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Transcript
OP
Operator
Operator
Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the VolitionRx Limited’s First Quarter 2017 Earnings Conference Call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be opened for questions. [Operator Instructions] This conference is being recorded today, May 11, 2017. I’d now like to turn the conference over to Mr. Scott Powell, Executive Vice President of VolitionRx Limited. Please go ahead, sir.
SP
Scott Powell
Analyst
Thank you, 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 of 2017, which ended March 31, 2016, along with a discussion of our recent activities and key upcoming 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, President and Chief Executive Officer; and Mr. David Vanston, our recently appointed 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 identified forward-looking statements. These forward-looking statements relate to the effectiveness of the company’s bodily-fluid-based diagnostic tests, upcoming milestones including results and completion of clinical studies 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…
CR
Cameron Reynolds
Analyst
Thank you, Scott, and thank you everyone for joining Volition’s first quarter 2017 earnings conference call. I’d like to thank you all again for taking an interest in Volition at this key time for us. As you know we held our end of year results earning call in March of this year in addition I saw many of you in New York around the same time. As it has not been long time since then, we will keep this update to the key events that occurred in 2017. I'm delighted with the progress we are making on many fronts. As I've always said, our team is extremely important to us and we continue to grow stronger. We have welcomed some key hires into the business this year. In January, we appointed Dr. Jasmine Kway as Vice President of Asia. We’re expecting to see a lot of activity this year in Asia from a very dynamic new hire. We are optimistic that our blood-based tests will uniquely get some strong traction in the very large and growing Asian markets as a result of their affordability. In April, we also named David Vanston as our Chief Financial Officer. David is a Grow Dynamic and experienced new hire, who will work with us to implement and comply with the requirements under the Sarbanes-Oxley Act of 2002 as well as to help us transition from research to revenue. Both of these we expect to be very important over the next 12-months. David Jones being on the call today to answer your questions. We've also added several other important members to our research and development team and from marketing team as we continue to develop new products and market them. We believe the U.S. healthcare market to be the most important market in healthcare in…
OP
Operator
Operator
Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question today is from Bruce Jackson of Lake Street Capital Markets. Please go ahead.
BJ
Bruce Jackson
Analyst
Good morning, everybody. Nice quarter.
CR
Cameron Reynolds
Analyst
Thank you. Thanks, Bruce.
BJ
Bruce Jackson
Analyst
So first with – just on you and Dr. Terrell talking about potentially 10,000 patient asymptomatic patient studies, when can we expect to hear more about that?
CR
Cameron Reynolds
Analyst
Very good question, Bruce. We made public for the last few months. In the last quarter, we’ve been really looking for a very large affordable trial, which would really put us on the math in U.S. to really show that a very clear path and timeline expect to see that soon. I can’t tell you exactly. We’re in discussions currently, but [indiscernible] and I think that will be a massive step change for the company because our plan all along has been to develop the products in Europe, where we can do it very cost effectively on very good populations with fantastic trial, but our aim has always been to shift back to the U.S. And a key part of that you can do at several ways, you can try CLEA labs and smaller trials by being a very serious company. We want to do a very serious trial of 10,000 plus asymptomatic patients, so expect to see soon.
BJ
Bruce Jackson
Analyst
Okay. And then moving over to Denmark, you’re in the process of doing the final logistics trials, I’d call them. How are those preceding when you think those might finish up and then what’s the potential for getting some kind of a commitment by the end of the year from the Danish screening program?
CR
Cameron Reynolds
Analyst
Yes, it's running. As we have said in the press releases, we’re through the logistics studies now. We've got approval for the second phase that's all progressing. We've had – back and forth with them that’s proceeding very well. I think there’s definitely a need for the product there. I think our products, as you’ve seen we've now confirmed it in a very large population of 8,000 positives. It was well and clearly within the specifications of – the minimum criteria we set was 90% of cancers and 20% of colonoscopy, so 95%, 24.5%. We’re well and purely met all that. So we're very hopeful. As you know Bruce, you never know until it's all done, but there's a very strong need. We have the product. It validates a large set. So we're very hopeful. I think everything we've said before is still on track with very much hope and expect to have something this year. And we’re also pushing in another market. And also as you've noticed, we're pushing into Asia, where we believe the – these markets in Taiwan for the similar products and in some other countries. So, yes, it's going very well. And we’re just continuing. Like we always do, we have a plan. We announced the plan and we're just working through that now with the aim of getting that revenue.
BJ
Bruce Jackson
Analyst
Okay. Last question, you’ve done a very good job in terms of the expense control. Should we expect in terms of the operating expense profile going forward? Would we expect it for the next couple of quarters to be at roughly the same level? Or given some of the increased activity with that move up at all?
