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Riot Platforms, Inc. (RIOT)

Q3 2013 Earnings Call· Thu, Nov 7, 2013

$16.63

-9.00%

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Transcript

Operator

Operator

Good morning, and welcome to the Venaxis Third Quarter 2013 Business Update Conference Call. (Operator instructions) Please note this event is being recorded. I'd now like to turn the conference over to Greg Tiberend. Please go ahead sir.

Greg Tiberend

Operator

Thank you, Denise, and thank you all for joining us this morning. With me on today's call are Steve Lundy, President and Chief Executive Officer; Jeff McGonegal, Chief Financial Officer; and Don Hurd, Senior Vice President and Chief Commercial Officer. This morning, Venaxis filed its Form 10-Q for the quarter ended September 30, 2013, and issued a news release that provided an overview of its current activities and upcoming milestones. If you need a copy of the press release, please contact our firm, Tiberend Strategic Advisors, at (212) 375-2686 and we will get one to you immediately. In a few moments, Steve will highlights Venaxis’ recent milestones and provide an update on the ongoing pivotal study of APPY1. Don will then provide an update on Venaxis' market development and commercialization efforts. Steve will provide some concluding remarks, and we'll open the call for a question-and-answer session, where Steve, Jeff and Don will be available to take your questions. Please note that certain of the information discussed on today's call is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Venaxis management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with this company's business. These forward-looking statements are qualified by the cautionary statements contained in Venaxis' news releases and SEC filings, including the quarterly report on Form 10-Q for the quarter ended September 30, 2013, which Venaxis filed this morning. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, November 7, 2013. Venaxis undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now I would like to turn the call to Steve Lundy, President and Chief Executive Officer of Venaxis. Steve?

Stephen T. Lundy

Analyst

Thank you, Greg. And thanks to everyone for joining us on the call today. 2013 continues to be a period of diligent execution of our pivotal clinical trial of APPY1. Throughout 2013 we have continued to optimize the way we monitor and manage our trial sites in the US, and I am happy to say that through these efforts we have been able to accelerate to the rate of patient enrolment, and we remain on track to meet our goal of completing enrolment in the pivotal trial at or around the end of the year. Advancing APPY1 towards potential US clearance continues to be our top priority, and we look forward to reporting top line data from the pivotal study in early 2014. In parallel, our market development and commercialization efforts continued to progress and in a few moments Don will provide an update on recent developments relating to our progress. Before I hand it over to Don, let me further comment on the US pivotal study, as well as our financial position. During the third quarter we announced that APPY1 passed each of the two scheduled interim futility analyses included in the study protocol. These analyses were performed by an external data and safety monitoring board, and involved the review of the validity, integrity, and clinical and scientific relevance of the study. Following these analyses, the most recent of which was performed on the first approximately 1100 patients, it was recommended by the external DSMB that our pivotal study continue to completion. We remain blighted to the interim study results. To date we have enrolled more than 1700 of the approximately 2200 patients we expect to enroll in order to achieve our target of 2000 net evaluable patients for the pivotal study. As I mentioned, we anticipate completing patient…

Don Hurd

Analyst

Thanks Steve. In the United States, while we are not able to market the APPY1 Test until FDA clearance, we are actively engaging in initial marketing and development efforts. One of the first steps in this process is to engage key hospital sites and connect with emergency physicians across the United States. Last month we hosted a booth at the annual meeting of The American College of Emergency Physicians in Seattle, and we were able to survey some 240 of the leading attendees with respect to their current practices and concerns regarding the diagnosis of appendicitis. The learnings from this research will assist us in honing our messages and product positioning upon potential FDA clearance. One clear message from the conference is that there continues to be an increased effort across the United States to decrease the use of CT scans in children and adolescents. We continue to be encouraged by the enthusiasm and positive feedback we are hearing from these thought leaders and potential end-users of APPY1, and we believe the test will be well positioned when we enter the market. In addition, we are in discussions with key opinion leaders in modeling and quantifying how the APPY1 Test could potentially reduce cost and improve clinical care when it is available for sale in the United States. On that front we are completing development of a modeling tool, which will help individual hospitals quantify their potential savings from possible use of the APPY1 Tests arising from areas such as reduced imaging, reduced length of stay and fewer surgical consults. The positive feedback we are receiving from similar efforts ongoing at selected hospital visits and demonstrations in Europe will be valuable to us in advancing US commercial launch process. We will continue to engage in market development efforts in the…

