e8vk
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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): April 16, 2007
ELI LILLY AND COMPANY
(Exact name of registrant as specified in its charter)
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Indiana
(State or Other Jurisdiction
of Incorporation)
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001-06351
(Commission
File Number)
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35-0470950
(I.R.S. Employer
Identification No.) |
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Lilly Corporate Center |
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
Item 2.02. Results of Operations and Financial Condition
On April 16, 2007, we issued a press release announcing our results of operations for the quarter
ended March 31, 2007, including, among other things, an income statement for that period. In
addition, on the same day we are holding a teleconference for analysts and media to discuss those
results. The teleconference will be web cast on our web site. The press release and related
financial statements are attached to this Form 8-K as Exhibit 99.1, and a 2006 pro forma
financial analysis is attached as Exhibit 99.2.
We use non-GAAP financial measures, such as adjusted net income and adjusted 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 first quarter of 2007 with the same period 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
affecting the first quarter of 2007 (described in more detail in the press release attached as
Exhibit 99.1):
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Restructuring charges associated with previously announced manufacturing decisions. |
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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, for the period ending March 31, 2007, we provided in the press release a pro forma
analysis of our results, prepared in accordance with GAAP, assuming that the acquisition of ICOS
was completed on January 1, 2006. This analysis includes adjustments to the first quarters of both
2006 and 2007 for the ICOS acquisition, as well as the adjustments described above for the first
quarter of 2007.
In the press release attached as Exhibit 99.1, we also provided financial expectations for the
second quarter and full year 2007. In addition to providing earnings per share expectations on a
GAAP basis, we provided earnings per share expectations on an adjusted basis and on a pro forma
basis (assuming the ICOS acquisition was completed January 1, 2006). In order to provide a more
meaningful earnings-per-share growth comparison between 2006 results and expected 2007 results, we
adjusted 2006 earnings per share for a product liability charge and asset impairments and
restructuring charges associated with manufacturing decisions recognized in the fourth quarter of
2006 (described in more detail in our Form 8-K dated January 29, 2007). We adjusted 2007 expected
earnings per share for the first-quarter 2007 items described above, and for the estimated
second-quarter in-process research and development charge associated with the acquisition of
Hypnion, Inc. (described in more detail in the press release attached as Exhibit 99.1). For the
pro forma presentation of our financial guidance, we also assumed that the ICOS acquisition was
completed on January 1, 2006.
Attached as Exhibit 99.2 is a pro forma 2006 financial analysis that will be made available on our
website in connection with the teleconference mentioned above. This analysis shows
2
consolidated income statements for each of the four quarters and the full year 2006, adjusted for
the 2006 items identified above and assuming 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.
Similarly, 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 2007.
The information in this Item 2.02, the press release attached as Exhibit 99.1, and the pro forma
financial analysis attached as Exhibit 99.2 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 April 16, 2007, together with related attachments |
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99.2
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Pro forma financial analysis |
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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: |
/s/ Derica W. Rice
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Name: |
Derica W. Rice |
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Title: |
Senior Vice President and Chief Financial Officer |
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Dated: April 16, 2007 |
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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 April 16, 2007, together with related attachments. |
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99.2
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Additional pro forma financial analysis |
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exv99w1
Exhibit 99.1
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
For Release: Immediately
Refer to: (317) 276-5795 Mark E. Taylor
Lilly Reports Strong First-Quarter Results; Raises Full-Year Sales and EPS Guidance
Q1 results include 14% sales growth and adjusted EPS of $.84; $.47 reported EPS
Company raises sales guidance to low-double-digit growth and adjusted EPS to $3.30 to $3.40 for 2007
Eli Lilly and Company (NYSE: LLY) today announced strong financial results for the first quarter of
2007 and raised its full-year sales and adjusted earnings per share guidance.
