Rod Hise William J. Megan - Principal Financial Officer and Senior Vice President of Finance Kevin T. Conroy - Chairman of The Board, Chief Executive Officer and President.

Brian Weinstein - William Blair & Company L.L.C., Research Division S.

Brandon Couillard - Jefferies LLC, Research Division Jeffrey Frelick - Canaccord Genuity, Research Division Peter Lawson - Mizuho Securities USA Inc., Research Division Zarak Khurshid - Wedbush Securities Inc., Research Division Chris Lewis - Roth Capital Partners, LLC, Research Division Raymond A. Myers - Alere Financial Partners LLC.

Good day, ladies and gentlemen, and welcome to the Exact Sciences Corp. First Quarter 2014 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would like to turn the call over to Rod Hise. Mr. Hise, you may begin..

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 any change in our expectations with regard thereto or to any change in events, conditions or circumstances on which any such statement is based.

It is my pleasure now to introduce our Senior Vice President of Finance, Bill Megan..

Thank you, Rod, and good morning, everyone. With the publication of the DeeP-C data in the New England Journal of Medicine and a positive FDA advisory committee review, we have achieved 2 important strategic milestones.

We also continue to make good progress on our commercialization and launch plan for Cologuard, our noninvasive colorectal cancer screening test. Kevin will discuss each of these in more detail in a moment. From a financial perspective, a quick note on revenue.

During the past 5 years, our revenue has been comprised of the noncash amortization of upfront license fee payments paid to us by Genzyme Corp. related to a noncore intellectual property transaction completed in early 2009. These payments were amortized over a 5-year period that ended in January 2014.

During the first quarter, we used $17 million of cash, ending the quarter with $116 million. Our recent equity offering generated $138 million in net proceeds.

Our plan for the use of these proceeds includes continuing to work to obtain approvals from FDA and CMS, funding commercialization of Cologuard pending FDA approval and finally, funding our continuing product development work. Specifically, we have previously talked about hiring 50 sales reps to call on high prescribing FIT and FOBT position.

Because of our competence in converting these positions to Cologuard, we now intend to hire 80 sales reps to call on them at launch, with the number of reps scaling to 100 by the end of the year.

The total size of the sales force will then be approximately 140, including key account executives and sales support and management, plus roughly 20 in marketing. We believe this will help fuel our commercial success following Cologuard launch. We continue to be pleased with the progress that's being made to ready the Exact Sciences' lab for launch.

The IT system, lab equipment and lab processes are in place and are being validated by the team. In addition, we continue to invest in our R&D effort, which supports the future launch of Cologuard and our pipeline of new products. It's now my pleasure to introduce Exact's President and CEO, Kevin Conroy..

Thank you, Bill, and good morning, everyone. We achieved 2 very important milestones during the first quarter. First, the publication of our DeeP-C data in the New England Journal of Medicine. We've had great feedback on the Journal article from key opinion leaders, policy makers and medical societies in the United States and around the world.

Second, we're very pleased with the outcome of the FDA advisory committee meeting in late March. I want to thank everyone on the Exact Sciences team for their contributions to both accomplishments. We continue to work with the FDA to move approval of Cologuard forward.

As part of the parallel review process, we are working closely with CMS on securing coverage of Cologuard. We expect this process to be completed within 90 days of FDA approval. Now I'll talk about the strategy we're executing to launch Cologuard.

The Cologuard launch strategy is aimed at driving demand from physicians, promoting compliance among patients and securing payment from both Medicare and private payers. The strategy will be supported by public relations activities, advocacy, Cologuard marketing campaigns and a strong presence on the web.

In addition to devoting significant resources to physician and system outreach, we also will undertake an active medical education program. We also expect to expand on our New England Journal of Medicine data with additional publications that highlight Cologuard's advantages.

We intend to reach patients through direct advertising, public relations placements in print, radio, TV and digital and other efforts. These campaigns are designed to encourage patients to ask about being screened for colorectal cancer with Cologuard.

Once patients are aware of Cologuard, our customer service center will be another way we can educate them about screening and ensure that they are screened. On the payer side, we continue to work with the CMS parallel review process, which is a great advantage to the company.

We are building the capacity to obtain reimbursement from private payers once Cologuard is approved. Taken together, this is a comprehensive program that we believe will successfully raise awareness of Cologuard and drive its adoption. Let's now turn now to our target customer segment. Our commercial strategy targets 2 customer segments.

