Earnings Labs

Veracyte, Inc. (VCYT)

Q4 2015 Earnings Call· Thu, Mar 10, 2016

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to Veracyte’s Fourth Quarter and Full Year 2015 Financial Results Webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] I’d now like to introduce your host for today’s conference, Ms. Shelly Guyer, Chief Financial Officer. Please go ahead.

Shelly Guyer

Analyst

Good afternoon, everyone, and thanks for joining us today for our fourth quarter and full year 2015 financial results conference call. Joining me today are Bonnie Anderson, President and Chief Executive Officer; and Chris Hall, Chief Operating Officer. During the course of this call, we may make forward-looking statements that are not purely historical regarding Veracyte’s or its management’s intention, beliefs, expectations and strategies for the future, including those relating to scale and sustainability, future growth, future revenues and expenditures, coverage and reimbursement for thyroid and pulmonology test, strategic investments, product launches, geographic expansion and market growth. Because such statements deal with future events, they are subject to various risks and uncertainties and actual results may differ materially from the company’s current expectations described in this call. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in Veracyte’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission in addition to today’s press release. The forward-looking statements in this call are valid as of March 10, 2016 and Veracyte assumes no obligation to publicly update these forward-looking statements. Our financial results press release for the fourth quarter and year ended December 31, 2015 crossed the wire a short while ago and is available on the Investor Relations page of our website at veracyte.com. I will now turn the call over to Bonnie.

Bonnie Anderson

Analyst

Thank you, Shelly. Good afternoon everyone and thanks for joining us today. I’m excited for the call today and the opportunity to share with you that we achieved all the goals we set out to accomplish when we did this call a year ago. We have tremendous momentum coming off of a great 2015. I’m also eager to lay out another set of aggressive goals for the business in 2016, as we continue to resolve the important healthcare issue diagnostic ambiguity, delivering significant value to patients by helping them avoid surgeries they don’t need and saving the healthcare system money. We’re emerging as a growth story with a solid foundation to our business. I’d like to start with highlights of the each of the three that we’ve used to define success in 2015. Number one is the growth of Afirma. Our Afirma growth was robust in ‘15. We grew revenue by 30% to $49.5 million, compared to $38.2 million in 2014. We also increased Afirma Gene Expression Classifier or GEC test volume by 38% for the year to nearly 20,000 tests compared to just over 14,000 in 2014. Our focus in the follicle [ph] execution was key to our success. This included a growing body of powerful clinical evidence for Afirma, where we now have nearly 20 scientific studies published in peer review journals. Among these are more than a dozen clinical utility studies, including two recent long-term durability studies showing that the Afirma GEC safely reduces surgeries with up to three full years of follow up. We also achieved inclusion of the Afirma GEC in the American Thyroid Association’s clinical practice guidelines in October. The Afirma GEC is the only genomic test with a high enough sensitivity and negative predictive value proven in multiple rigorous clinical trials to be…

Shelly Guyer

Analyst

Thanks, Bonnie. As Bonnie indicated, we experienced strong revenue growth during 2015. Our revenue for the fourth quarter was $14 million, up from $12.2 million for the same period in 2015, an increase of 15%. Excluding onetime revenue pick up in the fourth quarter of 2014 of over $800,000, the revenue increase was 23% for the fourth quarter of 2015 compared to the same quarter of the prior year. Our revenue for 2015 was $49.5 million, 30% increase compared to 2014 revenue of $38.2 million. Of note we accrued 58% of revenue in the fourth quarter of 2015, up from 41% in the same period of 2014. For the full year we accrued 55% of revenue. We reported 5609 Afirma GEC test during the fourth quarter of 2015, a year-over-year increase of 38% and up 11% over the third quarter. 13% of total FNAs received in the fourth quarter were for GEC only testing predominantly our institutional accounts. For the full year 2015, we reported 19,421 Afirma GEC tests, a year-over-year increase of 38%. 12% of total FNAs received in 2015 were for GEC only testing, up significantly over the 7% rate in 2014. Our gross margin quote-unquote for the fourth quarter of 2015 was 56% which is comparable to previous quarters, for the full year we achieved a gross margin of 57%, the same as in 2014. We previously indicated that our gross margin would not increase substantially in 2015 because of our limited ability to expand reimbursement for the Afirma GEC without coverage from our major Blues Plan and because of continued pricing pressure on cytopathology reimbursement. Operating expense for the fourth quarter of 2015 was $22 million, compared to $20.3 million for the comparable period in 2014. Operating expense for full year 2015 was $83 million, compared…

