Exact Sciences - Earnings Call - Q3 2012

Transcript

Operator (participant)

Good day, ladies and gentlemen, and welcome to the Exact Sciences Corporation third quarter earnings conference call. At this time, all lines are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. If anyone should require assistance throughout the conference, you may press star and then zero on your touch-tone telephone. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Brad Heiss. Please begin.

Brad Heiss (Head of Investor Relations)

Thank you, and thank all of you for joining us for Exact Sciences third quarter 2012 conference call. On the call today are Kevin Conroy, the company's President and Chief Executive Officer, and Manish Arora, our Chief Operating and Financial Officer. Exact Sciences issued a news release earlier this morning detailing our third quarter 2012 financial results. If you've not seen it, please go to our website at exactsciences.com or call 608-807-4607, and I'll provide it to you. Following the safe harbor statement, Manish will provide a summary of our third quarter financial results. Next, Kevin will provide an update on the Deep-C clinical study. Before we get underway, I'd ask everyone to take note of the safe harbor paragraph that appears at the end of the news release issued this morning covering the company's financial results.

This paragraph states that any forward-looking statements that we make are, one, speak only as of the date made, two, are subject to inherent risks and uncertainties, including those described in our most recently filed annual report on Form 10-K and our subsequently filed quarterly reports on Form 10-Q, and three, should not be unduly relied upon. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein or elsewhere to reflect our change in our expectations with regard thereto, to any changes in events, conditions, or circumstances on which any such statement is based. It is my pleasure now to introduce our Chief Operating and Financial Officer, Maneesh Arora.

Maneesh Arora (COO and CFO)

Thank you, Rod, and good morning, everyone. We are very pleased to report that patient enrollment for our Deep-C clinical trial will close in two weeks on November 15th. Kevin will provide a complete update on the trial and our FDA submissions in a moment. As the clinical trial concludes, we're continuing our efforts to make the company ready for commercialization of the test once it's approved by the FDA. These efforts are on track and will intensify as we approach FDA approval. We remain on track to meet our full year 2012 cash utilization target and narrow the guidance range for cash utilization to $42 million-$43 million. Our cash balance at the end of the third quarter was $118.6 million after we raised $57.8 million during the quarter. We now anticipate a 2012 year-end cash balance of between $108 million and $109 million.

It's now my pleasure to introduce Exact's President and CEO, Kevin Conroy. Kevin?

Kevin Conroy (CEO)

Thanks, Manish. First, before we get underway here, I'd just like to express on behalf of the entire team at Exact Sciences how concerned we are for all of those friends and colleagues of ours affected by Hurricane Sandy, and we hope that you and your families are safe and recover quickly from this devastating storm. Today, we would like to talk about five things. First of all, our recent cutoff study data. Secondly, an update on FDA and CMS. Third, an update on our clinical trial. Fourth, an update on how we plan to pursue our test commercial opportunity. And finally, a new opportunity that we see in screening in patients with inflammatory bowel disease.

We are very pleased to see the performance of the test in a large study showing 98% cancer detection in that study, 83% detection of high-grade dysplasia; we'll talk about high-grade dysplasia shortly, 57% detection of precancers greater than or equal to 1 centimeter, and 90% specificity. This data is the third consecutive study over the last three years showing that this is a test with great performance. I would like to drive home the point that point-in-time sensitivity is not the most important part of this test. Clinically, the impact of this test will be felt from repeated screening and the cumulative sensitivity, like the Pap Smear, of detecting precancers which take a long time to develop and turn into cancer. This study was conducted on 1,003 patients, a very large and statistically significant population. It exceeded our expectations.

It's important to note that the data was generated from samples processed on the very automation system that we're using in the Deep-C Study. Again, it detected 83% of high-grade dysplasia. This is very important because the majority of these precancers progress to cancer. Finally, the cutoff method that was established in this study has been locked down, submitted to the FDA, and will be used in the Deep-C Study. Another important aspect of this data is that we see a significant increase in the sensitivity of the test as the size of the polyp grows from 1 centimeter to over 3 centimeters. This is important clinically because as a polyp grows in size, the risk of progression to cancer increases. Over time, as a polyp grows, our test is better at detecting. This is an important part of increasing the programmatic sensitivity of the test.

