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CareDx, Inc (CDNA)

Q1 2015 Earnings Call· Tue, May 12, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the CareDx 2015 Q1 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 be given at that time. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host Leigh Salvo with Investor Relations, you may begin.

Leigh Salvo

Analyst

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 March 31, 2015. The release is currently available on the company’s website at www.caredx.com. Before we begin, I would like to remind you that management will make statements during this call that includes 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 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 description of the risks and uncertainties associated with our business, please see our filings with the SEC. CareDx disclaims any intention or obligations 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. The conference call contains time sensitive information and is accurate only as of the live broadcast today May 12, 2015. I will now turn the call over to Peter Maag. Peter?

Peter Maag

Analyst

Thanks Leigh, good afternoon everyone. Last week we spent with Ally, a heart transplant patient who has been short of breath throughout her childhood and was diagnosed with congenital heart disease at the age of 19, when someone finally checked her heart beat and realized that her heart rate was somewhere between 20 and 30. She was put on the waiting list and it took another seven years until she got a heart transplant. Five years later, Ally is full of life and continues to inspire people around her including CareDx and many donor awareness campaigns in which she is active. Ally has benefited from AlloMap in her surveillance management. I would like to start this call with a summary of our first quarter highlights and talk about our growth drivers and then our performance towards our strategic goals. I will then ask Ken to dive deeper into the financials for the first quarter and our guidance for 2015. And then we look forward to your questions. Now starting with our first quarter financial highlights, revenue was 7.2 million in the first quarter of 2015 at 22% increase over the first quarter of 2014. We also increased our cash balance by 2.6 million to 39 million through refinancing our term loan, which puts the company in a solid financial position. To recap our three primary strategic objectives and they are number one, increase the utilization of AlloMap; two, develop cell-free DNA test in transplantation; and three, add momentum through realizing inorganic growth opportunities. I’ll spend the next few minutes providing some of the highlights we achieved towards meeting each of these objectives during the quarter. Now starting with AlloMap we saw continued in increase in adoption of AlloMap, a blood based test used to monitor heart transplant patient recipient for…

Ken Ludlum

Analyst

Thank you, Peter. Starting with revenue in the first quarter revenue was $7.2 million up 22% from the first quarter of 2014. Note that 90% of that revenue was from U.S. AlloMap usage. The cost of testing in the first quarter was $2.7 million compared to $2.2 million in the first quarter of 2014. This was also up 22%, so the increase was generally in line with a higher AlloMap revenue. However this quarter was affected by some write offs of some expired consumables used in AlloMap testing. This is a quarter specific event and I expect ongoing cost of testing to be in line with expectations going forward. R&D expense is 1.4 million in the first quarter compared to 720,000 in the first quarter of 2014. As expected, higher R&D expenses reflect initiation of our cell-free DNA program as it moved beyond the initial development stage and into the enrollment in a cell-free DNA study in kidney. Sales and marketing expenses for the first quarter were on plan at $2 million compared to $1.5 million in Q1 2014. This line item increased mainly due to increased overall marketing and also to a Congress presence in the first quarter of the year and the travel expenses associated with that. G&A expenses were 2.7 million for the quarter, an increase of 900,000 over the 1.8 million we spent in Q1 of last year. This increase is entirely due to yearend audit and legal fees for a public company all recognized in the first quarter of this year and the increased expenses and personnel needed to run a public company. Regarding our contingent payment line item in operating expenses, the change in our stock price over the quarter made the estimated value of the stock payment to ImmuMetrix shareholders a bit lower.…

Peter Maag

Analyst

Well we had a busy Q1 at CareDx with AlloMap growth and major advances in our pipeline and addition of great talent to the organization. Thank you for your time and listening into this call. With that we’d now like to open the call up to question. Operator.

Operator

Operator

[Operator Instructions]. Our first question comes from the line of Bill Quirk of Piper Jaffray. Your line is now open.

