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, 2008~~MARCH 31, 2009

COMMISSION FILE NUMBER 001-6351

ELI LILLY AND COMPANY

(Exact name of Registrant as specified in its charter)


INDIANA (State or other jurisdiction of incorporation or organization)		35-0470950 (I.R.S. Employer Identification No.)

LILLY CORPORATE CENTER, INDIANAPOLIS, INDIANA 46285
(Address of principal executive offices)

Registrant’s 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.

Yesþ Noo

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer þ

Accelerated filer o

Non-accelerated filer o
(Do not check if a smaller reporting company)

Smaller reporting company o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yeso Noþ

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o

The number of shares of common stock outstanding as of ~~October~~April 20, ~~2008:~~2009:


Class		Number of Shares Outstanding
Common		~~1,136,953,333~~1,149,015,506

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CONSOLIDATED CONDENSED STATEMENTS OF INCOME ~~(LOSS)~~
(Unaudited)

Eli Lilly and Company and Subsidiaries

Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
(Dollars in millions except per-share data)
Net sales $ 5,209.5 $ 4,586.8 $ 15,167.5 $ 13,443.9

Cost of sales 1,155.2 1,054.6 3,467.4 2,976.0

Research and development 953.0 844.5 2,781.6 2,533.1
Marketing, selling, and administrative 1,649.2 1,477.8 4,899.8 4,339.3
Acquired in-process research and development (Note 3) 28.0 — 150.0 656.6
Asset impairments, restructuring, and other special charges (Note 4) 1,659.4 81.3 1,894.0 204.3
Other income — net (Note 12) (2.5 ) (49.8 ) (55.1 ) (89.9 )

5,442.3 3,408.4 13,137.7 10,619.4

Income (loss) before income taxes (232.8 ) 1,178.4 2,029.8 2,824.5
Income taxes (Note 9) 232.8 252.1 472.3 725.9

Net income (loss) $ (465.6 ) $ 926.3 $ 1,557.5 $ 2,098.6

Earnings (loss) per share — basic (Note 8) $ (.43 ) $ .85 $ 1.42 $ 1.93

Earnings (loss) per share — diluted (Note 8) $ (.43 ) $ .85 $ 1.42 $ 1.93

Dividends paid per share $ .47 $ .425 $ 1.41 $ 1.275


	Three Months Ended
	March 31,
	2009		2008
	(Dollars in millions, except
	per-share data)
Net product sales	$	4,891.8	$	4,709.4
Collaboration and other revenue (Note 4)		155.2		98.2

Total revenue		5,047.0		4,807.6

Cost of sales		816.4		1,111.3
Research and development		947.3		877.1
Marketing, selling, and administrative		1,529.2		1,550.5
Acquired in-process research and development (Note 3)		—		87.0
Asset impairments, restructuring, and other special charges (Note 5)		—		145.7
Other — net, expense (income) (Note 13)		70.7		(20.3	)

		3,363.6		3,751.3


Income before income taxes		1,683.4		1,056.3
Income taxes (Note 10)		370.3		(8.0	)

Net income	$	1,313.1	$	1,064.3


Earnings per share — basic and diluted (Note 9)	$	1.20	$	.97


Dividends paid per share	$	.49	$	.47

See Notes to Consolidated Condensed Financial Statements.

CONSOLIDATED CONDENSED BALANCE SHEETS
Eli Lilly and Company and Subsidiaries


	September 30,			December 31,
	2008			2007			March 31, 2009			December 31, 2008
	(Dollars in millions)						(Dollars in millions)
	(Unaudited)						(Unaudited)
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	4,353.6		$	3,220.5		$	3,313.1		$	5,496.7
Short-term investments (Note 5)		1,765.2			1,610.7
Accounts receivable, net of allowances of $99.2 (2008) and $103.1 (2007)		2,702.0			2,673.9
Short-term investments (Note 6)								195.2			429.4
Accounts receivable, net of allowances of $99.1 (2009) and $97.4 (2008)								2,676.4			2,778.8
Other receivables		557.0			1,030.9			483.5			498.5
Inventories		2,111.6			2,523.7			2,549.0			2,493.2
Deferred income taxes		631.4			642.8			391.2			382.1
Prepaid expenses		825.0			613.6			652.0			374.6

TOTAL CURRENT ASSETS		12,945.8			12,316.1			10,260.4			12,453.3

OTHER ASSETS
Prepaid pension (Note 10)		1,843.8			1,670.5
Investments (Note 5)		1,186.6			577.1
Investments (Note 6)								1,363.8			1,544.6
Goodwill and other intangibles — net (Note 3)		2,298.8			2,455.4			3,857.9			3,929.1
Sundry		1,170.0			1,280.6			2,664.5			2,659.3

		6,499.2			5,983.6			7,886.2			8,133.0

PROPERTY AND EQUIPMENT
Land, buildings, equipment, and construction-in-progress		14,895.6			14,841.3			14,943.0			15,315.9
Less allowances for depreciation		(6,633.5	)		(6,266.2	)		(6,492.8	)		(6,689.6	)

		8,262.1			8,575.1			8,450.2			8,626.3

	$	27,707.1		$	26,874.8		$	26,596.8		$	29,212.6


LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Short-term borrowings	$	426.5		$	413.7		$	1,602.8		$	5,846.3
Accounts payable		854.4			924.4			1,022.7			885.8
Employee compensation		662.5			823.8			472.4			771.0
Sales rebates and discounts		799.8			706.8			889.7			873.4
Dividends payable		—			513.6			—			536.8
Income taxes payable (Note 9)		403.7			238.4
Accrued marketing investigation charges (Note 11)		1,477.0			—
Income taxes payable								709.6			229.2
Other current liabilities		1,885.9			1,816.1			2,660.5			3,967.2

TOTAL CURRENT LIABILITIES		6,509.8			5,436.8			7,357.7			13,109.7

Long-term debt		4,185.6			4,593.5			6,870.8			4,615.7
Accrued retirement benefit (Note 10)		1,105.8			1,145.1
Long-term income taxes payable (Note 9)		930.8			1,196.7
Accrued retirement benefit (Note 11)								2,308.9			2,387.6
Long-term income taxes payable (Note 10)								942.8			906.2
Deferred income taxes		284.2			287.5			72.1			74.7
Other noncurrent liabilities		949.3			711.3			1,319.7			1,381.0

		7,455.7			7,934.1			11,514.3			9,365.2

SHAREHOLDERS’ EQUITY (Notes 6 and 7)
SHAREHOLDERS’ EQUITY (Notes 7 and 8)
Common stock		711.1			709.5			718.7			711.1
Additional paid-in capital		3,913.1			3,805.2			4,360.5			3,976.6
Retained earnings		12,336.3			11,806.7			8,967.9			7,654.9
Employee benefit trust		(2,635.0	)		(2,635.0	)		(3,013.2	)		(2,635.0	)
Deferred costs-ESOP		(88.8	)		(95.2	)		(84.1	)		(86.3	)
Accumulated other comprehensive income (loss)		(395.9	)		13.2
Accumulated other comprehensive loss								(3,130.3	)		(2,786.8	)
Noncontrolling interests								3.8			2.4

								7,823.3			6,836.9
		13,840.8			13,604.4
Less cost of common stock in treasury		99.2			100.5			98.5			99.2

		13,741.6			13,503.9			7,724.8			6,737.7

	$	27,707.1		$	26,874.8		$	26,596.8		$	29,212.6

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Eli Lilly and Company and Subsidiaries


	Nine Months Ended						Three Months Ended
	September 30,						March 31,
	2008			2007			2009			2008
							(Dollars in millions)
	(Dollars in millions)
CASH FLOWS FROM OPERATING ACTIVITIES
Net income	$	1,557.5		$	2,098.6		$	1,313.1		$	1,064.3
Adjustments to reconcile net income to cash flows from operating activities:
Changes in operating assets and liabilities, net of acquisitions		144.0			(621.5	)
Payments related to the Eastern District of Pennsylvania settlement (Note 12)								(1,063.1	)		—
Other changes in operating assets and liabilities, net of acquisitions								(672.0	)		70.2
Depreciation and amortization		842.3			773.1			306.3			277.5
Change in deferred taxes								129.1			111.9
Stock-based compensation expense		192.7			214.5			66.1			58.5
Change in deferred taxes		288.7			(283.1	)
Acquired in-process research and development, net of tax		107.3			634.7			—			56.6
Accrued marketing investigation charges, net of tax		1,456.3			—
Other, net		326.3			108.5			8.4			63.6


NET CASH PROVIDED BY OPERATING ACTIVITIES		4,915.1			2,924.8			87.9			1,702.6

CASH FLOWS FROM INVESTING ACTIVITIES
Net purchases of property and equipment		(671.5	)		(715.7	)		(157.0	)		(184.2	)
Net change in short-term investments		(237.3	)		(225.2	)		286.2			(715.7	)
Purchases of noncurrent investments		(1,295.4	)		(471.3	)		(67.7	)		(41.5	)
Proceeds from sales and maturities of noncurrent investments		653.5			924.7			184.8			36.0
Cash paid for acquisitions, net of cash acquired		(44.4	)		(2,667.5	)
Purchase of in-process research and development		(122.0	)		(25.0	)		—			(87.0	)
Other, net		(85.4	)		(84.0	)		(19.0	)		(41.6	)


NET CASH USED IN INVESTING ACTIVITIES		(1,802.5	)		(3,264.0	)
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES								227.3			(1,034.0	)

CASH FLOWS FROM FINANCING ACTIVITIES
Dividends paid		(1,541.5	)		(1,389.8	)		(536.8	)		(513.6	)
Net change in short-term borrowings								(4,243.6	)		(342.5	)
Proceeds from issuance of long-term debt		0.1			2,500.0			2,400.0			0.1
Repayment of long-term debt		(10.8	)		(1,057.7	)
Issuances of common stock under stock plans		—			21.6
Net change in short-term borrowings		(392.2	)		(432.1	)
Other, net		(6.8	)		3.8			—			(5.9	)


NET CASH USED IN FINANCING ACTIVITIES		(1,951.2	)		(354.2	)		(2,380.4	)		(861.9	)

Effect of exchange rate changes on cash and cash equivalents		(28.3	)		79.6			(118.4	)		118.2


NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS		1,133.1			(613.8	)
NET DECREASE IN CASH AND CASH EQUIVALENTS								(2,183.6	)		(75.1	)

Cash and cash equivalents at January 1		3,220.5			3,109.3			5,496.7			3,220.5


CASH AND CASH EQUIVALENTS AT SEPTEMBER 30	$	4,353.6		$	2,495.5
CASH AND CASH EQUIVALENTS AT MARCH 31							$	3,313.1		$	3,145.4

CONSOLIDATED CONDENSED STATEMENTS OF COMPREHENSIVE INCOME ~~(LOSS)~~
(Unaudited)

Eli Lilly and Company and Subsidiaries

Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007

(Dollars in millions)

Net income (loss) $ (465.6 ) $ 926.3 $ 1,557.5 $ 2,098.6
Other comprehensive income (loss)¹
(610.0 ) 374.4 (409.1 ) 621.1

Comprehensive income (loss) $ (1,075.6 ) $ 1,300.7 $ 1,148.4 $ 2,719.7


	Three Months Ended
	March 31,
	2009			2008
	(Dollars in millions)

Net income	$	1,313.1		$	1,064.3

Other comprehensive income (loss), net of tax¹		(343.5	)		193.8


Comprehensive income	$	969.6		$	1,258.1


¹		The significant ~~components~~component of other comprehensive income (loss) was a loss ~~were losses~~of $403.7 million from foreign currency translation adjustments ~~of $640.4 million and $376.7 million~~ for the three months ~~and nine months~~ ended ~~September 30, 2008, respectively. In addition, the other comprehensive loss for the nine months ended September 30, 2008 reflected unrealized losses on investment securities~~March 31, 2009, compared with a gain of ~~$103.4~~$259.9 million and reclassification adjustments of $58.1 million of other comprehensive income as a result of the amortization of unrecognized losses from our defined benefit plans into the income statement. The significant components of other comprehensive income were gains from foreign currency translation adjustments ~~of $304.3 million and $495.9 million~~ for the three months ~~and nine months~~ ended ~~September 30, 2007, respectively.~~March 31, 2008.

See Notes to Consolidated Condensed Financial Statements.

SEGMENT INFORMATION

We operate in one significant business segment — human pharmaceutical products. Operations of our animal health business segment are not material and share many of the same economic and operating characteristics as ~~our~~human pharmaceutical products. Therefore, they are included with pharmaceutical products for purposes of segment reporting. Our business segments are distinguished by the ultimate end user of the product: humans or animals. Performance is evaluated based on profit or loss from operations before income taxes. Income before income taxes for the animal health business for the first quarters of 2009 and 2008 was ~~$47.6~~$35.7 million and ~~$32.0~~$26.9 million, ~~for the quarters ended September 30, 2008 and 2007, respectively, and $102.9 million and $99.5 million for the nine months ended September 30, 2008 and 2007,~~ respectively.

