Earnings Labs

CareDx, Inc (CDNA)

Q2 2015 Earnings Call· Mon, Aug 10, 2015

$21.98

+0.59%

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to today’s Second Quarter 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, this conference is being recorded. I would like to introduce your host for today’s conference, Ms. Lynn Pieper with Investor Relations. Ma’am, you may begin.

Lynn Pieper

Analyst

Thank you. Thank you for participating in today’s call. Joining me from CareDx are Peter Maag, President and Chief Executive Officer; and Ken Ludlum, Chief Financial Officer. Earlier today, CareDx released financial results for the quarter ended June 30, 2015. The release is currently available on the company’s website at www.caredx.com. Before we begin, I’d like to remind you that management will make 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 and our future financial expectations are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description 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 time-sensitive information and is accurate only as of the live broadcast today, August 10, 2015. With that, I’ll turn the call over to Peter Maag. Peter?

Peter Maag

Analyst

Thanks, Lynn. Good afternoon, everyone. As we have done our previous quarterly calls, I’d like to start this update with a patient story. Many of you may have seen recent news on the double-hand transplantation, eight year-old, Zion Harvey. Zion was an ideal candidate for a hand transplant due to his previous kidney transplant. I encourage you to look up Zion’s story and watch the videos about his experience online. Zion’s care is provided by the transplant program at Children’s Hospital of Philadelphia. It is for patients like Zion, that we at CareDx come to work every day. This call marks one-year since we completed our IPO, we are proud of the progress that we are making towards our milestones. In particular, we are advancing the utility of cell free-DNA as a biomarker in organ transplantation, and moving cell free-DNA more and more to the center of our attention. Accordingly, I would like to start this call by covering the recent highlights in our cell free-DNA pipeline and clinical development. I’ll next cover the updates in our AlloMap business, where our focus continues to be increasing patient access to AlloMap as a surveillance tool in heart transplantation. Ken will cover the financials for the second quarter and our guidance for 2015. And then, we look forward to your questions. Before we go into those specific updates, I’d like to reiterate our three strategic objectives for the year. Number one, develop cell free-DNA tests in transplantation; number two, increase the utilization of AlloMap; and three, add momentum through realizing inorganic growth opportunities. Before moving to the pipeline, let me touch on our second quarter financials. Total revenue was $7.1 million in the second quarter of 2015. AlloMap test volume reached a record-level in the quarter and continues to be a strong…

Ken Ludlum

Analyst

Thanks Peter. Hi everybody, as you heard, revenue in the second quarter was $7.1 million up 5% from the second quarter of 2014. As Peter noted, we had record AlloMap volume in the quarter. However, revenues grew slower than AlloMap volume. This is a result of a few quarterly fluctuating factors. Last quarter, we had the opposite scenario where revenue growth exceeded volume growth for the quarter. In the second quarter, there was a dip in the mix of Medicare versus non-Medicare test volume. We expect that the higher AlloMap volume overall in Q2 will turn into revenue in the second-half of 2015, with our high reimbursement rates, but quarter fluctuations may continue. On July 1, we brought the reimbursement billing process in-house here at CareDx. We expect this to reduce the overall cost of our reimbursement effort and should increase effectiveness, as we will now have direct ownership of and direct control over the reimbursement process ourselves. As we build out CareDx, we see this reimbursement capability as core for a leading molecular diagnostics company. Cost of testing in the second quarter was $2.5 million, compared to $2.4 million in the second quarter of last year. This was up 4%, so the increase was generally in line with the higher AlloMap volume. R&D expense was $2.5 million in the second quarter, compared to $800,000 in the second quarter of 2014. This increase was primarily due to the headcount related expenses, cell-free DNA expenses, and increased clinical trial expense during the quarter. Sales and marketing expenses in the second quarter were also $2.5 million, compared to $1.6 million in the second quarter of last year. This is related to increased headcount in consulting expenses and increase in the marketing program, such as physician forums, speaker programs, and advertising and other…

Peter Maag

Analyst

I’m delighted by the progress we made throughout the first-half of this year, as we moved towards advancing our mission to improve patient outcomes in transplant care. We look forward to updating you on our progress. With that, I’d now like to open the call up to questions. Operator?

Operator

Operator

[Operator Instructions] One moment for our first question. Our first question comes from Mr. Bill Quirk with Piper Jaffray.

William Quirk

Analyst

Great. Thanks, and good afternoon, everybody. I guess, first question, Peter. So, I guess, from a tracking standpoint, are you providing any additional cell-free heart test outside of the D-OAR Registry?

Peter Maag

Analyst

.:

William Quirk

Analyst

Okay, all right. That’s very helpful. And then just to expand maybe a little bit upon the AlloMap variability product, and then, I know you certainly talked about this in the past in terms of the predictive power that multiple results can give. Just that we have our notes correctly, was that - did you say forecast over, was that 12 or 18 months?

Peter Maag

Analyst

Forecast over 24 month.

William Quirk

Analyst

24 month, excuse me. Okay. And so this is, clearly, going to be a tool to use, to try to increase the penetration within that two to five-year post-transplant population. Can you talk a little bit about maybe the timing around the other sales force rollout you mentioned September, but obviously, I would assume you probably have some sort of national meeting prior to them?

