Alkermes PLC Earnings Call Insights: Abilify Maintena Launch and 9070 Clinical Trials

Alkermes PLC (NASDAQ:ALKS) recently reported its fourth quarter earnings and discussed the following topics in its earnings conference call.

Abilify Maintena Launch

Jonathan Eckard – Citi: First, I was just going to ask. I now it’s pretty early but have you seen the signs of the ABILIFY MAINTENA launch, for example, have they – have these patients – were they previously on long-acting antipsychotic or were they – are they new patients to the class and were previously on oral drugs? And then just – what you should look for out of that launch?

Richard F. Pops – Chairman and CEO: It’s too early to say, we’re tracking the launch right now, as you are just starting to get the first data points on the launch curve, but recall from our side that we presented, we really see that there is two major domains that the long acting ABILIFY will and should go after and that is the patients currently on oral ABILIFY with schizophrenia, many of whom are non-compliant and then what’s exciting is to hear what J&J is saying about the long acting atypical class in general and what Otsuka and Lundbeck and we will echo which is the gross underutilization of a long-acting injectables in schizophrenia patients in general, the market share being around 2% of long-acting of the use of atypicals. So I think you’ll see more patients coming into long-acting therapy in general.

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Jonathan Eckard – Citi: Then the other question is if you could just give us a general ideal strategy regarding, potential partnering, when do you see the ideal time to potential partner some of your assets because, ex-U.S. I think that your goal is to focus on U.S. when would be the optimal time for that to help maybe mitigate some of the development costs going forward?

Richard F. Pops – Chairman and CEO: Well, we’re kind of running the experimental real time and the most important thing if we are partnering these assets O-U.S. is to find the right partner with the right business strategy and the right approach to launching the products. We have the financial wherewithal generally to run the program we tend to think about the development programs in an integrated global way. We don’t know it was executed necessarily that way, but we have a good sense of how to do this so we’re not really rate limited by the need for a partner to develop the products. So with 5461 maturing so nicely, 3831 maturing nicely. Some other things in the pipeline that you’ll see in July coming along and with lauroxil we have a portfolio and we’re having kind of series of discussions with folks on different elements of that portfolio, but they’ll be right, when they are right.

 

9070 Clinical Trials

Anant Padmanabhan – Cowen & Co.: So, Rich, I had a quick clarification. You mentioned 9070, the clinical trials. So, you had said the trial would report out in H1. So I just wanted to get a clarification on why there is a little bit of a delay? I guess it doesn’t make a difference of the patent. You can only launch after the ABILIFY patent, but just trying to get a sense of what’s happening with enrollment and the general trial itself?

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Richard F. Pops – Chairman and CEO: Yeah, as I said in the earlier remarks, there’s two halves to the study, the U.S. half and the O-U.S. half and the U.S. half has gone pretty much as plan, because we have a reasonable amount of experience around these types of studies or similar studies in the U.S. O-U.S. is a bit of a different world, because we’re in different countries. We’re in places like Ukraine and Russia, Bulgaria, Serbian places like that, no Serbia actually. So really the remodeling is based on our actual real road experience in getting regulatory approvals, import licenses, sites initiated and patients enrolled. So as we get more experienced with that we just have a better ability to project. And recall that the primary objective here is not rate; it’s quality, because a single study should suffice for FDA approval. So we’re erring on the side of care, being careful with site selection and patient selection rather than rate. Now, we don’t want us to go for ever into 2014. We want to be done, believe me, but we’re also making sure we’re doing this correctly…

Anant Padmanabhan – Cowen & Co.: Then a quick clarification for Jim as well. On the R&D guidance, for the nine months, you have a $125 million to $135 million. Does that include a Phase 3 for 5461 or the beginnings of a Phase 3?

James M. Frates – SVP and CFO: You are absolutely right. It does include additional spend with the positive data that we saw in that study. We’re trying to initiate as quickly as we can the broader pivotal studies for 5461. Now we still have to go down and talk to the FDA, but over the next nine months, we will be accelerating spend on that program in particular.

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Anant Padmanabhan – Cowen & Co.: If I could just sneak another one, so the guidance assumes FOCALIN XR through the summer. Is that correct?

Richard F. Pops – Chairman and CEO: Yes. And obviously, the timing of when the generic entry might come, it’s hard to know. It’s impossible to know really. So, we just want to make sure people knew that was our assumption.