Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)

GW Pharmaceuticals PLC (NASDAQ:GWPH)

F3Q 2013 Results Earnings Call

August 5, 2013 8:00 AM ET

Executives

Steve Schultz - Head, Investor Relations

Justin Gover - Chief Executive Officer

Stephen Wright - Director, Research & Development

Adam George - Chief Financial Officer

Chris Tovey - Chief Operating Officer

Analysts

Phil Nadeau - Cowen and Company

Josh Schimmer - Lazard Capital Markets

Bert Hazlett - ROTH Capital Partners

Mike Aitkenhead - Edison

Ritu Baral - Canaccord Genuity

Operator

Greetings. Welcome to the GW Pharmaceuticals Third Quarter 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief 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, Investor Relations for GW Pharmaceuticals. Thank you, Mr. Schultz. You may begin.

Steve Schultz

Thank you, Operator. Good morning and good afternoon to everyone. Welcome to GW Pharmaceuticals third quarter 2013 results conference call. Again, my name is Steve Schultz and I’m the Head of Investor Relations for GW, and I’m based in United States.

We hope you’ve had a chance to review our press release and our 6-K filing, both of which were issued earlier today. These documents provide additional details on the company’s third quarter financial and operating results.

Leading the call today will be Justin Gover, GW’s Chief Executive Officer, who will provide a corporate update. Dr. Stephen Wright, GW’s Director of Research & Development, will then provide an update focusing on the new clinical data release today, as well as an update on our pipeline. Adam George, GW’s Chief Financial Officer will then provide an overview of the financial highlights from the third quarter. Following closing remarks, we will then open the lines to answer some questions. Also joining us on the call today is Chris Tovey, our Chief Operating Officer.

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, including the regulatory clearance of our products, the timing of product launches, and statements related to market acceptance and commercial potential.

Forward-looking statements involve risk and uncertainties, and actual events could differ materially from those projected herein. A list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW Pharmaceuticals filings with the U.S. Securities and Exchange Commission.

Prospective investors are caution not to place undue reliance on these forward-looking statements which speak only as to the date hereof.

I’ll now turn the call over to Justin Gover, GW’s Chief Executive Officer.

Justin Gover

Thank you, Steve, and thank you to everyone for joining us on the call today. As I indicated on our last call at the time of our Q2 and half year results, by yearly presentation of results, this is standard frequency for U.K. listed companies and has been our history practice.

However, in view of our recent NASDAQ listing we have elected to provide quarterly update from now on to conform with U.S. market practice, as such this is the first time that GW has reported results for fiscal third quarter.

GW has continued to make substantial progress in the third quarter, advancing key objectives in a number of areas, including the completion in May of our IPO on NASDAQ, raising $30.4 million, the continued progress in recruitment of our two Sativex pivotal Phase 3 cancer pain trials, representing our lead U.S. indication, the filing with FDA of a Phase 3 IND for Sativex as a treatment for MS spasticity, continued commercial progress in Europe for Sativex including launch in Italy, positive topline results announcing the separate release today from the 12-month study of Sativex in MS spasticity, and the addition of two new patent allowances in the U.S. protecting Sativex.

Our financial highlights this quarter include Sativex product sales revenue of 0.5 million pounds or $800,000, reflecting increased shipment of inventory to our commercial partners. Total revenue for the quarter of 7.3 million pounds or $11 million, and we ended the quarter with cash and cash equivalents of 43.6 million pounds or $66.3 million.

With the completion of the NASDAQ IPO, GW’s cash balance at the end of this quarter is the highest reported in the company’s history. However, this NASDAQ listing represent much more than a financing exercise, we see it as a key strategic step for GW and for future value creation for our shareholders.

We expect to generate a significant portion of our future revenues in the United States and providing greater exposure for the company to the U.S. investment community is a key goal for GW moving forward.

Turning to the U.S. clinical program, we are currently evaluating Sativex in Phase 3 clinical trials for the treatment of cancer pain. This program represents the lead target indication for Sativex in the U.S. and is intended to support a regulatory filing with FDA, and with regulators in other markets around the world. GW anticipates the topline results from the two Phase 3 pivotal trials will be available in 2014 with the first reporting results around mid- ’14.

Beyond this initial cancer pain indication, an important new development for our company is the acceleration of our plans for the development of Sativex as a treatment for MS spasticity in the United States. As a reminder, this is the indication for which Sativex is currently being marketed in Europe and for which we have already obtained approval in 22 countries.

