CareDx, Inc
Q1 2018 Earnings Call Transcript

Published: 13 May 2018

[Operator:]

Greetings, and welcome to the CareDx First Quarter 2018 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would like to turn the conference over to your host, David Clair. Thank you. You may begin.

[David Clair IR:]

Good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended March 31, 2018. The release is currently available on the company's website at www.caredx.com. Peter Maag, Chief Executive Officer and President, and Michael Bell, Chief Financial Officer will host this afternoon's call. Before we get started, I'd like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including, without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing and enrollment matters and our future financial expectations are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. CareDx disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains sensitive information and is accurate only as of the live broadcast today, May 10, 2018. This call will also include a discussion of a financial measure that is not calculated in accordance with Generally Accepted Accounting Principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release filed with the SEC. I will now turn the call over to Peter. Peter Maag Thanks, David, and good afternoon, everyone. Thank you for joining us. We had an exciting first quarter. Most importantly, we gained significant traction on our transplantation focused initiatives. We recently welcomed the National Kidney Foundation's CEO, Kevin Longino, to our headquarters at CareDx. We have tremendous respect for what Kevin and his team at the National Kidney Foundation are doing, and would like to give a shout out to them at the start of this call. This afternoon, I will provide an update on the recent achievement across our three key business drivers

[Mike Bell:]

Thank you, Peter. Turning first to the income statement, our first quarter 2018 testing revenue increased 34% year-over-year to $10.6 million. Our 2018 first quarter testing revenue includes AlloSure volume of 1,051 tests, a 3% AlloMap volume increased to 3,847 tests and the January 1 increase in the AlloMap Medicare reimbursement rate from 2,840 to 3,240. We continue to be very pleased with the revenue and the momentum of AlloSure following the launch with test trajectory in line with our initial expectations. Our pre-transplant revenue decreased 10% year-over-year to $3.3 million. And as such, total revenue in the first quarter of 2018 was $14.1 million, representing a 21% increase compared to the prior year's $11.6 million. We adopted the new revenue recognition standard ASC 606 from January 1, 2018. This had a very minor impact on our testing revenue and no impact on our product revenue. Had we used the old ASC 605 revenue recognition standard, our total revenue in the first quarter of 2018 would have been $14.0 million. For the first quarter 2018, our non-GAAP net loss was $4 million compared to a non-GAAP net loss of $6.7 million in the same period of 2017. Our non-GAAP net loss per share in the first quarter of 2018 was $0.14 compared to $0.31 in the same period of 2017. Net cash used in operating activities in the first quarter 2018 was $4.5 million, which was in line with our expectations, and our cash and cash equivalents at March 31, 2018 was $18.7 million. As Peter mentioned, we completed our debt refinancing in mid-April and used some of the proceeds from our $15 million term loan with Perceptive Advisors to pay off our remaining debt of approximately $11 million over to Danske Bank and the Allenex former majority shareholders. Immediately following our refinancing in April, we had approximately $22 million in cash and $50 million in debt, which is a three-year interest only period. With this liquidity, and with the option to draw an additional $10 million debt from Perceptive within the next 12 months, we feel we have the balance sheet to support our growth initiatives. Turning to guidance. We are increasing our 2018 revenue expectations to reflect the growth of AlloSure and the impact of our Illumina partnership, and now anticipate $64 million to $66 million for the year. We remain focused on driving the company towards profitability, and given our expectations for ramping AlloSure contribution as 2018 progresses. Our partnership with Illumina, the positive Medicare price increase from AlloMap and the growth of our pre-transplant revenues from Olerup QTYPE, we continue to anticipate reaching non-GAAP EBITDA profitability during the second half of 2018. With that, I will open the call for questions.

[Operator:]

[Operator Instructions] And our first question is from Bill Quirk from Piper Jaffray. Please go ahead.

[Bill Quirk:]

First question is the - with respect to the new guidance, how much of that is from Illumina or from the newly acquired distributed products?

[Peter Maag:]

Bill, excellent question. We are obviously very early in the integration process and there is some handing overall customers as we are booking to sales as of June 1. I'll actually direct the question over to Mike, which is intricately closer to the numbers. Mike?

[Mike Bell:]

Yes, as Peter said, we'll be transferring the revenue from Illumina over to us over the next six months. We are looking at roughly $2 million from that Illumina business in the second half of the year. So that's some of the driver for the increase in guidance, the other being the increase ramp on AlloSure.

[Bill Quirk:]

Very good. And, I guess, just thinking about the aspirational guidance, Mike, that you gave a couple of quarters ago, and overlaying that with this very nice AlloSure ramp and now the new Illumina deal that should start to potentially generate some additional revenue in 2019 with new product launches. I guess, what's your comfort level around that? Dare I say the aspirational goal doesn't sound so aspirational anymore?

