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Precipio, Inc. (PRPO)

Q1 2013 Earnings Call· Wed, May 8, 2013

$31.02

+4.09%

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Transcript

Operator

Operator

Good day. And welcome to the Transgenomic First Quarter 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. (Operator Instructions) Also note today’s conference will be recorded and will be accessible both by phone and internet. Please refer to the press release on the conference -- 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 or any statement that 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 the forward-looking statements involve risks and uncertainties. Transgenomic actual result could differ materially for management’s current expectations. Please refer to the press release, the company’s Q-10 and Q-K, and other periodic SEC filings for the 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 the call is rebroadcasting, transmitting, or redistributed at a later date Transgenomic will not be reviewing or updating this material. I will now turn the conference over to Transgenomic CEO, Craig Tuttle. Please go ahead.

Craig Tuttle

CEO

Thank you, [Joyce]. Good afternoon, everyone, and thank you for participating in today’s call. I’m joined today by Mark Colonnese, our Chief Financial Officer. I’d like to start off this call by providing a brief first quarter performance summary. Then I’ll provide an overview of our key business initiatives and commercial programs. I’ll then turn the call over to Mark who will review the first quarter financial results and following that we will have our typical question-and-answer session. But before we get going, I want to make a note that the change in our reporting structure that went into effect in the first quarter of 2013. We consolidated our laboratory -- our clinical laboratories and pharmacogenomics services business segments into a single segment, given their highly complementary nature and going forward it will be referred to as our laboratories services segment. In the first quarter we saw modest 2% growth at the topline. We continue to see topline growth in the Laboratory Services segment, which increased 11% year-over-year. This business segment is where we made our greatest investments in 2012 and we believe it will continue to be a major growth driver for the company. We continue to anticipated growth both in our Laboratory Services and Diagnostic Tools segments, and we commercialize new technologies and test we’ve acquired licensed or develop internally as we expanded other markets and regions worldwide with these products either by ourselves or with commercial partners. As you know in recent quarters, we’ve been focused on several key initiatives designed to advance our long-term growth. First, I’d like to mention the recent press release announcing our collaboration with Amgen in colon cancer. This is a very important step in our transition deeper into oncology genetic testing and we look forward to further announcements in this area.…

Mark Colonnese

Chief Financial Officer

Thank you, Craig. I’ll recap the financials reported earlier today now. Net sales for the first quarter of 2013 increased by about $22,000 or 2% to $7.4 million compared to $7.2 million in the same period in 2012. The increase was principally driven by an 11% gain in our Laboratory Services segment largely reflecting revenue from our newer test including Nuclear Mitome, ScoliScore and the C-GAAP diagnostic tests, as well as a modest shift toward higher priced tests. In fact our CLIA laboratories group, which conduct patient testing showed a 15% increase over last year. This increase was partially offset however by lower sales of instruments in our Diagnostic Tools segment, although sales to consumables for that segment showed an 8% increase. Gross profit was $3.7 million or 50% of net sales, compared to gross profit of $3.1 million or 43% of net sales for the same period in 2012. The increase in gross profit was largely attributable to improved margins in Laboratory Services segment including our Nuclear Mitome test, which resulted from a change in vendors, and also to a favorable shift to higher margin instruments sold in Diagnostic Tools segment. Operating expenses were $7.5 million during the first quarter of 2013, compared with $5.5 million in the prior year. The increase was due to higher costs related to expansion of our field sales force to support the sales of C-GAAP and ScoliScore and other products and a higher bad debt provision. In summary, the net loss for the first quarter was $3.6 million or $0.04 a share, compared to a loss of $2.7 million or $0.05 a share for the first quarter of 2012. Modified EBITDA was $2.9 million loss for the first quarter of 2013, compared to a $1.6 million loss for the same period of 2012. Cash and cash equivalents were $7.7 million at March 31, 2013, compared to $4.5 million at the end of last year. And with that, I’ll now turn the call back to Craig.

