Good afternoon, ladies and gentlemen, and welcome to the Veracyte's Fourth Quarter and Full Year 2018 Financial Results Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded.

I would now like to turn the conference over to Angie McCabe, Veracyte's Vice President, Investor Relations and Corporate Communications. You may begin..

Thank you, Katherine. Good afternoon, everyone, and thanks for joining us today for a discussion of our fourth quarter and full year 2018 financial results. With me today are Bonnie Anderson, Veracyte's Chairman and Chief Executive Officer; Keith Kennedy, our Chief Financial Officer; and Chris Hall, our President and Chief Operating Officer.

Before we begin, I would 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 actual results and/or performance to differ materially from any future results, performance, or achievements discussed and/or implied by such forward-looking statements, and the 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 on a public forum.

Please refer to the company's February 25, 2019 press release and the risk factors included in the company's filings with the SEC for discussion of important factors that may cause actual events or results to differ materially from those contained in our forward-looking statements.

Additionally, non-GAAP financial measures will be discussed during this call. Please refer to the appendix section in our earnings release for a reconciliation of these measures to their most directly comparable GAAP financial measure.

Prior to this call, we announced our fourth quarter and full year 2018 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.

This presentation is also available on our website under Events & Presentations in the Investor Relations section of our website. With that I will now turn the call over to Bonnie Anderson, Veracyte CEO..

Thank you, Angie. And thank you everyone for joining us today as we discuss our 2018 fourth quarter and full-year results and provide you with our outlook for 2019. I am very pleased to report on an excellent 2018 which was a transformative year for Veracyte and one that we believe positions us for continued growth in 2019 and beyond.

This afternoon we reported full year 2018 revenue of $92 million representing a 28% increase over 2017 and genomic test volume of nearly 32,000 an increase of 22% over the prior year. Cash burn for the full year 2018 was $15.4 million an improvement of 39% over 2017.

Our fourth quarter 2018 results were particularly strong reflecting robust momentum as we closed out the year. Our revenue was $25.8 million an increase of 31% over the fourth quarter of 2017 and cash burn was $1.7 million an improvement of 73% over the prior year's fourth quarter.

With a strong position as we enter this year we are guiding to full-year 2019 revenue in the range of $113 million to $117 million. This represents 25% growth at the midpoint compared with last year driven by the growth of our three commercials stage revenue generating products, as well as our biopharmaceutical collaborations.

Also as Keith will speak to in more detail in his remarks, we are guiding to full-year 2019 net cash used in operating activities of $4 million to $6 million which includes $5 million of cash that we received from Johnson & Johnson in January 2019. At the midpoint of the range this represents a 63% improvement over last year.

This afternoon I'll highlight our accomplishments in 2018 and Keith will review our financial results and add some additional color on our guidance for 2019. Then I will share our thoughts on strategic growth drivers of the business and close by laying out the key milestones and catalyst that we expect to achieve this year.

Let's start with a review of 2018. We entered the year with five key metrics by which we would measure our performance. I will highlight our achievements for each of them. The first was commercial growth, our results demonstrates that our multiproduct sales strategy is working.

We experienced a more than 30% sequential growth from third quarter to the fourth quarter of 2018 and the number of multiproduct accounts. And about 30% of our Percepta accounts are also using Afirma and more than 80% of our Envisia accounts are using either Afirma or Percepta.

We are pleased with the leverage we are getting and the cross brand equity we are building with the sales approach. In our flagship Afirma business, we transitioned all of our customers to the Afirma genomic sequencing classifier or GSC.

The GSC runs on our RNA whole transcriptome sequencing platform and enables us to help even more patients avoid unnecessary surgery as part of fibrin cancer diagnosis.

We also introduced the Afirma Xpression Atlas which enables us to inform on hundreds of gene alteration to help guide physician treatment decisions including choices for targeted therapies. We believe our comprehensive Afirma solution extends our leadership in fibrin cancer diagnostic market.

In lung cancer diagnosis, we reported nearly 1550 tests for the Percepta classifier in 2018, the test first full year of broad commercialization. Of note this exceeded the 1500 reported Afirma gene expression classifier test in 2011 which was its first full year of commercialization.

Importantly, Percepta genomic volume accelerated 74% sequentially from the third to the fourth quarter of 2018 and by the end of the year ever 300 physicians at more than 200 institutions had ordered the test. We are also driving strong brand awareness for Percepta among physicians setting ourselves up well for continued growth in 2019.

Notably our internal research conducted last year showed that 33% of pulmonologist surveyed could name Percepta unprompted when asked about genomic testing in lung cancer diagnosis. This is an impressive rate at this early stage.

