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Veracyte, Inc. (VCYT)

Q3 2015 Earnings Call· Thu, Nov 5, 2015

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Transcript

Operator

Operator

Good day, good afternoon, ladies and gentlemen, and welcome to Veracyte’s Third Quarter 2015 Financial Results Conference Call. 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] As a reminder, today’s conference call is being recorded. I’d now like to turn the conference over to your host, Ms. Shelly Guyer, Chief Financial Officer. Please go ahead.

Shelly Guyer

Analyst

Good afternoon, everyone, and thanks for joining us today for our third quarter 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, reimbursement coverage for thyroid and pulmonology test, strategic investments, product expansion and 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 the call are valid as of November 5, 2015 and Veracyte assumes no obligation to publicly update these forward-looking statements. Our financial results press release for the third quarter of 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. We delivered solid growth in the third quarter and achieved key milestones that firmly established our Afirma Gene Expression Classifier as new standard of care in thyroid cancer diagnosis. The Afirma GEC is now included in all of the recently updated major thyroid guidelines and is covered for nearly 155 million Americans through policies deeming it medically necessary. We continue to amass extensive clinical data in all of our programs with more than a dozen studies published or presented at major medical meetings during the third quarter. This included four long term clinical utility studies for the Afirma GEC. We believe the breadth and depth of our clinical program truly sets us apart. And in an era when precision medicine is generating great excitement for its potential benefits for patients in the healthcare system, yet scrutiny over whether it can deliver real world results Afirma is delivering. To-date, we performed more than 45,000 Afirma GEC test, saving an estimated half of those patients from an unnecessary thyroid surgery and removing millions of dollars from the healthcare system. We are also very pleased with the progress in pulmonology where a feedback from pulmonologist regarding our Percepta Bronchial Genomic Classifier and the value it delivers in lung cancer diagnosis has been overwhelmingly positive. We now have nearly doubled our user base in the last quarter to over two dozen thought-leading institutions offering Percepta to their patients as we develop the clinical evidence needed to secure reimbursement for the test. Turning to our third quarter results, I will focus the three areas that define our success in 2015. They are the growth of Afirma, coverage and reimbursement progress and the advancement of our pulmonology pipeline. First the growth of Afirma, or…

Shelly Guyer

Analyst

Thanks Bonnie. As Bonnie indicated, we had a great quarter marked by significant growth in the number of Afirma GEC test performance. Our revenue for the third quarter of 2015 was $12.3 million, up from $9.8 million in the same period in 2014, an increase of 25%. Revenue for the nine months ended September 30, 2015 was $35.5 million compared to $26 million for the same period in 2014, an increase of 36%. Note that we accrue revenue of $7 million or 57% of total revenue in the third quarter of 2015. This is up slightly from our accrual percentage in the previous quarter and it’s more than double our accrual rate of 25% in the third quarter of 2014. Our accrued revenue included one-time pickup from no accrual payers of approximately $130,000. This was much lower than the one-time pickup from the past two quarters. In the second quarter of 2015, we had pickup of $240,000, and the first quarter it was $325,000. Our revenue from cash payers was $5.4 million. And notably, there was no large one-time increases in cash collection from these payers by comparison last year’s third quarter had a pickup of approximately $500,000, with one payers settling all them out due in one large payment. Variability in payment timing from cash based payers as well as from the process of moving payers from cash to accrual creates some lumpiness in our revenue. With some quarters benefitting more than others from one-time pickup, this quarter we had a very little benefit from such increases. We’ve reported 5,034 from a GEC test during the third quarter of 2015. A year-over-year increase of 46%, and this was up 6% over the second quarter. Historically, the third quarter is flat to slightly up from the second quarter in terms…

