GW Pharmaceuticals plc
Q3 2015 Earnings Call Transcript

Published: 7 Aug 2015

[Operator:]

Welcome to the GW Pharmaceuticals' Third Quarter 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Steve Schultz, Vice President of Investor Relations.

[Steve Schultz:]

Welcome all of you for joining us today. Again, I am Steve Schultz, Vice President of Investor Relations at GW and I am based in the United States. Today, I am joined by Justin Gover, GW’s Chief Executive Officer; Chris Tovey, our Chief Operating Officer; Dr. Stephen Wright, our Chief Medical Officer; and Adam George, our Chief Financial Officer. I am also very pleased to welcome Julian Gangolli GWs new President of North America. We hope you have had a chance to review our press release from earlier today. This document will be supplemented by an additional 6-K filing later today, which will include the full MD&A. As a reminder, during today’s call, we will be making certain forward-looking statements. These statements reflect GW’s current expectations regarding future events, including but not limited to statements regarding financial performance, clinical and regulatory activities and timing of product launches and statements relating to market acceptance and commercial potential. Forward-looking statements involve risks and uncertainties, and actual events could differ materially from those projected herein. A list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. These forward-looking statements speak only as of today’s date August 6, 2015. Finally, an archive of the call will be posted to the GW Web site in the Investor Relations section. And now I'll turn the call over to Justin Gover, GW's Chief Executive Officer.

[Justin Gover:]

Thank you, Steve, and welcome to all of those who are able to join us. I'd also like to offer warm welcome to Julian Gangolli on today's call his first as the member of the GW team. Julian while still fairly new to GW is nurse consult to the GW culture and has become to drive in important efforts of the U.S operations and the early stages of our Epidiolex, commercial development. Julian who comes to GW from Allergan offers extensive experience and successfully developing commercial organizations for a number of successful specialty pharmaceutical products. In addition to his role as President of GW in North America Julian was recently appointed to the GW Board of Directors. Also as previously indicated I have recently relocated to Southern California and will work on new U.S office alongside Julian and our emerging U.S team. I would like to ask Julian to provide a brief overview of his background and business philosophy so that you can begin to get to know him. I will also briefly review our recent progress Dr. Stephen Wright will then provide an update on our clinical and preclinical programs and Adam George will provide an overview of our financial results for the quarter. At the conclusion of our prepared remarks, we will open the line for questions. Let me now hand the call over to Julian.

[Julian Gangolli:]

Justin thank you and good morning everyone. Let me begin by saying how very pleased I am to be part of GW team this is a very exciting time for our company as we carry out the Epidiolex program in terms of epilepsy and advance the number of exciting pipeline product. As Justin indicated prior to coming to GW. I was the President of the North American Pharmaceutical division of Allergan managing some 1400 sick people in the commercial operations. With 2014 sales exceeding $3.8 billion I was also a member of the executive committee Allergan senior leadership team overseeing worldwide operations. Now you are all likely aware with the events last year surrounding Allergan and absolute, these were exciting but intense times for the whole executive team professionally and also demanding time for my family. At the conclusion of the agreement in March this year I fully expected to pick in time off. However that will change when I will contact to consider a position with GW. The more I look at the company and the opportunity the more I liked it and as you know I am now a member of the GW team. In terms of background I have been in the pharmaceutical business for over 25 years starting my carrier as a sales representative in United Kingdom. Over the course of my carrier I have been involved in most every aspect the commercial side of pharmaceutical industry. With depicted our focus on specialty products, I am dual citizen that United Kingdom and United States so I feel quite at home operating if you will on both sides of the Atlantic. I do believe that the markets for the therapeutic states from cannabinoid science is a significant opportunity. Especially for the approach that GW is taking, that approach is one that is aligned with the interest of patients and physicians run that office to promise of the entirely novel class of medicine and one that has the potential to change the entire complexion of the industry. Now it's been almost two months now since I've been with GW and as Justin has indicated we're in full motion regarding the early developments of the U.S. commercial organization. Our first steps are to build out the medical affair from the marketing teams and we've been very fortunate to access an extraordinarily talented people from the epilepsy industry to lead these organization. So I'm very comfortable that we’re off to a good start. As we go forward my intention would be on guiding our U.S. teams to expand our organization, developing the Epidiolex go-to-market strategy and as we get closer to Epidiolex's approval oversee the build out of a world class epilepsy sales and marketing organization. I'm very excited to be working closely with Justin in Carlsbad, California U.S. headquarter and most importantly look forward to bringing much needed new treatment patients that suffers from very difficult epilepsy condition. In our industry this is why we go to work each and every day with the prospect of making a meaningful difference in patient's life. Thank you. And I will now handover the call back to Justin.

