Paul Kinnon - President & CEO Mark Colonnese - CFO.

Bruce Galloway Rayman Yang.

Welcome to the Transgenomic's Third Quarter 2014 Financial Results Conference Call. (Operator Instructions). Also note today’s conference call 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..

Good morning everyone and thank for joining us in today's conference call. I'm joined by today by our Chief Financial Officer, Mark Colonnese. I will start by providing an overview of our continued progress in improving Transgenomic’s commercial focus and building a foundation for a robust and sustainable growth.

Then Mark will walk us through the operating results for the third quarter of 2014. Then we will then open the call for questions.

The period since the start of the third quarter has seen several developments that I believe together represents a turning point for the company and strengthen our position as we prepare to multiplexed ICE COLD-PCR to the market.

As Mark will describe in greater detail we’re once again reporting sequential quarter sales increases in our core laboratory services business. We’re managing our costs more effectively which results in a reduction in our operating expenses this quarter.

We continue to take action on our assessments on which asset should be part of our future growth strategy and which might be best redeployed to sharpen our focus and non-dilutive resources for the growth.

We have been more proactive in reaching to current investors and sharing our story with new investors by participating in a number of investor conferences.

Most significantly we’re reporting two late breaking developments that mark the real start of the commercialization phase of our multiplexed ICE COLD-PCR technology which is potential to enable the widespread adoption of personalized medicine for cancer one of the serious [ph] diseases.

Firstly today we announced that we have finalized an important research agreement with the University of Melbourne under the direction of renowned molecular pathology researcher Paul Waring.

Paul Waring's team will conduct validation studies aimed at showing the ultra-high sensitivity of our multiplexed ICE COLD-PCR technology produces results that are clinically valuable for the routine diagnosis and treatment of cancer.

We expect that this study and other validation studies conducted by Melbourne's Researchers will be critical in helping us to achieve the tremendous clinical and commercial potential of this breakthrough technology.

Secondly in our earnings release this morning, we reported the signing of our first commercial agreement with the leading biopharmaceutical company the use of multiplexed ICE COLD-PCR for biomarker identification and drug discovery and development.

The first contract in an existing -- is an exciting development in and of itself there is more so because the company in question is an oncology leader. I have more to say about these important developments later in the call.

Mark will walk us through third quarter numbers in more detail shortly but I want to take a moment to note a few trends that I believe are indicative of the fact that we are increasingly on the right track.

Most importantly we’re again achieving sustained quarterly revenue growth in our core laboratory services business which we see a central for the growth of our future business. In the laboratory services segment patient testing revenue were up 28% year-over-year expand [ph] by a number of new product launches in late 2013.

Based on the trends that we’re seeing, we’re optimistic that the growth in the segment will continue into Q4 and next year. We reported a small decline in revenue for our genetic assays and platforms business which was expected due to the divesture of our SURVEYOR product line.

However, sales in genetic assays and platform segment as it's comprised post-divesture posted and increase in third quarter compared to the same period last year. It's noteworthy that this business actually would have shown stronger growth with a couple of very large instrument orders having slipped from third quarter into fourth quarter.

These sales are now being booked and showed help ensure we have a strong Q4 for the business. Overall we’re optimistic that we will finish on a strong note this year in all three of our businesses and begin 2015 with good revenue growth and momentum. Let me now turn to the multiplexed ICE COLD-PCR agreement with researchers at University of Melbourne.

The study has Paul Waring, he is renowned molecular pathologist who is a long standing and longtime leader in advancing tools and measuring the molecular basis of cancer including students [ph] at Genentech and top academic cancer centers.

In this first study, Paul Waring and his team are seeking contain the ultra-high sensitivity of multiplexed ICE COLD-PCR produces results that are clinically valuable for the routine diagnosis and treatment of cancer.

The project team is optimistic that the study will be successful in validating the practical value of our technology and help differentiated from results generated with traditional Sanger and next-gen sequencing platforms.

If all goes well in the next phase of the project the Melbourne researchers will work for to validate the ability of ICE COLD to detect cancer mutilations with high sensitivity using liquid biopsies based on patient blood or plasma rather than tumor biopsies.

Prior research indicate that ICE COLD should perform well in these studies there by helping to pave the way for broader adoption, a personalized cancer treatment in collaborating our ICE COLD technology.

We expect these validation studies conducted by Melbourne's highly respected researchers will be very valuable in helping us to achieve the full clinical and commercial potential of this enabling and breakthrough technology.

As excited as we’re about our research collaborations University of Melbourne, our second multiplexed ICE COLD-PCR as of today is even more significant. So it's the first of what we expect to many business relationships to the use of ICE COLD technology for cancer drug discovery and development.

As we have previously stated, interest in working with the unique enabling properties of ICE COLD-PCR technology is on the rise in the biopharmaceutical industry and I'm delighted to report we have recently initiated our first ICE COLD-PCR evaluation with Amgen.

