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Precipio, Inc. (PRPO)

Q2 2015 Earnings Call· Thu, Aug 13, 2015

$31.65

+3.09%

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Transcript

Operator

Operator

Good day, and welcome to the Transgenomic Second Quarter 2015 Financial and Business Review Conference Call. All sites are currently in a listen-only mode. Please note there will be a question-and-answer session later on in the call. Also note, today’s conference call will be recorded and will be accessible both, by phone and on the Internet. For information, please refer to the conference call press release on the company’s website transgenomic.com for further details. 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

Management

Good afternoon everyone and thank you for joining us today’s second quarter 2015 conference call. I’m joined by our Chief Accounting Officer, Leon Richards. I will provide an overview and update of our progress during the quarter, and Leon will then briefly review the quarter's financial results in greater detail. Since the start of the second quarter, we have made tangible progress in strengthening our strategically important businesses. We also achieved major milestones in our transformation into an advanced technology company, primarily focused on commercializing the many applications of our breakthrough Multiplexed ICE COLD-PCR technology. First in the second quarter, net sales were up 11% year over year excluding the impact of our divested Surveyor business. This marks our second consecutive quarter of double-digit increase in net sales. In the key Laboratory Services segment, we recorded a healthy 26% increase in sales compared to the year-earlier period with higher testing volumes which are mainly driven by our patient testing and services businesses and the Laboratory Services segment which is a key area we have targeted for growth. The launch during the second quarter of our new genetic test for the diagnosis of the devastating genetic disorders leukodystrophy is a good example of the focused investments we are making in to grow these businesses. In the second quarter, we reported an expected decrease in the bioconsumables and instrument sales compared to the second quarter of 2014, primarily as a result of our divestitures of Surveyor product line last year and the delayed shipment of a number of instrument orders approximately $300,000 from Q2 into Q3. The continuing shift from our reliance on instrument service based revenues to a focus on revenues differ from product, service and licensing applications of our ICE COLD-PCR technology is consistent with our ongoing strategy to transform…

Leon Richards

Management

Thank you, Paul. I am going to start today with our analysis of our second quarter results. Net sales for the second quarter of 2015 were $7 million compared with $6.8 million for the same period in 2014. Net sales for the second quarter 2015 for our Laboratory Services segments increased $1 million or 26% as Paul mentioned earlier as compared to the second quarter of 2014. The increase came in both the patient testing portion and contract laboratory services portions of that business segment. In Genetic Assays and Platform segment, second quarter 2015 net sales declined by $700,000 when compared to the same period last year. But also as Paul mentioned, the Genetic Assays and Platforms segment was negatively impacted by the divestiture of our Surveyor product line during the third quarter of 2014. Gross profit was $2.9 million or 41% of net sales, compared with gross profit of $2.4 million or 35% of net sales in the same period in 2014. The increase in gross profit was a result of higher Laboratory Services sales, which resulting in a 54% gross margin and that was partially offsets by decreased gross profit in the Genetic Assays and Platform segment, again being impacted by the Surveyor product line and about $300,000 adjustments made for inventory obsolescence during the quarter. Operating expenses were $5.7 million during the second quarter of 2015, compared to $6.3 million in the prior year. The decrease was primarily due to lower – some lower personnel costs, lower operating supply costs, lower stock compensation costs in the current quarter. In summary, the net loss for the second quarter of 2015 was $3.3 million or approximately $0.30 per share, compared with a net loss of $3.9 million, or $0.57 per share, for the second quarter of 2014. Modified EBITDA,…

Paul Kinnon

Management

Thank you, Leon. And at this point operator, we are ready to open the call for questions.

Operator

Operator

Thank you. [Operator Instruction] We’ll take our first question from Bill Bonello [Craig-Hallum Capital Group LLC]. Your line is now open.

Bill Bonello

Analyst

Good afternoon guys, just a couple of questions. Paul, I was hoping that maybe you could elaborate a bit more on the pilot clinical study to validate the accuracy and utility of ICP for using clinical trials. May be tell us a bit more about endpoint for that study and about the specific role that the biopharma firms are playing and then may be give us some sense of timing and any plans for presenting or publishing data that comes out of those trials.