CR
Cameron Reynolds
Analyst
I’ll first start and let me introduce David, our new CFO, who very happy, has come on board. He has tremendous experience and background in accounting to really helps us to become fully compliant with all those areas. And of course one of his big areas is helping us to make sure we keep our control of our costs. I'll give a very top line answer then you can give some more detail. This was a slightly exceptional month with the move and some large trial work being paid for. But I think we would – so I would expect to go down from this month in the next couple months, but David would you add a little bit?
DV
David Vanston
Analyst
Sure, so, hi Bruce. In the quarter, you got a number of one-offs particularly if you look on the cash flow around about $875,000 that's due to the building fits out and also bringing in the capacity of the machines that we brought in. So I'd expect the run rate to not be as high that to be in the region of a quarterly burn rate between $2.5 million to $3 million going forward.
BJ
Bruce Jackson
Analyst
Okay. That’s…
DV
David Vanston
Analyst
So it’s slightly higher than we were, but below what we were this month. I think you got them on Bruce…
CR
Cameron Reynolds
Analyst
Absolutely.
BJ
Bruce Jackson
Analyst
Okay. Great, thank you very much.
DV
David Vanston
Analyst
You’re welcome.
CR
Cameron Reynolds
Analyst
Thanks for your time. Thank you.
OP
Operator
Operator
The next question is from Raymond Myers of Benchmark. Please go ahead.
RM
Raymond Myers
Analyst
Thanks for taking the questions. Cameron, let me ask you about this 10,000 patient screening study aimed at getting FDA clearance. How is it that you plan to do this in such an affordable manner? And when you say affordable, can you bracket what the cost of that test might be?
CR
Cameron Reynolds
Analyst
Yes. Thank you, Raymond. That’s actually a very important question to answer. I think one of the things, which people have considered perhaps a possible negative with us is I have a company that had to do very large extremely expensive trials in the tens of millions –$20 million to $30 million range. We have something very unique, because our tests do not cost much to run, make the trials cheaper. And also because we need a small amount of blood not a large amount of – like some companies do or a large amount of blood like all the other blood companies do typically, it means we can be part of a bigger program, which is what we're looking to do. So this is a really key difference. We’re talking – if you look in the K at the end of the year, we budgeted $5 million for that process and that's something that the range which we're very much trying to target. And if we do achieve, I think it will be a remarkable outcome for us to secure a population along the lines, which we discuss a very large recognized institution with a very large sample set. So it is a very key difference for us and I think it should be very well received by the market that A) we’re serious about the U.S. as the biggest market. We’re also very serious about having a very large trial in the U.S., not trying to do it in small ways and also very impressed that we will not need a massive dilutive events to get us there. So something we're very hopeful for and vey excited about and hope to be able to announce it soon that we're on that top, because that will be a massive change for us. I think the European revenue is fantastic and it makes us potentially a profitable company from all of the revenue from here. But I think a lot of what the U.S. market wants to see is and have been a bit skeptical of is that we can get our U.S. product out there without spending many tens of millions of dollars. So, we're very hopeful and is something which I think will be a very big deal when we do announce it and we do expect that reasonably soon.
RM
Raymond Myers
Analyst
That's great. And a follow-up on that is I presume this is a prospectively enrolled study. So how long do you expect this study to take?
CR
Cameron Reynolds
Analyst
Yes, that will be in the details, but typically it takes a couple of years. It depends on the more you spend, the quicker it can become to collect 10,000 or more patients you need a few years. And this would – these three perspectives into – obviously you said it’s much better to have a big perspective development to do, which task to have. So, yes, it takes a couple of years.
RM
Raymond Myers
Analyst
Okay, great. And then on the Danish side, you’re running some feasibility studies for Denmark. Can you update us on how those are going? What progress is being made? And are you still confident in launching that product this year?
CR
Cameron Reynolds
Analyst
Yes, it’s proceeded exactly as we outlined in Phase 2 as for ethical approval, it's on the same timescales as we have announced that’s absolutely it’s going through the very practical questions just for the listeners to understand the difference between the 8,000 patients study, which is now finished and validated in bank if you will, the level of the test work at which is 95% of cancers. What this says is much more practical question, how fits into the health care systems. So to launch – since for large bit size of a country taking on a program, which to my knowledge no company has ever really launched a nationwide blood test in Europe for colorectal cancer in any sort of screening program and this is something very, very big. If you want to make sure, you’re answering the very practical questions as to how the blood is collected, how many fences need to process the samples, well that is all those kinds of things needs to be turns up. So that's what we're doing. And I think there's always a tendency to try to push without that, but I think if you want to make sure our launch is successful, you want think of the very practical things before you launch nationwide. The countries like Denmark is not big, but you still don't want to trip over yourself on the launch. So it’s not taking an awful long time, but it's very important that we do that to make sure if it is picked up, which is – is what we expect by them that it is successful and because we want to make sure the first launch goes very smoothly. So, yeah, that's all going very well.
