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Alkermes, Inc. (NASDAQ:ALKS)

F2Q09 (Qtr End 09/30/08) Earnings Call Transcript

November 6, 2008, 4:30 pm ET

Executives

Rebecca Peterson – VP, Corporate Communications

Jim Frates – CFO, SVP and Treasurer

David Broecker – President and CEO

Analysts

Ian Sanderson – Cowen & Co.

William Ho – Bank of America

David Windley – Jefferies & Co.

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alkermes conference call to discuss the Company's second 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. Ma’am, you may begin.

Rebecca Peterson

Thanks very much. Good afternoon, and welcome to the Alkermes conference call to discuss our financial results for the second quarter of fiscal 2009, which ended on September 30, 2008. With me this afternoon are 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 continued 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 risks 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 second quarter financial results and revised financial expectations for fiscal 2009, David Broecker will then provide an update on the business. After our remarks, we'll then open up the call for Q&A. Now I will turn over the call to Jim to review the financial results.

Jim Frates

Thanks, Rebecca. Good afternoon everyone. We reported another profitable quarter our 13th in a row on a pro forma basis. Our balance sheet is strong with over $425 million in cash and investments and this distinguishes us from the vast majority of other biotechnology companies. We are pleased with our strong financial foundation and as we move forward we will continue to manage the business with discipline while investing in opportunities for long term growth. This discipline is exemplified in some of the strategic decisions we made during the quarter. For example we took advantage of the illiquidity of the debt markets and deployed our capital to repurchase a portion of our debt retiring $60 million of non-recourse RISPERDAL CONSTA notes. In addition to our debt repurchase, we continued our stock repurchase program albeit at a slower pace purchasing roughly 38,000 shares. Finally, we are working to manage our expenses prudently with a focus on operating cash flow. Excluding our repurchases this quarter, the business generated $10.7 million of cash during the quarter of which $7 million was generated from operations. Our ability to deliver healthy financial results in a difficult market environment is a testament to our business model.

From a product perspective, we have established a strong foundation with RISPERDAL CONSTA. End market sales by Johnson & Johnson for our second quarter were approximately $338 million, an increase of 15% compared to the same period last year. Based on sales during our first two fiscal quarters RISPERDAL CONSTA is on track for another strong year of growth. Behind RISPERDAL CONSTA we have another potential blockbuster product with Exenatide once weekly. We also have the opportunity to grow commercial upside with VIVITROL in our expanding pipeline of proprietary product candidates; David will provide an update on these programs in a moment.

I will now turn to our financial results for our second quarter of fiscal 2009. We reported a profitable quarter driven mainly by manufacturing and royalty revenues from RISPERDAL CONSTA. On a GAAP basis, we achieved net income of $1.7 million or a basic and diluted earnings per share of $0.02. On a pro forma basis, we reported net income of $5.5 million or $0.06 per basic and diluted share. For a full reconciliation of our pro forma net income to GAAP, please see our press release issued today.

Turning to revenues, total revenues for the second quarter of fiscal 2009 were $47.3 million compared to $58.6 million for the same period last year. The reduction in revenues compared to last year was driven mainly by lower net collaborative profit and lower R&D revenues from partner programs. If you look at our key revenue driver RISPERDAL CONSTA, revenues grew favorably. Manufacturing and royalty revenues for RISPERDAL CONSTA during the second quarter were $39.1 million compared to $30.3 million last year, an increase of 29.3%. Total operating expenses were $43.5 million for the quarter compared to $52 million last year and we are in line with our expectations.

Turning to VIVITROL, gross sales of VIVITROL by Cephalon were $4.7 million for the quarter compared to $4.7 million for the same period last year. Our shared losses on the product during the quarter were $9.2 million compared to $18.1 million for the same period last year. Our shared losses last quarter were $6.7 million. The sequential increase is primarily due to costs associated with manufacturing issues which we subsequently resolved. Excluding these manufacturing and other one-time costs, shared losses for the quarter were approximately $6.5 million. We will continue to manage the business aggressively to bring the cost structure in line with the sales trajectory for VIVITROL.

Let me now comment on our overall financial expectations for fiscal 2009. We are focused on profitability and we are maintaining our income expectation for the fiscal year. At this time however, based on the first six months of end market VIVITROL sales by Cephalon, we are revising our fiscal 2009 expectations for net collaborative profit and VIVITROL sales. We are also lowering expectations for certain operating expenses for fiscal 2009 thus our overall bottom line is not changing.