Alex Nowak

Analyst

Great, thanks. This is actually Alex Nowak in for Bill tonight. When do you expect to receive -- expect the OAR trials and the DOR trials to actually end and when do you expect the first data to read out for those?

Peter Maag

Analyst

Alex, thank you very much for this good question. The OAR and the DOR trials are actually set up as registry trials. So we will have them ongoing as long as we provide AlloMap and cell-free DNA going forward. Initial read outs have actually been provided at the ISHLT last year and even at this year there were a number of great news following the OAR and DOR registry. So think of this as an ongoing wealth of information coming out of the observational studies that we are doing on this registry trial.

Alex Nowak

Analyst

Okay, now that makes sense. And then I know I am looking well into the future with this next question but with the DART 2 -- well for the DART 2 study, when do you expect initial enrollment and maybe the initial data readout?

Peter Maag

Analyst

The initial data readout of the DART 1 study, we have guided in this call in about the first half of next year. As soon as we have the interim results of the DART 1 trial, that would be a good time to think about the start of the DART 2 trial with potential readouts then to be communicated at a later stage. Right now we are very focused on this interim readout analysis on H1 next year which will give us the confidence to start our DART 2 trial which then will be an interventional trial.

Alex Nowak

Analyst

Okay, great and then last question from me for cell-free DNA heart filling into an actual analytical test versus just a research use only test. I believe you are still looking for December 2015 and do you expect to launch any or publish any analytical studies or even clinical utility studies before launching that test, thanks?

Peter Maag

Analyst

Alex, thank you very much. I think we have all along mentioned that with cell-free DNA we will piggyback that onto our AlloMap results. We are very excited that we demonstrate that AlloMap and cell-free DNA in combination have actually additive value. So we’ll continue to make that test available while we have not foreseen any formal launch in cell-free DNA in heart and have communicated the timeline on this, we’ll continue to be in close conversations and discussions with key opinion leaders that are generating data and insights on cell-free DNA in heart.

Alex Nowak

Analyst

Great, thanks.

Operator

Operator

Thank you and our next question comes from the line of Nicholas Jansen of Raymond James & Associates. Your line is now open.

Nicholas Jansen

Analyst

Hey, guys can I get a little more color on the strong revenue growth this quarter relative to the test volume growth that might have been impacted a little bit by the weather dynamics, it certainly seems like it might have been more the cash revenue, but just wanted to get a sense of what drove the out performance on revenue versus test volume growth? Thank you.

Ken Ludlum

Analyst

Yes Nick, thanks for the question. So we had a better mix, there is two things we had a better mix of Medicare versus non-Medicare volume and Medicare volume is accrued right off the bat. And so when that mix favors Medicare that generates revenue in the quarter that the test occurred. Secondly, we had a couple of accounts that converted from cash accounting to accrual accounting through becoming a roster account. And then the third thing that generally we accelerated some of our cash payments on the general collection side, so there are really three factors, Medicare mix, conversion of couple of accounts to accrual basis, and better job on reimbursement team for collecting cash.

Nicholas Jansen

Analyst

That’s great color and then secondly regarding the significant increase in kind of the number of heart transplants have official protocols now. When we see an official protocol established what is the timeline for kind of adoption from this [Technical Difficulty] and how do we think about once their official protocol, how does it easily impact general volumes over a period of time?

Peter Maag

Analyst

Nick, thank you very much for that excellent question. I think well we’ve been very successful in establishing formal protocols and I think you are absolutely right that the next step is actually driving adherence to these protocols. That’s why I mentioned in my call that we continue to follow a center by center strategy on those. And we’ll be updating on the volume growth going forward but really the establishment of protocols is a very strong basis for our strategy to drive volume growth going forward. The next thing is adherence to protocol and that’s actually the biggest lever for us as a business and you will see that pull through, and be successful going forward based on the very strong adoption of protocols in these centers.