The first, is physicians who prescribe the highest number of FIT and FOBT tests. These are primary care physicians. The second is large health care networks and practice groups with centralized control of colorectal cancer screening. Based on our market research, we are targeting specific physicians based on our analysis of their FIT usage.

This research has shown that 5,000 physicians represent approximately 2 million FIT and FOBT tests per year. We will focus intently on converting this highly concentrated customer base to Cologuard, and data from our DeeP-C clinical studies strongly supports this conversion.

As a reminder, Cologuard outperformed FIT in the detection of cancers in Stage I and II by 94% to 70%. This significant performance difference for curable stage cancer highlights the superiority of Cologuard over FIT testing.

Even when lowering the cutoff value of the comparator FIT test to the low end of its measurement range, which is below the 100 micrograms per milliliter that is FDA cleared, the sensitivity of the FIT test improved only slightly. At the lower end of that range, the specificity of the comparator FIT test and Cologuard are similar.

We expect to see this data published in the future. As Bill mentioned, we are doubling the size of the physician sales force. As a result, we will be able to more actively address this significant opportunity among primary care physicians.

We believe these physicians will adopt Cologuard because of its superior performance and because of the added value that our compliance engine will provide to them and their patients. The second important customer segment is large practice groups and health care systems.

These large practice groups offer centralized decision-making for new screening methods. We will focus our initial efforts on the largest 200 of more than 1,100 group practices around the country that employ more than 125,000 primary care physicians. We've done extensive market research in this customer segment as well.

These large groups and systems are highly innovative and want the best tests available. They're looking for a highly-sensitive test that enables them to successfully address their colonoscopy-averse patients and other patient populations that they have difficulty getting screened.

Finally, they are dedicated to patient satisfaction and believe that Cologuard and our customer service center will help them deliver. Our lab and customer service center -- centers are key differentiators. Our goal with [indiscernible] is to make sure that Cologuard is easy for physicians to order and patients to use.

The 30,000 square-foot lab has the capacity to scale to 1 million tests per year. It is state-of-the-art and connected with our 24/7 customer service center, a big part of our patient compliance engine. Both the lab and the customer service center will be ready to meet the demand for Cologuard at launch.

Digestive Disease Week, or DDW, is being held this weekend in Chicago. It is the world's largest gathering of physicians and researchers in Gastroenterology. In collaboration with our partners at the Mayo Clinic, we will be giving a number of presentations and poster sessions at the meeting.

They highlight advances in our pipeline across the GI tract, including the detection of pancreatic cancer from pancreatic juice; DNA detection of Barrett's esophagus, which increases esophageal cancer risk; and the noninvasive detection of upper GI cancers. These 3 posters complement the work that we are continuing to do on colorectal cancer.

Although we have not spoken at great length about our pipeline, these presentations highlight the power of Exact Sciences' exclusive collaboration with the Mayo Clinic for the development of screening and diagnostic tests for the early detection and prevention of GI Cancers. A full list of the posters and presentations can be found at our website.

In conclusion, Exact approaches the launch of Cologuard in a strong financial position. We have a commercial strategy focused on physicians, patients and payers that is well supported by a comprehensive plan. Based on our assessment of the market, we are making additional investments in our sales force.

Our lab and customer service center will be ready for the demand at launch. We are excited to present the advances in our product pipeline being made through our collaboration with the Mayo Clinic at DDW later this week. We appreciate everyone's continued support of Exact as we work to bring Cologuard to patients and physicians.

We are now happy to answer your questions..

[Operator Instructions] And our first question comes from Jeff Hib [ph] of William Baird..

So, Kevin, my first question is on reimbursement.

Can you talk about -- in your latest conversations with CMS, how has the process changed? Are you still thinking the use of a cross walker? What's the latest update there?.

Yes. Well, we've been having very active discussions with CMS, and we are confident in where we are progressing as we had discussed before. We would expect to have a national coverage decision being made within 90 days of FDA approval. We remain more confident of that now than we were even before.

So we're really looking forward to that decision and that process. It highlights the benefit of the parallel review process, which Cologuard was the first product invited into that newly-created process.

On the payment side, we are also working very closely with the payment group within CMS, and we are very confident that there will be a cross-walking analysis performed as part of that process, and that CMS will eventually put out a payment level that we are pleased with.

We are having very active dialogues on both fronts, and we're confident in the outcome..

Good.

