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Alkermes plc (ALKS)

Q1 2015 Earnings Call· Thu, Apr 30, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Alkermes Conference Call to discuss the company's First Quarter’s 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 Communication at Alkermes. Please go ahead.

Rebecca Peterson

Management

Thanks, Brendan. Welcome to the Alkermes PLC Conference Call to discuss our financial results for the quarter ended March 31, 2015. With me today are; Richard Pops, our CEO; Shane Cooke, our President, and Jim Frates, our CFO. Before we begin, I encourage everyone to go to the Investor section of the 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 matters better represent and reflect the ongoing economics of our business. Our discussions during the conference call today will include forward-looking statements. Actual results could differ materially from these forward-looking statements. Please see our press release issued and quarterly report on Form 10-Q 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 contemplated in the forward-looking statements. We undertake no obligation to update or revise the information provided on this call today as a result of new information or future results or development. Today, Jim Frates will discuss our financial results and then Rich Pops will provide a brief update on the company. After our prepared remarks, we'll open up the call for Q&A. Now, I'd like turn over the call to Jim.

Jim Frates

Management

Thanks, Rebecca. Hello, everyone. We're pleased to report our results for the first quarter ended March 31, 2015, which were characterized by strong revenues from our portfolio of commercial products and focused and focused investments in our pipeline. In the first quarter we generated $611.2 million of total revenues and we earned $9.2million of non-GAAP net income. Within our key commercial portfolio, worldwide end market net sales of our long-acting atypical antipsychotic franchise, RISPERDAL, CONSTA and INVEGA SUSTENNA were approximately $665 million in the first quarter, compared to $683 million for the same period last year, primarily reflecting the unfavorable impact of currency movements. In the United States, INVEGA SUSTENNA sales showed impressive growth as a leading product in the class, with end market sales of $228 million during the quarter, reflecting approximately 25% growth year-over-year. For the quarter Alkermes recorded manufacturing and royalty revenues of $46.9 million for this product franchise. As a reminder our tiered royalty rate on INVEGA SUSTENNA sales resets to 5% at the beginning of each calendar year and increases its end market sales to achieve certain thresholds and we expect to enter the 9% tier for the reminder of the year during the second quarter. As our partners at Janssen await approval for INVEGA SUSTENNA’s three months formulation mid-year, and as new extended durations to become an important driver of growth in this market, we expect this franchise to continue to expand. For AMPYRA and FAMPYRA, our manufacturing and royalty revenues were $36.5 million for the quarter, compared to $20.6 million for the same period last year. This increase is driven in part by the timing of manufacturing and shipments to Acorda. And as usual we recommend looking at a rolling four quarter period to understand long term trend. VIVITROL is off to a…

Richard Pops

Management

That's great. Thank you, Jim. Good morning everyone. So when we were together last at our analyst and investor event in early March, we highlighted just how distinctive a company Alkermes has become. With this unusual focus on large chronic diseases of the CNS affecting millions of people and with an incredible diverse pipeline of late stage medicines. The potential value of this pipeline has come clearly into view, Aripiprazole Lauroxil for schizophrenia, ALKS 5461 for major depressive disorder, ALKS 3831 for schizophrenia and ALKS 8700 for Multiple Sclerosis. For each of these candidates, we’ve completed the human proof concept studies to give us confidence in their medical and economic value. We can see how these products can enter large dynamic market, where despite the existence of many medicines including Generic, there are clear opportunities to address important needs of patients, physicians, while offering a value proposition attractive to players in a large system. The early months of 2015 have been extremely productive; there’s been a flurry of data. I’ll take a minute now to quickly review some of the projects we’ve made ear-to-date. I’ll start with ALKS 3831. Our Novel, Oral Broad-Spectrum Antipsychotic drug candidate that’s designed to deliver the efficacy of Olanzapine without the associated weight gain and also to have utility in patients with schizophrenia and co-occurring alcohol use. You’re all well aware by now that we’ve obtained very compelling data from the first large Phase 2 study of 3831 schizophrenia, setting its efficacy and its effect on weight compared [indiscernible]. The results of the complete six months study were announced earlier this month. These complete data extended the findings from the first three months period and provided further confirmation of the positive weight effect and antipsychotic efficacy of ALKS 3831. Specifically for the patients who received…

Rebecca Peterson

Management

Thanks, Richard. We'll now open up the call for Q&A, operator.

Operator

Operator

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And from JPMorgan we have Cory Kasimov on the line. Please go ahead.

Unidentiied Analyst

Analyst

Hi, good morning and thanks for taking the question. This is Whitney on for Cory. For 9070, I guess how should we be thinking about that launch trajectory, well is it similar to MAINTENA or is there a reason to think that it might be different.