Nicholas Jansen

Analyst

Thanks and then last one for me regarding kind of the international news that was discussed this afternoon on plans, just want to get a little background in terms of how those discussions evolved, how long did it take for you guys to kind of close this opportunity and what are the regions or countries in Europe are actively looking at AlloMap as a potential solution currently, thanks?

Peter Maag

Analyst

Nick again excellent question. I think we as a company have realized that having a very strong partner that helps us in the distribution of AlloMap in Europe is the right thing to do. And establishing, I’ve always called it a clone map in Strasberg is a very fundamental step for us to be successful. Now if you have a partner and you have a lab, the third thing is reimbursement and there we go country-by-county. France is a national reimbursement decision, the same will be true for Germany, the same will be true for England and these are really the big transplant markets in Europe if you are adding Spain to it. Spain is somewhat a little bit different because there you have regional reimbursement authorities and in Italy you actually have 25 different reimbursement authorities that you need to work with. Let’s take this country-by-country as they come but clearly France, Germany, and Spain are the three countries to watch out for, for us to be successful. Germany being the next one with a very centralized reimbursement process and we hope to be reporting on news, positive news going forward. ISHLT needs in Europe has given us the opportunity to make a big splash and having France adopting the test in 15 of their 25 centers is giving us very, very positive and news flow in Europe overall.

Nicholas Jansen

Analyst

Great to hear guys, thanks for the color.

Operator

Operator

[Operator Instructions]. Our next question comes from the line of Peter Lawson of Mizuho, your line is now open.

Peter Lawson

Analyst

Hey Peter, on the DART 2 -- that push back I thought it was yearend event, now you are saying first half 2016?

Peter Maag

Analyst

I don’t think we are very consistent with reporting on the interim results in the first half of 2016. So we are consistent Peter there. It does take time to recruit these patients and then the interim analysis that we will be conducting requires a number of samples. So I think all along we’ve been communicating in the first half of next year.

Peter Lawson

Analyst

Got it, thank you and then how did that affect volumes in the quarter?

Peter Maag

Analyst

Peter it’s very difficult to put a specific number to that. If you look at the overall competitive space we’ve been following on some on the earnings call there has been a number of companies that mentioned bad weather as a function. It is right that in a setting where surveillance visits occur in the transplant setting that in the North East there was heavy, heavy snow and impact. But I think it’s hard for us to measure that, so I did mention that in a half a sentence on the sideline that weather might have played a role but overall I think weather did play a role in the first quarter by how much I wouldn’t be able to tell you and quantify.

Peter Lawson

Analyst

Got you and then just wonder if you could just talk through the commercialization plans for cell-free DNA.

Peter Maag

Analyst

No I think there is no changes at all. I think we are piggy banking on to AlloMap, the cell-free DNA in heart and then we are laser sharp focused on cell-free DNA in kidney. So, kidney is a huge opportunity for us, there is a huge unmet medical we solved at the AGC [ph] meeting and so I think there is no change in terms of updating our commercial strategy on neither heart nor on kidney.

Peter Lawson

Analyst

Do you do any kind of pre-commercialization priming for the kidney opportunity?

Peter Maag

Analyst

Excellent question Peter. I think the DART 1 and then the DART 2 trial are the unique opportunity for the company to build these relationships with these transplant centers. And once they have adopted the test in a clinical study protocol, we would like to convert these type of tests then into a real testing opportunity. When I am talking to kidney nephrologists, the kidney transplant nephrologists they have a big unmet medical need in optimizing the immune suppressive therapy. And they do say that serum creatinine is a very, very old marker and a very late marker. So they would like -- they are looking for a new tool and cell-free DNA might well be that.

Peter Lawson

Analyst

Great. Thanks so much.

Operator

Operator

Thank you and I am showing no further questions at this time. I will hand over the call to Peter Maag for any closing remarks.

Peter Maag

Analyst

Thank you very much Nicole. Thank you, we look forward to updating you on our progress in the future and have a great evening. Thank you for joining the call.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. That does conclude today's program. You may now disconnect, have a great day everyone.