Good morning, and welcome to the Alkermes plc Fourth Quarter and Year-end 2017 Financial Results. My name is Brendon and I’ll be your operator for this call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session [Operator Instructions] Please note this conference is being recorded. And I will now turn it over to Sandra Coombs, Co-Head of Investor Relations. Sandra, you may begin.

Thank you. Welcome to the Alkermes plc conference call to discuss our financial results for the quarter and year ended December 31, 2017. With me today are Richard Pops, our CEO; and Jim Frates, our CFO. Before we begin, I encourage everyone to go the Investors 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 in conjunction with the GAAP results are useful in understanding the ongoing economics of our business. Our discussions during this conference call will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our Slide 2 of the accompanying presentation, and our most recent annual and quarterly reports 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 revise the information provided on this call or in the accompanying presentation as a result of new information or future results or developments. Today, Jim Frates will discuss our financial results and 2018 guidance. And Richard Pops will provide an update on the company. After our remarks, we will open the call for Q&A. Now, I’ll turn the call over to Jim.

Thanks, Sandy. Good morning, everyone. 2017 was an important year for our business and we saw continued growth in VIVITROL and ARISTADA and executed on our objectives across the company. Our financial results for the fourth quarter and year ended December 31, 2017 were slightly ahead of expectations, and were characterized by strong revenue growth from our commercial portfolio notably our proprietary product s, upside from our collaboration with Biogen as well as focused investments in our advancing late-stage pipeline and CNS medicines. I will start with our key financial highlights. For the quarter, our total revenues were $275.4 million and we recorded a non-GAAP net income of approximately $50.3 million. This resulted in record total revenues for 2017 of $903.4 million and a non-GAAP net income of $27.8 million compared to a non-GAAP net loss of $10.3 million in 2016. Last year we grew revenues 21%, while expenses increased only 10% and we invested in our portfolio and our commercial operations. With approximately $591 million in cash and total investments at year end, and a portfolio of differentiated approved products in Phase 3 candidates in major markets. We are well-positioned to execute on our transformative growth as we await key milestones on each of our pipeline candidates in 2018. Let me now review some of the key drivers of our financial performance during the quarter, starting with VIVITROL. In the fourth quarter, VIVITROL net sales grew 22% to $75.6 million compared to $62.1 million for the same period last year. During the quarter, we saw unit growth of 28% compared to the fourth quarter of 2016, reflecting continued growth in both commercial and Medicaid units. On a sequential quarter basis, net sales grew 9%. Our fourth quarter growth did include inventory build that is typical at year-end of approximately…

That’s great. Thank you, Jim. Good morning, everyone. So some years are head down, focused on execution. That was the case in 2017 and we made important advances across our growing business. Other years are about news and that's the case in 2018. We're now on the cusp of significant value creating catalyst across our entire portfolio. For ARISTADA, a PDUFA date in June with expected FDA approval for our new initiation product. For ALKS 5461, potential FDA action on our recently submitted NDA for the adjunctive treatment of major depression. For ALKS 3831, pivotal Phase 3 data, which is positive will lead to an NDA submission for the schizophrenia medicine in 2019. For BIIB098, formerly ALKS 8700, completion of the clinical program and submission of the NDA. And for ALKS 4230, our immuno-oncology candidate eagerly anticipated early clinical data. 2018 is the year of transformative news flow. So before I get each of these important catalysts, I want to spend a moment on the organization we built at Alkermes, and how our actions are informed by our core progress of great science, deep compassion and real impact. Alkermes unique profile is based on the foundation of four key elements. The first is our distinctive focus in psychiatry. We develop innovative, patient centered medicines, designed to address large chronic diseases that affect millions of patients and represent major public health priorities. Second, we have a strong and growing commercial business and have built unique commercial capabilities in order to navigate these challenging disease areas. Third is the pipeline. It's robust, late stage and full of news flow in 2018. We've developed expertise in the biology and chemistry of the brands endogenous opioid system, which has opened new opportunities in depression, schizophrenia and other CNS diseases. And fourth, is the organization…

Thanks, Richard. Brendon, we will now open the call for Q&A, please.

Thank you. We'll now begin the question-and-answer session. [Operator Instructions] Thank you. And from Jefferies we have Biren Amin. Please go ahead.

Yes. Thanks for taking my question. Maybe I'll start with the VIVITROL guidance. On the low-end it's just a 50% year-over-year growth rate. Richard, I just wanted to get an understanding of what's driving guidance and what impact have you seen from X:BOT if any in the data that was presented last year?

Good morning, Biren. I will let Jim answer that one. Then I will give some color as well.