Bonnie Anderson

Analyst

Thanks Shelly. I’ll now move to our third key area success of the advancement of our pulmonology program. We’ve made tremendous progress with the commercialization of our Percepta Bronchial Genomic Classifier which is designed to help produce ambiguity in the invasive costly and risky procedures that often result in lung cancer diagnosis. The early feedback from ordering physicians has been quite positive. This includes emails from pulmonologist telling us about their cases and expressing great enthusiasm and relief in the test ability to help them make more informed decisions without surgery when their patient’s lung nodules are inconclusive based on bronchoscopy as you know we are focused on signing up a limited number of our leader sites as we assemble the clinical evidence needed to approach medicare for reimbursement. Today, 25 customers across the country have ordered the Percepta just in more than half of these have already ordered the test on multiple patients. More than a dozen additional sites are in the process of coming on board and are formally on track to secure the more than 50 active sites we are initially targeting. We reiterate that we believe we are well positioned to gain medicare coverage in 2016, but we not expect to see meaningful revenue from Percepta until 2017. We have already begun developing the clinical evidence to support the adoption and reimbursement or Percepta following publication in July of our strong clinical validation data the AEGIS trials in the New England Journal of Medicine more AEGIS related data were presented at the world conference on lung cancer in September. And at the CHEST 2015 meeting just last week. The latter included a clinical utility study in which leading researchers evaluated data from the AEGIS trials and concluded that the use of Percepta would have reduced unnecessary…

Operator

Operator

Thank you. [Operator Instructions] our first question comes from the line of Bill Quirk with Piper Jaffray, your line is open. Please go ahead.

Bill Quirk

Analyst

Great, thanks and good afternoon everyone. I am going to apologize at times background noise and you’re doing the costly input. I guess, first question is on PAMA, we certainly understand your arguments regarding just thinking on the PAMA levels going up, certainly understand the argument regarding the gap-fill versus crosswalk. And I guess we’re just going to have to - probably we can - again in [indiscernible] get that. If you could take a step forward and think about PAMA and data collection in such, will you likely be submitting your claims data due to the amount and if so can you help us think a little bit of I guess the stroke of what you’re turning in the network reimbursement out of network reimbursement obviously in some cases you guys are collecting much stock to payers. Just help us think a little bit about kind of how that client work here or what’s we’re going to install in 2015?

Shelly Guyer

Analyst

Okay. Well, there is still a little bit of ambiguity in terms of how all of this will exactly play out. So, we kind of do our best. So, with the reason of course that we got our specific code for the GBC, so that we would be prepared just summit the data that would set it up to be reimbursed in 2017 based on those commercial rates. It’s our understanding that the data that will be used to base those new comer reimbursement rates by medicare will include the liable rates on claims that are paid by commercial payers. It’s our understanding therefore that any claim that is rejected which as you know drag zone on average reimbursement rate that we talk a lot about and we continuously give you an update on those zero allowed claims would be removed from the calculation. We have also said in prior calls that we have worked very hard not to enter a contract with a payers that would have a potential impact on the allowed rate knowing that these gamma rules and this new process is coming about, but having said all of that I think the exact direction and exactly how it will work out for 2017 would depend a little bit on those final decision made by medicare and whether because of gap filled route for our 2016 payments. And so, we would just have to play that out, but once we get that decision we will be able to add a lot more clarity on the exact stuffs and directions that we see for both 2016 and 2017.

Bill Quirk

Analyst

Okay, got it. Thank you very much.

Christopher Hall

Analyst

Something I would add though just quick is that is that the whole PAMA legislation itself is going through a common period and will ultimately catches the pricing, but the actual payment track information is going through its own set of comments and then ultimately a final rule will be published in which time this all become much clear the mechanics of how to work as to report, what has to be reported.

Bill Quirk

Analyst

Okay thanks, I appreciate it. One follow-up and that is Bonnie based on your comments it is safe to assume that any good contract you are entering are going to essentially be close to half of the above where medicare pricing that’s kind of a lead through that you’re trying to imply.

Bonnie Anderson

Analyst

Yes. I mean, it would not have been in our best interest over the course of last 18 months as we moved a lot of these contracts to closure to have answered any contract that would have put an obvious pressure on the medicare price. We’ve been advocating for and actively involved in the PAMA legislation for some time. So, we always expected that would at some point to commercial rates. So, we’ve been very careful to use that negotiating to our advantage.

Bill Quirk

Analyst

Perfect. Thanks so much.

Bonnie Anderson

Analyst

Okay. Thank you Bill.

Operator

Operator

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

Unidentified Analyst

Analyst · William Blair, your line is open. Please go ahead.

Hi, it’s Orco [ph] calling in for Amanda. How are you?

Christopher Hall

Analyst · William Blair, your line is open. Please go ahead.