Now, taking a look at the detection of the test in cases of high-grade dysplasia and cancer, high-grade dysplasia is a condition that occurs and typically takes two to five years to progress to cancer. The goal is to detect as many of these high-grade dysplasias before cancer as possible. As you can see, the sensitivity of the test there is extremely strong. Our members of the scientific advisory board were very impressed with this level of sensitivity, and we're pleased that this should have a very significant impact clinically following approval of this test. Now, turning to an update on the FDA and CMS, I'm pleased to report that the company made a pre-PMA submission to the FDA, and we held a joint meeting with FDA and CMS following this meeting.

Agency comments have been incorporated into these submission plans, and we expect to pursue a modular submission that is a sequential submission of the manufacturing, analytical, and clinical modules. We also expect an expedited review. With CMS, we have worked very closely with both their coverage and payment groups, and we expect a national coverage determination to be made in parallel with FDA submission, leading to coverage, coding, and payment decisions within three months of FDA approval. This parallel review, we believe, differentiates us from other diagnostic tests and many other medical devices in that we expect to have FDA approval and CMS reimbursement, broad reimbursement, shortly after FDA approval and at the time of launch. This is important because nearly 50% of our intended patient population are covered by Medicare. This is unique for a molecular diagnostic to have such broad reimbursement at the time of launch.

Typically, private payers follow the inclusion of a test on the Medicare fee schedule. Further, the ACA mandates insurance coverage for screening tests that are rated either A or B by USPSTF, and we expect that the USPSTF will evaluate our test in the 2013 to 2014 timeframe. Now, turning to an update on our clinical trial. We expect to complete enrollment on or about November 15th. Today, we have had over 12,000 patients enrolled at 87 sites in 28 U.S. states and one Canadian province. Fifty cancer patients have been enrolled to date, and more are likely. There are over 1,500 patients that are in process for which we do not have colonoscopy or pathology data on yet. More cancers are likely from that patient population. We also expect to have over 700 precancerous polyps in the study or 700 precancer patients in the study.

This trial is one of the largest, most well-powered colon cancer screening trials ever conducted. This will put us in a very good position with FDA, CMS, and private insurers, and most importantly, physicians and patients. This team has shown incredible devotion to the cause to achieve our enrollment goals. As I mentioned a moment ago, we are very pleased with the results of our most recent validation study, which were announced earlier in October. These results give us great hope going into the Deep-C pivotal study testing. During late August, September, and October, we saw few new cancer patients enrolled into the clinical trial. Immediately, we made plans to enroll approximately 2,000 additional patients into the study. We have seen a significant increase in the number of cancer patients enrolled recently.

Today, we have approximately 50 cancer patients and are waiting on colonoscopy and pathology reports for an additional 1,700 patients. We have made two decisions that will push out the date of the data read. First, we made the decision to continue enrollment through November to maximize the trial's power. Secondly, after discussions with our statistical consultants and the agency, we made the decision to test all of the patient samples rather than a randomly selected portion of the over 10,000 normals as we had previously planned. By testing all of the patient samples, we reduced any risk of perceived bias in the trial. This, however, will take additional time and resources to complete. Though we realize that the delay in investors seeing the data is not optimal, we expect that these delays will push back submission of the final module by only 30-45 days.

We do not anticipate that this will materially affect the PMA review or approval timeline. FDA and CMS are both devoting significant resources to this project, and we anticipate making a high-quality FDA submission and CMS application. Our first module, the manufacturing module, will be submitted to the FDA in December as planned. Because of the two factors I've just described, our second analytical module will be submitted in February. We now expect to announce top-line results of the trial in March. Three submissions will follow the announcement of the top-line results. First, we will submit the final module to the FDA, which is the clinical module. Second, we will make our application to CMS for Medicare coverage of our test. Finally, we will submit manuscripts to peer-reviewed publications that we expect to be published in 2013.

