Impax Pharmaceuticals Licenses Exclusive U.S. Commercialization Rights to Zomig® (zolmitriptan) from AstraZeneca
February 01 2012 - 8:00AM
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 approximately 60%.
- 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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