VolitionRx's (VNRX) CEO Cameron Reynolds on Q1 2016 Results - Earnings Call Transcript

| About: VolitionRX Ltd (VNRX)

VolitionRx Limited (NYSEMKT:VNRX)

Q1 2016 Results Earnings Conference Call

May 13, 2016 08:30 AM ET

Executives

Scott Powell - VP, IR

Cameron Reynolds - CEO

Analysts

Bruce Jackson - Lake Street Capital Markets

Brian Marckx - Zacks Investment Research

Yi Chen - H.C. Wainwright

Operator

Good day and welcome to the VolitionRx Ltd First Quarter 2016 Earnings and Business Update Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Scott Powell, Vice President of Investor Relations. Please go ahead.

Scott Powell

Thank you, Vicky. And welcome everyone to today’s earnings conference call for VolitionRx Limited. This call will cover Volition’s financial and operating results for the first quarter ended March 31, 2016, along with a discussion of our key upcoming 2016 and 2017 milestones. Following our prepared remarks, we will open up the conference call to a question-and-answer session.

Also on our call today are Mr. Cameron Reynolds, Chief Executive Officer of VolitionRx, and Mr. David Kratochvil, Chief Financial Officer.

Before we begin our formal remarks, I’d like to remind everyone that some of the statements on this conference call may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as expects, anticipates, intends, plans, aims, targets, believes, seeks, estimates, optimizing, potential, goal, suggests, and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company’s bodily fluid-based diagnostic tests, as well as the Company’s ability to develop and successfully commercialize such test platforms for early detection of cancer.

The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company’s development pipeline, or any other diagnostic products that the Company might develop; the Company will face fierce competition and the Company’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission.

These statements are based on current expectations, estimates and projections about the company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this conference call and, except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics , NuQ and HyperGenomics, and their respective logos, are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to on this conference call are the property of their respective owners.

I’d now like to turn the call over to our Chief Executive Officer, Mr. Cameron Reynolds, who will discuss our first quarter 2016 financial results and our clinical and operational objectives for 2016 and 2017. Cameron?

Cameron Reynolds

Thank you, Scott. And thank you, everyone for joining VolitionRx’s first quarter 2016 earnings conference call. I’d like to thank you all for taking an interest in VolitionRx, and it’s very exciting time for us.

Firstly, I will start with the review of important Q1 events from this year. We continue to make excellent progress with our clinical trials. As a summary, we made good progress in colorectal cancer where we announced our best adenoma detection rates to-date in a targeted clinical trial of 430 patients conducted with Hvidovre Hospital and the University of Copenhagen in Denmark. Our panel of five NuQ biomarker assays in age adjusted algorithm accurately detected 75% of high-risk colorectal adenomas, those most likely to become cancer and 86% of stage 1 colorectal cancers.

Last month, we also released results for our prostate cancer study conducted in collaboration with the Surrey Cancer Research Institute at the University of Surrey in United Kingdom. A single NuQ biomarker assay detected 71% of early stage 1 prostate cancers at 73% specificity. This is significantly higher than the most common blood tests currently used to detect prostate cancer, the PSA, the Prostate Specific Antigen, and which is reported to detect only 53% of prostate cancers at 73% specificity.

In addition, we also released data from our first non-cancer clinical trial in Q1. Our NuQ blood tests detected 86% of subjects with a deadly lung disease called IPS or Idiopathic Pulmonary Fibrosis. This is a first set of results from a non-cancer trial of VolitionRx’s NuQ assays which demonstrated the technology’s potential as a diagnostic test for other diseases, which is very exciting for us. Also, as of today, we have more than 50 antibody programs in development. These are monoclonal antibodies, which are key components in our assays and our tests. A majority of the early programs have been successful and our now used in our clinical validation studies. The goal is to continue investing resources into this strategy in order to build our own proprietary antibody banks. Moreover, this will secure the supply of highly performant antibodies, will we believe will lead to more reliable clinical results and produce products further down the line.