And then shifting over to the pipeline I look forward to hearing more about it at DDW, but can you talk about the timing of when we could see some of these products perhaps come to market?.

At this point, Jeff, we're not ready to talk about the specific products that will come out of the work.

Let me start by saying the collaboration has been occurring in the background without the company talking a lot about it, and we have identified very powerful biomarkers throughout the GI tract, DNA methylation markers for each of the GI sites where cancers develop. As we hone our strategy, we will focus on that more.

I suspect, by the end of the year, we will lay out more -- much more clarity on the pipeline strategy that we have..

Our next question comes from Brian Weinstein of William Blair..

Kevin, can you remind us about how you and CMS have kind of worked together in determining cost effectiveness, and can you discuss any of the parameters and comparisons that were done with other screening methodologies at this point?.

Sure. There are 2 groups within CMS. One is the coverage group, and the coverage group typically looks at cost effectiveness as part of their coverage determination. We have provided very detailed oral cost-effectiveness data to CMS that they will use as part of the decision to cover Cologuard.

That is very different than what is presented to the payment group. The payment group, as you know, looks at new molecular tests with a new approach that was first laid out in 2012.

In a collaboration with the AMA, there were codes that were issued for individual DNA markers, and payment levels have been ascribed to those markers through a robust process that included the AMA, CMS National and the regional mix. That is a way to create a more standard approach to CMS paying for molecular tests.

We are very pleased with that process and believe that we can get very good value out of it. That process does not include a cost -- the cost-effectiveness analysis that is provided to the coverage group. And that's an important distinction that has to be made when looking at this, and sometimes people get confused about that.

Does that answer your question, Brian?.

Yes, it does.

And as a follow-up, if for some reason, a crosswalk is not used, can you talk about your comfort in getting a satisfactory reimbursement in a gap-fill methodology and what your -- any assumptions that you can share about getting us comfortable around that?.

Sure. We, of course, have done both the gap-fill analysis as well as the crosswalk analysis, and we're very comfortable that we would get an acceptable price for Cologuard with the gap-fill approach. The gap-fill approach looks at the resources utilized to create a -- to both develop and run a new diagnostic test.

Both of these processes are built right into the -- a coded federal regulation and I will point you to that. That is 414.508, payment for a new clinical diagnostic laboratory test. And it lays out the approach to gap-filling.

We are very comfortable should this test be gap-filled, although we don't think that it will be given the new approach to paying for molecular diagnostic tests laid out by CMS over a 2-year period of time..

And the next question comes from Brandon Couillard of Jefferies..

Kevin or Maneesh, can you give us a sense of how we should expect the productivity per sales rep to look upon launch and how we should expect that to develop, let's say, over the next 6 to 12 months?.

Sure, Brandon. So at the outset, we have done an immense amount of work to really understand -- we've brought the data we know who these high-prescribing FIT and FOBT physicians are. And so we have developed target lists, call lists for all the reps. They will have a call list of 300, but they'll have a focused list of 75.

So we are not -- you just turn back the page to 20 years ago, where you hired a rep and said, "Hey, go get some business." We have a very, very focused list, and we're incenting the reps on converting those high-volume physicians. These physicians -- the profiles of these physicians is a minimum of 400 FIT and FOBT tests per year.

So they are going to be extremely motivated and focused on targeting these physicians. So if you could imagine a rep in a very, very focused geography. We are working with a appointment service to make sure that they have appointments as soon as they get hired.

So we have the flexibility with the contract sales force to bring them up upon FDA approval in the geographies that we need, but we also will have these tools available to make sure that they're focused.

So from a load standpoint, while we haven't provided that guidance, you could imagine the leverage that we have calling on just high-prescribing physicians. If 1 was -- with 1 rep -- and I'll just walk you through an example -- if 1 rep was able to convert 1 doc, that's a high-prescribing doc, per week, you would get to pretty substantial numbers.

Now obviously, that's not the target. The target is higher. We believe that these reps will be able to reach a run rate of somewhere between $1.5 million to $2 million per rep at peak, but it will be -- it will obviously ramp to that, and we will provide more color through the launch as to how we will get to that..

That's helpful.

And then, Bill, could you give us just some parameters around what to expect for the cash burn in the second half of the year as the commercial organization ramps? And is it too soon to start thinking about the magnitude of the DTC marketing support, let's say, in the first 12 months of launch?.