~~SALES~~REVENUE BY ~~PRODUCT~~ CATEGORY

Worldwide ~~sales~~revenue by ~~product~~ category ~~were~~was as follows:


	Three Months Ended				Nine Months Ended				Three Months Ended
	September 30,				September 30,				March 31,
	2008		2007		2008		2007		2009		2008
									(Dollars in millions)
	(Dollars in millions)

Net sales — to unaffiliated customers
Net product sales — to unaffiliated customers:
Neurosciences	$	2,160.4	$	1,903.6	$	6,258.5	$	5,682.1	$	2,077.6	$	1,971.4
Endocrinology		1,483.2		1,363.7		4,412.3		3,990.1		1,326.2		1,316.0
Oncology		754.0		609.4		2,142.5		1,776.9		729.2		673.3
Cardiovascular		477.4		419.0		1,416.1		1,154.9		455.1		462.0
Animal health		277.1		236.6		766.9		666.4		264.1		235.3
Other pharmaceuticals		57.4		54.5		171.2		173.5		39.6		51.4

Net sales	$	5,209.5	$	4,586.8	$	15,167.5	$	13,443.9
Net product sales									$	4,891.8	$	4,709.4
Collaboration and other revenue										155.2		98.2

Total revenue									$	5,047.0	$	4,807.6

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS

Note 1: 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/A~~10-K for the year ended December 31, ~~2007.~~2008. Certain reclassifications have been made to the December 31, 2008 consolidated condensed financial statements to conform with the March 31, 2009 presentation.

Note 2: Implementation of New Financial Accounting Pronouncements

We adopted the provisions of Emerging Issues Task Force (EITF) Issue No. 07-3 (EITF 07-3), Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities, on January 1, 2008. Pursuant to EITF 07-3, nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities should be deferred and capitalized. Such amounts should be recognized as an expense when the related goods are delivered or services are performed, or when the goods or services are no longer expected to be received. This Issue is to be applied prospectively for contracts entered into on or after the effective date.

~~We adopted the provisions of~~ Financial Accounting Standards Board (FASB) Statement No. 157 (SFAS 157), Fair Value Measurements, on January 1, 2008. SFAS 157 defines fair value, establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value measurements. The implementation of this Statement was not material to our consolidated financial position or results of operations.

In March 2008, the FASB issued Statement No. 161, Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 (SFAS 161). SFAS 161 applies to all derivative instruments and related hedged items accounted for under FASB Statement No. 133, Accounting for Derivative Instruments and Hedging Activities. This Statement requires entities to provide enhanced disclosures about how and why an entity uses derivative instruments, how derivative instruments and related hedged items are accounted for under Statement 133 and its related interpretations, and how derivative instruments and related hedged items affect an entity’s financial position, results of operations, and cash flows. This Statement is effective for us January 1, 2009.

~~In December 2007, the FASB revised and issued Statement No.~~ 141, Business Combinations (SFAS 141(R))., is effective for us for business combinations for which the acquisition date is on or after January 1, 2009. SFAS 141(R) changes how the acquisition method is applied in accordance with SFAS 141. The primary revisions to this Statement require an acquirer in a business combination to measure assets acquired, liabilities assumed, and any noncontrolling interest in the acquiree at the acquisition date, at their fair values as of that date, with limited exceptions specified in the Statement. This Statement also requires the acquirer in a business combination achieved in stages to recognize the identifiable assets and liabilities, as well as the noncontrolling interest in the acquiree, at the full amounts of their fair values (or other amounts determined in accordance with the Statement). Assets acquired and liabilities assumed arising from contractual contingencies as of the acquisition date are to be measured at their acquisition-date fair values, and assets or liabilities arising from all other contingencies as of the acquisition date are to be measured at their

acquisition-date fair value, only if it is more likely than not that they meet the definition of an asset or a liability in FASB Concepts Statement No. 6, Elements of Financial Statements. This Statement significantly amends other Statements and authoritative guidance, including FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method, and now requires the capitalization of research and development assets acquired in a business combination at their acquisition-date fair values, separately from goodwill. ~~SFAS~~FASB Statement No. 109, Accounting for Income Taxes, was also amended by this Statement to require the acquirer to recognize changes in the amount of its deferred tax benefits that are recognizable because of a business combination either in income from continuing operations in the period of the combination or directly in contributed capital, depending on the circumstances. ~~This Statement is effective for us for business combinations for which~~

We adopted the ~~acquisition date is on or after January 1, 2009.~~

~~In December 2007, in conjunction with SFAS 141(R), the~~provisions of FASB ~~issued~~ Statement No. 160, Accounting for Noncontrolling ~~Interests.~~Interests (SFAS 160), on January 1, 2009. This Statement amends Accounting Research Bulletin No. 51, Consolidated Financial Statements (ARB 51), by requiring companies to report a noncontrolling interest in a subsidiary as equity in its consolidated financial statements. Disclosure of the amounts of consolidated net income attributable to the parent and the noncontrolling interest will be required. This Statement also clarifies that transactions that result in a change in a parent’s ownership interest in a subsidiary that do not result in deconsolidation will be treated as equity transactions, while a gain or loss will be recognized by the parent when a subsidiary is deconsolidated. We now classify our noncontrolling interest in a subsidiary as equity in our consolidated condensed statements of financial position at March 31, 2009 and retroactively

reclassified the December 31, 2008 balances accordingly. The net income attributed to the noncontrolling interest in a subsidiary for the first quarters of 2009 and 2008 is not material and has not been separately disclosed in the consolidated condensed statements of income.

We adopted the provisions of FASB Statement No. 161, Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133 (SFAS 161), on January 1, 2009. SFAS 161 applies to all derivative instruments and related hedged items accounted for under FASB Statement No. 133, Accounting for Derivative Instruments and Hedging Activities (SFAS 133). This Statement ~~is effective~~requires entities to provide enhanced disclosures about how and why an entity uses derivative instruments, how derivative instruments and related hedged items are accounted for ~~us January 1, 2009,~~under SFAS 133 and ~~we do not anticipate the implementation will be material to our consolidated~~its related interpretations, and how derivative instruments and related hedged items affect an entity’s financial position, or results of ~~operations.~~operations, and cash flows. These disclosures are included in Note 6.

~~In December 2007,~~We adopted the ~~FASB ratified the consensus reached by the EITF on~~provisions of Emerging Issues Task Force (EITF) Issue No. 07-1, ~~(EITF 07-1),~~ Accounting for Collaborative ~~Arrangements.~~Arrangements (EITF 07-1), on January 1, 2009. EITF 07-1 defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties. This Issue ~~is effective for us beginning January 1, 2009 and will be~~has been applied retrospectively to all prior periods presented for all significant collaborative arrangements existing as of the effective ~~date. While we have~~date by classifying revenues into two separate components: net product sales and collaboration and other revenue. See Note 4 for additional information.

We adopted the provisions of FASB Staff Position 115-2, Recognition and Presentation of Other-Than-Temporary Impairments (FSP 115-2), on January 1, 2009. FSP 115-2 amends the other-than-temporary recognition guidance for debt securities and requires additional interim and annual disclosures of other-than-temporary impairments on debt and equity securities. Pursuant to the new guidance, an other-than-temporary impairment has occurred if a company does not ~~yet completed our analysis, we do~~expect to recover the entire amortized cost basis of the security. In this situation, if the company does not ~~anticipate~~intend to sell the impaired security, and it is not more likely than not it will be required to sell the security before the recovery of its amortized cost basis, the amount of the other-than-temporary impairment recognized in earnings is limited to the portion attributed to the credit loss. The remaining portion of the other-than-temporary impairment is then recorded in other comprehensive income. This FSP has been applied to existing and new securities as of January 1, 2009. The applicable disclosures are included in Note 6. The implementation of this ~~Issue will be~~FSP was not material to our consolidated financial position or results of operations and there was no cumulative effect adjustment.

We adopted the provisions of FASB Staff Position 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly (FSP 157-4), as of March 31, 2009. FSP 157-4 provides additional guidance on estimating fair value when the volume and level of activity for an asset or liability have significantly decreased in relation to normal market activity. The FSP also provides additional guidance on circumstances that may indicate that a transaction is not orderly and requires additional disclosures. The implementation of this FSP was not material to our consolidated financial position or results of operations.

We adopted the provisions of FASB Staff Position 107-1, Disclosures About Fair Value of Financial Instruments (FSP 107-1), as of March 31, 2009. FSP 107-1 requires disclosures about fair value of all financial instruments for interim reporting periods. The applicable disclosures are included in Note 6. The implementation of this FSP was not material to our consolidated financial position or results of operations.

Note 3: Acquisitions ~~and Collaborations~~

~~SGX Pharmaceuticals, Inc. Acquisition~~

~~On August 20,~~During 2008 we acquired all of the outstanding common stock of SGX Pharmaceuticals, Inc. (SGX). The acquisition allows us to integrate SGX’s structure-guided drug discovery platform into our drug discovery efforts. It also gives us access to FAST^TM, SGX’s fragment-based, protein structure guided drug discovery technology, and to a portfolio of preclinical oncology compounds focused on a number of kinase targets. Under the terms of the agreement, the outstanding shares of SGX common stockseveral businesses. These acquisitions were ~~redeemed for an aggregate purchase price, including transaction costs, of approximately $66.5 million.~~

~~The acquisition has been~~ accounted for as a business combination under the purchase method of accounting. We allocated $28.7 million of the purchase price to deferred tax assets and $28.0 million to acquired in-process research and development (IPR&D). The IPR&D represents products in development and technology that were not yet approved for marketing or were not yet proven technology and had no alternative future use. Accordingly, the $28.0 million allocated to acquired IPR&D was expensed immediately subsequent to the acquisition. SGX’s results of operations are included in our consolidated condensed financial statements from the date of acquisition. The amount allocated to each of the intangible assets acquired is not deductible for tax purposes.

~~ICOS Corporation Acquisition~~

~~On January 29, 2007, we acquired all of the outstanding common stock of ICOS Corporation (ICOS), our partner in the Lilly ICOS LLC joint venture for the manufacture and sale of Cialis® for the~~

values as of the acquisition date in our consolidated financial statements. The determination of estimated fair value required management to make significant estimates and assumptions. The excess of the purchase price over the fair value of the acquired net assets, where applicable, has been recorded as ~~goodwill in the amount of $646.7 million. No portion of this goodwill is expected to be deductible for tax purposes. ICOS’s~~goodwill. The results of operations of these acquisitions are included in our consolidated financial statements from the date of acquisition.

~~We have determined the following estimated fair values for the assets purchased~~Most of these acquisitions included in-process research and ~~liabilities assumed as of the date of acquisition. The determination of estimated fair value required management to make significant estimates and assumptions.~~

Estimated Fair
Value
at January 29,
2007

Cash and short-term investments $ 197.7
Developed product technology (Cialis)¹
1,659.9
Acquired in-process research and development 303.5
Tax benefit of net operating losses 404.1
Goodwill 646.7
Other assets and liabilities — net (32.1 )
Deferred taxes (583.5 )
Long-term debt assumed (275.6 )

Total purchase price $ 2,320.7


¹		~~The intangible asset will be amortized over the remaining expected patent lives of Cialis in each country; patent expiry dates range from 2015 to 2017.~~

~~The acquired IPR&D~~development (IPR&D), which represented compounds, new indications, or line extensions under development that had not yet achieved regulatory approval for marketing. New indications for and formulations of the Cialis compound in clinical testing at the time of the acquisition represented approximately 48 percent of the estimated fair value of the IPR&D. The remaining value of IPR&D represents several other products in development, with no one asset comprising a significant portion of this value. In accordance with FIN 4, Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method, these IPR&D intangible assets totaling $303.5 million were written off by a charge to income immediately subsequent to the acquisition because the compounds had no alternative future use. This charge was not deductible for tax purposes. The ongoing activity with respect to each of these compounds under development is not material to our research and development expenses.

There are several methods that can be used to determine the estimated fair value of the IPR&D acquired ~~IPR&D.~~in a business combination. We utilized the “income method,” which applies a probability weighting to the estimated future net cash flows that are derived from projected sales revenues and estimated costs. These projections are based on factors such as relevant market size, patent protection, historical pricing of similar products, and expected industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. This analysis is performed for each project independently. In accordance with FASB Interpretation No. 4, Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method, these acquired IPR&D intangible assets totaling $4.71 billion in 2008 were expensed immediately subsequent to the acquisition because the products had no alternative future use. None of these charges were incurred during the first quarter of 2008. The ongoing activities with respect to each of these products in development are not material to our research and development expenses.

In addition to the acquisitions of businesses, we also acquired several products in development. The acquired IPR&D related to these products of $122.0 million in 2008, including $87.0 million in the first quarter of 2008, was also written off by a charge to income immediately upon acquisition because the products had no alternative future use.

ImClone Acquisition

On November 24, 2008, we acquired all of the outstanding shares of ImClone Systems Inc. (ImClone), a biopharmaceutical company focused on advancing oncology care, for a total purchase price of approximately $6.5 billion, which was financed through borrowings. This strategic combination will offer both targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combination also expands our biotechnology capabilities.

The acquisition has been accounted for as a business combination under the purchase method of accounting, resulting in goodwill of $419.5 million. No portion of this goodwill is expected to be deductible for tax purposes.

Allocation of Purchase Price

We are currently determining the fair values of a few of these net assets. The purchase price has been preliminarily allocated based on an estimate of the fair value of assets acquired and liabilities assumed as of the date of acquisition. The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. Although the final determination may result in asset and liability fair values that are different than the preliminary estimates of these amounts included herein, it is not expected that those differences will be material to our consolidated financial results.

~~Other Acquisitions~~

~~During~~13.5 percent, and the ~~second~~charge for acquired IPR&D of $4.69 billion recorded in the fourth quarter of 2007, we acquired all of the outstanding stock of both Hypnion, Inc. (Hypnion), a privately held neuroscience drug discovery company focused on sleep disorders, and Ivy Animal Health, Inc. (Ivy), a privately held applied research and pharmaceutical product development company focused on the animal health industry, for $445.0 million in cash. The ongoing activities with respect to these companies’ products in development are not material to our research and development expenses. The results of operations are included in our consolidated condensed financial statements from the respective dates of acquisition.

