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Alkermes Plc (NASDAQ:ALKS)

Q2 2014 Earnings Call

October 31, 2013 8:00 AM ET

Executives

Rebecca Peterson – SVP, Corporate Communications

Jim Frates – SVP and CFO

Richard Pops – Chairman and CEO

Analysts

Cory Kasimov – JP Morgan

Jonathan Eckard – Citi

Anant Padmanabhan – Cowen & Company

Michael Schmidt – Leerink Swann

Mario Corso – Mizuho USA

Terence Flynn – Goldman Sachs

Steve Byrne – Bank of America

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes Conference Call to discuss the company’s quarter ended September 30, 2013 Financial Results. At this time, all participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being recorded at Alkermes’ request.

At this time, I would like to introduce your host for today’s call, Ms. Rebecca Peterson, Senior Vice President of Corporate Communications at Alkermes. Please go ahead.

Rebecca Peterson

Thank you. Welcome to the Alkermes PLC conference call to discuss our financial results for the quarter ended September 30, 2013. With me today are Richard Pops, our CEO, Shane Cooke, our President, and Jim Frates, our CFO.

Before we begin today, let me remind you that we will make forward-looking statements relating to among other things, our expectations concerning the commercialization of RISPERDAL CONSTA, INVEGA SUSTENNA, AMPYRA/FAMPYRA, BYDUREON and VIVITROL, our future financial expectations and business performance, and our expectations concerning the therapeutic scope and value and clinical development of our products.

Listeners are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to a high degree of uncertainty and risk. Our press release issued today, our Annual Report filed with the SEC and our other filings with the SEC identify risk factors that could cause our actual performance and results to differ materially from those projected or suggested in the forward-looking statements. We undertake no obligations to update or revise the information provided on the call as a result of new information or future results or developments.

This morning, Jim Frates will discuss our financial results and Richard Pops will provide a brief update on the company. After our remarks, we’ll open up the call for Q&A.

Now I’d like to turn over the call to Jim.

Jim Frates

Thanks Rebecca. Good morning, everyone. I suppose I should say happy Halloween as well. The three months ended September 30th represented another strong quarter for Alkermes. We recorded total revenues of $139.8 million. Non-GAAP net income of $31.8 million and free cash flow of $26.2 million demonstrating the power of our commercial portfolio and business model to generate significant cash flows. Our total revenues were driven primarily by growth from our portfolio of five key commercial products which grew 38% compared to last year and now represent approximately 73% of our total revenue compared to approximately 59% in the same period last year.

Within that portfolio, revenues related to our long acting a typical franchise RISPERDAL CONSTA and INVEGA SUSTENNA were once again the most significant contributors to our top-line during the quarter. And market sales for RISPERDAL CONSTA and INVEGA SUSTENNA during the quarter were approximately $650 million compared to $563 million for the same period last year. As J&J stated on their recent conference call, the franchise grew approximately 15% year-over-year due to an increase in combined market share. J&J also announced the approval of INVEGA SUSTENNA in Japan where it will be sold under the trade name XEPLION, another important milestone for this growing franchise.

For the quarter, Alkermes recorded manufacturing and royalty revenues of $62.6 million for this product franchise compared to $50.3 million for the same period last year. For AMPYRA and FAMPYRA manufacturing and royalty revenues were $12.6 million for the quarter. This morning a quarter reported end market U.S. net sales of $77.8 million. And BYDUREON previously reported FAMPYRA net sales outside the United States of approximately $16.7 million for the quarter.

VIVITROL, had a very strong quarter with record net sales of $19.2 million compared to $15.2 million for the same period last year an increase of approximately 26%. This growth reflects the success our commercial team is having in identifying key prescribers, deepening utilization in those practices and enhancing up take. For BYDUREON, Alkermes reported royalty revenues of $7 million based on worldwide end market sales of $87.6 million which grew 31% compared to last quarter. This included U.S. net sales of $73.2 million and ex-U.S. sales of $14.3 million as reported by Bristol-Myers Squibb. Bristol-Myers and AstraZeneca are focused on growing the brand and introducing the dual-chamber pen device to the market by mid-2014.

