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): October 18, 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
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)) |
Item 2.02. Results of Operations and Financial Condition
On October 18, 2007, we issued a press release announcing our results of operations for the quarter
and nine month period ended September 30, 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 web cast on our web site. The press release and
related financial statements are attached to this Form 8-K as Exhibit 99.1.
For the third quarter and first nine months of 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 third quarter and first nine months of 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 a charge for a reduction in our expected product liability insurance
recoveries 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. in the second quarter of 2007. |
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We exclude the following charges in the first quarter of 2007: |
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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, the pro forma adjusted presentation assumes that the acquisition of ICOS was completed
on January 1, 2006, and includes adjustments to the third quarter and first nine months of both
2006 and 2007 for the ICOS acquisition.
In the press release attached as Exhibit 99.1, we also provided financial expectations for the
fourth 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 pro forma basis. 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 (i) the 2007 items described above and (ii) an
in-process research and development charge associated with an in-licensing transaction with
2
MacroGenics Inc.; and we 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.
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 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 October 18, 2007, together with related attachments |
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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/
Arnold C. Hanish |
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Name: |
Arnold C. Hanish |
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Title: |
Executive Director, Finance, and Chief
Accounting Officer
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Dated: October 18, 2007 |
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4
EXHIBIT INDEX
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Exhibit Number |
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Exhibit |
99.1
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Press release dated October 18, 2007, together with related attachments. |
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exv99w1
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
Date: October 18, 2007
For Release: Immediately
Refer to: (317) 276-5795 Mark E. Taylor
Lilly Delivers Strong Third-Quarter Results
Q3 reported results include 19 percent sales growth and EPS of $.85
Q3 pro forma adjusted results include 13 percent sales growth and EPS of $.91
Full-year pro forma adjusted EPS guidance updated to $3.50 $3.55, or $2.76 $2.81 reported
Eli Lilly and Company (NYSE: LLY) today announced strong financial results for the third quarter of
2007 and raised its full-year pro forma adjusted earnings per share guidance. The company now
expects full-year pro forma adjusted earnings per share to be in the range of $3.50 to $3.55 per
share, or $2.76 to $2.81 per share on a reported basis.
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.
Third-Quarter Highlights Reported Results
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Sales increased 19 percent, to $4.587 billion. |
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Products launched this decade Alimta®, Byetta®,
Cialis®, Cymbalta®, Forteo®, Strattera®,
Symbyax®, Xigris® and Yentreve® collectively grew
56 percent, to $1.498 billion, and accounted for 33 percent of total sales, compared
with 25 percent of total sales in the third quarter of 2006. |
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Net income and earnings per share both grew 6 percent to $926.3 million and
$.85, respectively, compared with third-quarter 2006 net income of $873.6 million and
earnings per share of $.80. Reported results include a $.06 per share charge for a
reduction in expected product liability insurance recoveries. |
Third-Quarter Highlights Pro Forma Adjusted Results
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Sales increased 13 percent, to $4.587 billion. |
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Sales of products launched this decade grew 30 percent and represented 33
percent of total sales. |
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Net income and earnings per share grew 20 percent and 18 percent, to $996.4
million and $.91, respectively. |
Product Sales Highlights
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% Change |
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% Change |
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(Dollars in millions) |
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Third Quarter |
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Over/(Under) |
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Year-to-Date |
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Over/(Under) |
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2007 |
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2006 |
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2006 |
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2007 |
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2006 |
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2006 |
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Zyprexa® |
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$ |
1,166.1 |
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$ |
1,084.7 |
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8 |
% |
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$ |
3,487.1 |
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$ |
3,207.1 |
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9 |
% |
Cymbalta |
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513.2 |
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348.6 |
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47 |
% |
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1,474.6 |
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892.3 |
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65 |
% |
Gemzar® |
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394.4 |
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354.6 |
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11 |
% |
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1,166.9 |
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1,036.9 |
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13 |
% |
Humalog® |
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362.5 |
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322.2 |
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12 |
% |
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1,060.4 |
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947.3 |
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12 |
% |
Evista® |
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263.2 |
