Good afternoon, ladies and gentlemen, and welcome to Veracyte's Second Quarter 2019 Financial Results Conference Call. As a reminder, today's conference call is being recorded. I’d now like to turn the conference over to Angie McCabe, Veracyte's Vice President, Investor Relations and Corporate Communications. You may begin.

Thank you, Dawn. Good afternoon, everyone, and thanks for joining us today for discussion of our second quarter 2019 financial results. With me today are Bonnie Anderson, Veracyte's Chairman and Chief Executive Officer; and Keith Kennedy, our Chief Operating Officer and Chief Financial Officer. Before we begin, I'd like to remind you that various statements that we may make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements include those regarding our future plans, prospects and strategy, financial goals and guidance, product attributes and pipeline, drivers of growth, expectations regarding reimbursement, and other statements that are not historical facts. Management's assumptions, expectations, and opinions reflected in these forward-looking statements are subject to risks and uncertainties that may cause the actual results and/or performance to differ materially from any future results, performance or achievements discussed in or implied by such forward-looking statements, and that company can give no assurance they will prove to be correct and will not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum. Please refer to the company's July 30, 2019 press release and the risk factors included in the company's filings with the SEC for a discussion of important factors that may cause actual events or results to differ materially from those contained in our forward-looking statements. Prior to this call, we announced our second quarter 2019 results, which are available on our website at veracyte.com under Press Releases in the Investor Relations section. We also published a financial presentation, which Keith will reference during his remarks. The presentation is also available on our website under Events & Presentations in the Investor Relations section of our website. I will now turn the call over to Bonnie Anderson, Veracyte’s Chairman and CEO.

Thank you, Angie, and thanks everyone for joining us today for our second quarter 2019 earnings call. We had another terrific quarter in which we continued our strong momentum and delivered exceptional results across the business. We generated record revenue of $30.1 million an increase of 32% and genomic test volume of 9,663 tests, an increase of 26% over the second quarter of last year. In tandem with this growth we improved our net cash used in operating activities to $2.5 million, an improvement of 21% over prior year. Based on these results, which exceeded our expectations and our increased visibility into the rest of the year, we are raising our full year 2019 revenue guidance to a range of $119 million to $122 million. We are also improving our outlook for net cash used in operating activities to a range of $2 million to $4 million for the full year and remain on track to reach operating cash flow breakeven before the end of 2019. I will now provide updates on the key metrics we're using to measure our success in 2019. The first is revenue growth. Starting with pulmonology and specifically with idiopathic pulmonary fibrosis or IPF, Medicare coverage for Envisia Genomic Classifier went into effect in the second quarter and we began to ramp commercial expansion. We increased Envisia test volume as well as the number of institutions ordering the test by more than 100% sequentially from the first quarter of 2019 to 130 tests and 76 sites, respectively. And Envisia test volume represented approximately 15% of our total pulmonary product volume in the quarter. We remain on track to report Envisia test volume of 500 to 1,000 tests for the year. In lung cancer, we achieved over a $1 million in revenue for our Percepta Classifier…

Thank you, Bonnie. As Angie mentioned earlier our second quarter 2019 financial presentation is available under events and presentations in the Investor Relations section of our website. Turning to Page 3 of our financial presentation, our performance against six financial key performance indicators or KPIs for the second quarter of 2019 as compared with the prior year’s quarter including select highlights for each metric at the bottom of the page are as follows. Revenue of $30.1 million increased 32%. Excluding $3.5 million of biopharmaceutical services, revenue of $26.7 million increased 20%. Genomic volume of 9,663 reported tests increased 26%. Gross margin of 71% increased 700 basis points. Excluding biopharma services, gross margins increased 400 basis points from 63% to 67%. Operating expenses excluding cost of revenue increased 20%. Net loss of $2.5 million improved 60%. Net cash used in operating activities of $2.5 million improved 21%. And at June 30, we had cash and cash equivalents of a $193 million. Turning to Page 4 of the presentation. Our performance against the six KPIs for the year-to-date period ended June 30, 2019 compared to the same prior year period shows strong comparable performance. In next six pages outline the sequential and year-over-year results underlying each of the six financial KPIs. A few observations. As illustrated by the revenue and genomic volume trends on slides 5 and 6 we continue to see positive momentum across the business. Our lung portfolio represented approximately 875 tests or 9% of our genomic volume this quarter. Turning to Page 12 and our 2019 guidance, as Bonnie stated earlier in her remarks, we’re increasing our revenue guidance to a range of $119 million to $122 million. At the midpoint of the range this represents a 31% increase over last year. We are tightening the range of our…