Yes, thanks, Biren. VIVITROL is a different product to guide for as you know. The sales are very fragmented driven by various state-by-state growth rates that we see. So we're just taking a path that we have in the past, which is taking the last quarter's growth and really extrapolating that forward. But I’d point you to the whole breadth of the guidance, which is closer to 20% at its midpoint, we’re going to continue to work with the new data that’s come out, new funding that we're seeing from Washington and the new policy approaches that we're taking to make sure we drive growth across the state. So, one more layer down, we're still seeing growth slowdown a little bit in a couple of our key states like Ohio and Massachusetts. But at the same time in the quarter we saw accelerating growth from key states like Illinois, Indiana and Pennsylvania. So this is looking across all the 50 states and trying to get our best guess about both short and near-term -- excuse me, short and long-term, but long-term we remain very optimistic about VIVITROL.

And Biren, the only thing I will add is that if this were any other therapeutic category, data like X:BOT, which was the large randomized government sponsored study which change practice by physicians almost immediately in the community. But addiction being addiction, how tribal it is, it's going to take time to disseminate that information and to change practice, that's why in my comments I made the point that money enough -- money itself is not enough coming out of the government. We also have to address this fractured and fragmented treatment system and begin to change practice to drive better outcomes. People measuring outcomes, they’re going to use more VIVITROL.

Got it. And then maybe just a pipeline question on 3831 with Enlighten-2 data coming up later this year. What should we expect in terms of difference in weight gain versus olanzapine?

Well, if you remember what we did in Phase 2, which is a large 300 patient randomized Phase 2 study, we showed a couple of important things. Number one was statistically significant separation in weight gain on 3831 versus olanzapine, a. B, we also showed basically a flat weight gain curve for 3831 after the first 21 days or so. So what we’re hoping is in a larger study of 540 patients, we will see very similar results.'

Great. Thank you.

You’re welcome.

From JPMorgan we have Cory Kasimov. Please go ahead.

Hey, good morning, guys. Thanks for taking my questions. I guess, first of all, congratulations to Shane on his retirement as well as the appointment to the Board. So I’ve two questions for you, one on 5461 and then on 4230. So on 5461 first, can you remind us of how many sales reps you have today and with the 200 you're bringing in for this program, I guess, first of all, I take this as a sign of confidence in your expectations for approval, but while you wait on that will these reps be able to reinforce your sales infrastructure for ARISTADA, maybe even to a lesser extent VIVITROL as well?

Sure. Good morning, Cory. Right now we have about 170 -- 185 people promoting ARISTADA and another 80 or 85 doing VIVITROL as well. So we have that sum total across the states right now. So adding another 200 on to that is actually quite straightforward process. Our expectation is to hire that group as we move through the FDA approval process with 5461. And so, yes, these folks will be able to start off on ARISTADA and maybe even some VIVITROL before the final approval and launch of 5461. Note that in this category, as I’m sure you’re aware, FDA approval is obviously important, but then there will be another 90 days probably for DEA scheduling coming out of the approval. So during that time, obviously we will know that the drug is approving, going to be launched. We will have the field force out there helping on 5461 and getting into their territories and that will help us be ready for the day one launch of 5461.

Okay, all right. That’s helpful. And then with regard to the potential new sub-Q formulation for ALKS 4230, I guess, what type of dosing schedule would you expect to use for that? Have there been any differences in how this version has performed preclinically? And then, also can you remind us of the dosing schedule you're currently using for the IV and your dose escalation studies?

Yes. So our first in man studies where we’re really just trying to capture the biology that we saw both in vitro and preclinically in vivo. We are using intravenous route which is a five-day IV infusion each cycle. And it's part of the reason why the first studies have taken a long time because we have to enroll people from inpatient procedure starting a very low dose and ramping slowly from there. So that’s well underway. The preclinical data show that the subcutaneous route of the same formulation actually provides very nice PK profile. We are not disclosing right now what the regimen will be for this sub-Q, but we will as we move into the clinic with it.

Okay. Thanks for taking the questions.

You’re welcome.

From Credit Suisse we’ve Vamil Divan. Please go ahead.

Hi, great. Good morning, guys. Thanks for taking my questions. So just one in VIVITROL, you’ve previously talked about ALKS 6428 as an agent to help patients transition onto VIVITROL. It seems like that’s still a significant limitation to that, to help people getting on that product. Can you just give us the latest update on that product or other steps you might be taking to help people successfully get on to VIVITROL? And then I have one unrelated follow-up.