Our biomarker identification business unit will be working with Amgen to conduct this initial study that uses multiplexed ICE COLD-PCR to detect certain cancer associated mutations using plasma samples from oncology patients.

We’re optimistic that many researchers in both biopharmaceutical industry and academia will be eager to use ICE COLD-PCR in research and commercially once they have the opportunity to assess the performance first hand.

We had promised we would post the first revenues from multiplexed ICE COLD-PCR projects and our biomarker business this year and we’re pleased that we’re delivering on that commitment with the start the work with Amgen.

We’re thrilled to be undertaking the first commercial project with the bio pharma industry and oncology leader and we expect to engage many more such projects with other clients. We look forward to reporting on our further progress in the month and quarters ahead as we continue with the rapid release and adoption of multiplexed ICE COLD-PCR.

One issue we continue to address is strengthening the cash position of the company. Early in the quarter we divested the SURVEYOR product line which will generate more than 4 million in cash to help from our future growth while also freeing up some internal resources.

We’re able to retain the rights to use the SURVEYOR product in our growing clinical business making us a win-win for both parties. Selectively redeploying and monetizing underutilized assets is an important part of our revitalization plan and we have been working on a strong pipeline of business development activities to implement this strategy.

We believe these activities could bring considerable additional non-dilutive cash to Transgenomic in the near to mid-term and we will keep you informed about the progress as it occurs. We also anticipate we will be establishing a number of collaborations, partnerships, and licensing agreements around ICE COLD-PCR technology in the near to mid-term.

These have the potential to include substantial upfront milestones, royalty fees and other cash opportunities and we’re actively developing the pipeline as well. As previously stated we anticipate 2015 will be an active period of deal making for the company.

Finally after the quarter's close we announced completion of a 2.4 million private placement that included both existing and new investors. Our focus here was on supplementing our current cash reserves in the limited way and we were successful in doing so.

We saw this as a simple means of bridging the gap between the company's short term cash needs and some of the near term monetization activities we are working on and expect completing near to mid-term. Overall we are increasingly confident that the company's turnaround is well underway.

Our three business units are starting to make significant progress and deliver increased sales and drives commercialize and monetize our key assets including ICE COLD just starting to pay-off. With that I will now hand the call over to Mark.

Mark?.

Thanks Paul. Good morning everyone. We released our financial results about an hour ago so I hope that all of you have got a chance to review the numbers and I will start today with a look of at our third quarter results.

I think the big story for Transgenomic this quarter is to continued resurgence of our core business and laboratory services segment that trends continue, that unit continued this trend of sequential quarter-over-quarter of sales growth for the third consecutive quarter.

We’re currently seeing that trend continue this quarter as well so revenue growth in that segment is now firmly on the right track and I think that’s a significant and important turnaround for the company. Turning now to our year-to-year comparisons.

Consolidated net sales for the third quarter of 2014 dip just slightly to 6.4 million from 6.6 million last year due to two very distinctive events.

First in our laboratory services segment sales decreased by 1% due to an extraordinarily large genetic development services contract we conducted in 2013 which negatively affected the prior year comparison. Notably this decline was partially offset by higher sales of patient test which increased by 28% as compared to the prior year third quarter.

The second event was in the genetic assays and platform segment whose comparison was negatively affected by the divesture of the SURVEYOR product line during the third quarter of 2014.

As Paul shared with you earlier the genetic assays and platform segment as it's currently constructed posted a modest sales increasing the third quarter of 2014 as compared to last year due to higher instrument sales.

Gross profit was 2.2 million or 35% of sales compared with gross profit of $2.4 million or 41% of net sales for the same period last year. The decrease in gross profit was a result of lower sales at our contract laboratory services unit which has a relatively fixed cost structure and due to the impact of the SURVEYOR product line divesture.

These decreases were partially offset by increased gross profit from our higher patient testing volume. Operating expenses were 6.2 million for the third quarter of 2014 compared to 7.9 million in the prior year.

The year-to-year decrease of more than 20% was primarily due to lower bad debt provisions in the current quarter partially offset by higher non-cash stock compensation cost.

In the other income and expense category, the most significant item is the net gain of $4.1 million that was recorded as a result of the sale of SURVEYOR product line in July this year. We received more than $3.6 million in cash upfront and we will get minimum of at least $600,000 over the next four quarters.

In summary the net loss for the third quarter of 2014 was about $80,000 or $0.05 a share compared with the net loss of $5.6 million or $0.78 per share for the third quarter of 2013. And as I mentioned earlier the 2014 figures include the $4.1 million gain from the SURVEYOR product line divesture.

Modified EBITDA showed income of 1.1 million for the third quarter of 2014 compared to a loss of 4.7 million for the same period in 2013 and you can find a reconciliation of EBITDA to net income in our earnings release.