We also made significant progress in Q1 towards the commercialization of our blood tests for colorectal and other cancers in both the U.S. and Europe. We have made several key expansions to our team including in January we announced the transition of Dr. Jason Terrell who is an MD to be our full time U.S. based Chief Medical Officer and Head of U.S. Operations. Dr. Terrell will lead our U.S. commercialization strategy for our NuQ blood tests including spearheading our FDA approval process.

Last month, we also announced the appointment of Louise Day as Chief Marketing and Communications Officer. Louise will lead VolitionRx’s communications and develop the Company’s branding and global marketing strategy in preparation for the initial market entry of our NuQ blood tests for cancer. The Company expects to commence the European launch of our NuQ tests in colorectal cancer in 2016 to be followed by the U.S. and the rest of the world. Both Jason and Louise are great fits for the Company and bring tremendous experience and knowledge to our team.

On the regulatory side, VolitionRx has also received the ISO Certification EN ISO 13485:2012 for our quality management system for the design, development, production and distribution of our NuQ blood tests for broad range of cancers. This is significant accomplishment and a key milestone for VolitionRx, demonstrating the Company’s meets the international regulatory standards and strict requirements for risk management and effective processes to design, manufacture and distribute our NuQ blood tests. This certification allows VolitionRx to continue our focused efforts for the commercialization of NuQ cancer tests in Europe and the other major markets worldwide.

We also announced in Q1, the CE marking of two additional NuQ biomarker assays for the detection of colorectal cancer. NuQ V001 and NuQ T003, which we expect when combined with other CE biomarker assays will comprise our first commercial blood test for colorectal cancer that will require only single drop of blood from the patient.

Finally and also very excitingly, we completed the secondary offering of our common stock in March, issuing approximately 4.3 million new sales at $3.25 a share, raising net cash proceeds of approximately $12.8 million after deducting underwriting discounts, commissions, and expenses payable by us. Raymond James & Associates Inc. acted as the sole book-running manager for the offering. This gave us a cash position of $17 million at the end of the first quarter of 2016. This is by far the largest cash position we’ve ever had. We expect to use this cash, primarily towards the completion of existing clinical trials, the commencement of new clinical trials, and our commercialization efforts in Europe, U.S. and elsewhere.

We are delighted to report on the current state of our finances, which includes no debt and puts us in a strong position as we prepare for commercial launch of our first product.

So looking forward, the milestones for 2016 and 2017, we expect to achieve many important clinical and commercial milestones, as we have had in the several years. Firstly, we expect CE marks in additional colorectal assays with a full panel CE marked and planned European launch for our blood tests at the end of this year. We expect more IP to be generated and granted in several countries as we continue to take our proprietary technology and the shareholder value as it has the potential to generate. Also as announced yesterday, we are initiating a study with DKFZ, the German Cancer Research Center to evaluate NuQ blood tests for the reflection of pancreatic cancer. This follows the two very successful pilot studies, which showed very good showed very detection using our biomarkers in pancreatic cancer. This 750-patient study has been previously collected and we expect to finish that this year.

We also expect in the future this year to announce one or more large clinical trials in one of the cancers we’ve had very successful pilot studies in and possibly to have more pancreatic, lung, prostate and ovarian to support our regulatory package development following initial pilot studies.

To assist with the rollout and delivery of products, we plan to move into a much bigger dedicated lab and research facility in Belgium in late 2016 as our current facilities are becoming probably small for our large spanning team and the large number of clinical trials and antibody program that we have underway. That’s another key milestone we aim to complete. We also expect more preliminary results from our ongoing lung and prostate and cancer trials.

We also expect final results from our 4,800-patient retrospective colorectal symptomatic population by the end of this year; this trial, which we have announced interim data from last year. We also expect the first detection [ph] from the prospective 14,000 colorectal screening trial also with Hvidovre Hospital in Denmark during the second half of this year.