While this timeline deviates from our original expectations, we don't believe that it will have a material effect on the timing of commercialization. Let's turn now to a new opportunity the company will pursue. Let me revise that. Now, let's turn our attention to our commercialization plans. First of all, we have decided to focus at launch on the highest impact group, and that is the 400 largest hospitals and systems that cumulatively employ about 40% of primary care physicians so that we can maximize our access to patients. These large hospitals and group practices make system-wide screening decisions. In other words, they choose which products will be used by their patients, whether it's colonoscopy or gFOBT or FIT. They also employ their own screening programs using techniques such as electronic reminders and mailers to get patients into the screening population.

Typically, they only offer one fecal test, a non-invasive test, not multiple tests. It is also important to note that over the last several years, the FIT test has rapidly penetrated the gFOBT market. Despite the FIT test's minimal increase in sensitivity, the FIT test is about 65% sensitive for cancer detection, whereas the gFOBT test is approximately 40% sensitive. This minor increase in cancer sensitivity has still generated an increase in penetration from 200,000 tests to 3.4 million tests and growing. Neither of these tests are particularly sensitive for precancer detection, both at or below 20% precancer sensitivity. By and large, they do not help in the prevention of cancer.

We believe that our test will outperform both of these tests, and we plan to aggressively pursue displacement of gFOBT and FIT testing in those institutions that employ large numbers of primary care physicians. Further, we are very focused on the 8% of the known primary care physician prescribers that generate 60% of the gFOBT and FIT test volume. We know who these physicians are, and part of Laura's commercial strategy is to focus intently on those physicians. Now, moving to a new opportunity: the detection of colon cancer and precancers in the inflammatory bowel disease population. This population includes patients with Crohn's disease and ulcerative colitis who suffer from a significant increase in a lifetime risk of colon cancer. It is a major, actually a leading cause of death in these patients. Inflammation obscures lesion detection by optical colonoscopy.

The test that we will deploy into this market uses our current markers and testing system. In one study by Mayo Clinic on a small sample population, there was 100% cancer sensitivity and 80% precancer sensitivity at an 89% specificity. We believe that this is a significant market opportunity because today, about half of patients with IBD won't get screened. They get what is called colonoscopy fatigued. It is clear from the key opinion leaders that they seek any improvement in IBD cancer surveillance because of this problem. Today, the main method for screening in these patients is to use colonoscopy, but rather than relying on optical colonoscopy, the standard is to take multiple biopsies and hope that you are able to biopsy the exact location of the precancer or cancer.

We have formed an advisory group of key opinion leaders that have looked at the data and our plans for this test. A protocol has been drafted. We are currently planning to get IRB approvals by the end of this year and begin enrolling patients in Q1, looking for 300 IBD patients, 30 with cancers and 20 with high-grade dysplasia, with 250 controls without dysplasia or cancer. We believe that this is a new, better solution to IBD patients for colon cancer screening, and we look forward to bringing this test to market. Today, there are over 1.4 million patients diagnosed with IBD, and some estimate that IBD patients comprise 1%-2% of the U.S. population, with 30,000 new diagnoses every year. The peak onset age is at age 15 to 30, with annual colon cancer screening recommended eight years after diagnosis.

There are only approximately 500 IBD specialists who screen about half of these patients for colon cancer, and so it's a very targeted audience for us to launch this test into. In conclusion, we see a major market opportunity for this test. It's a unique and patient-friendly product that directly addresses an underserved market. Not enough people are getting screened for colon cancer, and we believe that this test will increase the number of patients and the percentage of patients who are willing to be screened. The robustness of this test has been confirmed now through three separate studies. We have, again, one of the largest and most highly powered clinical trials ever for a prospective colon cancer screening study. The importance of the parallel review by Medicare and FDA can't be overstated, and we have a very focused commercial strategy focused on getting rapid adoption of this test.

In closing, I'd like to thank the entire team here at Exact Sciences who have worked tirelessly to make sure that we have this product available in a timely way so it can be most impactful into the market that we intend to pursue. Thank you. Any questions?

