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Alkermes plc (ALKS)

Q1 2011 Earnings Call· Fri, Aug 6, 2010

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes Conference Call to discuss the company’s first quarter fiscal 2011 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'd like to introduce your host for today's call, Ms. Rebecca Peterson, Vice President of Corporate Communications at Alkermes. Please go ahead.

Rebecca Peterson

President

Good afternoon and welcome to the Alkermes conference call to discuss our financial results for the first quarter of fiscal 2011 which ended on June 30th, 2010. With me this afternoon are Richard Pops, Chairman, President and CEO of Alkermes and Jim Frates, our CFO. Before we begin today, let me remind you that we will make forward-looking statements relating to among other things our expectations concerning the commercialization of Risperdal Consta, Vivitrol and Bydureon; our future financial expectations and business performance, our expectations concerning the future of business development transactions and our expectations concerning the therapeutic value and development of our product candidates. Listeners are cautioned that these statements are neither promises nor guarantees, but are subject to risks and uncertainties that could affect our actual results to different materially from the results contemplated by these forward-looking statements. You can find a list and a detailed description of these risks and other risks on our annual report on Form 10-K, and our quarterly report on Form 10-Q, as well as in other periodic reports filed with the SEC under the Securities and Exchange Act of 1934 as amended. We undertake no obligation to update or revise the information provided in this call. This afternoon, Jim Frates will discuss our first quarter financial results, and Richard Pops will provide an update on the Company. After our remarks we’ll open up the calls for Q&A. And now, I’d like to turn over the call to Jim.

James Frates

Management

Thanks Rebecca, good afternoon everyone. As we begin fiscal year 2011, am happy to report another quarter right inline with our expectations. Risperdal Consta continues to achieve solid quarterly sales and is a blockbuster product that will remain a profitable source of revenue for Alkermes for years to come. During the quarter, we recognized $35.2 million of manufacturing and royalty revenues from Consta. Vivitrol, in the alcohol dependence indication, achieved $6.2 million of net sales, our highest quarter to date in the fourth consecutive quarter growth. To give you more details on this quarter’s financial, total revenues were $42.3 million, driven by manufacturing and royalty revenues from Risperdal Consta. Royalty revenues were based on $365 million in end-market sales. As Johnson and Johnson stated on its recent quarterly earnings call, Risperdal Consta achieved second quarter sales growth of 3.4% on an operational basis, this is driven by very strong growth in Asia. Risperdal Consta continues be a blockbuster product, and is the only long acting atypical anti-psychotic, approved from both schizophrenia and bipolar 1 disorder in the United States. Risperdal Consta is the gold standard long-acting choice around the world choice around the world, and has span protection through 2020 in the United States and 2021 in the EU. One quarter into the fiscal year, we continue to see strength in Risperdal Consta and we are reiterating our expectations for total revenues for Consta in the range of 135 to $147 million this year. For our second quarter, we expect manufacturing revenues to be in the in the range of 25 to $30 million. Turning to Bydureon, as you know, the FDA has assigned us PUDFA date of October 22, 2010; we expect Bydureon to provide a substantial revenue stream by Alkermes upon the launch of this product. Bydureon will…

Richard Pops

Chairman

Great, thank you Jim. Good afternoon everybody, so given that it is August and we are fast approaching some really significant milestone, I’ll get right to the key updates since our last call. You’ve heard me say before that fiscal 2011 will be a pivotal year for the company, with news flow unprecedented in our history. From where we are right now, we have a pretty clear path of what we think will be major developments in the fall. At the top of the list, of course, are our PUDFA dates in October, October 12 for Vivitrol opioid and October 22 for Bydureon. Let’s start first about Bydureon, so we believe that Bydureon represents a new paradigm for the treatment of Type 2 diabetes, and is a major step forward for the GLP-1 class. It’s the first once-weekly product ever for the treatment of diabetes, and it exhibits benefits in terms of glucose control, weight loss, hypoglycemia and tolerability. The advantages of Bydureon over earlier GLP-1 products, are made possible by our technology; our proprietary long-acting Medisorb technology. By applying Medisorb, Byetta becomes Bydureon and its clinical advantages become more pronounced. This is not theory, it is supported now by a wide range of data collected from the duration studies showing Bydureon’s safety and efficacy. Bydureon and the GLP-1 class in general were the subject of a tremendous amount of interest and excitement in June at the American Diabetes Association’s annual meeting in Orlando. As you know, the ADA is the premier forum for thought leaders in the diabetes space, and this year’s meeting was very positive for Bydureon for two reasons. First, more new data was presented, adding to the significant data set already in existence and reinforcing the safety and efficacy profile of Bydureon, on its own and…

Rebecca Peterson

President

Thanks Rich, operator we’ll now open it up for the Q&A.