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257.9 |
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2 |
% |
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805.0 |
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775.0 |
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4 |
% |
Cialis1 |
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311.4 |
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55.0 |
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N/M |
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797.6 |
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161.2 |
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N/M |
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Humulin® |
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243.3 |
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230.0 |
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6 |
% |
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711.9 |
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668.3 |
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7 |
% |
Alimta |
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215.0 |
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157.2 |
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37 |
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610.0 |
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440.4 |
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39 |
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Forteo |
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180.5 |
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149.1 |
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21 |
% |
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511.1 |
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422.2 |
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21 |
% |
Strattera |
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130.5 |
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126.4 |
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3 |
% |
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412.6 |
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422.7 |
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(2 |
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Total Sales Reported |
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$ |
4,586.8 |
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$ |
3,864.1 |
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19 |
% |
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$ |
13,443.9 |
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$ |
11,445.7 |
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17 |
% |
Total Sales
Pro forma |
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$ |
4,586.8 |
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$ |
4,054.7 |
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13 |
% |
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$ |
13,516.6 |
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$ |
11,986.3 |
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13 |
% |
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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 third quarter of 2007 of $311.4 million
represent 27 percent growth over the third quarter of 2006. September year-to-date 2007
worldwide Cialis sales were $870.3 million and represented 24 percent growth over the first
nine months of 2006. |
- 2 -
Significant Events Over the Last Three Months
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The company today announced that it will acquire the exclusive rights to teplizumab, a
humanized anti-CD3 monoclonal antibody, from MacroGenics, Inc. In addition, the two
companies have entered into a global strategic alliance to develop and commercialize
teplizumab, as well as other potential next-generation molecules for use in the treatment
of autoimmune diseases. Teplizumab is currently being studied in the PROTÉGÉ trial, a
global pivotal Phase II/III clinical trial for individuals with recent-onset type 1
diabetes. |
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The company submitted a supplemental new drug application to the U.S. Food and Drug
Administration for Cymbalta for the management of fibromyalgia. |
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In September, the U.S. Food and Drug Administration approved Evista for a new use to
reduce the risk of invasive breast cancer in two populations: postmenopausal women with
osteoporosis and postmenopausal women at high risk for invasive breast cancer. |
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The company submitted an application with the European Medicines Agency for centralized
review of Alimta, in combination with cisplatin, for the first-line treatment of advanced
non-small cell lung cancer. |
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In September, the U.S. Food and Drug Administration approved a new, pre-filled insulin
pen, KwikPenTM, which will be available with any of the Humalog formulations.
Launch is expected in early 2008. |
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In October, the United States Supreme Court denied the petitions for certiorari that
were filed by Teva Pharmaceuticals and Dr. Reddys Laboratories regarding their challenges
to the validity of Lillys U.S. Zyprexa patent. |
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In October, as a part of ongoing discussions with the U.S. Food and Drug Administration,
the company updated the Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine HCl)
U.S. product labels. Specifically, the changes include new warnings for weight gain and
hyperlipidemia (elevation of triglycerides and cholesterol) and updated information in the
warning for hyperglycemia (elevated blood sugar). The label also states that while relative
risk estimates are inconsistent, the association between atypical antipsychotics and
increases in glucose levels appears to fall on a continuum and olanzapine appears to have a
greater association than some other atypical antipsychotics. |
Lilly continued to deliver excellent financial results to our shareholders in the third quarter,
and we remain on pace for a very solid year, commented Sidney Taurel, chairman and chief executive
officer. Our ongoing focus on volume-based revenue growth and cost containment
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again allowed us to leverage double-digit sales growth into robust earnings per share results for
the quarter on a pro forma adjusted basis.
Third-Quarter Reported Results
Worldwide reported sales for the quarter were $4.587 billion, an increase of 19 percent compared
with the third quarter of 2006. Worldwide sales volume increased 14 percent, while exchange rates
and selling prices contributed 3 and 2 percentage points of sales growth, respectively.
Gross margin as a percent of sales decreased by 0.7 percentage points, to 77.0 percent. This
decrease was primarily due to planned third-quarter 2007 maintenance shutdowns of certain
manufacturing facilities, the expense resulting from the amortization of the intangible assets
acquired in the ICOS acquisition and the impact of foreign exchange rates, offset in part by
manufacturing expenses growing at a slower rate than sales.
