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 SEPTEMBER 30, 2006
COMMISSION FILE NUMBER 001-6351
ELI LILLY AND COMPANY
(Exact name of Registrant as specified in its charter)
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INDIANA
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35-0470950 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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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.
Large
accelerated filer þ Accelerated filer o 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 October 20, 2006:
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Class
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Number of Shares Outstanding |
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Common
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1,131,588,452 |
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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Nine Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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(Dollars in millions except per-share data) |
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Net sales |
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$ |
3,864.1 |
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$ |
3,601.1 |
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$ |
11,445.7 |
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$ |
10,766.2 |
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Cost of sales |
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860.4 |
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845.7 |
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2,527.5 |
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2,576.0 |
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Research and development |
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755.7 |
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751.0 |
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2,271.3 |
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2,215.6 |
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Marketing and administrative |
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1,198.2 |
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1,070.9 |
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3,579.0 |
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3,307.4 |
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Asset impairments, restructuring, and other special charges |
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1,073.4 |
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Other income net |
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(56.0 |
) |
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(85.0 |
) |
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(135.1 |
) |
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(229.0 |
) |
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2,758.3 |
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2,582.6 |
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8,242.7 |
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8,943.4 |
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Income before income taxes |
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1,105.8 |
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1,018.5 |
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3,203.0 |
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1,822.8 |
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Income taxes |
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232.2 |
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224.1 |
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672.6 |
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543.8 |
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Net income |
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$ |
873.6 |
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$ |
794.4 |
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$ |
2,530.4 |
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$ |
1,279.0 |
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Earnings per share basic |
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$ |
.80 |
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$ |
.73 |
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$ |
2.33 |
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$ |
1.18 |
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Earnings per share diluted |
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$ |
.80 |
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$ |
.73 |
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$ |
2.33 |
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$ |
1.17 |
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Dividends paid per share |
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$ |
.40 |
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$ |
.38 |
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$ |
1.20 |
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$ |
1.14 |
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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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September 30, 2006 |
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December 31, 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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$ |
2,169.9 |
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$ |
3,006.7 |
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Short-term investments |
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1,448.6 |
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2,031.0 |
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Accounts receivable, net of allowances
of $73.1 (2006) and $62.5 (2005) |
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2,077.9 |
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2,313.3 |
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Other receivables |
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399.6 |
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448.4 |
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Inventories |
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2,199.8 |
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1,878.0 |
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Deferred income taxes |
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731.2 |
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756.4 |
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Prepaid expenses |
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744.2 |
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362.0 |
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TOTAL CURRENT ASSETS |
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9,771.2 |
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10,795.8 |
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OTHER ASSETS |
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Prepaid pension |
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2,450.1 |
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2,419.6 |
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Investments |
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1,294.5 |
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1,296.6 |
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Sundry |
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2,182.2 |
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2,156.3 |
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5,926.8 |
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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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13,731.7 |
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13,136.0 |
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Less allowances for depreciation |
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(5,516.3) |
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(5,223.5 |
) |
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8,215.4 |
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7,912.5 |
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$ |
23,913.4 |
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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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$ |
334.2 |
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$ |
734.7 |
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Accounts payable |
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630.6 |
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781.3 |
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Employee compensation |
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454.3 |
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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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725.2 |
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884.9 |
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Other current liabilities |
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1,738.5 |
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2,330.1 |
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TOTAL CURRENT LIABILITIES |
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3,882.8 |
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5,716.3 |
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LONG-TERM DEBT |
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4,553.3 |
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5,763.5 |
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DEFERRED INCOME TAXES |
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847.8 |
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695.1 |
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OTHER NONCURRENT LIABILITIES |
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1,574.8 |
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1,614.0 |
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SHAREHOLDERS EQUITY |
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Common stock |
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707.6 |
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706.9 |
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Additional paid-in capital |
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3,482.3 |
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3,323.8 |
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Retained earnings |
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11,692.5 |
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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 |
) |
Deferred costs ESOP |
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(102.5 |
) |
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(106.3 |
) |
Accumulated other comprehensive income (loss) |
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12.4 |
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(420.6 |
) |
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13,157.3 |
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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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13,054.7 |
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10,791.9 |
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$ |
23,913.4 |
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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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Nine Months Ended |
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September 30, |
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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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$ |
2,530.4 |
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$ |
1,279.0 |
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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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(1,318.6 |
) |
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(1,796.0 |
) |
Depreciation and amortization |
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628.2 |
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501.3 |
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Stock-based compensation expense |
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274.3 |
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309.5 |
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Change in deferred taxes |
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130.5 |
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(205.0 |
) |
Asset impairments, restructuring, and other special charges,
net of tax |
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979.7 |
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Other, net |
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(126.6 |
) |
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30.8 |
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NET CASH PROVIDED BY OPERATING ACTIVITIES |
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2,118.2 |
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1,099.3 |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Net purchases of property and equipment |
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(667.8 |
) |
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(878.5 |
) |
Net change in short-term investments |
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|
580.4 |
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833.1 |
|
Purchase of noncurrent investments |
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(1,218.7 |
) |
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(271.9 |
) |
Proceeds from sales and maturities of noncurrent
investments |
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1,135.1 |
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327.0 |
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Other, net |
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124.4 |
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(216.4 |
) |
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NET CASH USED IN INVESTING ACTIVITIES |
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(46.6 |
) |
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(206.7 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Dividends paid |
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(1,301.5 |
) |
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(1,245.7 |
) |
Purchases of common stock |
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(122.1 |
) |
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Issuances of common stock under stock plans |
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44.2 |
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|
71.2 |
|
Net change in short-term borrowings |
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(1.8 |
) |
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|
(1,984.6 |
) |
Net (repayments) issuances of long-term debt |
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|
(1,599.0 |
) |
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|
1,998.0 |
|
Other, net |
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6.3 |
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|
33.2 |
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NET CASH USED IN FINANCING ACTIVITIES |
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(2,973.9 |
) |
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(1,127.9 |
) |
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Effect of exchange rate changes on cash and cash equivalents |
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65.5 |
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(160.3 |
) |
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
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(836.8 |
) |
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(395.6 |
) |
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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 SEPTEMBER 30 |
|
$ |
2,169.9 |
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$ |
4,969.7 |
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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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Nine Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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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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$ |
873.6 |
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|
$ |
794.4 |
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|
$ |
2,530.4 |
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|
$ |
1,279.0 |
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Other comprehensive income (loss) 1 |
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|
132.3 |
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|
48.2 |
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|
433.0 |
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|
(468.7 |
) |
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Comprehensive income |
|
$ |
1,005.9 |
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$ |
842.6 |
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$ |
2,963.4 |
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$ |
810.3 |
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|
1 The significant components of other comprehensive income were gains of
$123.4 million
and $346.7 million from foreign currency translation adjustments for the three months and nine
months ended September 30, 2006, respectively, and losses of $421.4 million from foreign currency
translation adjustments for the nine months ended September 30, 2005.
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 was $47.8 million and $55.7 million for the quarters ended September 30, 2006 and 2005,
respectively, and $122.9 million and $143.0 million for the nine months ended September 30, 2006
and 2005, respectively.
SALES BY PRODUCT CATEGORY
Worldwide sales by product category for the three months and nine months ended September 30, 2006
and 2005 were as follows:
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Three Months Ended |
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Nine Months Ended |
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|
September 30, |
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September 30, |
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|
2006 |
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2005 |
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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 |
|
$ |
1,676.1 |
|
|
$ |
1,514.9 |
|
|
$ |
4,869.4 |
|
|
$ |
4,490.2 |
|
|
|
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|
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|
|
|
|
|
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Endocrinology |
|
|
1,221.0 |
|
|
|
1,115.9 |
|
|
|
3,680.9 |
|
|
|
3,402.2 |
|
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Oncology |
|
|
511.8 |
|
|
|
456.9 |
|
|
|
1,477.6 |
|
|
|
1,312.2 |
|
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|
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|
|
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|
Animal health |
|
|
216.2 |
|
|
|
215.7 |
|
|
|
615.5 |
|
|
|
612.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Cardiovascular |
|
|
117.3 |
|
|
|
135.8 |
|
|
|
387.9 |
|
|
|
459.6 |
|
|
|
|
|
|
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|
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|
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|
|
Anti-infectives |
|
|
58.5 |
|
|
|
104.7 |
|
|
|
216.0 |
|
|
|
326.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other pharmaceuticals |
|
|
63.2 |
|
|
|
57.2 |
|
|
|
198.4 |
|
|
|
163.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ |
3,864.1 |
|
|
$ |
3,601.1 |
|
|
$ |
11,445.7 |
|
|
$ |
10,766.2 |
|
|
|
|
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 Evistaâ 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. Teva has also submitted an ANDA seeking
permission to market a generic version of Evista. In June 2006, we filed a lawsuit against
Teva in the U.S. District Court for the Southern District of Indiana, seeking a ruling that
our relevant U.S. patents (expiring in 2012-2014) are valid, enforceable, and being
infringed by Teva. No trial date has been set in either case. We believe Barrs 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. 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 2006, 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. In response to our lawsuit, Sicor filed a declaratory judgment
action in the U.S. District Court for the Central District of California. The California
action has since been dismissed. In September 2006, we received notice that Mayne Pharma
(USA) Inc. (Mayne) filed a similar ANDA for Gemzar. In October 2006, we filed a lawsuit
against Mayne in the Southern District of Indiana in response to the ANDA filing. We are
awaiting the filing of an answer to our complaint against Mayne. In October 2006, we
received notice that Sun Pharmaceutical Industries Inc. (Sun) filed a similar ANDA for
Gemzar. We are evaluating our option to bring legal action against Sun. We expect to
prevail in litigation involving our Gemzar patents and believe that claims made by these
generic companies that our patents are not valid are without merit. However, it is not
possible to predict or determine the outcome of such 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
7
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, Humalogâ,
Humulinâ, 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. In September 2006, we received a subpoena from the California Attorney Generals
office seeking production of documents related to our efforts to obtain and maintain Zyprexas
status on Californias formulary, marketing and promotional practices with respect to Zyprexa, and
remuneration of health care providers. 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.
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 with various claimants attorneys involved in U.S.
Zyprexa product liability litigation to settle approximately 10,500 claims, 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 U.S. Zyprexa product liability claims not subject to these agreements include approximately
1,500 lawsuits in the U.S. covering approximately 9,700 claimants, and approximately 850 tolled
claims. The first trials are scheduled for April 2007 in the Federal District Court for the
Eastern District of New York. In addition, we have been served with a 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 four lawsuits seeking class-action status
in Canada on behalf of patients who took Zyprexa. One of these four lawsuits has been certified
for certain residents of Quebec. 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, West Virginia, Mississippi, and
New Mexico 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,
that 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. Four additional lawsuits were filed in 2006: two in the Eastern District of New York, one
in the Southern District of Indiana, and one in Indiana state court, all 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
8
in the federal court
in Indianapolis against certain 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.
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 cost 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, $700.0 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
that we will ultimately prevail on these issues. In June 2005, the United States Patent and
Trademark Office commenced a re-examination of the patent in order to consider certain issues
raised by us relating to the validity of the patent. A jury trial commenced in Boston on April 10,
2006 on the patent validity and infringement issues. On May 4, 2006, the jury issued an initial
decision in the case that Xigris and Evista sales infringe the patent. The jury awarded the
plaintiffs approximately $65 million in damages, calculated by applying a 2.3 percent royalty to
all U.S. sales of Xigris and Evista from the date of issuance of the patent through the date of
trial. We will seek to have the jury verdict overturned by the trial court judge, and if
unsuccessful, will appeal the decision to the Court of Appeals for the Federal Circuit. In
addition, a separate bench trial with the U.S. District Court of Massachusetts was held the week of
August 7, 2006, on our contention that the patent is unenforceable and impermissibly covers natural
processes. No decision has been rendered.
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
9
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.
EARNINGS PER SHARE
Unless otherwise noted in the footnotes, all earnings 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 $83.0 million and $101.3 million in the third quarter of 2006 and 2005, respectively. In the
first nine months of 2006 and 2005, we recognized stock-based compensation expense of $274.3
million and $309.5 million, respectively.
As of September 30, 2006, the total remaining unrecognized compensation cost related to nonvested
stock options and performance awards amounted to $128.9 million and $51.2 million, respectively,
which will be amortized over the weighted-average remaining requisite service periods, which are
approximately 17 months and 3 months, respectively.
Under our policy, all stock option awards are approved prior to the date of grant and the exercise
price is the average of the high and low market price on the date of grant. The Compensation
Committee of the Board of Directors approves the value of the award and the date of grant. Options
that are awarded as part of annual total compensation are made on specific grant dates scheduled in
advance. With respect to option awards given to new hires, our policy requires approval of such
awards prior to the grant date, and the options are granted on a predetermined monthly date
immediately following the date of hire.
RETIREMENT BENEFITS
Net pension and retiree health benefit expense included the following components:
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|
Defined Benefit Pension Plans |
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
(Dollars in millions) |
|
Components of net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
67.8 |
|
|
$ |
79.2 |
|
|
$ |
206.1 |
|
|
$ |
233.6 |
|
Interest cost |
|
|
81.8 |
|
|
|
73.5 |
|
|
|
244.0 |
|
|
|
222.5 |
|
Expected return on plan assets |
|
|
(121.2 |
) |
|
|
(111.8 |
) |
|
|
(361.5 |
) |
|
|
(334.8 |
) |
Amortization of prior service cost |
|
|
1.4 |
|
|
|
1.9 |
|
|
|
4.3 |
|
|
|
5.8 |
|
Recognized actuarial loss |
|
|
31.8 |
|
|
|
25.7 |
|
|
|
94.9 |
|
|
|
77.9 |
|
|
|
|
Net periodic benefit cost |
|
$ |
61.6 |
|
|
$ |
68.5 |
|
|
$ |
187.8 |
|
|
$ |
205.0 |
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retiree Health Benefit Plans |
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars in millions) |
Components of net periodic benefit cost |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Service cost |
|
$ |
18.0 |
|
|
$ |
14.7 |
|
|
$ |
53.9 |
|
|
$ |
44.1 |
|
Interest cost |
|
|
24.4 |
|
|
|
20.0 |
|
|
|
73.3 |
|
|
|
60.1 |
|
Expected return on plan assets |
|
|
(22.5 |
) |
|
|
(18.7 |
) |
|
|
(67.4 |
) |
|
|
(54.4 |
) |
Amortization of prior service cost |
|
|
(3.9 |
) |
|
|
(3.9 |
) |
|
|
(11.6 |
) |
|
|
(11.9 |
) |
Recognized actuarial loss |
|
|
27.0 |
|
|
|
21.5 |
|
|
|
80.9 |
|
|
|
64.6 |
|
|
|
|
Net periodic benefit cost |
|
$ |
43.0 |
|
|
$ |
33.6 |
|
|
$ |
129.1 |
|
|
$ |
102.5 |
|
|
|
|
In 2006, we contributed approximately $30 million to our defined benefit pension plans to
satisfy minimum funding requirements for the year. In addition, we contributed approximately
$140 million of additional discretionary funding to our defined benefit plans and approximately
$90 million of discretionary funding to our post retirement benefit plans. We do not expect to
contribute additional amounts to our plans during the remainder of 2006.
