e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
Quarterly Report Under Section 13 or 15(d) of the
Securities Exchange Act of 1934
FOR THE QUARTER ENDED MARCH 31, 2006
COMMISSION FILE NUMBER 001-6351
ELI LILLY AND COMPANY
(Exact name of Registrant as specified in its charter)
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INDIANA
(State or other jurisdiction of
incorporation or organization)
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35-0470950
(I.R.S. Employer
Identification No.) |
LILLY CORPORATE CENTER, INDIANAPOLIS, INDIANA 46285
(Address of principal executive offices)
Registrants telephone number, including area code (317) 276-2000
Indicate by check mark whether the Registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months and (2) has been subject to such filing requirements for the
past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o |
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of shares of common stock outstanding as of April 20, 2006:
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Class
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Number of Shares Outstanding |
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Common
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1,130,130,744 |
1
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED CONDENSED STATEMENTS OF INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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(Dollars in millions except |
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per-share data) |
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Net sales |
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$ |
3,714.7 |
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$ |
3,497.4 |
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Cost of sales |
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806.5 |
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859.0 |
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Research and development |
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740.8 |
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702.2 |
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Marketing and administrative |
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1,142.9 |
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1,090.4 |
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Other income net |
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(32.2 |
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(98.6 |
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2,658.0 |
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2,553.0 |
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Income before income taxes |
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1,056.7 |
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944.4 |
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Income taxes |
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221.9 |
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207.8 |
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Net income |
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$ |
834.8 |
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$ |
736.6 |
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Earnings per share basic |
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$ |
.77 |
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$ |
.68 |
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Earnings per share diluted |
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$ |
.77 |
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$ |
.68 |
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Dividends paid per share |
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$ |
.40 |
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$ |
.38 |
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See Notes to Consolidated Condensed Financial Statements.
2
CONSOLIDATED CONDENSED BALANCE SHEETS
Eli Lilly and Company and Subsidiaries
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March 31, |
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December 31, |
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2006 |
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2005 |
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(Dollars in millions) |
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(Unaudited) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
2,458.3 |
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$ |
3,006.7 |
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Short-term investments |
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2,045.4 |
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2,031.0 |
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Accounts receivable, net of allowances
of $65.7 (2006) and $66.3 (2005) |
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2,113.6 |
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2,313.3 |
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Other receivables |
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377.4 |
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448.4 |
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Inventories |
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1,969.1 |
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1,878.0 |
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Deferred income taxes |
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661.1 |
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756.4 |
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Prepaid expenses |
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735.7 |
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362.0 |
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TOTAL CURRENT ASSETS |
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10,360.6 |
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10,795.8 |
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OTHER ASSETS |
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Prepaid pension |
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2,390.4 |
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2,419.6 |
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Investments |
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1,318.4 |
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1,296.6 |
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Sundry |
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2,131.2 |
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2,156.3 |
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5,840.0 |
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5,872.5 |
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PROPERTY AND EQUIPMENT |
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Land, buildings, equipment, and construction-in-progress |
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13,273.3 |
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13,136.0 |
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Less allowances for depreciation |
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(5,327.0 |
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(5,223.5 |
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7,946.3 |
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7,912.5 |
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$ |
24,146.9 |
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$ |
24,580.8 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Short-term borrowings |
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$ |
736.0 |
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$ |
734.7 |
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Accounts payable |
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637.7 |
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781.3 |
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Employee compensation |
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336.4 |
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548.8 |
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Dividends payable |
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436.5 |
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Income taxes payable |
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896.7 |
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884.9 |
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Other current liabilities |
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1,919.4 |
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2,330.1 |
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TOTAL CURRENT LIABILITIES |
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4,526.2 |
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5,716.3 |
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LONG-TERM DEBT |
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5,612.5 |
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5,763.5 |
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DEFERRED INCOME TAXES |
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746.7 |
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695.1 |
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OTHER NONCURRENT LIABILITIES |
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1,567.3 |
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1,614.0 |
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SHAREHOLDERS EQUITY |
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Common stock |
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706.9 |
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706.9 |
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Additional paid-in capital |
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3,255.3 |
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3,323.8 |
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Retained earnings |
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10,865.0 |
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10,027.2 |
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Employee benefit trust |
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(2,635.0 |
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(2,635.0 |
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Deferred costs-ESOP |
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(105.0 |
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(106.3 |
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Accumulated other comprehensive loss |
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(290.4 |
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(420.6 |
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11,796.8 |
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10,896.0 |
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Less cost of common stock in treasury |
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102.6 |
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104.1 |
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11,694.2 |
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10,791.9 |
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$ |
24,146.9 |
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$ |
24,580.8 |
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See Notes to Consolidated Condensed Financial Statements.
3
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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(Dollars in millions) |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net income |
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$ |
834.8 |
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$ |
736.6 |
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Adjustments to reconcile net income to cash
flows from operating activities: |
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Changes in operating assets and liabilities |
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(947.1 |
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0.3 |
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Depreciation and amortization |
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204.9 |
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158.7 |
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Stock-based compensation expense |
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100.2 |
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108.2 |
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Change in deferred taxes |
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99.8 |
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(221.8 |
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Other, net |
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(38.1 |
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22.8 |
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NET CASH PROVIDED BY OPERATING ACTIVITIES |
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254.5 |
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804.8 |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Net purchases of property and equipment |
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(160.7 |
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(242.2 |
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Net change in short-term investments |
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(20.2 |
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2,085.6 |
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Purchase of noncurrent investments |
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(630.7 |
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(139.8 |
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Proceeds from sales and maturities of noncurrent investments |
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554.8 |
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187.5 |
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Other, net |
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85.1 |
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(67.6 |
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NET CASH (USED IN) PROVIDED BY INVESTING ACTIVITIES |
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(171.7 |
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1,823.5 |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Dividends paid |
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(433.5 |
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(413.2 |
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Purchase of common stock |
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(122.1 |
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Repayment of long-term debt |
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(97.7 |
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(97.1 |
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Issuances of common stock under stock plans |
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7.8 |
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12.5 |
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Net change in short-term borrowings |
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3.8 |
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(1,788.2 |
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Other, net |
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1.4 |
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0.9 |
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NET CASH USED IN FINANCING ACTIVITIES |
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(640.3 |
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(2,285.1 |
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Effect of exchange rate changes on cash and cash equivalents |
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9.1 |
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(100.8 |
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NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
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(548.4 |
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242.4 |
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Cash and cash equivalents at January 1 |
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3,006.7 |
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5,365.3 |
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CASH AND CASH EQUIVALENTS AT MARCH 31 |
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$ |
2,458.3 |
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$ |
5,607.7 |
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See Notes to Consolidated Condensed Financial Statements.
4
CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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(Dollars in millions) |
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Net income |
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$ |
834.8 |
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$ |
736.6 |
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Other comprehensive income (loss)1 |
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130.2 |
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(171.0 |
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Comprehensive income |
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$ |
965.0 |
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$ |
565.6 |
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1
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The significant components of other comprehensive income (loss) were a gain of $50.8
million from foreign currency translation adjustments and a gain of $66.8 million from cash flow
hedges for the three months ended March 31, 2006, compared with a loss of $138.5 million from
foreign currency translation adjustments and net unrealized losses on securities of $22.9 million
for the three months ended March 31, 2005.
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See Notes to Consolidated Condensed Financial Statements.
5
SEGMENT INFORMATION
We operate in one significant business segment pharmaceutical products. Operations of our animal
health business segment are not material and share many of the same economic and operating
characteristics as our pharmaceutical products. Therefore, they are included with pharmaceutical
products for purposes of segment reporting. Our business segments are distinguished by the
ultimate end user of the product: humans or animals. Performance is evaluated based on profit or
loss from operations before income taxes. Income before income taxes for the animal health
business for the first quarters of 2006 and 2005 were $34.2 million and $40.0 million,
respectively.
SALES BY PRODUCT CATEGORY
Worldwide sales by product category were as follows:
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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(Dollars in millions) |
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Net sales to unaffiliated customers: |
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Neurosciences |
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$ |
1,507.1 |
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$ |
1,427.8 |
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Endocrinology |
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1,228.6 |
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1,144.8 |
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Oncology |
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469.1 |
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400.9 |
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Animal health |
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198.3 |
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195.5 |
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Cardiovascular |
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143.1 |
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168.1 |
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Anti-infectives |
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87.9 |
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109.2 |
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Other pharmaceutical |
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80.6 |
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51.1 |
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Net sales |
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$ |
3,714.7 |
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$ |
3,497.4 |
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6
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
BASIS OF PRESENTATION
We have prepared the accompanying unaudited consolidated condensed financial statements in
accordance with the requirements of Form 10-Q and, therefore, they do not include all information
and footnotes necessary for a fair presentation of financial position, results of operations, and
cash flows in conformity with accounting principles generally accepted in the United States (GAAP).