Operator (participant)

Ladies and gentlemen, if you have a question at this time, please press star then one on your touchstone telephone. If your question has been answered and you wish to remove yourself from the queue, simply press the pound key. Again, ladies and gentlemen, to ask a question, simply press star then one on your touchstone telephone. Our first question comes from Brian Weinstein of William Blair. Please go ahead with your question.

Brian Weinstein (Managing Director of Medical Technology)

Question. Kevin, you talked a little bit about kind of a 30-45 day delay here.

Can you just talk about why you don't expect that would result in a delay to FDA approval and go through that again? What is your expected timeframe for FDA approval? Thanks.

Kevin Conroy (CEO)

Sure. Because of the sequential submission to the FDA, they will be reviewing first our manufacturing module and then the analytical module before getting to the clinical module. On the last call, we had said that we expected to submit both the analytical and clinical modules at the same time. That would have required the FDA to sequentially review those modules internally. We think that the submission, based on our discussions with the agency, the submission of a clinical module, and they would prefer to see the submission this way separated from the analytical module. That gives them time to first look at the analytical module, then examine the clinical module.

This should not have an impact on the ultimate approval timeline. As you may recall from our days at Third Wave Technologies, we had a similar, towards the end of that trial, we had a couple of months' delay in the data readout, but ultimately, FDA approval occurred in about nine months. Our feeling here, and there are no guarantees of this, but our feeling is that the attention level to this submission could not be higher on both the part of the FDA and CMS. We expect to submit an incredibly high-quality series of submissions. Our engagement level with the FDA and the number of turns on the, or the number of discussions that we have had leading up to these submissions, give us confidence that this will occur rapidly after submission to the agency.

Now, with that said, we do not plan on giving guidance as to when FDA approval occurs, although we will continually update investors qualitatively as to how the submission process is going along.

Brian Weinstein (Managing Director of Medical Technology)

Okay. That's helpful. And then how should we think about high-grade dysplasia here? Maybe you can kind of go through the importance of it and how it will be used in kind of a clinical setting and is an indication of disease. And then is it actually included in the Deep-C Study? Is it one of the kind of formal endpoints, or is it something that we'll just get a readout on? Thanks.

Kevin Conroy (CEO)

Yeah. So it's the latter. High-grade dysplasia is not part of the formal endpoint. Other than high-grade dysplasia is a subset of precancers. So high-grade dysplasia can occur in small polyps or large polyps, although it's much more frequent in larger polyps.

For example, with a 5 mm polyp that has high-grade dysplasia, that is included as one of our precancers. That's one exception to the 1-centimeter rule, that if that precancerous polyp shows signs of progressing further, and it's a pathology determination of having features of high-grade dysplasia, which simply means that starting to look more and more like cancer, that is included in the study. The importance clinically of this is that even small polyps, 5 mm polyps with high-grade dysplasia, are likely to progress to cancer. They're the riskiest polyps. It's really important to be able to detect these at a high level. Now, remember, optical colonoscopy, we know from the various back-to-back colonoscopy studies, only detects about 65%-75% of polyps.

This is a test that is probably quite similar to colonoscopy, maybe even a little bit better in identifying patients with those high-grade dysplasia precancers. We think this will be a powerful and motivating aspect of the adoption of this test, the high reliability of detecting these polyps.

Brian Weinstein (Managing Director of Medical Technology)

All right. Last thing for me is how easy do you think it's going to be for labs to bring on the instrumentation here once you get commercialization? What specifically are they going to need to kind of think about purchasing and any idea of kind of what that upfront total capital commitment is going to be?

Given that you're going after the large systems, will a large system be able to kind of handle what could be kind of an immediate surge in test volumes, or do you think that you'll have to do something in terms of supporting that?

Kevin Conroy (CEO)

Typically, it takes labs three to six months to bring on any new instrument or system. Let me take a step back. One of the most important strategic decisions we made was to pull our instrument program forward because the automation of this test was critical. As you know, last year, we were able to do that, meet our cash guidance, and then perform the testing on the product this year, on the assay this year on that automation platform.