Fine. Let’s take the question.

Unidentified Analyst

Analyst · William Blair, your line is open. Please go ahead.

I had a quick question about completion and have you seen any impacts on the composition of this or in additionally is there broader takeout message from CMS that you might have glean from you entrench with absolutely.

Christopher Hall

Analyst · William Blair, your line is open. Please go ahead.

I’m not sure I understood the second part of the question.

Bonnie Anderson

Analyst · William Blair, your line is open. Please go ahead.

So, the first was competition and then the second part of the questions you can repeat it was little broken up.

Unidentified Analyst

Analyst · William Blair, your line is open. Please go ahead.

Yes. Where there any broader take off messages from CMS, they’re looking to maybe perhaps reduce the cost and expenses in testing or was it a take home from that and your interactions with it lately.

Bonnie Anderson

Analyst · William Blair, your line is open. Please go ahead.

I will take that one first and then hand it over to Chris to speak to the competition. We don’t believe, we actually believe in an era of precision medicine becoming one of the top initiatives at the highest places in the government that this was more of a process issue as opposed to any intent to drive down molecular diagnostic pricing. I think, everyone agrees that superstition medicine to be successful diagnostics are at the heart of it and I would say that all of our interactions with the CMS administrators and White House staff that we’ve met with would all reiterate that. So, no we do not believe that this is in any way intended to specifically target those industry. And we’re hopeful that it will get resolved in at the end of the day PAMA coming into place will actually be the path going forward that will allow the molecular diagnostics to have a value in market driven pricing.

Christopher Hall

Analyst · William Blair, your line is open. Please go ahead.

On competition, I think everybody following the market knows that there have been multiple competitive entrance into the market and I think from our standpoint there is a lot of positives to that, the single biggest thing we compete against every day are physicians taking these patients to surgery. And you saw that in an ace abstract or not an ace abstract that was presented at the ITC meeting in Orlando, but it look to practice patterns with United States and across the globe and find a large percentage of patients still going on and getting surgery even though a growing number have some form of molecular testing done. We see it all of our market research and we see it in all of your market research that this is the single biggest thing we compete with. However, having people in the marketplace talking about this problem does two things. First of all, it helps us grow market right, because there is more validation that this is an approach that ought to be considered in both surgery. And secondly the data that any of these other potential competitors have is just very shallow data and that’s probably a function of just the fact that they’re brand new. So, it gives us always the opportunity to shine a spot line on what we believe is the strength of a pharma which is a deep library of published data which gets deeper and deeper as the months and the years go by and a broad based insurance coverage. And so, we’re always able to contrast that against any of these other competitors which just haven’t had the time in the marketplace develop any of that. And I think if you get into some of the data and you reprove it you will still see that even as these test have been proposed, you’re still missing way too many cancers to be a role out test at the same level of quality of the pharma. So, overall we continue to think it is a good thing to have more noise in the marketplace.

Unidentified Analyst

Analyst · William Blair, your line is open. Please go ahead.

Great. That’s very helpful. And I just had a couple of follow-up questions that are trajectory related. The first one is I’m not going to miss this first do you know when your price to private rates is that 2017 or is that not yet clear?

Bonnie Anderson

Analyst · William Blair, your line is open. Please go ahead.

This is not yet clear. We just kind of answered that. We have to let PAMA play out the commentary isn’t over yet, the final rolling isn’t out and then depending on the decision that they make for the pricing methodology for us for next year that could implement as well and we would just keep everyone informed as we long along the way.

Unidentified Analyst

Analyst · William Blair, your line is open. Please go ahead.

Thank you. That’s very helpful.

Bonnie Anderson

Analyst · William Blair, your line is open. Please go ahead.

Great. Thanks for joining us.

Operator

Operator

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

Doug Schenkel

Analyst · Cowen and Company, your line is open. Please go ahead.

Hey, thank you for taking the questions and we do appreciate you sharing some initial thoughts on 2016. I believe you indicated that you expect easy growth to approximately 25% to 30% this would seem to represent a little bit of moderation in growth relative to the 30% to 45% rate we see in the last few quarters. Can you provide any additional color on why the growth rate would moderate given the most recent sales force was completed only within the last few quarters and the market still seems to be in a pretty early stage of penetration. Thank you.