I will highlight for you now the line items that we are updating. You can look at our press release for a complete review of our expectations. We expect net collaborative profit to range from $5 million to $10 million compared to an earlier expectation of $10 million to $15 million. We now expect end market gross sales of VIVITROL by Cephalon to range from $19 million to $24 million compared to an earlier expectation of $25 million to $35 million. We now expect total revenues for fiscal 2009 to range from $200 million to $225 million compared to an earlier expectation of $205 million to $230 million. Our expectation for manufacturing revenues for RISPERDAL CONSTA remains unchanged in the range of $109 million to $118 million. As you know, these revenues fluctuate throughout the year due to the timing and product mix of our shipment to Johnson & Johnson. For our third fiscal quarter, we expect manufacturing revenues from RISPERDAL CONSTA to be in the range of $20 million to $24 million. We expect R&D expenses to range from $92 million to $97 million compared to an earlier expectation of $95 million to $100 million. We expect SG&A expenses to range from $48 million to $53 million compared to an earlier expectation of $50 million to $55 million. As I stated earlier, we expect GAAP net income to remain in the range of $19 million to $24 million or basic earnings per share in the range of $0.20 to $0.25. These per share calculations are based on the current share count of 95 million shares outstanding. It is important to note that we expect cash flow from operations to remain in the range of $50 million to $55 million this fiscal year.

To conclude, Alkermes delivered another profitable quarter and we are pleased with the progress we are making, financially for sure but also in terms of our goals of building a profitable multi-product company with potential for long-term growth. As we head into the second half of the fiscal year, we will continue to focus on supplying commercial products working hard with Cephalon to increase VIVITROL sales working with Amylin and Lilly to advance Exenatide once weekly and advancing our proprietary pipeline.

With that, I will turn the call over to David to provide an update on our products and programs.

David Broecker

Good afternoon everyone and thank you Jim for your financial update. Let me take a moment to provide my perspective on the strength of our business. As Jim just mentioned, we took the advantage of the current market conditions to strengthen our balance sheet further. From a financial perspective, the company has never been stronger. At the heart of our business model are our products and through them we are delivering value-added innovation to patients and physicians. We have two assets that form the cornerstone of our business, RISPERDAL CONSTA and Exenatide once weekly. RISPERDAL CONSTA is a blockbuster product and sales continued to grow. Exenatide once weekly has demonstrated best in class efficacy for the treatment of type II diabetes both in terms of glucose control and weight loss, and Amylin is moving towards the NDA submission. We believe these two products along with contributions from VIVITROL will enable us to generate $2 to $3 per share in 2013. At the same time, we are leveraging our technology platforms, commercial scale manufacturing, and R&D expertise to create new proprietary product opportunities. The bottom line is that we are building a commercial enterprise with excellent prospects for growth.

Let me now comment briefly on the most important product developments during the quarter starting with RISPERDAL CONSTA. J&J continues to invest heavily in this brand. RISPERDAL CONSTA is sold in more than 60 countries around the world and with patent protection through 2020 we believe there is room for continued growth in the years ahead. The story of RISPERDAL CONSTA is becoming stronger and stronger. Last month the FDA approved the use of this product as a deltoid injection for patients with schizophrenia. Over the past year, J&J submitted two sNDA applications seeking additional approvals for RISPERDAL CONSTA, one for use in bipolar one disorder and a second to treat a more severe form frequently relapsing bipolar disorder. If approved, RISPERDAL CONSTA would be the first and only long-acting treatment available for use in bipolar disorder. We expect the FDA to respond to these sNDA filings during calendar year 2009. With each of these label expansions, RISPERDAL CONSTA becomes increasingly differentiated from any potential competition.

The other noteworthy news is our progress with the development for the four-week formulation of RISPERDAL CONSTA. A formulation has been identified and successfully tested in pre-clinical models. We are moving this formulation into the clinic and we expect from the Phase I PK study to begin in the first quarter of calendar year 2009. Taking a step back, RISPERDAL CONSTA remains the only FDA approved long-acting atypical antipsychotic. The reason why we are in this unique position is because formulating, developing, and manufacturing these types of products is exceedingly difficult and we are the world’s experts. This perspective is important as it relates to Exenatide once weekly. We have been working with Amylin for several years now to develop the right formulation for Exenatide once weekly, establish its efficacy in clinical trials, build a commercial manufacturing facility, transfer the technology to Amylin and move through the regulatory approval process. There is a tremendous amount of substance underlying this development program. To be certain, this work is very challenging but we have applied our expertise in developing long-acting medication to the development of Exenatide once weekly and we remain confident that our efforts will prove successful once again.