Operator

Operator

Thank you, we will now begin the question-and-answer session. (Operator instructions). Our first question is from Mario Corso from Caris & Company; please go ahead. Mario Corso – Caris & Co.: Good afternoon, thanks for taking my question. I just wanted to ask a couple of questions on Vivitrol in the opioid indication, number one concerning the panel, obviously there’s a lot of reasons why the FDA can call a panel and certainly they can do it for rather benign reasons like just the fact that it’s a publicly important indication or a significant indication, but then there’s also issues or questions they may be looking for the panel to answer and I’m wondering what your thoughts are at this point on what the main thrust of the panel is. And number two, maybe talk a little about competitive positioning; I would imagine this is certainly in the planning stages right now and you mentioned Suboxone and I guess they’re used a little bit differently, do you envision detoxification and tapering with Suboxone and that’s where Vivitrol then enters the picture, maybe just a little bit of thoughts on that. Thank you.

Richard Pops

Chairman

Sure, Mario, it’s Rich. I’ll answer that for you. First on the panel as you know there’s a general trend towards more advisory committee meeting in general and -- so we actually welcome that, this is a comprehensive data set and we are looking forward to presenting it. We have not received, from the FDA, the questions yet which is also not unusual. They tend to occur fairly late. So we won't speculate as to what the questions will be that we will present the panel but we are preparing to present the efficacy and safety data and really argue strongly for the use of Vivitrol in this indication because I think the data is so clear. On the second point, the competitive positioning is almost -- you don’t even -- almost think about it as a competitive positioning because, and we don’t really see ourselves positioning the product against Suboxone, Suboxone has done a wonderful thing in this patient population in that it has provided a real treatment alternative for patients and has begun a significant process of medicalizing and the use of medicines more broadly in the treatment of opioid dependence. What Vivitrol is, it is a complete different proposition because it allows patients to become opioid free, so a necessary prerequisite to using Vivitrol will be detoxification and transitioning from opioid physical dependence to being able to tolerate Vivitrol injections; first one and then every month thereafter. So I almost think of it as a new market that’s growing, more patients are being attracted to treatment. In the old days, it was just methadone, Suboxone brought a lot more patients in the treatment and then ironically the methadone treatment numbers have gone up since Suboxone has been in the market, likewise with the presence now of a long-acting antagonist, which provides physicians with another treatment alternative for patients who have different treatment goals, so it’s far from a zero sum situation at this early stage.

Rebecca Peterson

President

Operator, we’ll take the next question.

Operator

Operator

Our next question comes from Steve Byrne from Banc of America/Meryl Lynch; please go ahead. Steve Byrne - Banc of America/Meryl Lynch: Hi, regarding the Vivitrol adcom panel coming up, do you know whether the views of NIDA or the office of National Drug Control Policy are either going to be presented or solicited from FDA?

Rebecca Peterson

President

Steve, that’s a good question. So my understanding is that the FDA will probably consult NIDA, they won’t be an active part of the adcom itself. But clearly, NIDA provided early funding support for the development of Vivitrol and additional tools in the tool kit are certainly welcome and needed.

Richard Pops

Chairman

As you know Steve, that would be a good thing because we think NIDA is a real strong supporter of this particular dosage form. Steve Byrne - Banc of America/Meryl Lynch: Okay, and with respect to your sales of Vivitrol, are your –reps able to pick up at all whether or not any of the scripts that are being made out there are for off label use for opioids or do you think that it’s still predominantly for alcohol dependency?

