e8vk
SECURITIES AND EXCHANGE COMMISSION
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 29, 2008
ELI LILLY AND COMPANY
(Exact name of registrant as specified in its charter)
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Indiana |
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001-06351 |
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35-0470950 |
(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.) |
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Lilly Corporate Center
Indianapolis, Indiana
(Address of Principal
Executive Offices)
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46285
(Zip Code) |
Registrants telephone number, including area code: (317) 276-2000
No Change
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On January 29, 2008, we issued a press release announcing our results of operations for the quarter
and fiscal year ended December 31, 2007, including, among other things, an income statement for
those periods. In addition, on the same day we held a teleconference for analysts and media to
discuss those results. The teleconference was webcast and podcast on our web site. The press release and
related financial statements are attached to this Form 8-K as Exhibit 99.1.
For the fourth quarter and full year 2007, the press release attached as Exhibit 99.1 includes an
adjusted pro forma presentation of our results. We use non-GAAP financial measures, such as
adjusted pro forma net income and adjusted pro forma earnings per share, that differ from financial
statements reported in conformity to U.S. generally accepted accounting principles (GAAP). In
the press release attached as Exhibit 99.1, we used non-GAAP financial measures in comparing the
financial results for the fourth quarter and full year 2007 with the same periods of 2006. Those
measures include operating income, income before taxes, income taxes, effective tax rate, net
income, and earnings per share adjusted to exclude the effect of the following charges (described
in more detail in the press release attached as Exhibit 99.1):
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We exclude the following charges that occurred in the fourth quarter of 2007: |
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Acquired in-process research and development charges for compounds acquired from
Macrogenics and Glenmark. |
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Asset impairments and restructuring related primarily to previously announced
site closures and other special charges related to Zyprexa product liability. |
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We exclude a charge for a reduction in our expected product liability insurance
recoveries that occurred in the third quarter of 2007. |
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We exclude the in-process research and development charges associated with the
acquisitions of Hypnion, Inc. and Ivy Animal Health, Inc. that occurred in the second
quarter of 2007. |
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We exclude the following charges that occurred in the first quarter of 2007: |
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Restructuring charges associated with previously announced manufacturing
decisions. |
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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 adjusted presentation assumes that the acquisition of ICOS was completed
on January 1, 2006, and includes adjustments to the fourth
quarter of 2006 and full years of both 2006
and 2007 for the ICOS acquisition.
2
In the press release attached as Exhibit 99.1, we also confirmed financial expectations for 2008.
In addition to providing earnings per share expectations on a GAAP basis, we provided earnings per
share expectations on an adjusted pro forma basis. In order to provide additional insight into the
earnings-per-share growth comparison between 2007 results and expected 2008 results, we:
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Adjusted 2007 earnings per share for the 2007 items described above |
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Adjusted expected 2008 earnings per share for an anticipated acquired in-process
research and development charge for an in-licensing transaction with BioMS Medical (as
described in the press release) |
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Assumed that the ICOS acquisition was completed on January 1, 2006. |
The items that we exclude when we provide adjusted results or adjusted 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 2007 to 2006 results and identify underlying operating trends that might
otherwise be masked by the inclusion of ICOS results in a part of 2007.
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
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Exhibit Number |
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Description |
99.1
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Press release dated January 29, 2008, together with related attachments |
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ELI LILLY AND COMPANY
(Registrant) |
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By: |
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/s/ Arnold
C. Hanish |
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Name:
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Arnold C. Hanish |
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Title:
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Executive Director, Finance,
and Chief Accounting Officer |
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Dated: January 29, 2008 |
4
EXHIBIT INDEX
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Exhibit Number |
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Exhibit |
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99.1
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Press release dated January 29, 2008, together with related
attachments. |
5
exv99w1
Exhibit 99.1
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
Date: January 29, 2008
For Release: Immediately
Refer to: (317) 276-5795 Mark E. Taylor
Lilly Caps Successful Year with Strong Fourth-Quarter Results
Q4 reported results include 22 percent sales growth and EPS of $.78
Q4 pro forma adjusted results include 16 percent sales growth and EPS of $.90
Full-year results highlighted by double-digit growth in both sales and EPS
Eli Lilly and Company (NYSE: LLY) today announced financial results for the fourth quarter and full
year of 2007.
Throughout this release, financial results are presented on both a reported and a pro forma
adjusted basis. Reported results were prepared in accordance with generally accepted accounting
principles (GAAP) and include all sales and expenses recognized by the company during the period.
Pro forma adjusted results exclude items described in the reconciliation tables below and also
assume the ICOS acquisition was completed January 1, 2006. The pro forma adjusted results are
presented in order to provide additional insights into the underlying trends in the business.
Financial guidance is also provided on both a reported and a pro forma adjusted basis.