Bonnie Anderson

Analyst

Thanks Shelly. We view 2016 as a breakout year for us. Within five years of launching our first test, we are now poised to have three commercial products by the end of the year, with all three generating revenue by the end of 2018. Our success this year will help give us a clear pathway to profitability and will firmly establish Veracyte on the map as a significant and differentiated provider of diagnostic solutions that deliver real clinical value to patients, physicians and payers. For 2016 guidance, we expect GEC test volume will be in the range of 24,000 to 25,500 tests. Annual revenue will be in the range of $59 million to $63 million. I would now like to conclude by discussing the metrics we will use to measure our success in 2016. They are Afirma growth and reimbursement expansion, Percepta coverage and the launch of our third commercial product for IPF. Some highlights on each of these. First, Afirma growth and reimbursement expansion, we would continue to drive growth of Afirma using our two proven models, the full solution and what we are now calling our Afirma Diagnostic Partner Model to further penetrate every segment of the market. We would expand our internal sales team and assume full sales and marketing responsibility for Afirma as we transition from our Sanofi Genzyme relationship. We would do this thoughtfully, in order to optimize the efficiency of our sales and marketing organization. The termination of our co-promotion agreement in the US as of mid-September will end the payment of 15% of Afirma revenue to Sanofi Genzyme and it will allow us to retain the full value of our Afirma solution. We’ve valued our relationship and are confident that both companies will work closely to ensure a smooth transition. To accommodate this…

Operator

Operator

[Operator Instructions] And our first question comes from the line of Dan Leonard from Leerink, your line is open.

Dan Leonard

Analyst

Thank you. So first off, I was hoping you could offer more color around your expectations for Afirma pricing in gross margin in 2016.

Bonnie Anderson

Analyst

Sounds great Dan, I will start with the top line of that and then maybe turn it over to Shelly to add a little bit on the cost side. So we - for 2016, we’re kind of coming in the year where most of the payers that we’ve already had under contract or contracted rates, we obviously had a lot of success toward the back half of last year with some of the Blues Plans that brought a few more of these covered lives into in-network contracts, but the biggest Blues Plans that are going to have the biggest impact on our ability to greatly expand that reimbursement rate. HCSC which came at the very end of the year, which we have not, obviously seen any impact to yet as well as Anthem which has 40 million lives and will be the most important decision to get us to a point where we can start predicting the expansion to those GEC rate. Given that - I mean we are pretty confident giving the clinical studies that have been done on long-term utility that we will certainly get Anthem in 2016, it’s kind of difficult to predict when these things happen and so therefore we may see some modest increase in GEC rate this year, but we wouldn’t expect to get up to that 3,000 plus range where we think we can get until we get more of these Blues Plans under in-network contracts and those will be our two key priorities for reimbursement.

Shelly Guyer

Analyst

And I guess just from the spend side, we expect that will be relatively flat on the cost of revenue spend as a percentage of revenue, so that one go down dramatically. The real uptick that you will get in gross margin is when you experience the uptick in the reimbursement side as Bonnie just went over and so I think that’s where you really look for the move in the gross margin. So we are not predicting right now absence having the Blues come in and pay at substantially higher rates. We are not expecting that that gross margin would move significantly during the year.

Dan Leonard

Analyst

Got it and then my follow up question, Bonnie when do you think it is right time to start talking more explicitly about Percepta volumes?