Richard Pops

Management

Hi, Whitney. It’s Rich, I want to pull you back to the comments we actually made in March, where I think that our modeling a bit is basically replicating the quicker launch for ABILIFY MAINTENA. Because many of the factors that drive the shape of that launch were driven by exogenous factors in this market, which is largely a Medicate and Medicare market, with a series of steps one needs to get through to get on formulating and you start getting ill relation. We think that their launch profile is a reasonable one and we just expect overtime to take the growth in the market. That numerically drives a $5 million to $10 million expectations for the fourth quarter of this year for us.

Whitney

Analyst

Great, that’s helpful. Thanks for taking the question.

Rebecca Peterson

Management

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

Operator

Operator

From Credit Suisse we have Ari Jahja on line. Please go ahead.

Ari Jahja

Analyst

Good morning and thanks for taking my questions. I’ve three year. First for Rich, Alkermes is well capitalized than [indiscernible]. So in light of the stock’s recent weakness can you share your perspectives on the M&A environment and where you’re thinking the company is positioned and then I have two more in pipeline. Thanks.

Richard Pops

Management

Well, I think we’ve got the most explosive late stage pipeline in TNS and maybe in form in general. So I’m very mindful where our valuation is and it’s our job to make sure that valuation continues to grow to reflect the value that we’re building in this pipeline. That’s so exciting about the second half of the year. There are so many catalysts, there are so many things that are going to happen that are going to make more even concrete, the progress that we’ve made over the course of 2015.

Ari Jahja

Analyst

Got it, okay. And then I appreciate your insight there. And then second, as it relates to 3831 and 5461, can you share additional color on what we can expect to learn at the ACP meeting in June?

Richard Pops

Management

Well, we’ll be presenting data on both of those and I think it’s really important. 3831, as you know as well as anybody, is a really exciting molecule and the data set has never really been presented in the scientific meaning in the comprehensive way, so people didn’t get a full flavor of the distinctive profile of 3831 versus Olanzapine. So we think with the ability to present the full data set and also with experts and peers around to comment on, I think investors will get a better sense of why we’re still excited about this as a new entrant in the oral antipsychotic market. 5461 is just really an exciting new area in the field of depression. As you know that whole field has been stared for a new mechanism of action, different than monoamine reuptake inhibition that has the potential to be used on top of the standard therapies for patients and the millions of patients who are not getting adequate [indiscernible] relief. So as we continue to grow more data on 5461, people will see that the quality of the data, the difference from the [indiscernible] also have a chance to interact with people in the community to understand how this drug will be used. Specifically we’ll be giving in all our presentation the preparation from FORWARD-1, so people will get a better sense of that data as well.

Ari Jahja

Analyst

Got it, thank you. And then lastly on Lauroxil, we saw that generic version of oral ABILIFY has been launched and separately [indiscernible] ABILIFY MAINTENA growth seems to decelerate, so how do these dynamics affect your launch preparation? Thanks.

Richard Pops

Management

Ari, I didn’t hear the second part. You said the growth of MAINTENA is accelerating or decelerating?

Ari Jahja

Analyst

Decelerating.

Richard Pops

Management

Well, I think ABILIFY MAINTENA is actually ramping very nicely and I think it’s running at over $250 million a year now and I said the launch profile of these long-acting injectables in the antipsychotic space are different than an oral brand launching different to these indications. We think that its well on its way to being a significant product and that’s why Aripiprazole Lauroxil [indiscernible] launch into a market that’s preconditioned to be using more and more long acting ABILIFY. So the generic launch that was previously was essentially relevant and our gaining element to launching into this market with our own development timings and the expiration of the patent which expired a couple of weeks ago. All so systems are go and we’re looking forward to launching into this market.

Ari Jahja

Analyst

Got it, thank you.

Operator

Operator

From Leerink Partners we have Michael Schmidt on the line. Please go ahead.

Michael Schmidt

Analyst

Hey, good morning. Do you guys expect a FDA panel for Aripiprazole Lauroxil?

Richard Pops

Management

No, we won’t have a panel.

Michael Schmidt

Analyst

Okay, great. And I guess on 1450, how do you think about the strategic fit of that molecule. I know it’s obviously very early in development, but do you foresee that to being developed in house or do you see that as part of a partnering strategy long term?

Richard Pops

Management

Let me say it this way Michael, blockbusters always a strategic fit. So our job is determined at the clinical, what the profile is of this medicine, which is easy to do. We’re going to put this in demand, we’re going to get a real sense of this district behaves and then we’ll make decisions from there.

Michael Schmidt

Analyst

Yeah, got it, okay. And then is it too early to talk about possible of Phase 3 designed for 3831 and 8700 later this year?