Fourth-Quarter Highlights Reported Results
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Sales increased 22 percent, to $5.190 billion. |
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Products launched this decade Alimta®, Byetta®,
Cialis®, Cymbalta®, Forteo®, Strattera®,
Symbyax®, Xigris® and Yentreve® collectively grew 55
percent, to $1.7 billion, and accounted for 33 percent of total sales, compared with 26
percent of total sales in the fourth quarter of 2006. |
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Net income and earnings per share grew to $854.4 million and $.78,
respectively, compared with fourth-quarter 2006 net income of $132.3 million and
earnings per share of $.12. |
Fourth-Quarter Highlights Pro Forma Adjusted Results
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Sales increased 16 percent, to $5.190 billion. |
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Sales of products launched this decade collectively grew 30 percent and
represented 33 percent of total sales. |
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Net income and earnings per share both grew 10 percent, to $986.4 million and
$.90, respectively. |
2007 Highlights Reported Results
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Sales increased 19 percent, to $18.634 billion. |
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Sales of products launched this decade collectively grew 57 percent and
represented 32 percent of total sales, compared with 24 percent of total sales in 2006. |
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Net income and earnings per share both grew 11 percent, to $2.953 billion and
$2.71, respectively. |
2007 Highlights Pro Forma Adjusted Results
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Sales increased 14 percent to $18.706 billion |
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Sales of products launched this decade collectively grew 33 percent and
represented 32 percent of total sales, compared with 28 percent of total sales in 2006. |
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Net income and earnings per share both grew 17 percent, to $3.863 billion and
$3.54, respectively. |
Product Sales Highlights
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% Change |
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% Change |
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Fourth Quarter |
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Over/(Under) |
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Full Year |
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Over/(Under) |
(Dollars in millions) |
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2007 |
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2006 |
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2006 |
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2007 |
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2006 |
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2006 |
Zyprexa® |
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$ |
1,273.9 |
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$ |
1,156.5 |
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10 |
% |
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$ |
4,761.0 |
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$ |
4,363.6 |
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9 |
% |
Cymbalta |
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628.3 |
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424.1 |
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48 |
% |
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2,102.9 |
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1,316.4 |
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60 |
% |
Gemzar® |
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425.5 |
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371.3 |
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15 |
% |
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1,592.4 |
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1,408.1 |
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13 |
% |
Humalog® |
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414.2 |
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352.2 |
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18 |
% |
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1,474.6 |
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1,299.5 |
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13 |
% |
Cialis1 |
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346.2 |
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54.6 |
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N/M |
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1,143.8 |
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215.8 |
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N/M |
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Evista® |
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285.8 |
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270.3 |
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6 |
% |
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1,090.7 |
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1,045.3 |
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4 |
% |
Humulin® |
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273.4 |
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257.0 |
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6 |
% |
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985.2 |
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925.3 |
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6 |
% |
Alimta |
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244.1 |
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171.4 |
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42 |
% |
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854.0 |
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611.8 |
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40 |
% |
Forteo |
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198.2 |
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172.1 |
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15 |
% |
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709.3 |
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594.3 |
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19 |
% |
- 2 -
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% Change |
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% Change |
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Fourth Quarter |
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Over/(Under) |
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Full Year |
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Over/(Under) |
(Dollars in millions) |
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2007 |
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2006 |
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2006 |
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2007 |
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2006 |
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2006 |
Strattera |
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156.8 |
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156.3 |
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0 |
% |
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569.4 |
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579.0 |
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(2 |
)% |
Total Sales Reported |
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$ |
5,189.6 |
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$ |
4,245.3 |
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22 |
% |
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$ |
18,633.5 |
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$ |
15,691.0 |
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19 |
% |
Total Sales Pro forma |
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$ |
5,189.6 |
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$ |
4,459.9 |
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16 |
% |
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$ |
18,706.2 |
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$ |
16,446.2 |
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14 |
% |
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1 |
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These amounts represent the reported Cialis sales in Lillys financial statements and
do not include Cialis sales from the joint-venture countries prior to the ICOS acquisition on
January 29, 2007. Total worldwide Cialis sales for the fourth quarter of 2007 of $346.2
million represent 29 percent growth over the fourth quarter of 2006. Full-year 2007 worldwide
Cialis sales were $1.216 billion and represented 25 percent growth over full-year 2006. |
Significant Events Over the Last Three Months
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On December 26, 2007, the company, along with its partner, Daiichi Sankyo Company,
Limited, submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug
Administration (FDA). The proposed trade name for prasugrel is EffientTM. The
submission follows the release of results of the TRITON TIMI-38 Phase III head-to-head
study of prasugrel versus clopidogrel in November at a meeting of the American Heart
Association. |
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In December, the company announced that Sidney Taurel, chief executive officer and
chairman of the board, will retire as CEO effective March 31, 2008. Taurel will remain
chairman of the companys board of directors until December 31, 2008, at which time he will
retire from the board and from the company. John C. Lechleiter, Ph.D., currently president
and chief operating officer, will assume the role of chief executive officer as of April 1,
2008. |
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In January 2008, the FDA approved Cialis for once-daily use to treat erectile
dysfunction. |
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In December, the company entered into a licensing and development agreement with BioMS
Medical Corp., granting Lilly exclusive worldwide rights to BioMS Medicals lead multiple
sclerosis (MS) compound, MBP8298. The compound is currently being evaluated in two pivotal
phase III clinical trials in secondary progressive MS (SPMS) and one Phase II clinical
trial in relapsing-remitting MS (RRMS). The transaction closed in January, 2008. |
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In December, the company ceased production at its manufacturing facility in Basingstoke,
England as part of the previously-announced site closure. |
- 3 -
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In November, the FDA approved Cymbalta for the maintenance treatment of major depressive
disorder (MDD) in adults. |
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In October, the company acquired the rights to a portfolio of transient receptor
potential vanilloid sub-family 1 (TRPV1) antagonist molecules from Glenmark Pharmaceuticals
S.A. The lead compound, GRC 6211, is currently in Phase II development as a potential
next-generation treatment for various pain conditions, including osteoarthritic pain. |
Lilly completed a very successful year by continuing to deliver strong financial results to our
shareholders in the fourth quarter, commented Sidney Taurel, chairman and chief executive officer.