[Justin Gover:]

Thank you Julian. First, let me reflect on the significant progress that GW has made in the Epidiolex epilepsy program over the past quarter. We now have all four of our Phase 3 pivotal trials of Dravet syndrome and Lennox-Gastaut syndrome under way, and announced today that recruitment is already complete and the first Dravet trial. The other three trials are all recruiting well and we expect to have initial data from the first trail in early 2016 and data from the remaining trials later in the first quarter of 2016. Alongside that pivotal program GW continues to support the physician-led expanded access program, and various U.S. state program. There are now over 300 children on Epidiolex to date under these programs and in total approximately 750 patients have now been authorized for treatment by the FDA. During this past quarter at the Annual Meeting of American Academy of Neurology those physicians again reported on the results of this open-label experience and have shown a continued promising benefit risk profile. At this time we think it is reasonable to expect the next updated refresh from that program will come at the American Epilepsy Society's Annual Meeting in December. Beyond epilepsy, GW's earlier stage clinical and preclinical pipeline programs have been more active than ever. Stephen will provide more detail on those activities in just a moment. Of course this progress has made possible only through the commitments of our investors to fund these programs, our April financing which met GW approximately $193 million with the full underwriters' overallotment is being utilized to ensure that we’re moving as quickly as possible. Let me now hand the call over Dr. Stephen Wright for more color on our pipeline. Stephen?

[Stephen Wright:]