OTHER INCOME NET
Other income net, was comprised of the following:
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|
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|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
|
|
|
|
(Dollars in millions) |
|
|
|
|
Interest expense |
|
$ |
62.7 |
|
|
$ |
24.3 |
|
|
$ |
193.5 |
|
|
$ |
60.9 |
|
Interest income |
|
|
(67.5 |
) |
|
|
(51.9 |
) |
|
|
(195.6 |
) |
|
|
(144.2 |
) |
Joint venture (income) loss |
|
|
(23.8 |
) |
|
|
(5.8 |
) |
|
|
(66.1 |
) |
|
|
7.3 |
|
Other |
|
|
(27.4 |
) |
|
|
(51.6 |
) |
|
|
(66.9 |
) |
|
|
(153.0 |
) |
|
|
|
|
|
$ |
(56.0 |
) |
|
$ |
(85.0 |
) |
|
$ |
(135.1 |
) |
|
$ |
(229.0 |
) |
|
|
|
The joint venture (income) loss represents our share of the Lilly ICOS LLC joint venture results of
operations, net of income taxes.
SHAREHOLDERS EQUITY
As of September 30, 2006, we have purchased $2.58 billion of our previously announced $3.0 billion
share repurchase program. During the nine months ended September 30, 2006, we acquired 2.1 million
shares pursuant to this program. We do not expect any share repurchases during the remainder of
2006.
IMPLEMENTATION OF NEW FINANCIAL ACCOUNTING PRONOUNCEMENTS
In September 2006, the FASB issued Statement No. 158, Employers Accounting for Defined Benefit
Pension and Other Postretirement Plans an amendment of FASB Statements No. 87, 88, 106, and
132(R). SFAS 158 requires the recognition of the overfunded or underfunded status of a defined
benefit postretirement plan (other than a multiemployer plan) as an asset or liability in its
statement of financial position, the measurement of a plans assets and its obligations that
determine its funded status as of the end of the employers fiscal year, and the recognition of
changes in that funded status in the year in which the changes occur through comprehensive income.
Additional footnote disclosures will also be required. SFAS 158 is effective for us as of
December 31, 2006 and is required to be adopted prospectively. Because the impact on our
consolidated financial position upon adoption will depend on the facts and circumstances as of
December 31, 2006, we cannot determine the impact at this time; however, if we would have adopted
SFAS 158 as of December 31, 2005, there would have been a reduction to our net assets and
shareholders equity of approximately $1.7 billion. There will be no impact to our statements of
income or cash flows. We do not expect the change in the measurement date to have an impact on
our financial statements.
In September 2006, the SEC issued Staff Accounting Bulletin (SAB) No. 108, which provides
interpretive guidance on how the effects of carryover or reversal of prior year misstatements
should be considered in quantifying a current year misstatement. The SEC staff believes that
errors should be quantified using both a balance sheet and income statement approach and evaluated
as to
whether either approach results in quantifying a misstatement that, when all relevant quantitative
and qualitative factors are considered, is material. The SEC staff has stated that it will not
object if there is a one-time cumulative effect adjustment recorded to correct errors existing in
prior years that previously had been considered immaterial quantitatively and qualitatively -
based on appropriate use of the registrants previous approach. SAB 108 describes the
circumstances where this would be appropriate as
11
well as the required disclosures and is effective
for fiscal years ending after November 15, 2006; therefore we will be required to apply this
Bulletin in the year ending December 31, 2006. We are currently evaluating SAB 108 and have not
yet determined its impact; however, based on currently available information, we do not expect a
material impact on our consolidated financial position or results of operations.
In June 2006, the FASB issued FIN 48, Accounting for Uncertainty in Income Taxes, an
interpretation of FASB Statement No. 109. FIN 48 prescribes a recognition threshold and
measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. The Interpretation is effective for fiscal years
beginning after December 15, 2006; therefore, we will be required to adopt this Interpretation in
the first quarter of 2007. We are currently evaluating FIN 48 and have not yet determined the
impact the adoption of this Interpretation will have on our consolidated financial position or
results of operations.
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.
POTENTIAL ASSET IMPAIRMENTS, RESTRUCTURING, AND OTHER SPECIAL CHARGES
As part of our ongoing efforts to maximize performance and efficiencies, including the streamlining
of manufacturing operations and research and development activities, as announced in June 2006, we
have been considering the future of three European facilities, which include the R&D facilities in
Mont St. Guibert, Belgium and Hamburg, Germany, and the dry products manufacturing facility in
Basingstoke, England. On October 16, 2006, the Board of Directors approved a plan to close the
Hamburg, Germany, facility and also approved a social package, including severance payments that
were negotiated with the site works council. Under the agreement, operations will decrease during
the rest of 2006 and into the first half of 2007, with the official closing anticipated by
mid-2007. This will result in a fourth-quarter charge to asset impairment, restructuring and other
special charges of $40 million to $50 million (pretax), or $.02 to $.03 per share (after-tax),
composed of $35 million to $40 million in severance related charges and lease termination costs,
substantially all of which is expected to be in cash, and $5 million to $10 million in non-cash
asset impairment charges. We have also been considering the closure of the Basingstoke plant as
well as the sale of the plant as an ongoing operation. Several companies have expressed interest
in potentially purchasing this site as an ongoing operation, and management intends to diligently
pursue the sale option and make a decision by year end. If no viable sale option has been
identified by that time, the Board has authorized management to proceed with the closure of the
facility and implementation of a severance package negotiated with the employee representatives.
No final decisions have been made with respect to the Basingstoke and Mont St. Guibert sites.
However, severance and impairment charges as a result of any potential sale or site closure could
be significant.
SUBSEQUENT EVENT
On October 17, 2006, we signed an agreement to acquire ICOS Corporation (ICOS) for approximately
$2.1 billion in cash. The acquisition brings the full value of Cialis® to us and enables us to
realize operational efficiencies in the further development, marketing and selling of this product.
Consummation of the acquisition is subject to antitrust clearance under the Hart-Scott-Rodino Act,
approval of the ICOS shareholders, and other customary closing conditions. Upon the closing of the
transaction, which is expected in late 2006 or early 2007, we will incur a one-time charge to
earnings for acquired in-process research and development (IPR&D), but it is premature to estimate
what that charge will be.
12
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 third quarter increased 7 percent to $3.86 billion. Net income was
$873.6 million, or $.80 per share, for the third quarter of 2006 compared with $794.4 million, or
$.73 per share, for the third quarter of 2005, representing an increase of 10 percent in both net
income and earnings per share. The earnings growth was driven by sales increasing at a faster rate
than cost of products sold and research and development expenses, offset partially by higher
marketing and administrative expenses and decreased other income. Net income was $2.53 billion, or
$2.33 per share, for the first nine months of 2006 compared with $1.28 billion, or $1.17 per share,
for the first nine months of 2005. These amounts include the impact of the product liability
litigation charge of $1.07 billion that was taken in the second quarter of 2005. In addition to
this product liability charge, the earnings increase in the nine-month period was driven primarily
by increased sales and decreased cost of sales, offset by decreased other income.
II. Business Development, and Recent Product and Late-Stage Pipeline Developments
|
|
|
On October 17, 2006, we announced our acquisition of ICOS Corporation for approximately
$2.1 billion in cash. The acquisition brings the full value of Cialis to us and enables us
to realize operational efficiencies in the further development, marketing and selling of
this product. We expect this acquisition will increase our earnings and earnings growth
rate beginning in 2008 and, after a significant addition to sales in 2007, will modestly
accelerate our sales growth rate thereafter. Upon the closing of the transaction, which is
expected in late 2006 or early 2007, we will incur a one-time charge to earnings for
acquired in-process research and development (IPR&D), but it is premature to estimate what
that charge will be. In addition, we expect the impact of including the operations of ICOS
in our financial results will be modestly dilutive to earnings in 2007. Consummation of
the acquisition is subject to antitrust clearance under the Hart-Scott-Rodino Act, approval
of the ICOS shareholders, and other customary closing conditions. |
|
|
|
|
We received an approvable letter from the U.S. Food and Drug Administration (FDA) for
Arxxant for the treatment of diabetic retinopathy. The FDA has indicated that it will
require efficacy data from an additional Phase III study before it will consider approving
the molecule. We have decided to appeal the FDAs decision and have recently begun
discussions with the agency. We reached this decision by considering the significance of
the unmet medical need that diabetic retinopathy represents, the efficacy demonstrated in
the completed clinical studies and the safety profile shown in more than 3,300 patient
years of clinical trial exposure. There can be no assurance that our appeal will be
successful. |
|
|
|
|
The Committee for Medicinal Products for Human Use of the European Medicines Evaluation
Agency issued a positive opinion recommending approval of Byetta® for the treatment of type
2 diabetes. Marketing authorization by the European Commission is expected later this
year. Byetta is already approved in the U.S. for this indication. |
|
|
|
|
We submitted data to the FDA for consideration of a new treatment-resistant depression
(TRD) indication for Symbyax®, available as a range of fixed combinations of Zyprexa and
Prozac, as well as for Zyprexa used in combination with Prozac. Symbyax is already
approved in the U.S. for the treatment of bipolar depression. |
|
|
|
|
During the second quarter of 2006, Gemzar was approved in the U.S. for the treatment of
recurrent ovarian cancer in combination with carboplatin. |
|
|
|
|
During the second quarter of 2006, we submitted a supplemental NDA to the FDA for
Cymbaltaâ for the treatment of generalized anxiety disorder. We are also conducting
Phase III studies on Cymbalta for the treatment of fibromyalgia, a chronic, often
debilitating pain disorder. |
|
|
|
|
During the second quarter of 2006, we initiated a Phase III clinical trial to study
enzastaurin as a maintenance therapy to prevent relapse in patients with diffuse large
B-cell lymphoma. We initiated a Phase III clinical trial of enzastaurin, a targeted oral
agent, during the first quarter of 2006, for the treatment of relapsed glioblastoma
multiforme, an aggressive and malignant form of brain cancer. |
13
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.
We have reached agreements with claimants attorneys involved in certain U.S. Zyprexa product
liability litigation to settle a large number of 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.
As previously disclosed, we have been considering the future of three European facilities, which
include the R&D facilities in Mont St. Guibert, Belgium, and Hamburg, Germany, and the dry products
manufacturing facility in Basingstoke, England. On October 16, 2006, the Board of Directors
approved a plan to close the Hamburg, Germany, facility by June 30, 2007. No final decisions have
been made with respect to the Basingstoke and Mont St. Guibert sites. However, severance and
impairment charges as a result of any potential sale or site closure could be significant.
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. In 2006, we are experiencing a one-time sales benefit as a
result of MMA; 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. Recently, language allowing for personal importation of a 90-day supply of medication
from Canada only was passed into law via the Homeland Security Appropriations bill. This language
only allows for medication to be carried in person from Canada to the U.S. and does not authorize
mail or Internet importation. Further, the language disallows certain medications including
injectibles. 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.
Additionally, notwithstanding the federal law that continues to prohibit all but the very narrow
drug importation detailed above, 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 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 also are attempting to extend discounted
Medicaid prices to non-Medicaid patients. As a result, we expect pressures on pharmaceutical
pricing to continue.
As it relates to the new Medicare program, we announced in the second quarter of 2006 that we
temporarily extended our U.S. patient assistance program, LillyAnswers. The temporary extension of
LillyAnswers allows patients who are not enrolled in Medicare Part D access to the LillyAnswers
program until December 31, 2006. We also temporarily extended LillyAnswers for patients who have
enrolled in a Medicare Part D plan and need assistance for Zyprexa and Forteoâ. We have
received a favorable opinion from the U.S. Department of Health and Human Services Office of the
Inspector General (OIG) for our proposal for an Outside Part D patient assistance program (i.e.,
the LillyMedicareAnswers program) which will provide assistance for Zyprexa, Forteo, and Humatrope®
beyond the end of this year to eligible patients enrolled in a Medicare Part D plan. We currently
anticipate that the specific LillyAnswers program extension involving Zyprexa, Forteo, and
Humatrope for patients enrolled in a Medicare Part D plan will continue to be available until
December 31, 2006. In order to participate in either the temporary extension as described above or
the new LillyMedicareAnswers program, certain eligibility and certification requirements must be
met.
International operations also are 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.
14
Sales
Sales growth for the third quarter and first nine months of 2006 was 7 percent and 6 percent,
respectively. The primary drivers for growth in the third quarter of 2006 were Cymbalta, Byetta,
Forteo, Alimta® and Zyprexa. Sales in the U.S. increased by $178.3 million, or 9 percent for the
third quarter of 2006, and $527.3 million, or 9 percent for the first nine months of 2006, compared
with the same periods of 2005. The U.S. growth comparison for the nine-month period also benefited
from an estimated $170 million of wholesaler destocking in the first nine months of 2005 as a
result of restructuring our arrangements with our U.S. wholesalers in the first quarter of 2005.
We experienced a one-time sales benefit resulting from a shift of certain low-income patients from
Medicaid to Medicare and increased access to medical coverage by certain patients previously
covered under our LillyAnswers program following the implementation of MMA in 2006. This
contributed part of the increases in U.S. net effective sales prices of 11 percent and 9 percent
for the third quarter and first nine months of 2006, respectively. Sales outside the U.S.
increased $84.7 million, or 5 percent, and $152.2 million, or 3 percent, for the third quarter and
first nine months of 2006, respectively. Worldwide sales volume and exchange rates both increased
by 1 percent and selling prices increased by 5 percent in the third quarter of 2006. For the first
nine months of 2006, worldwide sales volume and selling prices increased 4 percent and 3 percent,
respectively, while exchange rates decreased 1 percent.
