UPDATE 2-Elan says it can progress without Alzheimer drug

Wed Jul 25, 2012 9:40am EDT

* Elan CEO says fundamentals solid despite poor drug data

* Q1 revenue up 6 pct to $288 mln vs $299 mln expected

* Italian dispute could see $30-35 mln revenue deferred

By Padraic Halpin

DUBLIN, July 25 (Reuters) - Irish drugmaker Elan said on Wednesday it can progress with or without its biggest new drug hope after it failed to prove effective in the first of four high-stakes late-stage trials, battering the company's shares in the process.

Elan had described key data on Bapineuzumab, an Alzheimer's drug in which it has a 25 percent stake, as "potentially transformational" for the company, with a successful outcome possibly even leading to it receiving a lucrative takeover bid.

However Pfizer, which develops the drug with Johnson & Johnson, said on Monday it failed to improve cognitive and life function, the primary goals of the trial, toppling Elan's stock from a near four-year high.

"We built this company to move forward with or without Bapineuzumab," outgoing chief executive Kelly Martin told journalists on a conference call after the company posted slower-than-expected second quarter revenue growth.

"We can't control short term movements in our stock up or down, the only thing we can do is focus on the fundamentals of the business and we've strengthened the capital structure, the balance sheet, there's good revenue growth and there's good progress in our science."

"The underlying fundamentals, value and projections of the business as is remain positive and consistent frankly with performances over the last few quarters."

Shares in Elan, which closed 11 percent lower on Tuesday, were down a further 2.2 percent by 1350 GMT.

Elan, which discovered the drug, did not have to contribute to the $500 million invested in it since 2009 after selling a 25 percent stake to J&J. Its funding commitments resumed in the second quarter, however, when it spent $48.7 million, the first chunk of a maximum $200 million outlay.

Analysts at RBC Capital Markets said in a note they saw the most likely scenario for Elan being the failure of Bapineuzumab, prompting it to monetize its stake and then sell its 50 percent share in blockbuster multiple sclerosis drug Tysabri to partner Biogen Idec, into which it would then consolidate.

ITALIAN DISPUTE

Elan derives its revenue almost exclusively from Tysabri and it reported total sales for the three months to June 30 of $288 million, up 6 percent on a year ago once sales from its since-divested drug delivery business are omitted.

That compared to the $299 million forecast by four analysts surveyed by Reuters and was driven by in-market sales of Tysabri that rose 2 percent year-on-year to $395 million, also shy of the $419 million expected by analysts.

Biogen, which detailed the sales numbers when it reported second quarter results on Tuesday, attributed the softer-than-expected Tysabri sales to a dispute with the Italian government over pricing.

The number of patients on Tysabri rose 4 percent to 69,100, maintaining Elan and Biogen's 10 to 12 percent share of the MS drug market in the face of competition from Swiss drugmaker Novartis AG's Gilenya treatment, the first multiple sclerosis pill to come on the market.

The average addition of 185 new patients per week was the highest quarterly run-rate since the fourth quarter of 2009.

"Although overshadowed by the initial results from the Bapineuzumab trials, the key positive to take from Elan's Q2 out-turn is the continued acceleration in Tysabri patient numbers," said Jack Gorman, analyst at Davy Stockbrokers.

Elan, in which Johnson & Johnson is an 18 percent shareholder, said in April it expects to make adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of at least $200 million for 2012 versus $147 million in 2011.

It reiterated that on Wednesday but said its full-year guidance assumes a resolution of the Tysabri Italian dispute this year. If it is not resolved, Elan said it would defer around $30-35 million in revenue and $20-25 million in EBITDA as a result.

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