Sure. Good morning, Vamil. Yes, this -- one of the key findings from X:BOT and what we’re learning in the community is that this transition from patients on buprenorphine or even on opioids of any form to detoxification and induction with VIVITROL is quite straightforward for the people who do it. But for the people who don’t use VIVITROL, it can be quite intimidating. So there's been -- it's great interest from our company also from NIDA and other academic centers to start establishing these transition protocols, these induction protocols. 6428 was part of that process, saying that if we could put together a dosing kit of fractional doses of oral naltrexone that are send over a dosing card that would be coupled with decreasing doses of buprenorphine in the taper, that will be a nice kit. And so, what 6428 clinical work is telling us is that 6428 product itself may not even be necessary. What we’re showing is that through progressively reduced doses of buprenorphine coupled with comfort medication, the patients are very able at a high rate to transition from either being on buprenorphine or on short acting opioid agonists. So we expect this year to see more data. We’ve just completed our second clinical trial, which is a buprenorphine transition. We will present data on that this year and I think this can be a really important foundational element of the expanded use of VIVITROL over time.

Okay. Thanks. And then just one on 5461. What I assume you guys will announce publicly if and when that filing has been accepted, can you just confirm that? And then, just given the -- it sounds like a very large involved package, does that limit in any way to likelihood of receiving prior to your view simply based on the amount of data? I wasn’t sure how the FDA considers just the volume as opposed to these clinical impact that the drug may be having when they think about priority review status?

Well, I think that’s a great question actually because FDA's primary mandate is make sure they meet their obligations under PDUFA 6, the one that we are right now. So I suppose we're more relaxed about whether it's a standard review or a priority review as long as we have a first cycle approval, that's the -- that would be our goal. But I will confirm indeed will typical acceptance of that NDA will be within 60 to 74 days of that submission. So with the submission, at the end of January puts us in -- based on the calendar early April. And we will let you know when they get accepted for sure.

Okay. All right. Thank you.

From Evercore ISI we have Umer Raffat. Please go ahead.

Hi. Thanks so much for taking my question. Richard, there's so much interest in IL-2 space, but I get a sense this is not a program you've emphasized in the past, and I'm curious what are the key things you need to see to be more excited about it? And I was going to think about things like the pace at which this programs proceeded, so Nektar [ph], I think hit the Phase 1 about six months ahead of you guys, but they have a fair amount of more data. Maybe just speak to that. Perhaps, what are you guys seeing on T factor increase and Treg reduction versus Nektar, what dose do you think gets you to those levels as well as how important is the sub-Q program? Thank you.

Oh, good questions and I thought you wrote a nice piece on that stuff, Umer. I think it's fair to say that we haven't emphasized so much in our prepared remarks, in our public comments, because we’ve such a deep late stage pipeline, we’re really make -- trying to make sure our shareholders and investors understand 5461, 3831, 8700 before we get to a Phase 1 program. The biology of 4230 and the construction of the molecule, we're incredibly excited about. This was a new clinical area for us and because this was going to be a very active agent from the get-go and given the inpatient intravenous regimen, we just -- it took us a long time to move through the early dosing cohorts. But with the momentum now in the field and the fact that we're now into the more biologically active doses, I think that we should pick up some speed here for sure. We don't have data yet from our trials, because we really hadn't moved into the -- what we deem to be the therapeutically active doses on the tumor microenvironment and what are the -- the questioning has shifted with Nektar's progress to what's happening with respect to the tumor microenvironment. We will get those data as we move ahead. But what we're seeing so far is what we would have hoped to see which is expansion in CD8 cells, expansion in natural killer cells without a corresponding expansion in regulatory T cells. So, ultimately what drives the value in the program is a combination of the immunology plus tumor responses. And what we’re going to see now as we get to the -- hopefully we get to the dose that we think we can take into the expansion cohort, increase the denominator in multiple tumor types and start seeing this real beneficial effect for patients. That's for us. That's what’s going to drive the value of the program.

Richard, do you have a PD1 combo in your expansion cohort?

Not right now, but we will. We will expand into the combos as we go.

Okay, got it. So, I mean, just to be clear, as you start these expansion cohorts, maybe some of them will be monotherapy, but is it fair to assume that combo PD1 expansion cohorts are also starting at some point this year, meaning we could update on next summer for example for the combos?

I don’t want to put a timeline on, because I will say, Umer, our regional plan was simply to do the expansions as monotherapy. But based on more recent data and feedback from our investigators, I think there's real interest in the combos. So right now we’re planning to accelerate the combo elements of it, but I don't have a timeline for that yet.

Got it. Thank you so much.

You’re very welcome.