Craig Tuttle

CEO

Thanks Mark. So in summary, we continue to work diligently towards translating our strategic investments into value for Transgenomic’s many constituents including healthcare providers, patients and shareholders, and we look forward to updating you on progress through the balance of the year. And we are now happy to take any questions that you might have.

Operator

Operator

Certainly. (Operator Instructions) And we’ll go first to the side of Matt Hewitt with Craig-Hallum Capital Group. Please go ahead.

Matt Hewitt - Craig-Hallum Capital Group

Management

Good afternoon, gentlemen. Thank you for taking my questions.

Craig Tuttle

CEO

Hi, Matt.

Matt Hewitt - Craig-Hallum Capital Group

Management

First, could you maybe breakout little bit on ScoliScore test, some of the progress you’ve seen since you brought that under your umbrella, I think when you acquired it, it was around $2 million in revenues, you expected that you could get to $4 million with an increase sales present or actually sales present at all? And then also on the reimbursement side, where are we today on that timeframe?

Craig Tuttle

CEO

So, Matt, we are, the response is, that, a little bit more complicated. Number one, we are working to get specific reimbursement improvements with many of the payors for the test that includes both contracting efforts with them, as well as these publications that we are working with, I think the most significant thing we’ve done is reengage with all of the key opinion leaders in this market to actually work with them to further the awareness of the test because many had not been contacted in some time about the assay. But also to work with them to gain publications and the publications are really the critical step toward helping in deeper support for reimbursement. And finally, we begin direct-to-consumer marketing activities that are just beginning to bear fruit in terms of patient’s learning and patient’s families learning about the assay and so those just have to take group. So at this time, we are not forecasting what we will see in the year for ScoliScore. But we definitely believe throughout the year, we will have these publications that will then justify deeper reimbursement and more contracts with key payers. And we think that’s the key in critical success. We’ve also expanded the sales team’s responsibility for selling this, so all of our reps are now covering ScoliScore. We believe it is such a significant opportunity but that's just a very recent development.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. As far as publications are concerned, when should we be watching for those to hit? Is that something that could hit this summer or is it more in the second half of the year?

Craig Tuttle

CEO

Certainly, in the second half of the year, although we are working very diligently with a variety of these key opinion leaders to develop the data that are submitted for publication. Unfortunately, we cannot control when journals accept the publications, but I know there are several studies being developed right now or finished for submission.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Thank you for that. Secondly, ICE-COLD PCR, I know that there is a couple hospitals that have been working on some studies regarding ICE-COLD PCR. I think the plan has always been that they would complete their studies and seek publication of the data. Where do we stand with that and how can this ICE-COLD PCR ramp, as we look at the back half of the year?

Craig Tuttle

CEO

I will answer the first -- first, I will answer the last part of your question because I think it leads into the remainder. So this is an assay technology that we will have a variety of gene kits launched into the market as an RUO and for sales worldwide. And then from those sales, we expect to have deeper publications come out in combination with the studies that we are doing now. So that’s the first stab at the commercial effort. In terms of the hospital you asked about, we've actually had some customers that contacted us to buy ICE-COLD PCR kits to variety of labs and hospitals to look at the technology to see it, that something that they should include in their current clinical regimen and those are still ongoing. But equally important is the deep studies that we are doing with MD Anderson and Dana-Farber and still with UNMC here in pancreatic cancer, that should result in publications beginning as early as ASCO. So, we believe there will be some very exciting data in lung cancer at ASCO, both in circulating DNA assessment as well as circulating tumour cells. So you will see that quickly.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. So there will be imposers or papers at ASCO on ICE-COLD PCR, if I’m hearing you correctly?

Craig Tuttle

CEO

Yeah. That’s Correct.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay.

Craig Tuttle

CEO

Not just from us.