Paul Kinnon

Management

Sure Bill Bonello. And the four global companies are providing us with liquid biopsy samples of 1,000 plus samples for us to analyze in-house and in some cases they’re also carrying out the analysis in-house with our kits that we sell commercially. And we’ll be starting that study – we’ll be starting that study this quarter and we’ve actually completing it in this quarter as well and providing the data back to the pharma companies. The goal being obviously is for them to validate the technology and the benefit of using it to analyze and interpret the data generated through liquid samples. And then we will be using some of that data in some sort of formatting of public presentations whether its PowerPoint posters or conferences and we’ll look at whether or not we can actually produce a white paper to show the validation of the technology as well in the marketplace. And then the benefit from our point of view as well as once this is proven within the hands of the customers and with our data then they’ll also give us more business and start growing their business in terms of giving us clinical trial work, but will eventually end with ICE COLD being used as a companion diagnostic longer-term in the projects or projects with other partners as well.

Bill Bonello

Analyst

Okay, that’s helpful. And just – I mean when you say they’re trying to validate the utility for using clinical trials and what specifically do they want to see to confirm – to get comfortable for adopting the technology for a trial?

Paul Kinnon

Management

Well, it varies by client in terms of what they’re looking for, in terms of what mutations, what level of mutations and what stage of samples have been collected at. It could be – they’re looking at using in a study for a drug that’s been used early for identification of early stage cancer or latest stage. So, they’re looking at which mutations are present. And all the companies are also looking at and possibility of using it to identify unknown and known mutations or to stratify populations of their studies. So one of the examples could be is as with Amgen in the past, we’ve done a stratification study to say this population should not be given the drug therefore don’t include them in the study. We can do that more efficiently with blood samples and testing because we can get lower level of mutations. Therefore, the pharma company when they go to FDA, they eliminate that population before they do the study, therefore it’s a clean test, therefore it gets through the FDA quick and more efficiently. So there is a variety of different applications that they’re looking at. It’s not so much there looking at and validating do we detect low level mutations, it’s really targeting what their application is and what their utility for the technology is.

Bill Bonello

Analyst

Okay, that’s helpful. And just so I understand are they – is this a process that that they’re providing you the samples that’s their contribution, and then you’re not charging them for the data that you’re – or the testing that you’re doing or the data that you’re providing back to them that suggest in essence sort of part of the commercialization strategy?

Paul Kinnon

Management

We haven’t really disclosed what the commercial terms are, but in essence we’re working with them to allow them access the technology quickly and rapidly. They are providing us their samples whether they’re new samples or current samples they have in storage from clinical studies or from their own collections, but it’s a way of rapidly penetrating the market for us and getting commercial adoption with them and building a pipeline of strong commercial partners for us longer term as well.

Bill Bonello

Analyst

Okay. And then on the Clinical Advisory Committee, can you maybe tell us a little bit more about that and some of the specific objectives for that group and what they will be doing?

Paul Kinnon

Management

I mean well, you know, what we’re trying to do is pull together some of the – that what we think of the strongest candidate in the market, they are thought leaders in the opportunities and the applications for liquid testing and biopsies, who have applications in the real world, who will understand which genes and which exons and which mutations are relevant one. And the reason is it’s more of a Clinical-Commercial Advisory Board is, we are looking at how that’s helping us navigate the – sort of the rapidly expanding marketplace to prioritize which is the best market to go after, which is the best gene to go after or other areas that we aren’t developing yet that we should be considering. So really it’s a net – less scientific review, more commercial with scientific guidance.

Bill Bonello

Analyst

Okay that’s great. And then just Leon in thoughts on sort of cash burn going forward, I mean, it looks like you’re burning sort of $3 million, $3.5 million a quarter, what’s the outlook for the back half of the year?

Leon Richards

Management

That’s a little bit high, Bill. So for the second quarter, the cash burn from operations is going to be reported in the Q at about $2.5 million.

Bill Bonello

Analyst

Okay.

Leon Richards

Management

And that’s the number that we are obviously not thrilled, still $2.5 million, but it is down from what we burned in Q1. We continue to monitor any expenses as Paul indicated earlier that are not ICE-COLD related and anything that is – anything that we can do to reduce the cash burn, it is what we’re working on. So $2.5 million is our – the number we hit of Q2 and we’re looking to keep at that level and less.

Bill Bonello

Analyst

Okay, great. Thank you very much.

Operator

Operator

[Operator Instructions] And ladies and gentlemen, this will conclude our question-and-answer portion of the call. I’d like to turn it back over to management now for additional closing remarks.

Paul Kinnon

Management

Thank you, very much. I hope we’ve communicated our enthusiasm about the progress we are making in revitalizing Transgenomic along with our excitement about the major milestones we’ve achieved so far this year, as well as there – those soon to come in successfully commercializing ICE-COLD PCR during the next 18 months with its potential to transform both our company and emerging filed to precision medicine. We look forward to keeping you apprised of our progress and we will do so in the future.

Operator

Operator

We appreciate your participation. You may now disconnect. Thank you and have a great day.