Ladies and gentlemen, thank you for standing by and welcome to the Alkermes Conference Call to discuss the company’s Second Quarter 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.

Thanks, Brandon. Welcome to Alkermes Plc conference call to discuss our financial results for the quarter ended June 30, 2015. With me today are Richard Pops, our CEO; Shane Cooke, our President; and Jim Frates, our CFO. Before we begin today, I encourage everyone to go the Investors Relations section of alkermes.com to find our press release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we’ll discuss today. We believe that the non-GAAP financial results better reflect and represent the ongoing economics of our business. Our discussions during the call today will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our press release and our quarterly report on Form 10-Q issued earlier today and our most-recent annual report on Form 10-K for the important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements. We undertake no obligation to update or to revise the information provided on the call today as a result of new information or future results or developments. So on the today Jim will discuss our financial results and Rich will provide an update on the company. After that we will open it for Q&A. Now, I’d like to turn over the call to Jim.

Thanks, Rebecca. Good morning everyone. We’re pleased to report our results for the second quarter 2015, which were characterized by strong revenues from our portfolio of core commercial products and important investments in our pipeline and our commercial organization, ahead of the launch of ARISTADA which our proposed brand name for aripiprazole lauroxil. Today we’re also improving our financial guidance for 2015 based primarily on the solid growth we’ve seen in VIVITROL net sales. The strong results generated by our commercial team for this specialty injectable product are particularly encouraging as we prepare to launch ARISTADA. I will provide the highlights from our updated guidance, but first we’ll review our second-quarter performance. In the second quarter we generated 151.4 million total revenues and recorded 13.6 million of non-GAAP net loss. Within our key commercial portfolio worldwide end market net sales of our long-acting atypical antipsychotic franchise, RISPERDAL CONSTA and INVEGA SUSTENNA were approximately $683 million in the quarter compared to $696 million for the same period last year. Within that the franchise experienced underlying unit growth which was offset by the unfavorable impact of currency movement. In the United States INVEGA SUSTENNA sales showed impressive growth as the leading product in the class with end market net sales of $253 million during the quarter, reflecting approximately 25% growth year-over-year. For the quarter, Alkermes recorded manufacturing and royalty revenues of $60.8 million for this long-acting injectable product franchise. Also during the second quarter our partners at Janssen received FDA approval INVEGA TRINZA a three-months formulation of INVEGA SUSTENNA for the treatment of schizophrenia. That product was launched in recent weeks and will be included in our INVEGA SUSTENNA royalty stock. For AMPYRA and FAMPYRA, our manufacturing royalty revenues were $26.9 million for the quarter compared to $19.5 million for [indiscernible]. VIVITROL…

That’s great. Thank you, Jim. Good morning, everyone. We’re going to try to keep this call short. Since its summer, we’ve got a lot of things to cover. So we’ll get right into it. First of all, at the highest level, our distinctive strategy to pursue large chronic diseases of the CNS with highly differentiated medicines responsive to the needs of multiple elements of the healthcare ecosystem is playing out as planned. We’re now on the threshold of what will be a transformative period for Alkermes. In this space, over the next six months, we expect receive FDA approval for and launch ARISTADA. We’ll get the first data from the core efficacy studies from the ALKS 5461 pivotal program in major depressive disorder as well as other important supporting studies. Two of our additional emerging blockbusters ALKS 3831 and ALKS 8700 for [indiscernible] pivotal program on the strength of positive clinical trials completed earlier this year and two exciting new drug candidates will enter the clinic. Those are just the most highly visible milestones. We will have other important advances across the pipeline and across the commercial portfolio. In the case of each of our products they are designed to make a significant impact in major chronic diseases where current treatment for short of addressing the needs of patients, healthcare providers and payers. I am going to start with ARISTADA, which is rapidly approaching at August 22 PDUFA date. Our team is gearing up for launch in September and final preparations are underway. We designed ARISTADA to be the product that has the key attribute that psychiatrist are looking for when they treat with long-acting injectable antipsychotics, clear efficacy, a wide range of doses and ease-of-use. We are well positioned to launch ARISTADA. Last month we completed hiring the field…

Thanks, Richard. We’ll now open up the call for questions. Operator?

Thank you, Rebecca. We will now begin the question-and-answer session. [Operating Instruction] And from JPMorgan, we have Cory Kasimov online. Please go ahead.

Hey, good morning guys. Thanks for taking the questions. It’s a nice quarter. Two questions for you, one on VIVITROL and one on 8700. So, first on VIV, I’m just trying to understand, there’s anything unique or one-time about the performance this quarter or if it’s really just a sign of your gaining traction? I’m asking this to try and put your updated guidance into perspective. As that seems to assume even though it’s higher, really no growth at all on the low end or minimal growth on the high end in the second half of the year. So, are you just being conservative there or is there some particular headwind that you might be anticipating later this year? And then I have a follow-up on 8700.