Christopher Hall

Analyst · Cowen and Company, your line is open. Please go ahead.

Yes. First of all I think if you look at the overall numbers the same we’re still thinking the growth is roughly the same as its standing year-over-year and the sales force expansion that we went through started at the end of last year and sort of get done last year and so we’re really at a year of sales folks out there now. And so, I still think it’s what we’re seeing for this next year is actually quite aggressive and strong growth as we push forward into this direct channel where we’ve been selling the GEC enabled model and receiving samples directly from hospitals, directly from IDMs, directly from radiologist the sales cycle and that is always longer the community base endocrinologist. And so we still see as whenever your number gets bigger your growth rate will go down and that’s where we are right now.

Bonnie Anderson

Analyst · Cowen and Company, your line is open. Please go ahead.

Yes. We think it still represents a very solid number of GEC test that will have to maintain and go into deeper for the year.

Doug Schenkel

Analyst · Cowen and Company, your line is open. Please go ahead.

Okay, thank you.

Operator

Operator

Thank you. And our next question comes from the line of Karen Koski with BTIG , your line is open. Please go ahead.

Karen Koski

Analyst · BTIG , your line is open. Please go ahead.

Great, thank you. Can you guys hear me okay?

Bonnie Anderson

Analyst · BTIG , your line is open. Please go ahead.

We can. Thanks for joining us Karen.

Karen Koski

Analyst · BTIG , your line is open. Please go ahead.

Excellent. Here, you certainly had a good deal of what I would call very strong longer term data published and presented as of date. I don’t want to call these scenarios will improve, but other payers that were waiting for this waiting data that you think you can now go back to near-term or do you still think that there are payers out there that need more data to kind of get over the hump.

Christopher Hall

Analyst · BTIG , your line is open. Please go ahead.

Yes, I mean, it’s the need for more data, you’re almost right, but if you read the policies that have been issued from the Blue Cross plans they’ve called on wanting longer-term follow-up data. And it in the policies that’s what they’ve asked for inside those policies over the last few years. And so this data coming together, both can only come together after the test has been used long enough. And so we think that this is actually exactly the type of data that they need in order to move Afirma to being medically necessary for their members. So it actually aims squarely at the concern. And I would say, you know, we’re excited about the abstract that was presented from the HealthCore subsidiary of Anthem, where I think it’s the only study that’s ever been done to our knowledge. We’ve looked at - somebody’s looked at actual molecular diagnostic claims, and compared and looked at the clinical utility, not theoretically or not with what doctor said they did, but with what actually happened by how much money was spent. And they saw a dramatic change in the care curve. So we think that type of data is exactly what’s needed by these larger Blue Cross plans to move the needle.

Karen Koski

Analyst · BTIG , your line is open. Please go ahead.

Great. And I guess, as a follow-up, and congrats on the Blue Cross Blue Shield positions in the quarter. In the case of Massachusetts I know it’s a positive coverage and not yet a contract. But, has the preliminary clinical laboratory fee schedule, the terminations impacted your discussion with payers at all? I mean, do they look at that Medicare rate, things that they can get under contracts, it’s the lower rate or are they more focused on your true cost effectiveness data?

Christopher Hall

Analyst · BTIG , your line is open. Please go ahead.

I mean, they certainly do look at the Medicare rate. I don’t that - I’d be honest, I don’t think they really - I mean, I don’t think they know the ins and outs of all that’s occurring right now relative to it all. But we always in our discussions with them keep the dialogue, point it on the benefit and that were saving them and their members. And then the test is cost-effective and at the prices that we’re asking them to compensate us for it. And we try to keep the dialogue focused on that. But the Medicare - I mean, I don’t - they’re not packed into all the minutia of the policy stuff with these smart codes in these contracting organizations who know all of the ins and outs of all the CMS proposals.

Karen Koski

Analyst · BTIG , your line is open. Please go ahead.

Okay. And then, just a final question and again it was nice to see the GEC volumes pick up nice sequentially, where 3Q usually little bit lighter. And back to competition, are you even in fact seeing kind of competitive reps in the field or does it still feel pretty greenfield at this point?

Bonnie Anderson

Analyst · BTIG , your line is open. Please go ahead.

