Executives: Paul Kinnon – President and Chief Executive Officer Leon Richards – Chief Accounting

Officer
Analysts: Bill Bonello – Craig-Hallum Marco Petroni – Mg Capital Joel Marcus – Network 1

Financial
Operator: Good day and welcome to the Transgenomic Year-End 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 will be recorded and will be accessible both by phone and on the Internet. For more information, please refer to the conference call’s 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 results 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’ll now turn the call over to Transgenomic’s President and Chief Executive Officer, Paul Kinnon. Please go ahead, sir.

Paul Kinnon: Good afternoon, everybody, and thank you for joining us for today’s year-end 2015 conference call. I’m joined by our Chief Accounting Officer, Leon Richards. I’ll provide an overview and an update of our progress, and Leon will then briefly review the quarter financials and the annual review. Strategically, we have been focused this year on making Transgenomic the leading liquid biopsy company, we believe it can be. The transformation is required the discipline to divest the legacy businesses that provide most of our revenues in the past, a path that is now largely complete.

Recall that these businesses were inherently money losing propositions for Transgenomic with limited growth potential and the required time and investment to make them viable going forward. As a slim down high technology innovative enterprise, we are now able to turn our full attention to commercializing ICE COLD-PCR technology, which we believe as the potential to be a core enabling technology for the rapidly emerging liquid biopsy field, which is fundamentally changing medical practice and driving the adoption of personalized and precision medicine. We believe more than ever that this focus is our best opportunity to achieve robust growth and ultimately retain substantial value to our shareholders and we also believe that we have made good progress in 2015 in building a strong foundation for the future success. So 2015 has been a year of major change to Transgenomic as the company has followed its announced strategy, strategic plan, to divest its low potential legacy businesses and to focus on commercialization of our ICE COLD-PCR technology. We have achieved many of our strategic goals for the year intended to create a premier liquid biopsy focused company including launch and commercialization of ICE COLD-PCR across multiple sectors.

Broader commercialization is expected to provide increasing revenues as well as a foundation for expansion of the licensing and partnering strategy we are pursuing in order to realize the full potential of this broadly enabling technology. As noted implementing this strategy has involved a divestiture of businesses that comprise most of Transgenomic’s existing revenues. During the third quarter of 2015, we announced that company had sold off column separation business and the remaining Genetic Assays and Platforms business. These transactions closed in the fourth quarter of 2015. Last month, we’ve reported that we had initiated a strategic review and evaluation of our patient testing business that’s resulted in the decision to suspend testing at our CLIA laboratory in New Haven, Connecticut as we assess our strategic options for that business.

Please note that the patient testing business focused primarily on testing inherited disorders and diseases susceptibility and does not include ICE COLD-PCR based cancer tests that are running our Omaha laboratory. These divestments have made major effects in the company’s financial results. The Genetic Assays and Platforms business and Patient Testing business have been classified as discontinued operations. Information presented for current and prior year periods in the financial statements have been modified to reflect this. For 2015, we are posting a $23 million in discontinued operations and Leon will give you more details on these numbers shortly.

Our revenue in 2015 for continuing operations was $1.65 million for the core business related to ICE COLD-PCR including a pharma services, kits sales, CLIA testing, licensing fees and royalties. Initially, these revenues are primary being generated from pharma services, kits sales and CLIA testing. But over the coming two years, we anticipate that licensing and royalty revenues will begin to surpass these initial revenues. And that in the future, we could potentially be generating high gross margin, licensing and royalty revenues reaching $100 million a month. How do we achieve this future? Firstly by creating a solid foundation for expansion of our ICE COLD-PCR commercialization and licensing activities.

In 2015, we delivered a number of key strategic goals focused on the launch and the commercialization of ICP across multiple sectors. Firstly, late in the first quarter we launched ICE COLD-PCR as a pharmaceutical services offering to allow pharma companies and biotech industry to accept this powerful technology that pilots to these patient stratification and clinical testing targeting using the liquid biopsy technology. I am pleased to report we signed up four global customers immediately. The initial projects we are conducting with these customers should start to develop into substantial revenue, generating clinical studies over the coming years and months. Secondly, in late Q2, we launched our ICEme kits focused on enabling the large biomedical research market to buy our kits to facilitate oncology research designed to develop better drugs to treat cancer.