Turning to the Envisia Genomic Classifier we laid a strong foundation for commercialization upon which to build once we receive final Medicare coverage. We launched an early access program last May to address demand from physicians winning the tests for their patients.

As of today, 30 sites are participating in the program including leading centers such as Cleveland Clinic, Tulane University School of Medicine and the University of California Los Angeles and Emory among others. Next was reimbursement expansion and we are very pleased with the progress we made in 2018.

Early last year we entered into a contract with Anthem and are now in-network service lab for most major health plans and accomplishment that we believe only a small number of genomic labs ever achieve.

In addition to helping to drive further Afirma adoption and reimbursement we believe this accomplishment will facilitate coverage and reimbursement of our Percepta and Envisia classifiers. Additionally in August we received draft Medicare coverage for the Envisia classifier through the MolDX program.

We continue to expect a final positive coverage decision in early 2019.

This milestone would make the Envisia classifier the first test for improved diagnosis of idiopathic pulmonary fibrosis or IPF to be commercially available and covered by Medicare and would also make Veracyte one of the very few companies to achieve Medicare coverage for three genomic tests.

I will now turn to our third measure of success which was scientific innovation. During 2018 we transitioned most of our business to our RNA whole transcriptome sequencing platform which we believe will drive our ability to innovate and deliver value into the future.

The platform enables us to maximize the amount of genomic content that we extract from each non-surgical patient sample. Then we deploy our whole machine learning expertise to develop classifiers that answer specific clinical questions.

Additionally using this rich genomic content we can expand further along the care continuum providing information to help guide surgery strategy and therapy selection all at the same time of diagnosis. Our scientific platform is also attracted to biopharmaceutical company seeking to advance precision medicine.

In April, we announced an agreement with Loxo Oncology through which we are providing them with information on fibrin cancers with TRK fusions and RET alterations for their use in developing targeted cancer therapies.

Additionally in January of 2019, we were thrilled to announce our collaboration with Johnson & Johnson innovation which we expect will contribute an estimated $50 million of monetary and nonmonetary value. We have teamed up with J&J to advance the development of innovative diagnostic test using our novel field of injury science.

To detect lung cancer early when more lives can be saved. Most exciting is the acceleration of our first nasal swab test for early lung cancer detection a market opportunity we estimate at more than $30 billion globally.

Through the partnership, we believe we will also accelerate the transition of our Percepta test to its whole transcriptome sequencing platform. This opens up opportunities to inform other clinical questions along the clinical care continuum and provides the basis for efficiency and continuity in our laboratory operations.

We also delivered strong results with evidence development our fourth measure of success in 2018. In May clinical validation data for the Afirma GSC were published in JAMA surgery demonstrating the next-generation test's ability to help keep approximately 70% of patients with indeterminate thyroid nodules out of the surgery suite.

A subsequent publication in endocrine practice reinforce the Afirma GSC’s performance and clinical utility. We also presented 12 Afirma studies at three key endocrinology conferences throughout the year. These presentations included real world results showing that the Afirma GSC is performing consistently with the clinical validation study findings.

For Percepta, we presented early clinical utility results from our ongoing registry at the Chest Meeting in October. Our findings showed that the test changed clinical decision-making and reduced invasive procedures at every evaluation time point up to 12 months cross testing.

Also at Chest, we present in a clinical validation data for the Envisia classifier demonstrating its ability to help distinguish IPF from other interstitial lung diseases without the need for surgery. We look forward to publication of these data in the near future. Our final measure of success was financial discipline.

We demonstrated excellent operational efficiency in 2018 reducing our cash burn to $15.4 million a 39% improvement over 2017. We will continue to focus on disciplined financial management so that we can achieve sustainably profitable growth over the long-term.

I will now turn the call over to Keith for more detailed review of the financials and our 2019 guidance..

our revenue in cash flow guidance includes 5 million and anticipated revenue from our collaboration with Johnson & Johnson. We expect positive revenue in genomic volume trends from the layering in the multiple products in 2018 to continue to positively impact seasonal trends in 2019.

We expect margins to be stable within the 64% to 66% range excluding the impact of biopharmaceutical revenue that we may recognize. We expect to increase our investment in sales and marketing spending approximately $12 million to $13 million per quarter to support our growth efforts.

Our combined G&A and R&D spend is expected to stay within $1 million band around the average quarterly spend of approximately $10 million. With our strong financial position and continued focus on operational execution and financial discipline, we believe we are well-positioned to achieve long-term profitable growth.