Our additional investment in sales and marketing helped fuel accelerated double-digit sales growth
this quarter, which was once again driven mainly by volume. Our performance provided the financial
flexibility we sought to make appropriate investments in research and development, resulting in an
unprecedented 16 new candidates entering the clinic in 2007 and the execution of several strategic
in-licensing transactions. Looking ahead to 2008, Lilly is intent on building upon the success of
the past year, while driving change, continuing productivity initiatives and achieving superior
results under the leadership of John Lechleiter.
Fourth-Quarter Reported Results
Worldwide reported sales for the quarter were $5.190 billion, an increase of 22 percent compared
with the fourth quarter of 2006. Worldwide sales volume increased 15 percent, while exchange rates
and selling prices contributed 4 and 3 percentage points of sales growth, respectively.
Gross margin as a percent of sales decreased by 0.5 percentage points, to 75.5 percent. This
decrease was primarily due to the impact of foreign exchange rates and the expense resulting from
the amortization of the intangible assets acquired in the ICOS acquisition, offset in part by
manufacturing expenses growing at a slower rate than sales.
Overall, marketing, selling and administrative expenses rose 34 percent, to $1.756 billion. This
increase was largely due to the impact of the ICOS acquisition, as well as increased marketing and
selling expenses in support of key products, primarily Cymbalta and the diabetes care products, and
the impact of foreign exchange rates. Research and development expenses were
$953.6 million, or 18 percent of sales. Compared with the fourth quarter of 2006, research and
- 4 -
development expenses grew 11 percent. In addition to the acquisition of ICOS, this growth was due
to increases in discovery research and late-stage clinical trial costs.
Other income decreased by $70.6 million, to $32.1 million, primarily due to the acquisition of ICOS
and higher net interest expense. Prior to the acquisition of ICOS, the results of the Lilly ICOS
joint venture were presented in other income. Subsequent to the acquisition, all sales and expenses
associated with Cialis are included in their respective lines on Lillys income statement.
The reported effective tax rate was 18.8 percent, down from 38.5 percent in the fourth quarter of
2006. The reported effective tax rate of 18.8 percent was favorably impacted by changes in
estimates of the anticipated tax rate benefit from our international operations in the fourth
quarter of 2007. The 38.5 percent effective tax rate in the fourth quarter of 2006 was negatively
impacted by the lower tax benefit associated with a fourth-quarter 2006 Zyprexa product liability
charge.
Reported net income and earnings per share increased to $854.4 million and $.78, respectively,
compared with fourth-quarter 2006 net income of $132.3 million and earnings per share of $.12 due
primarily to fourth-quarter 2006 asset impairment, restructuring and Zyprexa product liability
charges. Fourth-quarter 2007 reported results include a $.07 per share charge for asset
impairments, restructuring and other special charges described in footnote (a) of the attached pro
forma adjusted income statement, as well as a $.05 per share charge related to acquired in-process
research and development associated with the MacroGenics and Glenmark in-licensing transactions.
Fourth-Quarter Pro Forma Adjusted Results
Worldwide pro forma sales for the fourth quarter of 2007 were $5.190 billion, an increase of 16
percent compared with the fourth quarter of 2006. Worldwide pro forma sales volume increased 8
percent, while exchange rates and selling prices each contributed 4 percentage points of the sales
growth. Gross margin as a percent of sales decreased by 0.6 percentage points, to 75.5 percent.
Marketing, selling and administrative expenses and research and development expenses increased 23
percent and 7 percent, respectively. Total operating expenses grew 17 percent. Other income
decreased $6.8 million. The effective tax rate was 20.4 percent.
- 5 -
Pro forma adjusted net income and earnings per share both grew 10 percent, to $986.4 million and
$.90, respectively, as a result of cost of sales and marketing and administrative expenses in
support of key growth products both growing at a faster rate than sales. Pro forma adjusted results
exclude the charges noted in the table below. For further detail, see the reconciliation below as
well as the footnotes to the pro forma adjusted income statement later in this press release.
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Fourth Quarter |
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Earnings per Share Reconciliation |
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2007 |
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2006 |
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% Growth |
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E.P.S. (reported) |
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$ |
.78 |
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$ |
.12 |
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Eliminate asset impairments,
restructuring and other special charges |
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.07 |
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.73 |
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Eliminate in-process research and
development charges associated with
MacroGenics and Glenmark in-licensings |
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.05 |
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Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
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(.03 |
) |
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E.P.S. (pro forma adjusted) |
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$ |
.90 |
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$ |
.82 |
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10 |
% |
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Full-Year 2007 Reported Results
Worldwide reported sales for the full-year 2007 were $18.634 billion, an increase of 19 percent
compared with 2006. Worldwide sales volume increased 12 percent, while exchange rates and selling
prices each contributed 3 percentage points of sales growth, respectively. (Numbers do not add due
to rounding).
Gross margin as a percent of sales decreased by 0.2 percentage points, to 77.2 percent. This
decrease was primarily due to the expense resulting from the amortization of the intangible assets
acquired in the ICOS acquisition, the impact of foreign exchange rates and production volumes
growing at a slower rate than sales, partially offset by manufacturing expenses growing at a slower
rate than sales.