In our opinion, the financial statements reflect all adjustments (including those that are normal
and recurring) that are necessary for a fair presentation of the results of operations for the
periods shown. In preparing financial statements in conformity with GAAP, we must make estimates
and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and
related disclosures at the date of the financial statements and during the reporting period.
Actual results could differ from those estimates.
The information included in this Quarterly Report on Form 10-Q should be read in conjunction with
our consolidated financial statements and accompanying notes included in our Annual Report on Form
10-K for the year ended December 31, 2005.
CONTINGENCIES
We are engaged in the following patent litigation matters brought pursuant to procedures set out in
the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984):
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Dr. Reddys Laboratories, Ltd. (Reddy), Teva Pharmaceuticals, and Zenith Goldline
Pharmaceuticals, Inc., which was subsequently acquired by Teva Pharmaceuticals (together,
Teva), each submitted abbreviated new drug applications (ANDAs) seeking permission to market
generic versions of Zyprexa prior to the expiration of our relevant U.S. patent (expiring
in 2011) and alleging that this patent was invalid or not enforceable. We filed lawsuits
against these companies in the U.S. District Court for the Southern District of Indiana,
seeking a ruling that the patent is valid, enforceable and being infringed. The district
court ruled in our favor on all counts on April 14, 2005. We are now awaiting a decision
by the Court of Appeals for the Federal Circuit, which on April 6, 2006 heard Reddys and
Tevas respective appeals of this ruling. We are confident Reddys and Tevas claims are
without merit and we expect to prevail. However, it is not possible to predict or
determine the outcome of this litigation, and accordingly, we can provide no assurance that
we will prevail on appeal. An unfavorable outcome would have a material adverse impact on
our consolidated results of operations, liquidity, and financial position. |
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Barr Laboratories, Inc. (Barr), submitted an ANDA in 2002 seeking permission to market a
generic version of Evista prior to the expiration of our relevant U.S. patents (expiring in
2012-2017) and alleging that these patents are invalid, not enforceable, or not infringed.
In November 2002, we filed a lawsuit against Barr in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid, enforceable,
and being infringed by Barr. No trial date has been set. We believe Barrs claims are
without merit and we expect to prevail. However, it is not possible to predict or
determine the outcome of this litigation, and accordingly, we can provide no assurance that
we will prevail. An unfavorable outcome could have a material adverse impact on our
consolidated results of operations, liquidity, and financial position. |
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Sicor Pharmaceuticals, Inc. (Sicor), a subsidiary of Teva, submitted ANDAs in November
2005 seeking permission to market generic versions of Gemzar prior to the expiration of our
relevant U.S. patents (expiring in 2010 and 2013), and alleging that these patents are
invalid. In February, we filed a lawsuit against Sicor in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid and are being
infringed by Sicor. No trial date has been set. We believe Sicors claims are without
merit and we expect to prevail. However, it is not possible to predict or determine the
outcome of this litigation, and accordingly, we can provide no assurance that we will
prevail. An unfavorable outcome could have a material adverse impact on our consolidated
results of operations. |
In March 2004, the office of the U.S. Attorney for the Eastern District of Pennsylvania advised us
that it has commenced a civil investigation related to our U.S. marketing and promotional
practices, including our communications with physicians and remuneration of physician consultants
and advisors, with respect to Zyprexa, Prozac®, and Prozac Weekly. In October 2005, the U.S.
Attorneys office advised that it is also conducting an inquiry regarding certain rebate agreements
we entered into with a pharmacy benefit manager covering Axid®, Evista, Humalog, Humulin, Prozac,
and Zyprexa. The inquiry includes a review of Lillys Medicaid best price reporting related to the
product sales covered by the
rebate agreements. We are cooperating with the U.S. Attorney in these investigations, including
providing a broad range of documents and information relating to the investigations. In June 2005,
we received a subpoena from the office of the Attorney General, Medicaid Fraud Control Unit, of the
7
State of Florida, seeking production of documents relating to sales of Zyprexa and our marketing
and promotional practices with respect to Zyprexa. It is possible that other Lilly products could
become subject to investigation and that the outcome of these matters could include criminal
charges and fines, penalties, or other monetary or non-monetary remedies. We cannot predict or
determine the outcome of these matters or reasonably estimate the amount or range of amounts of any
fines or penalties that might result from an adverse outcome. It is possible, however, that an
adverse outcome could have a material adverse impact on our consolidated results of operations,
liquidity, and financial position. We have implemented and continue to review and enhance a
broadly based compliance program that includes comprehensive compliance-related activities designed
to ensure that our marketing and promotional practices, physician communications, remuneration of
health care professionals, managed care arrangements, and Medicaid best price reporting comply with
applicable laws and regulations.
We have been named as a defendant in a large number of Zyprexa product liability lawsuits in the
United States and have been notified of many other claims of individuals who have not filed suit.
The lawsuits and unfiled claims (together the claims) allege a variety of injuries from the use
of Zyprexa, with the majority alleging that the product caused or contributed to diabetes or high
blood-glucose levels. The claims seek substantial compensatory and punitive damages and typically
accuse us of inadequately testing for and warning about side effects of Zyprexa. Many of the
claims also allege that we improperly promoted the drug. Almost all of the federal lawsuits are
part of a Multi-District Litigation (MDL) proceeding before The Honorable Jack Weinstein in the
Federal District Court for the Eastern District of New York (MDL No. 1596). The MDL includes three
lawsuits requesting certification of class actions on behalf of those who allegedly suffered
injuries from the administration of Zyprexa. We have entered into agreements with various
plaintiffs counsel halting the running of the statutes of limitation (tolling agreements) with
respect to a number of claimants who do not have lawsuits on file.
Since June 2005, we have entered into agreements in principle with various claimants attorneys
involved in U.S. Zyprexa product liability litigation to settle a majority of the claims. The
agreements cover approximately 10,500 claimants, including a large number of previously filed
lawsuits (including the three purported class actions mentioned above), tolled claims, and other
informally asserted claims. The settlements are being overseen and distributed by court-approved
claims administrators. The agreements in principle are subject to certain conditions, including
obtaining full releases from a specified number of claimants.
The U.S. Zyprexa product liability claims not subject to these agreements in principle include
approximately 800 lawsuits in the U.S. covering 4,700 claimants, and approximately 850 tolled
claims. In addition, we have been served with a new lawsuit seeking class certification in which
the members of the purported class are seeking refunds and medical monitoring. Finally, in early
2005, we were served with five lawsuits seeking class action status in Canada on behalf of patients
who took Zyprexa. The allegations in the Canadian actions are similar to those in the litigation
pending in the United States. We are prepared to continue our vigorous defense of Zyprexa in all
remaining cases.
In December 2004, we were served with two lawsuits brought in state court in Louisiana on behalf of
the Louisiana Department of Health and Hospitals, alleging that Zyprexa caused or contributed to
diabetes or high blood-glucose levels, and that we improperly promoted the drug. These cases have
been removed to federal court and are now part of the MDL proceedings in the Eastern District of
New York. In these actions, the Department of Health and Hospitals seeks to recover the costs it
paid for Zyprexa through Medicaid and other drug-benefit programs, as well as the costs the
department alleges it has incurred and will incur to treat Zyprexa-related illnesses. In 2006, we
were served with similar lawsuits filed by the states of Alaska and West Virginia in the courts of
the respective states.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide
class actions on behalf of all consumers and third party payors, excluding governmental entities,
which have made or will make payments for their members or insured patients being prescribed
Zyprexa. These actions have now been consolidated into a single lawsuit, which is brought under
certain state consumer protection statutes, the federal civil RICO statute, and common law
theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys
fees. In addition, in 2006 two additional lawsuits were filed in the Eastern District of New York
on similar grounds. As with the product liability suits, these lawsuits allege that we
inadequately tested for and warned about side effects of Zyprexa and improperly promoted the drug.
We have insurance coverage for a portion of our Zyprexa product liability claims exposure. The
third-party insurance carriers have raised defenses to their liability under the policies and are
seeking to rescind the policies. The dispute is now the subject of litigation in the federal court
in Indianapolis
against certain of the carriers and in arbitration in Bermuda against other carriers. While we
believe our position is meritorious, there can be no assurance that we will prevail.
In addition, we have been named as a defendant in numerous other product liability lawsuits
involving primarily diethylstilbestrol (DES) and thimerosal.