Bonnie Anderson

Analyst

Yeah, so I think that the key there is when we get Medicare coverage, because what we’re trying to do right now is take a very cautious approach to ceding the market at important medical centers with important pulmonologist that can help us really establish the clinical value and utility for the test. But we don’t want to expand our footprint in sales and drive volume much higher than those initial 50 sites until we know we can secure reimbursement. So we expect that we will be in a position to secure Medicare reimbursement for Percepta this year, but our intention isn’t to focus on driving volume until after we get to that point. So depending on when that would happen in the year, if it would be earlier rather than latter there may be a bit of upside, but I think we would reserve providing any direction on that until we know what point in the year that even happens.

Dan Leonard

Analyst

Okay, thank you.

Operator

Operator

Thank you. And our next question comes from the line of Amanda Murphy with William Blair, your line is open.

Amanda Murphy

Analyst · William Blair, your line is open.

Hi, good afternoon. So I just had a quick one on I guess Medicare reimbursement, so I think there are couple of other companies who had new code in 2016 mentioned that there were some issue with just kind of the logistics of implementing a new code is in terms of collection, did you see anything like that or I guess it hasn’t started really until January 1, but I’m curious if you could provide any insight there that would be helpful.

Chris Hall

Analyst · William Blair, your line is open.

Yeah, Amanda it’s Chris. We are in the process of implementing the new Afirma code. We have been working through with most of the payers, we don’t have all of them and we have not seen any issues to-date and in fact actually for us it’s has been a good thing. We have been receiving faster responses from payers and that the old miscellaneous code that we were using before always caused issues with payers because they were trying to figure out what it was for and to see is there other charges they get under that miscellaneous code. And so the feedback that we’ve gotten is that the specificity have been able to identify this is, Afirma has allowed them to know what it is and resolve it quicker. So we’ve seen this so far to be a net positive for us and we’ve not experienced any issues to-date.

Amanda Murphy

Analyst · William Blair, your line is open.

Got it that’s helpful and then I guess a follow up to Dan’s question on guidance. Wondering if you can give a little bit of context around volume trends thinking about GEC only as a percentage of total and how do you expect that trend in ‘16 and then also realizing that you’re not giving FNA volume at this point but can you give us any even anecdotal commentary around or qualitative commentary around how FNA volumes might look relative to 2015.

Bonnie Anderson

Analyst · William Blair, your line is open.

Right yes, a very good question so I will start with GEC, our core driver of values. So we had estimated about 25% to 30% increase in volume and I think our range kind of sets right with into that projection. GEC only driven through this new partner models with labs and institutions will continue to be a key driver of that. If you compute the GEC volume breakout this quarter or for 2015, what you will see is that we’ve already achieved over 40% of our GEC volume now coming from these partnered accounts institutions and enabled labs. So it was - we wouldn’t expect to continue to grow GEC only test volume at the quite the same rate, we were about hundred percent year over year growth for 2015, but it will definitely be a key driver of growth. With that though we do expect to continue to see modest growth with FNAs coming in for continued cytopathology testing, it’s amazing how stable and how we have been able to continue to lift up that part of the market in continue to drive adoption there. So it might be more in the neighborhood of 10% on the cytopathology, 10% to 12%, where the biggest driver of growth is kind of come from more of these partnered accounts with GEC only.

Amanda Murphy

Analyst · William Blair, your line is open.

Got it and then just thinking longer-term on that point and I think originally, you had talked about the community side being the larger opportunity in terms of market sizing. So where do you think ultimately the GEC only model would go, I mean maybe you can talk a little bit about the penetration on the community side over the longer-term.

Bonnie Anderson

Analyst · William Blair, your line is open.