GW together with our U.S. partner Otsuka held a pre-IND meeting with the FDA in December 2012 to discuss this indication and this meeting provided guidance on the U.S. development program.

Our recent milestone for this program has been the submission of an IND for the FDA with an investigational plan that includes the single Phase 3 trial protocol. Once feedback is obtained from the FDA on this IND, we expect to commence activities to set up the proposed Phase 3 trial.

For investors, in the event the discussions proceed with the FDA as expected, this would mean that GW will be in the somewhat unique position of having Phase 3 programs for two separate indications running simultaneously in the United States. I’ll remind you that cost of these Phase 3 programs are fully funded by Otsuka who hold exclusive commercial rights for Sativex in U.S.

Turning now to the Sativex commercial program and progress outside of United States, we are pleased that in the third quarter Sativex in-market sales volume for our commercial partners increased 21% over the comparable period last year. GW’s own reported revenues also showed a steady increase.

Importantly, our European commercial partner Almirall launched Sativex in Italy in July. We see Italy as an important market for Sativex, and I’m pleased to the note the successful outcome of the Italian pricing and reimbursement process.

Also in recent weeks, GW files the regulatory approval in France, the submission that was made possible following a decrease signed by the Minister of Health in France. In addition, Sativex received regulatory approval in Kuwait.

Beyond the 11 countries in which Sativex is now commercially available, there are an additional 11 countries in which approval has already been received and we should easily launched once relevant pricing reimbursement processes are complete. One additional country, Ireland, has recommended Sativex for approval and in addition, we have regulatory filings ongoing in further nine countries principally in the Middle East.

With the brief update on the situation in Germany, GW’s partner, Almirall, has launched legal proceedings to challenge the decision in March by the German authorities to impose price reduction. In addition to this, Almirall has been in contact with the German sick funds and the parties have entered into a new round of price negotiation. We expected to see a decision on the situation later in the year.

I will now hand over to Dr. Stephen Wright, our Direct of Research and Development.

Stephen Wright

Thank you, Justin. On today’s call, I’m trying to cover two areas, first, summarize the new Sativex clinical data released today; and second, to provide an update on our non-Sativex pipeline.

In a separate press releases issued this morning, we reported positive top-line results in 12 month outlined placebo-controlled study of Sativex in 121 patients with MS spasticity. The study was performed with the primary objective evaluating whether Sativex may have long-term adverse effects on cognition or mood.

The primary end-point with the change in cognitive function as assessed by the total Paced Auditory Serial Addition Test, also known as PASAT, a change in the total score from baseline to the end of treatment. Mood was assessed by the Beck Depression Inventory.

Results from the study showed that there was a slight and almost identical improvement in the PASAT score from the beginning to the end of the study in both the Sativex and placebo groups, thus confirming that there is no evidence of long-term cognitive impairment in patients taking Sativex compared with those taking placebo. Similarly, there was a slight improvement in mood over the 12-month period which was more or less identical in the Sativex and the placebo group, thus confirming no untoward effect of Sativex on mood.

We also took the opportunity to include in this study the secondary efficacy endpoints. Key among these were the global impression of change scores as assessed by the patient, physician and the carer of that. I’m pleased to report that each of these endpoints were highly significantly in favor of Sativex.

Overall, I’m delighted to report these positive and wholly reassuring results. We have now shown Sativex does not impair cognition either in short-term or now in long-term use in well designed, randomised, placebo controlled clinical trials. These data also provides further evidence of long-term efficacy consistent with that seen in previous shorter duration clinical trials.

Detailed data from this study is due to be presented at the ECTRIMS Congress which is being held in early October in Copenhagen, Denmark. ECTRIMS is one of the largest medical conferences for multiple sclerosis and this year, GW and our European commercial partner, Almirall, will be presenting a number of posters and papers.

As Sativex satellite symposium is being held at 12:45 on October 4th, and to those here any of you on the call are considering attending ECTRIMS, please do let us know as there maybe additional investor-focused activities that could be arranged.

I shall now turn to the cannabinoid pipeline. Beyond Sativex, GW is developing a number of additional product candidates based on the company’s proprietary cannabinoid platform. Following a program of promising preclinical studies, significant pipeline clinical trial activity is ongoing and expected to continue in the second half of 2013. This includes the following clinical studies.

For cannabinoid GWP42003 in the treatment of ulcerative colitis, the Phase 2a trial is currently active with data expected in the first half of 2014. For cannabinoid GWP42006 for the treatment of epilepsy, the Phase 1 trial is expected to commence in the second half of this year.

