Impax Laboratories Inc.
) third-quarter 2013 adjusted earnings of 25 cents per share
compared favorably with the Zacks Consensus Estimate of a loss of
6 cents. Earnings in the third quarter of 2013 were however below
the year-ago figure of 48 cents per share.
Total revenues for the quarter stood at $132.6 million, down
8.9% year over year. However, third-quarter revenues were ahead
of the Zacks Consensus Estimate of $109 million. The company
operates through the Global Pharmaceuticals and Impax
Global Pharmaceuticals revenues came in at $115.7 million in
the third quarter, up 15.3% year over year. Revenues increased
due to sales of new generic products launched this year,
partially offset by lower sales of Impax' authorized generic
attention deficit hyperactivity disorder (ADHD) product, Adderall
Revenues from the Impax Pharmaceuticals division came in at
$16.6 million in the reported quarter, down 61.8% year over year.
Sales were hurt by lower demand for Zomig tablets and ZMT
products due to generic competition. Zomig and Zomig-ZMT are
indicated for the treatment of migraine headaches. U.S.
exclusivity of the products expired on May 14, 2013.
Total research and development expenses for the quarter
decreased 20% to $16.1 million. Selling, general and
administrative expenses decreased 3.3% to $28 million.
Apart from announcing financial results, Impax modified its
expense guidance for 2013. Total research and development
expenses are now expected in the range of $70-$72 million
compared to the earlier guidance of $80-$87 million. This
includes generic research and development expenses of $43-$44
million (previously $45-$49 million) and brand research and
development expenses of $27-$28 million (previously $35-$38
Impax increased its patent litigation expenses forecast to the
range of $15-$16 million from the prior projection of $12-$15
The company reduced the upper end of its selling, general and
administrative expenses for 2013 to $113-$115 million from
Impax provided an update on its Hayward manufacturing
facility. At the regulatory meeting with representatives from the
U.S. Food and Drug Administration (FDA) in late Oct 2013, Impax
provided additional information and clarifications on the
responses and updates related to the Form 483 issued earlier in
the year on the facility. Impax will carry out a satisfactory
re-inspection of Hayward facility with the objective of resolving
Impax has an interesting pipeline candidate, Rytary, under
branded division. Impax is working with the FDA regarding a new
drug application (NDA) for Rytary. Additionally, in the second
half of 2014, it is likely to file in Europe.
Impax currently carries a Zacks Rank #3 (Hold). Currently,
) look well-positioned with a Zacks Rank #1 (Strong Buy).
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