UPDATE 1-Shire confident as ADHD competition heats up

Thu Feb 14, 2013 10:54am EST

* Posts 4 pct rise in Q4 earnings

* Unworried by FDA approval for Teva's cut-price Adderall XR

* Sees 2013 earnings in line with expectations

* Shares down 4 pct

By Paul Sandle

LONDON, Feb 14 (Reuters) - Pharmaceutical company Shire said the arrival of new cut-price versions of hyperactivity drugs would not hurt its leadership in the fast-growing market for daily medication to help students to concentrate.

The company said on Thursday sales of its Vyvanse ADHD medicine topped $1 billion last year, as a copy of its former blockbuster Adderall XR was approved by U.S. regulators.

London-listed Shire focuses on niche drug areas like hyperactivity and rare illnesses such as Gaucher's disease and Fabry's disease, which have sheltered it from patent expiries and pricing pressures in Europe that have hurt bigger rivals.

The group, which also makes expensive gene therapy drugs, posted a 14 percent rise in full-year earnings, broadly in line with market expectations, and said it was confident about its 2013 prospects.

In his last set of results before handing over to Flemming Ornskov, Chief Executive Angus Russell said the group's ADHD (attention deficit hyperactivity disorder) portfolio was performing well in a growing market.

"Vyvanse has achieved blockbuster status, delivering a 28 percent increase in revenues to over $1 billion for the first time," he told reporters.

The drug, an amphetamine, has been approved in Britain, and Russell said launch would likely come in the second quarter.

Higher Vyvasne sales, in a U.S. ADHD market growing around 9 percent a year, is helping to offset increased competition from cut-price versions of Adderall XR.

Teva, which already sells an authorised version of the drug under a 2006 license with Shire, said on Thursday it had won approval from the FDA for its own generic.

Shire's sales of Adderall XR fell 19 percent to $429 million in 2012, when it also faced new competition from a copy made by Activis and received a lower royalty rate for an authorised generic from Impax.

UPBEAT OUTLOOK

Shire's shares had a strong run into the results, rising by 21 percent in the last three months. They were trading down 4 percent at 2,059 pence by 1457 GMT.

Analysts at Jefferies said the company's fourth quarter results were in line with expectations, and its outlook remained upbeat despite the news of another generic.

Shire said it expected earnings growth in 2013 to be in line with current market expectations.

Analysts expect the company to report non-GAAP earnings per ADS of $6.72 in 2013, 10 percent up on their expectations for 2012, according to a company-compiled consensus.

The group company reported a 4 percent rise in fourth-quarter non-GAAP earnings per ADS of $1.58 on revenue up 5 percent to $1.2 billion, resulting in earnings for the year of $6.10, broadly in line with analyst expectations.