From Barclays we’ve Morgan Williams. Please go ahead.

Hi. Good morning. Thanks for taking the question. So just a quick follow-up on VIVITROL. Exactly how much of the 2018 guidance is coming from the top five states? And then, two quick questions. Just, first, if you could update us on the gross to net for ARISTADA and VIVITROL, specifically ARISTADA? Since you’ve mentioned there would be a modest increase from, I think about the low 40s that you communicated in the past. And then, just on the ARISTADA guidance, are you factoring in the initiation dose into the 2018 guidance? And if you could provide a little bit more color there on the sales ramp, assuming you get approval?

Sure, Morgan. Thanks. Good morning. It's Jim. I will take those and if I miss one just remind me. So, first, when it comes to VIVITROL, I think the top five states were not predicting as we go forward into 2018 guidance, a major change there. But obviously really the thing that drove our 2015 and 2016 growth was new states like Ohio and Pennsylvania really hitting a different growth trajectory. So I think if we see new states coming on with driving more growth, that will obviously change the top five, but that'll change the overall guidance for VIVITROL as well. So I think we're very much steady if she goes with VIVITROL as we seek to drive increased sales. The gross to nets are pretty consistent with what we saw in the third quarter and over the course of the year, little bit over 45% for VIVITROL and in the low 40% range for ARISTADA. And we're predicting that they move up a few percentage points through the year and that'll obviously have an impact on future growth. And then -- oh, the initiation dose. You know we are assuming approval for that and I think our view is that that's going to drive additional interest in the two-months as well, and that is all baked into our guidance as we go through the course of the year. But the important thing about the initiation dose, obviously, that’s a single dose and we obviously hope that patients are on numerous doses subsequently five or six doses on average would be what we would expect from a new start. So those new starts are very important, but they're not the majority of sales that you see coming from patient initiation.

So should we focus on, I think, in the past you said that about 30% of patients initiate therapy -- in patient. So is that kind of the bucket where we should be thinking of immediate impact from potential increased volumes there or should we be thinking about an expansion of that?

Yes, I think as Rich mentioned, long-term that that growth in the hospital is going to be key for us and that's one of the reasons we're excited about the initiation dose, but also the two-month dose because once we have the full complement of the ARISTADA family, it will be a nice opportunity for people to leave the hospital with two months of coverage and also get dose there without having to worry about oral supplementation. So that will be a nice opportunity for us as we go forward.

Great. Thank you so much.

You’re welcome.

Brendon, we have time for one more question please.

Thank you. And from Cowen & Company we have Pamela Barendt. Please go ahead.

Yes, hi. Thanks for taking my question. Good morning. The markets for …

Good morning.

… hi. The markets for addiction is poised to expand with competitive longer acting treatment option. Could you comment on how you see this impacting VIVITROL from a competitive standpoint, and also more broadly from an addiction treatment standpoint and market growth standpoint?

Hi, Pamela, it's Richard. I saw you give us an update from Pyongyang, but …

Yes, [indiscernible] right now, but he is doing everything, so …

It's pretty exciting though, I got to say. That’s great. Yes, the FDA approved at the end of last year a long-acting injectable form of buprenorphine and they’re -- they issued a complete response on another one. Our expectation is that the long-acting injectable bupes will come to market and that they're going to be a constructive part in changing the treatment paradigm that I referred to earlier. More doctors using injectable medicines that are branded and require access to specialty pharmacies and follow-up with their patients in combination with psychosocial counseling, this is all good. And so, because VIVITROL has such a numerically small market share compared to the partial agonist treatments. And couple also with the fact that X:BOT, this large randomized study shows that the efficacy is equivalent and the patients often prefer -- certain patients certainly prefer to be on antagonist treatment. I think it all bodes well for the continued medicalization of this category. It's difficult to overstate how different addiction treatment is from normal medicine. The treatment system is outside of medicine. Its comprised and built on an architectures that has been developed by the government with methadone clinics and waivered suboxone physicians rather than comprehensive centers treating addiction holistically. And as we move more in that direction, we think more long-acting medicines can be used, more long-acting buprenorphine that have less abuse and diversion potential in the community as well as more VIVITROL. So that’s a long-winded way of saying we’re on favor of it, and we expect it to be helpful to the market.

Thank you.

Thank you. We will now turn it back to Sandy Coombs for closing remarks.

Great. Thanks everyone for joining us on the call this morning. If you have any follow-up questions, please don’t hesitate to reach out to us. Thank you.

Thank you. And ladies and gentlemen, this concludes today's conference. Thank you for joining. You may now disconnect.