First-Quarter Highlights
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Sales increased 14 percent, to $4.226 billion. |
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Products launched this decade Alimta®,
Byetta®, Cialis®, Cymbalta®,
Forteo®, Strattera®,
Symbyax®, Xigris® and
Yentreve® collectively grew 57 percent, to
$1.259 billion, and accounted for 30 percent of total sales,
compared with 22 percent of total sales in the first quarter
of 2006. |
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Reported net income and earnings per share were $508.7
million and $.47, respectively, compared with first-quarter
2006 net income of $834.8 million and earnings per share of
$.77. Reported results include in-process research and
development charges associated with the ICOS acquisition and
OSI in-licensing agreement and restructuring charges
associated with previously announced manufacturing decisions. |
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Excluding these charges, adjusted net income and earnings per
share both grew 9 percent, to $913.3 million and $.84,
respectively. |
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On a pro forma basis, assuming the ICOS acquisition was
completed January 1, 2006, sales growth for the first quarter
was 11 percent, while adjusted net income and earnings per
share both grew 14 percent, to $901.9 million and $.83,
respectively. Additional pro forma information is provided
beginning on page 10 of this press release. |
Pharmaceutical Product Sales Highlights
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% Change |
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First Quarter |
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Over/(Under) |
(Dollars in millions) |
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2007 |
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2006 |
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2006 |
Zyprexa® |
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$ |
1,108.0 |
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$ |
1,007.4 |
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10 |
% |
Cymbalta |
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441.8 |
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233.3 |
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89 |
% |
Gemzar® |
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376.9 |
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338.8 |
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11 |
% |
Humalog® |
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339.5 |
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304.5 |
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11 |
% |
Evista® |
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263.8 |
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241.6 |
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9 |
% |
Humulin® |
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225.8 |
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218.5 |
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3 |
% |
Cialis1 |
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193.1 |
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55.4 |
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N/M |
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Alimta |
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187.8 |
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130.1 |
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44 |
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Forteo |
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153.4 |
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127.1 |
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21 |
% |
Strattera |
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139.9 |
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152.2 |
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(8 |
%) |
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This amount represents the reported sales in Lillys financial statements. Total
worldwide Cialis sales for the first quarter of 2007 were $265.8 million, representing 19 percent
growth. |
Significant Events Over the Last Three Months
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On January 29, 2007 Lilly completed the
acquisition of ICOS Corporation at a cost of
approximately $2.3 billion. The acquisition brings
the full value of Cialis to Lilly and enables the
company to realize operational efficiencies in the
further development, marketing and selling of this
product. Lilly expects the acquisition to be
accretive to earnings beginning in 2008. |
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In early January of 2007, Lilly licensed from OSI
Pharmaceuticals its glucokinase activator (GKA)
program for the treatment of type 2 diabetes,
including the lead compound PSN010. Lilly received
an exclusive license to develop and market any
compounds derived from the GKA program. |
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In February, Lilly announced that the U.S. Food
and Drug Administration (FDA) had approved
Cymbalta for the treatment of generalized anxiety
disorder (GAD). |
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In February, Lilly announced the launch of the
first insulin pen with memory, HumaPen® MEMOIR,
to help simplify the daily management of diabetes.
In addition, the company has launched
HumaPen® LUXURAä HD, an insulin
pen enabling half-unit dosing. |
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In early March, Lilly announced the acquisition of
Hypnion, Inc., a privately held neuroscience drug
discovery company focused on sleep disorders. The
deal expands Lillys presence in the area of sleep
disorder research and provides ownership of
HY10275, a novel Phase II insomnia compound with a
dual mechanism of action aimed at promoting better
sleep onset and sleep maintenance. The acquisition
was completed on April 3, 2007, for $315 million,
and will result in a second-quarter 2007
in-process research and development charge not to
exceed $0.30 per share. |
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In March, the U.S. FDA rejected Lillys appeal of
an approvable letter for Arxxantä for
diabetic retinopathy and reiterated its request
for further data that would require an additional
three-year study. Lilly subsequently withdrew its
Arxxant application in Europe and is currently
considering the next steps for the molecule. |
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In March, Lilly received an approvable letter from
the U.S. FDA for a treatment-resistant depression
(TRD) indication for Symbyax. Lilly is currently
working with the FDA regarding label negotiations
and postmarketing commitments, and is hopeful to
have an action on the approvable letter in the
second half of 2007. |
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In late March, Lilly announced that the European
Medicines Agency (EMEA) granted enzastaurin orphan
drug designation for the treatment of diffuse
large B-cell lymphoma (DLBCL). |
We have started the year with very solid financial results, delivering double-digit sales growth
and better-than-expected earnings per share for the first quarter, commented Sidney Taurel,
chairman and chief executive officer. We are especially encouraged by the robust growth of the
products we have launched this decade. We are confident that we can maintain this momentum
throughout the year, and are therefore raising both our sales and adjusted EPS guidance for 2007.