Sure, Corey. Good morning. Thanks. It’s Jim. No, there aren’t any specifics in the quarter. Inventory didn’t change a great deal and we are seeing momentum in the field at the local level as more physicians and with better reimbursement, lower hurdles to reimbursement and things like that. I think ultimately we’re just being conservative with VIVITROL. It’s obviously a very large growth rate, 72% over last year and so if we continue to see these trends going forward which we’re working hard to ensure, we’ll update you in the future as we see those trends continue. Two points in a line are one think, but we’ll wait until we see some more before we call a specific change going forward at that rate.

Okay. Sounds good. And then on 8700, just curious about your views of the MS market opportunity following the recent issues encountered by Biogen, just wondering if these developments alter your opinion at all on the ultimate potential for 8700?

Good morning, Corey. It’s Rich. Actually the underscore excitement and actually if you look at the core of the Biogen’s report on Tecfidera, it was approaching 900 million, there’s over a $300 billion drug and also represents the fact that it’s not a perfect drug and I think that Biogen is currently enjoying that market entirely to themselves. So, 8700 going into a pivotal program with the significant risk reduction having -- have done the work that we’ve done in advance of that I think is really exciting for us.

All right, great. Thanks guys. I’ll hop back in the queue.

Thanks, Corey. Operator, we’ll take the next question.

From Cowen & Co., we have Tyler Van Buren online. Please go ahead.

Hi, thanks for taking my question. Given that the 175 ARISTADA sales force is now higher, just want to get your thoughts on potentially leveraging that with another product in the reps’ bag? And if -- clearly have a lot going on in the clinic and if you kind of continue to focus on the clinical site of things, why would it may be not make sense to add a product to those reps’ bag? Thank you so much.

Hey, morning. I think it’s a good question, but I think it reflects the fact that we’re moving across a really important threshold now. We’ve been in the commercial market with VIVITROL for the last few years and building our few days as a strong sales force being able to commercialize a complicated product. As we launch aripiprazole lauroxil, ARISTADA, we really significantly augment that in terms of the size and the capabilities of that sales force. Now, for the purposes of the launch, the group is going to be very focused. Using the LAIs, the sales force is focusing on LAI is not a multiproduct in the bag sales force. This is a very, very dedicated sales force working on a complex product in a complex reimbursement environment. But the general condition that you point out is absolutely right. We are moving into a bigger commercial phase in this company’s history, and we will obsolete augment that product portfolio through internal development and, hopefully, over time through acquisitions and licensing as well.

Great. Thanks so much.

From Jefferies, we have Biren Amin online. Please go ahead.

Yeah. Thanks for taking my questions. Maybe, I’ll start with 6428. What is this taper kit consists of just from novel chemical entity perspective?

Hi, Biren. It’s actually quite – it’s quite straightforward. And what we’re thinking to do is codify things that are happening spontaneously in the community. And certainly there is academic literature on this as well. So essentially it’s a way of tapering down the opioid agonist and tapering up through small incremental doses of oral naltrexone to the point where the patient has clearly established ability beyond a long-acting antagonist.

Got it. And then what would the Phase III trial consists of? Is this mainly like a 12-week study, and what are timelines for completion of this Phase III?

I won’t give timelines now. It’s a fairly large study. We have 300 patients, and so we really want to do this quite broadly. The taper itself occurs over seven days, and the endpoint is really the idea of successful initiation on to VIVITROL. So it’s not a – it will be a long enrollment and a short in-life space. So we’ll guide to that, as we get into it. We’ll start it in Q3. But I think it’s important to understand why are we doing this now? Are we doing it now because we’re seeing a larger range of doctors are getting interested in the use? It’s not just those core people who understand how to do detoxification and transition to an antagonist. More and more doctors are realizing this may be a way of the future, and they want to understand the tools of transition from opioid agonism all the way to a full antagonist.

Got it. And then maybe just on aripiprazole lauroxil. Can you give us an update on every six week formulation?

You’re going to have to get used to not seeing aripiprazole lauroxil soon, Biren. We’ve gotten so used to the mouthful. But ARISTADA hopefully will be the name that comes out of the approval, and we like that name very much actually. And I think that we’re in the clinic with the six and the eight weeks durations. Based on the inherent properties of ARISTADA, we believe that we will get that type of interval. And we think that interval – both the six and the eight weeks – could be really important differentiators in a marketplace that’s driven by the need for flexibility for patients.

Great. Thank you.

Thanks, Biren. All right. We’ll take the next question.

Here from UBS, we have Marc Goodman online. Please go ahead.

Hi. This is Ami Fadia in for Marc Goodman. Maybe a follow-up on the last comment on ARISTADA. Could you elaborate around the clinical benefit and the need for the six- and eight-week duration? Secondly, on ARISTADA itself, what data points are you looking for over the next couple of months, as you launch the product, that might give you comfort on the longer-term potential for the product? And I will stop here.