For THC, CBD formulation candidate for the treatment of recurrent malignant glioma, the Phase 1b/2a trial is expected to commence in the second half of this year. For cannabinoid GWP42004 for the treatment of type 2 diabetes, following positive data from a Phase 2a study last year, a Phase 2 dose-ranging trial is expected to commence around the turn of the year. And finally for cannaboid GWP42003 for the treatment of schizophrenia, a Phase 2 trial is expected to commence in early 2014.

Separately, the research term of our preclinical research collaboration with Otsuka in the field of CNS disorders and oncology ended on June 30, 2013. Data generated under this collaboration is now being reviewed by Otsuka with a view to determining any future joint research. It is important to note that GW has an exclusive worldwide license to all data and product candidate not subject to any future research agreement with Otsuka.

At this point, I will turn the call over to Adam George, who will discuss our financial highlights for the quarter. Adam?

Adam George

Thank you, Stephen. I’m Adam George. I’m GW’s Chief Financial Officer. I intend to provide some general comments on today’s Q3 financial results. A more detailed discussion of our results is given in the interim result press release on 6-K that we issued earlier today.

GW presents its financial results in accordance to its International Financial Reporting Standards or IFRS accounting rules in British Pounds Sterling. For convenience purposes, I’ll give U.S. dollar equivalent to certain key numbers. I will start with revenues.

Total revenues for the quarter were 7.3 million pounds or $11 million, compared to 14.5 million pounds in Q3 2012. This decrease is due to a sizable milestone payment received in the comparable period last year of 9.8 million pounds.

In this three-month period of 30 June, 2013, milestone income was 0.3 million pounds, being a milestone for Italian reimbursement in pricing approval. So the total reduction in milestone income was 9.5 million pounds.

Sativex sales revenue increased this quarter to 0.5 million pounds, compared to 0.1 million pounds in Q3 2012 and R&D fees increased by 1.9 million pounds to 6.1 million pounds, [basically charged] [ph] for Ostuka principally to the Phase 3 cancer pain trials program which is entirely Otsuka funded and the growth correspond with increasing R&D spend as our patient recruitment into these trials progresses.

Total research and development expenditures for the quarter increased from 5.7 million pounds to 8.4 million pounds. This is made up of two elements, the first being the Otsuka funded Phase 3 R&D spend I referred to already, which increased by 1.9 million pounds to 6.1 million pounds, and the GW funded element, which increased by 0.8 million pounds to 2.3 million pounds.

This increase in GW funded R&D reflect the cost of concluding the successful 12-month Sativex spasticity study that we have reported today, plus the cost of set up of the various pipeline Phase 1 and Phase 2 studies that’s now in progress.

This will result again in loss before tax for the three months of 2.3 million pounds or $3.5 million, which compares to a profit of 7.9 million pounds for Q3 2012. Again, the reduction in profitability is due to the reduction in milestone income.

For the nine months ended 30th of June we’ve now recorded total revenues of 20.2 million pounds or $30.7 million. We spent 23.5 million pounds or $35.8 million on research and development, up by 28% on the prior nine-month period of June 2012 and most importantly 76% of this spend is being funded by Otsuka.

In terms of profitability, we are showing a loss before tax of 7 million pounds which has been offset by a 5.1 million pound tax credit to give a loss after tax of 1.9 million pounds or $2.9 million. [The gain in] [ph] prior period showed the profit after tax for the nine months of 4.7 million pounds due to the 9.8 million pounds milestone in Q3 2012 as I talked already.

Turning to cash flows for the nine months of 30 June, 2013, we recorded a core operating cash outflow to the nine months to date of 5 million pounds or $7.5 million. Capital expenditure was 1.8 million pounds and these outflows have been offset by inflows in the form of 2.8 million pound research and development tax credit from the U.K. Tax Authority, net proceeds from our NASDAQ IPO of 18.2 million pounds.

So in total we recorded a net inflow for the nine months to 30 June, 2013, of 14.2 million pounds or $21.7 million, leaving us with closing cash position at June 30th of 43.6 million pounds or $66.3 million, I have just indicated the highest reported in our history.

Finally, I’m pleased to confirm that my guidance in terms of Sativex sales, R&D spend, a lot for the year remains entirely consistent with the guidance which I gave you in May at the time of our Q2 results and that’s repeated in the text of today's announcement. Thank you.

I’ll now hand the call back to Justin.

