Good morning and welcome to the Alkermes Plc Fourth Quarter and Year End 2015 Financial Results Conference. My name is Brandon, and I'll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. And I will now turn it over to Eva Stroynowski, Director of Investor Relations at Alkermes. You may go ahead.

Welcome to the Alkermes Plc conference call to discuss our financial results for the quarter and year ended December 31, 2015. With me today are Richard Pops, our Chief Executive Officer; and Jim Frates, our Chief Financial Officer. Before we begin, I encourage everyone to go to the Investor 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 the non-GAAP financial results better represent the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from those forward-looking statements. Please see our press release issued today and our annual report on Form 10-K for the year ended December 31, 2015 for 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 this call as a result of new information or future results or developments. Today, Richard Pops will provide introductory remarks. Jim Frates will then discuss our financial results; and Richard will close with a brief update on the company. After remarks, we will open the call for Q&A. Now, I'll turn the call over to Richard. Richard F. Pops - Chairman & Chief Executive Officer: That's great. Thank you, Eva. Good morning everyone. So, since our release last month of the top-line results of the first two FORWARD efficacy studies for ALKS 5461 for major depressive disorder, we've talked to many of you, in some cases, multiple times, but I still wanted to start today's call by acknowledging the significant decline in our stock price and in the biotech market in general, and reaffirming the strength…

Thanks, Richard. We'll now take your questions. Operator?

Thank you. We will now begin the question-and-answer session. And from Barclays we have Jon Eckard on the line. Please go ahead.

Good morning. Thanks for taking the questions. Richard F. Pops - Chairman & Chief Executive Officer: Good morning, Jon.

Real quick on VIVITROL guidance for 2016. Based on the 30% Medicaid mix that Jim referenced, what does the new guidance reflect with regards to unit growth versus dollar growth because of the change in the gross and net? And I have a question on ARISTADA after. James M. Frates - Senior Vice President & Chief Financial Officer: Yeah, Jon, good morning. It's Jim. I won't go into specifics on the unit growth, obviously because we're giving a range. But it actually contemplates continued rapid growth in the share of Medicaid business that we're getting. So I think that's why you're seeing – we feel like VIVITROL is doing very well. Its growth has accelerated from 2014 into 2015 in terms of units and we still see that unit growth accelerating at those rates going forward, a little bit less growth maybe on net sales, because again, the Medicaid proportion is still growing fast. Does that make sense?

It does, thank you. James M. Frates - Senior Vice President & Chief Financial Officer: Yeah.

And then quickly to you again, Jim, your comments about the ABILIFY MAINTENA quarters two through five being like a reasonable guide or proxy to – for an ARISTADA launch. James M. Frates - Senior Vice President & Chief Financial Officer: Yeah.

I'm guessing that number for what you're saying for ARISTADA, would exclude the 11,000 samples that you referenced? And, based on your competitive intelligence, what's the level of sampling that was done with ABILIFY MAINTENA so that we could do a more clear apples-to-apples comparison for the demand of the two products? James M. Frates - Senior Vice President & Chief Financial Officer: Yeah. That's really an important point, Jon. I'm glad you asked about it. So, there wasn't a sample program that our competitor launched with back in 2013. And first, let me take a further step back. They launched in March. If you remember, we obviously launched in October. As we are moving into our quarters two through five, as you line up the launch curves, it makes sense to look at their quarters two through five, right? That's trying to line up apples-to-apples. The thing that's different is we have 11,000 samples in the field and they had zero. So all their demand came through net sales, which is obviously going to be part of that roughly $60 million for the first year. And we haven't yet seen our samples start to pull through. So, that's one of the things – it's one of the reasons why we may be trailing now, but it's also one of the things that our market research showed us that was really, really important, is that people want to be able to use samples and, before the reimbursement gets worked out, they want to be able to use it in the right patients and their practice and that's where they can use samples. So, it's not exactly apples-to-apples, but, again, we're early in the launch phase. These are just guides, and we think that the important point is that the full year of reimbursement cycle that we need to get through these government payers before people start to make conclusions about how big the long-term potential in this product is.

If I could squeeze in one quick. I noticed that the scripts for ARISTADA are mainly – are mostly driven towards a high dose, is there anything to look into for – from that mix of the different doses that being used? And that would be my end. Thank you very much. Richard F. Pops - Chairman & Chief Executive Officer: Hey Jon, it's Rich. I'll just take that one. Yeah, it's interesting to see that some of the first trials that we're getting from physicians using ARISTADA has been to take patients that have not been getting adequate clinical coverage from other medicines and trying them on a higher dose. And early returns are they're getting a good experience with that. We think that's great. I think at equilibrium, we expect a more even distribution across the doses, but I think the fact that we're starting at 882 mg with so many first trials, represents a need in the marketplace.

Thank you very much. Richard F. Pops - Chairman & Chief Executive Officer: Thank you.

From Leerink, we have Paul Matteis on the line. Please, go ahead.

Great. Thanks very much. Can you hear me okay? Richard F. Pops - Chairman & Chief Executive Officer: Sure, Paul.

