Exact Sciences Corp (EXAS) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by, and welcome to the Exact Sciences Corp. Third Quarter 2021 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker today, Megan Jones. Please go ahead.

Thank all of you for joining us for Exact Sciences Third 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.

Exact Sciences issued a news release earlier this afternoon 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.

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's now my pleasure to introduce the company's Chairman and CEO, Kevin Conroy.

Thanks, Megan, and thanks to everyone for joining us today. Exact Sciences is advancing life-changing solutions to transform cancer care, offering new hope to patients and physicians. This team has proven that they can take a test from an idea to standard of care.

We're currently focused on multicancer early detection, colon cancer screening and minimum residual disease and recurrence monitoring. We believe these opportunities will have the greatest impact on patients. We have a powerful commercial engine, which will become more efficient as we introduce new tests from our deep pipeline. This team is committed to finding cancer earlier, even during the global pandemic.

Cancer screens have been deprioritized throughout COVID, and the need to get people tested is urgent. Early detection can improve cancer outcomes, and getting more people screened is our top priority. We're also focused on enhancing our customer experience and advancing new diagnostic solutions. Executing on these priorities will ensure genomic information is routinely used to detect, diagnose and treat cancer.

Highlights from our third quarter include testing a record 950,000 patients, hiring 400 primary care field representatives from Pfizer, our co-promotion partner, increasing covered lives for the 45- to 49-year-old group to 70% for Cologuard, generating promising data in our Cologuard 2.0 program, initiating an important minimum residual disease study, publishing ONCOGUARD liver clinical validation data and securing regulatory approval for Oncotype DX Breast in Japan.

Today, we'll discuss our third quarter performance in more detail, fourth quarter and full year guidance and progress on our 2021 priorities. Our CFO and COO, Jeff Elliott, will now review our financial results.

Thanks, Kevin, and good afternoon. Third quarter revenue was $456 million, an increase of 12% or 39%, excluding COVID testing. Screening revenue contributed $280 million or 31% growth, with strong contributions from Cologuard rescreen in the 45 to 49 age group. 9,000 new health care providers ordered Cologuard during the quarter, and 253,000 have ordered since launch. Precision Oncology revenue was $145 million, an increase of 59%, including 9 points of growth from our Ashion acquisition. Growth was driven by Oncotype DX Breast in the U.S. and internationally. COVID testing revenue was $31 million as Delta variant cases increased rapidly during the quarter.

GAAP gross margin was 70%. Non-GAAP gross margin, which excludes amortization of acquired intangibles, was 75%. Margins were down 2 points, mainly due to lower COVID testing volume. Sales and marketing expense was $197 million. During the quarter, we made investments in our commercial team to support continued growth.

G&A expense was $187 million. This includes $10 million of acquisition and integration costs and $10 million of legal settlement costs. R&D expense was $75 million. The increase was driven by our multicancer and colorectal cancer programs. Adjusted EBITDA was a loss of $16 million. We ended the quarter with cash and securities of $1.2 billion.

Turning to the market backdrop. Cologuard grew slightly less than we had expected. This was due to a rapid rise in the Delta variant as cases tripled from late July to mid-September, reducing sales force access to physician offices. Growth was also impacted by actions taken by our commercial partner during the quarter.

Due to COVID concerns, Pfizer pulled their sales representatives out of the field starting in late July through September and then reduced the size of their internal medicine team in mid-September. Combined, the Delta variant and our partner Pfizer's decision caused our in-person sales calls to decrease 70% during this time period. This led to a flattening of Cologuard orders in August and September. In October, order growth accelerated during the month, reaching new weekly record due to an improving backdrop and actions we're taking. Delta cases are coming down, in-person sales access is improving, and Exact Sciences hired 400 representatives from Pfizer and got them back in the field.

It takes about 30 days between a Cologuard order and a completed test when we recognize revenue. This means that Cologuard orders in August and September had a modest impact on third quarter revenue and will have a bigger impact on the fourth quarter.

Fourth quarter is also affected by holidays, when seasonality leads to fewer orders around Thanksgiving and Christmas and a temporary delay in patients returning Cologuard kits. With that in mind, we're narrowing our full year revenue guidance toward the high end of our prior range. We now expect between $1.722 billion and $1.737 billion. We've lowered our screening revenue assumption and expect between $1.05 billion and $1.055 billion. We've increased our Precision Oncology revenue assumptions and now expect between $547 million and $552 million. We've also increased our COVID testing revenue assumption and now expect between $125 million and $130 million. For the fourth quarter, we expect revenue between $449 million and $444 million. This assumes screening revenue between $265 million and $270 million, Precision Oncology revenue between $134 million and $139 million and COVID testing revenue between $29 million and $34 million.