Sure, yeah. Well, just as a point of reference and a little bit of history, as you remember when we launched Afirma, we launched the test using a total solution where GEC was the centerpiece of the overall Afirma solution and we went after initially the physician office market because quite frankly it was by far the easiest part of the market to penetrate and a lot of low hanging fruit. In order to have the product set neatly into the workflow it was much easier for these doctors to collect cytopathology sample along with GEC and send those both to us. So from the very beginning in 2011 of commercialization, we’ve seen an upward trajectory of penetration into that specific segment of the market. And last year we estimated that we were just under about 30% penetrated into that segment keeping in mind that it represents about 60% of the overall FNA volume. In 2014 we began expanding our sales team with institutional account managers to be able to really penetrate the institutions to a greater degree, knowing that cytopathology was going to be done on site and something we were perfectly fine with. We then operationalized a model that today we call this our Afirma Diagnostic Partner Model, where they collect the GEC and handle that sample appropriately and then send it to us for the GEC after the cytopathology is done and is indeterminate. In 2015, we also a walled at models to partner up with some other regional laboratories that had already secured a very strong history of business with some of the doctors’ offices that otherwise, we would have had to connect to with our total solution model. So what that has done is really set us up with a couple different solutions that can work differently for every customer in the market. And it’s really been a powerful evolution and as we come off of this year we can think about penetrating the physician office ambulatory segment both by continuing to drive that total solution, but will also capture some of the GECs out of the segment with our diagnostic partner program. And so it’s not black-and-white one solution for one market and the other solution for the other and that’s why the GEC only business will drive the predominant growth.

Amanda Murphy

Analyst · William Blair, your line is open.

Got it, thanks very much.

Bonnie Anderson

Analyst · William Blair, your line is open.

Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Doug Schenkel from Cowen and Company, your line is open.

Unidentified Analyst

Analyst

Hi, good afternoon this is Chris on for Doug today. Thanks for taking my question. Maybe just start - could you tell us things about the pay thing that sales force hires related to the conclusion of Genzyme agreement and could you give us a sense of why this is the right time to make this decision.

Chris Hall

Analyst

Yeah, absolutely, so we talked about we’re going to layer in 10 additional sales folks and we are trying to frontload those towards the beginning of the year. You will see that most of those hires will occur and actually now towards the end of the first quarter and then some into the second quarter. It’s important for us to get those folks in and get them layered down and get them productive relatively early. We think that it takes anywhere from 3 to 6 months for sales reps to become - productive and get their arms around the market and then dynamics and so we’ll frontload that. The reason we thought now is the time quite frankly is that we really are very confident that we can take over the sales and marketing efforts for Afirma on our own. We’ve built a deep group of sales professionals now of 30 people that have a real depth in the market. We have longevity of our sales reps, these folks join us and the ones that have flourished and have stayed with us for quite some time, they’ve driven deep relationships, they’ve began to understand and really are probably experts in the construction of the FNA market and try to figure out how to go deeper into it. And we really believe that now is the right time for us to take it over and we have got the experience and skill set to be able to do it. In 2014, you remember we restructured the relationship where we took over the core sales efforts and Genzyme helped out with lead identification and account management. And that experience taught us that we were capable because in the midst of that we drove tremendous growth taking over the core sales piece and…

Unidentified Analyst

Analyst

Great, that was super helpful, thank you and maybe just one more on guidance. Could you help us think about what are the key drivers that get you from lower end to higher end of revenue and volume guidance and I guess more specifically or additionally how those guidance impact potentially obtaining Anthem coverage, thank you.

Chris Hall

Analyst

I mean the key thing there - it’s Chris again. The key thing on the way to think about the lower and the higher end of the guidance is - I think about it as really pivoting around some of the insurance contract success. Getting the insurance contracts done for Blue Cross Blue Shield plans is critically important for us to drive a higher ASP, but the Blue Cross Blue Shield plans, because they send the checks to the patient, it’s doubly important, it’s important because we are able to yield more of the money because less gets applied to the coinsurance amount or co-payment for the patient, but secondarily we are more likely to get it because it comes to us rather than the patients, rather than us have to go get it from the patient. So that’s one piece of the number, but second piece and where it works synergistically volume, is the ability for us to get insurance contracts. We believe helps go deeper into doctors accounts because the single biggest thing that holds us back in terms of volume is the inability to have widespread insurance contracts and that usually means lack of Blue Cross Blue Shield because that’s most doctors’ single biggest payer that they see in the practice or patients from those insurance plans. So the key milestone to be watching this year is our ability to execute on getting Blue Cross Blue Shield contracts done and continuing to layer in those coverage and that’s kind of the way to think about the pivot from the load behind.