With respect to the product liability claims currently asserted against us, we have accrued for our
estimated exposures to the extent they are both probable and estimable based on the information
available to us. In addition, we have accrued for certain
8
product liability claims incurred but
not filed to the extent we can formulate a reasonable estimate of their costs. We estimate these
expenses based primarily on historical claims experience and data regarding product usage. Legal
defense costs expected to be incurred in connection with significant product liability loss
contingencies are accrued when probable and reasonably estimable. A portion of the costs
associated with defending and disposing of these suits is covered by insurance. We record
receivables for insurance-related recoveries when it is probable they will be realized. These
receivables are classified as a reduction of the litigation charges on the statement of income. We
estimate insurance recoverables based on existing deductibles, coverage limits, our assessment of
any defenses to coverage that might be raised by the carriers, and the existing and projected
future level of insolvencies among the insurance carriers.
In the second quarter of 2005, we recorded a net pre-tax charge of $1.07 billion for product
liability matters. The $1.07 billion net charge takes into account our estimated recoveries from
our insurance coverage related to these matters. The charge covers the following:
|
|
|
The cost of the Zyprexa settlements described above; and, |
|
|
|
Reserves for product liability exposures and defense costs regarding currently known and
expected claims to the extent we can formulate a reasonable estimate of the probable number
and cost of the claims. A substantial majority of these exposures and costs relate to
current and expected Zyprexa claims not included in the settlements. We have estimated
these charges based primarily on historical claims experience, data regarding product
usage, and our historical product liability defense cost experience. |
During 2005, $700 million was paid in connection with Zyprexa settlements, while the cash related
to other reserves for product liability exposures and defense costs is expected to be paid out over
the next several years, including 2006. The timing of our insurance recoveries is uncertain.
We cannot predict with certainty the additional number of lawsuits and claims that may be asserted.
In addition, although we believe it is probable, there can be no assurance that the Zyprexa
settlements described above will be concluded. The ultimate resolution of Zyprexa product
liability and related litigation could have a material adverse impact on our consolidated results
of operations, liquidity, and financial position.
Because of the nature of pharmaceutical products, it is possible that we could become subject to
large numbers of product liability claims for other products in the future. We have experienced
difficulties in obtaining product liability insurance due to a very restrictive insurance market,
and therefore will be largely self-insured for future product liability losses. In addition, as
noted above, there is no assurance that we will be able to fully collect from our insurance
carriers on past claims.
In June 2002, we were sued by Ariad Pharmaceuticals, Inc., the Massachusetts Institute of
Technology, the Whitehead Institute for Biomedical Research and the President and Fellows of
Harvard College in the U.S. District Court for the District of Massachusetts alleging that sales of
two of our products, Xigris and Evista, were inducing the infringement of a patent related to the
discovery of a natural cell signaling phenomenon in the human body and seeking royalties on past
and future sales of these products. We believe that these allegations are without legal merit and
expect to prevail. However, there can be no assurance that we will prevail. In June 2005, the
United States Patent and Trademark Office commenced a reexamination of the patent in order to
consider certain issues raised by us relating to the validity of the patent. The reexamination is
currently in progress. A jury trial commenced in Boston on April 10, 2006 on the patent validity
and infringement issues. Any final decision of the trial court will be subject to an appeal to the
Court of Appeals for the Federal Circuit.
Also, under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly
known as Superfund, we have been designated as one of several potentially responsible parties with
respect to fewer than 10 sites. Under Superfund, each responsible party may be jointly and
severally liable for the entire amount of the cleanup. We also continue remediation of certain of
our own sites. We have accrued for estimated Superfund cleanup costs, remediation, and certain
other environmental matters. This takes into account, as applicable, available information
regarding site conditions, potential
cleanup methods, estimated costs, and the extent to which other parties can be expected to
contribute to payment of those costs. We have reached a settlement with our liability insurance
carriers providing for coverage for certain environmental liabilities.
The litigation accruals and environmental liabilities and the related estimated insurance
recoverables have been reflected on a gross basis as liabilities and assets, respectively, on our
consolidated balance sheets.
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity, but could possibly be material to the
consolidated results of operations in any one accounting period.
9
EARNINGS PER SHARE
Unless otherwise noted in the footnotes, all per-share amounts are presented on a diluted basis,
that is, based on the weighted-average number of outstanding common shares plus the effect of all
potentially dilutive common shares (primarily unexercised stock options).
STOCK-BASED COMPENSATION
We adopted Statement of Financial Accounting Standards No. 123 (revised 2004), Share-Based Payment
(SFAS 123R), effective January 1, 2005. SFAS 123R requires the recognition of the fair value of
stock-based compensation in net income. Stock-based compensation primarily consists of stock
options and performance awards. We recognized pretax stock-based compensation cost in the amount
of $100.2 million and $108.2 million in the first quarter of 2006 and 2005, respectively.
As of March 31, 2006, the total remaining unrecognized compensation cost related to nonvested stock
options and performance awards amounted to $233.1 million and $153.6 million, respectively, which
will be amortized over the weighted-average remaining requisite
service periods, which are approximately 2
years and 9 months, respectively.
RETIREMENT BENEFITS
Net pension and retiree health benefit expense included the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Defined Benefit Pension Plans |
|
Retiree Health Benefit Plans |
|
|
Three Months Ended March 31, |
|
Three Months Ended March 31, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Components of net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
69.3 |
|
|
$ |
80.1 |
|
|
$ |
19.7 |
|
|
$ |
14.7 |
|
Interest cost |
|
|
80.7 |
|
|
|
74.8 |
|
|
|
24.4 |
|
|
|
20.1 |
|
Expected return on plan assets |
|
|
(119.5 |
) |
|
|
(110.1 |
) |
|
|
(22.0 |
) |
|
|
(17.0 |
) |
Amortization of prior service cost |
|
|
1.4 |
|
|
|
2.0 |
|
|
|
(3.9 |
) |
|
|
(4.0 |
) |
Recognized actuarial loss |
|
|
30.3 |
|
|
|
26.2 |
|
|
|
25.2 |
|
|
|
21.6 |
|
|
|
|
Net periodic benefit cost |
|
$ |
62.2 |
|
|
$ |
73.0 |
|
|
$ |
43.4 |
|
|
$ |
35.4 |
|
|
|
|
In 2006, we expect to contribute approximately $26 million to our defined benefit pension plans
to satisfy minimum funding requirements for the year. In addition, we expect to contribute
approximately $130 million of additional discretionary funding in 2006 to our defined benefit
plans. We also expect to contribute approximately $120 million of discretionary funding to our
postretirement health benefit plans during 2006. As of March 31, 2006, $40.5 million of
contributions have been made to these plans.
OTHER INCOME NET
Other income net, was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Interest expense |
|
$ |
65.0 |
|
|
$ |
24.6 |
|
Interest income |
|
|
(59.7 |
) |
|
|
(46.0 |
) |
Joint venture (income) loss |
|
|
(19.8 |
) |
|
|
12.6 |
|
Other |
|
|
(17.7 |
) |
|
|
(89.8 |
) |
|
|
|
|
|
$ |
(32.2 |
) |
|
$ |
(98.6 |
) |
|
|
|
The joint venture (income) loss represents our share of the Lilly ICOS LLC joint venture
results of operations, net of income taxes.
10
SHAREHOLDERS EQUITY
As of March 31, 2006, we have purchased $2.58 billion of our previously announced $3.0 billion
share repurchase program. During the first quarter of 2006, we acquired 2.1 million shares
pursuant to this program. We do not expect any share repurchases for the remainder of 2006.
IMPLEMENTATION OF NEW FINANCIAL ACCOUNTING PRONOUNCEMENTS
In the fourth quarter of 2005, we adopted Financial Accounting Standards Board (FASB)
Interpretation (FIN) 47, Accounting for Conditional Asset Retirement Obligations, an
interpretation of FASB Statement No. 143. FIN 47 requires us to record the fair value of a
liability for conditional asset retirement obligations in the period in which it is incurred,
which is adjusted to its present value each subsequent period. In addition, we are required to
capitalize a corresponding amount by increasing the carrying amount of the related long-lived
asset, which is depreciated over the useful life of the related long-lived asset. The adoption of
FIN 47 on December 31, 2005 resulted in a cumulative effect of a change in accounting principle of
$22.0 million, net of income taxes of $11.8 million.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
OPERATING RESULTS
Executive Overview
I. Financial Results
Our worldwide sales for the quarter increased 6 percent, to $3.71 billion, driven primarily by
the collective growth of Cymbalta and our other newer products. Net income and earnings per
share increased 13 percent, to $834.8 million and $.77, respectively, driven primarily by
improved gross margins and sales growing at a faster rate than operating expenses, offset
partially by decreased other income.