First-Quarter Results
Worldwide reported sales for the quarter were $4.226 billion, an increase of 14 percent compared
with the first quarter of 2006. Worldwide sales volume increased 7 percent, while selling prices
and exchange rates increased sales 5 percent and 2 percent, respectively. Excluding U.S.
Actos®
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revenue in both periods due to the expiration of Lillys U.S. marketing rights, worldwide sales for
the quarter increased 17 percent.
Gross margins as a percent of sales declined by 0.1 percentage points, to 78.2 percent. This
decline was primarily due to the amortization of the value of Cialis acquired in the ICOS
acquisition and lower production volume, offset in part by higher product prices and manufacturing
expenses growing at a slower rate than sales.
Overall, marketing and administrative expenses rose 17 percent, to $1.337 billion. This increase
was largely due the impact of the ICOS acquisition, increased marketing and selling expenses in
support of key products, primarily Cymbalta and the diabetes care franchise, and an increase in
litigation-related costs. Research and development expenses were $834.2 million, or 20 percent of
sales. Compared with the first quarter of 2006, research and development expenses increased 13
percent. In addition to the acquisition of ICOS, this increase was due to costs associated with the
consequences of the FDAs decision on Arxxant and the withdrawal of the Arxxant application in
Europe, as well as increases in discovery research and late-stage clinical trial costs.
Other income increased by $6.1 million, to $38.3 million, primarily due to higher business
development income and lower interest expense partially offset by lower other miscellaneous income
and lower Lilly ICOS joint venture income. 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 29 percent, up from 21 percent in the first quarter of 2006,
because the in-process research and development charge associated with the acquisition of ICOS was
not deductible. The adjusted effective tax rate for the first quarter of 2007 was 22 percent.
Reported net income and earnings per share were $508.7 million and $.47, respectively, compared
with first-quarter 2006 net income of $834.8 million and $.77 earnings per share. Results in the
first quarter of 2007 were affected by the acquisition of ICOS and several other items noted in the
table below. Excluding those items in 2007, adjusted net income and earnings per share both grew 9
percent to $913.3 million and $.84, benefiting from sales growth, partially
-4-
offset by marketing and administrative expenses and tax expense growing at a faster rate than
sales. This 9 percent growth includes the dilutive impact from the ICOS acquisition related to the
incremental interest expense on debt used to finance the acquisition, the amortization of ICOS
intangibles and other integration costs. For further detail, see the reconciliation below as well
as the footnotes to the adjusted income statement later in this press release.
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First Quarter |
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Earnings per Share Reconciliation |
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2007 |
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2006 |
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% Growth |
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E.P.S. (reported) |
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$ |
.47 |
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$ |
.77 |
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Eliminate restructuring charges
associated with previously announced
manufacturing decisions |
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.08 |
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Eliminate in-process research &
development charges associated with
ICOS acquisition and OSI in-licensing |
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.29 |
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E.P.S. (adjusted) |
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$ |
.84 |
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$ |
.77 |
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9 |
% |
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Zyprexa
In the first quarter of 2007, Zyprexa sales totaled $1.108 billion, a 10 percent increase compared
with the first quarter of 2006. U.S. sales of Zyprexa increased 6 percent, to $523.3 million, due
primarily to higher prices, offset partially by lower demand. Zyprexa sales in international
markets increased 14 percent, to $584.7 million, driven by volume increases and the impact of
foreign exchange rates.