Thanks, Keith. In summary, we had a terrific quarter in which we continued to execute driving revenue and genomic test volume growth across the business. Our first-to-market Medicare coverage, genomic classifiers and biopharma collaborations are contributing to strong revenue growth. And our multi-product sales strategy is enabling us to drive this growth cost effectively. We also advanced our pipeline launching our next generation Percepta Classifier in lung cancer, while progressing our nasal swab programs for early lung cancer detection. Our world class scientific capability and technology are positioning us to answer additional clinical questions along the clinical care continuum and our recent capital raise gives us strategic flexibility, as we make the promise of precision medicine a reality for patients. I would now like to ask the operator to open the call up for questions.

[Operator Instructions] First question comes from Sung Ji Nam from BTIG. Your line is open.

Maybe starting out with Envisia, would love to hear any feedback you're getting, seeing a nice growth there initially. And then as you look at the number of sites using both Envisia, what's the overlap between the sites that are using both tests versus using each separately? And then also curious about what your strategy is in terms of selecting sites for Envisia, given that -- are you targeting kind of the IPF -- major IPS centers there or are you picking more of a kind of a broader kind of community type of setting that might benefit more from -- might realize the value proposition more for the test?

Well, Sung Ji, thanks for joining us and thanks for that very rich question of multiple levers. We will try to work through all those. Envisia is definitely getting off the ground very well. This test addresses such a big unmet need because other than surgery when HRCT is not confident for diagnosis, recognizing that UIP pattern which really only happens in general 25% to 30% of the time, there is no alternative. So bringing this test to market we knew there would be high demand and high unmet need and we're very pleased to see the level of interest. We also always anticipated that we would get sort of that extra leverage in pulmonology and in fact if we go back to the strategic rationale of doing our Allegro acquisition when we did in 2014 it was partially the result of the fact that our next pipeline product to bring to market was also in pulmonology. So we've always seen that that synergy would be there. Nevertheless as you also point to, there are different often clinical specialists that focus on one disease area versus the other. And so, we recognize that as well. And I have to point to, in fact I'm going to ask John Hannah who's here in the room with us today, our Chief Commercial Officer to speak briefly to this at the field level, but we've actually designed a structure of our sales team to include specialists and levels of people that can address these both collectively unifying the pulmonology call point, but also at a specialist level as it addresses unmet needs that are slightly different and perhaps different specialists that treat IPF/ILD patients versus lung cancer. John, do you want to add a little bit of color to that?

Yes. I'm happy to. Thanks so much Bonnie and thanks for the question. We're seeing a tremendous amount of synergy at the field level inside these pulmonary practices where they're performing lung cancer diagnostic bronchoscopies but their colleagues are also treating and managing interstitial lung disease in the practices. And so once we're within the account we have a relationship and our specialists can expand the business beyond lung cancer into ILD, it becomes a really effective way to grow. And as Bonnie shared, we grew by over 100% quarter-over-quarter in the Envisia volume and a lot of that is due to the ease of us kind of getting into those practices and then expanding the use of our product portfolio across that pulmonary practice once we're there.

And then just one follow-up, it's nice to see that Veracyte continues to focus on operational and financial discipline. But given the recent shaking of the balance sheet, would love to hear your thoughts and kind of what the cash deployment strategies or priorities are over the next I guess few years?

Yes, I mean I think as $1.4 billion company, we have the right level of cash on our balance sheet. So the market cap of the company, you’ve seen, can always come up when you want to have the strength there. And we certainly use a portion of it to pay down the debt essentially, so we're debt free. So that's all good. And I think also we're in a really great position having executed so well across these multiple clinical indications and with a strategy that is working very well sort of not just in gaining leverage at the field level in how we're structuring and now executing on that, but also the leverage of our scientific approach, the building up of clinical cohorts, all these things that can be repeated. So we think we're in a great position. If strategic options would come along, we now have the cash to take advantage of that as well. So it just positions us I think, as it should in the marketplace with lots of opportunities and options that we can act on.