Overall, marketing and administrative expenses rose 23 percent, to $1.478 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. Research
and development expenses were $844.5 million, or 18 percent of sales. Compared with the third
quarter of 2006, research and development expenses increased 12 percent. In addition to the
acquisition of ICOS, this increase was due to increases in incentive compensation, discovery
research and late-stage clinical trial costs.
In the third quarter of 2007, following a settlement with one of its insurance carriers over
Zyprexa product liability claims, the company reduced its expected product liability insurance
recoveries. This resulted in a recorded charge of $81.3 million.
Other income decreased by $6.2 million, to $49.8 million, primarily due to the acquisition of ICOS,
offset in part by higher business development income resulting from out-licensing of legacy and
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 21.4 percent, up from 21 percent in the third quarter of 2006.
- 4 -
Reported net income and earnings per share both increased 6 percent to $926.3 million and $.85,
respectively, compared with third-quarter 2006 net income of $873.6 million and earnings per share
of $.80. Third-quarter 2007 reported results include a $.06 per share charge for a reduction in
expected insurance recoveries.
Third-Quarter Pro Forma Adjusted Results
Worldwide pro forma sales for the third quarter of 2007 were $4.587 billion, an increase of 13
percent compared with the third quarter of 2006. Worldwide pro forma sales volume increased 8
percent, while exchange rates and selling prices contributed 3 and 2 percentage points of the sales
growth, respectively. Gross margin as a percent of sales decreased by 0.7 percentage points, to
77.0 percent. Marketing and administrative expenses and research and development expenses increased
13 percent and 7 percent, respectively. Total operating expenses grew 11 percent. Other income
increased $54.6 million, driven by lower net interest expense and increased business development
income resulting from out-licensing of legacy and development-stage products. The effective tax
rate was 20.9 percent.
As a result of sales growing faster than operating expenses and higher other income, pro forma
adjusted net income and earnings per share grew 20 percent and 18 percent, to $996.4 million and
$.91, respectively. For further detail, see the reconciliation below as well as the footnotes to
the pro forma adjusted income statement later in this press release.
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Earnings per Share Reconciliation |
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Third Quarter |
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% Growth |
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2007 |
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2006 |
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E.P.S. (reported) |
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$ |
.85 |
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$ |
.80 |
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6 |
% |
Eliminate charge for a reduction in
expected insurance recoveries |
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.06 |
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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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$ |
.91 |
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$ |
.77 |
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18 |
% |
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Zyprexa
In the third quarter of 2007, Zyprexa sales totaled $1.166 billion, an 8 percent increase compared
with the third quarter of 2006. U.S. sales of Zyprexa increased 4 percent, to $540.6 million, due
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to higher prices, offset in part by declining demand. Zyprexa sales in international markets
increased 11 percent, to $625.6 million, driven by the impact of foreign exchange rates and
increased demand.
Cymbalta
For the third quarter of 2007, Cymbalta generated $513.2 million in sales, an increase of 47
percent compared with the third quarter of 2006. U.S. sales of Cymbalta increased 45 percent, to
$444.3 million, due to strong demand. Sales outside the U.S. were $68.9 million, an increase of 64
percent, driven primarily by higher demand, as well as the impact of foreign exchange rates and
higher prices. Cymbalta continues to gain market share in the U.S. and internationally.
Gemzar
Gemzar had sales totaling $394.4 million for the third quarter, an increase of 11 percent from the
third quarter of 2006. Sales in the U.S. increased 9 percent, to $166.5 million, due to higher
prices and demand, while sales outside the U.S. increased 13 percent, to $227.9 million, as a
result of increased demand and the impact of foreign exchange rates.
Humalog
For the third quarter of 2007, worldwide Humalog sales increased 12 percent, to $362.5 million.
Sales in the U.S. increased 9 percent to $216.1 million, driven by increased prices and higher
demand. Sales outside the U.S. increased 19 percent to $146.4 million, driven by increased demand
and the favorable impact of foreign exchange rates, offset in part by declining prices.