Switching now to expenses. On the R&D front, we achieved an important development milestone for aripiprazole lauroxil with the completion of enrollment in the Phase 3 study. In parallel with the ongoing Phase 3, we’ve been expanding our focus to pre-launch activities and preparing and NDA Submission following Phase 3 completion. Both of these factors contributed to the relative increases in R&D and SG&A expenses during the quarter. In addition, SG&A reflected investment and increased promotional activities for VIVITROL. Going forward, we expect this level on the investment to continue in 2014 reflecting increased activity with incremental spending expected in R&D and SG&A as more late-stage clinical trials get underway and commercial activities accelerate for aripiprazole lauroxil.

As a reminder, we’ve changed our fiscal year end for March 31st to December 31st. On our February call we reported nine months fiscal period ending December 31, 2013. And we’ll also provide our financial expectations for calendar year 2014. Our optimism for the future is as strong as ever with $395 million in cash and total investments as of September 30th and a powerful business model, we’re well positioned to generate cash and invest in our late-stage pipeline.

With that, I’ll turn the call over to Richard.

Richard Pops

Great. Thank you, Jim. And good morning everyone. So, the pipeline progress in the last year has been remarkable. Our goal has been to develop one of the most diverse and exciting CNS pipelines in the biopharmaceutical industry and that’s now coming into focus. We capitalized on the opportunities ahead, we’re at the beginning of a whole new level of activity in our development to commercial programs. We’re taking the next steps to build a significant biotechnology company.

Looking at the pipeline programs first. Earlier this month, we announced a number of key events in the development of our late-stage candidates. For our most advanced candidate, aripiprazole lauroxil for the treatment of schizophrenia. We announced the completion of enrollment in the multinational Phase 3 program. Following a planned interim statistical analysis designed to confirm this study was well powered to analyze the primary end point. With enrollment complete, we’re on track for top-line data in the first half of 2014 and NDA submission shortly thereafter and expected launch in 2015. We see the opportunity for aripiprazole lauroxil growing as market dynamics shift in favor of long acting injectables coupled with aripiprazole lauroxil’s distinct product profile which is specifically designed for leadership. Many of you know that Otsuka’s long acting aripiprazole product ABILIFY MAINTENA is launching and beginning to grow. As you’ve heard us say again and again we believe that the entire long acting injectable market will benefit from multiple sales forces highlighting the advantages of long acting treatment for schizophrenia and we believe that’s exactly what’s happening now.

As Jim outlined end market net sales of INVEGA SUSTENNA and RISPERDAL CONSTA grew to $650 million during the quarter against the backdrop of the ABILIFY MAINTENA launch earlier in the year. We believe this underscores that the growth of the class will be supported by new entrance and we look forward to introducing aripiprazole lauroxil into this more than $2.5 billion market. Aripiprazole lauroxil is designed to provide a generational advance in dosing flexibility and product presentation. Completing enrollment in our single pivotal study was a major milestone and while our clinical and regulatory teams are focused on completing the study and preparing the NDA. Our commercial team is preparing for launch.

For ALKS 5461 our proprietary opioid modulator with a novel mechanism for the treatment of major depressive disorder we achieved rapid alignment with FDA on our proposed design for the pivotal program. In addition the FDA also granted ALKS 5461 Fast Track status further underscoring agencies focused on new treatment options with novel mechanisms for this debilitating disease. The purpose of Fast Track status is to get important new drugs to patients faster and the practical benefits are numerous. This designation confers eligibility for a rolling review which allows portions of are NDA package to be separately.

Fast Track status also confers eligibility for priority review which is a six month review clock versus the standard 10 month review from the time of an accepted filing. With this designation and agreement with FDA on our phase 3 program in hand we’re gearing up to start the phase 3 program in early 2014. the core efficacy studies will mirror the key design elements of the phase 2 study with Montgomery–Åsberg Depression Rating Scale scores or MADRS as the primary end point. The three core efficacy studies will include approximately 400 patients each and feature elements similar to those utilized in our phase 2 study including sequential parallel comparison design to our SPCD. In addition to SPCD we’ll continue to implement the rigorous quality control procedures we utilized in phase 2.