The following tables summarize our net sales activity for the three- and nine-month periods
ended September 30, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
|
|
|
September 30, 2006 |
|
September 30, |
|
Percent |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
Change |
Product |
|
U.S.1 |
|
Outside U.S. |
|
Total |
|
Total |
|
From 2005 |
|
|
(Dollars in millions) |
Zyprexa |
|
$ |
519.0 |
|
|
$ |
565.7 |
|
|
$ |
1,084.7 |
|
|
$ |
1,035.1 |
|
|
|
5 |
|
Gemzar |
|
|
153.0 |
|
|
|
201.6 |
|
|
|
354.6 |
|
|
|
334.3 |
|
|
|
6 |
|
Cymbalta |
|
|
306.5 |
|
|
|
42.1 |
|
|
|
348.6 |
|
|
|
182.8 |
|
|
|
91 |
|
Humalog |
|
|
199.0 |
|
|
|
123.2 |
|
|
|
322.2 |
|
|
|
306.2 |
|
|
|
5 |
|
Evista |
|
|
162.8 |
|
|
|
95.1 |
|
|
|
257.9 |
|
|
|
260.3 |
|
|
|
(1 |
) |
Humulin |
|
|
96.7 |
|
|
|
133.3 |
|
|
|
230.0 |
|
|
|
250.9 |
|
|
|
(8 |
) |
Animal health products |
|
|
98.0 |
|
|
|
118.2 |
|
|
|
216.2 |
|
|
|
215.7 |
|
|
|
0 |
|
Alimta |
|
|
89.9 |
|
|
|
67.3 |
|
|
|
157.2 |
|
|
|
122.3 |
|
|
|
29 |
|
Forteo |
|
|
104.2 |
|
|
|
44.9 |
|
|
|
149.1 |
|
|
|
102.6 |
|
|
|
45 |
|
Strattera® |
|
|
112.3 |
|
|
|
14.1 |
|
|
|
126.4 |
|
|
|
140.9 |
|
|
|
(10 |
) |
Humatrope |
|
|
49.3 |
|
|
|
52.3 |
|
|
|
101.6 |
|
|
|
100.2 |
|
|
|
1 |
|
Fluoxetine products |
|
|
37.8 |
|
|
|
40.5 |
|
|
|
78.3 |
|
|
|
112.4 |
|
|
|
(30 |
) |
Actos® |
|
|
34.7 |
|
|
|
42.3 |
|
|
|
77.0 |
|
|
|
64.3 |
|
|
|
20 |
|
ReoPro® |
|
|
26.6 |
|
|
|
40.3 |
|
|
|
66.9 |
|
|
|
70.9 |
|
|
|
(6 |
) |
Byetta |
|
|
62.1 |
|
|
|
|
|
|
|
62.1 |
|
|
|
10.6 |
|
|
NM |
Anti-infectives |
|
|
1.0 |
|
|
|
57.5 |
|
|
|
58.5 |
|
|
|
104.7 |
|
|
|
(44 |
) |
Cialis2 |
|
|
1.4 |
|
|
|
54.2 |
|
|
|
55.6 |
|
|
|
40.9 |
|
|
|
36 |
|
Xigris |
|
|
22.7 |
|
|
|
19.4 |
|
|
|
42.1 |
|
|
|
45.5 |
|
|
|
(7 |
) |
Other pharmaceutical
products |
|
|
29.6 |
|
|
|
45.5 |
|
|
|
75.1 |
|
|
|
100.5 |
|
|
|
(25 |
) |
|
Total net sales |
|
$ |
2,106.6 |
|
|
$ |
1,757.5 |
|
|
$ |
3,864.1 |
|
|
$ |
3,601.1 |
|
|
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
|
|
|
Nine Months Ended |
|
Ended |
|
Percent |
|
|
September 30, 2006 |
|
September 30, 2005 |
|
Change |
Product |
|
U.S.1 |
|
Outside U.S. |
|
Total |
|
Total |
|
From 2005 |
|
|
(Dollars in millions) |
Zyprexa |
|
$ |
1,555.8 |
|
|
$ |
1,651.3 |
|
|
$ |
3,207.1 |
|
|
$ |
3,170.1 |
|
|
|
1 |
|
Gemzar |
|
|
452.7 |
|
|
|
584.2 |
|
|
|
1,036.9 |
|
|
|
981.9 |
|
|
|
6 |
|
Humalog |
|
|
584.2 |
|
|
|
363.1 |
|
|
|
947.3 |
|
|
|
888.6 |
|
|
|
7 |
|
Cymbalta |
|
|
782.3 |
|
|
|
110.0 |
|
|
|
892.3 |
|
|
|
450.9 |
|
|
|
98 |
|
Evista |
|
|
486.9 |
|
|
|
288.1 |
|
|
|
775.0 |
|
|
|
770.8 |
|
|
|
1 |
|
Humulin |
|
|
264.8 |
|
|
|
403.5 |
|
|
|
668.3 |
|
|
|
757.5 |
|
|
|
(12 |
) |
Animal health products |
|
|
274.7 |
|
|
|
340.8 |
|
|
|
615.5 |
|
|
|
612.3 |
|
|
|
1 |
|
Alimta |
|
|
255.5 |
|
|
|
184.9 |
|
|
|
440.4 |
|
|
|
327.4 |
|
|
|
35 |
|
Strattera |
|
|
373.5 |
|
|
|
49.2 |
|
|
|
422.7 |
|
|
|
384.1 |
|
|
|
10 |
|
Forteo |
|
|
292.4 |
|
|
|
129.8 |
|
|
|
422.2 |
|
|
|
271.3 |
|
|
|
56 |
|
Actos |
|
|
237.0 |
|
|
|
121.7 |
|
|
|
358.7 |
|
|
|
338.0 |
|
|
|
6 |
|
Humatrope |
|
|
149.6 |
|
|
|
156.6 |
|
|
|
306.2 |
|
|
|
313.6 |
|
|
|
(2 |
) |
Fluoxetine products |
|
|
113.4 |
|
|
|
122.3 |
|
|
|
235.7 |
|
|
|
339.1 |
|
|
|
(30 |
) |
Anti-infectives |
|
|
25.3 |
|
|
|
190.7 |
|
|
|
216.0 |
|
|
|
326.7 |
|
|
|
(34 |
) |
ReoPro |
|
|
84.5 |
|
|
|
128.9 |
|
|
|
213.4 |
|
|
|
225.4 |
|
|
|
(5 |
) |
Cialis2 |
|
|
4.6 |
|
|
|
158.5 |
|
|
|
163.1 |
|
|
|
124.9 |
|
|
|
31 |
|
Byetta |
|
|
150.0 |
|
|
|
|
|
|
|
150.0 |
|
|
|
14.0 |
|
|
NM |
Xigris |
|
|
75.7 |
|
|
|
65.1 |
|
|
|
140.8 |
|
|
|
162.8 |
|
|
|
(14 |
) |
Other pharmaceutical
products |
|
|
76.7 |
|
|
|
157.4 |
|
|
|
234.1 |
|
|
|
306.8 |
|
|
|
(24 |
) |
|
Total net sales |
|
$ |
6,239.6 |
|
|
$ |
5,206.1 |
|
|
$ |
11,445.7 |
|
|
$ |
10,766.2 |
|
|
|
|
|
|
NM Not meaningful
|
|
|
|
1 |
|
U.S. sales include sales in Puerto Rico. |
|
2 |
|
Cialis had worldwide third-quarter and nine-month sales of $245.6 million and $701.8
million, respectively, representing increases of 26 percent and 31 percent, respectively, compared
with the same periods of 2005. The sales shown in the tables 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 statements of income. |
Product Highlights
Zyprexa sales in the U.S. increased 3 percent in the third quarter and decreased 1 percent in first
nine months of 2006, respectively, compared with the same periods of 2005. The increase resulted
from an increase in prices, partially offset by lower demand. However, U.S. prescription volume
has held steady during the first nine months of 2006. The increase in net effective selling prices
was partially due to the transition of certain low-income patients from Medicaid to Medicare.
Sales outside the U.S. increased 6 percent in the third quarter of 2006, driven by increased demand
as well as the favorable impact of exchange rates, offset partially by lower prices. International
sales for the first nine months of 2006 increased 3 percent, which was due to increased demand.
16
Diabetes care products, composed primarily of Humalog, Humulin, Actos, and Byetta, had worldwide
net sales of $712.4 million and $2.18 billion in the third quarter and first nine months of 2006,
respectively, representing increases of 9 percent and 6 percent compared with the same periods last
year. Diabetes care revenues in the U.S. increased 14 percent and 10 percent, to $408.6 million
and $1.28 billion for the third quarter and first nine months of 2006, respectively. These
increases were primarily driven by sales of Byetta for both periods. Diabetes care revenues
outside the U.S. increased 3 percent and 1 percent, to $303.8 million and $900.8 million in the
third quarter and first nine months of 2006, respectively. Results from our primary diabetes care
products are as follows:
|
|
|
Humalog sales in the U.S. increased 3 percent and 6 percent during the third
quarter and first nine months of 2006, respectively, due to higher prices, which
were partially offset by a decline in demand. Humalog sales outside the U.S.
increased 10 percent during the third quarter primarily due to increased demand, as
well as a favorable impact of exchange rates, offset partially by lower prices.
Humalog sales outside the U.S. increased 8 percent for the first nine months of
2006, primarily due to increased demand, offset by the unfavorable impact of
exchange rates. |
|
|
|
|
Humulin sales decreased 10 percent and 16 percent in the U.S. for the third
quarter and first nine months of 2006, respectively, driven primarily by the
decline in demand due to continued competitive pressures, offset partially by
higher prices. Humulin sales outside the U.S. decreased 7 and 9 percent during the
third quarter and first nine months of 2006, respectively, due to a decline in
demand. |
|
|
|
|
Actos revenues in the U.S., the majority of which represent service revenues
from a copromotion agreement in the U.S. with Takeda Pharmaceuticals North America
(Takeda), increased 17 percent and decreased 1 percent in the third quarter and
first nine months of 2006, respectively. Actos is manufactured by Takeda Chemical
Industries, Ltd., and sold in the U.S. by Takeda. As previously disclosed, since
our share of revenue from the agreement with Takeda will not necessarily track with
product sales, it is difficult to make quarterly comparisons for Actos revenue.
Our U.S. marketing rights with respect to Actos expired in September 2006; however,
we will continue receiving royalties from Takeda at a declining rate through
September 2009. The arrangement outside the U.S.
continues. |
|
|
|
|
Sales of Byetta, a first-in-class treatment for type 2 diabetes we market with
Amylin Pharmaceuticals (Amylin), launched in the U.S. in June 2005, were $126.4
million and $293.2 million during the third quarter and first nine months of 2006,
respectively. We report as revenue our 50 percent share of Byettas gross margins
and our sales of Byetta pen delivery devices to Amylin. |
Gemzar sales increased 2 percent and 5 percent in the U.S. for the third quarter and first nine
months of 2006, respectively, as compared to the same periods in 2005. This increase is
attributable to higher prices in both periods, offset partially by lower demand in the third
quarter due to competitive pressures. Gemzar sales outside the U.S. increased 9 percent and 6
percent for the third quarter and first nine months of 2006, respectively, which was due to
increased demand, offset partially by lower prices. The third quarter also benefited from the
favorable impact of exchange rates.
U.S. sales of Cymbalta, a treatment of major depressive disorder and diabetic peripheral
neuropathic pain, increased 80 percent and 85 percent for the third quarter and first nine months
of 2006, respectively, as compared to the same periods last year, due to strong demand. Cymbalta
sales outside the U.S. continue to reflect significant growth due to recent international launches.
Evista sales in the U.S. increased 1 percent for both the third quarter and first nine months of
2006, as compared to the same periods in 2005, due to higher prices, offset by a decline in demand.
Evista sales outside the U.S. decreased 4 percent and remained flat in the third quarter and nine
month periods of 2006, due primarily to lower prices in both periods, offset by an increase in
demand during the first nine months of 2006.
Alimta, a treatment of malignant pleural mesothelioma and second-line treatment of non-small-cell
lung cancer, generated an increase in U.S. sales of 17 percent and 22 percent for the third quarter
and first nine months of 2006, respectively, as compared to the same periods in 2005. Alimta sales
outside the U.S. increased 48 percent and 57 percent during the third quarter and first nine months
of 2006, respectively. These increases are attributable to growth in U.S. and international
demand.
Forteo, a treatment for severe osteoporosis, increased 48 and 59 percent in the U.S. in the third
quarter and first nine months of 2006, respectively, as compared to the same periods in 2005. In
addition to increased demand, U.S. sales significantly benefited from access to medical coverage
through the Medicare Part D program and from decreased utilization of our U.S. patient assistance
program, LillyAnswers. Sales outside the U.S. increased 39 percent and 48 percent for the third
quarter and first nine months of 2006, respectively, which was driven by increased demand along
with a favorable impact in exchange rates during the third quarter, offset by a decrease in prices.
17
U.S. sales of Strattera, a treatment of attention-deficit hyperactivity disorder (ADHD) in
children, adolescents, and adults, decreased 10 percent during the third quarter and increased 7
percent for the first nine months of 2006, compared with the same periods in 2005. The decline in
sales in the third quarter was attributable to a decline in demand, offset by an increase in
prices. The increase for the first nine months of 2006 was the result of higher prices as well as
the reductions in the U.S. wholesaler inventory levels in 2005, offset by decline in demand.
Total worldwide product sales of Cialis in the third quarter and first nine months of 2006 were
composed of $55.0 million and $161.2 million of sales in our territories, respectively, which are
reported in our net sales, and $190.6 million and $540.5 million of sales in the joint-venture
territories. Within the joint-venture territories, the U.S. sales of Cialis were $94.9 million and
$271.3 million in the third quarter and first nine months of 2006, respectively, representing
increases of 23 percent and 42 percent from the same periods of 2005. Cialis sales in our
territories are reported in revenue, while our 50 percent share of the joint-venture net income is
reported in other income net. Cialis sales growth reflects both gains in market share and growth
of the erectile dysfunction market during the third quarter and first nine months of 2006.
Gross Margin, Costs, and Expenses
For the third quarter of 2006, gross margins improved 1.2 percentage points, to 77.7 percent of net
sales, compared with the third quarter of 2005. For the first nine months of 2006, gross margins
increased 1.8 percentage points, to 77.9 percent of net sales, compared with the first nine months
of 2005. The increase for the quarter was primarily due to increased product prices and increased
production volume, partially offset by higher manufacturing expenses. This increase for the
nine-month period was primarily due to favorable product prices and the favorable impact of foreign
exchange rates, partially offset by higher manufacturing expenses.
Operating expenses (the aggregate of research and development and marketing and administrative
expenses) increased 7 percent and 6 percent for the third quarter and first nine months of 2006,
respectively, compared with the same periods of 2005. Investment in research and development
increased 1 percent, to $755.7 million, and 3 percent, to $2.27 billion, for the third quarter and
first nine months of 2006, respectively, and represent 20 percent of sales in both periods.
Marketing and administrative expenses increased 12 percent, to $1.20 billion, and 8 percent, to
$3.58 billion, for the third quarter and first nine months of 2006, respectively, driven largely by
increased marketing expenses in support of key products, primarily Cymbalta.
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.
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Interest expense for the third quarter and nine-month period in 2006 increased $38.4
million, to $62.7 million, and $132.6 million to $193.5 million, respectively, as compared
to the same periods in 2005. These increases are a result of higher interest rates and
less capitalized interest due to the completion in late 2005 of certain manufacturing
facilities. |
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Interest income increased $15.6 million, to $67.5 million and $51.4 million to $195.6
million for the third quarter and first nine months of 2006, respectively, as compared to
the same periods in 2005, due to higher short-term interest rates. |
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The Lilly ICOS joint-venture income was $23.8 million in the third quarter of 2006,
compared with $5.8 million in the third quarter of 2005. For the first nine months of
2006, income was $66.1 million, compared with a loss of $7.3 million in the first nine
months of 2005. The increase in both periods was due to increased Cialis sales and
decreased selling and marketing expenses. |
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Net other income and expense items decreased $24.2 million to $27.4 million for
third-quarter 2006 and decreased $86.1 million to $66.9 million for the first nine months
of 2006, as compared to the same periods in 2005. The decreases are largely a result of
less income from business development transactions. |
We incurred tax expense of $232.2 million and $672.6 million, for the third quarter and first nine
months of 2006, respectively, representing an effective tax rate of 21 percent in both periods.
Tax expense for the third quarter of 2005 was $224.1 million, representing an effective tax rate of
22 percent. Year-to-date comparisons to prior year are not meaningful due to the net loss before
income taxes experienced in the second quarter of 2005.