Overall, marketing, selling and administrative expenses rose 25 percent, to $6.095 billion. This
increase was largely due to the impact of the ICOS acquisition, as well as increased marketing and
selling expenses in support of key products, primarily Cymbalta and the diabetes care
products, and the impact of foreign exchange rates. Research and development expenses were
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$3.487
billion, or 19 percent of sales. Compared with 2006, research and development expenses increased 11
percent. In addition to the acquisition of ICOS, this increase was due to increases in discovery
research and late-stage clinical trial costs.
Other income decreased by $115.8 million, to $122.0 million, primarily due to the acquisition of
ICOS and higher net interest expense, offset in part by higher business development income
resulting from out-licensing of development-stage products. Prior to the acquisition of ICOS, the
results of the Lilly ICOS joint venture were presented in other income. Subsequent to the
acquisition, all sales and expenses associated with Cialis are included in their respective lines
on Lillys income statement.
The reported effective tax rate was 23.8 percent, up from 22.1 percent in 2006.
Full-year 2007 reported net income and earnings per share both increased 11 percent to $2.953
billion and $2.71, respectively, compared with 2006 net income of $2.663 billion and earnings per
share of $2.45. The 2007 and 2006 reported results include all charges listed in the reconciliation
table below.
Full-Year 2007 Pro Forma Adjusted Results
Worldwide pro forma sales for the full-year 2007 were $18.706 billion, an increase of 14 percent
compared with 2006. Worldwide pro forma sales volume increased 7 percent, while exchange rates and
selling prices contributed 3 and 4 percentage points of the sales growth, respectively. Gross
margin as a percent of sales decreased by 0.1 percentage points, to 77.2 percent. Marketing,
selling and administrative expenses and research and development expenses increased 16 percent and
7 percent, respectively. Total operating expenses grew 12 percent. Other income increased by $97.1
million. The effective tax rate was 21.4 percent.
As a result of pro forma sales growing faster than operating expenses and higher other income, 2007
pro forma adjusted net income and earnings per share both grew 17 percent, to $3.863 billion and
$3.54, respectively. Pro forma adjusted results exclude the charges noted in the table below. For
further detail, see the reconciliation below as well as the footnotes to the pro forma adjusted
income statement later in this press release.
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Full Year |
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Earnings per Share Reconciliation |
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2007 |
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2006 |
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% Growth |
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E.P.S. (reported) |
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$ |
2.71 |
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$ |
2.45 |
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Eliminate asset impairments,
restructuring and other special charges |
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.15 |
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.73 |
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Eliminate charge for a reduction in
expected insurance recoveries |
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.06 |
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Eliminate in-process research &
development charges associated with ICOS,
Hypnion, and Ivy acquisitions and OSI,
MacroGenics and Glenmark in-licensing
transactions |
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.63 |
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Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
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(.01 |
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(.15 |
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E.P.S. (pro forma adjusted) |
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$ |
3.54 |
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$ |
3.03 |
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17 |
% |
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|
Zyprexa
In the fourth quarter of 2007, Zyprexa sales totaled $1.274 billion, a 10 percent increase compared
with the fourth quarter of 2006. U.S. sales of Zyprexa increased 11 percent, to $608.6 million, due
to higher prices and increased volume caused by variations in wholesaler buying patterns. Demand
was essentially flat in the U.S. Zyprexa sales in international markets increased 10 percent, to
$665.3 million, driven by the favorable impact of foreign exchange rates. Demand outside the U.S.
was essentially flat, as growth in Japan and several European markets was offset by the impact of
generic competition in Canada and Germany.
For the full year of 2007, worldwide Zyprexa sales increased 9 percent, to $4.761 billion. U.S.
Zyprexa sales for 2007 were $2.236 billion, a 6 percent increase driven by higher net selling
prices, partially offset by lower demand. Zyprexa sales outside the U.S. were $2.525 billion, a 12
percent increase driven by the favorable impact of foreign exchange rates and increased demand.
Cymbalta
For the fourth quarter of 2007, Cymbalta generated $628.3 million in sales, an increase of 48
percent compared with the fourth quarter of 2006. U.S. sales of Cymbalta increased 45 percent, to
$547.3 million, driven primarily by strong demand and to a lesser extent increased prices.
- 8 -
Sales outside the U.S. were $81.0 million, an increase of 70 percent, driven primarily by higher
demand, as well as the favorable impact of foreign exchange rates.
For the full year of 2007, worldwide Cymbalta sales increased 60 percent, to $2.103 billion. U.S.
Cymbalta sales for 2007 were $1.836 billion, a 58 percent increase driven primarily by strong
demand. Cymbalta sales outside the U.S. were $267.3 million, a 70 percent increase, driven by
increased demand and favorable exchange rates.
Gemzar
Gemzar sales totaled $425.5 million for the fourth quarter, an increase of 15 percent from the
fourth quarter of 2006. Sales in the U.S. increased 11 percent, to $175.0 million, due to increased
demand and higher prices, while sales outside the U.S. increased 17 percent, to $250.5 million, as
a result of the favorable impact of foreign exchange rates and increased demand.
For the full year of 2007, worldwide Gemzar sales increased 13 percent, to $1.592 billion. U.S.
Gemzar sales for 2007 were $670.0 million, a 10 percent increase driven by higher prices and
increased demand. Gemzar sales outside the U.S. were $922.4 million, a 16 percent increase, driven
by increased demand and favorable exchange rates.
Humalog
For the fourth quarter of 2007, worldwide Humalog sales increased 18 percent, to $414.2 million.
