Earnings Labs

Alkermes plc (ALKS)

Q1 2009 Earnings Call· Thu, Aug 7, 2008

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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 financial results for fiscal 2009. 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 taped at Alkermes' request. Now I would like to introduce your host for today's call, Ms. Rebecca Peterson, Vice President of Corporate Communications at Alkermes. Please go ahead.

Rebecca Peterson

Management

Thanks you. Good afternoon, and welcome to the Alkermes conference call to discuss our financial results for first quarter of fiscal year 2009, which ended on June 30, 2008. With me this afternoon our; CEO, David Broecker; our CFO, Jim Frates and our Chairman Richard Pops. Before we begin let me remind you that during the call today, we will make forward-looking statements relating to among other things our expectations concerning the commercialization of RISPERDAL CONSTA and VIVITROL, our future financial and business performance, including our financial expectations for fiscal 2009 and our expectations concerning the therapeutic value and continuing 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 cause our actual results to differ materially from the results contemplated by these forward-looking statements. You can find a list and a detailed description of these and other risks in our Annual Report on Form 10-K, filled on May 30, 2008 and 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 on this call. This afternoon, Jim Frates will discuss our first quarter financial results and David Broecker will provide an update on the business. We'll then open up the call for Q&A session. Now I would like to turn over the conference Jim to review the financial results.

Jim Frates

Management

Thanks, Rebecca. Good afternoon everybody. I am pleased to report a profitable quarter driven by manufacturing and royalty revenues for RISPERDAL CONSTA in the previous announced payment from Lilly. On a GAAP basis, we achieved net income of $29.7 million or basic and diluted earnings per share of $0.31. On a pro forma basis, we reported net income of $9.5 million or $0.10 per basic and diluted share. Facial former net income is generated from our ongoing operation, and excludes the income recognized from Lilly's $40 million cash settlement we announced in June. From a cash flow perspective, the company was cash flow positive for the quarter and we expect to be cash flow positive on an operational basis for the full fiscal year. For a full reconciliation of our pro forma net income to GAAP as well as details in our quarterly revenues and expenses, please see the press release that we’ve recently issued this afternoon. Our financial performance is a testament to the strength of our business model. RISPERDAL CONSTA is a growing blockbuster product with long patent life, limited competition and with potential for our significant label expansion. In addition to RISPERDAL CONSTA we have a second potential blockbuster product with Exenatide once weekly. We also have the opportunity to grow additional commercial upside with VIVITROL and are expanding pipeline with proprietary products. Our goal is to deliver results today and for the long-term and we are confident about the future. I will now highlight the most important elements of our first quarter results beginning with RISPERDAL CONSTA. End market sales by Johnson & Johnson for our first quarter were a $343 million an increased of 11% sequentially and 23% compared to the same period last year. On their recent quarterly earnings call J&J stated that RISPERDAL…

David Broecker

Management

Good afternoon everyone and thank you Jim for your detailed review of what was a great quarter. We are making progress across all fronts of our business from our most advanced commercial product, RISPERDAL CONSTA to our earlier stage pipeline projects. I will not give you comprehensive review of all our programs today, but really want to focus on two key programs, RISPERDAL CONSTA and Exenatide once-weekly. I’d also like to provide brief update on VIVITROL and two of our pipeline programs ALKS 27 for COPD and ALKS 33, an oral alcohol candidate. We have never felt more confidence about our prospects. RISPERDAL CONSTA is a blockbuster product and sales continue to grow. We have another potential blockbuster with Exenatide once-weekly and the program is on track for NDA submission. We believe RISPERDAL CONSTA and Exenatide once-weekly along with growing contributions from VIVITROL will enable us to generate earnings of $2 to $3 per share in 2013. We’re also planning for beyond 2013 while leveraging our technology platforms, commercial scale manufacturing capability and R&D expertise to create new proprietary product opportunities. The bottom line is that we are building a multi-product commercial enterprise with excellent prospects for growth. Let me start with RISPERDAL CONSTA, giving that tremendous success J&J continues to invest in this important brand. Over the past nine months J&J submitted three supplemental new drug applications to the FDA for RISPERDAL CONSTA. One for use as a deltoid injection, a second seeking approval for use in frequently relapsing bipolar disorder and most recently a third seeking approval for use in the broader indication of bipolar disorder. Bipolar disorder is a serious chronic disease affecting 5.7 million people in the U.S. and approximately 27 million people worldwide. If approved, RISPERDAL CONSTA would be the first and only long acting…

Rebecca Peterson

Management

Thanks. Operator, we’ll open it up for question-and-answer session.