FINANCIAL CONDITION
As of September 30, 2006, cash, cash equivalents, and short-term investments totaled $3.62 billion
compared with $5.04 billion at December 31, 2005. Cash flow from operations of $2.12 billion was
more than offset by net repayments of long-term debt of $1.60 billion, dividends paid of $1.30
billion and net capital expenditures of $667.8 million. Total debt at September 30, 2006, was
$4.89 billion, a decrease of $1.61 billion as compared to December 31, 2005. We currently expect
to repay additional debt of approximately $500 million by the end of 2006. We also intend to incur
approximately $2.4 billion of debt to finance the ICOS acquisition at the time the transaction is
completed.
18
We believe that cash generated from operations, along with available cash and cash equivalents,
will be sufficient to fund our normal operating needs, including debt service, capital
expenditures, dividends, and taxes for the remainder of 2006. We believe that amounts available
through our existing commercial paper program should be adequate to fund maturities of short-term
borrowings, if necessary. 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. Teva has also submitted an ANDA seeking permission to market
a generic version of Evista. In June 2006, we filed a lawsuit against Teva in the U.S.
District Court for the Southern District of Indiana, seeking a ruling that our relevant
U.S. patents (expiring in 2012-2014) are valid, enforceable, and being infringed by Teva.
No trial date has been set in either case. We believe Barrs 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. 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 2006, 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. In response to our lawsuit, Sicor filed a declaratory judgment
action in the U.S. District Court for the Central District of California. The California
action has since been dismissed. In September 2006, we received notice that Mayne Pharma
(USA) Inc. (Mayne) filed a similar ANDA for Gemzar. In October 2006, we filed a lawsuit
against Mayne in the Southern District of Indiana in response to the ANDA filing. We are
awaiting the filing of an answer to our complaint against Mayne. In October 2006, we
received notice that Sun Pharmaceutical Industries Inc. (Sun) filed a similar ANDA for
Gemzar. We are evaluating our option to bring legal action against Sun. We expect to
prevail in litigation involving our Gemzar patents and believe that claims made by these
generic companies that our patents are not valid are without merit. However, it is not
possible to predict or determine the outcome of such 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. In September
2006, we received a subpoena from the California Attorney Generals office seeking production of
documents related to our efforts to obtain and maintain Zyprexas status on Californias formulary,
marketing and promotional practices with respect to Zyprexa, and remuneration of health care
providers. It is possible that other Lilly products could become subject to investigation and that
the
19
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.
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 with various claimants attorneys involved in U.S.
Zyprexa product liability litigation to settle approximately 10,500 claims, 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 U.S. Zyprexa product liability claims not subject to these agreements include approximately
1,500 lawsuits in the U.S. covering approximately 9,700 claimants, and approximately 850 tolled
claims. The first trials are scheduled for April 2007 in the Federal District Court for the
Eastern District of New York. In addition, we have been served with a 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 four lawsuits seeking class-action status
in Canada on behalf of patients who took Zyprexa. One of these four lawsuits has been certified
for certain residents of Quebec. 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, West Virginia, Mississippi, and
New Mexico 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,
that 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. Four additional lawsuits were filed in 2006: two in the Eastern District of New York, one
in the Southern District of Indiana, and one in Indiana state court, all 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 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
20
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:
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The cost 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, $700.0 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
that we will ultimately prevail on these issues. In June 2005, the United States Patent and Trademark
Office commenced a re-examination of the patent in order to consider certain issues raised by us
relating to the validity of the patent. A jury trial commenced in Boston on April 10, 2006 on the
patent validity and infringement issues. On May 4, 2006, the jury issued an initial decision in
the case that Xigris and Evista sales infringe the patent. The jury awarded the plaintiffs
approximately $65 million in damages, calculated by applying a 2.3 percent royalty to all U.S.
sales of Xigris and Evista from the date of issuance of the patent through the date of trial. We
will seek to have the jury verdict overturned by the trial court judge, and if unsuccessful, will
appeal the decision to the Court of Appeals for the Federal Circuit. In addition, a separate bench
trial with the U.S. District Court of Massachusetts was held the week of August 7, 2006, on our
contention that the patent is unenforceable and impermissibly covers natural processes. No
decision has been rendered.
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
21
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
For the full year of 2006, we expect earnings per share to be in the range of $3.07 to $3.18. This
guidance reflects the closure of the Hamburg, Germany research and development facility previously
discussed, which will result in a fourth-quarter charge to asset impairment, restructuring and
other special charges of $40 million to $50 million (pretax), or $.02 to $.03 per share (after
tax). It does not, however, reflect any other future material unusual items, such as the impact of
the ICOS acquisition, including the IPR&D charge, if the transaction closes in 2006. Nor does it
include any charges that may occur if further decisions are reached related to our other two
European sites.
We expect full-year 2006 sales to grow at approximately the low end of 7 percent to 9 percent
growth range. In addition, we expect gross margins
as a percent of sales to improve, operating expenses to grow in the mid-single digits in the
aggregate, and other income net, to contribute approximately $175 million to $250 million.
Excluding the tax associated with the potential charges discussed above, we also anticipate the
effective tax rate to be approximately 21 percent. In terms of cash flow, we expect capital
expenditures to be at approximately $1.2 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; the outcome of the Zyprexa patent appeal; other regulatory developments, government
investigations, patent disputes, and litigation; 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 September 30, 2006, and concluded that they are effective. |
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Changes in Internal Controls. During the third 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 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 70 suits
involving approximately 120 claimants. In the thimerosal litigation, we have been named as a
defendant in approximately 360 suits with approximately 975 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 quarter ended September 30, 2006:
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Total Number of |
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Shares Purchased as |
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Approximate Dollar |
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Part of Publicly |
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Value of Shares that May |
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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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Yet Be Purchased Under |
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Shares Purchased |
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per Share |
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Programs |
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the Plans or Programs |
Period |
(a) |
(b) |
(c) |
(d) |
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(in thousands) |
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(Dollars in millions) |
July 2006 |
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4 |
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$ |
55.66 |
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$ |
419.2 |
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August 2006 |
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16 |
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53.75 |
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419.2 |
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September 2006 |
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24 |
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55.86 |
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419.2 |
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Total |
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44 |
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The amounts presented in columns (a) and (b) above represent purchases of common stock related to
employee stock option exercises. The amounts presented in columns (c) and (d) in the above table
represent activity related to our $3.0 billion share repurchase program announced in March 2000.
As of September 30, 2006, we have purchased $2.58 billion related to this program. During the
third quarter of 2006, no shares were repurchased pursuant to this program and we do not expect to
purchase any shares under this program during the remainder of 2006.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits. The following documents are filed as exhibits to this Report:
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EXHIBIT 10.1
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The Eli Lilly and Company Bonus Plan, as amended |
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EXHIBIT 10.2
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2007 Change In Control Severance Pay Plan for Select Employees, as amended |
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EXHIBIT 10.3
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Agreement and Plan of Merger by and among Eli Lilly and Company, Tour Merger
Sub, Inc., and ICOS Corporation, which is incorporated by reference from Exhibit 2.1 to
the Form 8-K filed by ICOS Corporation on October 17, 2006 |
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EXHIBIT 11.
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Statement re: Computation of Earnings (Loss) per Share |
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EXHIBIT 12.
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Statement re: Computation of Ratio of Earnings From Continuing Operations to
Fixed Charges |
23
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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 |
24
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
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November 1, 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
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November 1, 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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25
INDEX TO EXHIBITS
The following documents are filed as a part of this Report:
|
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Exhibit |
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EXHIBIT 10.1
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The Eli Lilly and Company Bonus Plan, as amended |
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EXHIBIT 10.2
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2007 Change In Control Severance Pay Plan for Select Employees, as
amended |
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EXHIBIT 10.3
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Agreement and Plan of Merger by and among Eli Lilly and Company,
Tour Merger Sub, Inc., and ICOS Corporation, which is incorporated by
reference from Exhibit 2.1 to the Form 8-K filed by ICOS Corporation on
October 17, 2006 |
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EXHIBIT 11.
|
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Statement re: Computation of Earnings (Loss) per Share |
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EXHIBIT 12.
|
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Statement re: Computation of Ratio of Earnings From Continuing
Operations 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 |
26
exv10w1
EXHIBIT 10.1
The Eli Lilly and Company Bonus Plan
(as amended October 16, 2006)
TABLE OF CONTENTS
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Section 1 Purpose |
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2 |
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Section 2 Definitions |
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2 |
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Section 3 Administration |
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8 |
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Section 4 Participation in the Plan |
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9 |
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Section 5 Definition and Computation of Company Bonus |
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9 |
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Section 6 Time of Payment |
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13 |
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Section 7 Administrative Guidelines |
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14 |
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Section 8 Miscellaneous |
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15 |
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Section 9 Amendment, Suspension, or Termination |
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17 |
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- 2 -
The Eli Lilly and Company Bonus Plan
(as amended October 16, 2006)
SECTION 1. PURPOSE
The purpose of The Eli Lilly and Company Bonus Plan is to encourage and promote eligible employees
to create and deliver innovative pharmaceutical-based health care solutions that enable people to
live longer, healthier and more active lives, to outgrow our competitors through a constant stream
of pharmaceutical innovation, and to materially increase shareholder value. The Plan is designed
to accomplish the following key objectives:
|
a. |
|
motivate superior employee performance through the implementation of a
performance-based bonus system for all eligible management employees, United States
employees (including those in Puerto Rico) and other employees as may be designated
from time to time; |
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b. |
|
encourage eligible employees to take greater ownership of the company and
provide Answers that Matter daily by creating a direct relationship between key
company measurements and individual bonus payouts; and |
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|
c. |
|
enable the Company to attract and retain employees that will be instrumental in
driving sustained growth and performance of Eli Lilly and Company by providing a
competitive bonus program that rewards outstanding performance consistent with the
Companys mission, values and increased shareholder value. |
The Plan is intended to satisfy the requirements for providing performance-based compensation
under Section 162(m) of the Internal Revenue Code.
SECTION 2. DEFINITIONS
The following words and phrases as used in this Plan will have the following meanings unless a
different meaning is clearly required by the context. Masculine pronouns will refer both to males
and to females:
2.1 |
|
Applicable Year means the calendar year immediately preceding the year in which
payment of the Company Bonus is payable pursuant to Section 6. For example, the Applicable
Year for 2005 payout is January 1, 2004 through December 31, 2004. |
2.2 |
|
Bonus Target means the percentage of Participant Earnings for each Participant as
described in Section 5.6(a) below. |
2.3 |
|
Committee means (i) with respect to the Executive Officers of Lilly, the Compensation
Committee, the members of which will be selected by the Board of Directors of Lilly, |
- 3 -
|
|
from among its members; and (ii) with respect to all other Eligible Employees, the Compensation
Committee of the Board of Directors or its designee. Each member of the Compensation
Committee will, to the extent deemed necessary or appropriate by the Board of Directors,
satisfy the requirements of an outside director within the meaning of Section 162(m) of
the Internal Revenue Code. |
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2.4 |
|
Company means Eli Lilly and Company and its subsidiaries. |
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2.5 |
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Company Bonus means the amount of bonus compensation payable to a Participant as
described in Section 5 below. Notwithstanding the foregoing, however, the Committee may
determine, in its sole discretion, to reduce the amount of a Participants Company Bonus if
such Participant becomes eligible to participate in such other bonus program of the Company as
may be specifically designated by the Committee. Such reduction may be by a stated percentage
up to and including 100% of the Company Bonus. |
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2.6 |
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Company Performance Bonus Multiple means the amount as calculated in Sections 5.3 and
5.4 below. |
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2.7 |
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Disabled means a Participant who (i) has become eligible for a payment under The
Lilly Extended Disability Plan, assuming eligibility to participate in that plan, or (ii) for
those employees ineligible to participate in The Lilly Extended Disability Plan, has become
otherwise disabled under the applicable disability benefit plan or program for the
Participant, or, in the event that there is no such disability benefit plan or program, has
become disabled under applicable local law. |
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2.8 |
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Earnings Per Share (EPS) means the diluted earnings per share of the Company as
reported in the Companys Consolidated Statements of Income in accordance with generally
accepted accounting principles and Section 3.4 below. |
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2.9 |
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Earnings Per Share Growth (EPS Growth) means the percentage increase in EPS in the
Applicable Year compared to the prior year. |
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2.10 |
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Effective Date means January 1, 2004, as amended from time to time. |
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2.11 |
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Eligible Employee means: |
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a. |
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with respect to employees of Lilly or its Puerto Rican subsidiaries, a person
(1) who is employed as an employee by the Company on a scheduled basis of twenty (20)
or more hours per week and is scheduled to work at least five (5) months per year; and
(2) who is receiving compensation, including temporary illness pay under Lillys
Illness Pay Program or similar short-term disability program, from the Company for
services rendered as an employee. Notwithstanding anything herein to the contrary, the
term Eligible Employee will not include: |
|
(1) |
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a person who has reached Retirement with the Company; |
- 4 -
|
(2) |
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a person who is Disabled; |
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(3) |
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a person who is a leased employee within the meaning of
Section 414(n) of the Internal Revenue Code of 1986, as amended, or whose basic
compensation for services on behalf of the Company is not paid directly by the