Sales in the U.S. increased 10 percent to $248.5 million, driven by higher demand and increased
prices. Sales outside the U.S. increased 32 percent to $165.6 million, driven by strong demand and
the favorable impact of foreign exchange rates.
For the full year of 2007, worldwide Humalog sales increased 13 percent, to $1.475 billion. U.S.
Humalog sales for 2007 were $888.0 million, a 9 percent increase driven by higher prices and
increased demand. Humalog sales outside the U.S. were $586.6 million, a 20 percent increase, driven
by increased demand and favorable exchange rates, offset in part, by declining prices.
Cialis
Cialis sales for the fourth quarter were $346.2 million. Worldwide sales of Cialis grew 29 percent
compared with fourth-quarter 2006. U.S. sales of Cialis were $133.0 million in the fourth quarter,
a 24 percent increase compared with the fourth quarter of 2006, driven by higher prices
- 9 -
and increased demand. Sales of Cialis outside the U.S. increased 31 percent to $213.2 million,
driven primarily by higher volume and the favorable impact of foreign exchange rates.
For the full year of 2007, worldwide Cialis sales increased 25 percent, to $1.216 billion. U.S.
Cialis sales for 2007 were $458.5 million, a 20 percent increase driven by higher demand and higher
prices. Cialis sales outside the U.S. were $758.0 million, a 28 percent increase, driven by
increased demand, favorable exchange rates and higher prices.
Prior to the acquisition of ICOS on January 29, 2007, Cialis sales in Lilly territories were
reported in Lillys revenue, while Lillys 50 percent share of the joint-venture territory sales,
net of expenses, was reported in Lillys other income. After the acquisition of ICOS, all Cialis
sales are reported in Lillys revenue.
Evista
Evista sales were $285.8 million in the fourth quarter, a 6 percent increase compared with the
fourth quarter of 2006. U.S. sales of Evista increased 6 percent, to $187.7 million, driven by
higher prices. Sales outside the U.S. increased 5 percent, to $98.1 million, driven primarily by
favorable exchange rates and higher prices, partially offset by lower demand.
For the full year of 2007, worldwide Evista sales increased 4 percent, to $1.091 billion. U.S.
Evista sales for 2007 were $706.1 million, a 6 percent increase driven by higher prices. Evista
sales outside the U.S. were $384.6 million, a 1 percent increase, driven by favorable exchange
rates, offset in part by declining prices and lower demand.
Humulin
Worldwide Humulin sales increased 6 percent in the fourth quarter, to $273.4 million. U.S. sales
declined 2 percent to $101.5 million due to lower demand, partially offset by higher prices. Sales
outside the U.S. increased 12 percent to $171.9 million, driven primarily by the favorable impact
of foreign exchange rates.
For the full year of 2007, worldwide Humulin sales increased 6 percent, to $985.2 million. U.S.
Humulin sales for 2007 were $365.2 million, a 1 percent decrease driven by lower demand, offset in
part by higher prices. Humulin sales outside the U.S. were $620.1 million, an 11 percent
- 10 -
increase, driven by increased demand and favorable exchange rates, partially offset by lower
prices.
Alimta
For the fourth quarter of 2007, Alimta generated sales of $244.1 million, an increase of 42 percent
compared with the fourth quarter of 2006. U.S. sales of Alimta increased 33 percent, to $125.8
million, due primarily to increased demand, while sales outside the U.S. increased 54 percent, to
$118.3 million, due primarily to increased demand and the favorable impact of foreign exchange
rates.
For the full year of 2007, worldwide Alimta sales increased 40 percent, to $854.0 million. U.S.
Alimta sales for 2007 were $448.0 million, a 28 percent increase driven by increased demand and, to
a lesser extent, higher prices. Alimta sales outside the U.S. were $406.0 million, a 55 percent
increase, driven by increased demand and favorable exchange rates.
Forteo
Fourth-quarter sales of Forteo were $198.2 million, a 15 percent increase compared with the fourth
quarter of 2006. U.S. sales of Forteo increased 12 percent, to $138.4 million, driven primarily by
higher prices, partially offset by lower volume caused by variations in wholesaler buying patterns.
Sales outside the U.S. grew 24 percent, to $59.8 million, due to the favorable impact of foreign
exchange rates and higher demand.
For the full year of 2007, worldwide Forteo sales increased 19 percent, to $709.3 million. U.S.
Forteo sales for 2007 were $494.1 million, a 19 percent increase driven by higher net selling
prices. U.S. sales growth benefited from access to medical coverage through the Medicare Part D
program, decreased utilization of the companys U.S. patient assistance program and, to a lesser
extent, increased demand. Forteo sales outside the U.S. were $215.2 million, a 21 percent increase,
driven by increased demand and favorable exchange rates.
Strattera
During the fourth quarter of 2007, Strattera generated $156.8 million of sales, essentially flat
when compared with the fourth quarter of 2006. U.S. sales decreased 7 percent to $126.1 million,
- 11 -
due to a decline in demand. Sales outside the U.S. increased 49 percent to $30.6 million, due
primarily to higher demand and the favorable impact of foreign exchange rates.
For the full year of 2007, worldwide Strattera sales decreased 2 percent, to $569.4 million. U.S.
Strattera sales for 2007 were $464.6 million, a 9 percent decrease driven by lower demand.
Strattera sales outside the U.S. were $104.8 million, a 50 percent increase, driven by increased
demand and favorable exchange rates.