Thank you Justin, and good day everyone. We've made great strides in progressing GW's cannabinoid development programs in the last quarter. In particular our pivotal program in treatment resistant childhood epilepsies progressing as rapidly and smoothly as any clinical program that I've been involved with. As a result of significant interest within the Dravet community trials, we've now completed recruitment in the first pivotal Dravet study. Finally randomized number 120 patients or 60 per arm provides increased talent of the study without any meaningful delay. We expect results from this trial in very early 2016. We continue to see rapid recruitment in the other Phase 3 Dravet trial and two Phase 3 Lennox-Gastaut syndrome trial, the results from all these trials later in the first quarter of 2016. I would remind you that the design of these studies was a result of prior advice from pediatric neurology and have extensive consultation with FDA preceded the finalization of the protocol. Hence we’re confident in our choice of our primary and secondary endpoints. The continuing involvement of an independent advisory panel organized through the epilepsy consortium adds to their scientific and regulatory integrity. Our ambitions to Epidiolex in the field of pediatric epilepsy are not however limited to Dravet and Lennox-Gastaut syndrome. We've previously announced plans develop Epidiolex in tuberous sclerosis complex a genetic disorder that causes non-malign tumors to form in many different organs and which affects approximately 50,000 patients in the United States. The most common clinical feature of tuberous sclerosis complex is epilepsy. And significant comorbidities associated with tuberous sclerosis include cognitive impairment, autism spectrum disorders and neurobehavioral disorders. In addition to these three initial indications we continue to evaluate additional target orphan indication for Epidiolex as new data emerges from the expanded access program. We expect to commence additional clinical development programs in further orphan pediatric epilepsy indications during 2016. But beyond Epidiolex I’m also very excited by our other pipeline activities. Before I review the status of our clinical stage pipeline program I’d like to spend a few minutes on some of our more advanced preclinical work. Let me begin with autism spectrum disorder. Many of the pediatric epilepsy conditions within the Epidiolex expanded access program share considerable overlap with autism spectrum disorders. We republished clinical observations from this program suggest the potential role for cannabinoids in objecting symptoms of autism including deficits in cognition, behavior and communication. As a result of these observations there are ongoing initiatives within GW to evaluate the range of cannabinoids in preclinical autism spectrum disorder models. These conditions often fall in the orphan disease space and GW is working with several opinion leaders with the aim to starting clinical trials in 2016. We’re also examining the use of cannabinoids in Duchenne muscular dystrophy or DMD. Our development of a membrane stress hypothesis leads us to conclude that muscle cells respond positively to cannabinoid therapy by increasing metabolic output and improving metabolic function. DMD is clearly an area of significant unmet medical need and we’re looking forward to more data and ultimately to move into the clinic and this indication as well. And finally GW is evaluating the use of Cannabigerol, CBG another new cannabinoid in the treatment of chemotherapy-induced cachexia where preclinical data supports a multi-modal beneficial action. Turning now to GW's current clinical activity beyond the Epidiolex program. Our Phase 2a placebo-controlled 86 patients’ trial of CBD in schizophrenia is now completed. We expect to report the results of this trial in the coming few months. GW intends to commence a clinical program in the fourth quarter in the treatment of Neonatal Hypoxic-Ischemic Encephalopathy, NHIE using an intravenous CBD formulation. NHIE is an orphan condition whereby brain injury results deprivation of oxygen during the birth process. Among the patients who survive NHIE many suffer from major neuro development issues and typically develop Cerebral Palsy. Preclinical data across several atoms of species have shown CBD to have a striking ability to attenuate the neurological and other consequences of NHIE. GW is developing a second epilepsy product candidate which features the non-psychoactive cannabinoid, CBDV. We have successfully completed the Phase 1 trial of intravenous and oral CBDV in 66 healthy subjects and 120 patients Phase 2 dose ranging safety and efficacy study of CBDV in patients with epilepsy is now recruiting well with data expected from that study in the first half of 2016. We’re also studying a combination of CBD and THC in the treatment of the orphan indication of recurrent glioma. In preclinical model GW has shown these cannabinoids to be highly orally active in the treatment of glioma xenograft and have shown tumor response to be positively correlated with tissue levels of cannabinoids. The 20 patient placebo-controlled phase of our ongoing clinical study is now fully recruited with data expected in 2016. The preclinical data also suggest the potential utility of GW cannabinoids in other cancer types including breast cancer and ovarian cancer. GW is also testing the non-psychoactive cannabinoid, THCV in the treatment of Type 2 diabetes. Preclinical models have shown evidence of pancreatic islet cell protection and an earlier small scale proof of concept study has shown promising effect on glucose and insulin status in patients with Type 2 diabetes. Our ongoing Phase 2 study compares the efficacy, safety and tolerability of three doses of THCV with placebo in a total of 200 patients and is expected to report data in 2016 again. And finally, the remaining two Phase 3 Sativex cancer pain trials are expected to read out in the later part of this year. Let me conclude by emphasizing that this rich and diverse pipeline demonstrates the potential of a number of cannabinoids many of which have not been previously studied in any meaningful way. GW's proprietary approach to the development of cannabinoids based medicines supported by global network of academic collaboration a unique, robust and also the rationale way to maximize the therapeutic potential of this fascinating plant. Thank you and let me now hand the call to Adam George for financial results and review.

[Adam George:]

Thanks you, Stephen. I will provide some high level comments on today’s Q3 financial results. A more detailed discussion of our results given in Q3 press release that we issued earlier today. We present GWs result in accordance with international financial reporting standards in British pound sterling, but for conveniences purposes on this call, I propose to refer primarily to the U.S. dollar equivalent of the key numbers. Today's results for our third quarterly earnings release for the three months and the nine months ending June 30, 2015. Starting with Q3 revenues. Total revenues for the quarter were $13.6 million, 13% higher than the comparative period, driven primarily by increased R&D fee charges to our partner Otsuka, as our two remaining Sativex Phase 3 cancer pain trials near completion. The most important line of our income statement as usual is the research and development expenditure line. In Q3, total R&D expenditure increased to $32.7 million for the quarter. The Otsuka funded element of that spend increased to $11.3 million but the majority of the increasing spend have driven by the increase in run rate of spend on GW funded Epidiolex activities, which increased to $21.4 million for the quarter. This is about 220% higher than the comparative period and 30% higher than in Q2 of this year, the spending is definitely accelerating now as we scale our Epidiolex growing and manufacturing activities and is the Epidiolex Phase 3 clinical trial program advances. Our management and admin spend increased to $4.7 million in Q3 that’s roughly 26% more than in the comparative period these costs now include the pre-launch commercialization activities for Epidiolex in the U.S which is the main driver for the increase. In Q2 I reported a £4 million of $6 million unrealized foreign exchange gain on retranslation of our U.S dollar denominated cash deposits into pound sterling at the 31st March exchange rate. Weakening of the dollar against pounds sterling in Q3 has caused us to record an £8.9 million or $13.9 million unrealized loss in Q3. So this is offset the gains recorded during Q1 and Q2 to give accumulative net foreign exchange loss of £0.7 million or $1 million of the nine months ending 30th June. As we continue to hold the majority of our cash reserves in dollar we going to expect continued exchange rate related volatility and our income statement in future. This will resulted in a loss before tax of Q3 of £21.4 or $33.6 million and £32.3 million or $50.8 million for the nine months to date. Turning to cash flow the net cash outflow for the nine months to June 30 from operating activities was 37.8 million. In addition capital expenditures principally on our new manufacturing and growing facilities were $22.2 million. In early May we received the net proceeds from our recent offering totaling $193.3 million and for the net increase in cash for the nine months was equivalent of $140.6 million. At 30th June we have closing cash of £254 million of $398.9 million. Turning to full year guidance we now expect core cash outflow before equity receipts for the 2015 financial year to be in the range of £63 million to £66 million from $98 million to $103 million, that’s lower than the £72 million or $110 million that I previously guided primarily due to the timing of capital expenditure. Thank you. I'll now hand the call back to Justin.