[Mike Bell:]

Bill, we're still looking at that as an aspirational goal. I think we're focused on the revenue guidance, the revised revenue guidance for 2018. We'll give 2019 revenue guidance at the end of this year, start of next year, but I mean, we're still looking at that as aspirational, but the additional Illumina products are obviously going to help.

[Bill Quirk:]

Makes sense. And just last one for me. It's more of, I guess, just a housekeeping question. Can you give us the revenue split between AlloMap and AlloSure?

[Mike Bell:]

Bill, we're not breaking that out. We've not been breaking out the product revenue by product, so we're doing the same with testing, just giving an overall testing number. We did disclose the volume. So 1,051 AlloSure tests and 3,847 AlloMap tests in the quarter.

[Bill Quirk:]

Got it. Thank you.

[Operator:]

Our next question is from Per Ostlund from Craig-Hallum. Please go ahead.

[Per Ostlund:]

Want to start with AlloSure. It sounds like again everything is tracking very much in line with your expectations. Peter, you alluded to this a little bit in your prepared remarks, but I wonder if you could come back to it a little bit and discuss the mix of patients that are being tested with AlloSure. How many of those are that you're seeing are first year patients versus clinicians that are opting to offer the test to somebody that's a little further along post allograft? And then maybe similarly, curious as to the mix of centers that have adopted the test that were DART participants versus non-DART participants?

[Peter Maag:]

Terrific. Well, thank you so much. And Per, first of all, congratulations to your promotion to senior analyst and great to have you here holding [ph] the company even closer. Diving into the AlloSure, I would say there are really two things. One is, we are positively surprised about the 52 standards that we are now having seen cumulatively having used AlloSure. That's probably ahead of our expectations. The 1,000 patient results is very much tracking against our expectations. Now when you look into one of the things that we have learned is that actually the average patient duration after transplantation is above 365. So on average, these patients are actually older patients after transplantation that we have originally anticipated, because some standards are really finding the test very useful in patients where that come back in and they have a high suspicion of rejection and they put them on an AlloSure. And actually then many types on the multiple AlloSure protocol. So we see these two things now happening. One, we're driving this K-OAR early adoption of AlloSure in the first year post-transplant, and then we see many centers are actually using the tests in two and three years' post-transplant, which is exciting for us because it demonstrates the utility of the test. To your specific question on K-OAR, we did share with you that there are 63 patients enrolled in the first quarter. So if you think roughly the 63 patients having one AlloSure each in the first quarter, that gives you an approximation of the 1,051 probably around 60, 70 would be from patients enrolled in K-OAR.

[Per Ostlund:]

Okay. And then how about centers that participated in the DART study versus centers that did not? Is adoption being spread nicely across those two sets?

[Peter Maag:]

What is really confirming it that on the 50 transplant centers that have started using the tests, it really follows an 80/20 rule, where most of the volume is coming actually from 20% of the centers. So I think that's what we had anticipated and it really came through. Now in terms of how all these DART centers, no, not necessarily. We have a good mix. DART trials were really 14 centers that were all high volume and high academic institutions, and some of them, you can imagine, especially in tertiary care centers to have a large academic presence. It actually takes even longer to get something into a routine testing protocol. So I would say we're spread evenly distributed in these DART centers, but we continue to have excellent relationship with these centers because they are so important and valuable academic institutions.

[Per Ostlund:]

Very good. One more question on AlloSure, if I may. You mentioned the 80/20 rule here, Peter. I know you've talked about having 100 centers doing the vast majority of kidney transplants. So realizing that you would have been targeting those centers, front end center, the centers that haven't necessarily adopted the test yet, and again, realizing it's very, very early, is - are there pushback points that are keeping any of the centers from kind of tipping into the adoption ledger at this point? And if so, what are those push points?

[Peter Maag:]

Good question, Per. I actually have here with me, Robert Woodward, our Vice President of R&D, who might have any additional data point as he has been talking a lot with these transplant centers over the years and has additional insight. But I think this is very general technology adoption in large tertiary care hospitals. There is nothing unusual about many clinicians wanting to see more clinical information. They believe that their patient population is different than our study population and they like to see more data, so it's very difficult. I think one of the key questions that we get is integration into the electronic medical records and making it easy for the centers to adopt the technology by just doing a mouse click. But I think it's very typical and something that we had anticipated, which we know because of the AlloMap that we have done for years. Maybe Robert, you have an additional vantage point.