We also work a lot on our EU commercialization strategy including upcoming milestones for the timeline for European market access and sales of NuQ and colorectal as it remains on track. We also do a lot of work on our U.S. commercialization strategy for our NuQ blood tests for CC [ph] including FDA strategy this year. Importantly, we plan to submit a 510(k) application to the FDA which if approved would NuQ marketing clearance for use as an adjunct test for colorectal cancer. Our strategy positions NuQ for potential FDA clearance and commercial launch as early as the end of 2017.

Our 2017 milestones include the following: CE marks for pancreatic and lung cancer in the second quarter of 2017; also a U.S. PMA trial underway and likely see an early mix; [ph] an FDA 510(k) for lung or pancreatic cancer as adjunct test later in 2017.

We are excited about 2016 and we anticipate this will be the year we transition from a clinical stage company into commercialization stage Company with the launch of our French products. We achieved numerous milestones this quarter, which brings us close to commercialization including the two new key hires, two CE marks, the ISO Certification of our labs, the successful completion of our secondary offering in March. After that successful capitalization, we are very well capitalized and believe that we are well positioned to execute our commercialization strategy this year.

We are proud of our clinical and commercial accomplishments of the past quarter and look forward to reaching these numerous aforementioned milestones throughout 2016 and 2017. We are particularly enthusiastic about our upcoming commercialization plans for our blood tests for colorectal cancer, which as we said we plan to launch in Europe this year with the CE mark and then hopefully in the U.S. next year with a 510(k) clearance from the FDA as an adjunct test.

These have been many years of hard work and numerous clinical trials which have now brought up this Company to this inflection point. I’m very proud of how our teams and executives and scientists have collaborated in order to bring our blood test to market, which should lead to the detection of many more early stage cancers and greatly improved patient outcomes.

Thank you all very much for your interest in Volition and for joining our first quarter 2016 earnings conference call today. It is very exciting time for us. We would now like to open up the call to take any questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] And go first to Bruce Jackson with Lake Street Capital Markets.

Bruce Jackson

So, if we could just run through the U.S. timeline in a bit more detail. So, tell us about the 510(k) strategy, so what’s your predicated device going to be and what gives you the confidence that a 510(k) regulatory approval is going to be acceptable to the FDA? And then, just run through the some of the interim milestones. So, when do you plan to set up the U.S. trial; when do you think you are going to done; and how long do you think this submission is going to take?

Cameron Reynolds

Yes, very good questions Bruce. So, as I am sure you are aware, there is two ways you can get FDA approval with the 510(k), either predicates or the de novo reclassification. So, the predicates, as I am sure you are aware in this space, possibly epigenomics, but I think more likely where we would go for is the de novo reclassification, which I think you are probably also familiar [indiscernible] has just done on their ovarian cancer tests. So that’s the path we’re going down as an adjunct initially. I think obviously we’re in the process of working through the process of a PMA trial as well. So, I think we would like to get -- in colorectal is approved, in both aspects but the quickest way to market would be as an adjunct symptomatic tests which is what that would be.

So, as far as timelines, we’re in the process now of discussing with a range of CROs to be de novo reclassified as a 510(10). We need approximately 600 patients. So, the amount of time to run those trials also long, that kind of patient population, you can collect in six months. So, if you add that on to all the other timings of setting it up and then running it and then go to the FDA process, you have to add only 12 months to that. So, I think the minimum would be somewhere in the 18 months timescale. So, I think it’s something which is very well doing. I think there is a very much demand for adjunct tests in the initial steps and definitely in the cancers we’re looking at, its’ a very big need in lung, pancreatic colorectal and prostate because none of them have by any means an ideal test for them.