[Justin Gover:]

Thank you Adam. In summary the momentum of GWs research and development activities has never been greater and we have on the call today highlighted a diverse range of promising preclinical and clinical program. Most importantly of course we are approaching a very important period of news flow with respect to our epilepsy program with more data from the physician Epidiolex expanded access program at the American Epilepsy Society Annual Meeting followed shortly thereafter with results of the first pivotal Phase 3 trial in Dravet syndrome. This intern the followed by results of the additional Phase 3 Dravet trial as well as the two Phase 3 Lennox-Gastaut syndromes trial. We look forward to continuing to update investors on GWs progress on these and other programs in the months ahead. Thank you for your time today and for your interest in GW. I would now like to open the call for few questions.

[Operator:]

Thank you. At this time we will be conduction a question and answer session. [Operator Instruction] Our first question is from Josh Schimmer from Piper Jaffray. Please proceed with your question.

[Josh Schimmer:]

Maybe the first given a question about the autism spectrum disorders animal models. What are the animal models what are the single gene indications that give rise to those disorders from animal and in those Genta collaboration and related to the syndromes that maybe associated with [types] of those seizure disorders.

[Stephen Wright:]

Josh this is Stephen Wright here. We're using a mixture of few animal model both single gene mutations which results in abnormal animal behavior but also intact animals where you can induce abnormalities associated with interaction by chemical means actually, and the first results we’re getting from the social interaction studies are looking very interesting indeed in terms of reinforcing our conviction to carry along the autism spectrum disorders pathway. With regard to the individual or solitary gene mutations in the animal model, I think probably these if the contact more directly and I can give you more chapter that you can get through verifying detail about on this core. But I would emphasize we’re looking both at gene mutation that induce abnormalities in animal behavior and other model of abnormal animal behavior that echo and mirror some of the features of the autism spectrum.

[Josh Schimmer:]

Are the genetic models one that have been also identified as generic aberrant season in children who have autism spectrum disorders, so just trying to get how close the dynamic there?

[Stephen Wright:]

I think the cyclical view is validating the animal model is very difficult because as you know there is no treatment for autism spectrum in its broad sense, show their individual the redundant [high] results use for specific item of autism spectrum in children. So there is no way of knowing, actually whether there is good response in animal model is necessarily a reasonable good indicator of response in the human model.

[Operator:]

Our next question is from Tazeen Ahmad. Please proceed with your question.

[Tazeen Ahmad:]

So the first one is on the timing of your first survey study readout. I think in the past you had indicated that there might be possibility that reading out this year is the first half of the 2016 related to the fact that you added more patients than you thought you originally would?

[Justin Gover:]

Tazeen it's Justin here. Yes, as Stephen mentioned on the call, we have slightly exceeded the original number. If you recall the original number was 80, that was increased to a 100, we've ended up with 120 randomize. And that has led to literally a matter of a small number of weeks difference. So we were always bridging around the year-end. So as a result of that and additional final patients we’re now pushed into January.

[Tazeen Ahmad:]

And then can you just give us a little bit of color on why you think it's important to have a higher number of patients in the trial in order to increase the power and what that means for your endpoint?