Evista
Evista sales were $263.2 million in the third quarter, a 2 percent increase compared with the third
quarter of 2006. U.S. sales of Evista increased 4 percent, to $169.5 million, driven by higher
prices. Sales outside the U.S. decreased 1 percent, to $93.7 million.
Cialis
Cialis sales for the third quarter were $311.4 million. On a pro forma basis, worldwide sales of
Cialis grew 27 percent compared with third-quarter 2006, reflecting both strong demand and
increased prices in the U.S. and internationally. U.S. sales of Cialis were $116.6 million in the
third quarter, a 22 percent increase compared with the third quarter of 2006. Sales of Cialis
outside the U.S. increased 30 percent to $194.8 million. Prior to the acquisition of ICOS on
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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.
Humulin
Worldwide Humulin sales increased 6 percent in the third quarter, to $243.3 million. U.S. sales
declined 6 percent to $90.8 million due to lower demand, partially offset by higher prices. Sales
outside the U.S. increased 14 percent to $152.5 million, driven primarily by increased volume and
the favorable impact of foreign exchange rates, offset in part by declining prices.
Alimta
For the third quarter of 2007, Alimta generated sales of $215.0 million, an increase of 37 percent
compared with the third quarter of 2006. U.S. sales of Alimta increased 23 percent, to $110.8
million, due primarily to increased demand, while sales outside the U.S. increased 55 percent, to
$104.2 million, due primarily to increased demand.
Forteo
Third-quarter sales of Forteo were $180.5 million, a 21 percent increase compared with the third
quarter of 2006. U.S. sales of Forteo increased 20 percent, to $124.8 million, driven primarily by
higher net effective selling prices. Sales outside the U.S. grew 24 percent, to $55.7 million, due
to higher demand and the impact of foreign exchange rates.
Strattera
During the third quarter of 2007, Strattera generated $130.5 million of sales, a 3 percent increase
compared with the third quarter of 2006. U.S. sales decreased 8 percent to $103.6 million, due to a
decline in demand. Sales outside the U.S. increased 91 percent to $26.9 million, due primarily to
higher demand.
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 third quarter, Actos generated $97.8 million of revenue
- 7 -
for Lilly, over half of which was outside the U.S. Actos revenue increased 27 percent versus the
third quarter of 2006.
Worldwide sales of Byetta were $164.8 million in the third quarter, a 30 percent increase compared
with the third quarter of 2006. 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 third quarter, Lilly recognized
revenue totaling $87.1 million, representing a 40 percent increase compared with the third quarter
of 2006.
Animal Health
Worldwide sales of animal health products in the third quarter were $236.6 million, an increase of
9 percent compared with the third quarter of 2006. U.S. sales grew 15 percent to $112.4 million
while sales outside the U.S. grew 5 percent to $124.2 million. Sales growth in the U.S. benefited
from the recent acquisition of Ivy Animal Health, Inc.
Year-to-Date Results
For the first nine months of 2007, worldwide reported sales increased 17 percent, to $13.444
billion, compared with sales for the same period in 2006. Reported net income and earnings per
share were $2.099 billion and $1.93, respectively. Results for the first nine months of 2007 were
affected by the acquisitions of ICOS, Hypnion Inc., and Ivy Animal Health, Inc., as well as the
other items noted in the table below.
For the first nine months of 2007, worldwide pro forma sales increased 13 percent to $13.517
billion, compared with the first nine months of 2006. As a result of sales growing faster than cost
of sales and operating expenses, pro forma adjusted net income and earnings per share grew 20
percent and 19 percent, to $2.877 billion and $2.64, respectively. The pro forma reconciliation of
year-to-date earnings per share for 2007 is shown in the table below.
- 8 -
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Earnings per Share Reconciliation |
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Year-to-date |
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% Growth |
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2007 |
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2006 |
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E.P.S. (reported) |
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$ |
1.93 |
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$ |
2.33 |
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(17 |
%) |
Eliminate asset impairments and
restructuring charges associated with
previously announced manufacturing
decisions |
|
|
.08 |
|
|
|
|
|
|
|
|
|
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
in-licensing |
|
|
.58 |
|
|
|
|
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
|
|
(.01 |
) |
|
|
(.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$ |
2.64 |
|
|
$ |
2.21 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
2007 Financial Guidance
The company has raised its full-year pro forma adjusted earnings guidance for 2007, and now expects
full-year pro forma adjusted earnings per share to be in the range of $3.50 to $3.55 per share,
representing growth of 16 to 17 percent compared with full-year 2006 pro forma adjusted results.