Unidentified Analyst

Analyst

Great, thank you.

Operator

Operator

Thank you. Our next question comes from the line of Bill Quirk from Piper Jaffray, your line is open.

Bill Quirk.

Analyst

Great thanks, good afternoon everybody. First question Bonnie, you had your prepared comment around the PAMA I think for the first time in the recent prepared comment you made reference to potential implementation in ‘18. I guess I’m curious what are you guys are thinking about thinking PAMA in terms of when that would go into effect, it certainly seems like January of ‘17 is the pretty ambitious goal by them.

Bonnie Anderson

Analyst

Yeah, so hi Bill, thanks for the question and joining our call today. Yeah, so the reference, I mean there has been obviously a lot of talk about whether or not that will be delayed to ‘18 and I think the point we’re trying to make is, because we are coming off of November decision whereby GEC will be actually be gap filled and that process is underway. We believe there will be no disruption to us continuing current Medicare rates probably through ‘18 whether PAMA gets implemented earlier or later, it kind of is irrelevant at this point for us for that product. And so it really does give us a time of stability and a little more predictability than what we’ve had in the past from the way that we view it. And by the time it gets implemented, if it’s in ‘18 then we’ll be using the private payer rates to direct what Medicare will be paying and we feel that provides continued security. So that was really the point, not that I have any specific insight or information, but I know there has been a lot of comments and things about the fact that may be delayed. My point was just that it really doesn’t matter so much for where we are.

Bill Quirk

Analyst

Got it, okay and I appreciate the additional color on that, thanks Bonnie. And then I guess just kind of staying in macro topics again you touched on your prepared comments, but LDTs sufficed to say we’re probably not going to get this until late summer I suppose the best at least based on the FDAs meeting calendar, is that a fair assumption?

Bonnie Anderson

Analyst

Yeah, I mean I think there have been some rumblings that they are trying to move forward with some notification legislatively. We all know that will give us still 60 days’ notice on when it might be implemented, but I think when you look at the bigger picture of LDT guidance at least from everything that we can see in the draft guidance and what has been talked about publicly, it appears that they are going to be thoughtful in how they grow this out with high risk test typically companion diagnostics coming first and then our ability to kind of role into that process by registering our other tests and having some number of years and to come in under our compliance. So we believe that it is important for investors to understand that these two issues that have historically, especially in the recent past created a lot of turmoil and uncertainty really are kind of come into the point where we could get those wrapped around, I mean that could take a lot of that uncertainty off the table and we see that is a really good thing.

Bill Quirk

Analyst

Got it, understood, thanks Bonnie, I appreciate it.

Bonnie Anderson

Analyst

Okay thanks.

Operator

Operator

Thank you. Our next question comes from the line of Karen Koski with BTIG, your line is open.

Karen Koski

Analyst · BTIG, your line is open.

Thanks. Can you guys hear me okay?

Bonnie Anderson

Analyst · BTIG, your line is open.

Yes, you’re very clear.

Karen Koski

Analyst · BTIG, your line is open.

Excellent, just my first question on reimbursement and I certainly understand that your main focus for Percepta reimbursement in ‘16 will be gaining Medicare coverage, but just given the success you’ve had gaining Afirma coverage among private payers and everything you’ve learned over the last couple of years, is there an opportunity to start kind of priming private payers, keeping in mind that they would - the decisions would still likely come after Medicare, but that maybe the time after Medicare coverage could be much shorter.

Bonnie Anderson

Analyst · BTIG, your line is open.

