Expected to be Immediately Accretive to Impax’s Non-GAAP EPS in 2012
Impax Provides Updated 2012 Financial Outlook
HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Pharmaceuticals, the branded products business unit of
Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that it has
licensed from AstraZeneca the exclusive United States (U.S.) commercial
rights to Zomig® (zolmitriptan) tablet, orally disintegrating tablet,
and nasal spray formulations. As part of a Distribution, License,
Development and Supply Agreement, Impax will also have non-exclusive
rights to develop new products containing zolmitriptan and to
exclusively commercialize these products in the U.S. in connection with
the Zomig® brand. Under terms of the Agreement, Impax will pay
AstraZeneca quarterly payments totaling $130 million during 2012, and
thereafter, Impax will pay AstraZeneca tiered royalties on future sales
of zolmitriptan products. Impax will receive the benefit of the gross
profit on U.S. Zomig® sales commencing from January 1, 2012.
The transaction is expected to be immediately accretive on a
non-Generally Accepted Accounting Principles (GAAP) basis to Impax’s
earnings per share (EPS) in 2012 and potentially accretive on a GAAP
basis depending upon GAAP purchase price treatment, which will be
determined in due course.
“We are pleased to obtain a licensing agreement for Zomig®, consistent
with our goal to increase the revenue and financial contribution of our
Impax Pharmaceuticals business to Impax Labs,” said Michael Nestor,
president of Impax Pharmaceuticals. “Zomig®, with U.S. net sales for the
twelve months ended September 30, 2011 of $163 million, is a strong
neurology brand, and the nasal spray form has U.S. patents expiring as
late as 2021. The Zomig® product franchise fits well with the
capabilities of our neurology focused specialty sales force. It will
support the growth of our commercial organization as we prepare for the
potential launch of IPX066, our leading brand product candidate for
Parkinson’s Disease, and beyond.”
“We expect Zomig® will contribute meaningfully to our total company
revenues and earnings in 2012 and 2013. For the longer term
profitability of the brand business unit, we look to build sales of the
Zomig® nasal spray dosage form,” stated Larry Hsu, president and CEO of
Impax Laboratories. “The Zomig® license is the latest effort in our
active pursuit of additional long term growth opportunities for our
generic and brand businesses.”
Zomig® and Zomig-ZMT® are registered trademarks of the AstraZeneca group
of companies and are exclusively licensed in the U.S. to Impax in
connection with Impax’s commercialization of Zomig®. For more
information about Zomig®, go to www.zomig.com.
Impax Laboratories 2012 Financial Outlook
On January 9, 2012, Impax provided its 2012 financial outlook. The
Company has updated its 2012 financial outlook as noted below to reflect
the impact of the Distribution, License, Development and Supply
Agreement with AstraZeneca for Zomig®.
(Updated) - Gross margins as a percent of total revenues of
Total research and development (R&D) expenses across the generic and
brand divisions to approximate $89 million with generic R&D of
approximately $48 million and brand R&D of approximately $41 million.
Patent litigation expenses of approximately $10 million.
(Updated) - Selling, general and administrative (SG&A) expenses of
approximately $113 million. The Company expects to add approximately
20 sales representatives to its existing contract sales force of 64
reps to assist in the detailing of Zomig® and expects to incur
promotional costs to detail the product. In anticipation of approval
and launch of IPX066, the Company will be adding marketing, managed
markets and trade, medical affairs and compliance personnel, in
addition to spending on various marketing research. Included in the
$113 million estimate is approximately $6 million of expenses for the
existing contract sales force (approximately one-half of the annual
cost) which will continue to be reported as cost of goods sold through
June 30, 2012 as part of the Company’s co-promotion of Lyrica®.
Beginning July 1, 2012, upon expiration of the Company’s detailing
agreement of Lyrica®, the existing sales force costs will be accounted
for within SG&A.
Effective tax rate of approximately 36%.
Capital expenditures of approximately $78 million.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology-based specialty pharmaceutical
company applying its formulation expertise and drug delivery technology
to the development of controlled-release and specialty generics in
addition to the development of branded products. Impax markets its
generic products through its Global Pharmaceuticals division and markets
its branded products through the Impax Pharmaceuticals division.
Additionally, where strategically appropriate, Impax has developed
marketing partnerships to fully leverage its technology platform. Impax
is headquartered in Hayward, California, with a full range of
capabilities located in its Hayward, Philadelphia and Taiwan facilities.
For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, including the statements about
expected 2012 and 2013 revenues and earnings from Zomig®, these
statements are forward-looking in nature and express the beliefs and
expectations of management. Such statements are based on current
expectations and involve a number of known and unknown risks and
uncertainties that could cause the Company’s future results, performance
or achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Such risks and uncertainties include, but are not limited to, the effect
of current economic conditions on the Company’s industry, business,
financial position and results of operations, the ability to maintain an
effective system of internal control over financial reporting,
fluctuations in revenues and operating income, the ability to
successfully develop and commercialize pharmaceutical products,
reductions or loss of business with any significant customer or a
reduction in sales of any significant product, the impact of
competition, the ability to sustain profitability and positive cash
flows, any delays or unanticipated expenses in connection with the
operation of the Taiwan facility, the effect of foreign economic,
political, legal and other risks on operations abroad, the uncertainty
of patent litigation, consumer acceptance and demand for new
pharmaceutical products, the difficulty of predicting Food and Drug
Administration filings and approvals, the inexperience of the Company in
conducting clinical trials and submitting new drug applications, the
ability to successfully conduct clinical trials, reliance on alliance
and collaboration agreements, the availability of raw materials, the
ability to comply with legal and regulatory requirements governing the
pharmaceuticals and healthcare industries, the regulatory environment,
the ability to protect the Company’s intellectual property, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed with the Securities and Exchange Commission.
Forward-looking statements speak only as to the date on which they are
made, and Impax undertakes no obligation to update publicly or revise
any forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
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Source: Impax Laboratories, Inc.