The acquisition of Hypnion provided us with a broader and more substantive presence in the area of sleep disorder research and ownership of HY10275, a novel Phase II compound with a dual mechanism of action aimed at promoting better sleep onset and sleep maintenance. This was Hypnion’s only significant asset. For this acquisition, we recorded a charge of $291.1 million, representing the estimated fair value of the acquired compound, to acquired IPR&D in the second quarter of 2007 because the development-stage compound acquired had no alternative future use. This charge2008 was not deductible for tax purposes. ~~Because Hypnion was a development-stage company,~~

Posilac®

On October 1, 2008, we acquired the ~~transaction was accounted for~~worldwide rights to the dairy cow supplement Posilac, as ~~an acquisition of assets rather than~~well as ~~a business combination and, therefore, goodwill was not recorded.~~

the product’s supporting operations, from Monsanto Company (Monsanto). The acquisition of ~~Ivy~~Posilac provides us with ~~products~~a product that ~~complement~~complements those of our animal health ~~product line.~~ business. Under the terms of the agreement, we acquired the rights to the Posilac brand, as well as the product’s U.S. sales force and manufacturing facility, for an aggregate purchase price of $403.9 million, which includes a $300.0 million upfront payment, transaction costs, and an accrual for contingent consideration to Monsanto based on estimated future Posilac sales for which payment is considered likely beyond a reasonable doubt.

This acquisition has been accounted for as a business combination under the purchase method of accounting. We ~~have~~ allocated ~~$88.7~~$204.3 million to identifiable intangible assets related to Posilac, $167.6 million to inventories, and $99.5 million of the purchase price to ~~other identifiable intangible assets, primarily related to marketed products, $37.0~~property and equipment. We also assumed $67.5 million ~~to acquired IPR&D, and $25.0 million to goodwill. The IPR&D represents products in development that were not yet approved for marketing and had no alternative future use. Accordingly,~~of liabilities. Substantially all of the ~~$37.0 million allocated to acquired IPR&D was expensed immediately subsequent to the acquisition. The other~~ identifiable intangible assets are being amortized over their estimated remaining useful lives of ~~10 to~~ 20 years. ~~Goodwill resulting from this acquisition was fully allocated to the animal health business segment.~~ The amount allocated to each of the intangible assets acquired ~~including goodwill, was expected to be~~is deductible for tax purposes.

~~Product~~ SGX Pharmaceuticals, Inc.

On August 20, 2008, we acquired all of the outstanding common stock of SGX Pharmaceuticals, Inc. (SGX), a collaboration partner since 2003. The acquisition allows us to integrate SGX’s structure-guided drug discovery platform into our drug discovery efforts. It also gives us access to FAST^TM, SGX’s fragment-based, protein structure guided drug discovery technology, and to a portfolio of preclinical oncology compounds focused on a number of kinase targets. Under the terms of the agreement, the outstanding shares of SGX common stock were redeemed for an aggregate purchase price of $66.8 million.

The acquisition has been accounted for as a business combination under the purchase method of accounting. We allocated $29.6 million of the purchase price to deferred tax assets and $28.0

million to acquired IPR&D. The acquired IPR&D charge of $28.0 million was recorded in the third quarter of 2008 and was not deductible for tax purposes.

Acquisitions of Products in Development

In June 2008, we entered into a licensing and development agreement with TransPharma Medical Ltd. (TransPharma) to acquire rights to its product and related drug delivery system for the treatment of osteoporosis. The product, which is administered transdermally using TransPharma’s proprietary technology, was in Phase II clinical testing, and had no alternative future use. Under the arrangement, we also ~~gain~~gained non-exclusive access to TransPharma’s ViaDerm drug delivery system for the product. As with many development-phase products, launch of the product, if approved, was not expected in the near term. The charge of $35.0 million for acquired IPR&D related to this arrangement was included as expense in the second quarter of 2008 and iswas deductible for tax purposes.

In ~~December 2007, we entered into an~~January 2008, our agreement with BioMS Medical Corp. to acquire the rights to its compound for the treatment of multiple ~~sclerosis. This agreement~~sclerosis became ~~effective upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act in January 2008.~~effective. At the inception of this agreement, this compound was in the development stage (Phase III clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $87.0 million for acquired IPR&D related to this arrangement was included as expense in the first quarter of 2008 and ~~is deductible for tax purposes.~~

In October 2007, we entered into an agreement with Glenmark Pharmaceuticals Limited India whereby we acquired the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical-phase compound. The compound was in early clinical phase development as a potential next-generation treatment for various pain conditions,

including osteoarthritic pain, and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $45.0 million for acquired IPR&D was deductible for tax purposes and was included as expense in the fourth quarter of 2007. Development of this compound has been suspended.

In October 2007, we entered into a global strategic alliance with MacroGenics, Inc. (MacroGenics) to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next-generation anti-CD3 molecules for use in the treatment of autoimmune diseases. As part of the arrangement, we acquired the exclusive rights to the molecule, which was in the development stage (Phase II/III clinical trial for individuals with recent-onset type 1 diabetes) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $44.0 million for acquired IPR&D was deductible for tax purposes and was included as expense in the fourth quarter of 2007.

In January 2007, we entered into an agreement with OSI Pharmaceuticals, Inc. to acquire the rights to its compound for the treatment of type 2 diabetes. At the inception of this agreement, this compound was in the development stage (Phase I clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $25.0 million for acquired IPR&D related to this arrangement was included as expense in the first quarter of 2007 and was deductible for tax purposes.

In connection with these arrangements, our partners are generally entitled to future milestones and royalties based on sales should these products be approved for commercialization.

Note 4: Collaborations

We often enter into collaborative arrangements to develop and commercialize drug candidates. Collaborative activities might include research and development, marketing and selling (including promotional activities and physician detailing), manufacturing, and distribution. These collaborations often require milestone and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development, as well as expense reimbursements or payments to the third party. Revenues related to products sold by us pursuant to these arrangements are included in net product sales, while other sources of revenue (e.g., royalties and profit share payments) are included in collaboration and other revenue. Operating expenses for costs incurred pursuant to these arrangements are reported in their respective expense line item net of any payments made to or reimbursements received from our collaboration partners. Each collaboration is unique in nature and our more significant arrangements are discussed below.

Erbitux

Prior to our acquisition, ImClone entered into several collaborations with respect to Erbitux, a product approved to fight cancer, while still in its development phase. The most significant collaborations operate in these geographic territories: the U.S., Japan, and Canada (Bristol-Myers Squibb Company); and worldwide except the U.S. and Canada (Merck KGaA). The agreements are expected to expire in 2018, upon which all of the rights with respect to Erbitux in the U.S. and Canada return to us. In the ~~second~~first quarter of 2009, we recognized total revenue of $94.1 million for Erbitux, comprised of collaboration revenue of $68.0 million related to the net royalties received from our collaboration partners, and product sales of $26.1 million related to revenue from manufactured product.

Bristol-Myers Squibb Company

Pursuant to a commercial agreement with Bristol-Myers Squibb Company and E.R. Squibb (collectively, BMS), relating to Erbitux, ImClone is co-developing and co-promoting Erbitux in the U.S. and Canada with BMS, exclusively, and in Japan with BMS and Merck KGaA. The companies

had jointly agreed to expand the investment in the ongoing clinical development plan for Erbitux to further explore its use in additional tumor types. Under this arrangement, Erbitux research and development and other costs, up to threshold amounts, are the sole responsibility of BMS, with costs in excess of the thresholds shared by both companies according to a predetermined ratio.

Responsibilities associated with clinical and other ongoing studies are apportioned between the parties as determined pursuant to the agreement. Collaborative reimbursements received by ImClone for supply of clinical trial materials, for research and development, and for a portion of marketing, selling, and administrative expenses, are recorded as a reduction to the respective expense line items on the consolidated condensed statement of income. We receive a distribution fee in the form of a royalty from BMS, based on a percentage of net sales in the U.S. and Canada, which is recorded in collaboration and other revenue. Royalty expense paid to third parties, net of any reimbursements received, is recorded as a reduction of collaboration and other revenue.

We are responsible for the manufacture and supply of all requirements of Erbitux in bulk-form active pharmaceutical ingredient (API) for clinical and commercial use in the territory, and BMS will purchase all of its requirements of API for commercial use from us, subject to certain stipulations per the agreement. Sales of Erbitux to BMS for commercial use are reported in net product sales.

Merck KGaA

A development and license agreement between ImClone and Merck KGaA (Merck) with respect to Erbitux granted Merck exclusive rights to market Erbitux outside of the U.S. and Canada, and co-exclusive rights with BMS in Japan. Merck also has rights to manufacture Erbitux for supply in its territory. We manufacture and provide a portion of Merck’s requirements for API, which is included in net product sales. We also receive a royalty on the sales of Erbitux outside of the U.S. and Canada, which is included in collaboration and other revenue as earned. Collaborative reimbursements received for supply of product for research and development and marketing, selling, and administrative expenses are recorded as a reduction to the respective expense line items on the consolidated condensed statement of income. Royalty expense paid to third parties, net of any reimbursements received, is recorded as a reduction of collaboration and other revenue.

Exenatide

We are in a collaborative arrangement with Amylin Pharmaceuticals (Amylin) for the joint development, marketing, and selling of Byetta® and other forms of exenatide such as exenatide once weekly. Byetta (exenatide injection) is presently approved as an adjunctive therapy to improve glycemic control in patients with type 2 diabetes who have not achieved adequate glycemic control using metformin, a sulfonylurea and/or a thiazolidinediene (U.S. only), three common oral therapies for type 2 diabetes. Lilly and Amylin are co-promoting exenatide in the U.S. Amylin is responsible for manufacturing and primarily utilizes third-party contract manufacturers to supply Byetta. However, we are manufacturing Byetta pen delivery devices for Amylin. We are responsible for development and commercialization costs outside the U.S.

Under the terms of our arrangement, we report as collaboration and other revenue our 50 percent share of gross margin on Amylin’s net product sales in the U.S. We report as net product sales 100 percent of sales outside the U.S. and our sales of Byetta pen delivery devices to Amylin. We recorded revenue of $97.5 million and $82.7 million in the quarters ended March 31, 2009 and 2008, respectively, for Byetta. We pay Amylin a percentage of the gross margin of exenatide sales outside of the U.S., and these costs are recorded in cost of sales. Under the 50/50 profit-sharing arrangement for the U.S., in addition to recording as revenue our 50 percent share of exenatide’s gross margin, we also report 50 percent of U.S. research and development costs and marketing and selling costs in the respective line items on the consolidated condensed statements of income.

Exenatide once weekly is presently in Phase III clinical trials and has not received regulatory approval. Amylin is constructing and will operate a manufacturing facility for exenatide once weekly, and we have entered into a supply agreement in which Amylin will supply exenatide once weekly product to us for sales outside the U.S. The estimated total cost of the facility is approximately $550 million. In 2008, we paid $125.0 million to Amylin, which we will amortize to cost of sales over the estimated life of the supply agreement beginning with product launch. We would be required to reimburse Amylin for a portion of any future impairment of this facility, recognized in accordance with GAAP. A portion of the $125.0 million payment we made to Amylin would be creditable against any amount we would owe as a result of impairment. We have also agreed to loan up to $165.0 million to Amylin at an indexed rate beginning December 1, 2009; any borrowings have to be repaid by June 30, 2014.

Cymbalta®

Boehringer Ingelheim

We are in a collaborative arrangement with Boehringer Ingelheim (BI) to jointly market and promote Cymbalta, a product for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, and fibromyalgia, outside the U.S. Pursuant to the terms of the agreement, we generally share equally in development, marketing, and selling expenses, and pay BI a commission on sales in the co-promotion territories. We manufacture the product for all territories. Reimbursements or payments for the cost sharing of marketing, selling, and administrative expenses are recorded in the respective expense line items in the consolidated condensed statements of income. The commission paid to BI is recognized in marketing, selling, and administrative expenses.

Quintiles

We are in a collaborative arrangement with Quintiles Transnational Corp. (Quintiles) to jointly market and promote Cymbalta in the U.S. Pursuant to the terms of the agreement, Quintiles shares in the costs to co-promote Cymbalta with us. In exchange, Quintiles receives a commission based upon net product sales. According to the agreement, Quintiles’ obligation to promote Cymbalta expires in 2009, and we will pay a lower rate on net product sales for three years after their promotion efforts. The commissions paid to Quintiles are recorded in marketing, selling, and administrative expenses.

Prasugrel

We are in a collaborative arrangement with Daiichi Sankyo Company, Limited (D-S) to develop, market, and promote prasugrel, an antiplatelet agent for the treatment of patients with acute coronary syndromes (ACS) who are being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). Prasugrel was approved for marketing by the European Commission under the tradename Efient^® in February 2009, and the initial sales were recorded in the first quarter of 2009. We have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and are currently awaiting its decision. Within this arrangement, we have agreed to co-promote under the same trademark in certain territories (including the U.S. and five major European markets), while we have exclusive marketing rights in certain other territories. D-S has exclusive marketing rights in Japan. Under the agreement, we paid D-S an upfront license fee and agreed to pay future success milestones. Both parties share in the costs of the development and marketing in the co-promotion territories. D-S is responsible for supplying bulk product, but we will produce the finished product for our exclusive and co-promotion territories. Profits in the U.S. and other co-promotion territories will be shared according to the agreement. In our exclusive territories, we will pay D-S a royalty specific to those territories. Profit share payments made to D-S are recorded as marketing, selling, and administrative expenses. All royalties paid to D-S will be recorded in cost of sales.

