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Precipio, Inc. (PRPO)

Q4 2013 Earnings Call· Wed, Mar 12, 2014

$29.80

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Transcript

Operator

Operator

Good day. And welcome to the Transgenomic Fourth Quarter and Fiscal Year 2013 Financial Results Conference Call. All sites are currently in a listen-only mode. But please note there will be a question-and-answer session later on in the call. Also note today’s conference will be recorded and will be accessible both by phone and internet. Please refer to the press release about this conference call on the company’s website transgenomic.com for further detail. The company has asked that I read the following statement. Management will make comments today that contain forward-looking statements. Forward-looking statements are any statements that are made that are not historical facts. These forward-looking statements are based on current expectations of the management team and there could be no assurance that such expectations will come to fruition. Because forward-looking statements involve risks and uncertainties Transgenomic’s actual result could differ materially from management’s current expectations. Please refer to the press release, the company’s 10-Q, 10-K, and other periodic SEC filings for information about factors that could cause different outcomes. The information presented today is time sensitive and is accurate only at this time. If any portion of this call is rebroadcast, retransmitted, or redistributed at a later date Transgenomic will not be reviewing nor updating this material. I will now turn the call over to Transgenomic’s President and Chief Executive Officer, Paul Kinnon. Please go ahead sir.

Paul Kinnon

Chief Executive Officer

Good afternoon everyone and thank you for joining us on today's conference call. I am joined today by Chief Financial Officer Mark Colonnese, we have a few prepared comments. I'll start by providing you an overview of our ongoing progress on future plans then Mark will walk us through the operating results for the fourth quarter and the full year 2013. And following this we will open the call up for some follow-on questions. The last quarter 2013 marked a turning point for Transgenomic, when the Board of Directors asked me to take the helm and lead the revitalization aimed at optimizing the value of our company's many assets. It's still early days in that assets and the transition. But I'm pleased to report that we are making excellent progress by implementing key initiatives to achieve this goal, initiatives that we believe will begin to contribute to the company's results later in this year. The goal is to leverage our products, our distinctive technology in assets, our distribution infrastructure and our expertise to make Transgenomic, a leader in personalized medicine, providing products and services to improve patients’ outcomes globally. A cornerstone of this strategy is optimizing our commercial execution by building a network of world-class partners and collaborators to leverage our resources, while achieving great market access and operating efficiencies around the globe. These initiatives are designed to achieve greater commercial reach and enhanced efficiencies in all for our business units focusing resources in our portfolio in internally developed assets to have large current and future commercial potential and allowing us to refocus our internal resources on our areas of strength developing advance technologies, test and companion diagnostics using our proprietary and unique technologies for ultra high sensitive products, while focusing our internal sales and marketing efforts on tests for…

Mark Colonnese

Chief Financial Officer

Thanks Paul. Good afternoon everyone. We released our financial results about an hour ago, so I hope that you have had a chance to review the numbers. I will start today with an analysis of the fourth quarter results. So net sales in the fourth quarter of 2013 were $6.2 million compared with $7.3 million for the same period in 2012. The decline in 2013 is mainly due to decreased test volume in the laboratory services segment, principally in the neurology business, and an unfavorable shift in product mix. Regarding the mix change, as many of you recall, in last year’s fourth quarter, our lab caught up about half of the major backlog of NuclearMitome test that had built up last year when we shifted production of the test to a new lab. The NuclearMitome test is a comprehensive panel that is one of our more expensive tests hence the unfavorable comparison that incurred in this year’s fourth quarter. The decline in the lab segment though was partially offset by significant 35% increase in the genetic assays and platform segment as we actually had a terrific quarter in that business due to higher unit sales of instruments in the U.S. and Europe. Gross profit was $2.6 million or 41% of net sales compared with the gross profit of $3.5 million or 49% of net sales in the same period of 2012. This decrease in gross profit was mainly due to lower margins in the laboratory services segment and their volume related. Operating expenses were $6.2 million in the fourth quarter of 2013, a reduction of about 600,000 compared to the $6.8 million in the prior year. The decrease in operating expenses was primarily due to reductions in our lab services field sales force as we reduced the size of our…

Paul Kinnon

Operator

Thank you very much Mark. At this point operator, we’re ready to open the call to questions.