Yeah, so Karen I think that we kind of read these things together is that, we look at what is the driver that we can then back with growth and expanding our sales team, expanding our spend because not only do you then expand the sales team, it’s all the back office stuff that supports all of that. And given that Medicare covers about 50% of the patient population in this indication, we really think that that will be the key driver and the key pivot point where we’ll comfortable beginning to ramp up. All the rest of the payers that might have major roles for us in Afirma because of such a low Medicare population will have a less significant impact on the Percepta and ILD products. So while we think we are going to be terrific position to move Percepta and eventually ILD into all of those contracts we have been able to secure with Afirma, which is a real competitive advantage for us. We still believe that getting Medicare first is a really key decision because we are going to control our ramp and drive for growth on test volume on the back of that. And Chris do you have a few things to add to that.

Chris Hall

Analyst · BTIG, your line is open.

We believe that one of the key things that we are building a value here is this network of insurance contracts that we have, because when we’re able to do that then we’re part of the family basically or part of their extended network and so we can go in, we can have those discussions about the products that we are bringing to market in a relatively easy way. There are lot of diagnostic players that are small that have a lot of test that range from poorly validated, well validated, anything in between and insurance companies have a hard time sorting through that all that. There is a lot of noise with what they see and what they get and just peer volume of it, so having to sit at the table we’ve always believed was important and would allow us to accelerate the launch of products 2, 3, 4, 5 et cetera into those carriers and hopefully accelerate coverage from what it would be without that. So absolutely the idea is to leverage although we’re building on Afirma with insurance contracts to go faster with Percepta and ILD.

Karen Koski

Analyst · BTIG, your line is open.

Okay, great that’s very helpful. And then just a second question around international, I don’t think you really included it in your prepared remarks any update on progress with some of the partnerships you signed and I believe you also have an Ex-US agreement with Genzyme, I mean if that’s the case for you will you continue with that agreement?

Chris Hall

Analyst · BTIG, your line is open.

Yeah, we have not broken out the international we’ve announced some of the co-promotion relationships or distributor relationships that we’ve developed over the years. We really see the big opportunities in the United States and it’s where we’ve been investing our time and energy both driving Afirma in the United States, but spending the investment dollars we have in opening up this pulmonology channel because we think we are solving a real problem for patients, payers and physicians in the United States since that’s really where we’re focusing our investment dollars and we think we get the best return for investors relative to international and we have not broken out in international, we don’t plan to do that. With the Genzyme deal the internationals are relatively small piece when we restructured it in 2014. We ended up with activities in a few countries, Brazil being the most important of those and that relationship continues as of now.

Karen Koski

Analyst · BTIG, your line is open.

Okay, thanks so much.

Operator

Operator

Thank you. Our next question comes from the line of Steve Beuchaw from Morgan Stanley, your line is open.

Steve Beuchaw

Analyst

Hi, good afternoon it will be just one for me, a two-parter and not just because I think here we want to make sure that Shelly has some fun on the call as well. So it relates to cash and cash flows, the guidance for cash burn for 2016 was a little higher than I expected, but I want to make sure we look at it in an apples to apples way. So I wonder if you could help us understand whether there are any idiocy chronic drivers of incremental cash spending cash burn in 2016, whether that’s new reps or whether that’s tied to may be facilities, incremental R&D spend and then what is the seasonality of cash burn look like over the course of the year so that we can get a better understanding for what the organic trend is thank you.

Shelly Guyer

Analyst

Great, thanks so much, happy to answer your question. As noted in my prepared remarks the cash burn should be about the same in ‘16 as it was in ‘15 and you’re right there will be some specific idiocy increases in the year. So our goal overall is to actively manage and drive down the cash burn for the year, but on a quarterly basis it is going to be frontloaded. So if you notice in the fourth quarter, the burn was only 7 million and in part that’s because we were reimbursed by the landlord for over $3 million, so that would’ve been a higher burn. We are finishing our facility in the first quarter, so we do expect that we will have a higher burn in the first quarter and also always in the first quarter you are going to have things such as stock bonuses, audit and legal fees, things that always come into the first quarter. So you should expect a higher burn in the first quarter. As we go into the year the second and third quarters will still moderate somewhat, but not drop significantly until the fourth quarter. And so I think as we begin to ramp up entirely on the sales and marketing side as we transition away from Genzyme, but we still pay the Genzyme fee until the middle of September, you will see that really drop off than in the fourth quarter and set us up really nicely for 2017.The final thing I would notice that from an R&D perspective, we are getting ready for a launch at the yearend and we will have three products by year end. And so we feel that it is smart to invest in that R&D for this year, it will be a little higher than you may have expected, but that will then go down next year also. So we are investing in three products we think that position us extremely well for coming out of the year and then for leveraging next year much more efficiently.