Diabetes Care Products
For the first quarter of 2007, worldwide Humalog sales increased 11 percent, to $339.5 million,
driven by increased prices in the U.S. and increased volume outside the U.S. and exchange rates,
offset by decreased prices outside the U.S.
Worldwide Humulin sales increased 3 percent, to $225.8 million, driven primarily by increased
volume outside the U.S., partially offset by decreased prices outside the U.S. and lower U.S.
volume.
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
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America at a declining rate through September 2009. The arrangement outside the U.S. continues. In
the first quarter, Actos generated $86.2 million of revenue for Lilly, a decrease of $102.8 million
versus the first quarter of 2006.
Total sales of Byetta were $146.5 million in the first quarter, a 7 percent sequential increase
compared with the fourth quarter of 2006. Lilly reports as revenue its 50 percent share of Byettas
gross margins and its sales of Byetta pen delivery devices to its partner, Amylin Pharmaceuticals;
for the first quarter, this revenue totaled $71.5 million, representing a 4 percent sequential
increase compared with the fourth quarter of 2006.
Cymbalta
For the first quarter of 2007, Cymbalta generated $441.8 million in sales, an increase of 89
percent, compared with the first quarter of 2006. U.S. sales of Cymbalta increased 88 percent, to
$386.3 million, due to strong demand. Sales outside the U.S. were $55.5 million.
Gemzar
Gemzar had sales totaling $376.9 million for the first quarter, an increase of 11 percent from the
first quarter of 2006. Sales in the U.S. increased 9 percent, to $162.7 million due to higher
prices and wholesaler buying patterns, while sales outside the U.S. increased 13 percent, to $214.2
million as a result of higher volume and the impact of foreign exchange rates.
Cialis
Lillys total Cialis sales for the first quarter were $193.1 million, including all Cialis sales
made after the acquisition of ICOS on January 29, 2007. Total worldwide sales of Cialis were $265.8
million, including $72.7 million of sales in the Lilly ICOS joint-venture territories for the
period prior to the acquisition of ICOS. Worldwide sales grew 19 percent compared with
first-quarter 2006, reflecting strong global demand. U.S. sales of Cialis were $98.6 million in the
first quarter, an 18 percent increase compared with first quarter 2006 U.S. sales. Prior to the
acquisition of ICOS, Cialis sales in Lilly territories are reported in Lillys revenue, while
Lillys 50 percent share of the joint-venture territory sales, net of expenses, is reported in
Lillys other income. After the acquisition of ICOS, all Cialis sales are reported in Lillys
revenue.
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Evista
Evista sales were $263.8 million in the first quarter, a 9 percent increase compared with the first
quarter of 2006. U.S. sales of Evista increased 15 percent, to $172.1 million, driven by higher
prices. Sales outside the U.S. decreased 1 percent, to $91.7 million.
Alimta
For the first quarter of 2007, Alimta generated sales of $187.8 million, an increase of 44 percent
compared with the first quarter of 2006. U.S. sales of Alimta increased 34 percent, to $104.1
million due to increased demand and wholesaler buying patterns, while sales outside the U.S.
increased 60 percent, to $83.8 million due to increased demand.
In the first quarter of 2007, Lilly completed a study of Alimta versus Gemzar, when both are used
in combination with cisplatin as a first-line treatment for non-small cell lung cancer (NSCLC). The
study met its primary endpoint of non-inferiority relative to overall survival. Based on this data,
Lilly plans to submit Alimta for first-line NSCLC to the European Medicines Agency (EMEA) in 2007.
Forteo
First-quarter sales of Forteo were $153.4 million, a 21 percent increase compared with the first
quarter of 2006. U.S. sales of Forteo increased 23 percent, to $107.4 million. U.S. sales benefited
from access to medical coverage through the Medicare Part D program, decreased utilization of the
companys U.S. patient assistance program and increased demand. U.S. sales growth was partially
offset by wholesaler buying patterns. Sales outside the U.S. grew 15 percent, to $46.0 million.