Matt Hewitt - Craig-Hallum Capital Group

Management

That’s fantastic. As far as kind of hitting the bunch of different topics here and I apologize for bouncing around. Amgen, first of all, congratulations on your first announcement on the pharma partnership, that’s great news. Could you maybe provide or is that still going to come, as far as some details that you could provide as far as the opportunities concerned either domestically or internationally? Obviously with the European approval, I would say that that’s going to be your first revenues will come from that market. But how big of an opportunity is that?

Craig Tuttle

CEO

First of all, thanks, Matt. It was a great relationship that began sometime ago and it is nice to see it mature to this level. We really are duty bound by our partner to limit the amount of information we release on that collaboration in those products until their timeline. And they make -- they are supporting announcements but you should expect things shortly from us. But what I can tell you in terms of biologically treated metastatic colon cancer patient, it’s roughly 50,000 in the U.S. and a similar number in Europe. And we think then rest of world is a similar number and we certainly know that there is demand in the Middle East and in South America and obviously in Asia for these products. So, I will told I guess I could add to that up and say maybe 200,000 potential patients. Although the biologics treatment levels I don’t believe are quite at that higher level in South America and the Middle East yet. So that’s kind of an indication of the total population of biologically treated metastatic patients. So that’s certainly a market and we will be selling laboratory services as well as kits and instrument systems to support that.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Again that’s great news. As far as the Menarini partnership is concerned, how was that progressing, when should we anticipate the full blown launch of the WAVE MCE Systems, how soon can that start getting some traction?

Craig Tuttle

CEO

Again, another good question and the CRC RAScan product line will be involved in that. We are still in the final stages of beta site testing with some key European partners in collaboration with Menarini at the completion of the beta site trials. They anticipate they are through an aggressive launch. So it still remains a high priority product in their mind and our mind and it’s a strong collaboration. And we are in constant communication with them about it.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. You mentioned that you’re going to be rolling the pharmacogenomics business into the lab services business. Maybe -- I would assume that’s going to make it a little more difficult for us unless you plan on breaking out of the conference calls, the revenues or the business that you generated from the pharmacogenomics in any given quarter. How should we be thinking about that business going forward and there was a couple of phase 3 trials that I know that you had been waiting for the pharma customer partner to give the green light on. Where does those sit today?

Craig Tuttle

CEO

Well, on one hand we are told we cannot announce the projects that we have in queue, simply because they remain confidential and are subject to those pharma partner’s submissions. So at one point, we thought we would be able to announce but we have been informed otherwise. So you won’t hear that from us other than in terms of dollar volume tick ups in that business, which we anticipate shortly.

Mark Colonnese

Chief Financial Officer

Other than, Amgen, of course…

Matt Hewitt - Craig-Hallum Capital Group

Management

Yeah.

Mark Colonnese

Chief Financial Officer

…Which was a really nice opportunity for us to announce that.

Matt Hewitt - Craig-Hallum Capital Group

Management

Yeah. Okay.

Mark Colonnese

Operator

But going back to your first question, Matt, that business is about 90% of that is our patient testing business in our CLIA labs. So that will be the driver of how that business progresses and how it grows. It’s such a large piece of it that pharmaceutical’s number is just not going to materialize at least in the near term.

Matt Hewitt - Craig-Hallum Capital Group

Management

But if I recall correctly, I mean, a couple of CRC trials depending upon how quickly they phase in, those could be significant. I mean, if I think about $1 million Phase III trial that phases in over a couple of quarters. Now, is that 10% of that business anymore. It’s much greater than that. So how should we be thinking about modeling? For example, when I realized at the end of the day, it’s up to the customer to again give the green light but -- and I realized that you can state who the customer is but from a timing perspective, are we going to have any visibility on that or is it just wait-and-see what happens in the quarter?