We rapidly signed several overseas companies, distribute these products and expect to announce a large agreement in the next few months that will provide significantly more distribution fire power behind our ICEme kits. Thirdly, we launched our ICE COLD-PCR CLIA testing business to cancer. This exciting offer offers ICE COLD-PCR based cancer tests in panels and specific unmet needs in patient testing and marching. We are very power of the fact that in just six months, we are successfully launched eight targeted panels for colorectal cancer, lung cancer and melanoma. And shortly, we will announce the eminent – shortly, we will eminently launch the fast liquid biopsy test for metastatic breast cancer.

This is a major development and we will be offering a ten day turnaround compared to currently a thirty day turnaround for metastatic breast cancer patients by using blood samples and identifying some of the most important low level mutations in this devastating disease. We also expect to be launching additional cancer tests on ongoing basis with the intention of becoming a real player in the rapidly growing sector. Fourthly, we signed our first commercial license commercially for ICE COLD-PCR with Melbourne University, an important cancer center in Australia, allowing them to offer CLIA style tests for EGFR cancer in Australia. Finally and fifthly, we established a strong Commercial Cancer Advisory Board that include four leaders and three clinical advisors to provide us oncology guidance we need to make the ICE COLD-PCR technology enabling and to enable a precision medicine market. All of these activities have helped position us and establish a foundation for TBIO to become a leader in the liquid biopsies and precision medicine field through our own sales and especially via our strategic and broad based licensing and partnering strategy.

While we have not yet achieved our goal of signing our first major partnership we anticipate doing so in the next several months. Now that our divestments are almost complete, we believe that TBIO will be more focused and aligned organization that is better able to deliver on the promise of ICP, the Precision Medicine market. As we have stated previously, it’s important to provide access to the technology as broadly as possible. And in order to achieve this, we will continue to strategically partner with sequencing platform companies, life science companies, molecular testing labs, academic and commercial, and also service providers. This strategy is being well-received in the market by potential clients and partners as the performance of our ICE COLD products.

All of this gives us confidence in our strategy annotates right one. Overall we are pleased with the increasing momentum we are achieving and believe we are on track to realizing the key elements of our plans for ICE COLD in TBIO. And with our new streamline structure we’re now able to focus our full resources and energies on commercializing this technology whose versatility and ease of use, we believe are perfectly aligned to the needs of the market, and the emerging high growth sector for liquid biopsies. With that, I’ll now hand over the call to Leon. Leon?

Leon Richards: Thank you, Paul.

As Paul noted, 2015 was a transitional year for the company. And from a financial reporting perspective, the divestiture of the GAP Business in two separate transactions, and the suspension of Patient Testing – of testing in Patient Testing business have had a major effect on the manner in which the company presents its operations and financial results. The revenues and expenses associated with the GAP business and the Patient Testing business are no longer included in the company’s results. And information prevented both the current year and prior periods in the financial statement has been modified to reflect these as discontinued operations. My comments will be in regards to the continuing operations only.

Net sales for the year ended December 31, 2015 from continuing operations were $1.7 million, a 33% increase, compared to $1.2 million in the same period in 2014. $0.5 million increase reflects the higher sales from the contract laboratory services lab in Omaha. Gross profit was – actually reflected a loss of $300,000, compared with a loss of $900,000 for the same period in 2014. The loss of the gross profit line improved due to the higher revenues and lower costs for some operating supplies in 2015, as compared to the prior year. Operating expenses for the year were $8.9 million, compared with $9.6 million in the prior period.

The $7 million – $700,000 decrease in operating expenses reflects lower stock compensation cost and some lower research and development cost in the current year versus the prior year. In summary, the net loss from continuing operations for the year ended 2015, was $10.1 million or approximately $0.93 per share, compared with a net loss of $10.8 million or $1.59 per share in 2014. We have supplied a modified EBITDA calculation which is a non-GAAP measure which the company views as an appropriate and sound measure of the company’s results. And the loss was $8.1 million for 2015, compared with a loss of $9.1 million for the same period in 2014. And a reconciliation of that net loss to modified EBITDA has been presented in our earnings release.