Steve Beuchaw

Analyst

That’s just what we needed, thank you.

Shelly Guyer

Analyst

Great.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Paul Knight with Janney Montgomery. Your line is open.

Paul Knight

Analyst · Janney Montgomery. Your line is open.

Hi, Bonnie, the Percepta test, the specificity was 47% in both studies that have been performed AEGIS I and II, any comment on that 47% number should - what is ideal or what do you hope for, any color around that number?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open.

Hi Paul, thanks for joining us. So I mean I’ll mention first the most important metrics for the performance of Percepta is sensitivity and negative predictive value. Because similar to what we’re doing in Afirma, what we’re trying to do with Percepta is following an inconclusive bronchoscopy result, give the physician the information about the level of risk to adapt patients nodule as cancer. So they can choose to follow the pathway which they would typically do which would be an invasive surgical biopsy versus feeling comfortable moving that patient to watch full follow up by CT scan which of course is non-invasive. In order to be confident that that is a safe decision to make, we want to have a very high sensitivity and negative predictive value and I think in AEGIS I, AEGIS II the sensitivity was around 92%. When you look at the negative predictive value or the sensitivity of the overall procedure combining Percepta with bronchoscopy you get to a 98% sensitivity 97%, 98% which means together with bronchoscopy we’re not missing many cancers. Now, what the specificity number tells us is how many patients then would we expect that we could move to watchful waiting that would be low-risk. And the studies would have indicated somewhere around 40% to 50% and I think we predicted that our actual ability to move patients out of that surgical decision to watchful waiting early on we thought might be in the 30% to 40% range, but early indications from the recent studies shows that that could be as high as 50% reduction in invasive procedures. So all the performance kind of threads together in a way that we would expect it to be to support the clinical decisions we want to make.

Paul Knight

Analyst · Janney Montgomery. Your line is open.

And you still think that test will be done in conjunction with the bronchoscopy?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open.

It is, in fact our sample is collected at the same time the bronchoscopy is done. As you might recall there is about a quarter of a million patients every year that undergo a bronchoscopy procedure as part of their work up to diagnose a lung nodule. And the bronchoscopy yields inconclusive results on its own about 40% of the time roughly a 100,000 patients today per year in the US alone. And of course we might expect that number to grow significantly over the next couple of years as screening ramps up. Today the next step that typically would be done following that inconclusive result would be to take the patient into the operating room and get a needle biopsy which is quite invasive costly and risky and so physicians really don’t want to subject patients to that procedure unless it’s necessary. What we have done is position the Percepta test, so that it is collected at the same time the bronch is done. So that if the bronchoscopy is inconclusive the tested sample is already collected, the test can be run and those results delivered to the physician in time to help guide what he does next.

Paul Knight

Analyst · Janney Montgomery. Your line is open.

And what’s your - you have done I think 639 patients in those two trials is that, what’s your ultimate goal in terms of number of patients in the trials?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open.

Yes, right now because we are in kind of the thoroughly commercialization mode, we will be ramping up, we have patients being enrolled and registering over a period of time just like we have done with Afirma where we just saw the 20th peer-review publication come out and many of those on clinical utility. We will be building an ongoing library as evident here just like we have with Afirma, but certainly by the time we get to a couple of hundred patients that have had the test you can look at what decisions we are impacting and have a pretty good prediction of utility. But we will continue to collect evidence overtime and build up the body of evidence which will mean more and more patient numbers in those studies.