Turning to operating expense. We're decreasing our guidance from our prior range. We now expect lower sales and marketing expense of $800 million to $820 million. This is because our partner made fewer sales calls, reducing our fees to them. For G&A, we're raising our guidance of $635 million to $655 million due to additional investments in IT and people to support growth. This number excludes acquisition, integration and legal settlement costs. We're also lowering our R&D guidance to $370 million to $390 million due to the timing of enrollment for certain clinical studies. We continue to expect $95 million for intangible amortization and $125 million of CapEx.

I will now turn the call back to Kevin.

Thanks, Jeff. Achieving our mission of eradicating cancer starts with screening in the primary care setting, and we're taking actions to get more people tested. We expanded our talented primary care sales team this quarter by welcoming more than 400 members of Pfizer's top internal medicine team to the Exact Sciences family. This is the same team we partnered with over the past 3 years. They have a deep commitment to our mission and longstanding relationships with primary care physicians across the country.

Our strengthened commercial engine will fuel Cologuard adoption and help reach 110 million Americans who should be screened. In the future, we expect our primary care sales team to educate physicians about Cologuard 2.0, our colon cancer screening blood test, our multicancer early detection blood test and others. These tests will be easy to access, powered by our seamless customer experience, IP capabilities and deep relationships with health systems.

The pandemic has changed health care and emphasized the importance of digital engagement and at-home solutions. Our focus on the digital customer experience will benefit Cologuard and our future screening tests.

Even with the backdrop of fewer cancer screens throughout COVID and more recently due to the Delta variant, Cologuard is playing an important role in getting more people screened. Because Cologuard is accurate and convenient, we have screened nearly 3 million people since the pandemic began.

We're focusing on 3 areas where we can make an impact: one, building the best and most effective commercial organization in health care by investing in our leadership team, training and sales force effectiveness; two, improving the customer experience by making it simpler to order Cologuard electronically and continue rescreening patients every 3 years; and three, screening more people starting at age 45 to catch cancer earlier. These Cologuard growth initiatives are outperforming and will provide benefits for years to come.

Our electronic ordering rate continues to grow, rising from 40% to 48% this year. We've rescreened more people with Cologuard this year than we did in the prior 3 years combined. And we screened more people ages 45 to 49 in the third quarter than we did all of last year.

Our Precision Oncology business provides a differentiated growth platform with a powerful Oncotype DX brand and experienced team and strong evidence generation capabilities. Oncotype DX Breast is the standard of care because it is supported by unmatched evidence.

We've seen growth in a number of node-positive patients tested with Oncotype DX since sharing the responder study results last December. Responder definitively showed which women with known negative disease will benefit from chemotherapy, similar to TAILORx for node-negative.

The recent Japanese regulatory approval opens another growth opportunity for Oncotype DX. Breast cancer is the most common cancer in Japanese women, with more than 90,000 new breast cancer cases diagnosed in 2020. We plan to launch in Japan early next year and look forward to guiding more patients to the most effective breast cancer treatments.

We've successfully integrated new tests onto our Precision Oncology platform, improving our sequencing, bioinformatics and proteomics capabilities in the process. One example is the team at Ashion, which expanded our whole exome, transcriptome and matched germline sequencing capability and provides the foundation for our minimum residual disease testing capability.

Bringing in test from an idea to standard of care requires rigorous scientific evidence, and we're entering an exciting period for our pipeline in 2022. In colorectal cancer, we're thrilled by recent data generated internally for Cologuard 2.0 and plan to release that data at a conference in January. We also plan to share case sample data supporting our colon cancer blood test next year.

Our talented clinical trials team has enrolled nearly 12,000 patients in BLUE-C, our pivotal prospective study. To power the study and support FDA approval for Cologuard 2.0 and our colon cancer blood test, we are increasing enrollment to more than 20,000 patients due to lower-than-expected cancer incidents. Because it will take time to enroll more patients, we expect to read out top line BLUE-C results for Cologuard 2.0 in late 2022 or early 2023 and our blood test in the first half of 2023.