II. Recent Product Launches and Late-Stage Product Pipeline Developments
|
|
|
We submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for review of ruboxistaurin mesylate (proposed brand name Arxxant) for the
treatment of diabetic retinopathy. The FDA subsequently informed us that our Arxxant
application is fileable and will be given a priority review. |
|
|
|
|
We released preliminary data from the Raloxifene Use for the Heart (RUTH) trial. In
addition, initial results from the Study of Tamoxifen and Raloxifene (STAR) were released
by The National Surgical Adjuvant Breast and Bowel Project (NSABP). While the RUTH study
did not meet its primary endpoint on cardiovascular benefit, it did meet its primary
endpoint for the reduction of invasive breast cancer risk. In addition, the STAR study
showed that Evista is as effective as tamoxifen in reducing the breast cancer risk of
postmenopausal women who are at increased risk of the disease. Women who were assigned
to take Evista had 36 percent fewer uterine cancers and 29 percent fewer blood clots than
the women who were assigned to take tamoxifen. Using data from STAR and RUTH, along with
previously released data from MORE and CORE trials, we anticipate submitting a
supplemental NDA for Evistas expanded use in breast cancer risk reduction at the end of
2006. |
|
|
|
|
At the Anxiety Disorders Association of America conference, we announced the results
of a Phase III study that showed Cymbalta significantly reduced core anxiety symptoms
and associated painful physical symptoms in patients with generalized anxiety disorder. |
|
|
|
|
We initiated a Phase III clinical trial of enzastaurin, a targeted oral agent for
the treatment of relapsed glioblastoma multiforme, an aggressive and malignant form of
brain cancer. |
|
|
|
|
Alongside Amylin and Alkermes, we initiated a clinical study of a long-acting
release (LAR) formulation of Byetta in people with type 2 diabetes. This study could
form the basis of an NDA and will assess whether once-weekly exenatide LAR is at least
as effective in improving glucose control as twice-daily Byetta. |
|
|
|
|
We launched Humalog Mix50/50 in the U.S., a new pre-mixed insulin that is designed
to provide blood sugar control between meals but also includes a higher percentage of
rapid-acting insulin for people with diabetes who need more insulin control at
mealtime. |
III. Legal, Regulatory, and Other Matters
Certain generic manufacturers have challenged our U.S. compound patent for Zyprexa and are seeking
permission to market generic versions of Zyprexa prior to its patent expiration in 2011. On April
14, 2005, the U.S. District Court in Indianapolis ruled in our favor on all counts, upholding our
patents. The decision has been appealed.
11
We have reached agreements with claimants attorneys involved in certain U.S. Zyprexa product
liability litigation to settle a majority of the claims against us relating to the medication. A
large number of claims remain. As a result of our product liability exposures, the substantial
majority of which were related to Zyprexa, we recorded a net pretax charge of $1.07 billion in the
second quarter of 2005.
In March 2004, we were notified by the U.S. Attorneys office for the Eastern District of
Pennsylvania that it has commenced a civil investigation relating to our U.S. sales, marketing, and
promotional practices.
In the United States, implementation of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA), which provides a prescription drug benefit under the Medicare
program, took effect January 1, 2006. While it is difficult to predict the business impact of this
legislation, we currently anticipate a modest short-term increase in sales. However, in the long
term there is additional risk of increased pricing pressures. While the MMA prohibits the
Secretary of Health and Human Services (HHS) from directly negotiating prescription drug prices
with manufacturers, we expect continued challenges to that prohibition over the next several years.
Also, the MMA retains the authority of the Secretary of HHS to prohibit the importation of
prescription drugs, but we expect Congress to consider several measures that could remove that
authority and allow for the importation of products into the U.S. regardless of their safety or
cost. If adopted, such legislation would likely have a negative effect on our U.S. sales. We
believe there is some chance that the new and expanded prescription drug coverage for seniors under
the MMA will alleviate the perceived need for a federal importation scheme.
As a result of the passage of the MMA, aged and disabled patients jointly eligible for Medicare and
Medicaid began receiving their prescription drug benefits through the Medicare program, instead of
Medicaid, on January 1, 2006. This may relieve some state budget pressures but is unlikely to
result in reduced pricing pressures at the state level. A majority of states have implemented
supplemental rebates and restricted formularies in their Medicaid programs, and these programs are
expected to continue in the post-MMA environment. Moreover, under the 2005 federal Deficit
Reduction Act, states will have greater flexibility to impose new cost-sharing requirements on
Medicaid beneficiaries for non-preferred prescription drugs that will result in certain
beneficiaries bearing more of the cost. Several states are also attempting to extend discounted
Medicaid prices to non-Medicaid patients. Additionally, notwithstanding the federal law
prohibiting drug importation, approximately a dozen states have implemented importation schemes for
their citizens, usually involving a website that links patients to selected Canadian pharmacies.
One state has such a program for its state employees. As a result, we expect pressures on
pharmaceutical pricing to continue.
International operations are also generally subject to extensive price and market regulations, and
there are many proposals for additional cost-containment measures, including proposals that would
directly or indirectly impose additional price controls or reduce the value of our intellectual
property protection.
Sales
Sales increased 6 percent, to $3.71 billion. The sales increase was driven primarily by the
collective growth of Cymbalta and our other newer products. Sales growth comparisons benefited
from approximately $130 million of reductions in wholesaler inventory levels during the first
quarter of 2005 as a result of our restructuring arrangements with U.S. wholesalers. Excluding
this event, we estimate that our worldwide sales for the quarter would have increased 2
percent. Sales in the U.S. increased by $190.6 million, or 10 percent, for the first quarter
of 2006 compared with the first
quarter of 2005. Sales outside the U.S. increased $26.6 million, or 2 percent, for the first
quarter of 2006. Worldwide sales volume increased 6 percent, selling prices increased sales 3
percent and exchange rates decreased sales by 3 percent.
The following table summarizes our net sales activity for the three-month periods ended March
31, 2006 and 2005:
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
|
|
Three Months Ended |
|
March 31, |
|
Percent |
|
|
March 31, 2006 |
|
2005 |
|
Change |
Product |
|
U.S.1 |
|
Outside U.S. |
|
Total |
|
Total |
|
from 2005 |
|
|
(Dollars in millions) |
Zyprexa |
|
$ |
493.9 |
|
|
$ |
513.5 |
|
|
$ |
1,007.4 |
|
|
$ |
1,038.2 |
|
|
|
(3 |
%) |
Gemzar |
|
|
149.7 |
|
|
|
189.1 |
|
|
|
338.8 |
|
|
|
304.6 |
|
|
|
11 |
% |
Humalog |
|
|
188.6 |
|
|
|
115.9 |
|
|
|
304.5 |
|
|
|
286.2 |
|
|
|
6 |
% |
Evista |
|
|
149.1 |
|
|
|
92.5 |
|
|
|
241.6 |
|
|
|
248.9 |
|
|
|
(3 |
%) |
Cymbalta |
|
|
205.9 |
|
|
|
27.4 |
|
|
|
233.3 |
|
|
|
106.8 |
|
|
|
118 |
% |
Humulin |
|
|
88.2 |
|
|
|
130.3 |
|
|
|
218.5 |
|
|
|
256.9 |
|
|
|
(15 |
%) |
Animal health products |
|
|
84.0 |
|
|
|
114.3 |
|
|
|
198.3 |
|
|
|
195.5 |
|
|
|
1 |
% |
Actos |
|
|
151.4 |
|
|
|
37.6 |
|
|
|
189.0 |
|
|
|
168.7 |
|
|
|
12 |
% |
Strattera |
|
|
135.3 |
|
|
|
16.9 |
|
|
|
152.2 |
|
|
|
119.8 |
|
|
|
27 |
% |
Alimta |
|
|
77.9 |
|
|
|
52.2 |
|
|
|
130.1 |
|
|
|
93.9 |
|
|
|
39 |
% |
Forteo |
|
|
87.2 |
|
|
|
39.9 |
|
|
|
127.1 |
|
|
|
66.8 |
|
|
|
90 |
% |
Humatrope |
|
|
48.3 |
|
|
|
48.3 |
|
|
|
96.6 |
|
|
|
104.5 |
|
|
|
(8 |
%) |
Anti-infectives |
|
|
20.8 |
|
|
|
67.1 |
|
|
|
87.9 |
|
|
|
109.2 |
|
|
|
(20 |
%) |
Fluoxetine products |
|
|
36.2 |
|
|
|
41.2 |
|
|
|
77.4 |
|
|
|
112.5 |
|
|
|
(31 |
%) |
ReoPro |
|
|
29.6 |
|
|
|
44.5 |
|
|
|
74.1 |
|
|
|
76.7 |
|
|
|
(3 |
%) |
Cialis2 |
|
|
1.1 |
|
|
|
54.3 |
|
|
|
55.4 |
|
|
|
38.9 |
|
|
|
42 |
% |
Xigris |
|
|
27.9 |
|
|
|
22.4 |
|
|
|
50.3 |
|
|
|
59.5 |
|
|
|
(15 |
%) |
Symbyax |
|
|
12.9 |
|
|
|
0.5 |
|
|
|
13.4 |
|
|
|
12.6 |
|
|
|
6 |
% |
Other pharmaceutical
products |
|
|
47.3 |
|
|
|
71.5 |
|
|
|
118.8 |
|
|
|
97.2 |
|
|
|
22 |
% |
|
|
|
|
|
Total net sales |
|
$ |
2,035.3 |
|
|
$ |
1,679.4 |
|
|
$ |
3,714.7 |
|
|
$ |
3,497.4 |
|
|
|
6 |
% |
|
|
|
|
1 |
|
U.S. sales include sales in Puerto Rico. |
|
2 |
|
Cialis had worldwide first-quarter 2006 sales of $222.7 million compared with
first-quarter 2005 sales of $150.1 million. The sales shown in the table above represent results
in the territories in which we market Cialis exclusively. The remaining sales relate to the
joint-venture territories of Lilly ICOS LLC (North America, excluding Puerto Rico, and Europe).