We were really thrilled this summer when we generated data showing the kind of sensitivity for cancers and precancers on that automation platform. We are seeking a PMA approval on this platform, which means getting this platform into the clinical lab will be a relatively straightforward process. People are familiar with this type of automation, and they are very familiar with the utilization of it in a high-throughput setting in these labs. The value proposition to them is significant because they can generate about 43 results per shift. The automation focuses on the back end of the process, not on the front end. It really takes away all of the fine pipetting steps.

The impact to us as we go to launch this is that we will be prepared with our own lab to take on the surge in volume that we expect following the significant awareness that we expect to create around this test following FDA approval and CMS coverage. We need to be prepared for that surge in volume because if we were to get a significant number, tens of thousands of tests right away, we can't miss there. We do plan to have our own clinical lab and other lab partners available at launch to meet that demand. Does that answer your question, Brian?

Brian Weinstein (Managing Director of Medical Technology)

It does. Thank you very much.

Operator (participant)

Our next question comes from Jeff Elliott with Robert W. Baird. Please go ahead with your question.

Jeff Elliott (Senior Equity Research Analyst)

Just quickly on Deep-C enrollment, any guess on why you did not see the number of cancers you had expected through third quarter?

Kevin Conroy (CEO)

Jeff, this has been consistent throughout the trial that we tended to get cancer patients in groups. Early on, we saw a significant number of cancers, and then we saw a dry spell, and then we saw another uptick. Unfortunately, we saw another dry spell in late August, September, and going into this month. Just recently, we saw a significant number of cancer patients all within the same week. The good news here is that our goal was to get to 49. We are now at 50. I always say approximately 50 because patients can later be determined that it was not colon cancer or it was a metastasis from another organ. We need to be careful about that.

We're at 50 today with another likely, if you just look at the statistics, another seven or eight that we should see with the additional patients that we can enroll. Now that could be 5, or it could be 10, or it could be 0. If it's 0, we still have a study that is sufficiently powered as we previously planned. It did take more patients than we anticipated as recently as early August, but that is just part and parcel with running one of these studies. I think the thing that I'm most impressed with is how closely the team monitored this, and they put plans in motion very quickly to increase the number of patients into the study to take away any risk. At the end of the day, the impact on FDA submission is not material.

Jeff Elliott (Senior Equity Research Analyst)

Okay. It was really just random.

There were no issues with the trial. It just completely depended who walked in the door that day.

Kevin Conroy (CEO)

That's right. We have no control over whether a patient who is scoped has cancer or not. As expected, they don't happen in every week. You don't get one new patient. They tend to happen more in clumps.

Jeff Elliott (Senior Equity Research Analyst)

Okay. Just to follow on one of Brian's questions, you mentioned you were going to be prepared kind of at the get-go with Cologuard with your own lab. Can you talk about what kind of investments you'd have to make to prepare for that?

Maneesh Arora (COO and CFO)

Sure. At the end of the day, as Kevin said, this is not equipment, materials, CapEx that is out of the ordinary or unusual.

The investments required are going to be in the millions, a couple of million dollars that we would need to invest during 2013, but it's not going to be a material departure in a massive facility or manufacturing. You're not going to see huge CapEx. We think that with a concentrated facility along with lab partners, we'll be able to meet the demand at launch.

Jeff Elliott (Senior Equity Research Analyst)

Got it. Okay. And then just one last, if I could. The commentary on IBD is very exciting here. I'm just curious about what kind of additional R&D work or additional cash expense would you require in 2013 to bring that to market?

Kevin Conroy (CEO)

One of the things that's so exciting is this is the first extension and expansion of Cologuard, and the IBD opportunity is really a product of the R&D efforts and investments that we have made.

The most significant investment is going to be in the clinical validation. We are beginning those clinical efforts now, but as you can see from the end of this study of 300, it's nowhere near what we have just completed. We would anticipate the number at a couple of million dollars as opposed to the significant investment in the clinical study for Cologuard, but no material other R investments in developing the product. This is a product that we think we have through our Deep-C, excuse me, through our Cologuard development.