Cash and cash equivalents were $400,000 at December 31, 2015, compared with $1.6 million at December 31, 2014. And as previously announced, during the first quarter of 2015, the company completed a financing that raised approximately $2.2 million. At this point, I’m going to turn the call back to Paul.

Paul Kinnon: Thank you, Leon. In recap, Transgenomic has made major and significant progress towards becoming the focus precision medicine company, we’ve been targeting for the past 12 months.

We significantly advanced our ICE COLD-PCR commercialization strategy with the launch of multiple CLIA tests for cancer. We signed our first commercial license for ICE COLD, CLIA testing of disease, and continued to work with our pharma partners towards developing a scalable ICE COLD based services business. The company is still [indiscernible] while delivering on our promise to divest and monetize on non-strategic assets and generic non-dilutive funding to help fund our growth strategy. At this point, we’re ready to open the call for questions.

Operator: [Operator Instructions] And we will go ahead and take our first question from Bill Bonello with Craig-Hallum.

Please go ahead. Your line is open.

Bill Bonello: Thanks a lot. Good afternoon guys a few questions here. First of all, I am wondering, if you could walk us through sort of the timing expectations related to the various ICE COLD-PCR commercial activities, when we might start to see some uptick in revenue or revenue from those activities? And maybe even just some kind of ballpark of about how you are thinking about the size of the opportunity in the near-term?

Paul Kinnon: Sure and I appreciate it, Bill.

Obviously, we’ve got four or five clients in the ICE COLD testing side of it. With our pharma services business we’ve been running past with 30%. We see those projects generating revenue this year, took additionally to what we already get for our pharma services. Initially, there would be small projects, $250,000 to $0.5 million and as they increase, they’ll get up to maybe $1 million, $1.5 million like the Amgen project we did on Vectibix. So that will be a fairly good growth.

And we’re actually getting interest from other pharma companies and biotechs that we haven’t worked in the past because this area is becoming a very hot area as you know, whereby people want to use liquid biopsies to stratify the population and to eliminate overriding patients. So that will be the sort of read a book so to speak of the first business revenue. The kit business is starting to pickup and actually we’re generating significant activity there with lot of the U.S. and some of the international molecular academic centers. And that’s starting to pickup, but really we’re looking for a big distribution deal.

We’ve got one that we think we’ll be able to finalize and get announced this quarter, which will give us a very good standing in the market and maybe another few coming quite quickly after that. That will get the kit business up and running and get the kits being used in the academic market for people to start testing their drugs and development in academics. Secondly, the CLIA business, as I say, we launched eight tests in the first six months which is above what we planned. And we got a new one coming up which will accelerate the adoption of blood biopsies for breast cancer which is a really bad disease. And the treatments and diagnosis is very difficult in metastatic breast cancer, and it takes too long to get a tissue, analyze it, and then get the results.

So being able to do that quickly and rapidly, but also we’re looking at that as an opportunity to accelerate our licensing opportunities by talking to the large CLIA laboratory and also the academics you do the molecular testing in-house. And it’s actually generating a lot of interest, so we’re working in that region. They will probably be sort of similar revenues to the academic market for kit, but they will generate more revenue longer term because obviously they’ll be doing more testing in-house and that’s where the royalties and licensing becomes a benefit to us, because there’s no real work for us it just they’re doing the testing, they are running the tests and we just get the royalties which is a high margin. And then finally, the big licensing deals we’re hoping to get one of them done this year, probably in the next three or four months as well, whereby we get it on to a platform or into a company’s hands as they’re going to generate business for us in the same way they generate royalties. So overall, next 18 months, two years, it will be the kits and services and the CLIA business with oncologists.

And then after that the royalties and licensing revenue will pick up. We don’t give guidance, but in reality we do think the revenues we have so far will be small compared to what we’ll get in the next two years. And then in three to four years tying those revenues to stock growing significantly as we get royalties and licenses from the expansion of the technology and its adoption in the market very rapidly.