Turning to the nine month financial results, net sales were 19.4 million this year compared with $21.3 million for the same period in 2013.

Sales in laboratory services segment decreased by 8% compared to last year reflecting the impact of that unusually large 2013 service contract that I referred to earlier when discussing the three month comparison. Nevertheless, patient testing sales for the nine month period continued to show growth as compared to the prior year.

In the genetic assays and platform segment net sales declined by 11% during the first nine months of 2014 as compared to the same period in 2013 largely as a result of lower instrument sales in the first half, lower instrument sales this year.

However I should note that this is basically due to the first half sales and this business has started to show increases in the second half as we have recently started to register sales of the new products that we brought on board earlier this year.

Gross profit for the nine months ended September 30, 2014 was $7.1 million or 37% of net sales compared with gross profit of $8.1 million or 41% net sales for the same period last year.

As was the case with the three month comparisons the decrease in gross profit was due to lower contract laboratory revenues in the laboratory services segment and lower revenues in the genetic assays and platform segment.

Operating expenses were $18.6 million for the first nine months of 2014 compared to $20.8 million for the same period last year, the decrease again was largely due to lower bad debt provisions this year compared to last year along with lower employee related cost resulting from a reduction in our laboratory services sales force in 2013.

Both of these decreases were partly offset by increased non-cash stock compensation cost. In summary net loss for the nine months of 2014 which benefited from the gain related to the SURVEYOR sale was $8.1 million or $1.22 per share compared to the net loss of $12 million or $1.73 per share for the same period in 2013.

Cash and cash equivalents of $900,000 at the end of the September third quarter was compared to $1.6 million at the beginning of the year. As Paul mentioned after the close of the quarter, we raised gross proceeds of $2.4 million at a private placement financing with the syndicate of new and existing investors.

We also have a number of activities underway in the business development area that should replenish our cash position in the near term and as most of you are aware cash position is an area that we continue to keep a very close eye out. With that I will turn the call back to Paul..

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

(Operator Instructions) And we will take our first question from (indiscernible)..

Paul I understand you’re going to be relative restricted in any details you can give around the project with Amgen but I'm wondering if you can give us any more color at all just in terms of maybe where in this project where ICE COLD is being used along the sort of spectrum from discovery to development in this project and then how we think about maybe the revenue opportunity with a project like this?.

Well I think as we said -- I will start with the last question first, I think as we said in the past we see these small initial projects as non-material for the company. It could be classed as material to the business unit itself but it's non-material with company.

We see a large number of these being done in next 18 months of the technologies adopted early-on in the biopharma studies and you know it will be a good starting point for us to build revenue and these revenues will grow as we move through the continuum of being involved early stage and valuations, pre-clinical work, etcetera, etcetera as the company take the technologies through the FDA.

In terms of what the study involves and where it is, obviously we’re using plasma samples and it's identifying mutations known and unknown mutations in patient samples. Those samples can come from early studies, late studies and longer term studies depending on where the pharma wants to use the test.

And also as you know not many tests are being validated or approved for clinical use with the plasma sample and this is really starting to allow the pharma companies to use this data to start just to find those technologies being used.

So I think it's early stage pre-clinical all the way through the clinical and it's just a matter of where the pharma is and where all their target is in their clinical validation process and sort of without going into the specifics of their relationship it's sort of a broad adoption of the technology in a very, very large market giving us massive opportunity to grow the technology long term..

And so I understand that in general just specific to Amgen it sounds like you can't really tell us I guess I'm not clear if you’re seeing, hey they are using across that spectrum they are more focused in the preclinical trying to figure out if there are relevant mutations that they still can discovery or if you can just sort of say, look I can't tell you specific to Amgen..

Yes, I can't tell you specifically to Amgen, obviously it's confidential on what we’re working on and which target we’re working on, and where that target is that in that pipeline. Their restrictions are lot more restrictive than ours in terms of what the work is just to say and it's an exciting for us.

It's a really good project and we’re excited to be working with them still and continue to work with that relationship..

Okay and then you mentioned, you know expect a number of collaborations going forward. Are those similar to what you’re talking about here or because you mentioned potentially for royalties, substantial upfront payments etcetera. Are those different kinds of maybe you can just elaborate I guess..

Yes I mean we have talked about before we see, ICE COLD-PCR is being a broadly adopted across the market rapidly in many ways and in many areas.

We will be looking at expanding the opportunity for working with other companies and other partners whether it's pharma companies or life science companies and as the technology becomes more adoptive because it's enabling nature and it's broad application, we see those generation income for the company and that point 3 or 4 years, you know upfront licenses, royalties, all of those are options that we’re discussing and looking at and we’re building that pipeline as we discuss and I think we have talked about that in the past but we obviously see that as a way of making sure that technology is adopted in the market rapidly..