Our share of the joint-venture territory sales, net of expenses, is reported in Other income net,
in our consolidated condensed income statement. |
Product Highlights
In the first quarter of 2006, U.S. sales of Zyprexa decreased 5 percent, due to lower demand
compared with first quarter of 2005, partially offset by higher prices. Zyprexa sales in
international markets decreased 1 percent, driven by the unfavorable impact of foreign exchange
rates. Excluding the impact of exchange rates, sales of Zyprexa outside the U.S. increased 5
percent in the first quarter.
Diabetes care products, composed primarily of Humalog, Humulin, Actos, and recently launched
Byetta, had worldwide net sales of $763.4 million in the first quarter of 2006, an increase of 5
percent compared with the same period last year. Diabetes care revenues in the U.S. increased 11
percent, to $475.5 million, driven primarily by reductions in U.S. wholesaler inventory levels
during the first quarter of 2005. Diabetes care revenues outside the U.S. decreased 3 percent,
to $287.9 million, primarily as a result of a decrease in Humulin demand as a result of
competitive pressures and the unfavorable impact of foreign exchange rates. Humalog sales
increased 7 percent in the U.S. due to the previously mentioned wholesaler destocking and 5 percent
outside of the U.S. due to increased demand. Humulin sales decreased 16 percent in the U.S. and
14 percent outside of the U.S. in the first quarter of 2006. Actos is manufactured by Takeda
Chemical Industries, Ltd., and sold in the U.S. by Takeda. Actos revenues in the U.S., which
represent service revenues from a copromotion agreement with Takeda, increased 10 percent. Our
U.S. marketing rights with respect to Actos expire in September 2006; however, we will continue
receiving royalties from Takeda. As a result, our U.S. revenues from Actos will decline in 2006 and each subsequent year. Our
arrangement in the U.S. ceases after October 2009, although our arrangement outside the U.S.
continues. Sales of Byetta, a first-in-class treatment for type 2 diabetes that we market with
Amylin Pharmaceuticals and launched in the U.S. in June 2005, were $68 million in the first
quarter. We report as revenue our 50 percent share of Byettas gross margin and our sales of
Byetta pen delivery devices to Amylin; for the first quarter, this revenue totaled $35.8 million.
13
Gemzar sales in the U.S. increased 18 percent in the first quarter of 2006 due primarily to an
increase in demand and higher prices. Outside the U.S., Gemzar sales increased 6 percent due to
strong demand, partially offset by the unfavorable impact of foreign exchange rates.
U.S. sales of Evista decreased 6 percent in the first quarter of 2006 driven by a decline in demand
due to continued competitive pressures, offset partially by higher prices. Evista sales outside
the U.S. increased 2 percent due to strong demand, partially offset by the unfavorable impact of
foreign exchange rates.
Cymbalta was launched in the third quarter of 2004 for the treatment of major depressive disorder
and diabetic peripheral neuropathic pain. U.S. sales of Cymbalta increased 101 percent in the
first quarter of 2006. Sales outside the U.S. reflect international launches in key markets,
including Germany, the U.K., Italy, Spain, and Mexico.
Sales of Strattera, the only nonstimulant medicine approved for the treatment of attention-deficit
hyperactivity disorder in children, adolescents and adults increased due to reductions in U.S.
wholesaler inventory levels during the first quarter of 2005 and higher prices, offset partially by
a decline in demand.
Alimta, a treatment for malignant pleural mesothelioma and second-line treatment of non-small-cell
lung cancer, had U.S. sales increase 22 percent, while sales outside the U.S. increased 72 percent.
U.S. sales of Forteo, a treatment for severe osteoporosis, increased 106 percent, while sales
outside the U.S. grew 62 percent.
Total worldwide first-quarter sales of Cialis, a treatment for erectile dysfunction marketed by
Lilly ICOS LLC, increased 48 percent compared with first-quarter 2005 worldwide sales. Worldwide
Cialis sales are composed of $55.4 million of sales in our territories and $167.3 million of sales
in the joint-venture territories. Within the joint-venture territories, the U.S. sales of Cialis
were $82.5 million, a 93 percent increase compared with first-quarter 2005 U.S. sales. The U.S.
sales increase was primarily due to reductions in U.S. wholesaler inventory levels during the first
quarter of 2005. Cialis sales in our territories are reported in revenue, while our 50 percent
share of the joint-venture territory sales, net of expenses, is reported in other income.
Gross Margin, Costs, and Expenses
For the first quarter of 2006, gross margins as a percent of net sales improved by 2.9 percentage
points, to 78.3 percent. This increase was primarily due to increased production volume at our
facilities ahead of scheduled shutdowns, the favorable impact of foreign exchange rates, and
favorable product mix, partially offset by higher manufacturing expenses.
Operating expenses (the aggregate of research and development and marketing and administrative
expenses) increased 5 percent for the first quarter of 2006 compared with the first quarter of
2005. Research and development expenses were $740.8 million, or 20 percent of sales. Compared
with the first quarter of 2005, research and development expenses increased 5 percent, primarily
due to an increase in discovery research expenses and clinical trial expenses. Marketing and
administrative expenses increased 5 percent to $1.14 billion. This increase was primarily due to
increased marketing expenses in support of newer products and the diabetes care portfolio, offset
partially by the favorable impact of foreign exchange rates.
Other income net consists of interest expense, interest income, the after-tax operating results
of the Lilly ICOS joint venture, and all other income and expense items. The Lilly ICOS joint
venture income increased $32.4 million, to $19.8 million, due to increased Cialis sales and
decreased selling and marketing expenses. Net interest expense increased $26.7 million, to $5.3
million, as a result of increased interest rates and less capitalized interest due to the
completion of certain manufacturing facilities under construction in late 2005. Net other income
and expense items decreased $72.1 million, to $17.7 million, largely as a result of less income
from business development transactions.
Income tax expense increased 7 percent, to $221.9 million. The effective tax rate was 21 percent,
down from 22 percent in the first quarter of 2005.
FINANCIAL CONDITION
As of March 31, 2006, cash, cash equivalents, and short-term investments totaled $4.50 billion
compared with $5.04 billion at December 31, 2005. Cash flow from operations of $254.5 million
was more than offset by dividends paid of $433.5 million, capital expenditures of $160.7 million,
and repurchases of common stock of $122.1 million.
Total debt at March 31, 2006, was $6.35 billion, a decrease of $149.7 million from December 31,
2005. Our current debt ratings from Standard & Poors and Moodys remain at AA and Aa3,
respectively.
14
We believe that cash generated from operations, along with available cash and cash equivalents,
will be sufficient to fund our operating needs, including debt service, capital expenditures,
dividends, and taxes in 2006. We believe that amounts available through our existing commercial
paper program should be adequate to fund maturities of short-term borrowings, if necessary. Our
commercial paper program is also currently backed by $1.23 billion of unused committed bank
credit facilities. We currently expect to repay approximately $1.5 billion of debt by the end of
2006, using available cash. Various risks and uncertainties, including those discussed in the
Financial Expectations for 2006 section, may affect our operating results and cash generated from
operations.