Craig Tuttle

CEO

I think what we’ve said in the past and what’s true is that these projects that are big million dollar projects will take four, six, eight quarters to expand. So I think they will be incremental to our business but I don’t think it’s one that you’re going to see tripling of the business in any given quarter. But that said, I can tell you that the interest in our pharmacogenomic services business has expanded pretty quickly from the Amgen release. And we’ve gotten a lot of good feedback from potential customers already as a result of that announced collaboration. And what’s most rewarding to me on that one and I can go on and do it any deeper than that. But from an excellent collaboration with the partner like that, we have follow-on product that we can sell on our CLIA lab and that we can manufacture and sell into our kit -- or as a kit onto our systems worldwide. So that’s the exact model we were trying to pursue and it’s incredible for us to have it finally realized but we hope to continue duplicating that.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Maybe one more from me then I’ll jump back in the queue. Sorry, I’m monopolizing your time here. The new sales hire, obviously, it’s been a significant jump from Q1 of last year. I think you’re right, close to 30 at the end of Q4. Where does that team sit today and where do you see it shaking up maybe as we exit this year?

Craig Tuttle

CEO

Well, we didn’t finish that staff up until the end of 2012. So we are -- we continue to monitor and manage those new folks and help them to learn their territories and our products. Most of them came with deep experience in the cardiac space but we did bring in some additional really strong sales professionals on the neurology side to help with ScoliScore and then ourselves decided that it’s such a big opportunity. All of our team are selling that product line. So we manage that closely and track progress. And that said I can tell you that we are looking at other vehicles to add to that and other marketing efforts to drive Scoli and C-GAAP much more deeply into the market then maybe we can hit with just those resources. So it remains a key focus and then one, I think that we will certainly get an answer for fairly soon.

Matt Hewitt - Craig-Hallum Capital Group

Management

So are you still -- are you saying that you’re still around 30 with no immediate plans to add to that team or from a headcount’s perspective?

Craig Tuttle

CEO

That’s correct.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Great. Thanks. I’ll jump back in the queue.

Craig Tuttle

CEO

All right. Thanks Matt.

Operator

Operator

We’ll go next to the site of Alex Silverman with Special Situations. Please go ahead.

Alex Silverman - Special Situations

Analyst

Can you break down roughly the $1.5 million incremental on OpEx between the sales force growth and what the bad debt provision was?

Mark Colonnese

Operator

The bad debt provision was a large piece of it than the sales force increase.

Alex Silverman - Special Situations

Analyst

What was the bad debt provision in the quarter?

Mark Colonnese

Operator

It was about a $1.5 million in the quarter, $1.5 million.

Alex Silverman - Special Situations

Analyst

And was that a single receivable or what was that?

Mark Colonnese

Operator

No, that was -- and if you look at last year’s -- I think for the year last year we did about somewhere between a $0.5 million and $0.75 million every quarter. So this was higher than normal. This was related to some Medicaid receivables we had in our lab business that was the bulk of the write-offs and the low Medicaid reimbursement that we’ve been seeing are one of the top things that we’re planning to address very shortly.

Alex Silverman - Special Situations

Analyst

Okay. Thank you.

Operator

Operator

(Operator Instructions) And we will go to Brian Marckx with Zacks Investment -- I'm sorry -- with Zacks Investment Research. Please go ahead.

Brian Marckx - Zacks Investment Research

Analyst

Hey guys, most of my questions have been answered and the remaining has to do with the Amgen collaboration. I know you may be limited on what you can talk about, but I’ll give it a shot anyway. Can you talk about how the revenue model works with the collaboration?

Craig Tuttle

CEO

Well, the collaboration itself is a fee for service. So they are paying to -- for us to complete the development and get the CE-IVD designation for these kits. So that’s part one that’s a fee for service. And then of course then we will begin selling the kits and that could be a revenue item in our -- like other consumables in our tool business.

Brian Marckx - Zacks Investment Research

Analyst

And so does Amgen get a portion of the revenue?

Craig Tuttle

CEO

Can’t go into any of those financials associated with that.

Brian Marckx - Zacks Investment Research

Analyst

Okay.