In multicancer, we now expect to share 2 sets of case-control data next year. The first will show feasibility across multiple classes of marker. The second will show the power of combining the Exact Sciences and Thrive approaches in one test.

In the area of minimum residual disease, we recently announced we're partnering with the National Surgical Adjuvant Breast and Bowel Project, or NSABP, to conduct a prospective multicenter validation study with Stage II and III colorectal cancer patients. We previously partnered with NSABP on several important studies, including clinical validation studies for Oncotype DX Breast. The new study, called CORRECT-MRD II, is expected to enroll 750 patients to generate clinical validation data for our tumor-informed [approach]. We'll guide patients in every step (inaudible) recurrence risk and important treatment decisions. And our minimum residual disease (inaudible) surgery.

Moving to liver cancer. Clinical (inaudible) hepatology published validation (inaudible) to reliably detect early-stage liver cancer. At 87% sensitivity, ONCOGUARD liver demonstrated 82% early-stage sensitivity, nearly 20 points higher than the current guideline recommended testing option. This publication supported our submission to multi (inaudible) reimbursement, which we expect to receive in about [18 weeks].

We have completed or are working on more than 220 clinical trials, generating evidence for tests across the cancer continuum from screening through late-stage treatment. We're leveraging this expertise to support an outpouring of innovation from our deep pipeline.

Our scientific expertise and commercial engine position Exact Sciences to transform cancer care and defeat this terrible disease. We envision a future where genomic information is used to detect, diagnose and treat cancer routinely. We're at the forefront of this evolution, which will help us eradicate cancer.

We're now happy to take your questions.

(Operator Instructions) We have our first question coming from the line of Matt Sykes with Goldman Sachs.

This is Dave, on for Matt. Congrats on the quarter. We were excited to see the sales folks you've hired from Pfizer and glad things are rebounding strongly there. Could you tell us a little bit more about what they're doing to adapt to some of these headwinds of getting into physicians' offices in the COVID environment? And what would be some of the main changes for these folks now being full-time Exact employees instead of Pfizer?

Well, let's first start with our incredible team that we've built over the last 7 years in primary care promoting Cologuard is a remarkable team, and they've worked hand-in-hand with Pfizer reps over the last 3 years of our partnership. This team of Pfizer reps was team 1 within internal medicine, an average of 16 years of primary care experience, deeply committed to our mission. And we're in the very early innings of this team coming on full time with Cologuard as their position 1 selling gold. And we're already seeing strong results. Just in October, the first full month of their promotion of Cologuard as part of our team, orders are up 10%, accelerating in the back half of the month. So we couldn't be more excited about what this combined best-in-class primary care sales organization can do, combined with our OB-GYN sales force, our GI sales force, our health system sales force in Cologuard. So we're awfully excited about what we believe we can do next year as our country -- as the U.S. comes out of the pandemic and the opportunity for screening is desperately needed.

We have our next question coming from the line of Derik De Bruin with Bank of America.

Kevin, just why don't you think you've seen more telehealth and online ordering for Cologuard? I mean realizing that the pandemic has been going on for a while, but I think we would have expected just to see a little bit more pickup in that as opposed to the safe time given how long the product is on the market. And then I have a follow-up on -- just a little bit more clarity on the BLUE-C delay. There was some feedback on the line, and I think I missed some of that. So just -- could you go over that and sort of the reasons why -- just why the trial is being delayed a bit.

Well, we are thrilled with how quickly the team moved to bring up telehealth, and we're working to enhance that patient experience. So we learned a lot in terms of what all is required for a telehealth solution.

One of the things we learned is still cancer screening generally, whether it's mammography or colon cancer screening or cervical cancer screening, is something that is initiated in the primary care setting. And that will continue to be the biggest growth driver. With that said, we see that the most significant opportunity to generate self-initiated Cologuard testing is likely through partners that do face-to-face telehealth visits for other reasons. So just like you get screened when you go in to see your doctor, we believe you'll also get screened as you initiate a telehealth visit.

We do continue to -- we don't break this up, but we continue to see growth in this segment, and we're excited about that and what that means over the long term. The main growth drivers will continue to be our sales force and direct-to-consumer.

We have our next question coming from the line of Brian Weinstein with William Blair.