[Justin Gover:]

Stephen do you want to take that one?

[Stephen Wright:]

I wouldn't exactly say that it's important it's just we clearly we wouldn't want to recruit less than the target number because that would put the efficacy outcome in our view at some risk, and recruiting ultimately more than target number simply gives us more power to detect a difference between driven placebo and that’s got to be a welcome outcome. So I think we’re very comfortable that we've over recruited slightly in the study.

[Tazeen Ahmad:]

And do you have any more visibility on what you think a general placebo response rate will be, I know you have been asked this question many times there was a cannabinoid conference happened in NYU not too long ago where it show placebo response rate for cannabis therapy in some cases around the 30% range. What’s your view on that and applicability to your current trial?

[Stephen Wright:]

I think most students have the placebo response would say that the placebo response is a different indications rather than specific medicines. So there has been quite a lot of publication in we're done looking at placebo responses in epilepsy. And it's quite clear that the firstly the type of epilepsy that you study and secondly the message you use to determine efficacy both things have an impact on placebo responses. The best guidance that we feel we've taken is from studies that have been conducted in exactly the same indications that we’re studying with the drugs which aim to reduce total seizure frequency, when you look at those mainly Clobazam studies and others in Lennox-Gastaut and stiripentol studies in Dravet syndrome defined a very consistent placebo response around about 10% or so, some of it less, some of it more than that. So I think probably the most informed guidance that we can take and probably give as far as what we anticipate placebo response to be is to say that we've looked at all those and we've allowed for a larger placebo response than have been seen in those previous Lennox-Gastaut and Dravet studies. And just one more point to add to this, perhaps a bit more specific, and I remember Dr. Devinsky made this comment at our R&D meeting day in New York City last year which is when you use a responder analysis, that's a primary analysis you tend to find placebo responses being higher than when you use a mean frequency of seizures at the endpoint. And we’re using the mean seizure frequency reductions as our endpoint that without adding to our confidence that we've done what we can to reduce the placebo response.

[Tazeen Ahmad:]

And then the last question is, you will have a lot of data coming out in 2016, it looks like from the obvious data read outs for Dravet and LGS. Which of your earlier stage trials that you plan on releasing data for as you think we should see looking for in terms of presenting upside beyond your core epilepsy trials?

[Justin Gover:]

Tazeen, its Justin here. Obviously we only invest in clinical programs on the basis of they have promising data supporting them and commercial potential to I think I’d be wishing that give you a priority list, but as you heard today there are multiple programs in the clinical with data read outs. Even this year we have beyond the epilepsy schizophrenia next year you will see the early data the CPV data, and indeed looking even within epilepsy beyond Dravet LGS if we’re looking to stores and beyond. So I don't think we should take a favor of it or additional program on this call other than to say what we try to do today is emphasize there a huge amount of activity going on in this company in meaningful clinical trials even beyond the headline epilepsy program.

[Operator:]

Our next question is from Paul Matteis with Leerink Partners.

[Unidentified Analyst:]

This is [Lars] on for Paul Matteis. Just some follow ups on the Dravet powering, could you maybe comment specifically on the back size of single procedure reduction that you’re looking forward, do you have any of that quantitative information?

[Justin Gover:]

Yes, I do. If we aim to detect a 30% difference between drug and placebo and with the current recruitment status of that study we are substantially over 90% power to detect that difference. What that means is even if the difference is somewhat smaller we are still highly active to reach statistical significance and that really adds more color to what I was saying earlier on about having a certain level of comfort and having a small over recruitment in the study. So the study is very adequately power indeed to predict to identify 30% and actually 25% difference between drug and placebo will still find us coming on very easily.

[Unidentified Analyst:]

And then just a few questions on the NHIE studies, any more color do you guys can offer there on how big the studies might be that you’re launching later this year.

[Justin Gover:]

I can’t justify on, that looks even right. Preliminary discussions with FDA we proposed that the study we first carry out in [Neonat] will be approximately 100 newborn children in size. That remains to be finally confirmed but I think that’s a reasonable target size. As we previously guided we don’t anticipate starting proof of concept study in human newborns until the middle of 2016 we have some Phase 1 work and actually it's on juvenile toxicology work to get done before we start that first study in human newborn.

