AMLN Amylin Pharmaceuticals, Inc. (MM)

Alkermes Inc.’s (ALKS) first quarter fiscal 2012 adjusted net loss of approximately $0.04 per share compared favorably with the year-ago loss of $0.14. The Zacks Consensus Estimate was a loss of $0.11 per share. The narrower year-over-year loss was attributable to higher revenues recorded in the reported quarter.

Quarterly Results

Total revenues for the reported quarter climbed 46.3% to $61.9 million. Revenues for the reported quarter surpassed the Zacks Consensus Estimate of $54 million.

Alkermes generated $38.4 million from manufacturing Risperdal Consta, approved for treating schizophrenia and bipolar disorder, in the reported quarter as against $26.3 million a year ago. Risperdal Consta is marketed worldwide by Johnson & Johnson (JNJ) and manufactured by Alkermes.

Moreover, Alkermes derived $0.4 million in manufacturing revenues from Vivitrol in the first quarter of fiscal 2012. The company derived $0.6 million related to  type II diabetes candidate Bydureon in the first quarter of fiscal 2011.

Alkermes co-developed Bydureon with Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Company (LLY). Bydureon recently gained approval in the EU and was launched in the UK in July.

However, the regulatory path for Bydureon has not been smooth in the US where it has already received two complete response letters (CRLs) from the US Food and Drug Administration (FDA). A response to the second CRL was submitted last month.

Alkermes generated $10.1 million in royalty revenues during the reported quarter on global sales of $403.6 million for Risperdal Consta as opposed to $8.9 million on $355.7 million of global sales of the drug in the comparable quarter fiscal 2011.

Vivitrol was originally approved for the treatment of alcohol dependence. The label of the drug was expanded last year to prevent the relapse to opioid dependence, following opioid detoxification.

Sales of the product climbed approximately 56.5% to $9.7 million in the most recent quarter. Research and development (R&D) revenue from collaborations went up to $3.3 million in the reported quarter from $0.3 million a year ago.

Total expenses at Alkermes climbed 36.8% to $75.8 million. R&D expenses for the first quarter of fiscal 2011 climbed 22.1% to $28.1 million. The increase was attributable to Alkermes’ efforts to develop its pipeline. Selling, general and administrative expenses increased 59.7% to $31.5 million in the reported quarter on a reported basis.

Alkermes to Buy Elan’s EDT Unit

In May 2011, Alkermes announced that it will buy Elan Corporation’s (ELN) drug delivery unit Elan Drug Technologies (EDT) for approximately $960 million in cash and stock. The merger is expected to close in September 2011.

The merged entity will be known as Alkermes plc and will be headquartered in Dublin, Ireland. Alkermes plc will primarily focus on developing therapies for treating deficiencies of the central nervous system. It will boast a diversified product portfolio and a robust pipeline.

Per the terms of the deal, Alkermes will make a cash payment of $500 million apart from giving Elan 31.9 million of its ordinary shares. Alkermes will have a 75% stake in the combined company, the shares of which will be registered in the US. The merged entity is expected to trade on the NASDAQ stock exchange.

Neutral on Alkermes

Currently, we have a Neutral recommendation for Alkermes for the long run. The stock carries a Zacks #3 Rank (Hold rating) for the short run.

 
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