I don't know if you want to address Derik's other question before answering mine formally. But I guess as we just think more broadly on the CRC screening. Kevin, as you think about this opportunity, it's kind of a broad class, so not company-specific here, but it's a broad class. What do you think the market for these products looks like versus Cologuard if class performance is as good as Cologuard? And then if class performance is worse than Cologuard on the metrics that matter like early detection and Stage I in pre-cancer, I'm curious what you think performance for the broad class isn't likely to be whilst all the data is in.

Thanks, Brian. In a prospective study, class performance for blood test is not going to be close to Cologuard. Let's -- and it's not going to be close to Cologuard 1.0, our current version, and it's certainly not going to be close to 2.0. We know that because of the work that we have done in the space. However, with that said, blood testing play an important role. There are 45 million unscreened Americans. We know that choice gets more people screened. That's why we're investing in a blood-based colon cancer screening program. We are well positioned to lead in this space with the quality of our tests, with our brand, with our sales capability, with the infrastructure that we have built from electronic ordering to being able to deliver blood results. With that said, a blood test faces real hurdles that we don't want to minimize.

The data that we have seen and others have generated -- that we have seen internally and others have generated as case-control data. This case-control data we would expect a significant fall-off as you move into a prospective setting, more so even than in a stool study.

Also, we know from our BLUE-C enrollment that patients prefer a stool test over a blood test. In fact, in BLUE-C, we're seeing that 20% of people choose to complete a Cologuard test but refused to get a blood draw. So we know that the Cologuard brand will continue to be an incredibly important part of colorectal cancer screening for a long time to come.

Finally, the main guideline group, USPSTF, won't opine on a blood-based test until likely 2026. Medicare is right now only proposing to pay for a blood test every 3 years despite, we believe, the performance in a prospective setting will probably only justify a 1-year interval. So these are some of the headwinds, which, of course, we'll confront and deal with. But coming back to the first point, there are 45 million unscreened Americans, and blood testing hopefully will help get more people screened.

And then, Brian, to answer Derik's second question on BLUE-C enrollment, what we had said is that it's going to take more time to enroll a sufficient number of cancers. Really the goal of a large prospective study like this is to power the study by getting a sufficient number of cancers. It's going to take time. We have seen lower prevalence of cancer in the patients we have enrolled thus far. So we will keep that study open, likely north of 20,000 people to ensure we get enough number -- enough cancers to move forward with testing both our Cologuard 2.0 product as well as our colon cancer blood program.

We have our next question coming from the line of Vijay Kumar with Evercore ISI.

I had a 2-parter, one on Q4 and one bigger picture question on M&A. On the Q itself, Jeff, I think you mentioned a 6-week or a month delay between orders and revenue recognition. Given how volumes have trended, can we quantify the impact of lower physician office visits in 3Q that impacted revenues in Q4? Related to that, have those physician office visits normalized? Should there be some impact in Q1? So that's the question on Q.

Kevin, one for you on M&A. Is there a need for Exact Sciences to do a large transaction at this point in time? Considering that you guys have done a couple of large deals over the past 18 months, there's a lot to digest here.

I'll start on the quarter, Vijay. This is Jeff. Look, 2 things happened during the quarter. First was the Delta variant plate that we saw starting late in July and continuing through mid-September. That caused a significant decline in sales force access to physician offices. On top of that, actions taken by our partner, Pfizer, first by starting to pull reps out of the field in late July, and that continued, and then reducing the size of their sales force in mid-September. The combination of those 2 things led to a 70% decline in in-person sales calls during the quarter.

And look, Cologuard is promotionally sensitive. Normally, when we have access, we see a strong relationship between sales activities and orders. We are starting to see that return now. As Kevin mentioned, during October, we saw acceleration of Cologuard orders with 10% growth during the month. That makes us very optimistic as we exit this year. However, as I said, there is a normal 30-day lag between an order and a completed task, which is when we recognize revenue. So the impact of orders, which was felt primarily in August and September, impacts Q3 modestly. It has a much bigger impact on Q4.

To quantify the impact, as you asked, just look at what -- in Q3, I'll point to, we delivered 31% growth. The midpoint of guidance for Cologuard was 34% growth. And I would say that's a pretty good indication of the impact on Q3. And then if you compare the prior guide for Q4 is what we're pointing to today, that gives you a feel for the impact there. However, again, there's a lot of reasons to be optimistic here.