For ALKS 3831our novel oral atypical antipsychotic our first phase 2 program is ongoing ALKS 3831 is a proprietary combination of a novel opioid modulator ALKS 33 and olanzapine which is an important antipsychotic that causes particularly high instance weight gain in many patients. We’re developing ALKS 3831 as a broad spectrum antipsychotic with potential utility in two distinct patient populations those with the propensity for weight gain on olanzapine and those with schizophrenia exacerbated by alcohol use which represents approximately one third of the patients with schizophrenia.

The 400 patient phase 2 study currently underway will evaluate the impact of ALKS 3831 on weight and other metabolic factors compared to olanzapine in patients with schizophrenia. A second phase 2 study is planned to evaluate the potential utility of ALKS 3831 for schizophrenia exacerbated alcohol use. This study is expected to start at 2014 following a meeting with FDA. In addition the weight stage point we have disclosed three new product candidates MMF prodrugs which are oral medications for the treatment of multiple sclerosis. ALKS 7106 and opioid analgesic without the risk of overdose death and RDB 1419 a biologic immunomodulator for the treatment of certain cancers all being ready for human clinical trials.

Across the portfolio our development candidates represented high value opportunities because of their potential to be blockbuster products that offer meaningful benefit to patient’s providers and payers. We’ve been working to build a pipeline with a potential for such tremendous medical and economic significance. We’ve had some important success in the past few months and we’re excited to carry on into 2014. This is a unique company one with a here and now of a diverse and balanced cash generating commercial portfolio coupled with what is emerging as one of the most important CNS pipeline in the biopharmaceutical industry.

So with that I’ll finish and turn the call back to Rebecca for questions.

Rebecca Peterson

Great thanks Rich we’ll now open up the call for Q&A. [Paula]?

Question-and-Answer Session

Operator

Thank you. We will now begin the question and answer session. (Operator Instructions) And our first question comes from Cory Kasimov from JP Morgan. Please go ahead.

Cory Kasimov – JP Morgan

Hey good morning guys thanks for taking my questions and once again well done on the pre call music. A couple of questions around 9070. I’m curious on the significance of that interim analysis and may be you can explain of how detail of a look that DMC took to make the decision not to upsize the trial? And then also in terms of I guess I’m interested in the type of market research you’re doing for 9070 and what sort of commercial prep is currently underway that giving a little bit of a boost to SG&A? Thanks.

Richard Pops

Good morning Cory. So first on the inner look, it’s interesting because it was really a sample size re-estimation look. So we took no Appleton only it was not a bad determining whether we should stop or not stop – didn’t make sure that we were correct on the sample size estimation because we made that determination based on pre-specified or a modeling based on pan scores variability and retention rates and the like. So what we came back with was a very clear signal that above 540 patients we had plenty of power to analyze the primary end point for both doses. So with that we were able to start winding down the enrollment. We had enough momentum at the time that we kind of blew through the 540 we didn’t get quite at 690 but it was a really encouraging sign for us on that finding basis. But we obviously have no insight into the results themselves. What’s interesting about the market research right now is that much of the market research is playing out in front of us in real time with the launch of ABILIFY MAINTENA right so.

As I mentioned earlier the dynamic in the market place is playing out as we would have hoped and expected which is constant – our strengthening and more and more doctors are getting detailed by another complementary set of sales forces explain their virtues of long acting injectable medicines. As we showed at the R&D day in July if you recall the messaging if you look at the actual messaging behind CONSTA, SUSTENNA and MAINTENA they’re very complementary it’s not they’re not fighting over the same patients they’re basically educating in general long acting injectables are a better way to treat schizophrenia. So what we’re doing internally now is essentially preparing our organization to be able to go after this but we’re doing on a pathway that’s been written by both J&J and increasingly by the folks at Otsuka and Lundbeck. And if you’ve been – if you’ve been tracking the numbers the monthly numbers of ABILIFY MAINTENA you can see its beginning to ramp nicely now.

Cory Kasimov – JP Morgan

Right okay and then how big of a sales forces there behind MAINTENA?