Peter Maag

Analyst

Yes. We’ll do that in September, yes, we have ongoing efforts gathering input from key opinion leaders and talking about variability with these centers. Really the formal launch will be, so to speak, will be in September at the Heart Failure Society of America Meeting. Think of us as right now doing this in a one-on-one kind of conversation setting, while in September, we think of this as a more formal established process.

William Quirk

Analyst

Okay. Very good. Thanks, guys.

Operator

Operator

Thank you. Our next question comes from Mr. Dan Leonard with Leerink.

Dan Leonard

Analyst · Leerink.

Thank you. So, Peter, you detailed a number of tactical efforts to accelerate your volume growth. Do you expect these efforts are going to gain traction in the short-term here, or should we assume sort of a time lag before they gain hold?

Peter Maag

Analyst · Leerink.

No. I’m very upbeat about putting a team in place that builds the plan and the processes going forward. We communicated in the past 15% to 20% AlloMap growth rate and with the right team and the right processes in place, we believe that this is achievable going forward. There is still a lot of untapped potential. And so think of us as getting back to these growth rates in a relatively short order, if we have the right team and the process in place.

Dan Leonard

Analyst · Leerink.

Okay. And then my follow-up question. So can you share more around what the variability score is going to look like as you productize that? Is that going to be a standard feature on all AlloMap reports? And also, could you share some of the feedback from some of the clinicians you have who have used that to-date?

Peter Maag

Analyst · Leerink.

Yes. The AlloMap score in itself is an FDA regulated and clear to test. So the variability is, we provide as part of a clinical consultation alongside an AlloMap test as centers one to two opt-in into that process. And so for those centers that will be opting into the process will receive a second sheet, where we detailed the AlloMap score alongside of AlloMap variability. So it’s really the secondary process, because centers will need to opt in. But once that is opted in, you’ll see the AlloMap score and the multiple AlloMap score over time matched with the variability score for the last four scores, which give you a standard deviation of these scores, which will be indicative, if you compare that to publications that are provided on variability in terms of space and stratification.

Dan Leonard

Analyst · Leerink.

Okay.

Peter Maag

Analyst · Leerink.

Simply said the higher variability the higher the - is patient is at risk for lower - for poor outcomes in the future.

Dan Leonard

Analyst · Leerink.

I know, you’ve had some advocates for this type of information in the past. Can you help us understand, is there a meaningful portion of your customer base asking for this type of information, or was it a couple of standout KOLs or any sort of really feel for what the demand might look like for this type of an offering?

Peter Maag

Analyst · Leerink.

I think, what it allows us to do with, to continue generate data in a majority of the centers in the U.S. that are affiliated with the OAR Registry and that are affiliated with AlloMap. So don’t think of this as a major, major initiative, but an initiative that gets us back into the 15% to 20% growth range that we’re looking for. There’s a number of centers that are eager to receive that data on a standard basis, but I probably would put them into the 20 to 50 type of center range, not in the 100% of all centers that are using AlloMap.

Dan Leonard

Analyst · Leerink.

Got it. Thank you.

Operator

Operator

Thank you. Our next question comes from Nicholas Jansen with Raymond James.

Unidentified Analyst

Analyst · Raymond James.

Hi, guys. This is Bilal [ph] in for Nick.

Peter Maag

Analyst · Raymond James.

Hi, Bilal.

Unidentified Analyst

Analyst · Raymond James.

Hey. So I just had a couple of quick ones. You guys have recently been building the portfolio up and collaborating more extensively, latest one being DNAnexus. Can you elaborate on maybe what else you think you might want to - what other companies you might want to collaborate with, and where you want to build your portfolio to strengthen the AlloMap product and maybe bolster the cell free-DNA franchise?

Peter Maag

Analyst · Raymond James.

Yes. I think, we highlighted a few times this bioinformatics area for the company as really the core in the future. If you see the - what comes out of the sequencing analyzers and then to get translated into patient result, really, but it’s very important is that you have a strong bioinformatics machine. But think of us as also partnering with institutions that allow us to have direct-to-patient communication in the midterm. That’s what we reported on the patient portal. And there are numerous associations out there. For example, we partner with the Heart Brothers Foundation in Boston, a patient organization that is focused on heart transplantations that allows us to communicate. So really, think of this is a very broad ecosystem that we are trying to build and we continue to have collaborations alongside.

Unidentified Analyst

Analyst · Raymond James.

Great. And then, just quickly looking at DART trial, so you guys have six centers pretty much wrapped in, which is right on par with your latest slide deck. I’m wondering, how are further discussions going and should we assume that these six trials will most likely roll into the DART 2 study.

Peter Maag

Analyst · Raymond James.

Absolutely. I think that has been always our plan to have DART 1 centers role into DART 2 centers, reducing the timeline to recruitment. And you’ll see actually DART 1 centers continue to increase from the 6 to the 10, because we see that as a unique entry point into collaborating with these centers.

Unidentified Analyst

Analyst · Raymond James.

Great. Thanks, guys.

Operator

Operator

Thank you. At this time, I’m showing no further questions. I would like to turn the call back over to Mr. Peter Maag, for closing remarks.

Peter Maag

Analyst

Thank you very much. We look forward to updating you on our progress. And have a great evening.