This expanded sales team is now entirely out in the field. They are motivated. They are talented. The 400 people we welcome from Pfizer are thrilled to be part of this mission, and they're -- again, they are back on the field for the first time in 18 months.

We're also seeing wellness visits starting to improve. They're not back to normal yet. They're probably down 10% to 15%, but trending in a good direction. All that speaks to a very exciting year next year for Cologuard.

And relating to your question about our M&A philosophy, our first priority is to focus on Cologuard and to continue to grow as we -- as the pandemic abates. We're thrilled with the position that we're in heading into next year and strong performance we've seen that the team have as they have come back to the field following the abatement of the Delta variant. So we're excited about that as we head into next year.

There are other highlights for next year, the multicancer readouts, Cologuard 2.0 data and our CRC blood program and our minimum residual disease. So we have teams that are excited about delivering on the promise of end-to-end testing and being the platform and the solution provider of choice for cancer screening and cancer testing.

If something contributes to our long-term strategy and there's a good cultural fit, we can leverage this foundation that we built to help more patients. We'd consider it. Our first priority right now is to focus on the basics of our business and growing, and we're excited about that opportunity as we look at 2022.

We have our next question coming from the line of Catherine Schulte with Baird.

I guess just looking at your fourth quarter guidance, it looks like it implies about 6% to 8% year-over-year growth in screening revenue in the fourth quarter. Just given you're so early in terms of adoption, and I would think the environment shouldn't be worse than the fourth quarter last year, why shouldn't that growth rate be better? And does the guide incorporate any assumption around another potential wave of COVID cases?

Catherine, this is Jeff. If you look at the COVID cases, they are still very elevated, and the access to physicians is still very muted. I think, right now, the access is probably 50% of what it was before the pandemic. So that's still heavily built there. I talked about intra-quarter in Q3, and that is what the guidance assumes. It's the impact that we've already seen.

As far as going forward, we do not assume another spike, then COVID happened. COVID, as you know, is very difficult to predict. So we've assumed a continuation of the trends that we're currently seeing, which is slow and steady abatement of COVID cases and continued modest improvement in -- both in access and in patient one-off visits.

We have our next question coming from the line of Dan Brennan with Cowen.

Mr. Dan Brennan, your line is open. You may ask your question.

Why don't we move on to the next question? We'll come back to Dan.

We have our next question coming from the line of Dan Arias with Stifel.

Kevin or Jeff, on the outlook here, I know you're going to tackle 2022 in the guide next quarter, but I was kind of hoping we could maybe just touch on the beginning of the year again. And the reason I ask is because I know seasonality is a factor for you guys in 1Q. So as we think about the 4Q to 1Q transition, is Cologuard acceleration in 1Q the right way to think about it because you're still COVID constrained in 4Q? Or is that less likely to happen just because of the way that things typically start off for you guys in the first couple of months of the year?

Dan, this is Jeff. In a normal year, when you look at the impact from seasonality, the impact on revenue is larger in Q1 than Q4. So it's been normalized. Going forward, you should expect a sequential decline in Q1 revenue versus Q4 for Cologuard. There's a lot of moving pieces now. We're not prepared today to guide to Q1. But look, the trends that Kevin talked about are very exciting.

I would add to that. But when you look at other growth factors that we've talked about before, things like 3-year rescreen, tracking well above the prior guidance we had to put out there, well above $100 million, and expect significant growth next year from rescreens, 45 to 49. That launch there is going exceedingly well.

As Kevin mentioned in his remarks, coverage has picked up meaningfully. In fact, if you look at 45 to 49, the early pace of adoption is tracking faster than the initial launch of Cologuard did in the 50-and-over population. So really good spend there.

And last thing, I would add electronic ordering. Today, we're up to 48% electronic ordering. That compared to 40% at the start of the year. And when somebody -- when a physician orders electronically, they order far more than when they order via fax. So these are all very good trends that speak to a very exciting '22 for Cologuard.

We have our next question coming from the line of Andrew Cooper with Raymond James.

Maybe first, just...

Andrew, are you there?

Can you hear me?

Now we can.

Sorry about that. I don't know what was going on, but maybe just asking the near-term question a little bit differently. When we think back to last year, there was definitely some impact in 1Q despite COVID really not turning on in the U.S., more so into March. And then 2Q and 3Q, it feels like there's a little bit of a difference in sort of the lag that we saw then as opposed to the sequential move in the fourth quarter. So is there any way you can just sort of help balance maybe what's a little bit different now relative to then? Is it just the seasonality? How should we be thinking about why it might look obviously a little bit different from a trajectory standpoint?