So, whether we do PMAs in the other cancers is questionable. It depends and comes down in the population and the size of the trial you need to do with general screening. So, you probably stick in the other cancers to high risk populations, which in lung cancer is obviously higher. People who smoke, who have more than 30 pack a year, over 55 and in pancreatic, there is a very large initiative of high risk groups but the most obvious would be those who have diabetes. So, the strategy is with all of it. You look somewhere in the -- depends on the CRO between $0.5 million to $1.5 million for a study of that kind of size for each of the cancers. And that will be data driven as we go through the trials running out, which ones we attempt to do first. But we continued to do more than one concurrently, given the funding position we have. So, the trials themselves should be able to be completed in the six months period for that number of patients, but there is at least 12 months more of other work to be done around that before and after, any combination before and after. So, it would need to be an 18-month process for each of the cancers. And as I said concurrently, we would look to do a PMA in colorectal; the other one’s probably non- general screening population, but always to be a high risk. We’ve spoken to people about health economics and even the much lower incidence of cancer in say pancreatic, we would need to be extremely accurate to do a general population screen, much more in the 97%, 98% range, which is obviously a very, very, very high value. So, I think the 510(k) would be the main push in this. We have got to the level which is certainly not certain [ph] by any means.

Bruce Jackson

And just one follow-up then. How does this dovetail with what you are doing in Europe with the two Danish studies and then setting up the algorithm? So, how close are we actually getting the tests panel that you get…

Cameron Reynolds

As you know we’ve released data with an algorithm, which gets around 80%, 80%, which is very good result of -- far more accurate than any blood tests out there. We’re just beholding on because we’re doing more and more assays all the time to see how much better we can get with the panel. So, we’ve said we’re launching around next few months, we’re going to be picking the best panel we have to launch, so we’re going to have it ready by the end of the year. So, we’ve just been testing more different assays in the symptomatic population. So, the algorithm we use in Europe to launch the CE mark, sort of symptomatic population would be very similar with the same what we launched in the U.S. with the CRO trials through the 510(k) de novo reclassified tests. The 14,000 prospectus would be a European self screening test meaning we’re directly competing with the -- or comparing to the fecal test, the FIT, not with some colonoscopy. So that would be very useful and we’re going to get a separate CE mark, certainly the aim is to get a separate CE mark to be used in that context in the European screening, either -- in order to replace or be complementary to an FIT test and that will always to be data driven. So, that’s the process we’ll go through the first CE mark in symptomatic population in Europe and then apply -- use that same algorithm in the U.S. and then get a screening population in the European sense and CE mark that and then go through the process of the U.S. PMA trial attempting to get screening population in the U.S. But obviously that takes -- as you’ve seen from other companies, it takes quite a long time. So, we’ve got that process with everything else that’s going.

Bruce Jackson

And so, it’s the prospective 14,000 patient study that you are going to use with the screening dedication in Europe, okay.

Cameron Reynolds

Yes, in Europe and some -- screening is -- the frontline test is very, very rare in colonoscopy. So, the U.S. screening population, which an exact properly [indiscernible] and we would need to do if we are going for the same sort of population, we certainly at the high water mark, we need about 10,000 patients because the prevalence is about half of a percent. [Ph] So, to get 50, you need 10,000 patients where in Europe, there is not the frontline screening with the colonoscopy. What you are doing which is what we’re doing in this trial is going head to head with FIT positive and FIT negatives in a very large study. So that is an ideal study for the European screening market. And that would be a -- it remains to be seen how different the panels are, and could be a very similar panel to the symptomatic and could be exactly the same or it could be different that will be driven by the data.