Strattera
During the first quarter of 2007, Strattera generated $139.9 million of sales, an 8 percent
decrease compared with the first quarter of 2006. The sales decrease was due to a decline in demand
in the U.S.
Animal Health
Worldwide sales of animal health products in the first quarter were $215.1 million, an increase of
8 percent compared with the first quarter of 2006.
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2007 Financial Guidance
The company has raised its sales guidance for 2007 and now expects sales to grow in the low double
digits, an increase from previous guidance of high single digits to low double digits.
The company has also raised its earnings guidance for 2007 and now expects full-year adjusted
earnings per share to be in the range of $3.30 to $3.40 per share, an increase from the previous
guidance of $3.25 to $3.35 per share. For the second quarter, the company expects adjusted earnings
per share of $0.80 to $0.82. The increase in adjusted earnings guidance for 2007 reflects stronger
underlying business fundamentals. The adjusted earnings per share guidance excludes the estimated
charges noted in the tables below related to restructuring charges and acquired in-process research
and development, and any other future, material unusual items. Including the estimated charges
noted in the tables below, the company expects reported earnings per share to be in the range of
$0.50 to $0.52 for the second quarter, and $2.63 to $2.73 for the full year.
See reconciliations below for further detail.
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Q2 2007 |
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Q2 2006 |
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Earnings per Share Reconciliation |
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Expectations |
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Results |
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E.P.S. (reported) |
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$.50 to $.52 |
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$ |
.76 |
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Eliminate estimated in-process
research & development charge
associated with Hypnion acquisition |
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.30 |
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E.P.S. (adjusted) |
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$.80 to $.82 |
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$ |
.76 |
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2007 |
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2006 |
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Earnings per Share Reconciliation |
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Expectations |
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Results |
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E.P.S. (reported) |
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$2.63 to $2.73 |
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$ |
2.45 |
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Eliminate product liability charge |
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.42 |
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Eliminate asset impairments and
restructuring charges associated with
previously announced manufacturing
decisions |
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.08 |
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.31 |
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Eliminate in-process research & development
charges associated with ICOS acquisition
and OSI in-licensing and the estimated
charge associated with Hypnion acquisition |
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.59 |
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E.P.S. (adjusted) |
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$3.30 to $3.40 |
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$ |
3.18 |
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The company reconfirmed the remainder of its original financial guidance. Gross margins as a
percent of sales are expected to improve slightly compared with 2006. In addition, the company
expects operating expenses to grow in the low double digits, driven primarily by the inclusion of
all Cialis operating expenses subsequent to the acquisition and increased marketing and selling
expenses in support of Cymbalta, Zyprexa and the diabetes care franchise, as well as ongoing
investment in research and development. The company also expects other income to contribute less
than $100 million, a reduction from 2006 due to the removal of the Lilly ICOS joint venture
after-tax profit. Other income will primarily include net interest income and income from the
partnering and out-licensing of molecules. The company also anticipates the adjusted effective
tax rate to be approximately 22 percent. In terms of cash flow, the company expects a continuation
of strong cash flow trends in 2007, with capital expenditures of approximately $1.1 billion.
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Pro Forma Analysis
In the following section, pro forma results and guidance are presented in order to provide
additional comparisons of the companys performance. A pro forma adjusted income statement is also
provided at the end of this press release. In accordance with generally accepted accounting
principles (GAAP), pro forma results and guidance assume the ICOS acquisition was completed January
1, 2006. Differences from reported and adjusted financial results and guidance are highlighted
below.
Q1 Pro Forma Results
Worldwide pro forma sales for the quarter were $4.299 billion, an increase of 11 percent compared
with the first quarter of 2006. Worldwide pro forma sales volume increased 3 percent, while selling
prices and exchange rates increased sales 5 percent and 3 percent, respectively. Sales of products
launched this decade grew 37 percent on a pro forma basis, while marketing and administrative
expenses and research and development expenses increased 10 percent and 9 percent, respectively. As
a result of the operating leverage achieved from sales growing faster than operating expenses, pro
forma adjusted net income and earnings per share both grew 14 percent, to $901.9 million and $.83,
respectively. The pro forma reconciliation of earnings per share for the first quarter of 2007 is
identified in the table below.