Richard Pops

We understand that Otsuka is using something on the order of 200 people.

Cory Kasimov – JP Morgan

Okay, great. Thank you.

Richard Pops

You’re welcome.

Operator

And our next question comes from Jonathan Eckard from Citi. Please go ahead.

Jonathan Eckard – Citi

Good morning. Thank you for taking my question. I was just wondering if now that you are more confident with the enrollment and that you have a sufficient number of patients for aripiprazole lauroxil, is there any ability to narrow the timeline for the phase 3 data release in first half 2014? And then I have a follow up question on the pipeline?

Richard Pops

Good morning Jon. I know it’s a little bit like you press play now. We have the patients there is a certain amount of time that they’re on the oral aripiprazole lauroxil running then there is a three month in live phase where we’re looking at the primary end point and then there is an opportunity for roll into an extension so there is certain kind of protocol elements that push us then into the first half of 2014.

Jonathan Eckard – Citi

Okay, very good. And then with regards to the early pipeline programs mainly MMF prodrugs and ALKS 7106, outside the standard safety and kind of dosing questions that you’d like to answer. What are some of the other aspect that you of these drug profiles that you with to kind of answer from the initial human trials?

Richard Pops

It’s a good question and it’s – it illuminates some of the features of these programs that we find so attractive in the sense that those are early clinical trials can reveal significant amount about the characteristics of the drug and in fact lower the discount rate for subsequent studies. In the case of the MMF prodrugs of course you’re looking at replicating or creating a pharmacokinetic profile of the active moiety MMF that is the appropriate twice a day profile or the once a day profile that we’re interested in pursuing. Also, you can look at tolerability because one of the advantages we think the potential advantages of our dosage form is to prove the tolerability. So, that should demonstrate itself early in clinical trials if you run the correct initial studies which we have a tendency to do.

The 7106 as a pain product, we know as you seen from the animal models, we have a strong belief that this has an opioid modulator is going to be an effective analgesic. So, what we’ll be able to do is test early on these features of that lower dosed liability drug liking and the like. And so we can – we think that the first series of clinical trials on both of these progress will be incredibly informative for us, that’s why we’re so anxious to get them to the clinic as fast as we can in 2014 and we’re modeling sometime around midyear.

Jonathan Eckard – Citi

That’s great. Thank you, very much. I’ll get back in the queue.

Rebecca Peterson

Thanks Jon. We’ll take the next question.

Operator

And our next question comes from Anant Padmanabhan from Cowen & Company. Please go ahead.

Anant Padmanabhan – Cowen & Company

Good morning. Hi. Just a couple of questions, first on 5461. Could you just discuss when we might see the trials actually posted on clinical trials and what the duration of the trials would be and then potentially the timing of filing? And then I have another follow-up question.

Richard Pops

Hi, Anant. So, the Phase 3 program will include three core efficacy studies, we’ll also add a safety study and drive total number of exposure, so we meet ICH guidelines for the overall exposures. The first studies will begin in the beginning of 2014 and then they will kind of build through the year. The first posting, Rebecca on the quintals of GABA we guess would be in Q1?

Rebecca Peterson

Yeah, fairly close to the start of the actual study that – that’s what you’re required to do. So, you’ll get information as the studies go alive on that.

Richard Pops

The SPCD studies are not more narrow as I said almost identically what we did in Phase 2. So, you can expect these in the SPCD study at two phase study or a two stage study, each one is about five weeks in duration. So, most doc will stack those types of studies underneath the umbrella of this longer safety exposure study and that together will comprise the NDA submission. We’ve not yet guided yet to when we think it will end because we are just tuning up now when we’re getting them off start and how we’re going to stack it through and – but we’ll give you guidance on that next year.

Anant Padmanabhan – Cowen & Company

Okay, thanks. And then on VIVITROL, could you just discuss the label change and what impact it has on your promotional activities?