Operator

Operator

(Operator instructions) Our first question comes from Cory Kasimov of J.P. Morgan Cory Kasimov – J.P. Morgan: Hi, thank you. Good afternoon guys.

Jim Frates

Management

Hello Cory. Cory Kasimov – J.P. Morgan: Hey, how are you?

Jim Frates

Management

Good. Cory Kasimov – J.P. Morgan: Could you remind us how far en advance J&J typically orders their supply of RISPERDAL CONSTA?

Jim Frates

Management

Sure Cory. We actually work with a number of forecast, so there is long range of plan were it began, because we have to provide capacity for them, so as you know we have two lines and we have a third line that they’ve invested in and we can bring online if we need it, but then they have a committed forecast which is about four or five months out. So, as we look forward through the year we try and measure their orders as well as the growth prospects that we see in the marketplace. Cory Kasimov – J.P. Morgan: And that’s where your guidance comes from, correct?

Jim Frates

Management

Exactly. Cory Kasimov – J.P. Morgan: Okay and then I guess also to the point, can you comment on any changes that if any that you’ve noticed in J&J ordering patterns with (inaudible) for just now few weeks away?

Jim Frates

Management

Well, I mean I think that it’s hard for us to know what’s driving the changes in J&J’s orders other than the marketplace and that’s what we’re focused on. So, I think we’ve seen an increase in those orders over the last few months, which is why we’re changing our guidance in the upper direction. Cory Kasimov – J.P. Morgan: Okay, fair enough. And then in terms of bipolar, could you estimate now approximately how much of CONSTA used is currently off-label in the bipolar indication? Do you have any insight into that?

David Broecker

Management

Cory, this is Dave. We’ve really don’t have any insight into that; that’s probably a question you have to ask J&J. Cory Kasimov – J.P. Morgan: Okay, and then finally with regards to the comparability testing for LAR, I’m familiar with the three tests that are currently being debated and some being run. Is it an option now to take the data that you generate from the IVIVC study that’s being run right now and potentially filing with that and then taking and still running the subsequent trial and filing those as an amendment in the second quarter of 2009, when you would have anticipated finishing them in the first part.

Jim Frates

Management

Cory good question, again I think our initial strategy is to train and obviously get it moving forward with the IVIVC comparability strategy and as we highlighted in the call, and I think it is really in Amylin’s earnings call, the plan was to submit some of the data to the FDA in the next couple of months, that to basically get their pre-approval that this is acceptable so that we can file NDA and then not have to worry about the rest of those other strategies. So, that’s where we’re had it. Cory Kasimov – J.P. Morgan: Okay. Alright great thanks for taking the questions.

Rebecca Peterson

Management

Thanks Corey.

Jim Frates

Management

Welcome.

Operator

Operator

Thank you. Our next question comes from Enrique Iribarne of Roth Capital.

Enrique

Analyst

Good afternoon gentlemen. Iribarne – Roth Capital: Good afternoon gentlemen.

Jim Frates

Management

Hi.

Enrique

Analyst

I have a question; could you give us any comments or updates on RISPERDAL CONSTA in Japan? Iribarne – Roth Capital: I have a question; could you give us any comments or updates on RISPERDAL CONSTA in Japan?

Rebecca Peterson

Management

We have filed for regulatory approval in Japan and have not yet heard back from the Regulatory Authorities. I would have to refer you for J&J on specific timing as to when they expect approval, but clearly that’s another growth opportunity for the product.

Enrique

Analyst

Okay, thank you very much. Iribarne – Roth Capital: Okay, thank you very much.

Jim Frates

Management

Thanks.

Operator

Operator

(Operator instructions) Our next question comes from Ian Sanderson, of Cowen & Company. Ian Sanderson – Cowen & Company: Hi, good afternoon and thanks for taking the questions.

Jim Frates

Management

Hey, Ian.

Rebecca Peterson

Management

Hi, Ian. Ian Sanderson – Cowen & Company: On VIVITROL, could you just update us on what the sales and promotional support for VIVITROL looks like now between yourselves and Cephalon and on the SG&A guidance can you talk about, well both in the quarter end the outlook what is the major change here that it’s causing the reduction in the SG&A spend, and then finally, any update on the ownership of the ALKS 27 program?