TPG-Axon Capital

In 2008, we entered into an agreement with an affiliate of TPG-Axon Capital (TPG) for the Phase III development of our gamma-secretase inhibitor and our A-beta antibody, our two lead molecules for the treatment of mild to moderate Alzheimer’s disease. ~~Pursuant to the terms of~~Under the agreement, both we and TPG will provide funding for the Alzheimer’s clinical trials. Funding from TPG will not exceed $325 million and could extend into 2014. In exchange for their funding, TPG may receive success-based milestones totaling $330 million and ~~mid-to high-single-digit~~mid- to high-single digit royalties that are contingent upon the successful development of the Alzheimer’s treatments. The royalties will be paid for approximately eight years after launch of a product. ~~Our reported~~Reimbursements received from TPG for its portion of research and development costs incurred related to the Alzheimer’s treatments are ~~reflected net~~recorded as a reduction to the research and development expense line item on the consolidated condensed statements of ~~the at-risk funding we receive from TPG for their share of the development costs.~~income. The ~~funding~~reimbursement from TPG is not expected to be material in any period.

Summary of Collaboration Related Commissions and Profit Share Payments

The aggregate amount of commissions and profit share payments included in marketing, selling, and administrative expense pursuant to the collaborations described above was $77.6 million and $66.6 million in the quarters ended March 31, 2009 and 2008, respectively.

Note 4:5: Asset Impairments, Restructuring, and Other Special Charges

~~As discussed further~~The components of the charges included in Note 11, in the third quarter of 2008, we recorded a charge of $1.48 billion related to the pending Zyprexa® investigations led by the U.S. Attorney for the Eastern District of Pennsylvania, as well as the resolution of a multi-state investigation regarding Zyprexa involving 32 states and the District of Columbia.

In the third quarter of 2008, as a result of our previously announced agreements with Covance Inc. (Covance), Quintiles Transnational Corp. (Quintiles), and Ingenix Pharmaceutical Services, Inc., doing business as i3 Statprobe (i3), and as part of our efforts to transform into a more flexible organization, we recognized asset impairments, restructuring, and other special charges in our consolidated condensed statements of $182.4 million. We sold our Greenfield, Indiana site to Covance, a global drug development services firm, and entered into a 10-year service agreement under which Covance will provide preclinical toxicology work and perform additional clinical trials for us as well as operate the site to meet our needs and those of other pharmaceutical industry clients. In addition, we signed agreements with Quintiles for clinical trial monitoring services and with i3 for clinical data management services. Components of the third-quarter restructuring charge include non-cash charges of $148.3 million primarily related to the loss on sale of assets sold to Covance, severance costs of $27.8 million, and exit costs of $6.3 million. Substantially all of these costs will be paid in 2008.

In April 2008, we announced a voluntary exit program that was offered to employees primarily in manufacturing. In the second quarter of 2008, we recognized restructuring and other special charges of $88.9 million. Components of the second-quarter restructuring charge include total severance costs of $53.5 million related to these programs and $35.4 million related to exit costs incurred during the second quarter in connection with previously announced strategic decisions made in prior periods. Substantially all of these costs were paid by the end of July 2008. In addition, we recognized non-cash charges of $57.1 million for the write-down of impaired manufacturing assets that had no future use, whichincome are ~~included in cost of sales.~~described below.

In March 2008, we terminated development of our AIR^® Insulin program, which was being conducted in collaboration with Alkermes, Inc. The program had been in Phase III clinical development as a potential treatment for type 1 and type 2 diabetes. This decision was not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies. As a result of this decision, we halted our ongoing clinical studies and transitioned the AIR Insulin patients in these studies to other appropriate therapies. We ~~have~~ implemented a patient program in the U.S., and other regions of the world where allowed, to provide clinical trial participants with appropriate financial support to fund their medications and diagnostic supplies through the end of 2008.

We recognized asset impairment, restructuring, and other special charges of $145.7 million in the first quarter of 2008. These charges were primarily related to the decision to terminate development of AIR Insulin. Components of these charges included non-cash charges of $40.9 million for the ~~write-down~~write down of impaired manufacturing assets that had no use beyond the AIR Insulin program, as well as charges of $91.7 million for estimated contractual obligations and wind-down costs associated with the termination of clinical trials and certain development activities, and costs associated with the patient program to transition participants from AIR Insulin. This amount ~~includes~~included an estimate of ~~Alkermes’s~~Alkermes’ wind-down costs for which we were contractually obligated. The wind-down activities and patient programs ~~should be~~were substantially complete by the end of 2008. The remaining component of these charges, $13.1 million, is related to exit costs incurred in the first quarter of 2008 in connection with previously announced strategic decisions made in prior periods.

~~In connection~~Note 6: Financial Instruments

Financial instruments that potentially subject us to credit risk consist principally of trade receivables and interest-bearing investments. Wholesale distributors of life-sciences products account for a substantial portion of trade receivables; collateral is generally not required. The risk associated with ~~previously announced strategic decisions, we recorded asset impairment, restructuring,~~this concentration is mitigated by our ongoing credit review procedures and ~~other special charges of $123.0 million in~~insurance. Major financial institutions represent the ~~first quarter of 2007. These charges primarily related to a voluntary severance program at one~~largest component of our ~~U.S. plants and other costs related to this action as well as management actions taken~~investments in corporate debt securities. In accordance with documented corporate policies, we limit the fourth quarter of 2006. The component of these charges related to the non-cash asset impairment was $67.6 million and was necessary to adjust the carrying value of the assets to fair value. These restructuring activities were substantially complete at December 31, 2007.

1214

~~Note 5:~~ amount of credit exposure to any one financial institution or corporate issuer. We are exposed to credit-related losses in the event of nonperformance by counterparties to risk-management instruments but do not expect any counterparties to fail to meet their obligations given their high credit ratings.

Accounting Policy for Risk-Management Instruments

Our derivative activities are initiated within the guidelines of documented corporate risk-management policies and do not create additional risk because gains and losses on derivative contracts offset losses and gains on the assets, liabilities, and transactions being hedged. As derivative contracts are initiated, we designate the instruments individually as either a fair value hedge or a cash flow hedge. Management reviews the correlation and effectiveness of our derivatives on a quarterly basis.

For derivative contracts that are designated and qualify as fair value hedges, the derivative instrument is marked to market with gains and losses recognized currently in income to offset the respective losses and gains recognized on the underlying exposure. For derivative contracts that are designated and qualify as cash flow hedges, the effective portion of gains and losses on these contracts is reported as a component of other comprehensive loss and reclassified into earnings in the same period the hedged transaction affects earnings. Hedge ineffectiveness is immediately recognized in earnings. Derivative contracts that are not designated as hedging instruments are recorded at fair value with the gain or loss recognized currently in earnings.

We may enter into foreign currency forward and purchase option contracts to reduce the effect of fluctuating currency exchange rates (principally the euro, the British pound and the Japanese yen). Foreign currency derivatives used for hedging are put in place using the same or like currencies and duration as the underlying exposures. Forward contracts are principally used to manage exposures arising from subsidiary trade and loan payables and receivables denominated in foreign currencies. These contracts are recorded at fair value with the gain or loss recognized in other—net, expense (income). The purchased option contracts are used to hedge anticipated foreign currency transactions, primarily intercompany inventory activities expected to occur within the next year. These contracts are designated as cash flow hedges of those future transactions, and the impact on earnings is included in cost of sales. We may enter into foreign currency forward contracts and currency swaps as fair value hedges of firm commitments. Forward and purchase option contracts generally have maturities not exceeding 12 months. At March 31, 2009, we did not hold any foreign currency option contracts. At March 31, 2009, we had outstanding foreign currency forward commitments to purchase 244 million British pounds and sell 264 million euro, and commitments to purchase 758 million U.S. dollars and sell 581 million euro, which will settle within 30 days.

In the normal course of business, our operations are exposed to fluctuations in interest rates. These fluctuations can vary the costs of financing, investing, and operating. We address a portion of these risks through a controlled program of risk management that includes the use of derivative financial instruments. The objective of controlling these risks is to limit the impact of fluctuations in interest rates on earnings. Our primary interest rate risk exposure results from changes in short-term U.S. dollar interest rates. In an effort to manage interest rate exposures, we strive to achieve an acceptable balance between fixed and floating rate debt and investment positions and may enter into interest rate swaps or collars to help maintain that balance. Interest rate swaps or collars that convert our fixed-rate debt or investments to a floating rate are designated as fair value hedges of the underlying instruments. Interest rate swaps or collars that convert floating rate debt or investments to a fixed rate are designated as cash flow hedges. Interest expense on the debt is adjusted to include the payments made or received under the swap agreements. At March 31, 2009, approximately 78 percent of our total debt is at a fixed rate. We have converted approximately 34 percent of our fixed-rate debt to floating rates through the use of interest rate swaps.

The Effect of Risk-Management Instruments on the Statement of Income

The loss on the hedged fixed-rate debt and the offsetting gain on the related interest rate swaps for the three months ended March 31, 2009 were $139.6 million and both were included in other-net, expense (income).

We expect to reclassify an estimated $11.0 million of pretax net losses on cash flow hedges of the variability in expected future interest payments on floating rate debt from accumulated other comprehensive loss to earnings during the next 12 months.

For the three months ended March 31, 2009, the effective portion of losses on interest rate contracts in designated cash flow hedging relationships reclassified from accumulated other comprehensive loss into income of $2.5 million and the gains on foreign exchange contracts not designated as hedging instruments recognized in income of $36.6 million are reflected in other-net, expense (income). The effective portion of net gains on interest rate contracts in designated cash flow hedging relationships recorded in other comprehensive loss for the three months ended March 31, 2009 was $37.8 million.

During the three months ended March 31, 2009, net losses related to ineffectiveness and net losses related to the portion of our risk-management hedging instruments, fair value and cash flow hedges excluded from the assessment of effectiveness were not material.

Fair Value ~~Measurements~~of Financial Instruments

The following ~~table summarizes~~tables summarize certain fair value information at ~~September 30,~~March 31, 2009 and December 31, 2008 for assets and liabilities measured at fair value on a recurring basis, as well as the carrying amount and amortized cost of certain other investments:

Fair Value Measurements Using
Quoted
Prices in
Active Significant
Markets for Other Significant
Identical Observable Unobservable
Carrying Fair Assets Inputs Inputs
Description Amount Value (Level 1) (Level 2) (Level 3)

Short-term investments
Debt securities $ 1,765.2 $ 1,765.2 $ 543.0 $ 1,222.2 $ —

Noncurrent investments
Marketable equity $ 39.8 $ 39.8 $ 39.8 $ — $ —
Debt securities 1,030.5 1,030.5 449.0 581.5 —
Equity method and other investments 116.3 N/A

$ 1,186.6

Risk-management instruments — assets $ 57.2 $ 57.2 $ — $ 57.2 $ —


						Fair Value Measurements Using
						Quoted
						Prices in
						Active		Significant
						Markets for		Other			Significant
						Identical		Observable			Unobservable
	Carrying			Amortized		Assets		Inputs			Inputs		Fair
Description	Amount			Cost		(Level 1)		(Level 2)			(Level 3)		Value

March 31, 2009

Short-term investments Corporate debt securities	$	106.8		$	112.8	$	—	$	106.8		$	—	$	106.8
U.S. government and agencies		55.4			55.3		55.4		—			—		55.4
Other securities		33.0			32.7		—		33.0			—		33.0

	$	195.2		$	200.8


Noncurrent investments Corporate debt securities	$	461.9		$	535.7	$	—	$	461.9		$	—	$	461.9
Mortgage-backed		262.5			374.1		—		262.5			—		262.5
Asset-backed		166.6			202.2		—		166.6			—		166.6
U.S. government and agencies		90.7			87.8		90.7		—			—		90.7
Other debt securities		9.0			11.3		—		3.3			5.7		9.0
Marketable equity		240.2			180.8		240.2		—			—		240.2
Equity method and other investments		132.9			132.9								NA

	$	1,363.8		$	1,524.8


Long-term debt, including current portion	$	(7,290.2	)	NA		$	—	$	(7,433.7	)	$	—	$	(7,433.7	)

Risk-management instruments
Interest rate contracts designated as hedging instruments
Sundry	$	358.7		NA		$	—	$	358.7		$	—	$	358.7
Foreign exchange contracts not designated as hedging instruments
Prepaid expenses		5.1		NA			—		5.1			—		5.1
Other current liabilities		(13.8	)	NA			—		(13.8	)		—		(13.8	)

December 31, 2008

Short-term investments Corporate debt securities	$	172.4		$	180.1	$	—	$	172.4		$	—	$	172.4
U.S. government and agencies		212.3			212.0		212.3		—			—		212.3
Other securities		44.7			41.8		—		44.7			—		44.7

	$	429.4		$	433.9


Noncurrent investments Corporate debt securities	$	466.4		$	542.2	$	—	$	466.4		$	—	$	466.4


						Fair Value Measurements Using
						Quoted
						Prices in
						Active		Significant
						Markets for		Other			Significant
						Identical		Observable			Unobservable
	Carrying			Amortized		Assets		Inputs			Inputs		Fair
Description	Amount			Cost		(Level 1)		(Level 2)			(Level 3)		Value

Mortgage-backed		330.6			436.6		—		330.6			—		330.6
Asset-backed		204.0			240.1		—		204.0			—		204.0
U.S. government and agencies		179.2			176.8		179.2		—			—		179.2
Other debt securities		14.7			10.6		—		3.6			11.1		14.7
Marketable equity		221.9			175.1		221.9		—			—		221.9
Equity methods and other investments		127.8			127.8		—		—			—	NA

	$	1,544.6		$	1,709.2


Long-term debt, including current portion	$	(5,036.1	)	NA		$	—	$	(5,180.1	)	$	—	$	(5,180.1	)

Risk-management instruments
Interest rate contracts designated as hedging instruments
Sundry	$	500.3		NA		$	—	$	500.3		$	—	$	500.3
Foreign exchange contracts not designated as hedging instruments
Prepaid expenses		12.0		NA			—		12.0			—		12.0
Other current liabilities		(57.3	)	NA			—		(57.3	)		—		(57.3	)


		NA — Not applicable

We determine fair values based on a market approach using quoted market values, significant other observable inputs for identical or comparable assets or liabilities, or discounted cash flow analyses. The fair value of equity method investments and other investments is not readily available.

