Rebecca Peterson – Senior Vice President-Corporate Communications Richard Pops – Chief Executive Officer James Frates – Chief Financial Officer.

Cory Kasimov – JPMorgan Tyler Van Buren – Cowen & Co. Biren Amin – Jefferies Ami Fadia – UBS Terence Flynn – Goldman Sachs.

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 had a strong quarter with net sales of $37.2 million compared to $21.6 million for the same period last year, demonstrating growth of 72%. Sequentially, the product grew 19% from last quarter. We’re encouraged by the momentum we’ve seen, as more patients, provider’s governments and payers better understand the benefits of VIVITROL.

In terms of expenses, our total operating expenses for the second quarter were $203.9 million compared to $176.2 million for the same period last year.

This planned increase in operating expenses was driven primarily by investments in ARISTADA launch preparation, which included the hiring of the 175-person field sales force and by investments in our rapidly advancing late-stage clinical pipeline.

We expect SG&A expense to continue to increase into the third quarter in conjunction with the activities surrounding the expected launch of ARISTADA in September and to decrease slightly post-launch in the fourth quarter.

We expect that R&D expenses will continue to ramp throughout the remainder of the year, as additional clinical trials get underway – particularly, the pivotal development programs for ALKS 3831 and ALKS 8700, which are expected to commence in the fourth quarter.

We could in the second quarter with approximately $832 million in cash and total investment, which included net proceeds of approximately $50 million related to the strategic divestiture of the Gainesville facility during the second quarter.

With respect to our financial expectations for 2015, we are improving our guidance today to reflect the accelerating growth trend for VIVITROL and are increasing our expectations for VIVITROL net sales by $10 million to a range of $135 million to $145 million, and our expectations for total revenues to a range of $610 million to $640 million.

This increase drives an $8-million improvement in our expectations for non-GAAP net loss, which we now expect to be in the range of $47 million to $67 million from a previous range of $55 million to $75 million. Our complete financial expectations for 2015 are outlined in our press release issued earlier this morning.

We are pleased with our solid performance this year, as our commercial business led by INVEGA SUSTENNA and VIVITROL is ahead of plan, our team to launch ARISTADA into a long-acting atypical market that continues to grow is in place, and our development pipeline continues to progress.

We’re focused on executing on our business plans and building significant value. With that, I’ll turn the call over to Richard..

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 sales force of 175 professionals.

We’re excited by the caliber of talent that we have recruited. We had over 4000 applicants and selected its improved team with average experience of 16 years, most all having deep CNS experience and many having experience long-acting injectable. This group is in the final phases of training and preparation for launch.

Separate from assembling our new commercial team, we presented data to the medical and scientific community on aripiprazole lauroxil at the recent ASCP and APA meetings.

And one of the very encouraging overarching themes of these meetings was the increasing recognition that use of an LAI, early in the treatment of schizophrenia can lead to better outcome.

While we’ve been observing this benefit for many years, it’s very exciting to have it discussed at major medical meetings, and we believe this is an important step toward evolving the treatment paradigm in schizophrenia. ARISTADA is just the first of the next wave of our innovative CNS medicines approaching the market.

The next of our emerging blockbusters I want to touch on is ALKS 5461 for patients with major depressive disorder. 5461 is based on the new mechanism of action and is designed specifically for those patients who are not getting adequate relief from standard therapy. There are millions of patients in this category each year in the U.S.

Reflecting the reality that depression causes one of the greatest burdens of suffering and cause of any disease. Based on the compelling phase II data and with Fast Track designation in hand, last year we initiated the comprehensive FORWARD pivotal program.

The three core efficacy studies in the FORWARD program are enrolling well and we can report today further refinement an acceleration in our anticipated completion schedule. We expect the first study FORWARD-4 to be completed in early Q1 2016 with a potential for it move into late Q4 2015.

The next will be FORWARD-3 which we not anticipate will likely complete in Q1 2015 which is an improvement from our original Q2 estimate. FORWARD-5 is the third. It’s into early appointing its enrollment so it will not change our Q3 2016 estimate at this time.

We have an invested tremendous amount of time in the energy in conducting the FORWARD program with the highest level of care always you have heard us say putting quality ahead of time. But we’re excited to see that we are achieving both as the concluding stage of the program comes into view.

In addition to the core efficacy studies we’re running a comprehensive set of supporting studies to support U.S. registration and wide utilization of this medicine.

We will start to see data from these studies soon including the human abuse liability study later this year which will provide the clinical community with important confirmation of ALKS 5461 non-addictive property.

This is an important new medicine in the field of depression with the potential to affect the lives of many people and we’re entering an incredibly different rich phase of its development.

Moving to ALKS 3831 which is our novel oral broad spectrum antipsychotic drug candidate designed to deliver the efficacy of olanzapine without the associated weight gain. This program is also making excellent progress.

We presented the full six months data from the Phase II study at the recent ASCP meeting which showcased the ability of ALKS 3831 to olanzapine associated weight gain. These data have generated real interest in the clinical community which is been seeking new agents with powerful efficacy and favorable side effect profile.

We’re in the final stages of designing the pivotal program following a meeting with FDA and provide an update on the design of that in September. We’re on track with our plans to initiate the pivotal program in the fourth quarter of 2015.

Turning to the next compound in the pipeline ALKS 8700 is our monomethyl fumarate or MMF molecule for multiple sclerosis that’s designed to provide the efficacy of the active moiety of TECFIDERA and offer favorable tolerability.

As you know, we completed a large Phase I study earlier this year which show that ALKS 8700 provided MMF exposures equivalent to TECFIDERA with favorable gastrointestinal tolerability. And we meet with FDA next month to design the pivotal program and we’re on track to start it in the fourth quarter of this year.

In addition to our late stage pipeline, we have two pipeline candidates approaching the clinic, ALKS 7119 and RDB 1450. 7119 is our multivalent NCE for the treatment of Alzheimer’s agitation and other psychiatric indications. Based on our interactions with FDA we are conducting one additional pre-clinical study ahead of entering the clinic.

So we know expect to initiate the first clinical study of ALKS 7119 in early Q1 2016. For RDB 1450 our immuno-oncology candidate we filed the IND and we’re excited to get our first biologic into the clinic in the fall. Let me finish with VIVITROL. VIVITROL has always been important medicine and it’s exciting to see a clear uptick in momentum.

Our efforts are paying off. And we have additional plans in the works for growing the use of VIVITROL in commercial and government settings. One new initiative that we will disclose today is the initiation of a new Phase III program we call ALKS 6428.

6428 is a seven day taper kit designed to help physician transition patients from opioid agonist to antagonist therapy in an outpatient setting and then successfully initiate treatment with VIVITROL. We will begin the Phase III study of 6428 in the third quarter of 2015.

With increasing use of VIVITROL there is a growing need for tools to facilitate its use and the ALKS 6428 tapered kit could be an important new element in the treatment paradigm for opioid dependent. It’s exciting to see what’s happening with VIVITROL in the community and look forward to the growth ahead for this important product.

So as I wrap up let me say that the level of activity, growth and excitement at Alkermes right now is an unprecedented, as we execute our plans to create value in our late stage pipeline and grow the business. We look forward to updating you as we approach our next big milestone which is the PDUFA date for ARISTADA in just a few weeks.

And with that, I’ll turn it back over to Rebecca..

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..

Ladies and gentlemen, thank you for joining. This concludes today’s conference, you may now disconnect..