Earlier this week, Amylin reported an update on the submission of data from the in vitro in vivo correlation studies or IVIVC studies to the FDA to demonstrate comparability between clinical trial material manufactured at our facility at Wilmington, Ohio to that of the material manufactured on a commercial scale in Amylin’s facility. Amylin recently received feedback from the FDA that this data has not met the agencies requirements to demonstrate comparability. We felt that the IVIVC data Amylin submitted was compelling and we were somewhat disappointed that this method did not satisfy FDA requirements. Amylin is currently in discussions with the FDA regarding the best path forward to enable an NDA submission by the end of the first half of calendar year 2009. If the FDA requires a new clinical study, the timing of the NDA submission will depend on those study parameters. We are confident that the material made at Amylin’s facility is comparable to the material we manufactured at clinical scale and we believe that Amylin will be able to demonstrate comparability to the FDA. In fact material from Amylin’s facility is being used in the ongoing Duration study. Based on its clinical profile, we continue to believe that Exenatide once weekly will be approved and competitively positioned in the market. In terms of the competitive landscape, marketing studies are underway designed to show superiority compared to other approved products. Enrollment is now complete for the Duration-2 study which is a study comparing Exenatide once weekly to Actos and Januvia in more than 400 patients. The results of the Duration-2 study are expected in the first half of calendar year 2009.

Finally it is worth noting that Exenatide received an endorsement from the American Diabetes Association and the European Association for the Study of Diabetes when it was included for the very first time in the recently published treatment guidelines for type II diabetes. These guidelines have far-reaching implications as they serve as a reference for physicians and payers in terms of prescribing and reimbursement decisions. This is exactly the type of platform we want in place for the launch of Exenatide once weekly.

Let me now provide an update on VIVITROL. Sales were flat compared to last quarter and clearly we are focused on increasing the revenue for this product. However we have reasons to be optimistic that are not apparent in the numbers. As we look at the next 12 months, there are several milestones that will give us a sense of the ultimate potential of this product. First, we expect J&J to launch VIVITROL in Russia in the first quarter of calendar year 2009. The success of this launch will help us assess the commercial potential for VIVITROL outside the US. Second, we expect to have top line efficacy results from the registration study for opiate dependence in late calendar year 2009. This data will be used for our sNDA submission to expand the VIVITROL label into this new market opportunity. And finally we will be able to judge the success of our commercial plans and programs to increase sales. Our strategy is focused on doing the basics to improve product access and continuity of care among current VIVITROL prescribers and their patients. Our initiatives can be accomplished within the confines of our focused financial plans for the business.

To conclude, let me provide a brief review of the program milestones we expect in the coming months. We will update you on the clinical program and regulatory timeline for Exenatide once weekly, we expect to initiate clinical studies for ALKS 33 and ALKS 27. We expect J&J to initiate the Phase I PK study before RISPERDAL CONSTA. We expect VIVITROL to launch in Russia in the first quarter of calendar year 2009. We expect updates on the sNDA filings for RISPERDAL CONSTA and we will continue to provide you with updates on the developments of our pipeline.

With that, I will now turn the call back to Rebecca.

Rebecca Peterson

Great thanks, operator we will not open it up for Q&A.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) Our first question comes from Ian Sanderson from Cowen & Co.

Ian Sanderson – Cowen & Co.

Good afternoon, thanks for taking the question. Just to follow up on some of the milestones that you were just referencing David, on the ALKS 33 and ALKS 27, can you provide a little bit more color on exactly when you plan to start those trials? And then secondly on the initiation of the Phase I trials for the four-weekly, once every four week CONSTA, did you say that J&J would be in charge of initiating these trials?

David Broecker

Hi Ian, how are you, good question, for ALKS 33, as a reminder, this is the first compound out of our RPI Library which was a library of opiate receptor antagonists and agonists and we are planning to move that into the clinic by the end of the year. That is going to be a Phase I type of study. For ALKS 27, that is the COPD product trospium chloride and the plan is to initiate a Phase II study in the first quarter of calendar year next year. So we will have both those programs underway and then as it relates to four-week RISPERDAL CONSTA, what we have done is we have selected the formulation, made the material and we are shipping that up to J&J, they are going to be the ones that actually conduct the Phase I clinical study for that four-week product and the timing for that is by the first quarter of next year.

Ian Sanderson – Cowen & Co.

Okay by the end of the first quarter?

David Broecker

Yes.

Ian Sanderson – Cowen & Co.

And ALKS 29, any update on that program?

David Broecker

That one is also going to be in the clinic in the first quarter of next year, is that going to done by – I am looking at Rebecca here Ian –

Rebecca Peterson

Ian, I will take that. It is scheduled to start a clinical study before the end of the calendar year this year.

Ian Sanderson – Cowen & Co.

Okay, thank you.

David Broecker

You are welcome.