Bill Bonello: Okay. That’s very helpful.

And then can you just comment what your latest thinking of is in terms of either regulatory pathway, or trials, publications, et cetera, what at this point and do you think you need to do from either a regulatory or publication standpoint to drive adoption, particularly of the CLIA tests or the kits themselves, may be less on the licensing front.

Paul Kinnon: We sort of park then we simply say with the FDA and will continue to keep that there. And we don’t believe that FDA’s approval is required for the strategy we have for the licensing and commercialization we’re going through. The interest and the adoption we’re seeing and the activity we’re seeing from molecular labs and partners leaves me to believe that’s the right strategy. So that’s the – in terms of papers and publications, we’re presenting next week at the ASCO we got a very good paper on T790M another mutation, that are inherently critical to lung cancer.

Additionally, as I said we got the new breast cancer panel coming out. We’ve got some other papers coming out as well on concordance and such like that are actually very compelling and show great results. So we’ll continue to do papers and publications. We are actually trying to step up a little bit more of our academic collaborations to get those accelerated. And the study at Melbourne for their 0.2% clinical relevance has started.

We had trouble getting some of the samples and that study is underway now. So that will be working in the background. So really, I think it’s the partnerships, the strategies, the customers taking licenses for the products will start generating papers and publications and information. But the adoption of the technology is actually going to come from paper realizing it does work, starting to use known hands and the feedback we’ve got from end users. Mostly get the test and they start using it.

They realize how simple it is, how empowering it is and then we start adopting it. I think that will start generating the sort of adoption, accelerated so to speak and that put us in a good position. So I don’t see us spending millions of dollars paying for external collaborators to write papers or to run samples for us in the short-term. But I do see us collaborating more with some of the bigger institutes to generate work that will be co-published, that has our name on and their name on and is using their materials in-house.

Bill Bonello: Okay.

And then if I can just a couple of quick housekeeping numbers and may be I’ll go back into this one, but I don’t want to screw that. You gave full year results but not quarterly results because you did breakout a lot of the business into discontinued ops. Can you just tell us what the revenue from continuing operations for Q4 was?

Leon Richards: Yes, it was about a third Bill, it was about a third Bill.

Bill Bonello: One-third of the annual?

Leon Richards: Yes.

Bill Bonello: Okay.

Paul Kinnon: And the majority of that, Bill the majority of that was not ICE COLD-PCR.

Bill Bonello: Okay, okay. So what is that then just a curiosity?

Paul Kinnon: It’s the COLD pharma services, last year was a transformational year for the business. Additionally, it was a transformational year for the pharma services business in Omaha. So we continued presenting and talking to academic – so to pharmas about technology.

They’ve been evaluating it, talking with us running samples. So now we’re going to benefit from the fruits of that work where we will do studies and projects on the ICE COLD technology this year and start generating revenues from that where we will be using ICE COLD in our CLIA testing for pharmas. So in the past, as you know more historical projects like the ones we did with Amgen and like with Lilly in the past. So really it’s just our core genomic testing using our sequences in our next-gen sequencing platforms in Omaha to things like Vectibix and tissue samples not quite the blood biopsies where we’re going to be this year.

Bill Bonello: Okay that’s helpful.

And then just the last housekeeping thing on the balance sheet, is there any chance you can tell us where cash stands today and what cash burn is looking like right now?

Leon Richards: Yes, I mean, cash today don’t get me for a number out there, but on go-forward cash burns probably gone down significantly now and we’re looking at $450,000 to $500,000 a month. So we’ve reduced that by multiples to get the company focused and really clearly aligned to ICE COLD-PCR. The operation is all on generating revenue as we say from the services, the kits, the CLIA assays and then the licensing and partnering.

Bill Bonello: Thank you very much. Appreciate it.

Operator: Thank you. [Operator Instructions] Our next question comes from Marco Petroni with Mg Capital. Please go ahead. Your line is open.

Marco Petroni: Hi Paul.