Justin Grover

Thank you, Adam. Well, I’d just like to end the call with a brief summary. The progress highlights today, demonstrates the key strength of our business, a validated commercial stage lead, significant partner funded Phase 3 programs in the United States, continued commercial progress outside of the United States, a robust clinical stage pipeline and a strong balance sheet. As such, we believe that GW is well-positioned for future success and the significant value creations for our shareholders.

Finally, I would just like to note that GW expects to participate in the following upcoming investor conferences, the Canaccord Genuity Growth Conference in Boston on August 14th and 15th, Aegis Capital Healthcare Conference in Las Vegas, September 25th to 27th, and the Lazard Capital Market Healthcare Conference in New York, November 19th and 20th.

Thank you for your time today. And I would now like to open the call for questions.

Question-and-Answer Session

Operator

(Operator Instructions) Thank you. Our first question is from the line of Phil Nadeau of Cowen and Company. Please proceed with your question.

Phil Nadeau - Cowen and Company

Good morning and thanks for taking my questions. Just a couple, first on the trial results that you released this morning, would you give us maybe a little bit more detail on what drove the change in the global impression of change scores, was there specific domains or characteristics that drove those improvement?

Stephen Wright

Hi. Phil, Stephen Wright here. On the global impression of changes exactly what it is. So, the physician and the caregiver, and the patients are independent. They have to judge overall how their spasticity has changed since they started on the clinical trial. It doesn’t break down to separate domains, it’s genuinely a global assessment. And it’s fairly standard across a range of different clinical indications that are used for [constant] [ph] pain studies and a variety of other studies as well.

Phil Nadeau - Cowen and Company

So the statistics would suggest that it is very robust benefit, what was the magnitude of the benefit?

Stephen Wright

All P values were better than 0.004, essentially what it does is to compare the numbers of patients who improved, who show any category of improvement in their global impression on drugs versus numbers of patients who show any category of improvement on placebo counterbalanced by the number who show any evidence of deterioration on drugs versus those who show any evidence of deterioration on placebo. So it's such kind of ranking.

Phil Nadeau - Cowen and Company

Okay. Okay. That's very helpful. And then second on Germany, could you talk a little bit more about the procedure that Almirall is going through in the new pricing negotiations, is that a dispute resolution procedure or is that a more traditional path?

Justin Gover

Phil, it’s Justin. Thanks for your question. I’ll hand to Chris Tovey, who will address the answer to that question.

Chris Tovey

So, hi, morning. There is, I think there’s two separate [bags] [ph], in terms of the previous decisions taken by the authorities of sick funds Almirall are in dispute and they have basically started legal proceedings against the process and the decision that was made. Separately, they are opening up discussions and new round of negotiations with the sick funds now which will take a number of months before we’ll see a resolution from that.

So there is a sort of a dispute of what’s gone and how we got there and then there is a discussion now with the sick funds to negotiate hopefully a new pricing. I think I would also add to that, I think in terms of Almirall’s approach to Germany nothing has changed from the last time we discussed it and Almirall, I think are prepared to seek domestic distribution if they don’t reach a reasonable conclusion with the sick funds in terms of pricing. And they’re already preparing themselves for that eventuality should it occur.

Phil Nadeau - Cowen and Company

Okay. Great. That’s very helpful. And then just one last question that’s on the MS plan that’s been submitted to the FDA, is there any specific clocker or set of timelines for you to receive FDA feedback on your plan?

Chris Tovey

Well, the IND was submitted recently and I think what we’ve tried to stress in the statements and the comments today is that we have sought specifically a feedback from FDA. There isn’t a specific clock for that feedback. Of course, you’ll be familiar with the timing of an IND process. We’re hoping to gain that feedback in conjunction with the IND timeframe and obviously that allows us to be very clear as to what we plan to do next. So the long way of answering your question is that we’re not giving you specific guidance but obviously this is a live situation.

Phil Nadeau - Cowen and Company

Great. Thanks for taking my question.

Operator

Thank you. Our next question is from the line of Josh Schimmer of Lazard Capital Markets. Please proceed with your question.

Josh Schimmer - Lazard Capital Markets

Thanks for taking my question. How should we be thinking about R&D expenses going forward with the start of the new set of trials on the pipeline, what percent of R&D, expenses as we move forward will be funded by Otsuka?

Justin Gover

Adam? Thanks, Josh. I’ll hand to Adam for that.

Adam George

Thanks Josh. I think the guidance that we gave during the IPO process was that we expected our R&D spend to increase modestly over the next two years. I think each of the Phase 2 trials that we do is likely to cost between $1 million and $2 million. So I think that three or four new trials starting which will be phased over the next year to 18 months. So there will be a gradual increase but not substantial.