But if you got to the antibody program, what I talk about the ISO Certification and antibody program, I mean you can -- it just takes 20 seconds to say it, but it’s amazing amount of work that team has done, developing huge banks of monoclonal antibody, which allow us not only to produce a much lower cost product in antibodies but one which can be used forever. Once you have a monoclonal line, you can produce the antibodies forever and at much lower cost but also secure to the Company. So, having such a large bank of monoclonal antibodies means we can very quickly adapt new panels with new antibodies or for different cancers or the different uses within the same cancer, different antibodies that would develop. So, we have complete security of those one developed and much lower cost and much more adaptability at testing different antibodies and producing them. So, it’s a huge outcome for us and gives us much more flexibility to move ahead because we’ve relied in the past on both antibodies, which although that can be easy get, if it’s polyclonal, the issue is then that they are not reproducible further, once that amount is finished, it’s finished, because as you probably know, they are made from mass, [ph] so, you can only get so much of mass. [Ph] And the second, when you reproduce the polyclonal line, you’ve got to from scratch with new mass. [Ph] So, it’s a whole problem. So, we spend a lot of time in developing antibodies and the whole process so that we can be very -- much more nimble and much more board ranging what we do going forward.

Operator

[Operator Instructions] We’ll go next to Brian Marckx with Zacks Investment Research.

Brian Marckx

Relative just to the de novo pathway, it seems that that would certainly be appropriate, given that you are going to seek as an adjunct. But, have you had specific discussions with FDA and has FDA given you the green light that de novo is appropriate?

Cameron Reynolds

No, we haven’t started those discussions. Basically, we wanted to make sure we went to them full armed because, as said in the presentation and as I mentioned, the very good example what exactly just kind of panel has been used to de novo reclassification. But, we want to make sure we go fully armed with all the trail results and the CE mark process being completed; we’re very close to it. And then in every single cancer, I’m sure you are aware there’s currently a test or a blood test. And using an adjunct forward is a very good way to get into the market very quickly and very successfully.

If you look at something -- if you look at every one of the cancers, so colorectal has older existing markers, things like CA, for pancreatic there is CA19-9, obviously in colorectal is also fecal test, in ovarian CA-125. In every cancer, there is some sort of process involved. And this has actually been a big influence of Dr. Terrell who is actually an MD, not a PhD, like the rest of our doctors. And he very strongly advices, doctors are very keen to get more information, and it’s much lower marketing hurdle to be solved with what’s currently there, so just as a brand new test. We are now seeing that’s just a fantastic and incredibly revolutionary but the safest and easiest way to get into the market is to be an adjunct to whatever is there. And if we can show that ours possibly existing test is more accurate and I think that’s exactly what we are doing, if you look at our test trails, then it’s a real no-brainer for the doctor. If you are doctor Brain, and our test, say for example pancreatic where we’ve shown we are executing biomarker trial, it’s incredibly accurate. I don’t see why any doctor wouldn’t be prescribing our safety in conjunction. And I think it’s very solid to take the FDA. But as you know, there is no -- nothing first with the FDA, you’ve also got to go through the process. But, I think it makes a tremendous amount of sense why low cost blood test as an adjunct is certainly almost a no-brainer for physicians. And it think that’s a process we can get through with the FDA for all the reasons which they normally approve, it’s more accurate and very cost effective, very high compliance. I’d really struggle to see why that have been issue with [indiscernible].

You cannot predict what the FDA is going to do. So, what we can do is build a very, very strong case and take it to them. We are seeking very good advice. We will be setting up a meeting as soon as the panel has been chosen and went through that process, but we want to be very set and that we had it all lined up and a very, very strong value to take to them. I think you can -- as I say, you only get one chance to make a first impression. We want to make sure we go in very strong and very hard when we have it all together, rather than an ongoing process which we have now, but something we are putting together very strong package for now and we aim to start as [indiscernible]. And we started the process now of getting close through CROs for these trials for the FDA trials. So, it’s all coming together.