Other Diabetes Care Products
As previously disclosed, Lillys U.S. marketing rights with respect to Actos® expired in
September 2006; however, Lilly will continue to receive royalties from Takeda Pharmaceuticals North
America at a declining rate through September 2009. Lilly continues to market the product in many
countries outside the U.S. In the fourth quarter, Actos generated $93.2 million of revenue for
Lilly, the majority of which was outside the U.S. Actos revenue increased 4 percent versus the
fourth quarter of 2006. For the full-year 2007, Actos generated $370.6 million of revenue for
Lilly, a decrease of 17 percent versus 2006, reflecting the declining royalty rate from U.S. Actos
sales.
Worldwide sales of Byetta were $183.6 million in the fourth quarter, a 34 percent increase compared
with the fourth quarter of 2006. U.S. Byetta sales grew 29 percent to $176.3 million. Byetta sales
outside the U.S. were $7.3 million. Lilly reports as revenue its 50 percent share of Byettas gross
margin in the U.S., 100 percent of Byetta sales outside the U.S., and its sales of Byetta pen
delivery devices to its partner, Amylin Pharmaceuticals. For the fourth quarter, Lilly recognized
revenue totaling $92.1 million, representing a 34 percent increase compared with the fourth quarter
of 2006.
For the full year of 2007, worldwide Byetta sales increased 51 percent, to $650.2 million. U.S.
Byetta sales for 2007 were $636.0 million, a 48 percent increase driven by higher demand. Byetta
sales outside the U.S. were $14.2 million. For 2007, Lilly recognized revenue totaling $330.7
million, representing a 51 percent increase compared with 2006.
- 12 -
Animal Health
Worldwide sales of animal health products in the fourth quarter were $329.4 million, an increase of
27 percent compared with the fourth quarter of 2006. U.S. sales grew 37 percent to $179.7 million
driven by increased demand, the acquisition of Ivy Animal Health, Inc. and new companion animal
product launches. Sales outside the U.S. grew 16 percent to $149.7 million driven by increased
demand, the favorable impact of exchange rates and higher prices.
For the full year of 2007, worldwide sales of animal health products increased 14 percent, to
$995.8 million. U.S. animal health sales for 2007 were $480.9 million, an 18 percent increase
driven by increased demand, the acquisition of Ivy Animal Health, and new companion animal product
launches. Animal health sales outside the U.S. were $514.9 million, a 10 percent increase, driven
by favorable exchange rates and increased demand.
2008 Financial Guidance
The company confirmed its full-year 2008 financial guidance. For 2008, the company expects pro
forma sales to grow in the mid- to high-single digits, driven primarily by increased volume and
strong sales growth for Cymbalta, Cialis, Byetta, Alimta and Humalog. The company expects modest
improvement in gross margin as a percent of sales, driven primarily by manufacturing expenses
growing more slowly than sales. Total operating expenses are also expected to grow more slowly than
sales, with growth in the mid-single digits. Marketing, selling and administrative expenses are
expected to grow in the low-single digits, driven by investments in prasugrel, Cymbalta, Evista for
invasive breast cancer risk reduction, Humalog and Byetta, offset by decreases in other areas.
Research and development expenses are expected to grow in the high-single to low-double digits.
Other income is expected to contribute less than $100 million. The effective tax rate is expected
to be approximately 23 percent. Capital expenditures are projected to be approximately $1.1
billion.
The company expects 2008 pro forma adjusted earnings per share to be within the range of $3.85 to
$4.00. The pro forma adjusted earnings per share guidance excludes an estimated $.05 charge noted
in the table below related to the in-licensing transaction with BioMS. Including this $.05 charge,
the company expects reported earnings per share to be in the range of $3.80 to $3.95. See the
reconciliation table below for further detail.
- 13 -
Reconciliation of 2008 Earnings Per Share Expectations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
|
|
|
|
Expectations |
|
|
Results |
|
|
% Growth |
|
E.P.S. (reported) |
|
$3.80 to $3.95 |
|
|
$ |
2.71 |
|
|
|
|
|
Eliminate estimated
in-process research and
development charge
associated with BioMS
Medical in-licensing |
|
|
.05 |
|
|
|
|
|
|
|
|
|
Eliminate asset impairments,
restructuring and other
special charges |
|
|
|
|
|
|
.15 |
|
|
|
|
|
Eliminate charge for a
reduction in expected
insurance recoveries |
|
|
|
|
|
|
.06 |
|
|
|
|
|
Eliminate in-process
research & development
charges associated with
ICOS, Hypnion, and Ivy
acquisitions and OSI,
MacroGenics
and Glenmark
in-licensing transactions |
|
|
|
|
|
|
.63 |
|
|
|
|
|
Include pro forma as if the
ICOS acquisition was
completed on January 1, 2006 |
|
|
|
|
|
|
(.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$3.85 to $4.00 |
|
|
$ |
3.54 |
|
|
9% to 13% |
|
|
|
|
|
|
|
|
|
|
|
|
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the
fourth-quarter and full-year 2007 financial results conference call through a link on Lillys
website at www.lilly.com. The conference call will be held today from 9:00 a.m. to 10:00 a.m.
Eastern Standard Time (EST) and will be available for replay via the website through February 29,
2008.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class
and best-in-class pharmaceutical products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers through medicines and information for some of the
worlds most urgent medical needs. Additional information about Lilly is available at
www.lilly.com; Lillys clinical trial registry is available at www.lillytrials.com.