Jeff Elliott (Senior Equity Research Analyst)

Very good. Thank you.

Operator (participant)

Our next question comes from John Wood of Jefferies. Please go ahead with your question.

John Wood (SVP and Senior Research Analyst)

Hey. Good morning.

Operator (participant)

Good morning, John.

John Wood (SVP and Senior Research Analyst)

Hey. So Kevin, I guess it's not clear to me.

Given the cancer patients you've already enrolled and then what's expected from the 1,700, why are you leaving the trial open through the 15th?

Kevin Conroy (CEO)

Because every additional cancer patient that we enroll into the study increases the power of the study. With the investment that we've made to date and the importance of the Deep-C study, every one of these additional cancer patients matters. We actually made this decision a long time ago that if we had the opportunity to overpower, we would. We do now, and we're just going to, particularly with the sequential review requested by the FDA, it just makes sense to get in as many cancer patients as humanly possible.

John Wood (SVP and Senior Research Analyst)

Got it. Okay. Risk management. Can you give us any updated thoughts?

It might be too early, but on the expected fee schedule placement here, what's preferred by the company, and then any qualitative guidance you can give us around expected value vis-à-vis that fee schedule placement?

Kevin Conroy (CEO)

Sure. There is a debate going on about where certain molecular tests are going to end up on the lab fee schedule or the physician fee schedule. We think that this product, in part because of the parallel review, does not fall into that category of typically tests that do not go through the FDA review process. We think that this test most likely would fall onto the lab fee schedule rather than the physician fee schedule, given that there is not a physician interpretation component to this test. We will continue to have those discussions with CMS, and we will provide as much clarity as we can to investors as we have those discussions.

Right now, we would anticipate the lab fee schedule. In terms of the value, we are doing all of the necessary work to provide CMS and private payers with the fact that this test is a rare product that adds value both clinically and from a cost perspective. The simple math around that is private payers are paying $2,500 roughly per colonoscopy, and three of these tests over a 10-year period would be significantly less than that. You are actually taking costs out of the testing system, and over the long haul, you are taking tests out of the treatment area, which is obviously very expensive. We are not providing specific guidance on where we think this test will be reimbursed by CMS, but suffice it to say it is in the hundreds, not thousands, and it will provide a significantly positive value.

John Wood (SVP and Senior Research Analyst)

Okay. Good color.

The follow-up to that is, what's your expectation around health economic studies, either in terms of getting them done or presenting them? And then can you have reimbursement discussions with private insurers earlier than approval? Just give us a sense of how you're going to pursue the private path vis-à-vis the expected approval and CMS coverage decision.

Kevin Conroy (CEO)

We have already completed the first round of our health economics work. We have spent a lot of time over the last 12 to 18 months on that, and that work has heightened over the last several months. We do not expect to disclose that or publish that in the near term. We continue to do additional work to refine the models, which have basically been somewhat out of date, and the new costs of treatment and the like need to be updated in those models.

We're working on those, and we plan to submit that to payers, potentially including CMS, in the raw format before publication. We expect that there, over time, will be multiple health economic studies conducted and published by the company or key opinion leaders over time. In terms of our reach into private payers, those discussions have already started. It's an important discussion to make sure that we have in place. We will target the narrower universe of private payers based upon size and by also those private payers that cover the patients that are served by the large hospital systems and group practices that we focus on at launch. Initially, at launch, we'll have a much smaller universe of private payers that we'll have to negotiate with. Over time that will obviously expand.

John Wood (SVP and Senior Research Analyst)

Okay. Great. One last one for Manish.

Any sense on how to think about just kind of the sales and marketing expense line item through 2013? I mean, anything you're willing to kind of talk about at this point in terms of the ramp of that line item throughout 2013 would be great.