Thanks, Ami.

Good morning, Ami. I think the whole idea of ARISTADA is one about flexibility and accommodating the needs of patients and physicians and nurses. That’s why a range of doses matter. It’s why the product presentation itself in the easy-to-use syringe matters and it’s why the flexibility of durations matter, because every patient is different. Four-week interval, six-week interval, eight-week interval, it all allows a customization of the treatment approach for the particular patient family lifestyle circumstances. That’s something we’ve learned through the work we’ve done with originally CONSTA which is fairly rigid in this presentation. Two weeks, reconstitution, that was pretty much what you got, all the way through now to what’s happening in the real world with SUSTENNA where we see the range of does and flexing – the flexibility is so attractive. So we’ve integrate that into our product design for aripiprazole lauroxil and ARISTADA. I think that’s six-week dosing interval is just another reason to use ARISTADA versus a competitive product. We add 8 weeks to that, another reason, and it’s just part of this suite of flexibility. The key data points we’re going to be looking at in the launch, actually, to play your question back, we actually have tremendous confidence in long-term future of this market for the reasons that you can see playing out in the market right now. There are multiple entrants for the first time. The orals have gone away. The growth rates in the long-acting injectable market are significant. There’s a compelling public health as well as public economic reason for more use of LAI. So long-term we’re really confident in this market and the role that ARISTADA is going to play in it. In the short term it’s about access I believe. It’s about making sure we get on formulary, we educate about the existence of the product and we deploy our field force in a way to ramp the product so it becomes everyday medicine for many sites. And so, we’ve guided to a launch that basically mimics what we saw with the Otsuka Abilify Maintena launch. Because our thesis was that’s a good drug sold by a strong company. So I think it represents kind of a natural uptake rate for LAIs in this primarily government paid market, but we expect to take the growth and continue to really grow.

Thank you. And if I may ask another question on VIVITROL, when do you expect the study for the [ph] 6428 to be completed and I’m curious do you think that having that data more codified could help with acceleration in sales for VIVITROL?

Well, the whole purpose of it is to build a broader foundation of conditions to increase the growth of VIVITROL over time. But it won’t happen overnight. It will take a real guide, the completion of the study as we get into it, and – but as I said before, it’s a fairly large study in a lot of different sites and there’s an educational component to the whole thing as well. So I’m not so much obsessed on getting it done super-fast. I’m more excited that we’re starting it and that the community is beginning to rally around the idea of how do we transition people from agonist to antagonist, because remember that was heretical years ago and is quite exciting that people are beginning to feel the wind shift.

Thank you.

Thanks so much. Next question?

From Goldman Sachs we have Terence Flynn online. Please go ahead.

Hi. Thanks for taking the question. May be just two from me. First on 5461, thanks for the update on the program, just wondering if you can remind us if there’s any differences across those three trials? And then insight into any of the baseline characteristics and maybe how that compares to your earlier Phase II trial? And then just on 9070, the sales force footprint. Can you give us a sense of how many prescribers you’re going to plan to target there? Thank you.

Good morning, Terence. Yeah. On 5461, the [ph] free study I would describe the shades of the same color. They all employee kind of, the sequential parallel comparison design we talked about before, which we saw in Phase II to minimize placebo response, so there’ll conducted in these two phases with randomization of the placebo non responders, which we think is a really important design feature. The baseline characteristics are very, very similar and identical to the patients that we enrolled in Phase II, which are patients were non responsive to one or more courses – they will stay on that background therapy. And so we will be using 5461 in the adjunctive setting formally. So it’s very much patient population, we saw in Phase II and the patient population that we saw in forward one the data we had shown earlier this year. So its patient population and we are quite comfortable testing 5461 in. With respect to the 9070, aripiprazole lauroxil ARISTADA, there will be 175 people in the field force and about 20 people that are doing more of the national account stuff. We will not probably disclose at this moment our common strategy on that. I think it’s fair to say, in contrast to something like VIVITROL where we are creating this market – this is a very well-established group of doctors there’s only about 1,700 doctors who can write half of the prescriptions right now of LAIs and only about almost 6,000 doctors, who write about 80% so it’s a very concentrated opportunity right now at launch but the great opportunity, the great promises, of course, if there is another 20,000 or 30,000 prescribers who have written an LAIs before but don’t write any great level of intensity. So there’s a tremendous amount of education and market expansion ad potential with multiple entrance now calling on these docs.

Great. Thank you.

You’re welcome.

Thanks. Operator, I think we have time for one question, if anyone is in the queue.

Actually there is nobody in the queue right now. We will turn it back to you for closing remarks.

All right. Thanks everyone for dialing in today. Should you have any additional questions please don’t hesitate to call us here at the company, I know a lot of it reporting today but happy summer. Take care.