The biggest difference would be seasonality, Andrew. In the initial spike of COVID, it happened kind of the back half of March and into April. This time now, we're talking about like heading into Q4. So seasonality is going to be the biggest difference. Seasonally, the time period of kind of February, March, April, May is normally -- is very strong time for Cologuard orders. Sitting here now, we're heading into Thanksgiving when orders do decline. It's really because around the holidays, fewer patients go in for physicals. And then Cologuard is typically ordered during a physical. And so 30 days later is when you start to see a big impact. So it's a combination of Delta variant being a very significant spike in COVID cases and then you layer on top of that seasonality.

We have our next question coming from the line of Puneet Souda with SVB Leerink.

Just a brief very quick 2-parter. On the 20,000-patient update, just wondering if this is more of a class effect. There are 2 trials in the space that have now increased enrollment so far. Is there something about the event rate that you don't see that earlier on in the trial? And just trying to understand the dynamic there. Is this something you could have seen potentially earlier? And then just for Jeff, the sales rep as of today, how many are -- would you say what percent are in person? And apologies if I missed that.

For the first question, yes, we believe that other aspiring entrants into this space, and we are experiencing the same dynamic that the overall prevalence rate of colon cancer appears in our studies to be significantly lower than it was in the DeeP-C study. There could be many reasons for that, but that's what we're seeing. And because this has been event-based study that stops enrollment once you get through a sufficient number of patients with disease, that's what is driving the need to continue enrollment.

Puneet, this is Jeff. On your second question, I believe you asked on sales force access to physicians. Today, it's about 50% of what it was prior to the pandemic starting.

We have our next question coming from the line of Patrick Donnelly with Citi.

Kevin, you touched a little bit on the catalyst set for '22 on some of the other products. Can you dive into a little bit what we should expect in terms of timing? You touched on the multicancer. BLUE-C obviously sounds like it will be maybe late '22 in terms of the data. And then secondarily, with the BLUE-C data going, when do we expect Cologuard 2.0 on the market and commercial?

Well, Cologuard 2.0, we -- as I mentioned, we expect to complete that study and complete testing by the end of next year or the beginning of 2023. We will then need to submit to FDA, and I don't want to -- the FDA is awfully busy. So we'll see how long that takes following submission. It's -- in terms of the data supporting our belief that test will be -- will improve both sensitivity and specificity performance, we expect to present that data in January.

Multicancer screening, we expect 2 different readouts of case-control studies throughout the year. We haven't yet decided when we would present that data or how we would present that data, but that will occur in 2 different rounds of testing, one early in the year and another a little bit later in the year.

Minimum residual disease testing will be most likely in the back half of next year. Data on ONCOGUARD liver was published August 13. We touched upon that a little bit earlier. And then also, our PFS Genomics team expects to present data at the San Antonio conference coming up here in early December. So lots of -- I'm not sure I covered all of it, but that's best I can do for memory. Lots of data coming next year highlighting the significant and exciting investments that we're making from early cancer all the way through minimum residual disease testing.

We have our next question coming from the line of Mark Massaro with BTIG.

Just one quick one. Kevin, if you could just maybe clarify your comments on the MRD initiative. I think I heard you just say you're expecting data to read out in the second half of next year. And can you clarify, I think you said 700 patients in your prepared remarks? And frankly, when -- what's the earliest time that you think you could launch this? And I would assume that you're planning an LDT.

We are planning an LDT. The data that we release next year is not from the CORRECT-MRD II study. It's from another study, which I haven't yet highlighted in -- and we are also doing that CORRECT-MRD II or NSABP study. So that will be additional data. And we're working on other studies as well. So the initial data will come from a separate study. Does that answer your question?

We have our next question coming from the line of Brandon Couillard with Jefferies.

This is Matt, on for Brandon. One for Kevin or Jeff. Curious your updated thoughts on when we may potentially return to more normal levels of in-office access. Or is there a possibility of a sort of new normal going forward in the next few quarters? And can you touch on the various tools you guys have at your disposal and the scenario of this kind of new normal in 4Q and then into the first half of next year?