Yes. So, Brandon, no. I can provide a general color. So there are several critical unknowns, the timing of the FDA approval and CMS coverage and pricing decisions, and those are going to materially impact our launch and the timing of our spend -- timing of revenues. So we can't reasonably guide to specific numbers.

But in a more general term, you can see that operating expense and cash burn in the first quarter was about $17 million. It's an increase of about $4 million from the last quarter of 2013. We expect to see that continue to ramp as we move closer to launch.

And so as an example, right, so if you take sales and marketing, expense ramp is $4.5 million in the first quarter, and we talked about in our prepared remarks the size of the sales force. So -- and you can do some math here.

The sales force of 120 at launch, that's 80 sales reps calling on the high-prescribing FIT and FOBT primary care physicians that we just talked about, with a balance in key account execs, the sales support staff, the sales management team. And then we expect about 100 sales reps by year end.

So again, the cost of that and how it impacts our income statement, our balance sheet will be reflected in the timing of the launch. We can't determine that, so we can't give you specifics on what that is going to look like, but you can see that it is going to ramp up if you do that math.

Into that, you also have to add the development of our -- and execution of our marketing plans. So you have content creation, you have the campaigns, the advertising to impact the market, and add those in as well. Timing of those, again, will depend upon launch timing.

If you think about G&A, right, in the G&A, we are now building in our customer support team that will help deliver the compliance engine that we've talked about extensively. We're building our billing team, and that will also come into G&A.

And so you can see, G&A, it increased to roughly $4.5 million in the first quarter relative to a little less than $4 million in the fourth quarter of last year. That is going to continue to ramp up as we head towards launch. Again, timing undetermined. Non-OpEx, but still cash impacting CapEx. We spent a little less than $5 million in the first quarter.

If you look at all of last year, we spent a little less than $10 million. We expect to spend a bit more in 2014. And so that $5 million is going to continue to -- we're going to continue to invest for the rest of the year. It will be not quite the $5 million level.

But somewhere in that range, we'll end up with a little bit more than the roughly $10 million we spent in 2013. And then, lastly, inventory. So as we head towards launch, we'll be in to build our reagent inventory, our collection kit inventory that we are prepared to fulfill on demand.

And again, the amount and timing will depend upon those key decisions.

Does that help?.

Yes, it's great..

And our next question comes from Jeff Frelick of Canaccord..

Maybe this was [indiscernible].

The several thousand pc -- primary care doctors that we should focus on, if the concentration there [indiscernible] are you seeing in these doctors?.

We've done a whole bunch of work. And what we know is these are physicians that don't -- that believe in noninvasive testing. They have tried and tried to get their patients over time to go to get colonoscopy, and they've given up on it, quite honestly.

And so that's why we see such high volumes because they're big believers in noninvasive testing, and what we've seen is these are folks that have shifted from using the old fecal [indiscernible] blood test to the best noninvasive tests prior to Cologuard that's available. And so our focus is pretty simple for them, that we've done market research on.

If you believe in a noninvasive test, you should be offering the best noninvasive test. And so that's really the common theme, and that's what we're going to focus on as we launch..

Do you know what their kind of return rate is with the patient compliance, Maneesh?.

It's all over the board. It's all over the board. What we do know, when we talk to them through -- again, because there aren't great metrics out there, this is market research that we've done. But in the best case, they are going to get half of them back.

But the predominant case is some people will say I'll get 1 in 10 back because they don't have comprehensive compliance programs.

So we remain optimistic, and this is really where as we built the value proposition -- and when we talk to the physicians about our ability to tell them the colon cancer screening status of someone who offers Cologuard on a real-time basis, that's really compelling to them.

So we think the numbers are relatively modest for FIT, and that's one of the reasons we believe we can improve that..

And then just to follow-up on the sales reps build. So the 80 reps initially going to 100 by year end.

Will these be Exact Sciences' direct employees, or these are [indiscernible]? How should we think of that?.

These are contract sales reps, Jeff. So that's really what gives us the flexibility to put them where we need to put them and grow them very, very quickly. Eventually, these will be -- our intentions are for these to be Exact Sciences' employees.

But when we're referring to this physician field force of 100 that we increased and doubled based on our confidence in our market research and the discussions we've been having, those are contract sales folks that will eventually be Exact Sciences employees..

And they'll report into your area managers, your regional managers?.

Yes. So they will be reporting to area managers that are Exact Sciences' area managers. So they will be getting direction from folks that are Exact Sciences employees..