LEGAL AND REGULATORY MATTERS
We are engaged in the following patent litigation matters brought pursuant to procedures set out in
the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984):
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Dr. Reddys Laboratories, Ltd. (Reddy), Teva Pharmaceuticals, and Zenith Goldline
Pharmaceuticals, Inc., which was subsequently acquired by Teva Pharmaceuticals (together,
Teva), each submitted abbreviated new drug applications (ANDAs) seeking permission to market
generic versions of Zyprexa prior to the expiration of our relevant U.S. patent (expiring
in 2011) and alleging that this patent was invalid or not enforceable. We filed lawsuits
against these companies in the U.S. District Court for the Southern District of Indiana,
seeking a ruling that the patent is valid, enforceable and being infringed. The district
court ruled in our favor on all counts on April 14, 2005. We are now awaiting a decision
by the Court of Appeals for the Federal Circuit, which on April 6, 2006 heard Reddys and
Tevas respective appeals of this ruling. We are confident Reddys and Tevas claims are
without merit and we expect to prevail. However, it is not possible to predict or
determine the outcome of this litigation, and accordingly, we can provide no assurance that
we will prevail on appeal. An unfavorable outcome would have a material adverse impact on
our consolidated results of operations, liquidity, and financial position. |
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Barr Laboratories, Inc. (Barr), submitted an ANDA in 2002 seeking permission to market a
generic version of Evista prior to the expiration of our relevant U.S. patents (expiring in
2012-2017) and alleging that these patents are invalid, not enforceable, or not infringed.
In November 2002, we filed a lawsuit against Barr in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid, enforceable,
and being infringed by Barr. No trial date has been set. We believe Barrs claims are
without merit and we expect to prevail. However, it is not possible to predict or
determine the outcome of this litigation, and accordingly, we can provide no assurance that
we will prevail. An unfavorable outcome could have a material adverse impact on our
consolidated results of operations, liquidity, and financial position. |
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Sicor Pharmaceuticals, Inc. (Sicor), a subsidiary of Teva, submitted ANDAs in November
2005 seeking permission to market generic versions of Gemzar prior to the expiration of our
relevant U.S. patents (expiring in 2010 and 2013), and alleging that these patents are
invalid. In February, we filed a lawsuit against Sicor in the U.S. District Court for the
Southern District of Indiana, seeking a ruling that these patents are valid and are being
infringed by Sicor. No trial date has been set. We believe Sicors claims are without
merit and we expect to prevail. However, it is not possible to predict or determine the
outcome of this litigation, and accordingly, we can provide no assurance that we will
prevail. An unfavorable outcome could have a material adverse impact on our consolidated
results of operations. |
In March 2004, the office of the U.S. Attorney for the Eastern District of Pennsylvania advised us
that it has commenced a civil investigation related to our U.S. marketing and promotional
practices, including our communications with physicians and remuneration of physician consultants
and advisors, with respect to Zyprexa, Prozac, and Prozac Weekly. In October 2005, the U.S.
Attorneys office advised that
it is also conducting an inquiry regarding certain rebate agreements we entered into with a
pharmacy benefit manager covering Axid, Evista, Humalog, Humulin, Prozac, and Zyprexa. The inquiry
includes a review of Lillys Medicaid best price reporting related to the product sales covered by
the rebate agreements. We are cooperating with the U.S. Attorney in these investigations, including
providing a broad range of documents and information relating to the investigations. In June 2005,
we received a subpoena from the office of the Attorney General, Medicaid Fraud Control Unit, of the
State of Florida, seeking production of documents relating to sales of Zyprexa and our marketing
and promotional practices with respect to Zyprexa. It is possible that other Lilly products could
become subject to investigation and that the outcome of these matters could include criminal
charges and fines, penalties, or other monetary or nonmonetary remedies. We cannot predict or
determine the outcome of these matters or reasonably estimate the amount or range of amounts of any
fines or penalties that might result from an adverse outcome. It is possible, however, that an
adverse outcome could have a material adverse impact on our consolidated results of operations,
liquidity, and financial position. We have implemented and continue to review and enhance a
broadly based compliance program that includes comprehensive compliance-related activities designed
to ensure that our marketing and promotional practices, physician communications, remuneration of
health care professionals, managed care arrangements, and Medicaid best price reporting comply with
applicable laws and regulations.
15
We have been named as a defendant in a large number of Zyprexa product liability lawsuits in the
United States and have been notified of many other claims of individuals who have not filed suit.
The lawsuits and unfiled claims (together the claims) allege a variety of injuries from the use
of Zyprexa, with the majority alleging that the product caused or contributed to diabetes or high
blood-glucose levels. The claims seek substantial compensatory and punitive damages and typically
accuse us of inadequately testing for and warning about side effects of Zyprexa. Many of the
claims also allege that we improperly promoted the drug. Almost all of the federal lawsuits are
part of a Multi-District Litigation (MDL) proceeding before The Honorable Jack Weinstein in the
Federal District Court for the Eastern District of New York (MDL No. 1596). The MDL includes three
lawsuits requesting certification of class actions on behalf of those who allegedly suffered
injuries from the administration of Zyprexa. We have entered into agreements with various
plaintiffs counsel halting the running of the statutes of limitation (tolling agreements) with
respect to a number of claimants who do not have lawsuits on file.
Since June 2005, we have entered into agreements in principle with various claimants attorneys
involved in U.S. Zyprexa product liability litigation to settle a majority of the claims. The
agreements cover approximately 10,500 claimants, including a large number of previously filed
lawsuits (including the three purported class actions mentioned above), tolled claims, and other
informally asserted claims. The settlements are being overseen and distributed by court-approved
claims administrators. The agreements in principle are subject to certain conditions, including
obtaining full releases from a specified number of claimants.
The U.S. Zyprexa product liability claims not subject to these agreements in principle include
approximately 800 lawsuits in the U.S. covering 4,700 claimants, and approximately 850 tolled
claims. In addition, we have been served with a new lawsuit seeking class certification in which
the members of the purported class are seeking refunds and medical monitoring. Finally, in early
2005, we were served with five lawsuits seeking class action status in Canada on behalf of patients
who took Zyprexa. The allegations in the Canadian actions are similar to those in the litigation
pending in the United States. We are prepared to continue our vigorous defense of Zyprexa in all
remaining cases.
In December 2004, we were served with two lawsuits brought in state court in Louisiana on behalf of
the Louisiana Department of Health and Hospitals, alleging that Zyprexa caused or contributed to
diabetes or high blood-glucose levels, and that we improperly promoted the drug. These cases have
been removed to federal court and are now part of the MDL proceedings in the Eastern District of
New York. In these actions, the Department of Health and Hospitals seeks to recover the costs it
paid for Zyprexa through Medicaid and other drug-benefit programs, as well as the costs the
department alleges it has incurred and will incur to treat Zyprexa-related illnesses. In 2006, we
were served with similar lawsuits filed by the states of Alaska and West Virginia in the courts of
the respective states.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide
class actions on behalf of all consumers and third party payors, excluding governmental entities,
which have made or will make payments for their members or insured patients being prescribed
Zyprexa. These actions have now been consolidated into a single lawsuit, which is brought under
certain state consumer protection statutes, the federal civil RICO statute, and common law
theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys
fees. In addition, in 2006 two additional lawsuits were filed in the Eastern District of New York
on similar grounds. As with the product liability suits, these lawsuits allege that we
inadequately tested for and warned about side effects of Zyprexa and improperly promoted the drug.
We have insurance coverage for a portion of our Zyprexa product liability claims exposure. The
third-party insurance carriers have raised defenses to their liability under the policies and are
seeking to rescind the policies. The dispute is now the subject of litigation in the federal court
in Indianapolis against certain of the carriers and in arbitration in Bermuda against other
carriers. While we believe our position is meritorious, there can be no assurance that we will
prevail.
In addition, we have been named as a defendant in numerous other product liability lawsuits
involving primarily diethylstilbestrol (DES) and thimerosal.
With respect to the product liability claims currently asserted against us, we have accrued for our
estimated exposures to the extent they are both probable and estimable based on the information
available to us. In addition, we have accrued for certain product liability claims incurred but
not filed to the extent we can formulate a reasonable estimate of their costs. We estimate these
expenses based primarily on historical claims experience and data regarding product usage. Legal
defense costs expected to be incurred in connection with significant product liability loss
contingencies are accrued when probable and reasonably estimable. A portion of the costs
associated with defending and disposing of these suits is covered by insurance. We record
receivables for insurance-related recoveries when it is probable they will be realized. These
receivables are classified as a reduction of the litigation charges on the statement of income. We
estimate insurance recoverables based on existing deductibles, coverage limits, our assessment of
any defenses to coverage that might be raised by the carriers, and the existing and projected
future level of insolvencies among the insurance carriers.
16
In the second quarter of 2005, we recorded a net pre-tax charge of $1.07 billion for product
liability matters. The $1.07 billion net charge takes into account our estimated recoveries from
our insurance coverage related to these matters. The charge covers the following:
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The costs of the Zyprexa settlements described above; and, |
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Reserves for product liability exposures and defense costs regarding currently known and
expected claims to the extent we can formulate a reasonable estimate of the probable number
and cost of the claims. A substantial majority of these exposures and costs relate to
current and expected Zyprexa claims not included in the settlements. We have estimated
these charges based primarily on historical claims experience, data regarding product
usage, and our historical product liability defense cost experience. |
During 2005, $700 million was paid in connection with Zyprexa settlements, while the cash related
to other reserves for product liability exposures and defense costs is expected to be paid out over
the next several years, including 2006. The timing of our insurance recoveries is uncertain.