Richard Pops

Management

3831, we’ll meet with FDA in a couple of months time on that one and we’ll meet with FDA on 8700 a little bit after. Both of those we’re kind coning in on what the final designs would be. For 3831, I expect it to be fairly similar to what we just did in Phase 2 i.e., a study in schizophrenia, with the primary end point being a measurement of the antipsychotic efficacy of 3831 because really what we’re delivering to patients is the opportunity to experience a Olanzapine level efficacy with a better metabolic weight gain profile. So I would expect a six month study, where we look at primary end points being antipsychotic measurements, while a quantitative assessment of weight versus the active comparison of Olanzapine and we would expect to win.

Michael Schmidt

Analyst

Okay and 8700, I guess you’re still making plans there I suppose?

Richard Pops

Management

That’s right. We’re still working that, there’s a couple of flavors of Phase 3 programs. You saw what FORWARD is doing and so we’ll work that out as we go through with the FDA over the next couple of months.

Michael Schmidt

Analyst

Okay, great. Thanks so much and congrats on a good quarter.

Rebecca Peterson

Management

Thanks so much Michael. We’ll take the next question.

Operator

Operator

From Jefferies we have Biren Amin on line. Please go ahead.

Biren Amin

Analyst

Yeah, thanks for taking my questions. Maybe I’ll start with the 700, could you give us an update on the [indiscernible] formulation?

Richard Pops

Management

Yeah, Biren as you know in our first study we ran a series of different approaches, formulation on potential one state formulation as purchase. And we learned a lot, but we don’t have anything that’s ready to go that will reiterate, we have certain scientific insights now. We think of proprietary and quite interestingly more back at it. But we’re not ready to say that we have a formulation ready to be given once they’re back [ph].

Biren Amin

Analyst

And then I guess on 5461, I noticed the company recently started zero abuse liability [ph] study. Do you expect for 5461 to be a classified agent?

Richard Pops

Management

There is two simultaneous questions buried in that, right. So 5461 will have a certain status by virtue of its effects, it contains buprenorphine. So it will be scheduled like we scheduled, like we schedule three by virtue of that fact simply because it has buprenorphine. Recognizing the absolute levels of buprenorphine are very, very small, but we’re testing 2 milligrams and 0.5 milligrams, but by virtue of its inclusion in the [indiscernible] it will have that schedule. Separately, where we believe that 5461will have the zero abuse liability as a drug and that’s where we’re testing the human abuse liability study and we think that’s actually central to the positioning of the drug. Because when people hear the idea of an Opioid Modulator, the default assumption is that it has a addictive potential [ph] and one of the exciting news about 5461 is that we’ve had this profound effect on mood without the potential for addiction and that’s what we’ll elaborate in the studies that are underway.

Biren Amin

Analyst

Okay, and then I guess just a final question on Lauroxil. I know you’re running the Q6 and Q8 [indiscernible] formulation trials, when can we expect data and what would be the next steps after you have the data out?

Richard Pops

Management

Let me just say something, thank you for the question. I’m really excited about the Q6 and the Q8 because as you’ve heard us say before, it’s not that we think the market is going to shift Q6 to Q8 entirely. The center of the model value will always be once a month, but it’s just another reason for those patients who prove to be well adhering to the LAIs, it just gives them another reason to choose Aripiprazole Lauroxil versus any other brand because they have the choosing [ph] flexibility in minimizing [indiscernible] the they get over the year. For the answer to the question, we began that study in Q4 and we expect data from Rebecca of what we think publically on that.

Rebecca Peterson

Management

We haven’t given a timeline, but what he said is we would update you this year. So stay tuned.

Richard Pops

Management

Yeah, I expect it. You’ll update on the dose interval step this year for sure.

Biren Amin

Analyst

Great, thank you.

Operator

Operator

From UBS we have Marc Goodman on line. Please go ahead.

Ami Fadia

Analyst

Hi, this is Ami Fadia for Marc Goodman. I have three questions.

Richard Pops

Management

Hi, Ami.

Ami Fadia

Analyst

Hi, how are you.

Richard Pops

Management

Welcome back.

Ami Fadia

Analyst

Thank you, we will have to catch up later.

Richard Pops

Management

I have some questions to ask you.

Ami Fadia

Analyst

Okay. Maybe get to my questions. Firstly, for 9070 what type of formulary that is relative to the Otsuka drug and the Generic ABILIFY do you expect or that you’re targeting for your product and I’ll come back for the next two?

Richard Pops

Management

We expect to have equivalent formulary status for 9070 as the other brand is long acting typical to generic to generic, that’s a separate category. Although we expect all patients will start on oral generic and ultimately spat through them. But because this is a protected class, this is one of the medicine that we think all patients could have access to.