~~The~~A summary of the fair value of ~~the portion of our~~ available-for-sale securities in an unrealized gain or loss position and the amount of unrealized gains and losses (pretax) in other comprehensive loss follows:


	March 31, 2009		December 31, 2008

Unrealized gross gains	$	71.4	$	69.9
Unrealized gross losses		238.0		239.0
Fair value of securities in an unrealized gain position		579.5		767.5
Fair value of securities in an unrealized loss position		830.9		1,046.1

The total other-than-temporary impairment loss for the three months ended March 31, 2009 was ~~$700.3~~$17.9 million, ~~at September 30, 2008, with an unrealized gain~~ of ~~$6.8 million.~~which $12.6 million was recognized in other comprehensive loss resulting in a net charge of $5.3 million, which relates to credit losses on certain mortgage-backed securities. The ~~fair~~amount of credit losses represents the difference between the present value of ~~our available-for-sale~~cash flows expected to be collected on these securities and the amortized cost. Factors considered in assessing the credit loss were the position in the capital structure, vintage and amount of collateral, delinquency rates, current credit support, and geographic concentration.

The securities in an unrealized loss position ~~was $2.06 billion, with an unrealized loss~~are comprised of ~~$147.1 million. Substantially all~~fixed-rate debt securities of varying maturities. The value of fixed income securities is sensitive to changes in the yield curve and other market conditions, which led to the decline in value. Approximately 80 percent of the securities in a loss position are investment-grade debt ~~securities and have no indications of deterioration in credit quality.~~securities. The majority of these securities first moved into an unrealized loss position during 2008. At this time, there is no indication of default on interest or principal payments for debt securities other than those for which an other-than-temporary impairment charge has been recorded. We ~~have~~do not intend to sell and it is not more likely than not we will be required to sell the ~~intent and ability to hold these~~ securities ~~until~~in a loss position

before the market values recover or the underlying cash flows have been received, and we have concluded that ~~for those securities in an unrealized loss position,~~ no additional other-than-temporary loss ~~exists at September 30, 2008. As~~is required to be charged to earnings as of ~~September 30, 2008, we did not hold~~March 31, 2009. The fair values of our auction rate securities and collateralized debt obligations orwere determined using Level 3 inputs. We did not hold securities issued by structured investment ~~vehicles.~~vehicles at March 31, 2009.

In March 2009, we issued $2.40 billion of fixed-rate notes ($1.00 billion at 3.55 percent due in 2012; $1.00 billion at 4.20 percent due in 2014; and $400.0 million at 5.95 percent due in 2037) with interest to be paid semi-annually.

Note 6:7: Stock-Based Compensation

In ~~2008~~2009 and ~~2007,~~2008, our stock-based compensation expense ~~consisted~~consists primarily of performance awards (PAs), and shareholder value awards (SVAs)~~, and stock options.~~. We recognized pretax stock-based compensation cost ~~in the amount~~ of ~~$77.9~~$66.1 million and ~~$79.3~~$58.5 million in the ~~third~~first quarter of ~~2008~~2009 and ~~2007, respectively. In the first nine months of~~ 2008, ~~and 2007, we recognized stock-based compensation expense of $192.7 million and $214.5 million,~~ respectively.

PAs are granted to officers and management and are payable in shares of our common stock. The number of PA shares actually issued, if any, varies depending on the achievement of certain ~~earnings-per-share~~earnings-per share targets over a one-year and a two-year period. PA shares are accounted for at fair value based upon the closing stock price on the date of grant and fully vest at the end of the ~~fiscal year of the grant.~~measurement periods. As of ~~September 30, 2008,~~March 31, 2009, the total remaining unrecognized compensation cost

related to nonvested PAs amounted to ~~$47.7~~$211.8 million, which will be amortized over the weighted-average remaining requisite service period of ~~three~~approximately 14 months.

SVAs are granted to officers and management and are payable in shares of common stock at the end of a three-year period. The number of shares actually issued varies depending on our stock price at the end of the three-year vesting period compared to pre-established target prices. We measure the fair value of the SVA unit on the grant date using a Monte Carlo simulation model. The Monte Carlo simulation model utilizes multiple input variables that determine the probability of satisfying the market condition stipulated in the award grant and calculates the fair value of the award. As of ~~September 30, 2008,~~March 31, 2009, the total remaining unrecognized compensation cost related to nonvested SVAs amounted to ~~$59.6~~$81.6 million, which will be amortized over the weighted-average remaining requisite service period of 25approximately 27 months.

We discontinued issuing stock options beginning in 2007. As of September 30, 2008, the total remaining unrecognized compensation cost related to nonvested stock options amounted to $6.7 million, which will be amortized over the weighted-average remaining requisite service period of four months.

Note 7:8: Shareholders’ Equity

As of ~~September 30, 2008,~~March 31, 2009, we have purchased $2.58 billion of our previously announced $3.0 billion share repurchase program. During the ~~third~~first quarter of ~~2008,~~2009, we did not acquire any shares pursuant to this program, nor do we expect any share repurchases under this program for the remainder of ~~2008.~~2009. In the first quarter of 2009, we contributed an additional 10 million shares to the employee benefit trust, which resulted in a reclassification within equity from additional-paid-in capital of $371.9 million and common stock of $6.3 million to the employee benefit trust of $378.2 million.

Note 8:9: Earnings Per Share

Unless otherwise noted in the footnotes, all per-share amounts are presented on a diluted basis, that is, based on the weighted-average number of outstanding common shares plus the effect of all potentially dilutive common shares (primarily contingently issuable shares and unexercised stock options).

Note 9:10: Income Taxes

We file income tax returns in the United States (U.S.) federal jurisdiction and various state, local, and non-U.S. jurisdictions. We are no longer subject to U.S. federal, state and local, or non-U.S.

fibromyalgia, and one alleges the patent having claims directed to the active ingredient is unenforceable. Lawsuits have been filed in U.S. District Court for the Southern District of Indiana against Activis Elizabeth LLC; Aurobindo Pharma Ltd.; Cobalt Laboratories, Inc.; Impax Laboratories, Inc.; Lupin Limited; Sandoz Inc.; Sun Pharma Global, Inc.; and Wockhardt Limited, seeking rulings that the patents are valid, infringed, and enforceable. The cases have been consolidated and are proceeding.

	•		Gemzar®: Sicor Pharmaceuticals, Inc. (Sicor), Mayne Pharma (USA) Inc. (Mayne), and Sun Pharmaceutical Industries Inc. (Sun) each submitted an ANDA seeking permission to market generic versions of Gemzar prior to the expiration of our relevant U.S. patents (compound patent expiring in 2010 and ~~method of use~~method-of-use patent expiring in 2013), and alleging that these patents are invalid. We filed lawsuits in the U.S. District Court for the Southern District of Indiana against Sicor (February 2006) and Mayne (October 2006 and January 2008), seeking rulings that these patents are valid and are being infringed. The suit against Sicor has been scheduled for trial in ~~July~~September 2009. ~~The statutory stay barring final approval of~~ Sicor’s ANDAs ~~has expired;~~have been approved by the FDA; however, Sicor must provide 90 days notice prior to marketing generic Gemzar ~~upon receipt of final approval by the FDA~~ to allow time for us to seek a preliminary injunction. Both suits against Mayne have been administratively closed, and the parties have agreed to be bound by the results of the Sicor suit. In November 2007, Sun filed a declaratory judgment action in the United States District Court for the Eastern District of Michigan, seeking rulings that our method-of-use and compound patents are invalid or unenforceable, or would not be infringed by the sale of Sun’s generic product. This trial is scheduled for December 2009.

	•		Alimta®: Teva Parenteral Medicines, Inc. (Teva) ~~and~~, APP Pharmaceuticals, LLC (APP), and Barr Laboratories, Inc. (Barr) each submitted ANDAs seeking approval to market generic versions of Alimta prior to the expiration of the relevant U.S. patent (licensed from the Trustees of Princeton University and expiring in 2016), and alleging the patent is invalid. We, along with Princeton, filed lawsuits in the U.S. District Court for the District of Delaware against Teva, APP, and ~~APP,~~Barr seeking rulings that the compound patent is valid and infringed. ~~The court has not set a date~~Trial is scheduled for ~~trial in either case.~~November 2010 against Teva and APP.

	•		Evista®: 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. The lawsuit against Barr was administratively closed and, as a result, no trial date has been set.

			In 2006, Teva Pharmaceuticals USA, Inc. (Teva) ~~has also~~ submitted an ANDA seeking permission to market a generic version of Evista. In June 2006, we filed a lawsuit, similar to the Barr lawsuit, against Teva in the U.S. District Court for the Southern District of Indiana. The ~~lawsuit~~trial against Teva ~~is currently scheduled for trial beginning~~was completed in March ~~9, 2009, while no trial date has been set in the lawsuit against Barr.~~2009. In April 2008, the FDA granted Teva tentative approval of its ~~ANDA, but~~ANDA; however, Teva’s ability to market a generic product ~~before a decision at trial~~ is subject to a ~~statutory stay~~preliminary injunction that ~~expires on March 9, 2009.~~prevents Teva from launching its generic raloxifene product until the Court issues a final judgment. Teva has announced its intent to appeal the preliminary injunction.

	•		Strattera®: Actavis Elizabeth LLC (Actavis), Glenmark Pharmaceuticals Inc., USA (Glenmark), Sun Pharmaceutical Industries Limited (Sun), Sandoz Inc. (Sandoz), Mylan Pharmaceuticals Inc. (Mylan), Teva Pharmaceuticals USA, Inc. (Teva), Apotex Inc. (Apotex), Aurobindo Pharma Ltd. (Aurobindo), Synthon Laboratories, Inc. (Synthon), and Zydus Pharmaceuticals, USA, Inc. (Zydus) each submitted an ANDA seeking permission to market generic versions of Strattera prior to the expiration of our relevant U.S. patent (expiring in 2017), and alleging that this patent is invalid. We filed a lawsuit against Actavis in the United States District Court for the District of New Jersey in August 2007, and added Glenmark, Sun, Sandoz, Mylan, Teva, Apotex, Aurobindo, Synthon, and Zydus as defendants in September 2007. In December 2007, Zydus agreed to entry of a consent judgment in which Zydus conceded the validity and enforceability of the patent and agreed to a permanent injunction. In June 2008, Glenmark agreed to entry of a permanent injunction, enjoining it from selling a generic product prior to the expiration of the U.S. patent. Also in June 2008, Synthon notified us that it has withdrawn its ANDA and agreed to a stipulated dismissal of all outstanding claims. For the remaining defendants, trial is anticipated as early as December 2009.

	•		In Canada, several generic pharmaceutical manufacturers have challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In April 2007, the Canadian Federal Court ruled against the first challenger, Apotex Inc. (Apotex), and that ruling was affirmed on appeal in February 2008. In June 2007, the Canadian Federal Court held that an invalidity allegation of a second challenger, Novopharm Ltd. (Novopharm), was justified and denied our request that Novopharm be prohibited from receiving marketing approval for generic olanzapine in Canada. Novopharm began selling generic olanzapine in Canada in the third quarter of 2007. We ~~have~~ sued Novopharm for patent infringement, and the trial ~~is scheduled for November 2008.~~was completed in April 2009. We anticipate a decision in the second half of 2009. In November 2007, Apotex filed an action seeking a declaration of the invalidity of our Zyprexa compound and method-of-use patents, and no trial date has been set. We ~~have brought~~are involved in similar actions against Pharmascience (August 2007), Sandoz (July 2007), Nu-Pharm (June 2008), ~~and~~ Genpharm (June 2008)~~; none of~~ and Cobalt (January 2009). By agreement between the parties, or due to scheduling by the court, no substantive developments are expected in these suits ~~has been scheduled for trial. Pharmascience has agreed~~prior to ~~be bound by~~ the ~~outcome of~~decision in the Novopharm suit, and, pending the outcome of the lawsuit, we have agreed not to take any further steps to prevent them from coming to market with generic olanzapine tablets, subject to a contingent damages obligation should we be successful against Novopharm.suit.

	•		In Germany, generic pharmaceutical manufacturers Egis-Gyogyszergyar and Neolab Ltd. challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In June 2007, the German Federal Patent Court held that our patent is invalid. ~~We are appealing the decision to the German Supreme Court, which has scheduled a hearing for December 2008.~~ Generic olanzapine was launched by competitors in Germany in the fourth quarter of 2007. ~~Notwithstanding~~We appealed the decision to the German Federal Supreme Court and following a hearing in December 2008, the Supreme Court reversed the Federal Patent Court ~~ruling, we have sought preliminary injunctions against all~~and found the patent to be valid. Following the decision of the Supreme Court, the generic companies who are marketing generic olanzapine products in Germany. In May 2008 the Court of Appeal in Düsseldorf granted an injunction against the first of these generic companies, STADApharm GmbH, as a result of which STADA has hadeither agreed to withdraw ~~its generic olanzapine product~~ from the ~~German market. Preliminary injunction actions against other generic companies in Germany~~market or were ~~denied.~~subject to preliminary injunction. We ~~continue to pursue~~are pursuing these companies ~~in main actions~~ for damages arising from infringement.