And the proportion funded by Otsuka, I think it will go down marginally as we spend some more of our own cash on these pipeline studies. Although to some extent, it would depend on the timing of the start of the MS Phase 3 program which, of course, Otsuka will be funding.

Josh Schimmer - Lazard Capital Markets

And for some of these trials [inaudible] maybe the schizophrenia, the diabetes, and all sort of [inaudible] trials, what are you looking for in terms of signal specifically on efficacy, the various traditional development what -- do you have kind of go, no-go threshold in mind?

Stephen Wright

Hi, Stephen Wright here. Yeah, we do. So each of the studies is powered, they are powered at 80% to show a significant difference between drug and placebo for the primary outcome measure. So ideally, we’re looking for significant difference between the drug and placebo in each of those studies.

Now, you know that the nature of exploratory studies like this so what you might call proof-of-concept is that you might get a big signal that doesn’t quite hit statistical significance for the primary in which case the other endpoints come in to the equation. But we’re looking for generating the kind of evidence that we believe would make a compelling case for the further development of each of those compounds.

Josh Schimmer - Lazard Capital Markets

Got it. Thanks very much.

Operator

Our next question is from the line of Bert Hazlett with ROTH Capital Partners. Please proceed with your question.

Bert Hazlett - ROTH Capital Partners

Yeah. Thank you for taking the question. Just very briefly back to Germany, maybe you mentioned it. Maybe I missed it, but could you just discuss may be the timing of let’s call it a process that’s underway at this point?

Justin Gover

Yeah. I think the timing partly depends on the process itself than that might be outlined through the set. But actually we don’t know exactly when the process will finish. I think the target and the expectation really is around the end of the year but to be any more definitive than that would probably set a false impression of the process.

Bert Hazlett - ROTH Capital Partners

Thank you. And then just so with the additional rollouts you mentioned several other countries with regard to Sativex, are there any material expected milestones associated with those or are they more modest in nature and if there are material ones could you give us a sense of maybe the scale of those upcoming?

Justin Gover

Bert, this is Justin speaking. I mean, there are some modest milestones that maybe and as product is approved in some of the remaining markets, but they’re not material. And I think the guidance we can give with regard to milestone income is that the material increases in milestone really relates to U.S. regulatory activity.

Bert Hazlett - ROTH Capital Partners

Fair enough. Thank you my other questions have been answered. Thank you very much.

Operator

Our next question is from the line of Mike Aitkenhead of Edison. Please proceed with your question.

Mike Aitkenhead - Edison

Yeah. Hi. Thanks for taking my questions. I just had two, one on clinical data and one financial. Just turning to the cognition study, would it be possible for you to give us a little more detail on what the primary endpoint was designed to show? Was there any sort of non-inferiority design associated with the trial? I’m just a bit unclear as to how the trial was designed to compare the drug versus placebo in terms of this patch?

And secondly, just a quick question on the financials, I saw we had the R&D tax credits of $5 million finance with the cash flow statement. I’m just wondering if that’s going to be the expense for the year and how we might look at the R&D tax credits going forward from 2014 fiscal year. Thanks.

Dr. Stephen Wright

Hey Mike, Stephen Wright here. I’ll take the first one. Yes, you’re quite right. It was a non-inferiority design. The primary endpoint was this PASAT called Paced Auditory Serial Addition Test. Very briefly, the patient is asked to provide the sum of two digits within first a three-second period and then for the second part of the test a two-second period and the measure is the percentage of answer that they get correct.

And if you look through the literature, you’ll find that’s been really very commonly used in studies of multiple sclerosis to the extent that it is possible to compare results of one study with what has been seen previously. We’ve actually used it ourselves in previous studies as well.

The analysis was a non-inferiority. We constructed a hypothesis to any greater than X unit difference in the PASAT score between Sativex and placebo would be clinically relevant. And we failed to find any difference in the change in the PASAT score over the 12-month period between drug and placebo, therefore proving the hypothesis that Sativex is non-inferior to or non-superior either, actually both ways is two tail set. Essentially, Sativex is not different from placebo, in terms of way that it affects cognition over 12-month period.

Mike Aitkenhead - Edison

Okay. And just point from that, was mood (inaudible) that it was a non-inferiority analysis versus placebo?