Full-year pro forma adjusted earnings per share growth is expected to be fueled by pro forma sales
growing at a faster rate than pro forma operating expenses.
For the fourth quarter, the company expects pro forma adjusted earnings per share of $0.86 to
$0.91, which excludes an estimated $0.03 per share charge for acquired in-process research and
development related to the MacroGenics in-licensing agreement. Including this charge, the company
expects fourth-quarter reported earnings per share to be in the range of $0.83 to $0.88.
The earnings per share guidance includes an anticipated increase in the effective tax rate for the
fourth quarter, the impact of the potential launch of generic olanzapine by competitors in Germany,
normally scheduled manufacturing shutdowns, and additional investments in research and development
and sales and marketing to drive future growth. The full-year pro forma adjusted earnings per share
guidance excludes the charges noted in the tables below related to restructuring charges, acquired
in-process research and development and an adjustment to insurance recoverables. Including the
charges noted in the tables below, the company expects
- 9 -
reported earnings per share to be in the range of $2.76 to $2.81 for the full year, representing
growth of 13 to 15 percent compared with full-year 2006 reported results. See reconciliations below
for further detail.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q4 2007 |
|
|
Q4 2006 |
|
|
|
|
Q4 Earnings per Share Reconciliation |
|
Expectations |
|
|
Results |
|
|
% Growth |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (reported) |
|
$.83 to $.88 |
|
$ |
.12 |
|
|
NM |
Eliminate estimated in-process
research & development charge
associated with MacroGenics
in-licensing |
|
.03 |
|
|
|
|
|
|
|
|
Eliminate product liability charge |
|
|
|
|
.42 |
|
|
|
|
|
Eliminate asset impairments,
restructuring and other special
charges |
|
|
|
|
.31 |
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on
January 1, 2006 |
|
|
|
|
(.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$.86 to $.91 |
|
$ |
.82 |
|
|
5% to 11% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
|
|
Full-Year Earnings per Share Reconciliation |
|
Expectations |
|
|
Results |
|
|
% Growth |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (reported) |
|
$2.76 to $2.81 |
|
$ |
2.45 |
|
|
13% to 15% |
Eliminate estimated in-process research &
development charge associated with
MacroGenics in-licensing |
|
.03 |
|
|
|
|
|
|
|
|
Eliminate product liability charge |
|
|
|
|
.42 |
|
|
|
|
|
Eliminate asset impairments and
restructuring charges associated with
previously announced manufacturing
decisions |
|
.08 |
|
|
.31 |
|
|
|
|
|
Eliminate special charges related to
adjustment to insurance recoverable |
|
.06 |
|
|
|
|
|
|
|
|
Eliminate in-process research &
development charges associated with ICOS,
Hypnion, and Ivy acquisitions and OSI
in-licensing |
|
.58 |
|
|
|
|
|
|
|
|
Include pro forma as if the ICOS
acquisition was completed on January 1,
2006 |
|
(.01) |
|
|
(.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E.P.S. (pro forma adjusted) |
|
$3.50 to $3.55 |
|
$ |
3.03 |
|
|
16% to 17% |
|
|
|
|
|
|
|
|
|
|
The company reconfirmed its full-year 2007 sales guidance. The company continues to expect reported
sales to grow in the mid-teens and pro forma sales to grow in the low double digits. The
- 10 -
company continues to expect gross margin as a percent of sales to improve slightly compared with
2006. In addition, the company expects operating expenses on a pro forma adjusted basis to grow in
the low double digits, albeit at a slower rate than sales. Operating expense growth is expected to
be driven primarily by increased investment in research and development and ongoing expenditures
for marketing and selling efforts in support of Cymbalta and the diabetes care products. The
company has raised its guidance on other income and now expects other income to be approximately
$100 million. The company also anticipates the pro forma adjusted effective tax rate to be
approximately 22 percent. The company expects a continuation of strong cash flow trends in 2007,
with capital expenditures of approximately $1.1 billion.