F-LLY
This press release contains forward-looking statements that are based on managements current
expectations, but actual results may differ materially due to various factors. There are
significant risks and uncertainties in pharmaceutical research and development. There can be no
guarantees with respect to pipeline products that the
- 14 -
products will receive the necessary clinical and manufacturing regulatory approvals or that they
will prove to be commercially successful. The companys results may also be affected by such
factors as competitive developments affecting current products; rate of sales growth of recently
launched products; the timing of anticipated regulatory approvals and launches of new products;
regulatory actions regarding currently marketed products; other regulatory developments and
government investigations; patent disputes and other litigation involving current and future
products; the impact of governmental actions regarding pricing, importation, and reimbursement for
pharmaceuticals; changes in tax law; asset impairments and restructuring charges; acquisitions and
business development transactions; and the impact of exchange rates. For additional information
about the factors that affect the companys business, please see the companys latest Form 10-Q
filed November 2007. The company undertakes no duty to update forward-looking statements.
# # #
Actos® (pioglitazone hydrochloride, Takeda)
Alimta® (pemetrexed, Lilly)
Byetta® (exenatide injection, Amylin Pharmaceuticals)
Cialis® (tadalafil, Lilly)
Cymbalta® (duloxetine hydrochloride, Lilly)
Effient TM (prasugrel, Lilly)
Evista® (raloxifene hydrochloride, Lilly)
Forteo® (teriparatide of recombinant DNA origin injection, Lilly)
Gemzar® (gemcitabine hydrochloride, Lilly)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Humulin® (human insulin of recombinant DNA origin, Lilly)
Strattera® (atomoxetine hydrochloride, Lilly)
Symbyax® (olanzapine fluoxetine combination, or OFC, Lilly)
Xigris® (drotrecogin alfa (activated), Lilly)
Yentreve® (duloxetine hydrochloride, Lilly)
Zyprexa® (olanzapine, Lilly)
Eli Lilly and Company Employment Information
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
December 31, 2006 |
Worldwide Employees |
|
|
40,600 |
* |
|
|
41,500 |
|
|
|
|
* |
|
Headcount figures as of December 31, 2007 include certain personnel previously employed by Icos
Corporation, Hypnion, Inc. and Ivy Animal Health, Inc. |
- 15 -
Eli Lilly and Company
Operating Results (Unaudited) REPORTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31 |
|
December 31 |
|
|
2007 |
|
|
2006 |
|
|
% Chg. |
|
|
2007 |
|
|
2006 |
|
|
% Chg. |
|
Net sales |
|
$ |
5,189.6 |
|
|
$ |
4,245.3 |
|
|
|
22 |
% |
|
$ |
18,633.5 |
|
|
$ |
15,691.0 |
|
|
|
19 |
% |
|
Cost of sales |
|
|
1,272.8 |
|
|
|
1,019.0 |
|
|
|
25 |
% |
|
|
4,248.8 |
|
|
|
3,546.5 |
|
|
|
20 |
% |
Research and development |
|
|
953.6 |
|
|
|
858.0 |
|
|
|
11 |
% |
|
|
3,486.7 |
|
|
|
3,129.3 |
|
|
|
11 |
% |
Marketing, selling and
administrative |
|
|
1,755.8 |
|
|
|
1,310.8 |
|
|
|
34 |
% |
|
|
6,095.1 |
|
|
|
4,889.8 |
|
|
|
25 |
% |
Acquired in-process research
and development |
|
|
89.0 |
|
|
|
|
|
|
|
N/M |
|
|
|
745.6 |
|
|
|
|
|
|
|
N/M |
|
Asset impairments,
restructuring and other special
charges |
|
|
98.2 |
|
|
|
945.2 |
|
|
|
N/M |
|
|
|
302.5 |
|
|
|
945.2 |
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,020.2 |
|
|
|
112.3 |
|
|
|
N/M |
|
|
|
3.754.8 |
|
|
|
3,180.2 |
|
|
|
18 |
% |
|
Net interest income (expense) |
|
|
(2.1 |
) |
|
|
21.7 |
|
|
|
|
|
|
|
(13.0 |
) |
|
|
23.8 |
|
|
|
|
|
Joint-venture income |
|
|
|
|
|
|
30.2 |
|
|
|
|
|
|
|
11.0 |
|
|
|
96.3 |
|
|
|
|
|
Net other income |
|
|
34.2 |
|
|
|
50.8 |
|
|
|
|
|
|
|
124.0 |
|
|
|
117.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
32.1 |
|
|
|
102.7 |
|
|
|
|
|
|
|
122.0 |
|
|
|
237.8 |
|
|
|
|
|
|
Income before income taxes |
|
|
1,052.3 |
|
|
|
215.0 |
|
|
|
N/M |
|
|
|
3,876.8 |
|
|
|
3,418.0 |
|
|
|
13 |
% |
Income taxes |
|
|
197.9 |
|
|
|
82.7 |
|
|
|
N/M |
|
|
|
923.8 |
|
|
|
755.3 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
854.4 |
|
|
$ |
132.3 |
|
|
|
N/M |
|
|
$ |
2,953.0 |
|
|
$ |
2,662.7 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.78 |
|
|
$ |
0.12 |
|
|
|
N/M |
|
|
$ |
2.71 |
|
|
$ |
2.45 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.78 |
|
|
$ |
0.12 |
|
|
|
N/M |
|
|
$ |
2.71 |
|
|
$ |
2.45 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