Justin Gover

Yeah, absolutely right. Using the Beck Depression Inventory, again which has been very widely used in…

Adam George

And Mike, if I can take the tax element of your questions, if I could guide you to the note for, within today’s press release the tax note, it gives you a full breakdown of the 5 million pound tax credit. And you’ll see on the cash flow that we’ve actually used 2.8 million pounds this year, which is 2012’s claim that’s turned into cash during this period.

So 2013’s claim will be received in cash early next year. So I wouldn’t expect the full 5 million pound that’s shown in the income statement to flow through the cash flow statement this year.

Mike Aitkenhead - Edison

Okay. Thank you.

Adam George

Okay.

Operator

Thank you. Our next question is from the line of Ritu Baral of Canaccord Genuity. Pleased proceed with your question.

Ritu Baral - Canaccord Genuity

Hi, guys. Thanks for taking the question. Has there been any update in your thinking as far as what the primary endpoint of the U.S. Phase 3 trial will be with additional FDA interaction now?

Dr. Stephen Wright

Hi, Ritu, Stephen here. I think given that we’ve asked FDA for specific comments on our proposed protocol, it’s much better if I wait until we have those comments back from FDA before we disclose what the primary outcome issues and indeed the second results on that study.

Ritu Baral - Canaccord Genuity

Okay. And just following upon that the timing around the feedback and the start of the trial, is DEA input on logistics a gaining factor or will it be contributory to all of this versus strictly FDA at this point?

Dr. Stephen Wright

First stage, when doing clinical trial with the scheduled drug is that the protocol has to be formally approved by FDA. Only once that happened, will the DEA start to consider licensing the sites, of which the study is going to be carried out. So because they are sequential, you’re absolutely right that starting at individual sites can’t be done until the DEA process has been going through. DEA process can’t be started until FDA has expressed their comfort with the protocol.

I would say, however that because we don’t have to go through the DEA processes in Europe, we would anticipate a staggered start in this spasticity study with Europe coming down first and the U.S. following on as soon as the DEA processes have been completed.

Ritu Baral - Canaccord Genuity

Understood. That makes sense. And the MS spasticity data that was presented today, the cognition data, from the press release, I understand that the primary endpoint was the difference between base line and 12 months. Was there additional time reading over the course of the study and were there any differences in those time points, if any?

Dr. Stephen Wright

There were additional time points at three, six and nine months. And essentially from the efficacy point of view, we saw a progressive separation of Sativex from placebo. So, it was what you’d expect actually Sativex effect magnified with cumulative, if you like overtime. And from the point of view of the cognitive end of point, since there was no different between drug and placebo essential in the measure of condition and the measure of mood, that actually was sustained throughout whole study, so at no point that we see a difference between the two.

Ritu Baral - Canaccord Genuity

Great. Thanks. And my last question is on the ongoing ulcerative colitis trial. I guess, we have a slight delay in that data, if that due to enrollment or there are other sort of things going on in that trial that are update?

Dr. Stephen Wright

It’s Stephen Wright here again. If we had a period of relatively poor enrollment in the U.K. earlier this year a hump which we have now seen to got over and that’s the reason for a slight adjustment to the anticipated result timeline.

Justin Gover

And I think, Ritu, it’s Justin here, within a 2014 item at least from the NASDAQ prospectus some what, I think which is giving a little bit of a broad window but, there is no, the change is not material in all this.

Ritu Baral - Canaccord Genuity

Got it. And actually just following up to Joshua’s question, Steven, what would you say is the most important endpoint that you are watching out of the ulcerative colitis data that we are expecting?

Dr. Stephen Wright

Okay. That study in particularly is aim to determine whether remission can be endued by the use of 42003 in patients who have not achieve remission on first-line salicylate base therapies. So it’s looking at the induction of remission and we are using something called Mayo, which is the most widely used and it’s widely expected endpoint in that study of the Mayo score.

Ritu Baral - Canaccord Genuity

Great. Thanks for taking the question.

Operator

Thank you. We have reached to end of our allotted time for question-and-answer session today. I will turn the floor back to management for closing comments.

Justin Gover

Great. Thank you. Justin Gover speaking, just like to end the call by thanking everyone for their participation and interest today, the next earnings call for GW will be our Q4 and full year results a year ended September, so we’re expecting to report those results in around early December and we’ll be issuing announcement with the specific date near the time. So many thank you for your time today and we look forward to reporting progress later in the year. Thank you very much.

Operator

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

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: GW Pharmaceuticals' CEO Discusses F3Q 2013 Results - Earnings Call Transcript

Check out Seeking Alpha’s new Earnings Center »

This Transcript
All Transcripts