	•		We have received challenges in a number of other countries, including Spain, the United Kingdom ~~(UK)~~(U.K.), France, and several smaller European countries. In Spain, we have been successful at both the trial and appellate court levels in defeating the generic manufacturers’ ~~challenge,~~challenges, but ~~we anticipate~~ further legal ~~challenges from generic manufacturers.~~challenge is now pending before the Commercial Court in Madrid. In the ~~UK,~~U.K., the generic pharmaceutical manufacturer Dr. Reddy’s Laboratories (UK) Limited has challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In October 2008, the Patents Court in the High Court, London ruled that our patent was valid. ~~We anticipate that~~ Dr. Reddy’s ~~will~~appealed this decision, and a hearing date for the appeal ~~this decision.~~has been set for November 2009.

We are vigorously contesting the various legal challenges to our Zyprexa patents on a country-by-country basis. We cannot determine the outcome of this litigation. The availability of generic olanzapine in additional markets could have a material adverse impact on our consolidated results of operations.

~~Xigris®~~ Xigris®and Evista:In June 2002, Ariad Pharmaceuticals, Inc. (Ariad), 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 sued us, 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. ~~On May 4, 2006, a~~Following jury ~~in Boston 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. In addition, abench trials on separate ~~bench trial with~~issues, the U.S. District Court of Massachusetts was held in August 2006, on our contention that the patent is unenforceable and impermissibly covers natural processes. In June 2005, the United States Patent and Trademark Office (USPTO) commenced a reexamination of the patent, and in August 2007 took the position that the Ariad claims at issue are unpatentable, a position that Ariad continues to contest. In September 2007, the Court entered a final judgment ~~indicating~~in September 2007 that Ariad’s claims ~~are patentable,~~were valid, infringed, and enforceable, and finding damages in the amount of $65 million plus a 2.3 percent royalty on net U.S. sales of Xigris and Evista since the time of the jury decision. However, the Court deferred the requirement to pay any damages until after all rights to appeal ~~have been~~are exhausted. ~~We have appealed this judgment. We~~In April 2009, the Court of Appeals for the Federal Circuit overturned the District Court judgment, concluding that Ariad’s asserted patent claims are invalid. While Ariad may request the Court of Appeals to reconsider its decision, or the United States Supreme Court to consider the matter, we believe that these allegations are without legal merit, that we

will ultimately prevail on these issues, and therefore that the likelihood of any monetary damages is remote.

Government Investigations and Related Litigation

In March 2004, the Office of the U.S. Attorney for the Eastern District of Pennsylvania (EDPA) advised us that it had commenced an 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~~^®Prozac®, and Prozac Weekly™. ~~In November 2007, we received a grand jury subpoena from the EDPA for a broad range of documents related to Zyprexa.~~ In addition, the State Medicaid Fraud Control Units of more than 30 states ~~are coordinating~~coordinated with the EDPA in its investigation of any Medicaid-related claims relating to our marketing and promotion of Zyprexa. Twelve other states (Arkansas, Connecticut, Idaho, Louisiana, Minnesota, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia) have filed lawsuits over Zyprexa and are not participating in the coordinated investigation. In ~~October 2008,~~January 2009, we announced that we ~~are~~reached resolution of this matter, and on January 30, 2009, the court approved the settlement. As part of the resolution, we pled guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act for the off-label promotion of Zyprexa in ~~advanced discussions~~elderly populations as treatment for dementia, including Alzheimer’s dementia, between September 1999 and March 2001. In connection with the federal criminal and civil settlements, in the first quarter of 2009, we paid $1.06 billion. We also agreed to ~~resolve the ongoing investigations led by the EDPA, and we~~make available a maximum amount of approximately $362.0 million for payment to those states that agree to settle. We recorded a charge of $1.42 billion. The charge reflects our currently estimable exposure with respect to these matters. If the ongoing discussions are successfully concluded, we expect that they would settle the Zyprexa-related federal claims, as well as similar Medicaid-related claims of states participatingbillion for this matter in the ~~settlement.~~

~~In October 2005,~~third quarter of 2008. As part of the ~~EDPA advised that it is also conducting an inquiry regarding certain rebate agreements~~settlement, we have entered into ~~with~~ a pharmacy benefit manager covering Axid®, Evista, Humalog®, Humulin®, Prozac, and Zyprexa. The inquiry includes a review of our Medicaid best price reporting related to the product sales covered by the rebate agreements.

~~In June 2005, we received a subpoena from~~corporate integrity agreement with the Office of ~~the Attorney~~Inspector General ~~Medicaid Fraud Control Unit,~~(OIG) of the ~~State~~U.S. Department of ~~Florida, seeking production~~Health and Human Services (HHS), which requires us to maintain our compliance program and to undertake a set of ~~documents relating~~defined corporate integrity obligations for five years. The agreement also provides for an independent third-party review organization to ~~sales of Zyprexa~~assess and ~~our marketing~~report on the company’s systems, processes, policies, procedures, and ~~promotional practices with respect to Zyprexa.~~practices.

In September 2006, we received a subpoena from the California Attorney General’s Office seeking production of documents related to our efforts to obtain and maintain Zyprexa’s status on California’s formulary, marketing and promotional practices with respect to Zyprexa, and remuneration of health care providers.

~~In February 2007, we received a subpoena from~~ We expect this matter to be resolved if California participates in the ~~Office~~state component of the Attorney General of the State of Illinois seeking production of documents and information relating to sales of Zyprexa and our marketing and promotional practices, including our communications with physicians and remuneration of physician consultants and advisors, with respect to Zyprexa.EDPA resolution.

~~Beginning in August 2006, we received civil investigative demands or subpoenas from the attorneys general of a number of states under various state consumer protection laws. Most of these~~

~~requests became part of a multistate investigative effort coordinated by an executive committee of attorneys general.~~ In October 2008, we reached a settlement with 32 states and the District of ~~Columbia.~~Columbia related to a multistate investigation brought under various state consumer protection laws. While there is no finding that we have violated any provision of the state laws under which the investigations were conducted, we ~~will pay $62~~accrued and paid $62.0 million and agreed to undertake certain commitments regarding Zyprexa for a period of six years, through consent decrees filed inwith the settling states. The 32 states participating in the Multistate agreement are: Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.

We are cooperating in each of these investigations, including providing a broad range of documents and information relating to the investigations. 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. Except to the extent described above, we cannot 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.

Product Liability and Related Litigation

We have been named as a defendant in a large number of Zyprexa product liability lawsuits in the ~~United States~~U.S. 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 majority of non-federal cases are pending in the state court of Indiana.~~

Since June 2005, we have entered into agreements with various claimants’ attorneys involved in U.S. Zyprexa product liability litigation to settle a substantial majority of the claims. The agreements cover a total of approximately ~~31,350~~32,670 claimants, including a large number of previously filed lawsuits and other asserted claims. The two primary settlements were as follows:

	•		In ~~June~~ 2005, we ~~reached an agreement in principle (and in September 2005 a final agreement) to settle~~settled and paid more than 8,000 claims for $690.0 million, plus $10.0 million to cover administration of the settlement.

	•		In ~~January~~ 2007, we ~~reached agreements with a number of plaintiffs’ attorneys to settle~~settled and paid more than 18,000 claims for approximately $500 million.

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 residents of Quebec, and a second has been certified in Ontario and includes all Canadian residents except for residents of Quebec and British Columbia. The allegations in the Canadian actions are similar to those in the litigation pending in the U.S.

Since the beginning of 2005, we have recorded aggregate net pretax charges of $1.61 billion for Zyprexa product liability matters. The net charges, which take into account our actual insurance recoveries, covered the following:

	•		The cost of the Zyprexa product liability settlements to date; and

	•		Reserves for product liability exposures and defense costs regarding the known Zyprexa product liability claims and expected future claims to the extent we could formulate a reasonable estimate of the probable number and cost of the claims.

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 (EDNY). 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. We have been served with similar lawsuits filed by the states of Alaska, Arkansas, Connecticut, Idaho, Minnesota, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia in the courts of the respective states. The Connecticut, Idaho, Louisiana, Minnesota, Mississippi, Montana, New Mexico, and West Virginia cases are part of the MDL proceedings in the EDNY. The Alaska case was settled in March 2008 for a payment of $15.0 million, plus terms designed to ensure, subject to certain limitations and conditions, that Alaska is treated as favorably as certain other states that may settle with us in the future over similar claims. The following cases have been set for ~~trial in 2009:~~trial: Connecticut in the EDNY in ~~June, Pennsylvania in~~ November 2009, and South Carolina in ~~August,~~September 2009 and Pennsylvania in April 2010, both in their respective states.

In 2005, two lawsuits were filed in the EDNY purporting to be nationwide class actions on behalf of all consumers and third-party payors, excluding governmental entities, which have made or will make payments for their members or insured patients being prescribed Zyprexa. These actions have now been consolidated into a single lawsuit, which is brought under certain state consumer protection statutes, the federal civil RICO statute, and common law theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys’ fees. Two additional lawsuits were filed in the EDNY in 2006 on similar grounds. In September 2008, Judge Weinstein certified a class consisting of third-party payors, excluding governmental entities and individual consumers. We appealed the certification order, and Judge Weinstein’s order denying our motion for summary judgment, in September 2008. In 2007, The Pennsylvania Employees Trust Fund brought claims in state court in Pennsylvania as insurer of Pennsylvania state employees, who were prescribed Zyprexa on similar grounds as described in the New York cases. 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. The Pennsylvania case is set for trial in ~~October~~June 2009.

We cannot determine with certainty the additional number of lawsuits and claims that may be asserted. The ultimate resolution of Zyprexa product liability and related litigation could have a

few years, we have experienced difficulties in obtaining product liability insurance due to a very restrictive insurance market. Therefore, for substantially all of our currently marketed products, we have been and expect that we will continue to be completely self-insured for future product liability losses. In addition, there is no assurance that we will be able to fully collect from our insurance carriers ~~on past claims.~~in the future.

Environmental Matters

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 limited liability insurance coverage for certain environmental liabilities.

Note ~~12:~~13: Other ~~Income~~ — Net, Expense (Income)

Other ~~income~~ — net, ~~consisted of~~expense (income) comprised the following:


	Three Months Ended						Nine Months Ended
	September 30,						September 30,						Three Months Ended March 31,
	2008			2007			2008			2007			2009			2008
	(Dollars in millions)												(Dollars in millions)
Interest expense	$	44.0		$	55.8		$	146.4		$	167.9		$	87.6		$	59.8
Interest income		(53.2	)		(49.6	)		(156.8	)		(157.0	)		(27.4	)		(56.3	)
Joint-venture income		—			—			—			(11.0	)
Other		6.7			(56.0	)		(44.7	)		(89.8	)		10.5			(23.8	)

	$	(2.5	)	$	(49.8	)	$	(55.1	)	$	(89.9	)	$	70.7		$	(20.3	)

~~Posilac®~~

On October 1, 2008, we acquired the worldwide rights to the dairy cow supplement, Posilac (sometribove), as well as the product’s supporting operations, from Monsanto Company (Monsanto). The acquisition of Posilac provides us with a product that complements those of our animal health product line. Under the terms of the agreement, we acquired the rights to the Posilac brand, as well as the product’s U.S. sales force and manufacturing facility for a $300.0 million upfront payment as well as contingent consideration based on future Posilac sales. The allocation of the purchase price has not been finalized; however, we do not anticipate incurring an IPR&D charge.

This acquisition will be accounted for as a business combination under the purchase method of accounting, which requires the assets acquired and liabilities assumed from Monsanto to be recorded at their respective fair values as of the acquisition date in our consolidated financial statements. The results of operations will be included in our consolidated financial statements from the date of acquisition.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

OPERATING RESULTS

Executive Overview

I. Financial Results

~~Worldwide sales increased 14 percent and 13 percent~~Our worldwide revenue for the ~~third~~ quarter ~~and first nine months of 2008, respectively,~~increased 5 percent, to $5.05 billion, driven primarily by the collective growth of Cymbalta, Alimta, ~~Cialis, Humalog,~~ and ~~Gemzar,~~Humulog, and by the ~~favorable impact~~inclusion of ~~foreign exchange rates. Third-quarter net loss was $465.6 million and loss per share was $.43~~Erbitux revenue as ~~compared to 2007 net income~~a result of ~~$926.3 million and earnings per share of $.85.~~the ImClone acquisition in November 2008. Net income and earnings per share ~~decreased 26 percent~~ for the ~~first-nine-months~~first quarter of ~~2008,~~2009 increased to ~~$1.56~~$1.31 billion and ~~$1.42,~~$1.20, respectively, as compared with $1.06 billion and $.97, respectively, for the ~~same period~~first quarter of ~~2007.~~2008. Net income for the first ~~nine months~~quarter of 2008 ~~and the first nine months of 2007~~ was affected by the following significant items:

~~2008~~

	•		We recorded charges of $1.48 billion (pretax) related to the pending Zyprexa investigations led by the U.S. Attorney for the Eastern District of Pennsylvania, as well as the resolution of a multi-state investigation regarding Zyprexa involving 32 states and the District of Columbia, which decreased earnings per share by $1.33 in the third quarter.

	•		We recognized asset impairments, restructuring, and other special charges of $182.4 million (pretax), primarily associated with previously-announced strategic exit activities related to our Greenfield, Indiana site, which decreased earnings per share by $.11 in the third quarter.

	•		We incurred an in-process research and development (IPR&D) charge associated with the acquisition of SGX Pharmaceuticals, Inc. (SGX) of $28.0 million (pretax), which decreased earnings per share by $.03 in the third quarter.