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First Quarter |
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Earnings per Share Reconciliation |
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2007 |
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2006 |
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% Growth |
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E.P.S. (reported) |
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$ |
.47 |
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$ |
.77 |
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Eliminate restructuring charges
associated with previously announced
manufacturing decisions |
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.08 |
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|
|
|
|
|
|
|
|
Eliminate in-process research &
development charges associated with
ICOS acquisition and OSI in-licensing |
|
|
.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (adjusted) |
|
$ |
.84 |
|
|
$ |
.77 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
|
|
(.01 |
) |
|
|
(.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$ |
.83 |
|
|
$ |
.73 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
-10-
Pro Forma Financial Guidance
On a pro forma basis, the company expects sales to grow in the high single digits and operating
expenses to grow in the mid single digits, resulting in a continuation of positive operating
leverage. The pro forma reconciliation of earnings per share guidance for the second quarter and
full year of 2007 are identified in the tables below. Other elements of financial guidance are
unaffected.
|
|
|
|
|
|
|
|
|
|
|
Q2 2007 |
|
|
Q2 2006 |
|
Earnings per Share Reconciliation |
|
Expectations |
|
|
Results |
|
E.P.S. (reported) |
|
$.50 to $.52 |
|
$ |
.76 |
|
Eliminate estimated in-process
research & development charges
associated with Hypnion acquisition |
|
|
.30 |
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (adjusted) |
|
$.80 to $.82 |
|
$ |
.76 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on January
1, 2006 |
|
|
|
|
|
|
(.04 |
) |
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$.80 to $.82 |
|
$ |
.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
Earnings per Share Reconciliation |
|
Expectations |
|
Results |
E.P.S. (reported) |
|
$2.63 to $2.73 |
|
$ |
2.45 |
|
Eliminate product liability charge |
|
|
|
|
|
|
.42 |
|
Eliminate asset impairments and
restructuring charges associated with
previously announced manufacturing
decisions |
|
|
.08 |
|
|
|
.31 |
|
Eliminate in-process research & development
charges associated with ICOS acquisition
and OSI in-licensing and the estimated
charge associated with Hypnion acquisition |
|
|
.59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (adjusted) |
|
$3.30 to $3.40 |
|
$ |
3.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
|
|
(.01 |
) |
|
|
(.15 |
) |
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$3.29 to $3.39 |
|
$ |
3.03 |
|
|
|
|
|
|
|
|
|
|
-11-
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the
first-quarter 2007 financial results conference call through a link on Lillys website at
www.lilly.com. The conference call will be held today from 8:00 to 9:00 a.m. Eastern Daylight Time
(EDT) and will be available for replay via the website through May 16, 2007.
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. 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 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; 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-K
filed February 2007. The company undertakes no duty to update forward-looking statements.