Paul Kinnon: Hi.

Marco Petroni: Just following-up on the question from Craig-Hallum with the cash situation, due to the numbers you add, what you had at the end of the quarter you raised $2 million, you don’t have a lot of cash on hand. What are you guys going to do to bridge the gap between when revenue comes on the ICE COLD and now?

Paul Kinnon: Obviously, last year we did our non-dilutive capital in terms of the GAAP business. And obviously we announced our strategic review of the patient testing business which – and resulted in us doing the sort of suspension of testing. And obviously the goal there is to generate non-dilutive funding from the strategic review of that business.

I think that’s probably all I can actually say on that, Leon isn’t it?

Leon Richards: That’s – yes.

Marco Petroni: So, basically, we’re expecting some money from these assets start coming yet and that will bridge the gap between now and when ICE COLD will be supporting the company?

Paul Kinnon: That’s a good assumption Marco.

Marco Petroni: Okay. And then second question. I know you don’t give guidance, but you say that this is $100 million business and potentially more, but what is the distribution of that in the first.

I mean we talked about two years of $5 million, $10 million and then it goes to $50 million immediately. I mean how does this growth cycle work, is it the hockey stick or is it more gradual, just like distribution on that, where if we started June 1 of this year that was five years, how the year is going to look in terms of let’s say percentage of that $100 million?

Leon Richards: I appreciate the question. And we’ve spoken obviously on a regular basis. It’s not a hockey stick, we’ve got a plan that we built-out from the bottom down in terms of how many licensing deals, how many kits if someone buy comparing it to the other players in the market, comparing to the adoption whether it’s our kits sales or our CLIA testing and then also our pharma services. And then that grows and as I said, there is a pivotal point probably in year three, when the licensing and the royalty revenues will outstrip the cash generated from those other tests.

So for instance, if a customer says, I don’t know, pick a name of a large cancer facility whether it’s a cancer center of America Omaha. Say they take this the adoptive technology and we do a licensing deal with them. They would buy the kits of us at a discounted price and they would I guess a royalty on the test they provide. So we would be getting a discounted price of the kit sales and the royalty. In sort of the year, those royalties will start to adopt to be more than the revenue that we are getting from direct CLIA testing ourselves.

However, in the short-term that will be a bigger number. There won’t be a hockey stick and it won’t be a perfect straight line. But over a sort of two and a half year period, I’ll probably given that it’s all royalty number will become bigger than the actual direct sales, but we’ll still be getting revenue from the kit sales at discounted price in a lower margin. Then over the longer-term, there maybe in year four or five some of the larger companies or suppliers or customers may decide to build the kits themselves, therefore they will not – we won’t get the kit revenue, we’ll just get a royalty on their manufacturing rights. So really the drive is to get to the stage, we get the highest margin revenue in the three – year three or four, five onwards, but that then allows us to reinvest, but really it’s not quite a straight line.

Does that help Marco?

Leon Richards: Yes, it does, it does. I mean I guess when will you – when you guys going to feel comfortable, but you have some guidance to lay out some…

Paul Kinnon: I mean its hand on heart. If we outperform my plan which is conservative for this year, I’d be happy to give you guidance this time next year. Because if we outperform the foundation year, the next two or there years are easy, because this year is the growth year, this is a year where we get one or two things done and we start things, start to pick over. If we can outperform the plan in-house, I think we’d feel a lot more comfortable because we will have partners using the product, we’ll be enabling the marketplace.

If we can signup the number of people, I think we can this year, it’s easy for us then to predict because they will be running the sample, they will be running patient samples, they will be getting billed for them and paid for them, we’ll just be collecting money on them and also we will have our large distributors in place with the kit. So I would say probably this time next year we feel very comfortable doing it, because I’m fairly confident that we’ve got long – a big enough pipeline this year.

Marco Petroni: All right. Thank you, Paul.

Operator: Thank you.

[Operator Instructions] And we will go ahead and take our next question from Joel Marcus with Network 1 Financial. Please go ahead. Your line is open.

Joel Marcus: Yes. Hi, Paul.