Craig Tuttle

CEO

Yeah.

Brian Marckx - Zacks Investment Research

Analyst

Okay. So it’s RUO in U.S. right now and for clinical use in Europe, correct? So is it…

Craig Tuttle

CEO

And LTD.

Brian Marckx - Zacks Investment Research

Analyst

I am sorry?

Craig Tuttle

CEO

An LTD SA.

Brian Marckx - Zacks Investment Research

Analyst

Okay.

Craig Tuttle

CEO

I am sorry, LDT. It’s a lab developed test in our CLIA lab to make all the acronyms come out.

Brian Marckx - Zacks Investment Research

Analyst

Okay. Now I forgot my question. Relative to Menarini and how this potentially accelerates instrument placements?

Craig Tuttle

CEO

The interesting news here, Brian, is that the new exons and the mutations that are contained there. We have the only kit products on the market for them. And that’s because of our collaboration with Amgen. So that gives us a significant leg up. We believe to move into the marketplace immediately and hopefully begin securing revenue for that and to support patients. Anything beyond that, we just can’t say at the moment but there will be news relatively soon on all of that.

Brian Marckx - Zacks Investment Research

Analyst

Can you say estimated timeline of when the test rolls out in Europe?

Craig Tuttle

CEO

We’re going to put out a press release on that when we launch and that will be done very shortly.

Brian Marckx - Zacks Investment Research

Analyst

Okay. That’s it. Thanks a lot.

Craig Tuttle

CEO

Okay.

Mark Colonnese

Operator

Thanks Brian.

Operator

Operator

We’ll go back to the side of Matt Hewitt with Craig-Hallum Capital Group. Please go ahead.

Matt Hewitt - Craig-Hallum Capital Group

Management

Just a couple of follow-ups for me. First of all, as I look at the instrument business here in the first quarter versus a year ago period, were there any push outs or was there anything or onetime in nature that occurred here in the first quarter versus a year ago period or versus other normal quarter?

Craig Tuttle

CEO

This year is no. I think the big thing was last year we had a number of instruments sold to our distributor at distributor margins, and I think we’ve talked about this on past quarterly calls. So it’s more of fact that last year was a pretty good year for our instrument sales.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay.

Craig Tuttle

CEO

Yeah.

Matt Hewitt - Craig-Hallum Capital Group

Management

Cash flow and in CapEx in the first quarter just from a model.

Craig Tuttle

CEO

CapEx was very light. Cash flow, I don’t have that number in front of me, Matt. I can get it for you. But I can tell you it’s about $3.5 million spend. But I’d rather give you more accurate number. That’s a good ballpark for you.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Thank you for that. And then lastly, obviously you issued a press release here recently as far as Chad is moving on, what are your plans to replace that position and what kind of timeframe should we be thinking about?

Craig Tuttle

CEO

Well, we wish Chad well in his next position and we’ve already engaged a consultant to help us in commercialization of the Amgen product line as well as ICE COLD-PCR and that individual was previously the VP of Biz Development and General Manager of one of the leading divisions at Life Technologies. So he’s already been making really positive inroads in driving the commercial planning and activities around those two key programs both for the European launches as well as the U.S. So that’s the first side of it. And then the other is in the short-term, we’re picking up that responsibility and deeply engaged with our sales manager and team worldwide, but we will still look to replace that position.

Matt Hewitt - Craig-Hallum Capital Group

Management

Okay. Well, that’s great. Thank you very much for the update. We appreciate it and look forward to the coming press releases.

Craig Tuttle

CEO

Thanks, Matt.

Operator

Operator

I’m showing no further questions in queue at this time.

Craig Tuttle

CEO

Great. Thank you. Thanks for your questions and continued interest in the company and I look forward to further announcements of our key successes and business developments as they occur. Thank you.

Operator

Operator

This concludes today’s conference. You may disconnect at this time and enjoy the rest of your day.