And are those the types of things that could be potentially material from a revenue standpoint?.

Yes..

And you characterize that as relative near term? I mean do we think of that assort of next year, next quarter?.

It's everything from the beginning of next year through till 2016 - 2017.

It's a pipeline of building, it's the way we’re going to generate revenues around the multiplexed ICE COLD-PCR and it's basically how we’re going to grow that business and I think we have put slides up in the last few earnings conferences, we have been there where we show that we’re generating a revenue pipeline to show this technology could be worth 100s of millions of dollars and we see our addressable market is that but we see that this could grow to you know a large business for us and that will be made up of various pieces whether it's direct sales, whether it's partnerships, whether it's collaborations or whether it's licensing deals and that will start coming in next year and once -- it could be a material next year but then as it grows it will build revenue for us..

Okay. And then just a final question on the Melbourne project.

Is that essentially a discovery mutations, is that essentially what the initial goal of that is to find new clinically relevant mutations versus bearing out that mutations that are already known to be relevant can be identified in blood or is it both?.

So it's actually the study is oriented around validating the 0.02% which we actually surpassed because we can do 0.01%, detection of mutations in as counted [ph] sample, in this case it will be tissues. It's clinically relevant and makes sense to a clinician and could be used to clinician to make a determination of our patient.

So that’s the focus of this question to show that the ICE COLD enables that detection at the higher level of 0.02% compared to 0.01% to actually then show that’s clinically relevant for us clinician and then we will be doing future work with them working on plasma or showing other areas of the enabling nature of ICE COLD as well..

Okay so just to ask maybe stupid question, how do you demonstrate that it's clinically relevant? What are you trying to show?.

Well they will be using samples from known patients who had treatment and who haven't had treatment or have gone through treatment. So they will be using samples of already being used for patients and diagnostics etcetera.

So they will know what they are looking for and where it's coming from so they will be validating you know sort of like a retrospective study to show that the data they generate would have been clinically relevant and would have helped make the right decisions for the patients..

And we will take our next question from Bruce Galloway..

I have got a question about that also.

In the press release you know you didn’t mention anything about Amgen, you know what was the reasoning behind that? Did they not allow you to use their name and also you know I noticed that you’re saying that there is going to be many more collaborations and joint ventures and deals with different pharma companies and different healthcare companies.

I mean that’s pretty novel that Amgen didn’t want an exclusive with you.

Could you just elaborate on that?.

While I can answer the last question first, we are in the process or any sort of consideration of giving anyone an exclusive unless it was 100s of millions of dollars. We think this technology is phenomenally powerful and phenomenally enabling to the oncologist and to the medical market in terms of treating cancer patients better.

So unless one was going to spend an awful lot of money we wouldn’t consider an exclusive and in terms of the press release, in terms of the earnings press release that’s sort of a broad (indiscernible) of the whole earnings and where we’re.

Amgen, we’re happy for us to discuss and use their name in the earnings call and basically that’s what we agreed. Obviously they are a larger company than we are and they have got their own restrictions and limitations. You know we have had a very, very good relationship with Amgen over the last 2 or 3 years and we continue to do that.

We work very closely with them and they are very supportive and we have a good relationship and we talked about the future opportunities. This technology is generating significant interest. We have had a lots of companies talking to us and lots of pharma and biootech's.

The future is partnering, the future is collaborating and the future is getting people to work with us. We don’t see ourselves going out there head to head and competing directly with everybody. We want to partner, we want to enable the market to use this technology to improve healthcare oncologists and that’s the important part of this is.

This can help people get treated better, quicker, faster. And then monitory during the course the treatment so they know what's going on. You know mutations change, mutation has gone up about. To do all of that we got to enable other people to use and we got to work with the medical teams [ph] to get you in the marketplace.

So that’s all about partnerships and collaborations..

And we will take the next question from Rayman Yang. Go ahead sir..

Just a quick question on the collaboration with the University of Melbourne.

Can you elaborate on the types of tumors used in the consolidation studies?.

I think to be honest I'm specifically aware at this moment Rayman, to be specific, I think it's combination of lung, colon and maybe breast and melanoma. I would have to go back and look at the research project to be honest. I can't remember but I think that’s the four categories that are required but I'm not 100% sure.

Obviously they are the top four as well by the way in the oncology market in terms of the largest number of patients..

And is there a time line for completion of these studies?.

There is a project timeline; we actually think it will be fairly short. I would say this first study will probably take less than six months..

(Operator Instructions). And there are no additional questions at this time and ladies and gentlemen this will conclude our question and answer portion of the call. I would like to turn it back over to management for additional closing remarks..

So thank you very much everybody. Hope we will convey to you a sense of the progress the company is making and the revitalization of Transgenomic. We look forward to keeping you appraised of our progress and we look forward to speaking to you in the future..

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