Your next question comes from Puneet Souda from SVB Leerink.

Hi, Bonnie, congrats on the quarter. So first -- and obviously to Keith as well for having the additional new role. Now I get to ask him maybe twice the questions. If I could ask Bonnie just on, in terms of the biopharma collaborations, that's been a positive driver for you and then obviously including the guide for the year as well. So wanted to get a sense of potential leveraging of these biorepositories of lung and thyroid into more broader collaborations and sort of what efforts are you doing there? And how should we think about that opportunity longer term for you?

Right. Well, it's an excellent question. I think, as we -- maybe unlike others in the space, we did not expand into biopharma services specifically to drive a new segment of the business unto itself. We were very much looking at taking the indications that we're in and leveraging our assets, our capability, our position in clinical diagnostic testing and leverage that into relationships with biopharma that would bring additional value. And that value can be created as you can see in many different ways. In our Loxo collaboration, it's being driven by the fact that we are a clear market leader in the thyroid cancer testing space, then the volume of the doctors we touch every day, the samples we bring into our laboratory, coupled with the fact that every sample we run is run on our whole RNA transcriptome platform, allows us to gain more knowledge around those thyroid cancer samples and thyroid cancer in general than anyone else out there. So their interest in targeted therapies as it relates to these rare variants that often would be more difficult to find, we were a great stopping point, given the volume of our commercial sample of repository. In the case of J&J, it was really tapping our joint interest in tackling the issue of people dying with lung cancer. Both companies focus on early detection, J&J looking at early detection and interventive therapies that can impact disease and the strong collaboration that we built through the acquisition, of course, and then onwards into the work we're doing with them today around their work in field of injury and how we can advance less invasive sample collection tools to address broader and broader and broader market opportunities over time. So I think the collaborations can take on different shapes and sizes, but it all comes back to us building something here at Veracyte that is another value creation lever for the business. We believe that Envisia is another opportunity as we go forward. I mean it’s very early with Envisia because we're just now getting ourselves established in the marketplace, but there is no question that there is going to be many stakeholders looking to improve the diagnosis of IPF whether it be in early drug trials, in patient enrollment end trials or just better management of patients and prescriptions of therapy for those cases and we are really the only company and very nicely positioned to have an impact there. And so, I think as we go forward with Envisia over the next 12, 24, 36 months, we will be gaining a lot of credibility as a market leader in really changing the whole diagnostic paradigm for this disease in these patients and we hope we can help to get them diagnosed earlier on treatment earlier and help to advance better therapies to market and it will all be win-win for everybody.

Great. Thanks for that. And then maybe a broader question now. You have the three products in the market, just if you could share your thoughts about the product expansion and how you are sort of thinking about and maybe how potentially Veracyte could look to potentially three to five years from now, anything you can share there would be helpful?

Thank you, Puneet, for the question. I appreciate it. Yes, I think that our strategy -- we are really only 11 year old company. We were very focused for many of those years around building out a base of products now with three clinical classifiers, we have actually brought five of those products to market because two of them are already second generation tests, but building a strong hold at the point of diagnosis of disease. We think that entry point into the marketplace is very attractive because it allows us to be working with doctors and health systems and specialists alike to improve on the diagnosis of disease and then with technology that we are tapping be able to answer other clinical questions, downstream clinical questions at the same time of diagnosis. So, the fact that we have build all of our clinical biorepositories and all of our knowledge around a broad-based disease at the stage of diagnosis, we have got patients with the disease, without the disease, expected to having this disease, early disease, late disease, metastatic disease, you name it, that's all in our arsenal. And then, combining that with the reach of whole RNA transcriptome data and having the capability scientifically, machine learning and all of that, pipeline development that we have in data side, we have been able to show that entering in the thyroid space, in the diagnostic space, has allowed us to answer downstream questions at the same time of diagnosis that is now impacting surgery decisions and treatment decisions for these patients. And thyroid cancer is not the poster child for targeted therapy and early decisions around treatment but other indications that we’re in are. And so, we believe this strategy is really powerful and the tools that we're using allow us…

Your next question comes from Brian Weinstein from William Blair. Your line is open.