Stephen T. Lundy

Analyst

Thanks Don. I will conclude by reiterating our commitment to gaining US regulatory clearance and developing the market for APPY1, which we believe has the potential to improve the way emergency physicians manage their patients who present with abdominal pain. As was further confirmed at the recent ACEP meeting, that is the Emergency Medicine Meeting in Seattle, reducing CT scans and improving ER workflow are widely recognized as top priorities, and we are excited to deliver a product to help physicians meet these important goals. To that end our pivotal study is nearing completion and we look forward to sharing the top line pivotal data with you, and submitting to FDA as soon as possible. As Don said, market development efforts continued to accelerate remaining a priority in both the US and in Europe. Based on the positive feedback and enthusiasm we are hearing from leading hospitals, we feel optimistic about approaching the US market as well as ramping sales of our European distribution partners in 2014. At this time I look forward to taking your questions. You may go ahead operator. Thank you.

Operator

Operator

(Operator instructions) We have a question from Jeff Frelick from Canaccord. Please go ahead.

Jeffrey Frelick - Canaccord Genuity

Analyst

Yes, good morning folks. Steve, how many patients are you enrolling per month, I think the update you gave us in July was tracking around 200 per month, what has that been since then?

Stephen T. Lundy

Analyst

It has increased Jeff. I would say looking at the last few weeks, we were up closer to 250 on a monthly basis, maybe even more. Last week for example we had our biggest week ever at around 75 patients. So, 250 or so has been -- is pretty much where we are at now.

Jeffrey Frelick - Canaccord Genuity

Analyst

And then when do you plan to submit the FDA package in relation to when you release the top line data, would you submit it before or shortly after?

Stephen T. Lundy

Analyst

Well it will be shortly after Jeff, you know, the actual package, you know, a lot of the elements of the package are in place, and some of those are written already in terms of the analytical performance of the test and things like that. Really the longest part of this is first of all getting all the patients, you know, the follow up information as you know, the negative patients required two weeks of follow up. We had to go through a fairly rigorous process of closing the database, locking database if you will, in each one of the hospitals, and we have about 25 hospitals enrolled. So that is no small task. So, you know, as soon as that is done, we close the database, we lock it, and then, you know, we do the analyses and report top line data. The submission comes very shortly thereafter.

Jeffrey Frelick - Canaccord Genuity

Analyst

Okay. And then with respect to the study that will be presented later this month in Paris, can you comment about that study in France, how does it relate to the pivotal study, just share with patient enrolment, how big it is, is it just pediatrics, or is it all comers to the ER?

Stephen T. Lundy

Analyst

Yes, Jeff, I will let Don comment on that, but it was a study mainly to look at the -- they are running the test in a real laboratory, and what kind of performance they would get just on the test itself. It didn’t relate to follow up of patients and that type of thing. Don, do you want to comment on that?

Don Hurd

Analyst

You said it very well Steve. Jeff but I wanted to do that study in Europe because obviously our product is going to be used in the laboratory and laboratorians are going to end up taking our instruction for use in validating MRP and CRP. So I wanted to have some additional third-party sources showing how good our test was and that is what that study was for.

Jeffrey Frelick - Canaccord Genuity

Analyst

Okay. And you have talked -- Don, you have talked about some additional studies with key opinion leaders, will these be compared to [Indiscernible] or in how many of these, or when do we start seeing some of those publications? Thanks.

Don Hurd

Analyst

First off, generally those studies were designed for helping us to find the economic value, if you will, and how APPY1 would help reduce costs or time or effort in the emergency room Jeff. So, statistically speaking anything that has to do with sensitivity, specificity or negative predicted value is handled through the clinical trial in the United States. We already are CE Marked in Europe, so we don’t have to do that again. So, those studies specifically were economic type studies Jeff, and as far as finishing them, it varies country by country, but with the experience I have gained over the last few months, each of those studies one they start, it will start to look like they will take about four or five months to finish.

Jeffrey Frelick - Canaccord Genuity

Analyst

Okay, great. Thanks guys.

Operator

Operator

(Operator instructions) Our next question is from Greg James from [Indiscernible]. Please go ahead, sir. Hi, Mr. James. I am sorry. It seems that he removed himself from the question queue. (Operator instructions) I show no further questions at this time. So that would conclude our question-and-answer session. I would like to turn the call back over to management for closing remarks.

Stephen T. Lundy

Analyst

We appreciate everybody joining the call today, and we continue to look forward to reporting on our progress in the future and thank you very much.

Operator

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.