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the
third-quarter 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 to 10:00 a.m. Eastern Daylight Time
(EDT) and will be available for replay via the website through November 19, 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
- 11 -
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; 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 August 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)
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)
KwikPenTM
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
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
Worldwide Employees |
|
|
41,000 |
* |
|
|
41,500 |
|
|
|
|
* |
|
Headcount figures as of September 30, 2007 include certain personnel previously employed by
Icos Corporation, Hypnion, Inc. and Ivy Animal Health, Inc. |
- 12 -
Eli Lilly and Company
Operating Results (Unaudited) REPORTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30 |
|
|
|
|
|
|
September 30 |
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
% Chg. |
|
|
2007 |
|
|
2006 |
|
|
% Chg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
4,586.8 |
|
|
$ |
3,864.1 |
|
|
|
19 |
% |
|
$ |
13,443.9 |
|
|
$ |
11,445.7 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
1,054.6 |
|
|
|
860.4 |
|
|
|
23 |
% |
|
|
2,976.0 |
|
|
|
2,527.5 |
|
|
|
18 |
% |
Research and development |
|
|
844.5 |
|
|
|
755.7 |
|
|
|
12 |
% |
|
|
2,533.1 |
|
|
|
2,271.3 |
|
|
|
12 |
% |
Marketing and administrative |
|
|
1,477.8 |
|
|
|
1,198.2 |
|
|
|
23 |
% |
|
|
4,339.3 |
|
|
|
3,579.0 |
|
|
|
21 |
% |
Acquired in-process research
and development |
|
|
|
|
|
|
|
|
|
NM |
|
|
656.6 |
|
|
|
|
|
|
NM |
Asset impairments,
restructuring and other special
charges |
|
|
81.3 |
|
|
|
|
|
|
NM |
|
|
204.3 |
|
|
|
|
|
|
NM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,128.6 |
|
|
|
1,049.8 |
|
|
|
8 |
% |
|
|
2,734.6 |
|
|
|
3,067.9 |
|
|
|
(11 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) |
|
|
(6.2 |
) |
|
|
4.8 |
|
|
|
|
|
|
|
(10.9 |
) |
|
|
2.1 |
|
|
|
|
|
Joint-venture income |
|
|
|
|
|
|
23.8 |
|
|
|
|
|
|
|
11.0 |
|
|
|
66.1 |
|
|
|
|
|
Net other income |
|
|
56.0 |
|
|
|
27.4 |
|
|
|
|
|
|
|
89.8 |
|
|
|
66.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
49.8 |
|
|
|
56.0 |
|
|
|
|
|
|
|
89.9 |
|
|
|
135.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
1,178.4 |
|
|
|
1,105.8 |
|
|
|
7 |
% |
|
|
2,824.5 |
|
|
|
3,203.0 |
|
|
|
(12 |
%) |
Income taxes |
|
|
252.1 |
|
|
|
232.2 |
|
|
|
9 |
% |
|
|
725.9 |
|
|
|
672.6 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
926.3 |
|
|
$ |
873.6 |
|
|
|
6 |
% |
|
$ |
2,098.6 |
|
|
$ |
2,530.4 |
|
|
|
(17 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.85 |
|
|
$ |
0.80 |
|
|
|
6 |
% |
|
$ |
1.93 |
|
|
$ |
2.33 |
|
|
|
(17 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.85 |
|
|
$ |
0.80 |
|
|
|
6 |
% |
|
$ |
1.93 |
|
|
$ |
2.33 |
|
|
|
(17 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
.425 |
|
|
$ |
0.40 |
|
|
|
6 |
% |
|
$ |
1.275 |
|
|
$ |
1.20 |
|
|
|
6 |
% |
Weighted-average shares
outstanding (thousands)
basic |
|
|
1,090,067 |
|
|
|
1,085,603 |
|
|
|
|
|
|
|
1,089,809 |
|
|
|
1,085,441 |
|
|
|
|
|
Weighted-average shares
outstanding (thousands)
diluted |
|
|
1,090,228 |
|
|
|
1,086,412 |
|