Jim Frates

Management

Sure Ian. Let me just make sure I get that in order, so in general you can look at our sales and marketing expenses. The overall expenses for the partnership are about $10 million each quarter and I would say that you can use Standard Pharmaceutical approaches where we’re looking at 50% or so in SG&A in that area. Ian Sanderson – Cowen & Company: So, I think it was more just in terms of the structural; has the support for VIVITROL stabilized since you made the original cuts at the end of last year?

Jim Frates

Management

Yes, that’s right, yes sorry about that. So, what we did in October and November, December timeframe is we brought down the size of the sales force about 70 people now. We have about 15 people in the field and that’s what you see running through our SG&A expense and Cephalon has the remaining 55 and as you look at our SG&A expense, really some of the savings that we had in the restructuring have come out larger than we anticipated and secondly, Cephalon is taking some of the activities in SG&A that we originally planned in our budget. So that’s why you see that savings in SG&A. So, it’s also stable to the rest of the year we think. Ian Sanderson – Cowen & Company: Okay, thank you.

Jim Frates

Management

You’re welcome.

Operator

Operator

(Operator instructions) Our next question comes from Andrew Hilgenbrink Jefferies & Company Andrew Hilgenbrink – Jefferies & Company: Thanks guys, taking my question.

Jim Frates

Management

Hi, Andrew.

David Broecker

Management

Hi, Andrew. Andrew Hilgenbrink – Jefferies & Company:

David Broecker

Management

Andrew Hilgenbrink – Jefferies & Company: Do you guys have made decisions on what size of needle would be used for Exenatide LAR or is that completely on Amylin’s side of it?

Jim Frates

Management

Could you repeat the question Andrew again? Andrew Hilgenbrink – Jefferies & Company: Have you guys made any decisions on the needle size that would be used with Exenatide LAR or is that on Amylin’s?

Rebecca Peterson

Management

Yes Andrew, so we’re using a needle gauge size, it’s a 23 gauge needle, it’s a quarter inch needle thin walled and it’s a very low injection volume under Amylin. So, as you know 90% of the patient in the clinical trial or who finished the clinical trial, the Phase III elected to go onto the extension and people seem quite satisfied with the needle and ability to take their medication only once a week. Andrew Hilgenbrink – Jefferies & Company: Great, thank you guys.

Jim Frates

Management

Okay.

Rebecca Peterson

Management

Thanks Andrew.

Operator

Operator

There is a follow-up question from Ian Sanderson of Cowen & Company. Ian Sanderson – Cowen & Company: Just a quick update on the ALKS 29 program and where that currently stands and if may see some data out of that sometime next year?

David Broecker

Management

Ian, David here. The plan is to get that and was planning by the first quarter calendar year 2009. So, we anticipate that probably towards the middle of next year we should have some date on that. Ian Sanderson – Cowen & Company: Okay, thank you.

Rebecca Peterson

Management

Thank you. Operator, are there any further questions?

Operator

Operator

Yes, actually we have one more question, Patti Bank of Pacific Growth. Patti Bank – Pacific Growth Equities: Good afternoon. Just two quick questions on CONSTA; can you just talk about inventory levels, they were brought down end of last year if they are kind of normalized now and where they stand and then also can just update us on the manufacturing side in terms of the manufacturing lines and what the capacity of those are?

Jim Frates

Management

Sure, yes we haven’t seen a dramatic in the inventory levels this year and so we don’t think that J&J is making major changes in that regard; we think we went through that last year. In terms of the manufacturing capacity, we’ve talked about in the past as each of our lines having about $750 million or $800 million of end sales capacity with RISPERDAL CONSTA by current prices. So, you can do the math; we have two lines up in running now; that gets you to about $1.5 billion to $1.6 billion and a third line ready to come on board, that will bring us up over $2 billion worth of end user capacity and so we feel like we’re well prepared as the sales continue to grow. Patti Bank – Pacific Growth Equities: Great, thanks.

Jim Frates

Management

You’re welcome.

David Broecker

Management

Thanks Patti.

Operator

Operator

I’m not showing any further questions.

Rebecca Peterson

Management

Great, thanks everyone for dialing in and we will be available afterwards if there are any additional questions. Have a good evening.

Operator

Operator

Thank you. Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the program. You may all disconnect. Everyone have a great day.