So just to start out with something on pricing. Can you just give some directional insight into your expectation for recognized revenue per test by product, and how that is -- how you expect that to trend through this year? And then also kind of longer term, just how those reimbursement -- or how the pricing is going to trend up and how we should be thinking about the pacing of that for Envisia and Percepta, if there's any kind of new thoughts on that as that continues to grow?

Absolutely. Thanks for joining and asking questions. Keith?

Thank you, Brian. As I talked about last quarter, look at the revenue rate per reported test, just at a high level, and on Afirma our underlying guidance implies $2,700 revenue per reported test and $1,300 for each Envisia and Percepta that was plus or minus, but those are round numbers that gets you to the midpoint of that range. And I would expect that obviously Afirma, we've completed the journey on the managed care side. We still have obviously -- last quarter, we had TRICARE that we added. We continue to add things, but as you already got 207 million covered lives it doesn't move the needle as much when you add three or four plans. But we are continuing to make progress on Afirma. Percepta and Envisia, we're going through the journey there. We got coverage -- our effective coverage, as Bonnie mentioned, on Envisia for Medicare on April 1st, we had coverage for Percepta. So we're covered on all three products at Medicare. But those commercial journeys will happen over the next couple of years as we develop clinical evidence and adoption at the facilities and physician level.

Yes. We always believe that the evidence will drive guideline inclusion and guideline inclusion is the biggest lever at driving the rest of the commercial payer coverage. It's -- we’re in a unique -- a different position with the two lung programs given that those patients are roughly half Medicare. And so there is a lower volume distributed amongst all of the commercial payers. So the timing of when we actually lean in on a given payer to request and work with them on coverage, you just want to make sure you have enough members using the test in those region before you approach them, because you don't want them to reach out to their provider base and not have more than one doctor aware of the test. So, when it's early, that's always a little challenge. But, I think we are on track to continue. We continue as we have this quarter to proliferate incredible evidence. We continue to get our evidence published in top tier journals and that will continue. And I would expect over the course of the next 12 to 24 months, we will be skinned to move the needle meaningfully and the coverage of Percepta and Envisia at the commercial level and that will start to march that average reimbursement price up the ladder. Our reimbursement for Medicare Envisia is a little bit higher than where the other products are. I think we said publicly that sort at the high end of that 3,000 to 4,000 range we had given. But ultimately as these tests all reach their peak in reimbursement we'll be in terrific position expanded margins and a great financial story as a result.

So Brian as you are thinking through this, we have done a really nice job on the cost of revenue side. So our cost of revenue for these past have come down around $700 and that was $800, close to $900 not too distant past. So when you are thinking about $1,300 in revenue from these new products, it’s going to be this period here where we're going on that commercial journey as we get up to the Medicare rate of $3,000 to $4,000 for these tests where we're going to spend more on our OpEx than we are on total net profitability like we have in Afirma. But we do believe that will be a defined period of time and we'll talk more and more about that as we move through the quarters and in the next year's guidance.

That was a great detailed response. Thank you for that. I don't think that you just specifically said that, sort of backing and everything that you kind of talked about, there is no change to the expectation for the year, genomic customer volume growth of 20% to 25%, correct?

That's right.

That's right.

That should imply somewhere between 39,000 or 40,000 tests. We have about -- we have two less days in the next quarter than we had this quarter. So it’s probably about 300 tests or about 4% sequential quarter basis. You are looking on a days basis, but we are looking at around 10,000 to 10,500 tests a quarter sort of average for rest of the year.

Okay. Great. And then last on from me. Where you guys on your sales force right now? Do you think if there is any need to expand sales force in any way over the next kind of six to 12 months? Are you guys happy with where things are today? Thank you.