Paul Knight

Analyst · Janney Montgomery. Your line is open.

And then lastly I’m assuming that you are really - you are not including a lot of international expansion in this guidance number we’re receiving today?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open.

That’s correct, as Chris kind of articulated quite nicely early on, we do have some seeded partners in international and we have one individual who sort of looks after that business, but we’ve purposely made the decision to not invest what we think we would need to invest to make that a significant growth anthem for us. We are much better served by using our pulmonology products here in the US as that growth engine. Now, that might change two or three years down the road as we get these products here and get them reimbursed and paid for, then we can look at deploying cash in other regional areas where we might be able to drive additional growth. We see it as very opportunistic and very selective right now in terms of the countries and the partnerships we go after.

Paul Knight

Analyst · Janney Montgomery. Your line is open.

Okay, thanks.

Operator

Operator

Thank you. Our next question comes from the line of Bryan Brokmeier from Cantor Fitzgerald, your line is open.

Bryan Brokmeier

Analyst

Hi, good afternoon. Earlier this year the analytical verification study - verification data and the clinical utility data for Percepta were published in separate publications. Is there any other data that would be required for Medicare coverage or what other milestones this year do you need to complete in order to receive that Medicare coverage?

Chris Hall

Analyst

Yeah, what we believe is that we need to have studies for clinical validity and we’ve published two now, the BMC Genomics article and then obviously the New England Journal article and both of those show that when we give a low risk test result the patient is truly at low risk. And those were perspective and really high quality work. The second piece that we need is analytic validity studies which you just referenced and those studies basically show that the test gives the same answer run to run under different conditions and it’s kind of expected that you do that. The third is clinical utility studies and we published our first one and we will continue to invest in those. That is the essence of the library of studies that we’ll be building throughout the year and role our goals to have the product covered this year. There is no magic formula in terms of you need this and you need that and you need this, we think that it’s ultimately - we’ll end up with the really strong submission with strong data and we’ll end up right now with four sets of articles. And quite frankly, to have this much data on a test this early with the New England Journal anchoring it is truly a phenomenal spot for most companies to have in their first product to learn their second product. So we really feel like we’re well positioned and we’ll continue to invest in building data, not just to get Medicare coverage, but it’s a never ending journey. I mean we started the call I think Bonnie said, we had over 20 studies with Afirma and to be clear, we didn’t have anywhere near that when we had Medicare coverage there. So this is an endless journey that we just keep building the depth of evidence that gives physicians, patients and payers the confidence for getting quality results from us.

Bryan Brokmeier

Analyst

Okay and there have been number of competing thyroid tests introduced over the last year, have you seen any positive impact on the market awareness as a result of those competitors coming in?

Chris Hall

Analyst

Absolutely, we always remind people that most of these patients do not get a molecular test done, they get surgery done. And that’s unfortunately, sadly where 70% of them end up getting their thyroids removed and so what we’re all collectively doing, us and the other companies that create noise in the marketplace is we’re trying to dislodge surgery as the means to have these patients treated. And what we know because we’re by far the market leader as we’re successful in doing that, most of those tests end up coming to us. And so we think that having competitors and more discussion and more noise in the marketplace is a good thing as we try to make sure that patients get more data before they have surgery done. And what we know is that we end up shining whenever that happens and I think you can see this year, we just turned in a year of phenomenal growth and it was the year of competitive noise and discussion out there and we were able to perform well on that and we’ve always said, this is good for us and good for the markets and I think the numbers speak for themselves that it’s good for us to have this going on in the marketplace.

Bryan Brokmeier

Analyst

Great, thanks a lot.

Bonnie Anderson

Analyst

Thanks, Bryan.

Operator

Operator

At this time I’m showing no further questions. I’d like to turn the call back over to Bonnie Anderson for any closing remarks.

Bonnie Anderson

Analyst

Thank you all for joining us today. We appreciate your ongoing support and look forward to updating you on our progress next quarter.