I'll now turn the call back over to Bonnie to discuss our strategy and milestones for 2019..

first revenue growth as indicated by our full year 2019 revenue guidance of $113 million to $117 million driven by total genomic volume growth of 20% to 25% per year.

Second is evidence development as we expect additional publications of clinical validation and utility data forecast which is extremely important to drive early stages of commercial growth and reimbursement expansion.

Third, pipeline advancement with an eye towards data this year on our first nasal swab test for early lung cancer detection and a midyear launch of our next-generation Percepta classifier.

And finally financial discipline, we will continue on our pathway to profitability through the efficient use of resources including our multiproduct sales strategy to drive revenue growth. I will now like to take a moment to make an important announcement.

After nine incredible years of helping to build Veracyte into the company we are today Chris Hall, our President and COO will be retiring on July 1 of this year to spend more time with his family.

Chris I want to thank you for nine amazing years and I would want to acknowledge that everyone listening today your valuable contributions to successfully building our key functional areas including sales and marketing, managed-care, laboratory operations, client services, and billing operations which are all now being led by very strong and very capable executives a true sign of a great leader.

Join me in a round of applause for Chris. We plan on transitioning Chris’ responsibilities as we near his date of retirement while we are very sad to see him leave on behalf of everyone at Veracyte we wish him well on his new adventures. So in summary, we are thrilled with the results we produced in 2018 and are really excited about 2019 and beyond.

We are expanding our capabilities to advance the early detection of disease to save lives, further improved diagnostic accuracy and informed treatment decisions.

We believe that through this approach as well as continued operational execution and financial discipline, we will continue to drive even more value for patients, physicians, the health care system and our shareholders.

Finally I'd like to thank all of our Veracyte employees for their ongoing dedication without their focus creativity and hard work we would not be in this exciting position that we are in today. I will now ask the operator to open up the call for questions..

[Operator Instructions] And our first question comes from Sung Ji Nam with BTIG. Your line is open..

Thanks for taking the questions and Chris congratulations and thank you for your contribution.

So maybe for starting off your Percepta customers, I know this might be early but are you seeing an increase in bronchoscopy procedure even if anecdotally among the customers who are using Percepta or among those who have been using it for a while?.

Chris why don't you take that..

Well I think that the overall position of the product is to do less invasive procedures because we resolve a good chunk of the bronchoscopies that are non-malignant and that's been the core value proposition. We've been really excited that that's been embraced.

I think one of the challenges with lung cancer diagnosis is always been that patient sometimes goes straight to a TTNA or go straight to a surgical lung biopsy rather than a bronchoscopy.

And we've always believe that the product successfully use my make bronchoscopy be more successful which would mean more invasive procedures to start, but it's too early to say that that's happening. I think that at this stage we're just really excited that the core value proposition of the product is being embraced..

And then on Envisia if I'm remembering this correctly, I feel like this is a product where you have engaged KOLs - not only from the U.S. but also from Europe from the very beginning.

So was wondering if there might be efforts underway from a commercial standpoint could also be early here but was curious as if there are any kind of commercial strategies that you guys are putting together?.

Yes, I think 2018 was interesting because of all of our products. This is the first product that we've ramped in early access program for mostly because of physician demand and we did hold a scientific advisory board meeting about a month ago.

And we had participation from physicians in Europe where there is a lot of - it’s a small community of experts that drive excellence in care and trying to get these ILD patients diagnosed. We did have three to four of our clinical trial sites in Europe.

So while we've always been hesitant to not to get too far out in front of spending to open up new markets outside the U.S. it's certainly something that we’re looking at but we have no immediate plans to go after that.

I think right now we’re focused on the near-term goals of getting the Medicare decision finalized in getting our price established there. And ramping from - we have increased the early access sites by a few so we’re now up to 30 and then we’ll focus on the methodical expansion of that through 2019.

And I think do some groundwork to see whether or not offering this test more broadly would make sense perhaps in 2020..

And then lastly from me just a housekeeping question for Keith, sorry if I missed it but is there incremental contribution from Loxo Oncology this year for pharma services?.

So we are expecting another $1 million return 50,000 per quarter. That’s 1 million and it will be we've said 5 million from J&J so 6 million in biopharmaceutical revenue what we had last year..

Our next question comes from Puneet Souda with SVB Leerink. Your line is open..

Bonnie congrats on the quarter and Chris thanks for all the great work, we’ll definitely miss you. So, first one if I could ask on J&J just want to clarify the 15 million that you have potentially longer term.