[Robert Woodward:]

Yes, thanks, Peter. In addition to just numerous things that are just a standard in marketing and sales activities. On the research side, as Peter mentioned, they're often interested again with how does the data compare to by center, have you done kind of case that looks exactly like this. And we saw a lot of interest at our symposium that we held at the CEoT meeting in February where some solved cases that were presented by some of the initial users that really caused certain centers to think, hey that looks like what I've seen. I want to start using the test more. And so we expect that the strong program that we have for our program at ATC and a lunch time symposium with an even larger audience and attended ATC will have I think some of the same because we've got seven presenters with variety of application and how they've used AlloSure and that's going to really, I think, cause a lot of centers to see whether this use that matches what their expectations are and what they're looking for.

[Per Ostlund:]

That's excellent color. Last question for me on AlloMap and again you did address this in the prepared remarks, Peter. On the volume growth there being potentially a little bit impacted by weather. I guess, first part of the question would be, is there a way to roughly quantify what that impact might have been? Secondly, was there any lack of focus on AlloMap because of the genesis of the AlloSure launch? And then, I guess, the last piece of it is coming back to HeartCare, how do you envision HeartCare ultimately driving AlloMap adoption going forward? Thanks.

[Peter Maag:]

Well, thank you very much for the question. Per, we continue to believe that AlloMap is growing in this - between rigid range. We'll feel comfortable with this volume growth range that we have targeted. HeartCare is very exciting but it will take some time to get traction. We'll roll it out through a clinical registry trial as well, that's called Sure [ph]. And so it'll take some time to come through. We are excited about the concept. In terms of the specific impact on the weather, we saw a little bit of a slower growth in the beginning of the quarter and then caught up in the second part of the quarter, but as long as this is still within our gross volume corridor, we focus more on driving adherence going forward.

[Per Ostlund:]

Excellent. Thank you guys.

[Operator:]

[Operator Instructions] Our next question is from Yi Chen from H.C. Wainwright. Please go ahead.

[Yi Chen:]

Congratulations on the unit volume ramp up for AlloSure test. And so I noticed that for your first quarter sales and marketing and G&A expenses, they are quite significantly higher than the previous quarters. So I'm just wondering, was there any onetime expense? Or these are the kind of level expenses we should expect going forward? Or will they even increase in the future quarters once you start distributing Illumina products?

[Peter Maag:]

Well, excellent question, Yi Chen. Thank you very much. I'll actually divert that over to Mike Bell, who again has the details.

[Mike Bell:]

Yes. On the quarter itself, yes, the sales and marketing expense pretty much reflects the fact that we've increased our sales and marketing territories and we've added four territory account managers in the quarter. So on the base business, we should expect that sales and marketing expense to stay reasonably flat now for the next foreseeable quarters. There was one time expense in Q1 as there always has been Q1 for us with our audit costs of about some $500,000 to $700,000, which won't repeat itself in future quarters. And then we did mention that with the - with this Illumina deal in the second half of the year, our overall OpEx will increase by about $2 million to $3 million. So if you're modeling out the numbers, adding that for the second half of the year should definitely be enough.

[Yi Chen:]

Got it. Thank you.

[Operator:]

We actually do have a follow-up question here from Bill Quirk from Piper Jaffray. Please go ahead.

[Bill Quirk:]

On HeartCare is this a product that we should expect every AlloMap patient to get? Or is this going to continue to be used to try to incrementally increase adoptions in AlloMap to clean some of those centers that had historically been resistant?

[Peter Maag:]

Excellent question. And I think the answer to it, it will be different by center by center almost. What we continue to believe is that we have a lot of lack of adherence to the follow-up protocol. So what HeartCare will allow us to roll out is the hearts protocol, which you might be familiar with the hearts protocol in the kidney transplant sitting. We - for hearts, we call it the hearts protocol where be suggest to the centers that are signing up for the HeartCare to have a rigorous follow-up of these patients with multiple testings in the first year and then also frequent testing in the second and the third and the fourth. So with HeartCare, we're establishing what we learned from kidney into the heart modality. So we anticipate that there will be a volume impact from HeartCare as centers are adopting HeartCare.

[Bill Quirk:]

Understood. And certainly makes a lot of sense to me, Peter. I guess flipping the question over to Mike. How should we think about this from a gross margin standpoint? Presumably, you're just billing for AlloMap, but presumably, you'll be adding any additional cost of goods associated with AlloSure?

[Mike Bell:]

Yes, we'll be adding in the additional variable cost for AlloSure-Heart. It shouldn't have a significant impact on gross margins this year, Bill based on the sort of the expected volume. So with those targeting 60% to 65% in gross margin throughout the year, so there shouldn't be any significant impact on that.

[Bill Quirk:]

Okay, got it. Thank you.

[Operator:]

Thank you. This concludes the question-and-answer session. I'd like to turn the floor back over to management for any closing comments.

[Peter Maag:]

Well, thank you very much. We are very excited on continuously building our business around genomic information and transplantation. Thank you very much for joining our call and I'm looking forward to updating you as we are making progress at CareDx. Thank you so much.

[Operator:]

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.