Ami Fadia

Analyst

Got it. Secondly, what are your business development priorities with respect to either out licensing or partnering on any of your current pipeline asset and also what would need to happen for you to consider end licensing or adding another product the leverage the sales force infrastructure you’re building?

Richard Pops

Management

Yeah, on the out licensing set up, our interest in out license is a general matter relate to commercialization on a global basis rather than development. We have a really strong development team that’s actually got much stronger even in the last couple of years as we lunched these pivotal programs and we really loved the ability to run unencumbered. We have the capital, we have the people with the expertise, we have more domain knowledge now, we are building a real name for ourselves in psychiatry both in the clinical setting and also in the regulatory settings and we like that. Ultimately we want these medicines to get to patients all over the world and we just don’t have the infrastructure in Malaysia, in Sri Lanka and places like that and overtime we hope that we’ll enter into collaboration likely to do that. What would need to happen in terms of our end licensing something for the pipeline, given how abundant the pipeline is right now, what would need to happen is that have to a really good molecule. And we’re after looking all the time because there’s never enough and the portfolio can always be strengthened, particularly we think that to have a different risk profile and a different technological approach. As you know the whole environment has been so blain recently that most assets are really highly valued right now. And that tends to happen to flow overtime, but we’ve got strategic levels of capital to do what we want to do and we have certain amount of expertise other people don’t have. So we are always looking.

Ami Fadia

Analyst

Got it, thank you. And maybe a last housekeeping question. With respect to share count, came in around 157, which is a little bit above your guidance. Could you recap any plans for share buyback?

Jim Frates

Management

Hi, Ami. It’s Jim. I think we’re comfortable with the year’s guidance on a fully diluted basis and in terms of a share buyback, I think right now our plans are focused on investing in that pipeline as Rich talked about. I mean we’re on the cost of - and we’ve had some great success over the last few months. So pushing that pipeline forward will be the focus for us. We’ve done share buybacks in the past and well, I’m sure we’ll continue to do that in the future, but at this stage we’re focused on investing in that pipeline.

Ami Fadia

Analyst

Thank you.

Rebecca Peterson

Management

Great. Operator, we’ll take the next question.

Operator

Operator

From Goldman Sachs Credit Suisse we have Terence Flynn on line. Please go ahead.

Unidentified Analyst

Analyst

Hi, this is [indiscernible] filling in for Terence, thanks for taking my question. I understand you don’t want to provide 2016 guidance at this point, but perhaps could you - given your pipeline progress with multiple programs and late stage development. Should we be expecting R&D in 2016 to increase relative to 2015 or do you think you can keep this relatively flat? Thanks.

Richard Pops

Management

I think you answered your own question. So we won’t give 2016 guidance now. We’ll see how whole of the pipeline plays out of the year because the guidance will be driven by the work we need to do in that year and that will be determined by the cards we turn over, over the course of the year.

Rebecca Peterson

Management

Yeah, our philosophy has been to invest into success and as you know we have a very broad anti-pipeline, but we’re also very pragmatic in so far as determining which candidates weren’t moving forward and we’re judicious about our investments. So I think we maintain that discipline.

Unidentified Analyst

Analyst

Great, thanks.

Rebecca Peterson

Management

Thanks so much. Operator I think we have time for one more question.

Operator

Operator

Yes, from Bank of America Merrill Lynch we have Steve Byrne on line. Please go ahead.

Sarah Cooper

Analyst

Hi, this is Sarah on for Steve. Thanks for taking our question. So we [ph] conducted a survey that indicated that not all LAIs are covered on formulas and you’ve talked a little bit about this, though. What’s specifically given that [indiscernible] has a protected cost, but what is the process needed to ensure access for Aripiprazole , what steps have been taken thus far?

Richard Pops

Management

Well, we won’t go into the whole asset strategy that we have for the launch of Aripiprazole Lauroxil. Just know that particularly because we have a differentiated medicine, we’ve an offering that has real features for patients and tradition. We expect to be on these formulas. Now, some of them take time and so the fact that, if you look at the assumption in time, if there are certain formulas that aren’t providing all the LAIs, it can be a timing issue and sometimes some of the timing can be annoyingly flow. So we have the models from both CONSTA and SUSTENNA as well as ABILIFY MAINTENA, so there’s a very well led path that we will follow.

Sarah Cooper

Analyst

Okay, thanks and do you expect to sampling to outpatients in the early part of the launch?

Richard Pops

Management

Well, we’re not going to disclose today, any of our launch strategy.

Sarah Cooper

Analyst

Okay, thank you.

Rebecca Peterson

Management

Thanks you Sarah. Everyone thanks for dialing in today. If you have any additional follow up questions, please don't hesitate to give us a call here at the company. I know there is a lot of earnings results being [indiscernible], but we’re here as ready should you need any more information. Thanks, so much and have a great day.

Operator

Operator

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