We cannot predict with certainty the additional number of lawsuits and claims that may be asserted.
In addition, although we believe it is probable, there can be no assurance that the Zyprexa
settlements described above will be concluded. The ultimate resolution of Zyprexa product
liability and related litigation could have a material adverse impact on our consolidated results
of operations, liquidity, and financial position.
Because of the nature of pharmaceutical products, it is possible that we could become subject to
large numbers of product liability claims for other products in the future. We have experienced
difficulties in obtaining product liability insurance due to a very restrictive insurance market,
and therefore will be largely self-insured for future product liability losses. In addition, as
noted above, there is no assurance that we will be able to fully collect from our insurance
carriers on past claims.
In June 2002, we were sued by Ariad Pharmaceuticals, Inc., the Massachusetts Institute of
Technology, the Whitehead Institute for Biomedical Research and the President and Fellows of
Harvard College in the U.S. District Court for the District of Massachusetts alleging that sales of
two of our products, Xigris and Evista, were inducing the infringement of a patent related to the
discovery of a natural cell signaling phenomenon in the human body and seeking royalties on past
and future sales of these products. We believe that these allegations are without legal merit and
expect to prevail. However, there can be no assurance that we will prevail. In June 2005, the
United States Patent and Trademark Office commenced a reexamination of the patent in order to
consider certain issues raised by us relating to the validity of the patent. The reexamination is
currently in progress. A jury trial commenced in Boston on April 10, 2006 on the patent validity
and infringement issues. Any final decision of the trial court will be subject to an appeal to the
Court of Appeals for the Federal Circuit.
Also, under the Comprehensive Environmental Response, Compensation, and Liability Act, commonly
known as Superfund, we have been designated as one of several potentially responsible parties with
respect to fewer than 10 sites. Under Superfund, each responsible party may be jointly and
severally liable for the entire amount of the cleanup. We also continue remediation of certain of
our own sites. We
have accrued for estimated Superfund cleanup costs, remediation, and certain other environmental
matters. This takes into account, as applicable, available information regarding site conditions,
potential cleanup methods, estimated costs, and the extent to which other parties can be expected
to contribute to payment of those costs. We have reached a settlement with our liability insurance
carriers providing for coverage for certain environmental liabilities.
The litigation accruals and environmental liabilities and the related estimated insurance
recoverables have been reflected on a gross basis as liabilities and assets, respectively, on our
consolidated balance sheets.
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity, but could possibly be material to the
consolidated results of operations in any one accounting period.
FINANCIAL EXPECTATIONS FOR 2006
We expect second quarter earnings per share of $.74 to $.76. For the full year of 2006, we expect
earnings per share to be in the range of $3.10 to $3.20. We expect sales to grow 7 to 9 percent
and gross margins as a percent of sales to improve modestly compared with 2005. In addition, we
expect operating expenses to grow in the mid-single digits in the aggregate, with marketing and
administrative expenses accelerating while research and development expense growth moderates
somewhat. However, we will continue to be among the industry leaders in terms of research and
development investment as a percent of sales. We also expect other income - net, to contribute
approximately $175 million to $275 million; this ongoing net contribution is expected to be
17
driven
primarily by net interest income, Lilly ICOS joint venture after-tax profit, and partnering and
out-licensing of molecules. We also anticipate the effective tax rate to be approximately 21
percent. In terms of cash flow, we expect capital expenditures to be flat at about $1.4 billion in
2006.
We caution investors that any forward-looking statements or projections made by us, including those
above, are based on managements belief at the time they are made. However, they are subject to
risks and uncertainties. Actual results could differ materially and will depend on, among other
things, the continuing growth of our currently marketed products; developments with competitive
products; the timing and scope of regulatory approvals and the success of our new product launches;
asset impairments, restructurings, and acquisitions of compounds under development resulting in
acquired in-process research and development charges; foreign exchange rates; wholesaler inventory
changes; other regulatory developments, litigation, and government investigations; the outcome of
the Zyprexa patent appeal; and the impact of governmental actions regarding pricing, importation,
and reimbursement for pharmaceuticals. Other factors that may affect our operations and prospects
are discussed in Item 1A of our 2005 Form 10-K, Risk Factors. We undertake no duty to update
these forward-looking statements.
AVAILABLE INFORMATION ON OUR WEBSITE
We make available through our company website, free of charge, our company filings with the
Securities and Exchange Commission (SEC) as soon as reasonably practicable after we electronically
file them with, or furnish them to, the SEC. The reports we make available include annual reports
on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements,
registration statements, and any amendments to those documents.
The website link to our SEC filings is http://investor.lilly.com/edgar.cfm.
Item 4. Controls and Procedures
(a) |
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Evaluation of Disclosure Controls and Procedures. Under applicable SEC regulations,
management of a reporting company, with the participation of the principal executive officer
and principal financial officer, must periodically evaluate the companys disclosure controls
and procedures, which are defined generally as controls and other procedures of a reporting
company designed to ensure that information required to be disclosed by the reporting company
in its periodic reports filed with the commission (such as this Form 10-Q) is recorded,
processed, summarized, and reported on a timely basis. |
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Our management, with the participation of Sidney Taurel, chairman and chief executive officer,
and Derica W. Rice, senior vice president and chief financial officer, evaluated our disclosure
controls and procedures as of March 31, 2006, and concluded that they are effective. |
(b) |
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Changes in Internal Controls. During the first quarter of 2006, there were no changes in
our internal control over financial reporting that materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting. |
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
See Part I, Item 2, Managements Discussion and Analysis, Legal and Regulatory Matters, for
information on various legal proceedings, including but not limited to:
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The U.S. patent litigation involving Zyprexa, Evista, and Gemzar |
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The civil investigation by the U.S. Attorney for the Eastern District of Pennsylvania
relating to our U.S. sales, marketing, and promotional practices |
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The Zyprexa product liability and related litigation, including claims brought on behalf
of healthcare payors |
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The legal proceedings we have filed against several of our product liability insurance
carriers with respect to our coverage for the Zyprexa product liability claims |
That information is incorporated into this Item by reference.
Other Patent Litigation
We refer to Part I, Item 3, of our Form 10-K annual report for 2005 for the discussion of
litigation in Germany regarding the validity of our Zyprexa compound and method-of-use patent
(expiring in 2011). A hearing will be held in this matter on November 28, 2006, and we expect a
decision soon thereafter.
18
Other Product Liability Litigation
We refer to Part I, Item 3, of our Form 10-K annual report for 2005 for the discussion of product
liability litigation involving diethylstilbestrol (DES) and vaccines containing the preservative
thimerosal. In the DES litigation, we have been named as a defendant in approximately 85 suits
involving approximately 177 claimants. In the thimerosal litigation, we have been named as a
defendant in approximately 366 suits with approximately 976 claimants.
While it is not possible to predict or determine the outcome of the patent, product liability, or
other legal actions brought against us or the ultimate cost of environmental matters, we believe
that, except as noted above, the resolution of all such matters will not have a material adverse
effect on our consolidated financial position or liquidity but could possibly be material to the
consolidated results of operations in any one accounting period.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table summarizes the activity related to repurchases of our equity securities during
the three-month period ended March 31, 2006:
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Total Number of |
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Shares Purchased as |
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Approximate Dollar Value |
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Part of Publicly |
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of Shares that May Yet |
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Total Number of |
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Average Price Paid |
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Announced Plans or |
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Be Purchased Under the |
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Shares Purchased |
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per Share |
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Programs |
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Plans or Programs |
Period |
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(a) |
(b) |
(c) |
(d) |
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(in thousands) |
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(in thousands) |
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(Dollars in millions) |
January 2006 |
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4 |
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56.99 |
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541.3 |
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February 2006 |
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2,184 |
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56.90 |
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2,145 |
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419.2 |
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March 2006 |
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6 |
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58.00 |
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419.2 |
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Total |
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2,194 |
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2,145 |
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The amounts presented in columns (a) and (b) above include purchases of common stock related to our
$3.0 billion share repurchase program announced in March 2000 and to employee stock option
exercises. The amounts presented in columns (c) and (d) in the above table represent activity
related only to our share repurchase program. As of March 31, 2006, we have purchased $2.58
billion related to this program.