Company; |
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(4) |
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a person who is classified as a Fixed Duration Employee, as
that term is used by Lilly; |
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(5) |
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a person who is classified as a special status employee because
his employment status is temporary, seasonal, or otherwise inconsistent with
regular employment status; |
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(6) |
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a person who is eligible to participate in the Eli Lilly and
Company Prem1er Rewards Plan or such other Company bonus or incentive program
as may be specifically designated by the Committee or its designee; or |
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(7) |
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a person who submits to the Committee in writing a request that
he not be considered eligible for participation in the Plan or is a member of
the Board of Directors of Lilly unless he or she is also an Eligible Employee. |
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(8) |
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any other category of employees designated by the Committee in
its discretion with respect to any Applicable Year. |
|
b. |
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with respect to those employees who are employed by the Company, but not by
Lilly or a Puerto Rican subsidiary, an employee of the Company designated by the
Committee as a Participant in the Plan with respect to any Applicable Year. In its
discretion, the Committee may designate Participants either on an individual basis or
by determining that all employees in specified job categories, classifications, levels,
subsidiaries or other appropriate classification will be Participants. |
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c. |
|
Notwithstanding anything herein to the contrary, the term Eligible Employee
will not include any person who is not so recorded on the payroll records of the
Company, including any such person who is subsequently reclassified by a court of law
or regulatory body as a common law employee of the Company. Consistent with the
foregoing, and for purposes of clarification only, the term employee or Eligible
Employee does not include any individual who performs services for the Company as an
independent contractor or under any other non-employee classification. |
2.12 |
|
Lilly means Eli Lilly and Company. |
- 5 -
2.13 |
|
Lilly Executive Officer or Section 162(m) Participant means a Participant who
has been designated by the Board of Directors of Lilly as an executive officer pursuant to
Rule 3b-7 under the Securities Exchange Act of 1934, as amended. For purposes of this Plan, a
Lilly Executive Officer will be considered a Section 162(m) Participant whether or not he is a
covered employee under Section 162(m). |
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2.14 |
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Participant means an Eligible Employee who is participating in the Plan. |
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2.15 |
|
Participant Earnings means (A) those amounts described below that are earned during
the portion of the Applicable Year during which the employee is a Participant in the Plan: |
|
(i) |
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regular compensation (including applicable
deferred compensation amounts), overtime, shift premiums and other
forms of additional compensation determined by and paid currently
pursuant to an established formula or procedure; |
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(ii) |
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salary reduction contributions to The Lilly
Employee Savings Plan or elective contributions under any similar
tax-qualified plan that is intended to meet the requirements of
Section 401(k) of the Internal Revenue Code or similar Company
savings program; |
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(iii) |
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elective contributions to any cafeteria
plan that is intended to meet the requirements of Section 125 of the
Internal Revenue Code or other pre-tax contributions to a similar
Company benefit plan; |
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(iv) |
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payments made under the terms of Lillys
Illness Pay Program or other similar Company or government-required
leave program during an Applicable Year to a Participant who is on
approved leave of absence and is receiving one hundred percent (100%)
of his base pay; and |
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(v) |
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other legally-mandated or otherwise
required pre-tax deductions from a Participants base salary. |
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(B) |
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The term Participant Earnings does not include: |
|
(i) |
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compensation paid in lieu of earned
vacation; |
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(ii) |
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amounts contributed to the Retirement Plan
or any other qualified plan, except as provided in clause (A)(ii),
above; |
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(iii) |
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payments made under the terms of Lillys
Illness Pay Program or other similar Company or government-required
leave program during an Applicable Year to a Participant who is on
approved leave of absence and is receiving less than the full amount
of his base pay; |
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(iv) |
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amounts paid under this Plan or other bonus
or incentive program of the Company; |
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|
(v) |
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payments made under The Lilly Severance Pay
Plan or any other |
- 6 -
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severance-type benefit (whether company-sponsored or mandated by
law) arising out of or relating to a Participants termination of
employment; |
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(vi) |
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payments based upon the discretion of the
Company; |
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(vii) |
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in the case of a person employed by a
Lilly subsidiary, foreign service, cost of living, or other
allowances that would not be paid were the person employed by Lilly; |
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(viii) |
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amounts paid as commissions, sales bonuses, or Market Premiums (as
defined under the Retirement Plan); or |
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(ix) |
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earnings with respect to the exercise of
stock options or vesting of restricted stock. |
2.16 |
|
Performance Benchmarks mean the amounts as calculated in Section 5.3 below. The
Performance Benchmarks will be established after considering expected pharmaceutical peer
group performance and based on performance measures as described in Section 5.2. |
|
2.17 |
|
Plan means The Eli Lilly and Company Bonus Plan as set forth herein and as hereafter
modified or amended from time to time. The Plan is an incentive compensation program and is
not subject to the Employee Retirement Income Security Act of 1974, as amended (ERISA),
pursuant to Department of Labor Regulation Section 2510.3. |
|
2.18 |
|
Plant Closing means the closing of a plant site or other Company location that
directly results in termination of employment. |
|
2.19 |
|
Reduction in Workforce means the elimination of a work group, functional or business
unit or other broadly applicable reduction in job positions that directly results in
termination of employment. |
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2.20 |
|
Retirement means the cessation of employment upon the attainment of age fifty-five
with ten years of service (55 and 10) or at least eighty (80) points, as determined by the
provisions of the Retirement Plan as amended from time to time, assuming eligibility to
participate in that plan. For persons who are not participants in the Retirement Plan,
Retirement means the cessation of employment as a retired employee under the applicable
retirement benefit plan or program as provided by the Company or applicable law. |
|
2.21 |
|
Retirement Plan means The Lilly Retirement Plan. |
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2.22 |
|
Sales means, for any Applicable Year, the consolidated net sales of the Company as
set forth in the Consolidated Statements of Income as reported by the Company in accordance
with generally accepted accounting principles and Section 3.4 below. |
|
2.23 |
|
Sales Growth means the percentage increase in Sales in the Applicable Year compared
to the prior year. |
- 7 -
2.24 |
|
Section 162(m) means Section 162(m) of the Internal Revenue Code of 1986, as amended. |
|
2.25 |
|
Service means the aggregate time of employment of an Eligible Employee by the
Company. |
- 8 -
SECTION 3. ADMINISTRATION
3.1 |
|
Committee. The Plan will be administered by the Compensation Committee of the Board
of Directors of Eli Lilly and Company or, if the name of the Compensation Committee is
changed, the Plan will be administered by such successor committee. For all Eligible
Employees other than Lilly Executive Officers, the Compensation Committee may delegate all or
a portion of its responsibilities within its sole discretion by resolution. Any reference in
this Plan to the Committee or its authority will be deemed to include such designees (other
than with respect to Lilly Executive Officers or a member of the Board of Directors or for
purposes of Section 9). |
|
3.2 |
|
Powers of the Committee. The Committee will have the right to interpret the terms
and provisions of the Plan and to determine any and all questions arising under the Plan,
including, without limitation, the right to remedy possible ambiguities, inconsistencies, or
omissions by a general rule or particular decision. The Committee will have authority to
adopt, amend and rescind rules consistent with the Plan, to make exceptions in particular
cases to the rules of eligibility for participation in the Plan (except with respect to Lilly
Executive Officers), and to delegate authority for approval of participation of any Eligible
Employee except for Lilly Executive Officers or a member of the Board of Directors. The
Committee will take all necessary action to establish annual Performance Benchmarks and
approve the timing of payments, as necessary. |
|
3.3 |
|
Certification of Results. Before any amount is paid under the Plan, the Committee
will certify in writing the calculation of EPS, EPS Growth, Sales and Sales Growth (or other
applicable performance measures) for the Applicable Year and the satisfaction of all other
material terms of the calculation of the Company Performance Bonus Multiple and Company Bonus. |
|
3.4 |
|
Adjustments for Significant Events. Not later than 90 days after the beginning of an
Applicable Year, the Committee may specify with respect to Company Bonuses for the Applicable
Year that the performance measures described in Section 5.2 will be determined before the
effects of acquisitions, divestitures, restructurings or special charges or gains, changes in
corporate capitalization, accounting changes, and/or events that are treated as extraordinary
items for accounting purposes; provided that such adjustments shall be made only to the extent
permitted by Section 162(m) in the case of Lilly Executive Officers. |
|
3.5 |
|
Finality of Committee Determinations. Any determination by the Committee of Sales,
Sales Growth, EPS, EPS Growth, any other performance measure, Performance Benchmarks and the
level and entitlement to Company Bonus, and any interpretation, rule, or decision adopted by
the Committee under the Plan or in carrying out or administering the Plan, will be final and
binding for all purposes and upon all interested persons, their heirs, and personal
representatives. The Committee may rely conclusively on determinations made by Lilly and its
auditors to determine Sales, Sales Growth, EPS, EPS
Growth and related information for administration of the Plan, whether such |
- 9 -
|
|
information is
determined by the Company, auditors or a third-party vendor engaged specifically to provide
such information to the Company. This subsection is not intended to limit the Committees
power, to the extent it deems proper in its discretion, to take any action permitted under
the Plan. |
SECTION 4. PARTICIPATION IN THE PLAN
4.1 |
|
General Rule. Only Eligible Employees may participate in and receive payments under
the Plan. |
|
4.2 |
|
Commencement of Participation. An Eligible Employee will become a Participant in the
Plan as follows: (i) in the case of Eligible Employees under Section 2.11(a), on the date on
which the individual completes at least one hour of employment as an Eligible Employee within
the United States or Puerto Rico, and (ii) in the case of Eligible Employees under Section
2.11(b), on the date as of which the Committee has designated the individual to become a
Participant in the Plan. |
|
4.3 |
|
Termination of Participation. An Eligible Employee will cease to be a Participant
upon termination of employment with the Company for any reason, or at the time he otherwise
ceases to be an Eligible Employee under the Plan. |
SECTION 5. DEFINITION AND COMPUTATION OF COMPANY BONUS
5.1 |
|
Computation for Eligible Employees. Company Bonus amounts will depend significantly
on Company performance as well as Participants individual performance for certain Eligible
Employees. As more specifically described below, a Participants Company Bonus is calculated
by multiplying the Participants Bonus Target by his Participant Earnings and the Company
Performance Bonus Multiple. For eligible management and Lilly employees and those
Participants designated by the Committee, individual performance will also impact the Company
Bonus calculation, as described in Section 5.6(c) below. Company Bonuses are paid out to
eligible Participants in the manner provided below. |
|
5.2 |
|
Establishment of Performance Measures. Not later than 90 days after the beginning of
each Applicable Year, the Committee will, in its sole discretion, determine appropriate
performance measures for use in calculating Company Bonus amounts. These performance measures
may include Sales Growth, EPS Growth, growth in net income, return on assets, return on
equity, total shareholder return, EVA, MVA or any of the foregoing before the effect of
acquisitions, divestitures, accounting changes, restructurings and special charges or gains
(determined according to objective criteria established by the Committee not later than ninety
(90) days after the beginning of the Applicable Year).
Unless otherwise specified in a written resolution adopted by the Committee for the
Applicable Year, the Committee will use EPS Growth and Sales |
- 10 -
|
|
Growth, in each case before the
effect of acquisitions, divestitures, accounting changes, restructurings and special charges
or gains (determined as described above) as performance measures. |
|
5.3 |
|
Establishment of Performance Benchmarks. Not later than 90 days after the beginning
of each Applicable Year, the Committee will establish Performance Benchmarks for the Company
based on the performance measures described in Section 5.2 above. Unless otherwise specified
in a written resolution adopted by the Committee for the Applicable Year, the Performance
Benchmarks will correspond with EPS Growth and Sales Growth amounts for the Applicable Year,
established after considering expected pharmaceutical peer group performance. The Performance
Benchmarks will correspond to EPS Growth and Sales Growth multiples equal to 1.0. The
Committee will also adopt a formula that will determine the extent to which the performance
measure multiples will vary as the Companys actual results vary from the Performance
Benchmarks. |
|
5.4 |
|
Company Performance Bonus Multiple. Unless otherwise specified in a written
resolution adopted by the Committee not later than 90 days after the beginning of the
Applicable Year, the Company Performance Bonus Multiple is equal to the product of the EPS
Growth multiple and 0.75 plus the product of the Sales Growth multiple and 0.25 (i.e., Company
Performance Bonus Multiple = (EPS Growth multiple * 0.75) + (Sales Growth multiple * 0.25)). |
|
5.5 |
|
Company Performance Bonus Multiple Threshold and Ceiling: Notwithstanding Sections
5.3 and 5.4, the Company Performance Bonus Multiple will not be less than 0.25 or greater than
2.0 in an Applicable Year. If the calculations described in Sections 5.3 and 5.4 above result
in a number that is less than 0.25, the Company Performance Bonus Multiple will equal 0.25 for
the Applicable Year. If the calculations described in Sections 5.3 and 5.4 above result in a
multiple greater than 2.0, the Company Performance Bonus Multiple will equal 2.0 for the
Applicable Year. Notwithstanding the foregoing, the Committee may reduce the Company
Performance Bonus Multiple (including but not limited to a reduction to below 0.25) for some
or all Eligible Employees, in its discretion. |
|
5.6 |
|
Participant Company Bonus. |
|
a. |
|
Bonus Target. Not later than 90 days after the beginning of the
Applicable Year, the Bonus Target for each Participant will be determined by the
Committee on a basis that takes into consideration a Participants pay grade level and
job responsibilities. The Bonus Target for each Participant for the Applicable Year
will be expressed as a percentage of Participant Earnings as of December 31 of the
Applicable Year. Early in the Applicable Year, each Participant will receive
information regarding the Participants Bonus Target. In the event that a
Participants pay grade level changes during the Applicable Year (e.g., because of
promotion, demotion or otherwise), the Participants Bonus Target will be prorated
based on the Bonus Target applicable to |
- 11 -
|
|
|
each pay grade level (with related job responsibilities) and the percentage of time that
the Participant is employed at each pay grade level during the Applicable Year. |
|
|
b. |
|
Company Bonus Calculation. Except as described in Section 5.6(c)
below, a Participants Company Bonus will equal the product of the Company Performance
Bonus Multiple and the Participants Bonus Target and the Participants Earnings. |
|
|
c. |
|
Adjustment for Performance Multiplier, if Applicable.
Notwithstanding anything herein to the contrary, all eligible management employees
(except Lilly Executive Officers), United States employees and other employees as may be
designated from time to time by the Committee are subject to individual performance
multipliers. For all such Participants subject to an individual performance multiplier,
the amount calculated in Section 5.5(b) above will be adjusted based on the
Participants performance rating at the end of the Applicable Year as described below.
For each such Participant, the performance rating will be determined by the
Participants supervision. |
|
1. |
|
Exemplary Performance. If the
Participant receives an exemplary or equivalent performance rating
(using the applicable performance rating system then in effect for
the Participant), the amount calculated in Section 5.6(b) will be
multiplied by an amount determined by the Committee, not to exceed
1.5, to obtain the Participants actual Company Bonus. |
|
|
2. |
|
Satisfactory Performance. If the
Participant receives a satisfactory or equivalent performance rating
(using the applicable performance rating system then in effect for
the Participant), the amount calculated in Section 5.6(b) will be
multiplied by 1.0 so that the Participants actual Company Bonus will
equal the amount calculated in Section 5.6(b) above. |
|
|
3. |
|
Unsatisfactory Performance. If the
Participant receives a year-end unsatisfactory or equivalent
performance rating (using the applicable performance rating system
then in effect for the Participant), the amount calculated in Section
5.6(b) will be multiplied by 0.0 so that the Participants actual
Company Bonus will equal $0.00. |
In the event that a Participant does not receive a year-end performance rating, but is eligible for
a Company Bonus, the amount calculated in Section 5.6(b) will be multiplied by 1.0 so that the
Participants actual Company Bonus will be the amount calculated in Section 5.6(b) above.