The team is doing a great job of getting into offices. And so things are opening up. That's a real positive. We're seeing the signal again. October was a great month of growth month-over-month. We expect that to continue. Many offices want reps back in. They have missed having reps in the office. And you really see it now as physicians are trying to get their HEDIS scores and their Stars scores up, they're calling and asking for help. We've had a significant number of what we would call bulk or program orders of practices that want dozens, hundreds and, in some cases, over 1,000 people screened all at once. So the signal is good.

And remember, we've had 250,000 physicians order Cologuard since launch. So we know there are physicians that we can get access to. The key things that we're back out in the field, because of the pandemic and because we were -- our partnership, they made decisions that were slightly different than ours in terms of field access. And that team now being part of our team has full access to the field, and they're getting access to physician offices. And face-to-face visits are now up over, I think, 70% of all business that we're doing. And that's with the principal health care providers. So we're getting to offices.

Another point that I find -- we find compelling as we look at next year is the fact that if you segment our customer base to the bottom 60% in terms of ordering frequency, they are ordering at a rate of about 50% higher than they were prepandemic. Now these are physicians that typically we don't call on. The power of the Cologuard brand is evident there. Our more -- our better customers order Cologuard more frequently. Their ordering rate is down about 15% prepandemic. They are the most sensitive to promotion. And so as we get now 850 people back out in the field, calling on the top 40% of ordering physicians, we expect to see a tremendous growth in 2022, and we're excited about that.

We have our next question coming from the line of Jack Meehan with Nephron.

I had 2 follow-up questions on liquid biopsy. The first is in BLUE-C. Why is the timing of the blood readout later than that for Cologuard 2.0? And then second, Kevin, you commented that you think going from case control to prospective, the blood performance in colon cancer would drop more than what you showed in stool. Could you just elaborate on why you think that?

Yes. Sure. The first question again? I mean of colon blood versus Cologuard 2.0. The key thing there is that when you enroll a patient into the study, you're asking for stool and blood. 20% of the time, they provide stool but not blood. And this is indicative of something that we have known for a long time is patients prefer getting screened with an at-home test than getting a blood drawn. We think that, that is a powerful indicator of where the market is long term. We believe that the 2 leading tests will continue to be colonoscopy and Cologuard. That is really the significant one. And then, Jeff, do you want to take the second point?

Yes. The second one really comes down to the biology of the colon relative to the biology of the blood stream. With the stool, a stool goes to the colon, it has come in direct contact. This is important, direct contact with polyps in small early-stage cancers and full-blown cancers. And so the stool is in more of an enriched sample type, and that's why we can find through a stool sample very high levels of both precancer and early-stage cancer.

In blood, you think of how they use the biology of the colon works. Early-stage colon cancers generally do not protrude out into the outer walls of the colon, and that's by design, to keep its wall from getting [infected]. It's not at all an (inaudible) prove-out. It's typically a late Stage II to Stage III where it protrudes out into the outer layer of the colon, where there's muscle. That's within the blood supply. That's when you can start to more reliably pick up colon cancer in a blood sample. So there's some of that comes on to the biology differences between a stool sample and a blood sample, which is what gives us confidence with Cologuard 2.0 and beyond. We will have more [factors, not a bit to] test out there.

And to add on to that, in the DeeP-C study, we saw 40% of all cancers being Stage I cancers. About half of those, 20% are typically removed during the colonoscopy procedure because they're embedded in a large polyp. Case-control studies don't have access to those patients because the polyp is removed already. The cancer is gone prior to surgery, so collecting a blood sample can't be done. And that's why we see in blood studies a strong bias towards higher sensitivity for Stage I than you would typically see in a prospective study. Obviously, that's not the case when you collect a stool sample before a prospective Cologuard-colonoscopy comparator study. So these are the types of things that we all deal with when we're looking at case control studies, and then you have to do internal modeling to figure out where the ultimate sensitivity will be. And that's where we come to the conclusion with our program that, that sensitivity probably drops because of that Stage I dynamic.

We have our next question coming from the line of Dan Brennan with Cowen.

Apologize about before, Kevin and Jeff and Megan. Maybe the first one, just on Pfizer, I know you talked about -- Kevin, I just heard -- kind of read the notes already expecting a nice impact as we head into '22. Any way to think through just how impactful it could be? I mean certainly having the work we did when the deal was first signed was that Pfizer reps having the relationships can really drive a lot of usage. So I'm just trying to think through just any way to help quantify just the magnitude of the benefit now having the salespeople as part of the exact once things kind of normalize with COVID.