Yes. Thanks for the clear question. Brian, as we have always said, I mean we have a model that will -- we will continue to expand our sales team. But what we're doing is expanding the sales team in cadence with how we want to drive revenue -- volume growth which will drive revenue with a little bit of tailwind and then doing that at a pace, where we can keep the operational spend in check. And that's actually the model and the recipe we're following to get to the positive results on cash flow. And we think it works very well. John actually has a very detailed model and the hiring is done at particular times in the year, it takes four to six months to get these reps up to speed. And we always build that in as we're building the hiring plan in advance of delivering the future growth. But it's a pretty home model and John has done a terrific job of leading all that. So thanks for the questions.

Your next question comes from Steve Unger from Needham. Your line is open.

And just to start-up, I was just curious if you could give us a little bit more color on the ordering trends for Xpression Atlas. It sounded like you're starting to see that populate most or even the majority of Afirma ordering? And then if you could just give us some color as to with the new Percepta GSC, how would that product inform treatments?

So I'll start with Xpression Atlas, because whether Xpression Atlas is -- today that's an Afirma product, because the variants that are curated and validated and reported off of the Xpression Atlas tests are all done as part of the Afirma testing portfolio. And so there some of the variants actually can drive decisions around extent of surgery. So not everything that is a variant informs a treatment, of course. But now that we can inform on all of these, at the same time that we're moving 70% of the patients to a benign call, we're finding that our solution is resonating with more doctors out there. And that more of the patients that they are testing, they are willing to send for Afirma testing, because just our portfolios of answers has grown and the second generation test has certain subtleties of performance improvements over certain subtypes of cells. So that's all going very well, but the Xpression Atlas was launched last May. These new products that aren't answering a very specific clinical question sort of takes some time to resonate. We came off of the early meetings this year, ACE and ENDO where I think for the first time probably at ATA last year in the fall we had the first ever focus on targeted therapies in thyroid cancer. So you have to keep in mind that this whole field is still very young in thyroid cancer, because we have this silver bullet of radioactive iodine that has been predominantly the treatment of choice. These new therapies that are pan cancer therapies are being tested in areas of recurrence of disease where it looks like they're having quite a positive impact. So going forward, that standard-of-care could change. In terms of Percepta GSC and where we will head there informing treatments decisions, it's really going to be a repeat of the strategy that was played out with Afirma. It's taking the platform that we're running the Percepta GSC on, be able to curate the targets that are interested in targeted for lung cancer therapy and see how we might be able to package our solution in lung cancer to answer those questions at the same time that we are answering questions on diagnosis. It's really about shortening the timeframe, eliminating the follow-on procedures to get more samples and being able to do it all quickly to get the patients on the best treatment that they can get on as fast as possible. And now that the Percepta has moved over to the next generation platform, we have the opportunity to start that turning as well.

Got it. Great. And then, as far as the biopharma services milestone payments from J&J, it looks like you got the Percepta milestone. What is the next milestone that you’ve added to guidance, what is that related to and what quarter do you expect that to hit the P&L?

Our milestones were driven across two products, the Percepta GSC which you might imagine are the ones that have accelerated given that we did accelerate that program when we announced the collaboration being a part of all of that. And then we have other milestones that relate to the advancement of nasal test and I believe -- one of those milestones I believe is what we are targeting to achieve this year. And then there will be additional milestones yet to come that will relate to the nasal programs moving along.

Keith, that was the third quarter you expected.

Yes. So, we expect to recognize $2 million in the third quarter from J&J. We do not currently expect to recognize any revenue in the fourth quarter but we'll see how things develop.

And we expect because these are milestone driven, this revenue in the biopharma side can be very lumpy and unpredictable. So we will be continuing to keep our focus on the product growth areas, the growth of our key clinical products and then we will try to give you some specifics like Keith just did on when these boluses of revenue could fall from services side.

And then I would add just because you’re sort of new to story and we are recognizing $250,000 in service revenue from Loxo each quarter and we will expect to recognize that in Q3 and Q4 and then in next year as well. So you’re keeping that since Johnson & Johnson really just don’t leave that off the table either.

Right.

Understood, understood.

Okay?

Yes. Thank you.

Thank you very much for joining us today.

Ladies and gentleman, this concludes our call today. Thank you for joining us. You may now disconnect.