5.7 |
|
Conditions on Company Bonus. Payment of any Company Bonus is neither guaranteed nor
automatic. A Participants Company Bonus is not considered to be any form of compensation,
wages, or benefits, unless and until paid. |
- 12 -
5.8 |
|
Required Employment. Except as provided below in this Section 5.8 or as otherwise
designated by the Committee, if a Participant is not employed by the Company on the last day
of the Applicable Year, or is otherwise not an Eligible Employee on that date, the Participant
is not entitled to any Company Bonus payment under this Plan for that Applicable Year. |
|
a. |
|
Leaves of Absence. A Participant who, on the last day
of the Applicable Year, is on approved leave of absence under the Family and
Medical Leave Act of 1993, military leave under the Uniformed Services
Employment and Reemployment Rights Act, or such other approved leave of absence
will be considered to be an Eligible Employee on that date for purposes of this
Plan. |
|
|
b. |
|
Transfer. An employee who is a Participant in this
Plan for a portion of the Applicable Year and then transfers to a position
within the Company in which he is ineligible to participate in this Plan, but
who remains employed by the Company on the last day of the Applicable Year,
will be treated as satisfying the last-day-of-Applicable Year requirement for
purposes of this Plan. In that event, his Company Bonus will be based on his
Participant Earnings for the portion of the Applicable Year in which the
employee was a Participant in the Plan. |
|
|
c. |
|
Retirement, Disability or Death. A Participant who was
an Eligible Employee for some portion of the Applicable Year and then takes
Retirement, becomes and remains Disabled through the end of the Applicable
Year, or dies during the Applicable Year will be considered to satisfy the
last-day-of-Applicable-Year requirement described in this Section 5.8 for
purposes of this Plan. |
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d. |
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Reallocation, Medical Reassignment, Plant Closing or
Reduction in Workforce. A Participant who was an Eligible Employee for
some portion of the Applicable Year and whose employment is terminated as a
result of his failure to locate a position following his reallocation or
medical reassignment in the United States, or a Plant Closing or Reduction in
Workforce will be considered to satisfy the last-day-of-Applicable Year
requirement described in this Section 5.8 for purposes of this Plan. The
Committee or its designees determination regarding whether a Participants
termination is a direct result of either a Plant Closing or a Reduction in
Workforce will be final and binding. |
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e. |
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Notice of Resignation. In addition, a Participant who
submits a notice of resignation from employment with the Company prior to the
end of the Applicable Year and whose effective date of resignation is two (2)
weeks or less from the date of notice of resignation will be considered
employed by the Company for purposes of this Plan until the end of his
specified notice period. |
- 13 -
5.9 |
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New Participants. If an Eligible Employee began participation in the Plan during an
Applicable Year and is eligible for a Company Bonus, his Company Bonus will be based on
Participant Earnings earned after the employee became a Participant. An Eligible Employee who
became assigned to a position eligible for a Company Bonus at any time other than the first of
the month will become a Participant the first of the following month. |
5.10 |
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Section 162(m) Requirements, Bonus Maximum. In the case of Lilly Executive Officers,
all determinations necessary for computing a Company Bonus for the Applicable Year, including
establishment of all components of EPS, EPS Growth, Sales, Sales Growth, Company Performance
Bonus Multiple and Bonus Target percentages, shall be made by the Committee not later than 90
days after the commencement of the Applicable Year. As and to the extent required by Section
162(m), the terms of a Company Bonus for a Lilly Executive Officer must state, in terms of an
objective formula or standard, the method of computing the amount of compensation payable to
the Lilly Executive Officer, and must preclude discretion to increase the amount of
compensation payable that would otherwise be due under the terms of the award.
Notwithstanding anything elsewhere in the Plan to the contrary, the maximum amount of the
Company Bonus that may be payable to a Lilly Executive Officer in respect of any Applicable
Year will be $7 million. |
SECTION 6. TIME OF PAYMENT
6.1 |
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General Rule. Payment under the Plan will be made prior to April 1 of the year
following the Applicable Year. |
6.2 |
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Terminated Employee. Except as provided in Section 5.8 above, in the event an
Eligible Employees employment with the Company ends for any reason prior to the last day of
the Applicable Year, he will not receive any Company Bonus for the Applicable Year. |
6.3 |
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Deceased Eligible Employee. In the event an Eligible Employee dies before payment
under the Plan is made, the Committee may, in its sole discretion, authorize the Company to
pay to his personal representative or beneficiary an amount not to exceed the amount
established by the Committee to reflect the payment accrued at the date of death. |
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SECTION 7. ADMINISTRATIVE GUIDELINES
7.1 |
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Establishment and Amendment by the Committee. The Committee may establish objective
and nondiscriminatory written guidelines for administering those provisions of the Plan that
expressly provide for the determination of eligibility, Company Bonus or benefits on the basis
of rules established by the Committee. The Committee may, from time to time, amend or
supplement the administrative guidelines established in accordance with this subsection 7.1.
The administrative guidelines established or amended in accordance with this subsection 7.1
will not be effective to the extent that they materially increase the Plans liability, or to
the extent that they are inconsistent with, or purport to amend, any provision of the Plan set
forth in a document other than such administrative guidelines. |
7.2. |
|
Amendment by Board of Directors. Any administrative guidelines established by the
Committee pursuant to subsection 7.1 may be amended or revoked by the Board of Directors,
either prospectively or retroactively, in accordance with the general amendment procedures set
forth in section 9 below. |
- 15 -
SECTION 8. MISCELLANEOUS
8.1 |
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No Vested Right. No employee, participant, beneficiary, or other individual will
have a vested right to a Company Bonus or any part thereof until payment is made to him under
Section 6. |
8.2 |
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No Employment Rights. No provision of the Plan or any action taken by the Company,
the Board of Directors of the Company, or the Committee will give any person any right to be
retained in the employ of the Company. The right and power of the Company to dismiss or
discharge any Participant for any reason or no reason, with or without notice, is
specifically reserved. |
8.3 |
|
No Adjustments. After the certification of the calculation of EPS, EPS Growth,
Sales, Sales Growth and any other material terms of the calculation of the Company
Performance Bonus Multiple and Company Bonus for the Applicable Year as described in Section
3.3 above, no adjustments will be made to reflect any subsequent change in accounting, the
effect of federal, state, or municipal taxes later assessed or determined, or otherwise.
Notwithstanding the foregoing, the Company reserves the right to and, in appropriate cases,
will, seek restitution of any Company Bonus awarded to a Lilly Executive Officer if: |
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a. |
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The amount of the Company Bonus was calculated based upon the
achievement of certain financial results that were subsequently the subject of
a restatement of all or a portion of the Companys financial statements; |
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|
b. |
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The Lilly Executive Officer engaged in intentional misconduct
that caused or partially caused the need for such a restatement; and |
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c. |
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The amount of the Company Bonus that would have been awarded to
the Lilly Executive Officer had the financial results been properly reported
would have been lower than the amount actually awarded. |
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This subsection is not intended to limit the Companys power to take such action as it
deems necessary to remedy the misconduct, prevent its recurrence and, if appropriate,
based on all relevant facts and circumstances, punish the wrongdoer in a manner it deems
appropriate. |
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8.4 |
|
Other Representations. Nothing contained in this Plan, and no action taken
pursuant to its provisions, will create or be construed to create a trust of any kind, or a
fiduciary relationship between the Company and any employee, participant, beneficiary, legal
representative, or any other person. Although Participants generally have no right to any
payment from this Plan, to the extent that any Participant acquires a right to receive
payments from the Company under the Plan, such right will be no greater than the right of an
unsecured general creditor of the Company. All payments to be made hereunder
will be paid from the general funds of the Company and no special or separate fund will |
- 16 -
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be established, and no segregation of assets will be made, to assure payment of such amount. |
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8.5 |
|
Tax Withholding. The Company will make such provisions and take such steps as it
may deem necessary or appropriate for the withholding of all federal, state, local, and other
taxes required by law to be withheld with respect to Company Bonus payments under the Plan,
including, but not limited to, deducting the amount required to be withheld from the amount
of cash otherwise payable under the Plan, or from salary or any other amount then or
thereafter payable to an employee, Participant, beneficiary, or legal representative. |
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8.6 |
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Currency. The Company Bonus will be based on the currency in which the highest
portion of base pay is regularly paid. The Committee will determine the appropriate foreign
exchange conversion methodology in its discretion. |
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8.7 |
|
Effect of Plan on other Company plans. Nothing contained in this Plan is intended
to amend, modify, terminate, or rescind other benefit or compensation plans established or
maintained by the Company. Whether and to what extent a Participants Company Bonus is taken
into account under any other plan will be determined solely in accordance with the terms of
such plan. |
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8.8 |
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Construction. This Plan and all the rights thereunder will be governed by, and
construed in accordance with, the laws of the state of Indiana, without reference to the
principles of conflicts of law thereof. |
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8.9 |
|
Notice. Any notice to be given to the Company or Committee pursuant to the
provisions of the Plan will be in writing and directed to Secretary, Eli Lilly and Company,
Lilly Corporate Center, Indianapolis, IN 46285. |
- 17 -
SECTION 9. AMENDMENT, SUSPENSION, OR TERMINATION
The Board of Directors of the Company will have the right to amend, modify, suspend, revoke, or
terminate the Plan, in whole or in part, at any time and without notice, by written resolution of
the Board of Directors. The Committee also will have the right to amend the Plan, except that the
Committee may not amend this Section 9. Solely to the extent deemed necessary or advisable by the
Board (or the Committee) for purposes of complying with Section 162(m), the Board (or the
Committee) may seek the approval by the Companys stockholders of the Plan or any amendments to the
Plan or any aspect of the Plan or Plan amendments. Any such approval shall be obtained in a
separate vote of stockholders, with approval by a majority of the votes cast on the issue,
including abstentions to the extent abstentions are counted as voting under applicable state law
and the Articles of Incorporation and By-laws of the Company. To the extent deemed necessary or
advisable by the Board of Directors to comply with Section 162(m), the material terms of the
performance measures used in calculating Company Bonus amounts will be disclosed to and reapproved
by the stockholders of the Company no later than the Companys 2009 annual meeting.
exv10w2
EXHIBIT 10.2
ELI LILLY AND COMPANY
2007 CHANGE IN CONTROL SEVERANCE PAY PLAN
FOR SELECT EMPLOYEES
1. PURPOSE
This Eli Lilly and Company 2007 Change in Control Severance Pay Plan For Select Employees has been
established by the Company to provide for the payment of severance pay and benefits to Eligible
Employees whose employment with a Participating Employer terminates due to certain conditions
created by a Change in Control of the Company. The purpose of the Plan is to assure a continuity
in operations of the Company during a period of Change in Control by allowing employees to focus on
their responsibilities to the Company knowing that they have certain financial security in the
event of their termination of employment. The accomplishment of this purpose is in the best
interests of the Company and its shareholders. The Plan replaces the Change in Control Severance
Pay Plan for Select Employees that was originally adopted by the Board on March 1, 1995, and shall
become operative immediately upon the expiration of such plan with respect to a Change in Control
occurring on or after March 1, 2007.
2. DEFINITIONS
The terms defined in this Section 2 shall have the meanings given below:
(a) Base Salary means an Eligible Employees gross annualized rate of base salary at the
time of any determination hereunder, before any deductions, exclusions or any deferrals or
contributions under any Participating Employer plan or program, but excluding bonuses, incentive
awards or compensation, employee benefits or any other non-salary form of compensation.
(b) Board means the Board of Directors of the Company.
(c) Change in Control has the meaning given in Section 3.
(d) Code means the Internal Revenue Code of 1986, as amended.
(e) Committee means the Compensation Committee of the Board, or such other committee
appointed by the Board to perform the functions of the Committee under the Plan, provided that at
all times the Committee shall be constituted solely of directors who are Continuing Directors (as
defined in Section 3) to the extent any such directors remain on the Board and are willing to serve
in such capacity.
(f) Covered Termination has the meaning given in Section 6.
(g) Company means Eli Lilly and Company, an Indiana corporation.
(h) Eligible Employee means a Tier I Employee or a Tier II Employee.
(i) ERISA means the Employee Retirement Income Security Act of 1974, as amended.
(j) Exchange Act means the Securities Exchange Act of 1934, as amended.
(k) Participating Employer has the meaning given in Section 4.
(l) Plan means this Eli Lilly and Company 2007 Change in Control Severance Pay Plan for
Select Employees.
(m) Retirement Age means the date the Eligible Employee reaches age 65, unless the Companys
senior most officer responsible for the Human Resources department has approved a later date as the
Retirement Age for the Eligible Employee.
(n) Severance Period means the two (2) year period immediately following a Covered
Termination.
3. CHANGE IN CONTROL
For purposes of the Plan, a Change in Control of the Company shall be deemed to have occurred
upon:
(a) the acquisition by any person, as that term is used in Sections 13(d) and 14(d) of the
Exchange Act (other than (i) the Company, (ii) any subsidiary of the Company, (iii) any employee
benefit plan or employee stock plan of the Company or a subsidiary of the Company or any trustee or
fiduciary with respect to any such plan when acting in that capacity, or (iv) Lilly Endowment,
Inc.) of beneficial ownership, as defined in Rule 13d-3 under the Exchange Act, directly or
indirectly, of 15% or more of the shares of the Companys capital stock the holders of which have
general voting power under ordinary circumstances to elect at least a majority of the Board (or
which would have such voting power but for the application of the Indiana Control Shares Statute)
(Voting Stock); provided, however, that an acquisition of Voting Stock directly
from the Company shall not constitute a Change in Control under this Section 3(a);
(b) the first day on which less than two-thirds of the total membership of the Board shall be
Continuing Directors (as that term is defined in Article 13(f) of the Companys Articles of
Incorporation);
(c) consummation of a merger, share exchange, or consolidation of the Company (a
Transaction), other than a Transaction which would result in the Voting Stock of the Company
outstanding immediately prior thereto continuing to represent (either by remaining outstanding or
by being converted into voting securities of the surviving entity) more than 60% of the Voting
Stock of the Company or such surviving entity immediately after such Transaction;
2
(d) a complete liquidation of the Company or a sale or disposition of all or substantially all
the assets of the Company, other than a sale or disposition of assets to any subsidiary of the
Company;
(e) either (i) the Company shall have entered into a definitive agreement with any Person,
which, if consummated, would result in a Change in Control as specified in paragraphs (a) through
(d) of this Section 3 or (ii) any Person initiates a tender offer or exchange offer to acquire
shares of the Voting Stock which, if consummated, would result in a Change in Control as specified
in paragraphs (a) through (d) of this Section 3; provided, however, that if the
Board shall make a final determination that such agreement, tender offer or exchange offer will not
be consummated, the occurrence of any such event shall cease to constitute a Change in Control and
the termination of employment of an Eligible Employee after such determination shall not be treated
as a Covered Termination on the basis of such event; or
(f) the Board adopts a resolution to the effect that any Person has taken actions which, if
consummated, would result in its having acquired effective control of the business and affairs of
the Company; provided, however, that if the Board shall make a final determination
that such actions will not be consummated, the occurrence of any such event shall cease to
constitute a Change in Control and the termination of employment of an Eligible Employee after such
determination shall not be treated as a Covered Termination on the basis of such event.
For purposes of this Section 3 only, the term subsidiary means a corporation or limited liability
company of which the Company owns directly or indirectly fifty (50) percent or more of the voting
power.
4. PARTICIPATING EMPLOYERS
A. Designation of Participating Employers. The Company and each subsidiary corporation of which
the Company owns directly or indirectly one-hundred (100) percent of the voting power at the time
of the Change in Control shall be Participating Employers under the Plan. In addition, the
Committee may designate other affiliates of the Company as Participating Employers under the Plan,
from time to time and under such terms and conditions, as shall be specified by an action in
writing by the Committee. Such terms and conditions may impose limitations on the extent to which
any such affiliate participates in the Plan (including but not limited to the duration of any such
participation), but shall not provide rights or benefits to Eligible Employees that are broader
than those set forth in the Plan. Any entity that is a Participating Employer at the time of a
Change in Control shall continue to be a Participating Employer following a Change in Control, and
any person, firm or business that is a successor to the business or interests of a Participating
Employer following a Change in Control shall be treated as a Participating Employer under the Plan.