Operator

Operator

Thank you. (Operator Instructions). We’ll take our first question from Matt Hewitt with Craig-Hallum Capital. Please go ahead.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Good afternoon, gentlemen and thank you for taking my questions. First one for me, the assays or the tools segment, the tools segment itself was up modestly here and a nice performance there. I am wondering how much of that was contribution from equipment sales versus the assays themselves?

Mark Colonnese

Chief Financial Officer

Yes. In the fourth quarter, we had a very nice improvement that actually saw our full year sales in that segment maintain, actually slightly grow for the first time in a few years. In the fourth quarter, those were largely instrument sales that our team sales largely in Europe and in the U.S.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

And those are the way it sort of subtracts?

Mark Colonnese

Chief Financial Officer

These are principally on [obvious] systems that we -- these are high ticket systems that major labs will bring in as they move to automate some of their processes and this is equipment that we OEM.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay, all right. As far as, the clinical lab segment I think you explained that it was -- challenges in the neurology business. How much of that decline would you say was related to that versus some of the ongoing reimbursement challenges that the entire industry has been facing?

Mark Colonnese

Chief Financial Officer

Yes, I think the neurology -- most of it was volume related issues in the company that were unrelated to the reimbursement. I think we like everyone else in the industry have had our reimbursement challenges and they contributed modestly to the decline in sales, but the unit declines had to do with, as I mentioned the NuclearMitome test that were made up very strongly in the last quarter of last year and then just general volume declines, basically the competition in neurology. I would want to add though that we actually have a new team onboard that we brought on late last year and a new leader Steve Miller to run that. And we have already seen a very significant increase; recapture I guess is probably a better word in volumes as we started the first quarter this year in that neurology business. So I think we have addressed those issues and I am happy to see the progress that we made this year.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay. So as far as looking at the first quarter is concerned, you anticipate that it should pop back up to the high $3s-$4 million range is that the way to think about it?

Mark Colonnese

Chief Financial Officer

I don’t want to give guidance here. That’s not something that we typically do, but I would say that Neurology -- I would tell you that the Neurology segment has seen a tremendously strong recovery back to levels that we saw in the first half of last year.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay, alright.

Paul Kinnon

Operator

Mark’s alluding to the fact that when we said we were upscaling the organization, that’s one of the areas where we think we have significantly improved the level of our staff and the ability for them to go out and achieve our goals.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay. Regarding ICE COLD-PCR and you touched on it a little bit, there is the webinar tomorrow. What are your expectations for that platform this year, what type of milestone should we be watching for to monitor that progress?

Paul Kinnon

Operator

So, we plan on releasing more collaborative data, revalidating and validating this performance, it’s used as a liquid biopsy tool to generate significant data. That will be ongoing at the regular conferences like ASCO and [CO]. We will probably do a couple more releases on partnerships and collaborations, not all of them being academic collaborations, but really trying to drive into the commercialization phase. And that’s where we will be focusing on it. Our first goal will be bringing it into the biomarker identification business and then further going into the other markets and the other business as we progress in the coming years.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

So from a financial perspective, do you anticipate that starting to contribute on a revenue basis this year or do you see, -- is this year really about laying the ground work and the commercialization efforts paying off in 2015?

Paul Kinnon

Operator

It will be an impact in the biomarker identification business on the revenue basis because it will be used in collaborative programs rather being paid for our services with pharma and biotechs and then in the future it will be bringing revenues into the markets as we develop and commercialize it from there.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay. That’s a good update and it kind of leads into my next question. As far as the clinical trials business is concerned, I think back to when the Amgen agreement or partnership was announced last year, it generated a fair amount of activity. New potential partners are reaching out to you. Has that translated into incremental business, how is the clinical trials segment functioning today and what can we anticipate from that this year?