# # #
|
|
|
Actos®
(pioglitazone hydrochloride, Takeda) |
|
Alimta® (pemetrexed, Lilly) |
|
Arxxantä (ruboxistaurin mesylate, Lilly) |
|
Byetta® (exenatide injection, Amylin Pharmaceuticals) |
|
Cialis® (tadalafil, Lilly) |
|
Cymbalta® (duloxetine hydrochloride, 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) |
|
HumaPen® MEMOIR (Lilly) |
|
HumaPen® LUXURAä HD (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 |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2007 |
|
December 31, 2006 |
Worldwide Employees |
|
|
41,400 |
* |
|
|
41,500 |
|
|
|
|
* |
|
Headcount figures as of March 31, 2007 include personnel previously employed by ICOS Corporation. |
-12-
Eli Lilly and Company
Operating Results (Unaudited)
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31 |
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
% Chg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
4,226.1 |
|
|
$ |
3,714.7 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
922.5 |
|
|
|
806.5 |
|
|
|
14 |
% |
Research and development |
|
|
834.2 |
|
|
|
740.8 |
|
|
|
13 |
% |
Marketing and administrative |
|
|
1,336.8 |
|
|
|
1,142.9 |
|
|
|
17 |
% |
Acquired in-process research and development |
|
|
328.5 |
|
|
|
|
|
|
|
N/M |
|
Asset impairments and other special charges |
|
|
123.0 |
|
|
|
|
|
|
|
N/M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
681.1 |
|
|
|
1,024.5 |
|
|
|
(34 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) |
|
|
4.0 |
|
|
|
(5.3 |
) |
|
|
|
|
Joint venture income |
|
|
11.0 |
|
|
|
19.8 |
|
|
|
|
|
Net other income |
|
|
23.3 |
|
|
|
17.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
38.3 |
|
|
|
32.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
719.4 |
|
|
|
1,056.7 |
|
|
|
(32 |
)% |
Income taxes |
|
|
210.7 |
|
|
|
221.9 |
|
|
|
(5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
508.7 |
|
|
$ |
834.8 |
|
|
|
(39 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.47 |
|
|
$ |
0.77 |
|
|
|
(39 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.47 |
|
|
$ |
0.77 |
|
|
|
(39 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
0.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
Weighted-average shares outstanding (thousands) basic |
|
|
1,089,732 |
|
|
|
1,086,035 |
|
|
|
|
|
Weighted-average shares outstanding (thousands) diluted |
|
|
1,089,879 |
|
|
|
1,086,994 |
|
|
|
|
|
N/M not meaningful
-13-
Eli Lilly and Company
Operating Results (Unaudited) ADJUSTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31 |
|
|
|
|
|
|
2007 (a) |
|
|
2006 |
|
|
% Chg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
4,226.1 |
|
|
$ |
3,714.7 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
922.5 |
|
|
|
806.5 |
|
|
|
14 |
% |
Research and development |
|
|
834.2 |
|
|
|
740.8 |
|
|
|
13 |
% |
Marketing and administrative |
|
|
1,336.8 |
|
|
|
1,142.9 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,132.6 |
|
|
|
1,024.5 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense |
|
|
4.0 |
|
|
|
(5.3 |
) |
|
|
|
|
Joint venture income |
|
|
11.0 |
|
|
|
19.8 |
|
|
|
|
|
Net other income |
|
|
23.3 |
|
|
|
17.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (deductions) |
|
|
38.3 |
|
|
|
32.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
1,170.9 |
|
|
|
1,056.7 |
|
|
|
11 |
% |
Income taxes |
|
|
257.6 |
|
|
|
221.9 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
913.3 |
|
|
$ |
834.8 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.84 |
|
|
$ |
0.77 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.84 |
|
|
$ |
0.77 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
0.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
Weighted-average shares outstanding (thousands) basic |
|
|
1,089,732 |
|
|
|
1,086,035 |
|
|
|
|
|
Weighted-average shares outstanding (thousands) diluted |
|
|
1,089,879 |
|
|
|
1,086,994 |
|
|
|
|
|
|
|
|
(a) |
|
The 2007 amounts are adjusted to eliminate the $.29 per share IPR&D charges related to
the ICOS acquisition ($303.5 million) and the OSI in-licensing ($25.0 million), as well as
the $123.0 million (pretax), or $.08 per share (after-tax), first-quarter charge for asset
impairments, restructuring and other special charges. |
-14-
Eli Lilly and Company