B. Limitations in Foreign Jurisdictions. Notwithstanding the foregoing or anything elsewhere in
the Plan to the contrary, the Committee shall have the discretionary authority, as specified below,
to exclude from participation or limit the participation of any Participating Employer with respect
to individuals employed outside of the United States. The Committee shall exercise this authority
only by an action in writing taken prior to a Change in Control on the basis of a good faith
determination that, as a result of the specific effect of applicable local law or practice
3
with respect to the Plan or severance benefits generally, it would be in the best interests of the
Company to so exclude or limit such participation. In addition, to the extent specified by an
action in writing prior to a Change in Control, the Committee may offset the benefits provided
under the Plan to any such Eligible Employee by benefits under severance arrangements that exist by
reason of applicable local law or practice.
5. ELIGIBLE EMPLOYEES
All employees of the Participating Employers, including executive officers (as defined in Rule 3b-7
under the Exchange Act), who are classified by the Company as G-6 level (Executive Director) or
above (or any successor classifications) immediately prior to the Change in Control shall be
eligible to participate in the Plan and shall be considered an Eligible Employee for all purposes
hereunder. Any person who is an Eligible Employee in accordance with the foregoing shall continue
to be an Eligible Employee notwithstanding any change in his/her position or classification
following a Change in Control, subject to Section 6 hereof relating to certain terminations of
employment. The Committee shall notify each Eligible Employee of his/her participation in the Plan
prior to the Change in Control.
6. COVERED TERMINATIONS
A. General. An Eligible Employee shall be treated as having suffered a Covered Termination
hereunder if his/her employment is terminated, within a period of two (2) years immediately
following the date of a Change in Control, by a Participating Employer other than for Cause or by
the Eligible Employee for Good Reason.
For purposes of the foregoing, the two (2) year time period specified above within which a
termination of employment may be treated as a Covered Termination shall commence on the date the
Change in Control becomes effective and, with respect to a Change in Control under paragraphs (e)
and (f) of Section 3, shall recommence (for the full applicable period) on the date of consummation
of the underlying actions. For purposes of the Plan, a termination of employment shall be
effective as of the last date of the Eligible Employees employment with the Participating
Employer.
An Eligible Employee shall not be treated as having suffered a Covered Termination in the event of
(1) death, (2) total disability (within the meaning of the Companys Extended Disability Plan), (3)
transfer of employment among Participating Employers (unless such transfer gives rise to a Good
Reason), (4) involuntary termination by the Participating Employer for Cause, (5) voluntary
termination by the Eligible Employee other than for Good Reason, (6) a termination of employment
for any reason by either the Participating Employer or the Eligible Employee that does not occur
during the time periods specified above or (7) a termination of employment for any reason by either
the Participating Employer or the Eligible Employee after the Eligible Employee reaches Retirement
Age.
B. Termination For Cause. For purposes hereof, the termination of an Eligible Employees
employment shall be deemed to be a termination for Cause if as a result of:
4
(i) the willful refusal of the Eligible Employee to perform, without legal cause, his/her
material duties to the Participating Employer, resulting in demonstrable economic harm to any
Participating Employer, which the Eligible Employee has failed to cure after thirty (30) calendar
days advance written notice from the Company;
(ii) any act of fraud, dishonesty or gross misconduct of the Eligible Employee resulting in
significant economic harm to any Participating Employer or other significant harm to the business
reputation of any Participating Employer; or
(iii) the conviction of the Eligible Employee by a court of competent jurisdiction of any
crime (or the entering of a plea of guilty or nolo contendere to a charge of any
crime) constituting a felony.
A termination for Cause shall be communicated to the Eligible Employee in writing by the
Participating Employer and shall specify the provisions of the Plan and factual matters relied upon
in making the Cause determination.
C. Termination for Good Reason. For purposes hereof, an Eligible Employee may terminate his/her
employment for Good Reason as a result of:
(i) a material diminution in the nature or status of the Eligible Employees position, title,
reporting relationship, duties, responsibilities or authority, or the assignment to him/her of
additional responsibilities that materially increase his/her workload;
(ii) any reduction in the Eligible Employees then-current Base Salary;
(iii) a material reduction in the Eligible Employees opportunities to earn incentive bonuses
below those in effect for the year most recently completed before the date of the Change in
Control, taking into account all material bonus factors such as targeted bonus amounts and
corporate performance measures;
(iv) a material reduction in the Eligible Employees employee benefits and coverages
(including, without limitation, pension, profit sharing and all welfare, retiree welfare and fringe
benefits) that are provided to the Eligible Employee from the benefit levels in effect immediately
prior to the Change in Control;
(v) the failure to grant to the Eligible Employee stock options, stock units, performance
shares or similar incentive rights during each twelve (12) month period following the Change in
Control on the basis of a number of shares or units and all other material terms (including vesting
requirements) at least as favorable to the Eligible Employee as those rights granted to him/her on
an annualized average basis for the three (3) year period immediately prior to the Change in
Control;
(vi) relocation of the Eligible Employee by more than fifty (50) miles from his/her regularly
assigned workplace existing immediately prior to the date of the Change in Control; or
5
(vii) any failure by a successor entity to the Company (including any entity that succeeds to
the business or assets of the Company) in connection with a Change in Control to assume by
operation of law or otherwise the obligations of the Company under the Plan, or any attempted
amendment, termination or repudiation of the Plan by such successor entity, other that pursuant to
the provisions of Section 15.
For purposes of the foregoing, but without limitation of the Eligible Employees right to otherwise
terminate employment for Good Reason, if the Eligible Employee is in charge of a principal business
unit, division or function of the Company immediately prior to a Change in Control, Good Reason
shall not be deemed to exist based solely on the fact that the Eligible Employee is not in charge
of such principal business unit, division or function of the combined entity following the Change
in Control, unless as a result thereof, the Eligible Employee suffers a material diminution in the
nature or status of the Eligible Employees position, title, reporting relationship, duties,
responsibilities or authority or suffers some other Good Reason event.
A termination for Good Reason shall be communicated to the Participating Employer in writing
by the Eligible Employee within thirty (30) days following his/her knowledge of the circumstances
constituting Good Reason, and shall specify the provisions of the Plan and the factual matters
relied upon in making the Good Reason determination. The Participating Employer shall have the
opportunity to cure the circumstances constituting Good Reason within 15 days following receipt of
such written notice from the Eligible Employee, and if such circumstances are fully cured, such
circumstances shall cease to constitute the basis for a Good Reason termination hereunder.
7. SEVERANCE PAYMENT
The amount of the severance payment to be received by an Eligible Employee whose employment is
terminated under conditions constituting a Covered Termination shall equal two (2) times the sum
of:
(i) the Eligible Employees Base Salary at the time of Covered Termination (calculated without
regard to any reduction in Base Salary that results in a Good Reason termination) or, if greater,
at the time of the Change in Control, plus
(ii) the greater of (a) the amount of the Eligible Employees target annual cash incentive
bonus for the year of Covered Termination or (b) the amount of the Eligible Employees annual cash
incentive bonus earned for the year immediately prior to the Change in Control.
The severance payment to be made hereunder shall be paid to the Eligible Employee in a single
lump-sum cash payment, less any required tax withholding, within thirty (30) calendar days after
the date of the Eligible Employees Covered Termination. Any payment required under this Section 7
or any other provision of the Plan that is not made in a timely manner shall bear interest at a
rate equal to one hundred twenty (120) percent of the monthly compounded applicable federal rate,
as in effect under Section 1274(d) of the Code for the month in which the payment is required to be
made.
6
8. OTHER SEVERANCE BENEFITS
In addition to the severance payment provided under Section 7, an Eligible Employee shall be
entitled to the following benefits and other rights in the event of his/her Covered Termination:
A. Welfare Benefits. The Eligible Employee shall be entitled to continued coverage and benefits
for the duration of the Severance Period under the Participating Employers medical and dental
plans, group life insurance plans, company-provided death benefit, supplemental life insurance and
long-term disability plans for which he/she was eligible at the time of Covered Termination (or, if
it would provide benefits or other terms more favorable to the Eligible Employee, at the time of
the Change in Control), as though his/her termination of employment had not occurred (the Welfare
Continuation Coverages). All Welfare Continuation Coverages shall apply to the Eligible Employee
and any of his/her dependents who would have been eligible for coverage if the Eligible Employee
remained employed for the Severance Period. The Company may provide the Eligible Employee with the
Welfare Continuation Coverages under arrangements other than its generally applicable welfare
benefit plans, provided that the benefit coverages so provided are at least as favorable to the
Eligible Employee as coverage under the otherwise applicable Welfare Continuation Coverages, on a
coverage by coverage basis, and taking into account all tax consequences to the Eligible Employee.
At the expiration of the Severance Period, the Eligible Employee shall be treated as a then
terminating employee with respect to the right to elect continued medical and dental coverages in
accordance with Section 4980B of the Code (or any successor provision thereto).
B. Retiree Welfare Benefits. For purposes of determining eligibility for the retiree medical and
dental plans applicable to Eligible Employee (the Retiree Welfare Plans), the Eligible Employee
shall receive additional credit for the number of years equal to the Severance Period for purposes
of both age and service requirements under the Retiree Welfare Plans, but not beyond the Retirement
Age of the Eligible Employee. If an Eligible Employee shall be eligible for participation in the
Retiree Welfare Plans at the time of Covered Termination (including by reason of this Section
8.B.), then (i) for the Severance Period, he/she shall be entitled to continue to participate in
either the Retiree Welfare Plans or the Welfare Continuation Coverage pursuant to Section 8.A.
hereof, whichever provides greater benefits to the Eligible Employee on a coverage by coverage
basis, and (ii) following the Severance Period, he/she shall be entitled to continue to participate
in the retiree welfare benefit program provided to retired employees of the Participating Employer
generally, or if no such program is provided, the program of the successor entity following the
Change in Control, if any.
C. Pension Supplement. The Eligible Employee shall be entitled to the additional pension benefits
that would be payable to him/her, under all defined benefit pension plans of a Participating
Employer in which he/she is participating at the time of Covered Termination (or, if it would
provide benefits or other terms more favorable to the Eligible Employee, at the time of the Change
in Control), including all such tax-qualified and supplemental plans, by taking into account under
such plans (i) an additional number of years equal to the Severance Period for purposes of the age
and service credit of the Eligible Employee under such plans and (ii) the amount of the severance
payment to which the Eligible Employee is entitled under Section 7, expressed on an annualized
basis for the number of years equal to the Severance Period, for purposes of the compensation
credit
7
of the Eligible Employee under such plans (but only to the extent such additional credit would
produce a higher benefit for the Eligible Employee than if it were not taken into account). The
additional pension benefits provided hereby shall be paid pursuant to a supplemental pension plan
of the Company, at the same time and in the same form as pension benefits are otherwise payable to
the Eligible Employee (subject to clause (iii) of Section 8.E). Notwithstanding the foregoing, the
Eligible Employee will only receive additional age, service and compensation credit hereunder until
his/her Retirement Age.
D. Equity Incentives. Immediately upon a Covered Termination, (i) any stock options, or similar
equity-based incentive rights granted to the Eligible Employee under a stock incentive plan of a
Participating Employer that are not then fully vested and exercisable shall become fully vested and
immediately exercisable, (ii) the Eligible Employee shall be entitled to exercise any stock options
or similar equity-based incentive rights until the expiration of three years following the date of
the Covered Termination (or until such later date as may be applicable under the terms of the
option or other right upon termination of employment), subject to the maximum full term of the
option but without regard to any earlier termination otherwise applicable in the event of
termination of employment, and (iii) any performance shares, stock units or shares of restricted
stock granted to the Eligible Employee under a stock incentive plan of a Participating Employer
that remain subject to forfeiture, performance conditions or transfer restrictions at such time
shall become fully and immediately vested and all such conditions and restrictions shall
immediately lapse. In addition, as to any other types of equity-based incentive awards granted to
the Eligible Employee under a stock incentive plan of a Participating Employer prior to the date of
Covered Termination, any restrictions on exercise, payment or transfer shall immediately lapse, and
the Eligible Employee shall have all rights associated with such awards as of the date of Covered
Termination. The provisions of this Section 8.D shall apply equally to any awards or rights into
which the equity incentive rights described herein are converted or for which such rights are
substituted in connection with a Change in Control.
E. Accrued Rights. The Eligible Employee shall be entitled to the following payments and benefits
in respect of accrued compensation rights at the time of a Covered Termination, in addition to all
other rights provided under the Plan: (i) immediate payment of any accrued but unpaid Base Salary
through the date of Covered Termination; (ii) payment within fifteen (15) calendar days of Covered
Termination of the accrued annual cash bonus for the year in effect on the date of the Covered
Termination, determined on the basis of the bonus earned under terms of the applicable bonus plan
through the date of termination or, if greater, the pro-rata amount of the target annual cash bonus
for the period of such year through the date of termination; (iii) payment within fifteen (15)
calendar days of Covered Termination of all non-tax-qualified deferred compensation rights, in lieu
of payment in respect of such rights that would otherwise be made at a later date in accordance
with the terms of such arrangements, except to the extent such rights are funded by amounts held
under an irrevocable grantor trust or other irrevocable commitment of funds by the Company; and
(iv) all benefits and rights accrued under the employee benefit plans, fringe benefit programs and
payroll practices of a Participating Employer (other than those described in clause (iii) above) in
accordance with their terms (including, without limitation, employee pension, employee welfare,
incentive bonus and stock incentive plans).
8
F. Outplacement; Relocation. The Eligible Employee shall be provided, at the Companys sole
expense, with professional outplacement services selected by the Eligible Employee consistent with
his/her duties or profession and of a type and level customary for persons in his/her position;
provided, however, that the Company shall not be required to pay fees in connection
with the foregoing in an amount greater than fifteen (15) percent of the Eligible Employees Base
Salary for purposes of clause (i) of Section 7. The Company shall honor any prior agreement or
understanding with an Eligible Employee who has suffered a Covered Termination to reimburse his/her
relocation expenses to the Indianapolis, Indiana metropolitan area or, if it does not result in a
greater cost to the Company, to such other location selected by the Eligible Employee.
G. Indemnification. With respect to any Eligible Employee who is, immediately prior to a Change in
Control or a Covered Termination, indemnified by the Company for his/her service as a director,
officer or employee of a Participating Employer, the Company shall indemnify such Eligible Employee
to the fullest extent permitted by applicable law, and the Company shall maintain in full force and
effect, for the duration of all applicable statute of limitation periods, insurance policies at
least as favorable to the Eligible Employee as those maintained by the Company for the benefit of
its directors and officers at the time of Change in Control, provided that such insurance policies
are commercially available from carriers of recognized standing, with respect to all costs, charges
and expenses whatsoever (including payment of expenses in advance of final disposition of a
proceeding) incurred or sustained by the Eligible Employee in connection with any action, suit or
proceeding to which he/she may be made a party by reason of being or having been a director,
officer or employee of a Participating Employer or serving or having served any other enterprise as
a director, officer or employee at the request of a Participating Employer.
H. Retention Bonuses and Loans. Immediately upon a Covered Termination, there shall automatically
be forgiven any repayment obligation of the Eligible Employee to the Participating Employer that
arises under any retention bonus agreement, forgivable loan or similar arrangement that provides
for the lapse of the Eligible Employees repayment obligation over time based on continued
employment or other conditions (but not under any other loan obligations of the Eligible Employee
that do not include forgiveness provisions).