It still feels pretty greenfield at this point. As Chris pointed out earlier, our biggest competition continues to be battling the standard of care today, which is to take a lot of these people to surgery. And it’s a long road. The data and evidence that we’ve amassed, having all of these long-term utility studies come out, because of the length of time now that the test has been used on patients. We have a significant first mover advantage at maintaining that leadership and none of these tests meet the performance criteria to be a rule-out test. And at the end of the day that’s what’s going to drive healthcare cost down.

Christopher Hall

Analyst · BTIG , your line is open. Please go ahead.

Our focus as a thyroid focused sales team is unique among these three companies. We’ve been competing with both Rosetta and Interpace have a suite of diagnostic products that they’re piecing together to be able to offer a comprehensive solution into different customer bases and an CBL pathology offers a comprehensive suite of pathology services. So it’s a very-focused thyroid company calling into this call-point. It’s a unique proposition as compared to having products that are into - that are part of an overall puzzle that you’re offering in a lab or a pathologist if that makes sense. It’s a slightly different approach from a sales and marketing standpoint. At least that…

Karen Koski

Analyst · BTIG , your line is open. Please go ahead.

Yes, no, that’s very helpful. Great color. Great. Well, that’s all I had. Thanks so much.

Bonnie Anderson

Analyst · BTIG , your line is open. Please go ahead.

Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Paul Knight with Janney Montgomery. Your line is open. Please go ahead.

Paul Knight

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Hi, Bonnie.

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Hi, Paul.

Paul Knight

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Can you talk - how are you? I’m at my desk. I’m not on a mobile phone, so I’m unclear I hope.

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Yes, yes, very clear.

Paul Knight

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Good. On the covered live, you’re now 155 million. What’s the optimal number before it is incremental news to investors?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Yes. What will really move the needle and push us towards the 200 million mark will be the wealth - are Anthem and HCSC. So those are the two Blues plans that we have been focused on getting this long-term clinical utility data out and published, and happy to see some of the independent studies that are coming out. And we really believe that these will be the final piece of evidence that’s been requested. And we’re going to push hard to try to get a Blues coverage decision as soon as we can.

Paul Knight

Analyst · Janney Montgomery. Your line is open. Please go ahead.

And then, I know last year the institutional demand was that they want GEC volumes only, I know you’ve addressed that issue. Is it kind of where you wanted to be with the billing process on the institutional side?

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Yes, we’re very pleased. We actually managed most of the billing for all of these because these types of samples tend to be collected in an outpatient setting. And as you can see from what we pointed to is 97% growth of GEC only samples year-over-year, and this is in the quarter, that last year where we began to actually see the uptick GEC only sample. So you may have predicted that growth to drop off a little bit from the prior couple of quarters this year. And it’s still very strong. So we’ve got a good opportunity to continue to drive their - not just with endocrinologist where we amassed a great position, but radiology physicians as well, which we have to serve in this institutional environment. So we think we’re positioned very well to continue that.

Paul Knight

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Thank you.

Bonnie Anderson

Analyst · Janney Montgomery. Your line is open. Please go ahead.

Thank you.

Operator

Operator

Thank you. [Operator Instructions] And I’m showing no further questions at this time. And I would like to turn the call back over to Ms. Bonnie Anderson for any closing remarks.

Bonnie Anderson

Analyst

Thank you, Operator. It has been two years since our IPO. Since that time, we’ve grown from a trailing 12-month revenue of $17 million to nearly tripling our revenues. We’ve moved from being a single product company with $800 million addressable market to one that is poised to launch its third product within a year targeting a combined addressable market of $2 billion. We’ve amassed an extensive library of clinical evidence supporting our products, including both the Afirma GEC and Percepta flagship clinical validation study published in the New England Journal of Medicine. Our Afirma GEC is included in all of the recently updated relevant medical guidelines. And we now have 150 million lives under coverage and nearly 125 million getting access to the Afirma GEC through in-network service contracts. Most important of all, we estimate we saved more than 20,000 patients from necessary surgery and have taken millions of dollars out of the healthcare system. In a nutshell, our molecular cytology approach is working, and our momentum is strong. I’d like to thank you for joining us today. We appreciate your ongoing support and look forward to updating you afore our progress in the future. Thank you.

Operator

Operator

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.