I just want to clarify 2019 you're baking in only 5 million of that or is there any additional contribution that you're expecting in later part of the year?.

That’s right we’ll update you throughout the year..

And then nasal swab could you elaborate Bonnie just in term of the data when should we expect - you gave sort of sometime layer on data. But just wanted to understand of what sort of venue would this data be in and sort of how should we be benchmarking this data should this be compared with Percepta here.

And then I just have a quick follow-up on Percepta as well?.

Yes I think as our program is always unfold we usually - the first data that gets unveiled either at a meeting or sometimes we hold a special meeting to unveil data to key opinion leaders those involved in the clinical trials with us, I am sure that will involve J&J this year.

Is usually looking at what early classifier development looks like and whether or not the performance goals that we set for our product which will be a little bit different for this product then it is for Percepta.

Percepta is positioned to really improve with very high sensitivity, the ability to detect low risk patients so they can be halted from further invasive procedures and be followed by follow-up CT because we know those patients have nodules.

There are a couple different places in the clinical pathway of care that we envision developing nasal swab tests. This first test we will reveal more about that positioning as time goes on, but I would say I know in the last half of the year we will be in a good position to see some of the early discovery data unveiled.

And if we get more clarity on what and when I'm sure we’ll well show that with folks..

And then just on Percepta I know you started out the year with a thought so that you will exit 500 to a 1,000 on Percepta and you’re exiting at 650.

So just wanted to get a sense of in 2019 how you're looking at Percepta overall and the contribution here and the reason, one of the reasons I ask is it new entrant to the market from a liquid biopsy I think and this position through a different pathway you are more closer to the pulmonologist in this.

So maybe just educate us how you're thinking about positioning of Percepta in the market with some new entrants as they try to enter from a liquid biopsy? And thank you..

Yes, I think that we always talk a lot about one of our – one of the things that we believe we do really well as a company, is not just the development of the test but figuring out how to integrate the test into today's standard of care.

So that it is positioned at a point where it really adds a lot of value to what the doctor is doing today and doesn't require the doctor to believe in the test to not do what they might do today as a standard of care procedure to get the diagnosis.

And I think that is even more important in an aggressive cancer like lung cancer then it was with our Afirma program. And so I think with some of data that we shared in our prepared remarks of the number of doctors 300 now across 200 institutions ordering the product.

We just came off of a meeting actually just in the last few days the lung cancer meaning where the team was quite excited with the reaction from the doctors in one form we were asking physicians what they want them for the future and they told us that they thought the current product was totally on point so just help them get it used more and more.

These things are always anecdotal but pretty exciting news to hear. I think that are focus on having Percepta position to complement bronc and yield a 97% sensitivity.

When you think about that when you combine our tests with its companion procedure we are only missing a small, small number of cancers in order to improve the overall care and reduce invasive procedures that’s the kind of stuff we look for.

So if we were to come in advance of the procedure you certainly have to be as good if not better than that in terms of missing cancers and especially when it’s one cancer. So that sets a very high bar weekly for performance on any new tests that might come along.

I also think that people have to realize the length of time it takes to deliver the results from these studies that we talk about having data on today.

This is at three, four year, five year journey to get these studies in place, IR being in patient consent so that we can follow the patient collect all this data and then we're already a year plus on the backside of a Medicare coverage decisions. So we feel really, really good that we are getting significant uptick.

Our customers are really happy with the product and we are positioned to expand that in 2019 gain more reimbursement coverage from commercial payers. And in terms of some color around what e that could look like we’d expect Percepta volume and revenue would probably roughly double in 2019 over 2018.

And if you just look at what it takes to continue to drive traction as we would exit the year, we were pleased that we ended 2018 right where we thought we would be.

And Envisia of course will be a little bit behind that there I think we would expect that a 500 to 1000 tests in 2019 and of course that assumes that we would get a final Medicare coverage early this year in the next couple of months.

So that sort of how we look at it, we have a lot of experience now and in how these products ramp and what it takes to get not just volume but sticky volume that allows us to become part of the operation within the institution that's doing the work out and that's key to success..

[Operator Instructions] And our next question comes from Paul Knight with Janney Montgomery. Your line is open..

Congratulations on the quarter and congratulations on the retirement? How much service are you expecting in the year 2019?.

Biopharma service revenue?.

Yes..

So we would estimate that now at about a total of $6 million in revenue that includes the estimate and $5 million from J&J that we spoke about on the back of that announcement and then about 1 million in addition to that. We think the majority of that given the structure of the J&J deal will be recognized in the first half of 2019.