Great. Thank you. I have a few. One is on 5461. I'm wondering – so you talked about FORWARD-4 being supported at a study of the 2 mg/2 mg dose, to the degree that you're able, could you expound upon the actual magnitude of drug placebo difference you saw in that study, in light of other drugs like SEROQUEL and ABILIFY that saw two point to three point differences on the (25:36) between them and placebo? Richard F. Pops - Chairman & Chief Executive Officer: I won't, other than to say we think it's a very healthy response and you'll see the data when we present the data at ASCP. And so why don't we talk about it as you see it. Because what I really want people to understand is that these analyses of FORWARD-4 are only really relevant in the context of a submission that would come with a positive FORWARD-5 or a subsequent study. So, in that setting, I think that you'll be able to take a look at the data and make your own conclusions. But I think there's very little ambiguity from our perspective and our KOL perspective the 2 mg/2 mg dose is separating really nicely in FORWARD-4.

Okay. Thanks. That's helpful. And then, you, Rich, and I'm not sure if you specified this in your prepared remarks, but for FORWARD-5 you talked about making a few changes. One of them was increasing the end, and another one was actually tweaking the stats plan. So for increasing the end, I know one concern was the potential for an associated increase in variability. So maybe you could address that. And secondarily, with the stats change you've made, can you just confirm that the new statistical analysis plan for this study would be something that you think the FDA would okay and has approved other drugs in this area? Richard F. Pops - Chairman & Chief Executive Officer: Well, I think it's a fairly obvious statement that we wouldn't submit a stat plan if we didn't think the FDA would approve them also. In fact, the final stat plan has not even been submitted for FORWARD-5, so it's flexible up until the time that we underlined. But, what was the first part of the question, I forgot that?

Just the end, and does that include (27:03)? Richard F. Pops - Chairman & Chief Executive Officer: That's right. Yeah, the decision we made to increase the end is really based on kind of looking the way the study is proceeding right now. So, we would not add new sites or new investigators in order to drive them. So this is kind of a naturalistic, logical landing place if we let the well-enrolling sites that are doing a good job continue on their enrollment path for a reasonable period of time. So that's why I'd say it's a gentle increase in the sample size. The studies architecture is still its basic architecture and so, I think that the primary change will come from this modest increase in sample size and a more refined statistical plan that incorporates the learnings from the additional 800 patients' worth of data.

Okay. Thanks for taking my question. Richard F. Pops - Chairman & Chief Executive Officer: You're very welcome.

From JP Morgan we have Cory Kasimov on line. Please go ahead.

Hey, good morning guys. Thanks for taking the questions. I just – I guess, Rich, want to first follow up on FORWARD-5 and just try to get a better sense of, what ultimately drives the decision to modify the statistical plan and analysis for that study? Is it just the continued learnings that you're getting from 3 and 4, is it – are you waiting for feedback from kind of your consultants on that? Or it's – because it sounds like this kind of has been ongoing – a decision hasn't been finalized yet. I'm wondering kind of what the additional variables or inputs are that may make that decision for you. Richard F. Pops - Chairman & Chief Executive Officer: Yeah, I think it's not particularly esoteric. It's just the fact that when we first designed this statistical analysis for FORWARD-3 and 4 it was based on a 142-patient randomized study in Stage 2 – in Phase 2, which was quite successful. But that's a certain-sized data set and we provide the way of modeling the two curves. Now, with another 800 patients' worth of data, we just have a more nuanced way of looking at the analytical plan over that distribution. So, I think it's really just a way you do the math. And we'll continue to refine it statistically and figure out the best way to do it. And what I'm also struck by is the fact within FORWARD-4, recall that we tested three – there were three treatment arms, there was placebo, there was the 2 mg/2 mg dose, as well as the 0.5 mg/0.5 mg dose which was ineffective in that study. So, within the setting of a single study, we can actually can see what an efficacious dose looks like at 2 mg/2 mg and ineffective dose of 0.5 mg/0.5 mg compared to placebo. So, we're just getting a little bit able more resolution statistically in the best way to model this and to demonstrate the difference in a large study.

Okay, all right. Great. And then quickly on ARISTADA, really just wondered if you could characterize the physician feedback your sales force has gotten on the product. You guys have been very clear for some time on the marketing message that you'd have and the differentiating features, how has that been resonating with doctors and considering that you're going into – you're at least initially targeting prescribers of LAIs, is there much education or do they kind of get it right away? Richard F. Pops - Chairman & Chief Executive Officer: I think it's really consistent with what we would have hoped for given the kind of explicit differences and attributes that ARISTADA has versus the competition. And the point I made about the 882 mg, I think underscores – I think it's probably the most interesting new learning since we've been in the real world of the marketplace, which is how many physicians are interested in exploring that higher dose. But the fact that we have this range of intervals, the existence of the six-week dosing interval is instructive, because it's not just the physicians say, I can go ahead and dose it every six weeks. It reflects the fact that there's a little bit more dosing forgiveness on the back end, because the PK profile is different than other products. So the fact that 882 mg can be dosed every six weeks just underscores the fact that we've got a different wave form of presentation in ARISTADA. So I think the flexibility of three doses, and that being underscored by the range of intervals. And then, of course, while not in the marketplace at all, but I think today's data on the two-month at a higher mass just underscores the fact that ARISTADA is going to be a really, really robust product family, more analogous to what SUSTENNA has brought to the market on the risperidone side. And that's a $1 billion drug in the U.S. and growing rapidly. And I think that we've mimicked those features and that flexibility in the ARISTADA side of – in the aripiprazole side of the market, and that's why we're so confident against the backdrop of a market that's growing so rapidly, given the features that we have in the product that are kind of self-evident. You don't really need to explain them at great length and to draw distinction between one dose and multiple doses, and multiple durations. I think we're going to do just fine.