	•		We recognized restructuring and other special charges of $88.9 million (pretax), primarily associated with previously-announced strategic exit activities related to manufacturing operations, which decreased earnings per share by $.05 in the second quarter.

	•		We recognized asset impairments associated with certain manufacturing operations (included in cost of sales) of $57.1 million (pretax), which decreased earnings per share by $.04 in the second quarter.

	•		~~We incurred an IPR&D charge associated with the licensing arrangement with TransPharma Medical Ltd. of $35.0 million (pretax), which decreased earnings per share by $.02 in the second quarter.~~

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	•		We recognized a discrete income tax benefit of $210.3 million as a result of the resolution of a substantial portion of the IRS audit of our federal income tax returns for years 2001 through 2004, which increased earnings per share by ~~$.19 in the first quarter.~~$.19.

	•		We recognized asset impairments, restructuring (exit costs), and other special charges of $145.7 million ~~(pretax)~~(pre-tax), primarily associated with certain impairment, termination, and wind-down costs resulting from the termination of the AIR Insulin program, which decreased earnings per share by ~~$.09 in the first quarter.~~$.09.

	•		We incurred an IPR&D ~~charge~~charges associated with the licensing arrangement with BioMS Medical Corp. of $87.0 million (pretax), which decreased earnings per share by ~~$.05 in the first quarter.~~$.05.

~~2007~~II. Late-Stage Pipeline Developments

	•		The U.S. FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). We ~~incurred~~are awaiting final FDA action on prasugrel.

	•		The European Commission granted marketing authorization for Efient (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing PCI. The product has now been launched in both Germany and the United Kingdom.

	•		The FDA approved a ~~special charge following a settlement with one~~new indication for Symbyax® for the acute treatment of ~~our insurance carriers over~~treatment-resistant depression (TRD) in adults.

	•		The FDA approved two new combination indications for Zyprexa ~~product liability claims, which led to a reduction~~(olanzapine) and fluoxetine for the acute treatment of ~~our expected product liability insurance recoveries. This resulted~~bipolar depression and TRD in ~~a charge of $81.3 million (pretax), which decreased earnings per share by $.06 in the third quarter.~~adults.

	•		We ~~incurred IPR&D charges associated with~~received a complete response letter from the ~~acquisition of Hypnion of $291.1 million (no tax benefit) and the acquisition of Ivy of $37.0 million (pretax), which decreased earnings per share by $.29 in the second quarter.~~

	•		We incurred IPR&D charges associated with the acquisition of ICOS of $303.5 million (no tax benefit) and the licensing arrangement with OSI Pharmaceuticals of $25.0 million (pretax), which decreased earnings per share by $.29 in the first quarter.

	•		We recognized asset impairments, restructuring, and other special charges associated with previously announced strategic decisions affecting manufacturing and research facilities of $123.0 million (pretax), which decreased earnings per share by $.08 in the first quarter.

~~II. Late-Stage Pipeline Developments and Business Development Activity in 2008~~

~~Pipeline~~

	•		~~We, along with our partner Daiichi Sankyo Company, Limited, confirmed that the U.S. Food and Drug Administration (FDA) did not complete its review~~FDA for the prasugrel New Drug Application (NDA) by the Prescription Drug User Fee Act goal date of September 26, 2008. We continue to have discussions with the FDA regarding the review of this application. We are seeking FDA approval for prasugrel as a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention. We also submitted prasugrel to the European Medicines Agency (EMEA) for the same indication.

	•		~~In September, the FDA approved Alimta, in combination with cisplatin, as a~~ first-line treatment for locally advanced and metastatic non-small cell lung cancer (NSCLC) for patients with nonsquamous histology. In April, the European health authorities approved Alimta, in combination with cisplatin, as a first-line treatment for non-small-cell lung cancer patients with other than predominantly squamous cell ~~histology.~~

	•		~~We submitted tadalafil as a treatment~~carcinoma of the head and neck (SCCHN) supplemental Biologics License Application (sBLA) for ~~pulmonary arterial hypertension (PAH) to regulatory authorities in both the U.S. and Japan.~~

	•		~~The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Zypadhera~~^TM (also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine. The opinion issued by the CHMP will need to be ratified by the European Commission before the new indication is considered approved.

	•		~~In July, the European Commission approved Cymbalta for the treatment of generalized anxiety disorder (GAD).~~

	•		~~In June, the FDA approved Cymbalta for the management of fibromyalgia, a chronic widespread pain disorder.~~Erbitux.

	•		We submitted a ~~supplemental New Drug Application (sNDA)~~reply to the FDA ~~seeking approval for a new indication for Cymbalta for~~regarding the ~~management of chronic pain.~~

	•		~~In May, the FDA approved Strattera for maintenance treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents.~~

	•		~~We, along with our partner Amylin Pharmaceuticals, Inc., submitted Byetta® as a monotherapy treatment for type 2 diabetes to the FDA.~~

	•		In April, the European Commission approved a new indication for Forsteo® for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. We have also received an approvableagency’s complete response letter ~~from the FDA for Forteo® for the same indication.~~

	•		In March, we terminated development of our AIR Insulin program, which was being conducted in collaboration with Alkermes, Inc. The program had been in Phase III clinical development as a potential treatment for type 1 and type 2 diabetes. We noted that this decision is not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.

	•		~~In February, we received a not-approvable letter from the FDA~~ for Zyprexa long-acting injection for the treatment and maintenance treatment of schizophrenia in adults. In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1 percent of patients in clinical trials. In the second quarter, we submitted a complete response to the FDA’s not-approvable decision.

~~Business Development~~

	•		In October, we along with ImClone Systems, Inc. (ImClone), approved a definitive merger agreement to acquire ImClone through an all-cash tender offer of $70 per share, or approximately $6.5 billion. We expect the transaction to close in either the fourth quarter of 2008 or the first quarter of 2009. If we close in the fourth quarter, we will incur a one-time charge to earnings for IPR&D, but it is premature to estimate what that charge would be.

	•		In October, we acquired the worldwide rights to the dairy cow supplement, Posilac (sometribove), as well as the product’s supporting operations, from Monsanto Company (Monsanto) for an upfront payment of $300.0 million, as well as contingent consideration based on future Posilac sales. The acquisition of Posilac provides us with a product that complements those of our animal health product line, and will be included in our results of operations from the date of acquisition.

	•		~~In October, we sold our Greenfield Laboratories site in Greenfield, Indiana, to Covance Inc.~~injection. We also ~~signed a 10-year service agreement,~~launched this product under ~~which Covance will assume responsibility for our toxicology testing and other R&D support activities at~~ the ~~site.~~

	•		In August, we acquired SGX for approximately $64 million in cash. The acquisition allows us to integrate SGX’s structure-guided drug discovery platform into our drug discovery efforts. It also gives us access to FASTtradename Zypadhera^TM~~, SGX’s fragment-based, protein structure guided drug discovery technology, and to a portfolio of preclinical oncology compounds focused on a number of kinase targets.~~ in several countries within the European Union.

	•		In June, we entered into a licensing and development agreement with TransPharma Medical Ltd. (TransPharma) to acquire rights to its product and related drug delivery system for the treatment of osteoporosis. The product, which is administered transdermally using TransPharma’s proprietary technology, is currently in Phase II clinical testing.

	•		In the second quarter, we entered into an agreement with an affiliate of TPG-Axon Capital (TPG) for the Phase III development of our two lead molecules for the treatment of Alzheimer’s disease. This agreement provides TPG with success-based milestones and royalties in exchange for clinical trial funding.

	•		In March, we entered into a licensing and collaboration agreement with Transition Therapeutics Inc. in which we were granted exclusive worldwide rights to develop and commercialize Transition’s gastrin-based therapies, including the lead compound TT-223, which is currently in early Phase II testing as a potential treatment for type 2 diabetes.

III. Legal, Regulatory, and Other Matters

We have reached agreements with claimants’ attorneys involved in U.S. Zyprexa product liability litigation to settle a total of approximately 31,350 claims against us relating to the medication. Approximately 1,615 claims remain. As a result of our product liability exposures, since the beginning of 2005, we have recorded aggregate net pretax charges of $1.61 billion for Zyprexa product liability matters.

In March 2004, we were notified by the U.S. Attorney’s office for the ~~Eastern District of Pennsylvania (EDPA)~~EDPA that it had commenced an investigation relating to our U.S. marketing and promotional practices for Zyprexa, Prozac, and Prozac Weekly. In ~~November 2007, we received a grand jury subpoena from the EDPA requesting documents related to Zyprexa. In~~ October 2008, we announced that we ~~are~~were in advanced discussions to resolve the ongoing investigations led by the EDPA, and we recorded a charge of $1.42 billion. ~~The charge reflects our currently estimable exposure with respect to these matters. If~~In January 2009, we announced that the ~~ongoing~~ discussions ~~are~~had been successfully concluded, and that we ~~expect that they would settle~~settled the Zyprexa-related federal claims, as well as similar Medicaid-related claims of states ~~participating~~which decided to participate in the settlement.

~~Beginning~~ In addition, in ~~August 2006, we received civil investigative demands or subpoenas from the attorneys general of a number of states under various state consumer protection laws seeking Zyprexa documents. In~~ October 2008, we reached a settlement with 32 states and the District of ~~Columbia. While there is no finding that we have violated any provision of the~~Columbia related to a multistate investigation brought under various state consumer protection laws, under which we paid $62.0 million. However, we have been served with lawsuits brought by Alaska, Arkansas, Connecticut, Idaho, Louisiana, Minnesota, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia, alleging that Zyprexa caused or contributed to diabetes or high blood-glucose levels, and that we improperly promoted the ~~investigations were conducted, we~~drug and seeking to recover the costs paid for Zyprexa through Medicaid and other drug-benefit programs, as well as the costs alleged to have been incurred and that will ~~pay $62.0 million and undertake certain commitments regarding Zyprexa~~be incurred to treat Zyprexa-related illnesses. The Alaska case was settled in March 2008 for a ~~period~~payment of ~~six years, through consent decrees filed~~$15.0 million, plus terms designed to ensure, subject to certain limitations and conditions, that Alaska is treated as favorably as certain other states that may settle with us in the ~~settling states.~~future over similar claims. The cases in Connecticut and South Carolina have been set for trial in 2009; the trial in Pennsylvania is scheduled for 2010.

In the third quarter of 2008, we initiated a strategic review of our Tippecanoe ~~Labs~~manufacturing facility in Lafayette, Indiana. Options being considered for this site include continuing operations with a revised site mission, exploring opportunities to sell the facility, and ceasing operations altogether. The review is expected to last ~~six~~up to ~~twelve~~12 months. No final decisions

have been made at this time; however, depending on the decision, we could record significant charges.

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), continues to ~~effectively~~ provide aan effective prescription drug benefit under the Medicare program (known as Medicare Part D). Uncertainty exists surrounding the new administration and Congress and the impact any government decisions or programs will have on the pharmaceutical industry. Various measures have been discussed and/or passed in both the U.S. House of Representatives and U.S. Senate that would impose additional pricing pressures on our products, including proposals to legalize the importation of prescription drugs and either allow, or require, the Secretary of Health and Human Services to negotiate drug prices within Medicare Part D directly with pharmaceutical manufacturers. Additionally, various proposals have been introduced that would increase the rebates we pay on sales to Medicaid ~~patients.~~patients or impose additional rebates on sales to patients who receive their medicines through Medicare Part D or other government programs. Further, proposals to expand coverage to the uninsured could include some form of price rebates or tax on the pharmaceutical industry. In addition, many U.S. states are facing substantial budget difficulties due to the downturn in the economy and are expected to seek aggressive cuts or other offsets in healthcare spending. We expect pricing pressures at the federal and state levels to ~~continue.~~become more severe, which could have a material adverse effect on our consolidated results of operations.

In its preliminary budget submission to Congress, the new administration proposed changes to the manner in which the U.S. would tax the international income of U.S.-based companies. While it is uncertain how the U.S. Congress may address this issue, reform of U.S. taxation of international income continues to be a topic of discussion for the U.S. legislature. A significant change to the U.S. tax system that would change the taxation of international income could have a material adverse effect on our consolidated results of operations.

In addition, the federal government is considering creating a regulatory pathway for biosimilars (copies) for the majority of biologic products in the U.S.; the proposals vary as to which biologic products would be eligible, how quickly a biosimilar might reach the market, and the ability to interchange the biosimilar and the original biologic product at the pharmacy.

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, limit access to reimbursement for our products, or reduce the value of our intellectual property protection.