Maneesh Arora (COO and CFO)

Yeah. So we're going to be ready to talk about that more on our next call as those plans and commercialization plans are being formalized. One way to think about it is you've seen this huge R&D line that's going to obviously drop, and the significant expense increase you'll see is sales and marketing. We don't anticipate that the sales and marketing increase will exceed the R&D line. You won't see a massive hockey stick in 2013. We want to be prudent about making significant investments in advance of both data and approval.

The way to think about it is we'll be able to make decisions on the S&M line after the top-line data. We'll provide more clarity on our year-end call, but then much more after we see that data. You'll see an increase probably in the Q3, Q4 timeframe.

John Wood (SVP and Senior Research Analyst)

Okay. What I'm hearing is if I look at the overall P&L, it's unlikely in kind of the current plan that the overall operating burn would increase materially, correct? Because basically what you're saying is S&M would offset the decline in R&D.

Maneesh Arora (COO and CFO)

That's pretty straightforward. That's probably a good way to look at it. The overall operating burn would not materially change.

John Wood (SVP and Senior Research Analyst)

Very good. Thank you.

Operator (participant)

Our next question comes from Raymond Myers with Benchmark. Please go ahead with your question.

Raymond Myers (Research Analyst)

Thank you. Good morning. My first question is the IBD study.

How long do you think that will take to complete enrollment?

Kevin Conroy (CEO)

That study currently we anticipate being started and completed within 2013, and we'll have a better read on that as we get through the first quarter.

Raymond Myers (Research Analyst)

Will that be the same sites or some subset of the sites that you're currently using now?

Kevin Conroy (CEO)

There is some overlap, but not 100% overlap. The focus on this study are the IBD centers that focus on seeing and treating IBD patients.

Raymond Myers (Research Analyst)

Okay. That makes sense. How many total patients do we now expect to enroll in the pivotal study? Is it 12,000 goes to 14,000? Is that the right way to think about it?

Kevin Conroy (CEO)

Approximately 12,500.

Raymond Myers (Research Analyst)

What would be the total number that you expect to enroll as of November?

Kevin Conroy (CEO)

Yeah.

We've enrolled just over 12,000 to date, and we expect another 500 or so patients over the next couple of weeks.

Raymond Myers (Research Analyst)

Okay. I think that about does it. Thank you.

Kevin Conroy (CEO)

Thank you, Ray.

Our next question comes from Zorak Kershit with Wedbush Securities. Please go ahead with your question.

Zorak Kershit (Analyst)

Hi. Thanks for taking the question, guys. Congrats on the parallel review. Sounds pretty good. My phone cut off midway. Just had kind of a simple logistical question. At this point, have any of the Deep-C samples been processed on the instrument, or is everything still kind of sitting in a freezer?

Kevin Conroy (CEO)

No. Good question. There will be three clinical trial sites, our lab being one of them. We actually already have a lab facility within our facility.

All of those samples will be assigned randomly by a biostatistician to those three sites, and they will be processed starting in December. It will take a few months, a couple, three months to process all that sample. There will be about a week of data analysis before the statisticians after unblinding, and then we will release the data to the public.

Zorak Kershit (Analyst)

Great. Just as a follow-up, thanks for the color on the 8% of docs or high-volume docs that represent a large fraction of the market. Just curious, where do they live or exist? Is it sort of are they within specific large networks or HMOs?

Kevin Conroy (CEO)

Laura.

Laura Stoltenberg (CCO)

This is Laura Stoltenberg. They're both within the large healthcare systems as well as we've identified them by zip code.

Zorak Kershit (Analyst)

Okay. Thanks.

Operator (participant)

I'm not showing any other questions in the queue.

I'd like to turn it back over for Kevin Conroy for closing comments.

Kevin Conroy (CEO)

Again, I'd like to end this as we started. There is a much bigger issue out there in the world right now, or at least in this country in the Northeast. Our concern for all of our friends and colleagues is deep. If there is anything that the people here on dry land can do to help out, please reach out to us directly. Thank you.

Operator (participant)

Thank you, ladies and gentlemen. Thank you for participating in today's conference. This does conclude the conference. You may now disconnect. Good day.