Our next question comes from Peter Lawson of Mizuho Securities..

Kevin, just on the broader pipeline. When should we -- you said at year end, we should hear about that.

Is that going to be at an Analyst Day or conference or just going to be in the earnings script?.

Peter, we haven't decided yet. Our focus really has been on making sure that the panel meeting went really well, that the New England Journal publication was published in the first quarter.

As we move into launch, what we're really doing is focusing a significant amount of the company and resources on Cologuard, as you would expect, while creating a team that will, including marketing leadership, that will lay out this pipeline strategy internally first in a real thoughtful way.

And then once we are confident in, let's call it, our first couple of pipeline products -- and there are really many that we could choose from -- to come out of that pipeline, we will lay that out to the Street.

We just want to be very -- we want to focus on Cologuard and then make sure -- as we talk about the pipeline as in the past, we do things that we say we're going to do. So we don't want to get out caught ahead of ourselves there. But I do expect that it would be at the end of the year, very well may be at an Investor Day so that we can go deep..

Got you. And then just going back to the sales ad, can you -- what's sort of the timing and how you're thinking of adding people? Are you adding them now, or is it kind of a -- more of a 3Q event? And let me just clarify this. So it's 80 reps, 40 managers at launch, and then you go up to 100 sales reps.

Is it still 40 managers at that point by year-end?.

So, Peter, great question. This really goes back to one of the reasons we elected to go with a contract sales approach. Because it gives us the flexibility to bring these folks on at or really close to FDA approval. Get them trained and get them -- so that we have flexibility. Depending upon that timing, that's really where we'll start at the 80.

And between now -- between whenever that happens and the end of the year, our plan is to scale that up. And that would be the contract sales reps.

What -- as Bill said, just for staying in control, because those managers for those 100 reps by the end of the year will be Exact Sciences' folks, those folks need to -- that's part of the 40 that are sales management, sales infrastructure, sales operation, sales support, key account executives are included in that.

Those are folks that form a really important part of our strategy, that whole portion that's calling on large systems and networks. So that's really the composition and the timing by the end of the year..

And should we be thinking about 2Q costs jumping up again, or is it -- should we....

Peter, I think you should think about us continuing to ramp -- you see a ramp -- a significant ramp from fourth quarter to first quarter. So sequentially, you're going to see that accelerate. And as we get into launch mode, it'll accelerate even more..

Got you. That's helpful.

And then just the soft launch, is that more of a 3Q event now?.

We aren't providing guidance at this point, but we're working intently with FDA on approval and CMS on coverage. And we expect to ramp up very rapidly upon FDA approval, with the official launch being on the CMS coverage day..

Got you. And then just the cost differential between these reps and the managers.

What price range should we be thinking about those?.

So, Peter, I think you have to average over the entire workforce. And you think about the compensation or expense [indiscernible], their bonus, incentives, there's a lot of P&E [ph] that will be related to these guys. If you think about it all up, you're going to be somewhere in the $200,000 average across that population..

And the next question comes from Zarak Khurshid of Wedbush Securities..

Can you help us understand where you are in the building out of IT around the compliance engine? And if you could put some numbers around the required investment there and the recurring costs going forward, that would be great..

Sure, Zarak. So we're really pleased, as Bill mentioned, in his update that we have built the back-end IT systems. We are putting it through its paces. Right now, we're going to be doing some testing and validation. So that's the space that we're in. We're not trying to do things that have never been done.

We are simply putting together systems that exist to make sure that it will support our business. So at the end of the day, we have built it. It's included in the vast majority of the numbers that you see from a CapEx perspective. I'll let Bill speak to ongoing costs, but it's ready to go..

We incurred about $5 million in CapEx on investment in the first quarter. And as I mentioned just a moment ago, we expect to move up that $10 million a bit overall in the year. So you'll see that the investments start to damp down a bit, but we'll continue to invest.

Particularly, we'll ramp the equipment load in the manufacturing operation that and the lab as we begin to get near the launch and build up processing capacity. So you'll see that the systems are largely built, and we're in the validation and testing of those systems, the integration testing, the at scale impact testing and so forth.

So framing it out, about $5 million in this first quarter, and that will begin to damp down a bit in the next 3 quarters..

Great. And then just following up on the last question.

I'm curious, how many people you had at the end of Q1 in the commercial team? And where are you with the 40 or so managers and key account execs? How many of those are on board currently?.