|
$ |
1.70 |
|
|
$ |
1.60 |
|
|
|
6 |
% |
Weighted-average shares
outstanding (thousands)
basic |
|
|
1,092,472 |
|
|
|
1,088,612 |
|
|
|
|
|
|
|
1,090,430 |
|
|
|
1,086,239 |
|
|
|
|
|
Weighted-average shares
outstanding (thousands)
diluted |
|
|
1,092,636 |
|
|
|
1,089,097 |
|
|
|
|
|
|
|
1,090,750 |
|
|
|
1,087,490 |
|
|
|
|
|
|
|
|
N/M not meaningful |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- 16 -
Eli Lilly and Company
Operating Results (Unaudited) PRO FORMA ADJUSTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31 |
|
December 31 |
|
|
2007 (a)(d) |
|
|
2006 (c)(d) |
|
|
% Chg. |
|
|
2007 (b)(d) |
|
|
2006 (c)(d) |
|
|
|
%Chg. |
|
Net sales |
|
$ |
5,189.6 |
|
|
$ |
4,459.9 |
|
|
|
16 |
% |
|
$ |
18,706.2 |
|
|
$ |
16,446.2 |
|
|
|
14 |
% |
|
Cost of sales |
|
|
1,272.8 |
|
|
|
1,066.7 |
|
|
|
19 |
% |
|
|
4,264.7 |
|
|
|
3,730.0 |
|
|
|
14 |
% |
Research and development |
|
|
953.6 |
|
|
|
890.0 |
|
|
|
7 |
% |
|
|
3,498.7 |
|
|
|
3,260.1 |
|
|
|
7 |
% |
Marketing, selling and
administrative |
|
|
1,755.8 |
|
|
|
1,422.1 |
|
|
|
23 |
% |
|
|
6,131.0 |
|
|
|
5,308.2 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,207.4 |
|
|
|
1,081.1 |
|
|
|
12 |
% |
|
|
4,811.8 |
|
|
|
4,147.9 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) |
|
|
(2.1 |
) |
|
|
(17.2 |
) |
|
|
|
|
|
|
(25.5 |
) |
|
|
(126.1 |
) |
|
|
|
|
Joint-venture income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net other income |
|
|
34.2 |
|
|
|
56.1 |
|
|
|
|
|
|
|
126.0 |
|
|
|
129.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (deductions) |
|
|
32.1 |
|
|
|
38.9 |
|
|
|
|
|
|
|
100.5 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
1,239.5 |
|
|
|
1,120.0 |
|
|
|
11 |
% |
|
|
4,912.3 |
|
|
|
4,151.3 |
|
|
|
18 |
% |
Income taxes |
|
|
253.1 |
|
|
|
226.6 |
|
|
|
12 |
% |
|
|
1,048.9 |
|
|
|
857.4 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
986.4 |
|
|
$ |
893.4 |
|
|
|
10 |
% |
|
$ |
3,863.4 |
|
|
$ |
3,293.9 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.90 |
|
|
$ |
0.82 |
|
|
|
10 |
% |
|
$ |
3.54 |
|
|
$ |
3.03 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.90 |
|
|
$ |
0.82 |
|
|
|
10 |
% |
|
$ |
3.54 |
|
|
$ |
3.03 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
|
$ |
1.70 |
|
|
$ |
1.60 |
|
|
|
6 |
% |
Weighted-average shares
outstanding (thousands)
basic |
|
|
1,092,472 |
|
|
|
1,088,612 |
|
|
|
|
|
|
|
1,090,430 |
|
|
|
1,086,239 |
|
|
|
|
|
Weighted-average shares
outstanding (thousands)
diluted |
|
|
1,092,636 |
|
|
|
1,089,097 |
|
|
|
|
|
|
|
1,090,750 |
|
|
|
1,087,490 |
|
|
|
|
|
|
|
|
(a) |
|
The 2007 fourth-quarter amounts are adjusted to eliminate a charge of $89.0 million
(pre-tax) or $.05 per share (after-tax) for acquired in-process research and development
for compounds acquired from MacroGenics and Glenmark, and a charge of $98.2 million
(pre-tax) or $.07 per share (after-tax) for asset impairments, restructuring related to
previously announced site closures and other special charges related to Zyprexa product
liability, covering settlements, reserves for claims not covered by the settlements, and
defense costs. |
|
(b) |
|
The 2007 full-year amounts are adjusted to eliminate charges totaling $745.6 million
(pre-tax), or $.63 per share (after-tax), for acquired in-process research and development
associated with the ICOS, Hypnion and Ivy acquisitions and the in-licensing of compounds
from OSI, MacroGenics and Glenmark, a charge of $81.3 million (pre-tax) or $.06 (after-tax)
for special charges related to an adjustment to insurance |
- 17 -
|
|
|
|
|
recoverables on product litigation, as well as a $221.2 million (pretax) charge, or $.15 per
share (after-tax), for asset impairments, restructuring, and other special charges. |
|
(c) |
|
The 2006 fourth-quarter and full-year amounts are adjusted to eliminate a
fourth-quarter 2006 charge of $494.9 million (pretax), or $.42 per share (after-tax)
related to Zyprexa product liability, covering settlements, reserves for claims not covered
by the settlements, and defense costs. In addition, these amounts are also adjusted to
eliminate the $450.3 million (pretax), or $.31 per share (after-tax) charge for asset
impairments, restructuring and other special charges. |
|
(d) |
|
In accordance with generally accepted accounting principles (GAAP), the 2007 and 2006
financial statements have been restated assuming the acquisition of ICOS was completed by
Lilly effective January 1, 2006. |
- 18 -