Item 4. Submission of Matters to a Vote of Security Holders
We held our annual meeting of shareholders on April 24, 2006. The following is a summary of the
matters voted on at the meeting:
(a) |
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The four nominees for director were elected to serve three-year terms ending in 2009, as
follows: |
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Nominee |
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For |
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Withhold Vote |
Martin S. Feldstein, Ph.D. |
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994,478,097 |
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14,725,193 |
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J. Erik Fyrwald |
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992,336,061 |
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16,867,229 |
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Ellen R. Marram |
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993,873,285 |
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15,330,005 |
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Sidney Taurel |
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987,089,283 |
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22,114,007 |
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(b) |
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The appointment of Ernst & Young LLP as our principal independent auditors was ratified by
the following shareholder vote: |
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For: |
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991,621,210 |
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Against: |
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11,263,452 |
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Abstain: |
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6,318,628 |
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(c) |
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By the following vote, the shareholders did not approve the shareholder proposal requesting
the Board issue a report to shareholders on the feasibility of amending the Companys Animal
Care and Use Policy: |
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For: |
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30,460,451 |
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Against: |
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752,268,841 |
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Abstain: |
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109,113,328 |
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Broker Nonvote: |
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117,360,670 |
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(d) |
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By the following vote, the shareholders did not approve the shareholder proposal requesting
separating the roles of Chairman and Chief Executive Officer: |
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For: |
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239,864,110 |
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Against: |
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643,444,355 |
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Abstain: |
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8,534,155 |
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Broker Nonvote: |
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117,360,670 |
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(e) |
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By the following vote, the shareholders approved a shareholder proposal that the Directors
take the necessary steps to adopt and implement annual election of each director: |
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For: |
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506,904,363 |
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Against: |
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376,426,188 |
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Abstain: |
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8,512,069 |
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Broker Nonvote: |
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117,360,670 |
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(f) |
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By the following vote, the shareholders did not approve the shareholder proposal that the
Board of Directors initiate the appropriate process to amend the Companys articles of
incorporation to provide that director nominees shall be elected by the affirmative vote of
the majority of votes cast: |
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For: |
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275,806,807 |
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Against: |
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598,089,257 |
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Abstain: |
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17,946,556 |
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Broker Nonvote: |
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117,360,670 |
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Item 6. Exhibits
The following documents are filed as exhibits to this Report:
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EXHIBIT 11.
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Statement re: Computation of Earnings per Share |
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EXHIBIT 12.
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Statement re: Computation of Ratio of Earnings to Fixed Charges |
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EXHIBIT 31.1
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Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the Board and Chief
Executive Officer |
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EXHIBIT 31.2
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Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President and Chief
Financial Officer |
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EXHIBIT 32.
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Section 1350 Certification |
20
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
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(Registrant) |
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Date May 2, 2006
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/s/James B. Lootens |
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James B. Lootens |
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Secretary and Deputy General Counsel |
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Date May 2, 2006
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/s/Arnold C. Hanish |
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Arnold C. Hanish |
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Executive Director, Finance, and |
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Chief Accounting Officer |
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21
INDEX TO EXHIBITS
The following documents are filed as a part of this Report:
Exhibit
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EXHIBIT 11.
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Statement re: Computation of Earnings per Share |
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EXHIBIT 12.
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Statement re: Computation of Ratio of Earnings to Fixed Charges |
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EXHIBIT 31.1
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Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the
Board, and Chief Executive Officer |
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EXHIBIT 31.2
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Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice
President and Chief Financial Officer |
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EXHIBIT 32.
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Section 1350 Certification |
22
exv11
EXHIBIT
11. STATEMENT RE: COMPUTATION OF EARNINGS PER SHARE
(Unaudited)
Eli Lilly and Company and Subsidiaries
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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BASIC |
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Net income |
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$ |
834.8 |
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$ |
736.6 |
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|
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Average number of common shares outstanding |
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1,085.2 |
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1,086.6 |
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Contingently issuable shares |
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|
.8 |
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.3 |
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Adjusted average shares |
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1,086.0 |
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1,086.9 |
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Basic earnings per share |
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$ |
.77 |
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$ |
.68 |
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DILUTED |
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Net income |
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$ |
834.8 |
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$ |
736.6 |
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Average number of common shares outstanding |
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1,085.2 |
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1,086.6 |
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Incremental shares stock options and
contingently issuable shares |
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1.8 |
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2.6 |
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Adjusted average shares |
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1,087.0 |
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1,089.2 |
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Diluted earnings per share |
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$ |
.77 |
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$ |
.68 |
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Dollars and shares in millions except per-share data.
exv12
EXHIBIT 12. STATEMENT RE: COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
(Unaudited)
Eli Lilly and Company and Subsidiaries
(Dollars in millions)
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Three Months Ended |
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March 31, |
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Years Ended December 31, |
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2006 |
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2005 |
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2004 |
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2003 |
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2002 |
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2001 |
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Consolidated pretax
Income before cumulative
effect of a change in
accounting principle |
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$ |
1,056.7 |
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$ |
2,717.5 |
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$ |
2,941.9 |
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$ |
3,261.7 |
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$ |
3,457.7 |
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$ |
3,506.9 |
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Interest |
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90.7 |
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245.7 |
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162.9 |
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121.9 |
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140.0 |
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253.3 |
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Less interest capitalized
during the period |
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(25.7 |
) |
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(140.5 |
) |
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(111.3 |
) |
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(60.9 |
) |
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(60.3 |
) |
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(61.5 |
) |
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Earnings |
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$ |
1,121.7 |
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$ |
2,822.7 |
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$ |
2,993.5 |
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$ |
3,322.7 |
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$ |
3,537.4 |
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$ |
3,698.7 |
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Fixed charges |
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$ |
90.7 |
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$ |
245.7 |
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$ |
162.9 |
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$ |
121.9 |
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$ |
140.0 |
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$ |
253.3 |
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Ratio of earnings to
fixed charges |
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12.4 |
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11.5 |
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18.4 |
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27.3 |
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25.3 |
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14.6 |
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exv31w1
EXHIBIT
31.1 Rule 13a-14(a) Certification of Sidney Taurel, Chairman of the Board and Chief
Executive Officer
CERTIFICATIONS
I, Sidney Taurel, chairman of the board and chief executive officer, certify that:
1. |
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I have reviewed this report on Form 10-Q of Eli Lilly and Company; |
2. |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
3. |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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a) |
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Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in
which this report is being prepared; |
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|
b) |
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Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
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c) |
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Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
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d) |
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Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and |
5. |
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The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants board of directors (or persons
performing the equivalent function): |
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a) |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize, and report
financial information; and |
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|
b) |
|
Any fraud, whether or not material, that involves management or other employees
who have a significant role in the registrants internal controls over financial
reporting. |
Date: May 2, 2006
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By:
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/s/Sidney Taurel |
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Sidney Taurel |
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Chairman of the Board |
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and Chief Executive Officer |
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exv31w2
EXHIBIT
31.2 Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice
President and Chief Financial Officer
CERTIFICATIONS
I, Derica W. Rice, senior vice president and chief financial officer, certify that:
1. |
|
I have reviewed this report on Form 10-Q of Eli Lilly and Company; |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
3. |
|
Based on my knowledge, the financial statements, and other financial information included
in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in
which this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally
accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure controls and
procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report
based on such evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
that has materially affected, or is reasonably likely to materially affect, the
registrants internal control over financial reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and
the audit committee of the registrants board of directors (or persons performing the
equivalent function): |
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a) |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrants ability to record, process, summarize, and report
financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrants internal controls over
financial reporting. |
Date: May 2, 2006
|
|
|
|
|
By:
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|
/s/Derica W. Rice |
|
|
|
|
|
|
|
|
|
Derica W. Rice |
|
|
|
|
Senior Vice President |
|
|
|
|
and Chief Financial Officer |
|
|
exv32
EXHIBIT
32. Section 1350 Certification
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350,
chapter 63 of title 18, United States Code), each of the undersigned officers of Eli Lilly and
Company, an Indiana corporation (the Company), does hereby certify that, to the best of their
knowledge:
The Quarterly Report on Form 10-Q for the quarter ended March 31, 2006 (the Form 10-Q) of the
Company fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange
Act of 1934 and information contained in the Form 10-Q fairly presents, in all material respects,
the financial condition and results of operations of the Company.
|
|
|
|
|
Date May 2, 2006
|
|
/s/Sidney Taurel |
|
|
|
|
|
|
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|
|
Sidney Taurel |
|
|
|
|
Chairman of the Board |
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|
|
|
and Chief Executive Officer |
|
|
|
|
|
|
|
Date May 2, 2006
|
|
/s/Derica W. Rice |
|
|
|
|
|
|
|
|
|
Derica W. Rice |
|
|
|
|
Senior Vice President |
|
|
|
|
and Chief Financial Officer |
|
|