Richard Pops

Sure. And for those of you if you don’t know it was a very positive development and that the black box warning was removed from VIVITROL’s label. And the removal of black box in general, not just specific to VIVITROL allows you to do things that you can do when you have a black box product. VIVITROL is such a specialized product and being focused on the [indiscernible] group of doctors right now. I would say that in the immediate aftermath of removal of the black box warning, it was more of a sigh of relief and then representing a step change in a way that doctors will see the people are prescribing VIVITROL right now understand VIVITROL. And but it does have the implications for the future as the drug begins to ramp as its doing right now, it gives us much more flexibilities, we begin to expand the exposure of VIVITROL.

In the immediate short-term then what happened is that we essentially incurred some expense because repined all the promotional materials all the marketing materials everything to change the emphasis because with the black box warning, you have to basically leave your promotional materials with the black box warning. So, we were able to kind of retool all of our marketing materials.

Anant Padmanabhan – Cowen & Company

Great. Thanks.

Rebecca Peterson

Thanks, Anant. We’ll take the next question.

Operator

And the next question comes from Michael Schmidt from Leerink Swann. Please go ahead.

Michael Schmidt – Leerink Swann

Hey, good morning. Thanks for taking my question. I had a follow up on 5461. I was just wondering if you just could provide some more incremental color on what you have agreed on specifically with the FDA in terms of the pivotal study design, how are the studies powered, why are you running three efficacy studies. And what are your thoughts with regards to a past forward ex-U.S. for this product? Thanks.

Richard Pops

Okay. Hi, Michael. So, we said in pre-meeting briefing package done with FDA before our – end of Phase 2 meeting. And in that we proposed the program that I’ll describe in a second. And we were gratified to see the FDA basically came back and said yes we agree with that you’ve proposed and so there really was no need for a face to face meeting and we updated you promptly thereafter. The program that we proposed was three efficacy studies, three core efficacy studies as I mentioned to Anant question, three core efficacy studies. And we proposed utilization of the SPCD design. As we have told you in advance and we really don’t think that was particularly controversial we actually thought it was good science and FDA agreed with that.

So, you saw in Phase 2 within and they’ve got a 150 patients we were able to show statistically significant results. We’re going to power those up a little bit more of these studies as we said we’ll do that 400 patients each. In part, not necessarily driven so much by the biostatistical analysis but we just want to get total number of exposures in the total clinical trial program to a size where it supports how meaningful this product could be and how many patients we think this drug could be useful for.

So, we’ll run about – we’ll run three studies each on the order of about 400, there will be pushes and pulls between them based on the design. Two of them are – two of the studies will be very similar to SPCD design you saw in Phase 2. The third is a little more new ones based on some design elements that we have that we won’t disclose right now that we’re quite excited about pursuing. And the ideas you run three to – I’m sure that you have two that you can file on. That said, we don’t expect to fail on these studies, we expect that the drug has a clear signal and if we continue to run these studies in a specific manner that we’ve been doing, we think those drug signal will continue to present itself.

Under the umbrella, those three studies of a larger safety study, we’re just going to make sure patients stay on this drug for long periods of time so we make sure we have a full safety profile for the NDA submission.

Michael Schmidt – Leerink Swann

Sure. Thanks. And the…

Richard Pops

I’m sorry, you asked about the ex-U.S. too, I mean to say that. We’re seeking scientific advice on that right now. And well the studies that I just described to you were primarily designed with U.S. registration in mind. We’re absolutely mindful of the global opportunity on this one but we have not quite yet integrated all the European advising to the program yet. We’ll update you when we do.

Michael Schmidt – Leerink Swann

Great. Thank you.

Rebecca Peterson

Okay. [Paula] we’ll take the next.

Operator

And our next question comes from Marc Goodman from UBS. Please go ahead.

Richard Pops

You there Marc?

Operator

Mr. Goodman, your line is now open. I’ll go on to the next question. Our next question comes from Mario Corso from Mizuho USA. Please go ahead.

