ALKS

Alkermes plc (ALKS)

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Alkermes Inc., (ALKS)

F2Q2011 (Qtr End 09/30/2010) Earnings Call

November 4, 2010 4:30 pm ET

Executives

Rebecca Peterson - VP, Corporate Communications

Richard Pops - CEO

Jim Frates - CFO

Analysts

Cory Kasimov - JPMorgan

Ami Fadia - UBS

Steve Byrne - Bank of America

Mario Corso - Caris & Company

Ian Sanderson - Cowen and Company

Presentation

Operator

Welcome to the Alkermes second quarter fiscal year 2011 conference call. (Operator Instructions) I will now turn the call over to Rebecca Peterson, Vice President, Corporate Communications.

Rebecca Peterson

Good afternoon and welcome to the Alkermes conference call to discuss our financial results for the second quarter of fiscal 2011 which ended on September 30, 2010. With me this afternoon are Richard Pops, our CEO; and Jim Frates, our CFO.

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, the approval and commercialization of 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 products.

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 different materially from the results contemplated by these forward-looking statements. Including but not limited to the risk that we rely on our partners to inform us on a timely manner about developments concerning the regulatory status of BYDUREON, and the marketing strategies for RISPERDAL CONSTA.

You can find a list and detailed description of these and other risks in our annual report on Form 10-K, and 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 on this call. This afternoon, Richard Pops will provide an update on the Company, and Jim Frates, will discuss our second quarter financial results. After our remarks we'll open up the call for Q&A.

Now, I'll turn over the call to Richard.

Richard Pops

Great, thank you Rebecca. Hello everybody. So we've reported another strong quarter today. The solid top line results, driven by continuing growth for RISPERDAL CONSTA, allow us aggressively drive multiple new product development program with minimal cash burn, while also maintaining a significant cash balance with no debt.

So these financial results reflect the business strategy, which has always been characterized by a diverse portfolio. I think that it came even more clear this quarter with our three key products CONSTA, VIVITROL and BYDUREON. Plus this emerging pipeline, we have built-in diversification. We continue to build this company without depending on any single program, this lead to a certain resiliency in the business. So we're switching it up this quarter.

I'm going to start with an overview of where we stand as we exit, what turned out to be a very eventful October, as we head into the end of the calendar year. Then Jim will provide a little bit more granularity on the financial. And then we'll take the questions.

October obviously, was a big month for us, with two FDA action days. The first was for VIVITROL. On October 12, we announced that the FDA had granted marketing approval for VIVITROL for the prevention of relapse opioid dependency, following opioid detoxification. As we said then, we're tremendously pleased by the approval and by the strength of this label, because opioid dependence is characterized by high rates of relapse.

Prevention of relapse is a powerful new concept and represents a paradigm shift for the treatment of the disease. Opioid dependence is an established medical market. The leading products in the market are Suboxone and methadone, and their sales exceed $1 billion a year. VIVITROL represents a new treatment option as the first and only, not addictive, non-narcotic, once monthly medication for the prevention of relapse to opioid dependence.

So since the approval we've been moving quickly. We brought our commercial team together the week before last to review the label and complete the initial training. As of Monday of last week, our sales reps were back in the field and are actively promoting the new indication. Targeting physicians, who are current prescribing VIVITROL to introduce new indication and to discuss the label.

Once sales materials are pre-cleared by DDMAC, we'll continue to broaden the (inaudible) to include new phsysician located at both inpatient and outpatient treatment facility. For more details on the opioid dependence market and our commercialization strategy, you can listen to the replay of our October 13, conference call, which is on our website www.alkermes.com.

We're excited to be in the market now, talking to doctors about opioid dependence and we'll update you on the progress we're making in the coming months. Our other FDA action in October of course was for BYDUREON. As you all know by now, on October 19, we announced that Amylin received a complete response letter from FDA. Per the letter, the FDA would like Amylin to provide two additional studies for review.

The first is called the thorough QT study or TQT. The TQT study is a standard test conducted to see if the drug has an effect on heart rhythm. The FDA's second request was for data from DURATION-5, which is a safety and efficacy study of BYDUREON that was completed in December 2009. The FDA requested results for the DURATION-5 study to evaluate the efficacy and the labeling and the safety and effectiveness of the commercial formulation of BYDUREON. Neither of these studies was requested in the FDA's first complete response letter, which we received in March.

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