I would say that -- so we've made really good progress. And obviously, we're not going to bring all of those managers on. We're ramping this as we go. I would say that we've got about half of that team on board now and are continuing to make those investments before FDA approval..

That's right. Half of that support team, that leadership team, the management team, that's about right. So in the 20 range..

Our next question comes from Chris Lewis of Roth Capital Partners..

I wanted to start on the testing interval.

Can you walk us through the process there? And I was wondering, as part of the CMS decision to come out, will a testing interval be included in their coverage decision?.

one is through this modeling exercise; and two is through long-term 10-, 20-year government-funded studies. So it's -- we think that the guideline committees will act pretty quickly after FDA approval..

Okay, great.

And then can you talk on the private pay side? Can you maybe just talk through maybe the discussions you're having with the private payers now? What are they going to be looking for in order to provide coverage over time? And how does the publication advance those conversations?.

Well, obviously, the publication helps significantly. We've had extensive conversations with private payers. We just had a board meeting this week with 3 people with -- from private payers coming in to talk to our Board of Directors. We have done a significant amount of research in this area, and we've been out talking to groups.

And one of the things that's very important to know is that these payers are aware that under the Affordable Care Act, a test that is rated A or B by the United States Preventive Services Task Force, which we would expect our tests to be rated A or B -- we expect Cologuard to be rated A or B -- by, call it, the end of 2015.

Under the Affordable Care Act, any colon cancer screening test rated A or B has to be covered. So that puts us in a very strong position to have conversations with the payers now. Many of them are following our progress very closely, and those payers want to get more people screened and they want to get them screened in a cost-effective way.

And our data supports that Cologuard is a very cost-effective way of screening for colon cancer. So without providing more color there. We think this test is going to eventually be covered by all of the payers in the U.S. and that puts us in a very good position to drive adoption of the test..

Okay, that's great.

As a follow-up to that, just on the task force, can you remind us when they're scheduled to meet, I guess? And are you going to be submit all that data in the publication by the time they meet for the next review?.

Sure. So we have submitted the data to the United States Preventive Services Task Force -- I know it's a mouthful, USPSTF -- which kicked off their process. And it's public, so you can Google it and find the criteria and the subjects that they are looking at. Stool DNA is one of the many subjects that they are considering.

We would expect that process to be completed sometime next year. We think -- for our planning purposes, we're assuming the end of 2015..

And our next question comes from Raymond Myers of Alere Financial..

Kevin, one of the remarks you made today struck a chord. I am interested in your comment that you're even more comfortable -- or even more confident than before in the FDA approval and CMS reimbursement under parallel review within 90 days. Can you just expand on that a little bit? What makes you even more confident? Something must have happened..

Well, let's make sure that you understand really clearly what I said about the 90 days. We would expect the coverage decision to occur within 90 days of FDA approval. I want to make sure that nobody misunderstands that we're guiding to FDA approval within 90 days. We're working with the FDA, and that will occur when it occurs.

But under the review process, we would expect the coverage decision to occur within 90 days. We've just been having very active conversations with both agencies. You may have listened to the advisory panel, but it went very well, the agency was complimentary of the data that was presented and the study and the study design.

I don't want to get into any specific conversations that we've had with either agency. Suffice it to say is our confidence level is increased..

Mr. Conroy, I'm not showing any further questions at this time. Please proceed with any further remarks..

Thank you very much. Well, one thing that I'd really like to drive home is the performance difference that we showed in this DeeP-C study. There are 10 million FIT and FOBT tests used every year in the U.S., and they suffer from a lack of solid performance.

Only 70% of cancers early stage I, Stage I and II cancers are detected in a prospective setting with the current FIT test. And it's recommended FDA cover versus 94% for Cologuard in Stage I and II cancers. This is really important.

There is another problem with FIT testing that we think Cologuard will solve, and that is -- there is a huge study done by the VA that showed the repeat usage of the FIT test every year drops to 14%. 14% after 4 years. You can't rely on an inferior test that is required to be used every year to get to basic, decent performance.

It's just not a viable way to screen for colon cancer. Cologuard represents a significant advancement.

One of the members of the panel approached me after the FDA panel meeting and said "This is the most significant improvement in cancer screening in 2 decades." So we are excited to get this data in front of primary care physicians and to begin to change the landscape for colon cancer screening. That's our goal.

We're totally committed to it, and we really look forward to talking to you 3 months from now. Thank you..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day..