Well, there's always reason to be cautious as we're coming out of the pandemic. We don't know what's around the next corner. With that said, this is an amazing sales team that we have built. In primary care, our historical team, combined with the team from Pfizer, OB-GYN, GI. And our Net Promoter Score has increased from 24 a year ago to 40 today. That's among primary care physicians. That's a big deal, which is telling you that the -- this dynamic of Cologuard getting a lot of attention during the pandemic when screenings were uniformly down is having an impact now on how physicians think about Cologuard. And now getting this team back into the field where we know the frequency of calling absolutely correlate in a straight line with Cologuard test orders, especially among those -- our better customers.

So when you look at those dynamics, there's every reason to be optimistic about 2022. In terms of quantifying that, we'll have an opportunity to do that as we enter next year. I'd love, Dan, to give you a number, but I think Jeff would not be happy with me if I did that.

We have our next question coming from the line of Alex Nowak with Craig-Hallum.

Great. Already a number of MRD tests out there in the market, and they're already going into additional cancers and CRC. So I just want to understand a bit better how you're positioning your recurrence test uniquely despite not being the first-mover advantage there. Does it come down to the sales team? And then, yes, does it come down to the sales team? Or I guess what else are you trying to do to make that test unique when it comes to the market?

I think if you look at this long term, you look at where the customers start their journey. In colon cancer, many of them start with Cologuard. And so we have a relationship with the physician. In breast cancer, we're seeing almost half of all breast cancer patients and their tissue samples. So we have a deep relationship, and the starting point of the tissue that would be the starting point for a tissue informed test.

We also are unique in that we have deep methylation capabilities. So we have the ability to do both tissue informed and blood-based native testing with MRD, which nobody else has that type of combined capability. And we also can leverage -- and we're excited about this -- the technologies that come from our acquisition of Thrive in this field, giving us great scientific capabilities.

And then in addition to all of that, our infrastructure, our Epic IT backbone allows us to connect from this initiation of testing all the way through ultimately options presented for treatment based upon the data that's generated. So we believe that this is -- we're obviously not first in this space. But over the long term, we have great strengths that will allow us to lead.

We have our next question coming from the line of Kyle Mikson with Canaccord.

So just had a multiparter, a very simple one, though. So on sales force, just wondering what the productivity trends were that you're assuming in the fourth quarter guidance. I guess just like -- just for that context, the 9,000 providers added in the third quarter, then access is still, I guess, 50% of pre-COVID. And then similar to that, I guess, there's a broad range of companies trying to break into screening or even different cancers, just obviously the benefit from your sales force and network of provider relationships really helped. So would you ever consider maybe offering a portion of your sales force on like a temporary contract basis maybe to competitor and whether it's screening or, again, monitoring things like that?

And finally, I just think this is an important question to kind of ask and to think about, with all these pipeline tests being launched in '23 and '25, that kind of time frame, there's a lot of long-term potential, obviously, what's going to be the most exciting, I guess, think about Exact between now and then from an investor perspective?

This is Jeff. I'll start. So on the sales force productivity trend question. Look, we have high expectations for this team. We know what they're capable of, and this broader team now is getting back into the field more fully relative to where we were at in August and September. So I expect productivity to improve throughout the rest of this year and into next year. So that's probably the biggest driver for the Cologuard business going forward.

On the second question, would we consider -- I think the question is co-promoting another project. We would. We love what we have internally with the [broker deal] capability, the IT platforms we have, the marketing engine that we have. This is something that we'll only get more productive as we add other products to it. And we still have a full pipeline, as Kevin talked a lot about that, the same foundation we've established for Cologuard down the road will support Cologuard 2.0, multicancer, colon blood, other products. And so that will allow us to leverage this and not only improve the productivity, but also improve the profitability of this investment. So we would consider it, although the level what we have internally.

Last on the busy time frame 2023 through 2025, what they said -- I'll answer for myself personally, I think it's the breadth of opportunities we have are really unsurpassed in this space. Internally, we've talked a lot today about the growth of Cologuard, the growth our Oncotype franchise. We also have a robust pipeline, and you hit on a really busy period for Cologuard 2.0, multicancer, MRD. That's going to be a really exciting next few years.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.