I think the one question about where some of the funding is going to come from which is I guess the sale of facility where you just used to have the Patient Testing and everything. If I understood correctly, seems to want to give guidance on what those assets might be sold for, if I was wrong obviously guidance would be appreciated. And unfortunately all of this happens so quickly, I really haven’t had time to read the K lines for lines for line, but on the balance sheet, it does jump out that you have $7 million in debt maturity this year and you don’t seem to have any palpable way to pay that down or less to re-negotiate it. So what are your plans for dealing with that debt that’s maturing this year to get us to the very bright future that you’ve outlined for as where they installed?

Paul Kinnon: Third Security remains very, very supportive of the company. They always have been; they still are.

And the company, the organization is fully behind what we are doing. We ramp it on a very regular basis. And personally I don’t see us – we obviously want to pay that debt back as quickly as possible, as effective as possible. We understand it’s a hurdle, it’s out there. But we haven’t got any plans to make that paydown today, tomorrow.

But we obviously work with Third Security on a regular basis to see how we do that and we need to do. And then if you would like to add anything, Leon about that from a financial standpoint?

Leon Richards: I think at this point that is as much as we can say in regards to that Paul.

Joel Marcus: Okay. And is there any guidance you would like to give on what the assets behind the Patient Testing facilities where you just suspended operations, again as I say, I thought I understood you to say that you couldn’t, but I will just ask again in a case that I misheard you because all of this is happening so quickly as we say that really have time to refuel a lot to repair myself for this, but can you give any guidance as to what those facilities and what that ongoing business might be able to be so forth?

Paul Kinnon: I appreciate the clarification; we can’t give you specific guidance of how much. I can’t say that we are actively working on a number of transactions that relate to the Patient Testing business that should bring in funds in.

As any or if any of that becomes material, we will obviously disclose it. We’re confident that it will bring in funds and that will allow us to keep on moving forward with ICE COLD and that’s what we’ve been working on. It’s been a long restructuring process. I think the company has done a good job of building it. In the press release we do list out the achievements that we’ve got on ICE COLD.

And I’d say it’s probably when we did it hindsight and look back this year and said what we’ve done, we actually did perform a lot and get a lot of stuff and all things done. And that’s according to the rest of the business in the focus. But really we just need to move forward now and make Transgenomic, TBIO sort of the right business for the liquid biopsy company, the tests were coming out whether the right test, good test, the technology is being accepted and really we just going to keep going with that, get these deals closed and do what we need to do, but we can’t really give you anymore clarity than that, but I appreciate the question, Joel.

Joel Marcus: Okay. And I guess my final observation is you’ve accomplished an awful lot.

I mean you’ve got a very healthy intellectual property portfolio, I mean you’ve got these things out there and your share counts for a company that’s achieved all this is still remarkably low. So I mean if you have a dampened equity to raise more money to get from here to there, I mean it’s not the end of the world because you kept the share count remarkably low for a company that’s developed like you’ve developed over the course of the years.

Paul Kinnon: Yes. Actually that brings up one point that I completely forgot to mention in the discussion actually. We actually spend it the IP against the patent roll in U.S.

And basically, we got both patents issued and confirmed and actually got six new claims granted as well, which is actually you unheard out. So the validity of the patents and the strength of the patents was confirmed during the year because we actually did defend the patents in the U.S. PDO as well.

Joel Marcus: Great. Okay, that’s the end of my question.

Thank you, Paul.

Paul Kinnon: Thank you.

Leon Richards: Thank you.

Operator: Thank you. [Operator Instructions] And it does appear that we have no further questions at this time.

I will now hand it back over to Paul Kinnon for any additional or closing remarks.

Paul Kinnon: Now I will tell you, thank you very much. I hope we’ve communicated our enthusiasm about the progress we are making in revitalizing TBIO and advancing the commercialization of ICE COLD-PCR with its potential to transform the company and the precision medicine market. And we look forward to keeping you upraised of our progress.

Operator: And that does conclude today’s program.

We’d like to thank you for your participation. Have a wonderful day and you may disconnect at any time.