Impax Laboratories, Inc.'s
) fourth quarter 2012 adjusted earnings of 30 cents per share,
were above the Zacks Consensus Estimate of 20 cents but below the
year-ago earnings of 33 cents per share.
Total revenues for the fourth quarter stood at $141.0 million,
down 11% year over year, but ahead of the Zacks Consensus
Estimate of $127 million.
Fourth quarter revenues consisted of revenues from Impax
Laboratories' two divisions-Global Pharmaceuticals and Impax
Revenues of Global Pharmaceuticals came in at $91.9 million in
the fourth quarter, down 40% year over year. Revenues declined
during the quarter on account of reduced sales of Impax's
authorized generic version of attention deficit hyperactivity
disorder drug Adderall XR. However, this was partially mitigated
by the US sales of Zomig, used for the treatment of migraine
Revenues from Impax Pharmaceuticals division came in at $49.1
million in the reported quarter compared to $5.3 million in the
year-ago quarter. The growth was driven by US sale of Zomig.
Total research and development expenses of Impax Laboratories
for the quarter increased 10.9% to $22.6 million. Selling,
general and administrative expenses of Impax Laboratories
increased 66.6% to $33.4 million.
Expansion of infrastructure and commercial spending on Zomig
and Rytary caused operating expenses to increase in 2012.
Full-year adjusted earnings of Impax Laboratories came in at
$1.91 per share, well above the Zacks Consensus Estimate of $1.78
and approximately 95% above the year-ago earnings. Revenues
climbed 13% to $581.7 million in 2012, above the Zacks Consensus
Estimate of $576 million.
The financial guidance of 2013 includes anticipated launch
expenses related to Rytary on its approval.
Total research and development expenses in the generic and
brand divisions of Impax Laboratories are expected in the range
of $87-$95 million. This however excludes patent litigation
Generic research and development expenses are expected in the
range of $49-$53 million, where as, brand research and
development expenses are expected in the range of $38-$42
Impax Laboratories estimates patent litigation expenses in the
range of $10-$12 million.
Selling, general and administrative expenses should be in the
range of $115-$120 million, down from the previous estimate of
We believe that the investor focus will remain on the approval
status of Rytary. Notably, a New Drug Application (NDA) for
Rytary was filed in Dec 2011. However, in Jan 2013, the FDA
issued a complete response letter in relation to the NDA for
Rytary. We note that the company is seeking approval for Rytary
for the treatment of Parkinson's diseases. The company intends to
work closely with the FDA to resolve the issues raised in the
Impax Laboratories currently carries a Zacks Rank #4 (Sell).
However, stocks such as
Salix Pharmaceuticals Ltd.
Avanir Pharmaceuticals, Inc.
) appear to be more favorably placed. They all carry a Zacks Rank
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