Shire Earnings Impress

The company reported strong drug sales as it prepares to roll out a new ADHD treatment.
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British drugmaker

Shire

(SHPGY)

said Wednesday that first-quarter earnings nearly doubled and revenue rose 29% thanks to big sales gains for most of its products.

The news sent the stock climbing $3.16, or 4.7%, to $70.60 by early afternoon on higher than average trading volume. The stock rose as high as $71.06.

For the three months ended March 31, Shire earned $112.7 million, including special items, on revenue of $528.2 million. For the same period last year, it earned $61.1 million on revenue of $411 million.

Earnings per share, measured in American Depositary receipts, rose to 64 cents from 36 cents, including special items.

Shire raised full-year sales guidance to a growth rate in the low-20% range, up from the previous prediction of "around 20%." This forecast includes the assimilation of

New River Pharmaceuticals

, which Shire acquired on April 19 for $2.6 billion. Shire didn't discuss an earnings prediction.

Shire is best known for Adderall XR, for attention deficit hyperactivity disorder, or ADHD. The drug accounts for 47% of corporate revenue, and it produced first-quarter sales of $249.1 million, up 21% vs. the year-ago quarter.

"We're not just an ADHD company," CEO Matthew Emmens told analysts during a conference call. Four smaller Shire drugs had first-quarter sales growth ranging from 10% to 56%. Another drug gained 192%, and two other drugs were too new to compare vs. last year. Shire's drugs include treatments for several rare diseases, epilepsy and ulcerative colitis.

Still, ADHD was the biggest topic of conversation during Wednesday's call with analysts, because Shire is getting ready to launch Vyvanse, which had been developed by New River. Shire had a marketing agreement with New River before deciding to acquire its partner.

Emmens predicted Vyvanse will be bigger than Adderall XR, which has a 26% -- and leading -- market share in the United States. The Food and Drug Administration

approved Vyvanse in February for children ages six to 12. Shire will soon ask the FDA to approve Vyvanse for adults, he said. Adderall XR is approved for children, teenagers and adults.

Emmens expects to begin selling Vyvanse in the U.S. in June, as soon as he hears from the Drug Enforcement Administration. Because Vyvanse is a controlled substance, it needs a DEA rating for abuse potential.

While the drug was being developed, New River and Shire had hoped Vyvanse would get a better rating than the Schedule II designation for Adderall XR and other stimulant treatments for ADHD. But the FDA recommended a Schedule II rating. The rating system goes from Schedule I, the highest abuse potential, to Schedule V, the lowest.

Shire executives have said their research shows Vyvanse has a reduced abuse potential vs. other stimulant drugs. In February, they said they would release label details after the DEA assigned a rating. But

TheStreet.com

Senior Writer Adam Feuerstein reported in March that

there is little difference between the drugs based on his analysis of the proposed FDA label.

Many analysts say Shire must move quickly to switch patients from Adderall XR to Vyvanse before April 2009 when Adderall XR becomes subject to generic competition. The older drug Adderall is already generic.

Emmens said he can't predict the speed of switching, but he admonished analysts for what he says is a narrow focus on Vyvanse vs. Adderall XR.

He predicted that Vyvanse will attract patients taking other ADHD drugs, such as Concerta from

Johnson & Johnson

(JNJ) - Get Report

. Concerta, also a stimulant, contains methylphenidate. Adderall XR is an amphetamine, and Vyvanse is a form of amphetamine.

Emmens also said Wednesday that Shire's marketing push for Vyvanse means the company probably won't sell two other ADHD drugs this year that are now under FDA review.

The agency will rule next month on SPD465, which contains the active ingredient in Adderall XR. The drug, which would be prescribed for adults, remains active for 16 hours vs. 12 hours for Adderall XR. Emmens said this was a "back-up compound" in case Shire didn't buy New River.

In June, the FDA will decide on SPD503. This non-stimulant is an extended-release version of a blood-pressure drug that has lost patent protection. It would be prescribed for children ages six to 17.

Shire continues to sell another ADHD drug,

Daytrana, for children ages six to 12. Developed by

Noven Pharmaceuticals

(NOVN) - Get Report

, Daytrana delivers methylphenidate via a skin patch. It had first-quarter sales of $11.9 million. Sales were affected by patch problems that, Emmens said, have been corrected.