|
|
|
|
|
|
1,090,095 |
|
|
|
1,086,449 |
|
|
|
|
|
N/M not meaningful
- 13 -
Eli Lilly and Company
Operating Results (Unaudited) PRO FORMA ADJUSTED
(Dollars in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30 |
|
|
|
|
|
|
September 30 |
|
|
|
|
|
|
2007 (a) (b) |
|
|
2006 (b) |
|
|
% Chg. |
|
|
2007 (a) (b) |
|
|
2006 (b) |
|
|
% Chg. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
4,586.8 |
|
|
$ |
4,054.7 |
|
|
|
13 |
% |
|
$ |
13,516.6 |
|
|
$ |
11,986.3 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
1,054.6 |
|
|
|
906.2 |
|
|
|
16 |
% |
|
|
2,991.9 |
|
|
|
2,663.3 |
|
|
|
12 |
% |
Research and development |
|
|
844.5 |
|
|
|
788.8 |
|
|
|
7 |
% |
|
|
2,545.1 |
|
|
|
2,370.1 |
|
|
|
7 |
% |
Marketing and administrative |
|
|
1,477.8 |
|
|
|
1,302.3 |
|
|
|
13 |
% |
|
|
4,375.2 |
|
|
|
3,886.1 |
|
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
1,209.9 |
|
|
|
1,057.4 |
|
|
|
14 |
% |
|
|
3,604.4 |
|
|
|
3,066.8 |
|
|
|
18 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) |
|
|
(6.2 |
) |
|
|
(34.2 |
) |
|
|
|
|
|
|
(23.4 |
) |
|
|
(108.9 |
) |
|
|
|
|
Joint-venture income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net other income |
|
|
56.0 |
|
|
|
29.4 |
|
|
|
|
|
|
|
91.8 |
|
|
|
73.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (deductions) |
|
|
49.8 |
|
|
|
(4.8 |
) |
|
|
|
|
|
|
68.4 |
|
|
|
(35.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
1,259.7 |
|
|
|
1,052.6 |
|
|
|
20 |
% |
|
|
3,672.8 |
|
|
|
3,031.3 |
|
|
|
21 |
% |
Income taxes |
|
|
263.3 |
|
|
|
220.6 |
|
|
|
19 |
% |
|
|
795.8 |
|
|
|
630.8 |
|
|
|
26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
996.4 |
|
|
$ |
832.0 |
|
|
|
20 |
% |
|
$ |
2,877.0 |
|
|
$ |
2,400.5 |
|
|
|
20 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share basic |
|
$ |
0.91 |
|
|
$ |
0.77 |
|
|
|
18 |
% |
|
$ |
2.64 |
|
|
$ |
2.21 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share diluted |
|
$ |
0.91 |
|
|
$ |
0.77 |
|
|
|
18 |
% |
|
$ |
2.64 |
|
|
$ |
2.21 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share |
|
$ |
.425 |
|
|
$ |
.40 |
|
|
|
6 |
% |
|
$ |
1.275 |
|
|
$ |
1.20 |
|
|
|
6 |
% |
Weighted-average shares outstanding (thousands)
basic |
|
|
1,090,067 |
|
|
|
1,085,603 |
|
|
|
|
|
|
|
1,089,809 |
|
|
|
1,085,441 |
|
|
|
|
|
Weighted-average shares outstanding (thousands)
diluted |
|
|
1,090,228 |
|
|
|
1,086,412 |
|
|
|
|
|
|
|
1,090,095 |
|
|
|
1,086,449 |
|
|
|
|
|
|
|
|
(a) |
|
The 2007 third-quarter and year-to-date amounts are adjusted to eliminate a $81.3
million (pretax) charge, or $0.06 per share (after-tax), for special charges related to an
adjustment to insurance recoverables on product liability litigation; the 2007 year-to-date
amounts are also adjusted to eliminate a second-quarter charge of $328.1 million (pretax)
charge, or $0.29 per share (after-tax), for acquired in-process research and development
related to the Hypnion and Ivy acquisitions, a $328.5 million (pretax) first-quarter
charge, or $0.29 per share (after-tax), for acquired in-process research and development
for compounds acquired from ICOS and OSI Pharmaceuticals, as well as a $123.0 million
(pretax) charge, or $0.08 per share (after-tax), 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. |
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