9. EXCISE TAX REIMBURSEMENT
(a) In the event it shall be determined that any payment, right or distribution by the Company
or any other person or entity to or for the benefit of an Eligible Employee pursuant to the terms
of this Plan or otherwise, in connection with, or arising out of, his/her employment with a
Participating Employer or a change in ownership or effective control of the Company or a
substantial portion of its assets (a Payment) is a parachute payment within the meaning of
Section 280G of the Code on account of the aggregate value of the Payments due to the Eligible
Employee being equal to or greater than three times the base amount, as defined in Section
280G(b)(3) of the Code, (the Parachute Threshold) so that the Eligible Employee would be subject
to the excise tax imposed by Section 4999 of the Code (the Excise Tax), concurrent with the
making of such Payment, then (i) in the event the aggregate value of the Payments exceeds the
Parachute Threshold by less than 3%, one or more Payments shall be reduced so that the aggregate
value of the Payments is $1.00 less than the Threshold Amount, or (ii) in the event that the
aggregate value of the Payments exceeds the Parachute Threshold by 3% or more, the Company
9
shall pay to the Eligible Employee an additional payment (the Gross-Up Payment) in an amount
such that the net amount retained by the Eligible Employee, after deduction of any Excise Tax on
such Payments and any federal, state or local income tax and Excise Tax on the Gross-Up Payment
shall equal the amount of such Payments. In the event the Internal Revenue Service subsequently
may assess or seek to assess from the Eligible Employee an amount of Excise Tax in excess of that
determined in accordance with the foregoing, the Company shall pay to the Eligible Employee an
additional Gross-Up Payment, calculated as described above in respect of such excess Excise Tax,
including a Gross-Up Payment in respect of any interest or penalties imposed by the Internal
Revenue Service with respect to such excess Excise Tax. The rights of the Eligible Employee to a
Gross-Up Payment under this Section 9 shall apply without regard to whether the Eligible Employee
has incurred a Covered Termination and shall apply to all payments whether or not in connection
with a Covered Termination.
(b) All determinations required to be made under this Section 9, including whether any Payment
is a parachute payment and whether and when a Gross-Up Payment is required and the amount of such
Gross-Up Payment and the assumptions to be utilized in arriving at such determination, shall be
made by a nationally recognized accounting firm designated by the Company which is not the auditor
of the Company or another party involved in the Change in Control (the Accounting Firm) and shall
be based upon substantial authority (within the meaning of Section 6662 of the Code). The
Accounting Firm shall provide detailed supporting calculations both to the Company and the Eligible
Employee within 15 business days of the receipt of notice from the Company or an Eligible Employee
that there has been a Payment, or such earlier time as is requested by the Company. All fees and
expenses of the Accounting Firm shall be borne by the Company. Any Gross-Up Payment, as determined
pursuant to this Section 9, shall be paid by the Company to the Eligible Employee within five
business days of the receipt of the Accounting Firms determination. Any determination by the
Accounting Firm shall be binding upon the Company and the Eligible Employee.
10. RELEASE OF CLAIMS
All payments and benefits that may be made to an Eligible Employee upon a Covered Termination under
the Plan shall be contingent upon the Eligible Employee entering into a general release of
employment law claims against the Company in substantially the form attached hereto as Exhibit A,
subject to such modifications as may be determined by the Committee in good faith to take into
account changes in employment laws or differences in employment laws in other jurisdictions.
11. NO MITIGATION OR OFFSET
The Eligible Employee shall be under no obligation to minimize or mitigate damages by seeking other
employment, and the obtaining of any such other employment shall in no event effect any reduction
of the Companys obligation to make the payments and provide the benefits required under the Plan.
Except as provided in Section 10, the Companys obligation to make the payments and provide the
benefits required under the Plan shall not be affected by any circumstances, including, without
limitation, any set-off, counterclaim, recoupment, defense or other rights which a Participating
Employer may have against the Eligible Employee.
10
12. UNFUNDED STATUS
The Plan is intended to constitute an employee pension benefit plan under ERISA which is unfunded
and is maintained primarily for the purpose of providing deferred compensation for a select group
of management or highly compensated employees, and shall be interpreted and administered
accordingly. The payments and benefits provided hereunder shall be paid from the general assets of
the Company. Nothing herein shall be construed to require the Company to maintain any fund or to
segregate any amount for the benefit of any employee, and no employee or other person shall have
any right against, right to, or security or other interest in any fund, account or asset of the
Company from which the payment pursuant to the Plan may be made. Consistent with the foregoing,
the Company may, in its sole discretion, deposit funds in a grantor trust or otherwise establish
arrangements to pay amounts that become due under the Plan, and, notwithstanding anything elsewhere
in the Plan to the contrary, the payments and benefits due under the Plan shall be reduced to
reflect the amount of any payment made in respect of any Eligible Employee from a grantor trust or
other arrangement established for this purpose.
13. ADMINISTRATION
The Committee shall be the named fiduciary of the Plan and the plan administrator for purposes of
ERISA. The Committee shall be responsible for the overall operation of the Plan and shall have the
fiduciary responsibility for the general operation of the Plan. The Committee may allocate to any
one or more of the Companys employees any responsibility the Committee may have under the Plan and
may designate any other person or persons to carry out any of the Committees responsibilities
under the Plan. As plan administrator, the Committee shall maintain records pursuant to the Plans
provisions and shall be responsible for the handling, processing and payment of any claims for
benefits under the Plan.
14. CLAIMS AND DISPUTES
Within fifteen (15) calendar days following a Covered Termination, the Company shall notify each
Eligible Employee whom the Company determines is entitled to payments and benefits under the Plan
of his/her entitlement to such payments and benefits. An Eligible Employee who is not so notified
may submit a claim for payments and benefits under the Plan in writing to the Company within ninety
(90) calendar days after becoming entitled to such benefits as described in Section 6. All such
claims shall be approved or denied in writing by the Company within fifteen (15) calendar days
after submission.
11
Any denial of a claim by the Company shall be in writing and shall include: (i) the reason or
reasons for the denial; (ii) reference to the pertinent Plan provisions on which the denial is
based; (iii) a description of any additional material or information necessary for the Eligible
Employee to perfect the claim together with an explanation of why the material or information is
necessary; and (iv) an explanation of the Plans claim review procedure, described below.
An Eligible Employee shall have a reasonable opportunity to appeal a denied claim to the Company
for a full and fair review. The Eligible Employee or authorized representative shall have sixty
(60) calendar days after receipt of written notification of the denial of claim in which to request
a review and to review pertinent documents of the Plan. The Company shall notify the Eligible
Employee or his/her authorized representative of the time and place for the claim review. The
Company shall issue a decision on the reviewed claim promptly, but no later than fifteen (15)
calendar days after receipt of the request for review. The Companys decision shall be in writing
and shall include: (i) the reasons for the decision, and (ii) references to the Plan provisions on
which the decision is based.
If the Eligible Employee shall dispute the Companys final decision, the dispute shall be submitted
to an arbitration proceeding, conducted before a panel of three arbitrators, in accordance with the
rules of the Center for Public Resources (or such other organization selected by mutual agreement
of the Company and the Eligible Employee). Such arbitration shall take place in the location most
practicably proximate to the Eligible Employees principal workplace. Judgment may be entered on
the arbitrators award in any court having jurisdiction. Notwithstanding the foregoing, if an
Eligible Employee believes the claims procedure or dispute resolution mechanism provided under this
Section 14 would be futile or would cause such Eligible Employee irreparable harm, the Eligible
Employee may, in his/her sole discretion, elect to enforce his/her rights under the Plan pursuant
to Section 502 of ERISA.
The Company shall bear the expense of any enforcement proceeding brought by an Eligible Employee
under the Plan and shall reimburse the Eligible Employee for all of his/her reasonable costs and
expenses relating to such enforcement proceeding, including, without limitation, reasonable
attorneys fees and expenses, provided that the Eligible Employee is the prevailing party in such
proceeding. For purposes hereof, the trier of fact in such enforcement proceeding shall be
requested to make a determination as to the reimbursement of the Eligible Employees costs and
expenses as a prevailing party hereunder. In no event shall the Eligible Employee be required to
reimburse the Company for any of the costs or expenses relating to such enforcement proceeding.
15. TERM AND AMENDMENT
The Plan shall become effective as on July 1, 2004, but shall only be operative with respect to a
Change in Control occurring on or after March 1, 2007, the date as of which the Plan as previously
in effect shall have been terminated by action of the Board. The Plan shall continue to be
effective until terminated in accordance with this Section 15. The Board shall have the right, by
resolution or other written action, to terminate or amend the Plan; provided,
however, that the Plan
12
may only be terminated or amended prior to a Change in Control, and then only (i) with respect to
an amendment or termination that becomes effective upon the second (2nd) anniversary of notice
being given thereof to Eligible Employees generally, or (ii) to the extent any such amendment is of
a technical or clarifying nature, or increases the rights or benefits of all affected Eligible
Employees, and does not in any manner reduce the rights or benefits of any Eligible Employee,
unless the Company has obtained the express written consent, in return for good and valuable
consideration, of all affected Eligible Employees in respect of any such amendment. Notwithstanding
the foregoing, in the event of a Change in Control, the Plan shall continue in effect, and no
termination or amendment of the Plan shall occur, until the satisfaction of all severance payments
and benefits to which Eligible Employees are or may become entitled to under the Plan. Upon the
occurrence of a Change in Control during the term of the Plan, the Plan shall not be operative with
respect to any subsequent Change in Control.
16. SUCCESSORS AND ASSIGNS
The Plan shall be binding upon any person, firm or business that is a successor to the business or
interests of the Company, whether as a result of a Change in Control of the Company or otherwise.
Any successor to the Company shall be required to assume the Plan in writing and honor the
obligations of the Company and the Participating Employers hereunder. All payments and benefits
that become due to an Eligible Employee under the Plan shall inure to the benefit of his/her heirs,
assigns, designees or legal representatives.
17. ENFORCEABILITY
The Company intends the Plan to constitute a legally enforceable obligation between it and each
Eligible Employee, and that the Plan confer vested rights on each Eligible Employee in accordance
with the terms of the Plan, with each Eligible Employee being a third-party beneficiary thereof.
Nothing in the Plan, however, shall be construed to confer on any Eligible Employee any right to
continue in the employ of a Participating Employer or affect the right of a Participating Employer
to terminate the employment or change the terms and conditions of employment of an Eligible
Employee, with or without notice or cause, prior to a Change in Control, or to take any such action
following a Change in Control, subject to the consequences specified by the Plan.
The Plan shall be construed and enforced in accordance with ERISA and the laws of the State of
Indiana to the extent not preempted by ERISA, regardless of the law that might otherwise govern
under applicable principles or provisions of choice or conflict of law doctrines. To the extent
any provision of the Plan shall be invalid or unenforceable under any applicable law, it shall be
considered deleted herefrom and all other provisions of the Plan shall be unaffected and shall
continue in full force and effect.
13
exv11
EXHIBIT 11. STATEMENT RE: COMPUTATION OF EARNINGS PER SHARE
(Unaudited)
Eli Lilly and Company and Subsidiaries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
|
|
(Dollars and shares in millions except per-share data) |
|
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
873.6 |
|
|
$ |
794.4 |
|
|
$ |
2,530.4 |
|
|
$ |
1,279.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of common shares outstanding |
|
|
1,085.2 |
|
|
|
1,088.6 |
|
|
|
1,085.0 |
|
|
|
1,087.6 |
|
Contingently issuable shares |
|
|
.4 |
|
|
|
.3 |
|
|
|
.4 |
|
|
|
.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted average shares |
|
|
1,085.6 |
|
|
|
1,088.9 |
|
|
|
1,085.4 |
|
|
|
1,087.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
.80 |
|
|
$ |
.73 |
|
|
$ |
2.33 |
|
|
$ |
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
873.6 |
|
|
$ |
794.4 |
|
|
$ |
2,530.4 |
|
|
$ |
1,279.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average number of common shares outstanding |
|
|
1,085.2 |
|
|
|
1,088.6 |
|
|
|
1,085.0 |
|
|
|
1,087.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incremental shares stock options and
contingently issuable shares |
|
|
1.2 |
|
|
|
2.8 |
|
|
|
1.4 |
|
|
|
3.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted average shares |
|
|
1,086.4 |
|
|
|
1,091.4 |
|
|
|
1,086.4 |
|
|
|
1,091.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share |
|
$ |
.80 |
|
|
$ |
.73 |
|
|
$ |
2.33 |
|
|
$ |
1.17 |
|
|
|
|
exv12
EXHIBIT 12. STATEMENT RE: COMPUTATION OF RATIO OF EARNINGS TO FIXED CHARGES
(Unaudited)
Eli Lilly and Company and Subsidiaries
(Dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
|
|
|
Ended |
|
|
|
|
September 30, |
|
Years Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
2001 |
|
|
|
Consolidated pretax
income before cumulative
effect of a change in
accounting principle |
|
$ |
3,203.0 |
|
|
$ |
2,717.5 |
|
|
$ |
2,941.9 |
|
|
$ |
3,261.7 |
|
|
$ |
3,457.7 |
|
|
$ |
3,506.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
|
273.1 |
|
|
|
245.7 |
|
|
|
162.9 |
|
|
|
121.9 |
|
|
|
140.0 |
|
|
|
253.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less interest capitalized
during the period |
|
|
(79.6 |
) |
|
|
(140.5 |
) |
|
|
(111.3 |
) |
|
|
(60.9 |
) |
|
|
(60.3 |
) |
|
|
(61.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings |
|
$ |
3,396.5 |
|
|
$ |
2,822.7 |
|
|
$ |
2,993.5 |
|
|
$ |
3,322.7 |
|
|
$ |
3,537.4 |
|
|
$ |
3,698.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed charges |
|
$ |
273.1 |
|
|
$ |
245.7 |
|
|
$ |
162.9 |
|
|
$ |
121.9 |
|
|
$ |
140.0 |
|
|
$ |
253.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ratio of earnings to
fixed charges |
|
|
12.4 |
|
|
|
11.5 |
|
|
|
18.4 |
|
|
|
27.3 |
|
|
|
25.3 |
|
|
|
14.6 |
|
|
|
|
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. |
|
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): |
|
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: November 1, 2006 |
|
|
|
|
|
|
|
By:
|
|
/s/Sidney Taurel
|
|
|
|
|
Sidney Taurel |
|
|
|
|
Chairman of the Board
and Chief Executive Officer |
|
|
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; |
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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 |
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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) |
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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) |
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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. |
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Date: November 1, 2006 |
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By:
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/s/Derica W. Rice
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Derica W. Rice |
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Senior Vice President
and Chief Financial Officer |
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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 September 30, 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.
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Date November 1, 2006 |
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/s/Sidney Taurel
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Sidney Taurel |
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Chairman of the Board and
Chief Executive Officer |
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Date November 1, 2006 |
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/s/Derica W. Rice
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Derica W. Rice |
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Senior Vice President and
Chief Financial Officer |
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