Richard Pops

Chairman

I talked to our commercial team about that today to get the answer to that question because I expected it and the answer was no, they don’t think so. Maybe it’s because our commercial team is so concentrated and focused on the alcohol docs that are writing Vivitrol, but we’re really not at this point. Steve Byrne - Banc of America/Meryl Lynch: And then I just have one last one for you on the ALKS-9070, do you have any data, pharmacokinetic data on this to either animal models or humans to demonstrate the longevity of this product in the body?

Richard Pops

Chairman

Absolutely, if you have any schizophrenic animal that you want treated, we have superb data and we’ve been working on this for quite some time. So this transition to humans is always a major step but we do so with a significant amount of preclinical data. Steve Byrne - Banc of America/Meryl Lynch: And what can you tell me about it though?

Richard Pops

Chairman

Basically, we are looking at a monthly regiment but as you know, this is one of our LinkeRx pro-drugs essentially. It’s a new chemical entity designed specifically for intra-muscular injection to serve as a depot without requiring polymers or microspheres. So essentially, it just releases slowly from the muscular compartment and metabolizes into Aripiprazole. So the study will be super informative, because we look at kinetic levels both for the pro-drug and of the active moiety, and if the active moiety is within therapeutic concentration over a time period, it’s very easy to model steady state kinetics in the next steps of the clinical program because we know that Aripiprazole is a very effective atypical anti-psychotic. Steve Byrne - Banc of America/Meryl Lynch: Okay, thank you.

Richard Pops

Chairman

You’re welcome.

Rebecca Peterson

President

Thanks Steve, we’ll take the next question.

Operator

Operator

Our next question comes from Tom Russo from Baird; please go ahead

Tom Russo - Baird

Analyst

Thanks for taking the question. Just wanted to check in the latest thinking and plans around adding reps for the Vivitrol opportunity, obviously the panel is important variable but I guess I just asked the question what is the latest thinking on the number and the timing to add to the sales force?

Richard Pops

Chairman

It’s entirely consistent with where we’ve been all along which is we just added 10 and per our plan in the summertime and those folks will now represent the full cadre that will be onboard for the launch, which put the total commercial team around 60.

Tom Russo - Baird

Analyst

Okay, and then, I wanted to ask maybe a more of philosophical or strategic question, totally understand the strategy for fiscal 2011 and probably little beyond that investing in the pipeline. And as we look further out for the last 5 years excluding 2009, the investment in R&D as a percent of sales has been roughly 50%, and am just wondering is there a point in time at which you would manage that to a lower percentage of sales and obviously it would depend on the success of the pipeline but, is there a point in time that you would manage that to a lower percentage of sales and if so how it would be?

Richard Pops

Chairman

This is Rich, I’ll answer a bit of it of ask Jim for his comments, but the important thing to realize as we move into the next phase of growth for Alkermes is really driven by one’s expectations for the launch of Bydureon, because our sales line in (inaudible) is going to be growing significantly. I do not expect our R&D line to keep pace at 50% of our sales line and we think it’s going to ramp pretty significantly; so we actually have said all along, we feel that this pipeline and we’ll prove it in the next several months, and we’re all going to be skeptical until we see the data from this clinical trial. But we just believe that these platforms are very productive right now and will allow us to put not just product candidates into the clinic, but product candidates have a really interesting risk profile because they tend to be based on known pharmacology but with real value added through our chemistry, and through our technology. So we’ll put them in demand particularly those early clinical trials that don’t cost comparatively a whole lot of money, and then we’ll have assets that we will partner some we believe and we’ll continue to develop some. But we have not historically been solving for R&D as a percentage of any number, it’s been pursuing the opportunity as aggressively as we can, Jim.

James Frates

Management

Yeah, and I think Tom we’ve talked about this before as Rich mentioned, the two ways to change that are to spend less on R&D or to grow the top line and we as the management team, I think, when you said 4 of the last 5 years, I thought you were actually going to talk about our profits which we’ve been actually cash flow positive for 4 out of the last 5 years. So I think we’ve been pretty disciplined in how we spend and what we need to see is growth in Vivitrol and growth in Bydureon to be able to deliver that bottom line growth that we are striving for.

Tom Russo - Baird

Analyst

Okay, thanks.

Rebecca Peterson

President

Thanks. Operator do we have any additional questions?