RM
Raymond Myers
Analyst
Very good. And then lastly, I wanted to ask if you would touch on the regulatory and commercial milestones to address the Asia market?
CR
Cameron Reynolds
Analyst
Yes, it’s a very good question. So, of course, the first product we have is the Triage Test, which we were 100% certain what the market is in Asia, because there are some fecal screening programs, which would be natural for that. So, Dr. Kway has been doing a lot of work. He’s very dynamic. You can see a video there on the web outlining a lot of this. So but Asia is also a very big region of course I'm sure everyone is very much aware of that. So we’re just trying to cut through in what countries the Triage Test possibly usable, so she started in Taiwan. We have the first study underway in Taiwan already, which is a huge outcome and a big milestone. We're also getting the product regulatory approved in Singapore, which means you can sell at any one of the Asian countries, which is broader. But as with the U.S. and in Europe, the very big product is the frontline test, the first test, not the Triage Test. So we've been asked many times, do you need to do trial work in Asia? Do the tests work? We would expect the test to work in these populations, but the best way to show that is to have a trial in an Asian population and there are several different Asian populations, Chinese, Indians, Malay, a few different groups Japanese. So we're looking to do some confirmatory trials in those countries as well. They're not very expensive and don't have to take very long, but I think even just for India and China together a couple of billion people. It's worthwhile just showing that it works in their populations. So what has been used on that both form the Triage side, which we have started already…
RM
Raymond Myers
Analyst
Thank you, Cameron. That's all I have.
CR
Cameron Reynolds
Analyst
Thank you, Raymond. Take care.
OP
Operator
Operator
[Operator Instructions] Our next question comes from Yi Chen of Rodman & Renshaw. Please go ahead.
RM
Roshni Mahadeo
Analyst
Hi, this is Roshni on behalf of Yi. Thanks for taking my questions.
CR
Cameron Reynolds
Analyst
Thank you. How are you?
RM
Roshni Mahadeo
Analyst
I'm good. When do you anticipate being granted regulatory approval in Singapore?
CR
Cameron Reynolds
Analyst
The process lasts between 6 and 12 months. So it would be sometime next year.
RM
Roshni Mahadeo
Analyst
Okay. And when do you expect to start generating revenue? And also can you provide some color on what R&D will look in the subsequent quarters?
CR
Cameron Reynolds
Analyst
Yes. So the revenue side, we said we’re working with the Danish government now and we're hopeful that that would be sometime late this year where we get a lot order for a part of the country or a large part of the country, which would be a very significant event. The other countries we're working on now and we'll have some more news as it comes up. As far as R&D, I think projections, we give more of a top level answer just so far as we expect – what I guess is important is the overall burn rate of the company has trended in excess cash at about $2.5 million a quarter. We were about $3.2 million this quarter, but there were some big exceptional and say that very well outlined. So, we expect that to go back towards trend, but given how much more we're doing the trend will go up, but somewhere in the sub $3 million per quarter, just is under $1 million per month range.
DV
David Vanston
Analyst
Yes, it’s correct.
CR
Cameron Reynolds
Analyst
And we're also hoping very much that we can announce some non-diluted funding from the frozen regions and governments. And also in the medium-term, we’re looking for non-dilutive funding coming from the U.S. as we launch products. So I think all together we’re in a very strong financial position certainly compared to the last six years. We have a good solid runway ahead of us. We have a product, which we’re in the process of launching and we're now with the new facility really pushing towards that frontline test, which ultimately is the big one. The big one the frontline test in the U.S. and in Europe for which we hope to be able to announce the very big milestones would be a large trail as we talked about before of over 10,000 patients for the U.S. market.
RM
Roshni Mahadeo
Analyst
Okay, thank you.
CR
Cameron Reynolds
Analyst
Thank you and take care.
OP
Operator
Operator
There are no further questions at this time. I would like to turn floor back over to Cameron Reynolds for closing comments.
CR
Cameron Reynolds
Analyst
Thank you everyone for joining us today for our first quarter 2017 earnings call. We really appreciate your interest in Volition and look forward to speaking with you again in the near future. Thank you very much for your time. Good bye.
OP
Operator
Operator
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.