And Dr. Terrell has been working extremely hard over the last few months, working on the FDA strategy and the CROs as we’ve been working very hard on getting the trials finished in Europe, so we can pick the panel for those tests. And as you can see, we’re starting up bigger trials now. As of yet today, we’ve just signed up the large pancreatic trial and 750 patients is very big trial in pancreatic, 300 pancreatic patients, cancer patients. So, it’s a big one. So, all the time we’re gathering more and more data. But, just as an order of magnitude, I think if you’ve seen in our presentation, adjunct tests or tests which aren’t approved for screening process can still be a massive seller. If you look at CA19-9, it’s predicted there will be 46 million sold in two years’ time, every year in just the top five countries, 46 million test prescribed. So, it’s potentially a massive market as an adjunct test, in the meantime while we’re in the process of the colorectal PMA. I think each of those markets is potentially as big as CA19-9 or the other ones. So, it’s a strategy we’re very happy with and very committed to. But, we’ll know exactly what the FDA is going to think, once we’ve got everything together and taken to them. And we’re planning on doing that just I think later this year.

Brian Marckx

On the new pancreatic cancer study that you just announced, is it -- will that be using any or all of the assays that were in the two pilot studies, will it be using anymore additional assays other than that and will also be incorporating the CA19-9?

Cameron Reynolds

Yes, we aim to use the ones which are so successful in other clinical trials as well as some new ones. As you have seen form our clinical trials, we’re getting better and better at picking the best biomarkers within our IP. I think you probably remember that we -- there is thought to be around or more than a 1,000 biomarkers on new treatments. And we’re running 28 in clinical trials so far and we’re finding actually some very good ones now in addition to the ones we’ve been using. So, that’s the process. And yes, we aim -- there is typically in any pancreatic study, the pancreatic patients do have CA19-9 performed on them. I guess that’s 46 million every year. So we’ll do some ourselves and take some of the existing data. So, the short answer is yes, we will use CA19-9; yes, we will use all the ones that work so well in the pilot studies; and yes, we will look to do some of the new ones, which is why if you’ve noticed we’ve got 50 antibody programs underway and we’re adding at least four or five every month now. So, we’re going to have a massive bank of antibodies. And we actually aim to get to well into the 100 in a few years, which will give us a very unique asset and very unique library.

That on top of our IP, on top of all the clinical trials and our knowledge will put us in an incredibly position to really dominate in this entire field. So that when we look at a new cancer or when something new comes up, we can use the existing antibodies, we have very well defined monoclonal line, or we can develop a new through the processes we have to target that one, whatever the new structure is to add to our panels. And going forward, the clinical trials what we do prospectively, we’re going to be clicking quite a bit more -- than we’ve been, so that when we do get new biomarkers, we can test it on the population very quickly. So, everything is getting a lot quicker and easier in what we do, as we develop a lot of knowledge in this field, a unique knowledge, we’re still not aware of anyone who has done any real work in the [indiscernible] on top of all the other things we do. It should give us, if we play our strategy right, extremely dominant position in this whole field going forward.

Brian Marckx

When do you expect you will have at least some preliminary data on the 750 pancreatic study?

Cameron Reynolds

They are already collected. So, it’s -- I would be very surprised if it wasn’t this year. It’s going to be quick. And don’t forget, we’re also getting the pan cancer study started, the process. So, we’ll have data in 27 cancers by this time next year in about 20, 25 different biomarkers. So, we’re developing a lot of information very, very quickly. So, we expect to see pancreatic. Now, if that goes well, there is absolutely no reason we can’t launch in Europe next year in pancreatic. And again, it’s very hard to tell what the FDA is going to do, but where there is such an unbelievable need in pancreatic cancer and you have something -- if it does continue to go anywhere as well the other [ph] than these studies, I think we could do a U.S. trial pretty quickly, given small number of patients in it and the high risk population to get to market. And I think I would imagine the FDA would be very helpful with us. If the tests are going as well as they look to be going that we tremendously help patients. So, I wouldn’t expect that much resistance from the FDA. Colorectal is a little different because its’ quite a crowded market; there is a lot of things out there, obviously Exact and Epigenomics and existing biomarkers in colonoscopy, the fecal test; where in lung and pancreatic, it really isn’t much. So, I would expect I guess we will find out when once we get through, finished through the process But, I would expect quite a bit of support, especially from key opinion leaders as well because they’re really quite…

Brian Marckx

Great, thanks Cameron.

