you can present at a venue like ACG or conference like that? Just wanted to get the timing on that. And thank you again for the question, thank you.

[KevinConroy]

Which the blood base colon or multi cancer?

[JeffElliott]

I think Puneet said the likely timing, again, this is dependent on publication and the acceptance and conference, but the likely timing for our CRC blood product is in the -- sometime in the next year, the first half of next year. This is case control data, multi cancer case control data, also likely to be published at a science -- the first half of next year.

[Operator]

And your next question comes from the line of Alex Nowak from Craig-Hallum.

[AlexNowak]

Hey, good afternoon, everyone. Just a follow up to Puneet's question there just on the case control data for CRC blood. Kevin, you said in the prepared remarks, it's going to be an initial work. That label initially seemed to be new around the case control data. So am I right there? And if not, this looks like the business support the ultimately the FDA approval and reimbursement of that test, so do you need more data do you think?

[KevinConroy]

So with CRC blood, we're excited about the opportunity. As we've said in the past, we believe that we -- the test that we've developed with the curated methylation panel, and potentially other marker classes that we haven't disclosed, will generate sensitivity and specificity equal to or better than others that have shown their data publicly. We've been -- we've had the luxury of not having to show our data. And when I say initial, I don't mean initial to us, I mean, initial to the public. And that data we think we'll support continued progress as we move forward with our BLUE-C study and ultimately FDA approval and making that test available. Now, it's also makes sense to comment on where we think our blood test fits into the overall schema of colon cancer screening modalities. To date, clearly the two best tests or the two best ways to get screened for colon cancer are colonoscopy and Cologuard, why? Early detection is what matters the most. And with colonoscopy and Cologuard, the guideline groups that point to 95% sensitivity for colonoscopy, 94% sensitivity for Cologuard for stage one and two, that's the high bar for a blood test. And nobody's been able to show anything close to that, if you or your loved one wants to get screened for colon cancer, ask for the most sensitive test. And we believe that Cologuard in particular Cologuard 2.0 is going to set a new bar for non invasive colon cancer screening and the ease of use is actually easier than a blood draw. So there's been a thesis out there that blood kind of reinvents the game, the data aren't there to show that either from a sensitivity specificity standpoint, or from an ease of use standpoint, it's why we believe we'll have a range of tests available, we continue to believe that if you're going to get screened is either with Cologuard for colonoscopy and don't ask for the Fit Test or blood test that is present today. So hopefully that answers not only the question you asked, but also a question you didn't ask.

[Operator]

And your last question comes from the line of Kyle Mikson from Canaccord Genuity.

[KyleMikson]

Thanks. Hi, guys, thanks for taking the questions. So on this $13 million headwind in the second half, in your opinion, is that weighted more towards the wellness visit or I guess salesforce access, just wanting to know, kind of perceive those factors going forward? And you would also like similarly, rank order, maybe some of the drivers upside that give you some more optimism, whether that's epic or rescreening, et cetera. That'd be helpful. And I just one timing question on the MRD clinical validation data, is there any time you could kind of tell us better understand that as well. Thank you.

[JeffElliott]

This is Jeff. ON the $13 million, if you think of the two pandemic related factors, salesforce access and wellness as it's both are very important here. I want to make that clear. If you look at the where we are relative to pre pandemic levels, salesforce access is far more impacted. Still 55% of primary care doctors we surveyed say they're not allowing primary care reps into their offices. So that one's much farther from where it would have been; wellness visits are back to call it 80% 90% of pre pandemic levels. As far as MRD data timing, I think it was one of them. The timing of that at some point next year, we haven't been more specific than that. But next year very good progress being made in MRD.

As far as growth drivers, I mean look, the beauty of this model is that for screening, there's many growth drivers out there, there are 45 million people today who need to be screened. That's a big opportunity. Salesforce is always one of the top drivers in healthcare for us. I think it certainly is. And that's why getting the reps back out there in front of physicians is so important. For three year rescreening, this year, I've guided to at least $100 million. So that's another really big one longer term rescreen become I would think at least half of our revenue. So that will be a big driver for many years to come. Electronic ordering, were up five points year-to-date, that's a nice tailwind and we continue to expect at least 50% of Cologuard orders to be electronic by year end. So these factors are all very important. And they actually work together. So it's hard to say which one's the most important, but they're all important together. I do want to clear up one thing I said in my remarks. Guidance for COVID testing for the year is $75 million to 80 million. I think in my remarks he said $75 million to $85 million. We're looking for $75 million to $80 million.

[Operator]

And this concludes today's conference call. Thank you all for participating. You may now all disconnect.