Paul Kinnon

Operator

Yes. I mean we see that business as a very big area for our growth, we’ve got some very strong relationships. And those releases on that activity that we carried out last year, will actually grow this year as well with other customers. We’ll be attending some seminars and enormous amount of interest as we say on the ICE COLD-PCR, and we see a growth market for us. And that feeds the rest of the business and allows us to take the technology into other markets as well. So, that’s really the first gating process, get that relationship, grow that relationship with the pharmas and biotechs, develop these assays with them and then move them through the continuum of the biomarker business, the patient testing business and our clear testing and also the genetic assays and platforms marker and our partners such as PerkinElmer. So, that’s our first step grows our builder foundation and allow us to move forward. So, we see that market expanding and we’ve got a lot of interest and we will be capitalizing on that interest in the coming months.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay. Are there any significant trials already in queue and you are just waiting for a partner to kick those off? I mean, in the past, there have been some million dollar trials kind of sitting in queue.

Paul Kinnon

Operator

Yes. So if you think of it from the point of view of the -- the million dollar trial starts off as you know a $150,000 to $100,000 and $150,000 study, that study then improves and as time goes on. We had a few of them in 2013, we expect to have a lot more in 2014 and then 1 or 2 of them, we’ll move through the pipeline. And it’s like any other sales process; you start off with 10 or 15 [you then end] with 5 or 10. So, we’re optimistic that we can move some of them through the pipeline and bring them forward to that larger scale, and we’ll see how that progresses and keep you informed.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay, alright. Thank you. Maybe one last one from me, and then I’ll go hop back in the queue. As far as the cash positions concerned, congratulations on the additional funding, as I look at your balance sheet today, you should be fine for the near future. But when do you anticipate getting to a cash flow breakeven or if you prefer an adjusted EBITDA breakeven standpoint, is that something we can anticipate maybe later this year or do you think that’s early ‘15?

Mark Colonnese

Chief Financial Officer

Yes. We haven’t set a timeline on that but I do think that the cash that we raised earlier this year should certainly get us into 2015. That’s our full expectations.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay, all right. Thanks. I’ll hop back in the queue.

Paul Kinnon

Operator

Okay.

Operator

Operator

Thank you. (Operator Instructions). Mr. Hewitt, you may continue.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

All right, just a couple of follow-ups. Number one, NASDAQ, you’ve submitted to list, has there been -- has your listing application been accepted, any sense of the timeline for that?

Mark Colonnese

Chief Financial Officer

Yes. Matt, I think you ask such great questions; everybody just wants to sit back and listen to you.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Right, absolutely.

Mark Colonnese

Chief Financial Officer

Yes. I think we mentioned before, we filed the application in December. We’ve gotten the response back from NASDAQ. We’ve answered all the questions. The last issue that we’re aware of, the only one that’s unanswered at this point in time is that the normal requirement from NASDAQ is that you have to have 3 Independent Board Members on an audit committee. At the present time, the company only has 2. But this is an activity that our Board undertook some time ago. And I think in the very near-term, we should have some news that would resolve that final issue. And then, we think it’s going to be a very short time before NASDAQ allows us to go forward.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Right, fantastic. Last one for me and it’s something that I am sure you’ve gotten questions about. I’ve actually been getting questions periodically, recently, I’ve gotten a few. There is another lab in company in the space that has highlighted the use of ICE COLD-PCR utilizing urine. And I am curious if -- and I know that -- if I am not mistaken, there is some existing relationship, Board member is also an employee there, I think was just [then] CEO there. Do you have a license in place or does Trovogene have a license in place or how is that being handled between the two companies?

Paul Kinnon

Operator

So, we continue to review the competitive situation and monitor the marketplace. As you are aware, it’s a very, very aggressive and a fast moving market. We’re continuing to monitor it. We address those issues. And as we see it will implement, we will have a strategies we need to, going forward. We’re aware of them and we continue just to monitor situation. And we’ll appraise the marketplace if anything material comes to happen.

Matt Hewitt - Craig-Hallum Capital

Analyst · Craig-Hallum Capital. Please go ahead

Okay, alright. Well that I think about hits all of them. So thank you very much for taking my questions again.

Paul Kinnon

Operator

[Thank you] Matt.

Operator

Operator

(Operator Instructions). We have no further questions at this time. I will turn it back to the management for closing remarks.

Paul Kinnon

Operator

So thank you very much. We appreciate your participation and interest. And we would like to thank everybody for attending the call and look forward to speaking to you in the near future.

Operator

Operator

Ladies and gentlemen, this does conclude this conference for today. We appreciate your participation. You may now disconnect.