HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ:IPXL) today provided its
full year 2014 financial outlook. The Company will discuss its 2014
outlook at the 32nd Annual J.P. Morgan Healthcare Conference
at 8:00 a.m. Pacific Standard Time today. Individuals may listen to the
live or an archived presentation made at the conference, which will be
posted in the investor relations section of the Company’s web site at www.impaxlabs.com.
This presentation will be archived on the Company’s web site for 30 days.
The Company’s full year 2014 estimates are based on management’s current
belief about prescription trends, pricing levels, inventory levels, and
the anticipated timing of future product launches and events. The
Company’s estimates exclude the impact from any products for which the
Company has not yet received approval from the U.S. Food and Drug
Administration.
2014 Financial Outlook
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Adjusted gross margins as a percent of total revenue are expected to
be in the low 50% range, excluding preliminary projections of Hayward
facility remediation costs.
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Total research and development (R&D) expenses across the generic and
brand divisions of approximately $82 million to $88 million; generic
R&D expenses of approximately $46 million to $49 million and brand R&D
expenses of approximately $36 million to $39 million.
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Patent litigation expenses of approximately $11 million to $13 million.
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Selling, general and administrative expenses of approximately $115
million to $120 million.
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Capital expenditures of approximately $40 million to $45 million.
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Effective tax rate of approximately 32% to 34% on a GAAP basis, which
assumes that the U.S. R&D tax credit is renewed for 2014. The R&D tax
credit expired on December 31, 2013. The Company anticipates that its
non-GAAP effective tax rate may experience volatility as the Company’s
tax benefits may be high compared to the Company’s operating income or
loss.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) 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 central nervous
system disorder 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 develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such as
injectables, nasal sprays, inhalers, patches, creams and ointments. 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; 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; fluctuations in revenues and operating income; the Company’s
ability to promptly correct the issues raised in the warning letter and
Form 483 observations received from the FDA; the Company’s ability to
successfully develop and commercialize pharmaceutical products in a
timely manner; reductions or loss of business with any significant
customer; the impact of consolidation of the Company’s customer base;
the impact of competition; the Company’s ability to sustain
profitability and positive cash flows; any delays or unanticipated
expenses in connection with the operation of the Company’s Taiwan
facility; the effect of foreign economic, political, legal, and other
risks on the Company’s operations abroad; the uncertainty of patent
litigation; the increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies; consumer acceptance and
demand for new pharmaceutical products; the impact of market perceptions
of the Company and the safety and quality of the Company’s products; the
difficulty of predicting FDA filings and approvals; the Company’s
ability to achieve returns on its investments in research and
development activities; the Company’s inexperience in conducting
clinical trials and submitting new drug applications; the Company’s
ability to successfully conduct clinical trials; the Company’s reliance
on third parties to conduct clinical trials and testing; impact of
illegal distribution and sale by third parties of counterfeits or stolen
products; the availability of raw materials and impact of interruptions
in the Company’s supply chain; the use of controlled substances in the
Company’s products; disruptions or failures in the Company’s information
technology systems and network infrastructure; the Company’s reliance on
alliance and collaboration agreements; the Company’s dependence on
certain employees; the Company’s ability to comply with legal and
regulatory requirements governing the healthcare industry; the
regulatory environment; the Company’s ability to protect its
intellectual property; exposure to product liability claims; changes in
tax regulations; the Company’s ability to manage growth, including
through potential acquisitions; the restrictions imposed by the
Company’s credit facility; uncertainties involved in the preparation of
the Company’s financial statements; the Company’s ability to maintain an
effective system of internal control over financial reporting; the
effect of terrorist attacks on the Company’s business; the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines 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 the Company undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
Source: Impax Laboratories, Inc.