Operator

Our next question comes from William Ho from Bank of America.

William Ho – Bank of America

Hi guys, thanks for taking my question. I was just wondering since we really haven’t had much opportunity to find out anything about the FDA’s concerns, can you give us any additional clarity as to why they did not deem I guess the IVIVC study equivalent, it seems to me from your analysis of it that it did seem equivalent to both parties involved. So any clue as to what the concern is from the FDA?

David Broecker

William, good questions, I mean I think that that is what is on the mind of a lot of people that obviously are following the program. Suffice it to say we see the material as comparable, when we have done the tech transfer and process scale up and then turning the manufacturing process over to Amylin, we had to have a basis of comparison and a basis of comparability. So when we look at the product and the product that comes out of the Amylin facility and compare that to the product that we manufactured in our site, it is comparable. The approach in the methodology obviously that we took in filing this with the FDA and trying to make some arguments that we could show them comparability based on some of that in vitro data and correlate it to some of the in vivo data that is what we were hoping to do when we filed that. I can’t go into the specifics of what the FDA’s questions and concerns were because that is really up to Amylin, they are the primary person when it comes to the discussions with the FDA. So as I mentioned, we were a little surprised obviously because we thought the package that has been put together was a compelling package but what we will do is Amylin going forward have conversations with the FDA and as soon as we can provide more clarity on that, we will let you know or they will let you know.

William Ho – Bank of America

The package that you have put together for the FDA that demonstrated what you deem as comparability is that very similar to other packages that you have put together in the past that they have accepted and is this more specifically towards the BYETTA or it is certainly not as bad as the Exenatide LAR I guess specific problem.

David Broecker

All three sort of the three long-acting injectable programs that we have RISPERDAL CONSTA, VIVITROL and Exenatide once weekly, they are all different and they are all slightly unique in terms of the way they were studied and what went into that or the NDA around that. For RISPERDAL CONSTA, the whole clinical program was done at the commercial scale already, so there was no need really to show any sort of comparability. For VIVITROL, we made lots of 1 kg batches to supply to the Phase III clinical program and then we scaled up and then showed how that material was comparable to the 1 kg material. Now what was different in the Exenatide once weekly program is there actually is a site change, you are going from our site just outside Cincinnati to Amylin site so there needs to be a little bit more data and more rigor associated with that. So we quit that package together working with Amylin and unfortunately the FDA did not buy into some of the arguments around that methodology. So each of the three programs were different but again we remain confident that Amylin is going to be able to show the comparability for this material.

William Ho – Bank of America

Alright, thank you.

Operator

Our next question comes from David Windley from Jefferies & Co.

David Windley – Jefferies & Co.

Hi, thanks for taking the questions, beyond the comparability are there any studies that are planned or have been ramped regarding – I am looking at safety particularly maybe around pancreatitis?

David Broecker

As part of the program, I mean there is obviously a Phase III study and the extension and just sheer patient numbers associated with that form essentially the safety experience. Then they have got the other sort of marketing superiority studies the Duration-2 and the Duration-3, I am looking at Rebecca just in terms of what the specifics of each of those are but obviously they are gathering efficacy data and safety data in that. So that is going to form the basis of the safety data when it gets submitted.

David Windley – Jefferies & Co.

Okay. And David, you had mentioned Duration-2, what was the timing around that? Where does it stand?

David Broecker

My understanding is enrollment has been complete and the data for that will be shared sometime in the second half of 2009, sorry first half of 2009.

David Windley – Jefferies & Co.

Okay and on ALKS 27 does the (inaudible) data, will you provide any insights or have any impact on your development plans for that product?

David Broecker

This is the (inaudible).

David Windley – Jefferies & Co.

Right.

David Broecker

We looked a little bit at that data but it does not have any direct correlation to our program.

David Windley – Jefferies & Co.

Okay, alright, thank you.

Rebecca Peterson

Thanks, Dave.

Operator

That is our Q&A session for today, I would now like to turn the conference back over to Ms Peterson.

Rebecca Peterson

Great, if there are no further questions which I am presuming there is not from the operator, we will wrap up for the night and will certainly be available following the call if anyone has any additional questions and they would like to contact either Jim or myself. So have a great evening.

Operator

We do have a question on the phone line.

Rebecca Peterson

Okay, great, thanks we will take another.

Operator

I am sorry, that got disconnected.

Rebecca Peterson

Okay, anybody else or are we good for tonight.

Operator

I am sure there are no further questions at this time.

Rebecca Peterson

Excellent, thank you very much for dialing in and as I said, if you have any questions, please do not hesitate to call the question. Have a good evening.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program for today, you may all disconnect and have a wonderful day.

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