[Operator:]

[Operator Instructions] Our next question is from Phil Nadeau from Cowen & Company.

[Phil Nadeau:]

First, on the Epidiolex Phase 3 program, what are your plans for the other three studies, will you enroll those up to 60 patients per arm or are those likely to be enrolled to the original plan of 50 patients?

[Justin Gover:]

It’s Justin here. Obviously with studies that are ongoing, I don't think I can give you a definitive answer to that, I mean I think the experience we have with the first Dravet study was that there was significant numbers of those parents risk their children participate in these studies and as study was coming to end we needed to accommodate that at the same time we have a one month screening period. So we’re also trying to assess or predict to what the final randomized number might be. And so it's a decision that needs to be taken in real time as oppose to in advance. So if the experience is similar in these additional studies there maybe some additional patients recruited beyond the target but I can’t be definitive at this point.

[Phil Nadeau:]

Then second just follow up to the last question I appreciate that the phases substantially over the 30% placebo adjusted difference, but 20% do you have those statistics with powering should be difference with 20%?

[Justin Gover:]

I can answer that. It actually all depends on the variability and the response that we see. We’re anticipating a 56% standard deviation in the response. What we’re seeing by that access program is about 45% down the deviation which is observed in the clinical trials actually add further to the power. So it's not possible to give you a very specific answer to your question of what happen is that a 20% difference. It absolutely depends upon the variability of that difference. If the variability is what you're seeing so far and my confident prediction is that we would have a significant study even at 20% difference between drug and placebo of course our strong preference is that the difference between drug and placebo is at larger that could possibly be. But that will be all become clear in due course.

[Phil Nadeau:]

And in the -- you stated the efficient term background Clobazam should seem to be collaborated with the higher rate of response. How was Clobazam confident in dosing being handled in the Phase 3 trials? Is that a randomization factor to make sure that the arms are balanced or is there some other mechanism?

[Justin Gover:]

Currently I don’t believe it's clear from anything is been published so far. But there is a better or worse function patient on or off Clobazam. There is an indication that there might be a drug drug interaction with Clobazam. But even the publication that referred to attention to the fact that reduction of Clobazam is not casued any reduction in efficacy. So I think that should be clear first of all and the answer to that will be come to in the placebo control trial. And because of that line mid I can't tell you the numbers of patients in each group on or off Clobazam. But you're right there will be about 40% of the total sample not taking Clobazam, our experience previously. And in terms of the analysis the presence or absence of Clobazam is being accounted for in the statistical model as is the gender for example, the age for example, the number plenty epilepsy drug thereon duration of that and so on and anyone of those factors might have an impact on the efficacy. If they do it's really a question for the labeling. In terms of instructions to physicians they are to treat the patients to any adverse events that they see in the patients as they would normally do. So for example if they see a patient can get them problems which make them suspicious of a heart attack or a cardiac problem then they would investigate and for a cardiac problem. Similarly if they get patients where they think there might be an issue related to the underlying Clobazam then they investigate the level of the underlying Clobazam and if necessary adjusted will treat the patient accordingly and that applies really across all of our clinical trials in pretty sound of practice.

[Phil Nadeau:]

And last one from me is on the schizophrenia read out. Could you give us sense of what you would consider proof of concept in schizophrenia. What measures efficacy measures are you taking in what would be an intriguing result.

[Justin Gover:]

The study is regarded an early Phase 2 exploratory study. So in line with various IPH guidelines we have a series of what I called exploratory end points that all relate to different aspects of schizophrenia. For example the positive and negative symptoms call various measures of combination of low test side effects and so on. And I think what we would like to see are a number of our exploratory end point being statically significant and those that are not showing a reasonable trend towards significant. I think that would make us feel that we would have a study that wanted see further investigation.

[Operator:]

Ladies and gentlemen we have reached the end of the question-and-answer session. Now I'd like to turn the floor back to Justin Gover for closing comments.

[Justin Gover:]

Thank you very much it just leads me to thank you for time today. I think hopefully we've been able to say to you the intense level of activity within GWs research programs right now. And the plans we're making towards our U.S. commercial activities as well. We look forward to significant use flow over the coming period and look forward to updating you at the time of our year end results and around the American Epilepsy Society Meeting. So thank you very much today.

[Operator:]

This concludes today's teleconference. Thank you for your participation. You may disconnect your lines at this time.