And it could be higher depending on the timing of some of the milestones achieved in the financial treatment of some of those milestones but that is our best directional guidance at this point..

And Bonnie J&J has made a large investment of over 3 billion for Auris to do, I guess next generation biopsy technology in the market.

How do you feel that new generations of biopsy technologies fit in with your long tests I should say with house is it fit in with the continuum of the swab test someday and also Percepta?.

I think it will end up being quite a compelling investment and compelling offering across the lung cancer area was quite excited to be a party to it. And I think as you think about where we are today what will happen out of all of these initiatives is the effort to get earlier and earlier at diagnosing and treating early cancers.

And so through J&J's efforts at looking at ways they can do surgical procedures et cetera less and less invasively, but we’ll also be moving to earlier and earlier size nodules. And many of those nodules depending on the site couldn’t be reached by any bronchoscopy device.

So I think the market is going to be really transformed for lung cancer the size and stage of cancers that are going to be detected three four years from now are not going to be the same as they were five years ago.

When many of these clinical trial s were done and I think being teamed up with a consumer oriented company with their eye on early detection like J&J and our nasal program is going to position us very modernly with the testing of cohorts that represent what this new stage of patients is going to look like in lung cancer and unfold our programs for discovery and validation in that space where we will likely be in a leading position as that market changes over time.

So we’re pretty excited about it..

And lastly Bonnie what is the sensitivity of traditional biopsy does it still not require.

If I can do a biopsy could I not also use Percepta in conjunction if I can do a better biopsy?.

Well biopsies by nature depending on the institution of course and the quality of the care center, sensitivity can be anywhere from 40% to 60% and that’s exactly the rationale behind us positioning Percepta as a complement to the bronchoscopy biopsy because we give the physician a reason to do the procedure and as one of our KOLs describes it, we save every biopsy by providing an answer.

So we’re not having doctors stop doing what they do today that they're comfortable and confident in and having to develop confidence in a new test replaces that. We’re just increasing overall confidence in what they are doing today because our test is making it better.

And we think that is a smart way to introduce tests into new markets and new indications and build the scientific credibility with these thought leaders and users of our tests so that down the road we might be able to evolve to bring test that are positioned differently. And that's exactly what we’re doing across our lung cancer portfolio..

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

Chris congratulations to you on the retirement. I know [indiscernible] is bumped that you beat him to retirement as he is already touched, so congrats. So I think a lot has been asked but just a couple of quick ones here.

First Keith can you elaborate a little bit on the need for the specific investments that you guys are planning on for 2019 that will value you to grow with that 25% can you just be a little bit more specific on what you're doing there?.

We’re investing again another year of putting our money into sales and marketing as I covered in the prepared remarks. We’re spending of around $10 million, $10.5 million on a quarterly basis last year. We’re going to 12 million to 13 million this year.

We found that provides a very nice return investing in the sales force and touching physicians and ordering physicians. And so that's where we're continuing to push on that lever..

And then on Xpression Atlas, can you give us any idea about kind of contribution that is seeing at this point and the feedback you're getting and how do you move that beyond, I think you said it 30% of Afirma GSC orders are coming with that.

But how do you technically kind of move that higher and do you have any thoughts about where that should be next year or even longer term?.

Yes, well the way to think about it in terms of percentages is that when we do a genomic sequencing classifier test in thyroid today roughly 70% of those patients are going to be benign and so having 30% of the suspicious patients, the other 30% of the suspicious patient will be the ones that will benefit most from the Xpression Atlas because that's where you will guide extend a surgery and whether or not targeted therapies could be a consideration.

And so we would never expect to get the number of orders coming in with Xpression Atlas super, super high, but what we want to do is make sure that it gets ordered on those that end up not being benign and driving those patient to a better quality of care.

I think it’s early and I think we do have evidence that the new, the new brand material that was rolled out beginning actually the end in January/February. We always have a very massive national sales meeting at that time of the year and a lot of this new material and new data is just still coming out on Xpression Atlas.

So I think it could edge up to perhaps may be pick 50%/60% of orders over time that the key will be getting those orders so that the patients that can benefit those will benefit. And in terms of the revenue piece, we don't track this product as a separate product you just end up getting into the weeds and all these things.

We do bill, we do get incremental revenue from the product but we sort to track it as an overall number with our GSC and Afirma genomic testing. And that way it just kind of keeps it simple and not too many assumptions going in can be wrong and sort of magnify each other.

Does that makes sense?.

Yes, makes total sense. Thanks for the detail on that and congratulations on a really good strong solid 2018..

Thank you. And I’m showing no further questions. We would like to thank everyone for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day..