Okay, great. Thanks for taking the questions. Richard F. Pops - Chairman & Chief Executive Officer: You're welcome.

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

Yeah. Thanks guys for taking my question. On the ARISTADA two-month data, are you planning at all to – evaluating a switch study from MAINTENA to this two-month dosing schedule as a way of potentially transitioning and trying to convert patients away from MAINTENA? Richard F. Pops - Chairman & Chief Executive Officer: I think the switches from MAINTENA will come naturally, based on limitations that physicians are seeing with MAINTENA to the extent those exist. Now, I think that the two-month is really, as you've heard us say before, Biren, you think about it this way. If you're going to initiate a patient on a LAI, initiating one on one like ARISTADA, where if your patient is compliant and enjoying being on that medicine, you can cut their number of injections in half each year. That's really the offering rather than we're going to try to shift the market toward two-month. In the same way that we see in INVEGA, SUSTENNA's three-month we think the two-month will do that for us as well. So, I guess, the answer to your question, which I didn't answer directly, which is, no, I don't see immediately, we'll leave it to the team. I don't think immediately the need to run the study, to switch people from MAINTENA.

Thank you. Richard F. Pops - Chairman & Chief Executive Officer: Thank you.

Operator, it looks like we have time for one more question.

Thank you. From UBS we have Marc Goodman. Please go ahead.

Hi, good morning. This is Ami Fadia on behalf of Marc. Couple of questions, firstly, on ARISTADA, in your guidance – well, you didn't give specific guidance. But, as you thought about your 2016 guidance, how much more sampling are you anticipating in 2016? And if you could just give us the amount of inventory stocking in the fourth quarter, that would be helpful. And then I have another one. Richard F. Pops - Chairman & Chief Executive Officer: Ami, why can't you ask a question on behalf of Ami? No, we're not going to disclose our sampling plan, that's competitive in 2016. Jim, did you want to answer that? James M. Frates - Senior Vice President & Chief Financial Officer: Yeah. Well, and I would say on inventory – again, I mentioned, I think, there has been some stocking. Obviously, that's being worked through. We think the second quarter of launch, this 2016's first quarter will be down a little bit from last year. But, again, we won't give specifics. I think IMS has started to track the data quite nicely. And, again, these are very small numbers. So through the year, we're quite comfortable. We don't think there are high inventory levels right now.

Okay. So, now, all the sort of prescriptions are being pulled through? James M. Frates - Senior Vice President & Chief Financial Officer: Yeah, I think that's a fair statement. And again, in a normal base, because it's going to be growing much more than we believed than the $4.5 million in sales we saw last quarter.

Got it. And then just another question on 5461, have you had conversations with the FDA around kind of some of the outcomes of the FORWARD studies and how the FDA might look at a positive FORWARD-5 study along with Phase 2, would that be enough for them to really approve a drug? Richard F. Pops - Chairman & Chief Executive Officer: Yeah, we will. We haven't yet. One of the reasons we want to present at ASCP is that the FDA typically attends ASCP. It's a fairly small community of folks that are involved in these studies around major depressive disorder. But what we would do with a positive FORWARD-5, well we have a pre-NDA meeting with FDA, and discuss the filing package. But we – yes, we do think it would be sufficient and based on historical precedent, we think that there's a pathway absolutely for 5 and for successful registration based on that clinical trial program.

Got it. And then just thirdly on VIVITROL, the drug has been continuing to grow nicely. Have you changed your thinking around the sales resources behind that product? Do you need to put in more? Or do you feel like it's at a steady-state and you don't need to and you could probably repurpose some of them towards ARISTADA or some other product? Richard F. Pops - Chairman & Chief Executive Officer: Well, I think that there's a couple different alternatives in there. One thing we're not going to do is repurpose people. What's happening with VIVITROL, VIVITROL has an enormous amount of excitement within our commercial team and I think increasingly in the country. And it's still promoted in the U.S. with a very small team of people in the field, on the order of 70 people. What we've been augmenting over the past couple years has not the field team as much as it's been on the policy at the state and the federal level, and that's going to continue. I think there's no question that if VIVITROL continues to grow at this rate, we will expand the field base force, as what happens typically is a territory will get particularly lively and we'll break a particular territory into two, as opposed to opening new parts of the country that were not being covered. So I think it will happen organically, and all of that's embodied in the guidance that Jim has given you.

All right. Thank you everyone. That's all the time we have today. If you have any questions, please don't hesitate to reach out at any time.