Operator

Operator

(Operator instructions). Our next question comes from Dave Windley from Jeffries; please go ahead.

Dave Windley - Jeffries

Analyst

Hi, good afternoon, thanks for taking the questions. A couple small ones I guess, on Vivitrol but for the Russia opportunity, we haven’t really heard you call anything out on that, I wondered if there is anything to say? Any updates.

Rebecca Peterson

President

Dave, as you know that Vivitrol has partnered with J&J in Russia and approved for alcohol dependence, as the launch to date has been modest in the alcohol dependence arena although it’s our understanding that J&J plans to proceed the opioid dependence indication as well.

Dave Windley - Jeffries

Analyst

Okay, and then the tail of the opportunity -- not to dog here but on Bydureon on this polymer supply, it looks like there is no margin on that in this quarter? Would you expect to have a positive margin on that?

James Frates

Management

Yeah Dave, we will ultimately and I think that relates really to just manufacturing at low levels as we start here and as the product starts to sell, we’ll start to see some margin delivered there.

Dave Windley - Jeffries

Analyst

Okay, Jim in our conference earlier in the summer you mentioned BD focus kind of having flipped from in-licensing to out-licensing, I wondered if you or Rich could provide some color on how you see that getting out, how are you thinking about out-licensing activities and when we should expect those to potentially be headlines.

Richard Pops

Chairman

Hey Dave, it’s Rich, I think that we are in such a great position right now for a couple of reasons; number one, environmentally, we’ve never seen such strong demands from big form of…to fill pipeline. That’s well commented on and everybody knows that. We don’t need pharmaceutical companies typically Biotech companies need pharmaceutical companies to partner in order to have the capital to advance the projects or to provide IP or manufacturing support or something, we don’t need any of that. We’ve got the financial resources to drive these products in the clinic to the real value adding clinical data, and that’s kind of the point I was making earlier in my remarks, so we don’t really see partnering in anything until we get that data in hand, because we think the value changes dramatically, and we'll kind of rank order the opportunities based on the quality of the data coming and these really clinical trials and am speaking particularly about 33, 37, 9070, in particular which are the ones that are [indiscernible]

Dave Windley - Jeffries

Analyst

Okay great, thanks and then last one; any update -- I believe you previously talked about 6931?

Rebecca Peterson

President

Yeah Dave, that’s in pre-clinical studies right now so stay tuned for further development on that.

Dave Windley - Jeffries

Analyst

Okay, thank you

Rebecca Peterson

President

Thanks so much.

Operator

Operator

Our next question comes from Steve Yoo from Leerink Swann; please go ahead

Steve Yoo - Leerink Swann

Analyst

Thanks for taking my question. I just had a quick question about OUS opportunities for opioid dependence, I thought I heard you mention that J&J will be pursuing the opioid dependence in Russia, so does that mean they are handling the European filing or what’s the situation there?

Richard Pops

Chairman

The license for J&J for Vivitrol extends only to Russia and the CIF, so it’s very narrow because they have a strong commercial presence in those markets. OUS, exclusive of Russia, we’re having discussions now with potential partners on that.

Steve Yoo - Leerink Swann

Analyst

And have you been in discussions with the EME to know whether your current trial is enough, or have they given you guidance for additional trials?

Richard Pops

Chairman

Our judgment right now is very specific questions for each individual partnering with whom we might collaborate, so we are right now not independently pursuing an approval strategy separate from knowing what our commercial strategy would be.

Steve Yoo - Leerink Swann

Analyst

So basically you are going to find a European partner before you file for opioid dependence, right?

Richard Pops

Chairman

Yeah, nothing is casting stone on that but that’s how we’re operating right now.

Steve Yoo - Leerink Swann

Analyst

Okay, thank you very much.

Richard Pops

Chairman

You’re very welcome

Rebecca Peterson

President

Thanks Steve.

Operator

Operator

We have no further questions at this time.

Rebecca Peterson

President

Great, well thanks everyone for dialing in, it’s August so we’ll wrap this up quickly. If you have any additional questions, please don’t hesitate to call either Jim Frates or myself. Have a good evening.

Operator

Operator

Thank you ladies and gentlemen. This concludes today’s conference. Thank you for participating, you may now disconnect.