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| LLY > SEC Filings for LLY > Form 8-K on 29-Jan-2009 | All Recent SEC Filings |
29-Jan-2009
Results of Operations and Financial Condition
Charges related to the acquisition of ImClone Systems, including in-process research and development, as well as ImClone operating results subsequent to the acquisition, incremental interest costs and amortization of the intangible asset associated with Erbituxฎ.
Asset impairments, restructuring and other special charges.
A tax benefit based upon the determination at final resolution of the agreement that a portion of the EDPA settlement charge, taken in the third quarter of 2008, is tax deductible.
The following items in the third quarter of 2008:
Charges related to Zyprexa investigations with the U.S. Attorney for the Eastern District of Pennsylvania, as well as the resolution of a multi-state investigation regarding Zyprexa involving 32 states and the District of Columbia.
Asset impairments and restructuring primarily driven by the sale of its Greenfield, Indiana site.
Acquired in-process research and development associated with the SGX acquisition.
The following items in the second quarter of 2008:
Restructuring (exit costs) and other special charges, primarily associated with previously-announced strategic exit activities related to manufacturing operations.
Asset impairments associated with certain manufacturing operations (included in cost of sales).
In-process research and development (IPR&D) charges associated with the licensing arrangement with TransPharma Medical Ltd.
The following items in the first quarter of 2008:
A tax benefit from resolution of a substantial portion of an IRS audit of the company's federal income tax returns for the years 2001 to 2004.
Asset impairments, restructuring (exit costs), and other special charges primarily related to the decision to terminate the development of the company's AIR Insulin program.
In-process research and development charges associated with an in-licensing transaction with BioMS Medical.
The following charges in the fourth quarter of 2007:
ง Acquired in-process research and development charges for compounds acquired from Macrogenics and Glenmark.
ง Asset impairments and restructuring and other special charges related to previously announced site closures and Zyprexa product liability.
A charge for a reduction in our expected product liability insurance recoveries in the third quarter of 2007.
In-process research and development charges associated with the acquisitions of Hypnion, Inc. and Ivy Animal Health, Inc. in the second quarter of 2007.
The following charges in the first quarter of 2007:
ง Restructuring charges associated with previously announced manufacturing decisions.
ง Acquired in-process research and development charges associated with the acquisition of ICOS Corporation (which closed on January 29, 2007) and an in-licensing transaction with OSI Pharmaceuticals.
In addition, the pro forma non-GAAP presentation assumes that the acquisition of
ICOS was completed on January 1, 2007, and includes adjustments to the full year
of 2007 for the ICOS acquisition.
In the press release attached as Exhibit 99.1, we also confirmed financial
expectations for 2009. In addition to providing earnings per share expectations
on a GAAP basis, we provided earnings per share expectations on an pro forma
non-GAAP basis. In order to provide additional insight into the
earnings-per-share growth comparison between 2008 results and expected 2009
results, we:
Adjusted 2008 earnings per share for the 2008 items described above
Present 2008 as if the ImClone acquisition were completed on January 1, 2008
Show the anticipated dilutive impact in 2009 of the ImClone acquisition
The items that we exclude when we provide non-GAAP results or expectations are
typically highly variable, difficult to predict, and of a size that could have a
substantial impact on our reported operations for a period. We believe that
these non-GAAP measures provide useful information to investors. Among other
things, they may help investors evaluate our ongoing operations. They can assist
in making meaningful period-over-period comparisons and in identifying operating
trends that would otherwise be masked or distorted by the items subject to the
adjustments. Management uses these non-GAAP measures internally to evaluate the
performance of the business, including to allocate resources and to evaluate
results relative to incentive compensation targets.
Investors should consider these non-GAAP measures in addition to, not as a
substitute for or superior to, measures of financial performance prepared in
accordance with GAAP. For the reasons described above for use of non-GAAP
measures, our prospective earnings guidance is subject to adjustment for certain
future matters, similar to those identified above, as to which prospective
quantification generally is not feasible.
In accordance with GAAP, we have provided pro forma results in order to help
investors make meaningful comparisons of 2008 to 2007 results and 2009
expectations and identify underlying operating trends that might otherwise be
masked by the inclusion of ICOS results in a part of 2007 or ImClone results in
a part of 2008.
The information in this Item 2.02 and the press release attached as Exhibit 99.1
are considered furnished to the Commission and are not deemed filed for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended.
Item 9.01. Financial Statements and Exhibits
Exhibit Number Description
99.1 Press release dated January 29, 2009, together with related attachments.
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