Mario Corso – Mizuho USA

Good morning. Thanks for taking my questions. Couple of things on the pipeline, as you alluded to some pretty significant increases in spending in the quarter, I’m wondering if you could talk a little bit about the pre-commercial activities and then what that covers and what you’re looking for out of that on 5461 I’m wondering if there is any difference in design between Phase 2 and Phase 3, whether it’s efficacy measurements secondary endpoints that you would highlight. And then thirdly kind of related, your R&D budget as we think about the pushes and pulls there going forward, I think post the EDT merger, $180 million or so was kind of the top end of the range you guys talked about. But I’m wondering if that contemplated a Phase 3 program which is the one you’re embarking upon with 5461. Thanks very much.

Jim Frates

Sure, Mario. Thanks. It’s Jim. I leave the question on the design study to Rich but I’ll try and tackle the two financial ones first. So, with SG&A spend, you did see an increase in the quarter, I think that was really driven by – we think the best kind of SG&A spend you can have and really sales and marketing spend rather than G&A. So, we have a growing product in VIVITROL. And we’ve decided to put some increased promotional spend behind that as we’re obviously the product is doing quite well compared to our expectations this year. So, investing in that profitable growth is something we think is very smart. And then in terms of aripiprazole lauroxil as we’ve come to the point where we’ve finished enrollment in the study and now we can see the light at the end of the tunnel again that market preparation getting close to the changing market right now with the launch of ABILIFY MAINTENA beginning to add a little bit to our professional leadership staff for 5461. And I think, and I think you’ll see those investments continue as we go given the strong revenue a growth that we’re also seeing.

And then in terms of the R&D expense, specifically we’ll guide to 2014 when we guide in February we haven’t given guidance out that far. And we’re obviously within our guidance this year as we finish the large phase 3 you’ll begin to see the end of the large phase 3 for 9070. We’ll also be rolling on thanks to the success we’ve had in the pipeline a large phase 2 study for 831 and obviously the 5461 phase 3 program so. As I said in my remarks just to give you a little bit more color I think you can use our current level of investment that will continue and you’ll probably see some incremental spending growth through 2014 on top of that. And so I’ll turn the 5461 design question over to Rich.

Richard Pops

I think as I said in some of our early comment it’s very, very similar to our phase 2 program. Let me just highlight a couple of things in a little more specific on that. Particularly what do we care about, we care about the patient’s profile to what we’ll use the same idea of patients with major depressive disorder who are not currently getting adequate relief from use of SSRIs or SNRIs because this is where we’ve had success before in the previous days and we continue in that patient population we’re settled on dose we’re settled on study design which will mirror what we did in phase 2 at the SPCD and the end point to analytics are the same. So it’s very, very much shades of the exact same color that we would have, we’ve had in phase 2 which is I think in our view exactly where we wanted to end up because in the probability for replication goes up.

Rebecca Peterson

Alright [Paula] we’ll take the next question if there is, open the queue.

Operator

Our next question comes from Terence Flynn from Goldman Sachs. Please go ahead.

Terence Flynn – Goldman Sachs

Hi thanks for taking the questions. May be just a follow up on 5461 Rich, I was wondering specifically in terms of the criteria using to edema a responder versus a non-responder. I was wondering if you’re still using that the HAM-D cut off of 50% there in the phase 3 trials. And then one question on the MMF prodrug you’re working on. I think Biogen had some data at ACTRIMS this year where they showed gene transcription changes that take place with MFF and DMF are different there are some hypothesis that maybe DMF does have a clinical impact. So I’d just love your guys thoughts on that as well. Thanks a lot.

Richard Pops

Yeah two good questions on the first one actually I quite understood your 5461 question Terence not in terms of responders, are you talking about how we stratify or enroll patients who are non-responsive to their base line therapy or actually the responder analysis or efficacy analysis?

Terence Flynn – Goldman Sachs

Yeah I guess it would be more of the enrollment. So once you enroll the patient being them a non-responder and then they go on to randomized after that?

Richard Pops

Yeah the patients that are enrolled instead of patients who have not responded to one or more SSRIs or SNRIs and the determination about their response, the HAM-D non-responders of cancer and I will get that answer to you. I don’t know whether its 50% or its 22% but there is a pre-specified non-response threshold. On the MMF, DMF I mean fantastic question because I think it’s very much in Biogen’s interest to draw a distinction between MMF and DMF based on the IP.