Operating Results (Unaudited) PRO FORMA ADJUSTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31 |
|
|
|
|
|
|
2007 (a) (b) |
|
|
2006 (b) |
|
|
% Chg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
4,298.8 |
|
|
$ |
3,882.0 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
938.4 |
|
|
|
850.5 |
|
|
|
10 |
% |
Research and development |
|
|
846.2 |
|
|
|
773.9 |
|
|
|
9 |
% |
Marketing and administrative |
|
|
1,372.7 |
|
|
|
1,242.9 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,141.5 |
|
|
|
1,014.7 |
|
|
|
12 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense |
|
|
(8.5 |
) |
|
|
(38.8 |
) |
|
|
|
|
Joint venture income |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
|
|
Net other income |
|
|
25.3 |
|
|
|
19.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (deductions) |
|
|
16.8 |
|
|
|
(19.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
1,158.3 |
|
|
|
995.1 |
|
|
|
16 |
% |
Income taxes |
|
|
256.4 |
|
|
|
205.3 |
|
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
901.9 |
|
|
$ |
789.8 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.83 |
|
|
$ |
0.73 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.83 |
|
|
$ |
0.73 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
0.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
Weighted-average shares outstanding (thousands) basic |
|
|
1,089,732 |
|
|
|
1,086,035 |
|
|
|
|
|
Weighted-average shares outstanding (thousands) diluted |
|
|
1,089,879 |
|
|
|
1,086,994 |
|
|
|
|
|
|
|
|
(a) |
|
The 2007 amounts are adjusted to eliminate the $.29 per share IPR&D charges related
to the ICOS acquisition ($303.5 million) and the OSI in-licensing ($25.0 million), as well
as the $123.0 million (pretax), or $.08 per share (after-tax), first-quarter charge for
asset impairments, restructuring and other special charges. |
|
(b) |
|
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. |
-15-
exv99w2
Exhibit 99.2
Eli Lilly and Company
Operating Results (Unaudited) PRO FORMA ADJUSTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
March 31 |
|
|
June 30 |
|
|
Sept. 30 |
|
|
Dec. 31 |
|
|
December 31 |
|
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
3,882.0 |
|
|
$ |
4,049.6 |
|
|
$ |
4,054.7 |
|
|
$ |
4,459.9 |
|
|
$ |
16,446.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
850.5 |
|
|
|
906.6 |
|
|
|
906.2 |
|
|
|
1,066.7 |
|
|
|
3,730.0 |
|
Research and development |
|
|
773.9 |
|
|
|
807.4 |
|
|
|
788.8 |
|
|
|
890.0 |
|
|
|
3,260.1 |
|
Marketing and administrative |
|
|
1,242.9 |
|
|
|
1,340.9 |
|
|
|
1,302.3 |
|
|
|
1,422.1 |
|
|
|
5,308.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,014.7 |
|
|
|
994.7 |
|
|
|
1,057.4 |
|
|
|
1,081.1 |
|
|
|
4,147.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest expense |
|
|
(38.8 |
) |
|
|
(35.9 |
) |
|
|
(34.2 |
) |
|
|
(17.2 |
) |
|
|
(126.1 |
) |
Joint venture income |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
Net other income |
|
|
19.2 |
|
|
|
24.8 |
|
|
|
29.4 |
|
|
|
56.1 |
|
|
|
129.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (deductions) |
|
|
(19.6 |
) |
|
|
(11.1 |
) |
|
|
(4.8 |
) |
|
|
38.9 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
995.1 |
|
|
|
983.6 |
|
|
|
1,052.6 |
|
|
|
1,120.0 |
|
|
|
4,151.3 |
|
Income taxes |
|
|
205.3 |
|
|
|
204.9 |
|
|
|
220.6 |
|
|
|
226.6 |
|
|
|
857.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
789.8 |
|
|
$ |
778.7 |
|
|
$ |
832.0 |
|
|
$ |
893.4 |
|
|
$ |
3,293.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.73 |
|
|
$ |
0.72 |
|
|
$ |
0.77 |
|
|
$ |
0.82 |
|
|
$ |
3.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding
(thousands) diluted |
|
|
1,086,994 |
|
|
|
1,085,310 |
|
|
|
1,086,412 |
|
|
|
1,089,097 |
|
|
|
1,087,490 |
|
|
|
|
(a) |
|
In accordance with generally accepted accounting principles (GAAP), the 2006 financial
statements have been restated assuming the acquisition of ICOS was completed by Lilly
effective January 1, 2006. |
|
(b) |
|
The fourth quarter and full year 2006 amounts are adjusted to eliminate the $494.9
million (pretax), or $.42 per share (after tax), charge to cover Zyprexa product liability
settlements and claims costs, and the $450.3 million (pretax), or $0.31 per share (after
tax) charge for asset impairments, restructuring and other special charges. |