Operator

We’ll go next to Yi Chen with H.C. Wainwright.

Yi Chen

My question is how large a sales team do you think you would need to marketing the colorectal test in the U.S. versus in putting efforts in Europe?

Cameron Reynolds

So, basically I’ll just go through Europe and U.S. and contrast them. Europe is 28 countries, 31, 32 if you include some of the other ones like Turkey and other and each one is a bit different. So, we are targeting the bigger countries first where we have home advantage, obviously England. Louise Day, our new Communications and Marketing Director is very knowledgeable about the FDA and as some of our team because they’ve been working in England, so there is some really good strong local advantage. And we’ve been working with the consultants now for the long time. We also have -- that would be a very obvious one to start and that’s what we are doing a lot of work in now.

We obviously have a good home advantage in Belgium as well, particularly the French area, we’ve been very strongly supported by the government there, and we’ve been working through that process. And we’ve done large trails in Denmark and Germany now, so those countries. It comes down more than a sales force. Ultimately the government is -- 80%, 90% of the market in all the European countries. So, it’s a matter of convincing the processes as reimbursement or insurance for the government programs. So, it’s not like exactly you need a large sales force in Europe because you are not selling directly to doctors. You are sort of keeping this ultimately the big -- more of a lobbying role, if you will. There is a private [ph] market in Europe but it’s typically in single digits of the entire market in this country. So, it’s much more of a few key people are lobbying in the European countries. So, we’ll start with those countries and then roll it out. So, we do not need a large footprint in Europe.

And also, I think a recalibration of what most people think, when you are -- I’m not exactly sure of the exact price, but I think that’s $599 or thereabout and it’s a separate system of analysis; you need a whole separate biosphere [ph] for the product where when you are -- a blood test which is a very easy to run and part of it on the blood work, you don’t need that whole separate sales network and supply network for the product. So, I don’t see ourselves anywhere near the sales force; there are lot of other products. [Ph] I think as we get into normal clinical stage, and [indiscernible] sub 100 dozen and have quite a lot below $100, I mean you can really be part of the normal biosphere of how tests are provided.

So, for all those reasons -- now as part of this large fund raise, we’ve also negotiated with [Indiscernible] Pharmaceuticals who are launching through their products in U.S. in the colorectal space, not directly diagnostic but in the colorectal space where they have a right to negotiate with us and us launching U.S. as well, they are a multibillion dollar company and looking to launch their own product. So, we’ll be utilizing them; hopefully, we can come to good terms with them as per the agreement. And we’ll always look to license to the bigger diagnostic companies and their auto analyzing machine, Roche, Abbott, Siemens.

So, what we look to do is in different markets really approach in different ways, some direct marketing, some through some product sales, some through for example in France is one centralized company has been given the government programs to negotiate with them, so to [indiscernible] Europe and in some U.S. It’s a much more some key regulatory and keeping the leaders to develop the demand for the product through the keeping the doctors and then making sure it’s provided, getting reimbursed and through the process including the large companies on their large analyzing machines. So, none of that requires sales forces in the hundreds; it’s a matter of hiring key people and key people to negotiate all those agreements, which is what we’ve been doing in Europe now with as you’ve seen these new key people in this quarter. And we’ll continue to add key people as we roll out in those markets.

Operator

[Operator Instructions] And we have no more questions at this time. So, I’ll turn the call back over to our speakers for any additional or closing remarks.

Cameron Reynolds

Okay. Thank you, Vicky. And thank you everyone for joining us today to VolitionRx’s first quarter 2016 earnings conference call. We really appreciate your interest in us and look forward to speaking to you again in the future and reporting our next results for the second quarter of 2016. Thank you. Good morning, good bye.

Operator

That does conclude today’s conference. We thank you for your participation.

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