The important thing to understand is that there is not much DMF that appears systematically. If you read the summary basis approval or even a label for TECFIDERA, MMF is the active moiety, this is described by the sponsor in the NDA and we believe biologically the driver of the effect is MMF notwithstanding the fact that in vitro systems or in gene expression arrays you can show differences. But that maybe important or not important but we think the driver of the efficacy is MMF but we will see when we get into the clinic. But the most important thing for us right now is the make sure we have a prodrug and a delivery system join together to not only deliver MMF consistently in a reliable way but also against the wave form that we think we can sculpt with our drug delivery technology allows us to provide a differentiated twice a day product or even a once a day product.

Rebecca Peterson

And Terence just follow up for some color on ALKS 5461 for those on the phone who may not know. But 5461 is designed as an adjunct therapy. So recall that patient will have bailed or had an inadequate response from one or more SSRI or SNRI. But they will remain or continue on that base line therapy and 5461 will be layered on to that. Alright [Paula] we’ll take the next one.

Operator

And our next question comes from Steve Byrne from Bank of America. Please go ahead.

Steve Byrne – Bank of America

Hi, I wanted to drill into the VIVITROL commercial sales force a bit. You indicated it’s been, it’s in an expansion mode. Can you talk a little bit about how many reps you have out there now and is the focus to expand geographically now that presumably you have enough pilot data that you can pitch this product in new regions?

Unidentified Company Speaker

Sure Steve and let me just draw a distinction and perhaps under spoke. But we haven’t expanded our field sales force what we’ve been expanding is our promotional spend the sort of advertising and promotional spend that you would, that you typically do. So the sales force remains about 66 people, 65, 66 people. We’ll be looking at that in next year’s budget to makes sense in those areas of the country that wanted more investment I think we’ll do that again. The product is profitable and we’ll continue to look to drive profitable growth. One of the things that we’re seeing is the product is being used more deeply in the key prescribers offices. It does take some time for those prescribers to understand how to use VIVITROL and I think you’ll see next year a broadened effort at education across a number of fronts both government affairs, direct promotion with the sales force and more advertising that’s allowed now at the black box is no longer part of the warning. So you’ll see some investment there. Again we’ll – the growth is accelerating but it is gradual and we’ll continue to invest to see if we can accelerate that in the next year.

Richard Pops

Hey Steve its Rich let me just make one point to amplify what Jim said. On the policy side we are I think ahead of the curve in terms of thinking by the integration of policy into our commercial organization. And it reads not just on the VIVITROL but also on the aripiprazole lauroxil, BYDUREON, CONSTA, SUSTENNA everything in an environment where payers are focused on long term outcomes and long term economic better adherence to good drugs is a money statement proposition. So on the VIVITROL side we are definitely powering up you’ve heard us talk before about our state based programs and we’re powering up integration of our state and federal activities as it relates to VIVITROL because there is enough data now in the system that we can begin to really promulgate the message that’s been developed down in the field.

Rebecca Peterson

All right [Paula]. I think we have, I’m sorry Steve please go ahead.

Steve Byrne – Bank of America

Alright – well thank you Rebecca I just had a follow up financial question for Jim and that was, you had a significant increase in the non-cash comp or stock based comp in the quarter. Is that lumpy and did that contribute to the sequential increase in the SG&A and R&D line items?

Jim Frates

Yeah Steve it is lumpy in the sense of its, it was the annual grant that went to our Board of Directors and given their service through the course of the year we take that all in one quarter. That is a non-cash comp expense and that will be outlined in the quarterly our 10-Q that we filed think earlier this morning with not eminently. And also its driven by a higher share price as well given that share price is higher that obviously goes into the accounting charges that you take higher charge for higher share price grant.

Rebecca Peterson

Okay. [Paula] I think we have time for one more question. I know there is a lot of folks reporting this morning. So, we’ll try to be respectful with them on time.

Operator

We’re showing no further questions. I will now turn the call back over to the company.

Rebecca Peterson

Everyone thank you for dialing in and as Jim said Happy Halloween. Take care.

Operator

Thank you ladies and gentleman. This concludes today’s conference. Thank you for participating you may now disconnect.

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