~~Sales~~Revenue

~~Third-quarter and first-nine-months 2008 sales growth of 14~~Revenue increased 5 percent, ~~and 13 percent, respectively, was~~to $5.05 billion, driven primarily by the increase in net product sales related to the collective growth of Cymbalta, Alimta, ~~Cialis, Humalog,~~ and ~~Gemzar,~~Humulog, and the increase in collaboration and other revenue due to the inclusion of Erbitux revenue as a result of the ImClone acquisition. Revenue in the U.S. increased by $325.3 million, or 13 percent, for the ~~favorable~~first quarter of 2009 compared with the first quarter of 2008. Revenue outside the U.S. decreased $85.9 million, or 4 percent, for the first quarter of 2009 due to the negative impact of foreign exchange rates. ~~Sales in the U.S.~~Worldwide volume increased ~~by $291.9 million, or 12~~7 percent, and $704.4 million, or 10 percent, for the third quarter and first nine months of 2008, respectively, compared with the same periods of 2007. Sales outside the U.S. increased $330.9 million, or 16 percent, and $1.02 billion, or 17 percent, for the third quarter and first nine months of 2008, respectively. For the third quarter of 2008, worldwide sales volume, exchange rates, andwhile selling prices contributed ~~6 percent, 4 percent, and~~ 3 percent ~~respectively, to worldwide~~of sales growth, partially offset by the unfavorable impact of foreign exchange rates of 6 percent (numbers do not add due to rounding). ~~For the first nine months of 2008,~~

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~~worldwide sales volume, exchange rates, and selling prices contributed 6 percent, 5 percent, and 2 percent, respectively, to worldwide sales growth.~~

The following ~~tables summarize~~table summarizes our ~~net sales~~revenue activity for the ~~three-~~three months ended March 31, 2009 and ~~nine-month periods ended September 30, 2008 and 2007:~~2008:

Three Months Ended
Three Months Ended September 30, Percent
September 30, 2008 2007 Change
Product U.S.¹ Outside U.S. Total Total From 2007
(Dollars in millions)

Zyprexa $ 555.6 $ 633.9 $ 1,189.5 $ 1,166.1 2
Cymbalta 597.1 119.3 716.4 513.2 40
Gemzar 189.2 251.0 440.2 394.4 12
Humalog 245.1 187.5 432.6 362.5 19
Cialis 139.8 236.8 376.6 311.4 21
Alimta 149.3 164.6 313.9 215.0 46
Animal health products 127.9 149.2 277.1 236.6 17
Humulin 95.1 176.5 271.6 243.3 12
Evista 170.8 94.9 265.7 263.2 1
Forteo 117.0 75.7 192.7 180.5 7
Strattera 109.5 40.0 149.5 130.5 15
Other pharmaceutical products 272.6 311.1 583.7 570.1 2

Total net sales $ 2,769.0 $ 2,440.5 $ 5,209.5 $ 4,586.8 14


							Nine Months										Three Months
							Ended				Three Months Ended						Ended
	Nine Months Ended						September 30,		Percent		March 31, 2009						March 31,		Percent
	September 30, 2008						2007		Change				Outside				2008		Change
Product	U.S.¹		Outside U.S.		Total		Total		From 2007		U.S.¹		U.S.		Total		Total		from 2008
	(Dollars in millions)										(Dollars in millions)

Zyprexa	$	1,618.5	$	1,931.0	$	3,549.5	$	3,487.1		2	$	535.4	$	587.6	$	1,123.0	$	1,120.2		0
Cymbalta		1,651.1		324.8		1,975.9		1,474.6		34		597.1		112.2		709.3		605.1		17
Humalog^®												286.2		164.4		450.6		407.4		11
Gemzar		548.3		758.2		1,306.5		1,166.9		12		169.4		198.4		367.8		426.2		(14	)
Humalog		733.2		544.6		1,277.8		1,060.4		21
Cialis²		391.2		684.5		1,075.7		797.6		35
Cialis^®												149.1		209.7		358.8		336.9		6
Alimta		400.8		435.2		836.0		610.0		37		172.8		162.5		335.3		247.2		36
Animal health products												153.6		110.5		264.1		235.3		12
Evista		520.4		286.2		806.6		805.0		—		163.8		93.1		256.9		261.1		(2	)
Humulin		279.8		521.0		800.8		711.9		12
Animal health products		352.3		414.6		766.9		666.5		15
Forteo		364.7		219.6		584.3		511.1		14
Strattera		326.4		106.3		432.7		412.6		5
Humulin^®												99.0		141.6		240.6		257.7		(7	)
Forteo^®												121.8		65.7		187.5		185.0		1
Strattera^®												115.6		43.3		158.9		148.0		7
Other pharmaceutical products		809.5		945.3		1,754.8		1,740.2		—		173.0		266.0		439.0		479.3		(8	)

Total net sales	$	7,996.2	$	7,171.3	$	15,167.5	$	13,443.9		13
Total net product sales												2,736.8		2,155.0		4,891.8		4,709.4		4
Collaboration and other revenue²												135.1		20.1		155.2		98.2		58

Total revenue											$	2,871.9	$	2,175.1	$	5,047.0	$	4,807.6		5


²		~~Prior to the acquisition~~Collaboration and other revenue is primarily comprised of ~~ICOS in January 2007, the Cialis sales shown~~Erbitux royalties and 50 percent of Byetta’s gross margin in the table above represent results only in the territories in which we marketed Cialis exclusively. The remaining sales for that one-month period 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 and taxes, is reported in other income — net in our consolidated condensed income statement. Subsequent to the acquisition, all Cialis product sales are included in our net sales in our consolidated condensed income statement. Cialis sales for the first nine months of 2008 represent 24 percent growth over total worldwide sales of $870.3 million for the first nine months of 2007, which includes the joint-venture territory sales.U.S.

Product Highlights

Zyprexa, our top-selling product, is a treatment for schizophrenia, acute mixed or manic episodes associated with bipolar I disorder, and bipolar maintenance. In the ~~third~~first quarter of ~~2008,~~2009, Zyprexa sales in the U.S. increased 37 percent compared with the ~~third~~first quarter of ~~2007,~~2008, driven by ~~increased net effective selling~~higher prices and the favorable impact of wholesaler buying patterns, partially offset ~~partially~~ by decreased demand. ~~In the first nine months of 2008, U.S. Zyprexa sales decreased 1 percent compared with the same period of 2007 driven by decreased demand, offset partially by increased prices.~~ Sales outside the U.S. ~~increased 1~~decreased 5 percent, ~~and 4 percent during the third quarter and first nine months of 2008, respectively,~~ driven by the ~~favorable~~unfavorable impact of foreign exchange rates, partially offset by ~~decreased demand and decreased prices.~~increased demand. Demand outside the U.S. was ~~unfavorably~~favorably impacted by the withdrawal of generic competition in ~~Canada and Germany, offset by growth in Japan and several European markets.~~Germany.

U.S. sales of Cymbalta, a product for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, and fibromyalgia, increased ~~34 percent and 28~~17 percent during the ~~third~~first quarter of 2009, driven by increased demand, higher prices, and ~~first nine months~~the favorable impact of ~~2008, respectively,~~wholesaler buying patterns. Sales outside the U.S. increased 19 percent, driven primarily by increased demand, and, to a lesser extent, increased prices. Sales outside the U.S. increased 73 percent and 74 percent, respectively, driven primarily by increased demand and, to a lesser extent, the favorable impact of foreign exchange rates. Increased demand outside the U.S. reflects both increased demand in established markets, as well as recent launches in new markets.

U.S. sales of Gemzar, a product approved to fight various cancers, increased 14 percent and 11 percent during the third quarter and first nine months of 2008, respectively, driven by increased demand and increased prices. Sales outside the U.S. increased 10 percent and 13 percent, respectively, driven primarilypartially offset by the ~~favorable~~unfavorable impact of foreign exchange rates.

U.S. sales of Humalog, our injectable human insulin analog for the treatment of diabetes, increased
13 20 percent ~~and 15 percent for~~during the ~~third~~first quarter ~~and first nine months~~ of ~~2008, respectively,~~2009, driven by ~~increased demand~~higher prices and ~~to a lesser extent,~~ increased ~~net effective selling prices.~~

demand. Sales outside the U.S. ~~increased 28 percent and 29~~decreased 3 percent during ~~both periods, respectively,~~the first quarter driven by the unfavorable impact of foreign exchange rates, partially offset by increased ~~demand~~demand.

U.S. sales of Gemzar, a product approved to fight various cancers, decreased 4 percent during the first quarter of 2009, due to the unfavorable impact of wholesaler buying patterns and lower net effective selling prices, partially offset by increased demand. Sales outside the U.S. decreased 21 percent as a result of the unfavorable impact of foreign exchange rates, lower prices and the ~~favorable impact~~entry of ~~exchange rates.~~generic competition in most major markets.

~~Total worldwide~~U.S. sales of Cialis, a treatment for erectile dysfunction, increased 21 percent ~~and 24 percent~~ during the ~~third quarter and~~ first nine months of 2008, respectively. This comparison includes $72.7 million of sales in the Lilly ICOS joint-venture territories for the one-month period prior to the acquisition of ICOS in January 2007. Prior to the ICOS acquisition, Cialis sales in our territories were reported in revenue, while our 50 percent share of the joint-venture net income was reported in other income — net. Total U.S. sales increased 20 percent during the third quarter of ~~2008,~~2009, driven by ~~increased~~higher prices, and, to a lesser extent, increased demand. For the first nine months of 2008, U.S. sales increased 20 percent, driven by increased demand and, to a lesser extent, increased prices. Total sales outside the U.S. increased 22 percent during the third quarter of 2008, driven primarily by the favorable impact of foreign exchange rates and increased demand. For the first nine months of 2008, sales outside the U.S. increased 26 percent, driven primarily by increased demand, and the favorable impact of wholesaler buying patterns. Sales outside the U.S. decreased 2 percent, driven by the unfavorable impact of foreign exchange ~~rates.~~rates, partially offset by increased demand and higher prices.

U.S. sales of Alimta, a treatment for various cancers, increased ~~35 percent and 24~~42 percent during the ~~third~~first quarter ~~and first nine months~~ of ~~2008, respectively, driven by increased demand. Alimta~~

~~sales outside the U.S. increased 58 percent and 51 percent during the same periods, driven by~~2009, due primarily to increased demand, and to a lesser extent, higher prices. Sales outside the ~~favorable~~U.S. increased 30 percent, due to increased demand, partially offset by the unfavorable impact of foreign exchange rates.

U.S. sales of Evista, a product for the prevention and treatment of osteoporosis in postmenopausal women and for risk reduction of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer, ~~increased 1~~decreased 4 percent ~~and remained essentially flat~~ during the ~~third~~first quarter ~~and first nine months~~ of ~~2008, respectively, driven by increased prices,~~2009, as a result of decreased demand, partially offset by ~~decreased demand. Evista sales~~higher prices. Sales outside the U.S. increased 14 percent for the third quarter of 2008, driven by the favorable impact of foreign exchange rates and increased prices, offset by decreased volume. Sales outside the U.S. for the first nine months of 2008 remained essentially flat due to the favorable impact of buying patterns in Japan, partially offset by the unfavorable impact of foreign exchange ~~rates, offset by decreased demand and decreased prices.~~rates.

U.S. sales of Humulin, an injectable human insulin for the treatment of diabetes, increased ~~by 5 percent and~~ 6 percent during the ~~third~~first quarter ~~and first nine months~~ of ~~2008, respectively, driven primarily by~~2009, due to higher net effective selling ~~prices. Humulin sales~~prices and increased demand. Sales outside the U.S. ~~increased 16~~decreased 14 percent ~~for both periods,~~ driven by the ~~favorable~~unfavorable impact of foreign exchange rates, and ~~increased demand.~~to a lesser extent, lower prices.

U.S. sales of Forteo, an injectable treatment for osteoporosis in postmenopausal women and men at high risk for fracture, ~~decreased 6~~increased 3 percent during the ~~third~~first quarter of ~~2008, driven by changes in wholesaler buying patterns, offset partially by~~2009, due to higher net effective selling ~~prices. For~~prices, partially offset by decreased demand. Sales outside the ~~first nine months of 2008, sales increased 3~~U.S. decreased 1 percent, due to ~~increased prices, offset partially by decreased demand. Forteo sales outside~~ the ~~U.S. grew 36 percent and 41 percent during the same periods, respectively, driven by increased demand and the favorable~~unfavorable impact of foreign exchange ~~rates.~~rates, partially offset by increased demand.

U.S. sales of Strattera, a treatment ~~for~~of attention-deficit hyperactivity disorder in children, adolescents, and adults, ~~increased 6 percent~~were essentially flat during the ~~third~~first quarter of ~~2008 driven primarily by increased prices. For the first nine months of 2008, sales decreased 4 percent driven~~2009, due to higher net effective selling prices offset by decreased ~~demand, offset partially by increased prices. Strattera sales~~demand. Sales outside the U.S. increased 4933 percent, ~~and 43 percent during the same periods, respectively,~~ driven by a one-time benefit from the resolution of pricing discussions in Canada, and to a lesser extent, increased demand, ~~and~~partially offset by the ~~favorable~~unfavorable impact of foreign exchange ~~rates, and for the third quarter of 2008, increased net effective selling prices.~~rates.

~~Worldwide sales of~~We market Byetta, an injectable product for the treatment of type 2 diabetes, ~~which we market~~ with Amylin ~~Pharmaceuticals (Amylin), increased 22 percent to $201.2 million and 21 percent to $564.9~~. For the first quarter of 2009, we recognized total revenue of $97.5 million for ~~the third quarter and first nine months~~Byetta, an increase of ~~2008, respectively. We report as~~18 percent, comprised of collaboration revenue of $70.2 million related to our 50 percent share of Byetta’s gross margin in the U.S., ~~100 percent~~and product sales of $27.3 million related to sales outside the U.S., and our sales of Byetta pen delivery devices to Amylin. ~~Our revenues~~Worldwide sales of Byetta increased ~~25 percent and 23~~7 percent to ~~$109.2 million and $293.1~~$181.4 million during the ~~third~~first quarter of 2009, driven by growth in international markets. U.S. sales of Byetta of $157.7 million were essentially flat in the first quarter whiles sales of Byetta outside the U.S. were $23.7 million.

For the first quarter, we recognized total revenue of $94.1 million for Erbitux, a product approved to fight cancers, comprised of collaboration revenue of $68.0 million related to the net royalties

received from our collaboration partners, and ~~first nine months~~product sales of ~~2008, respectively.~~$26.1 million related to revenue from manufactured product.

Animal health product sales in the U.S. increased 1443 percent, ~~and 17 percent during~~primarily due to the ~~third quarter and first nine months~~inclusion of ~~2008, respectively, driven by increased demand and~~Posilac sales from the ~~2007 launch of Comfortis~~^TM~~, a new companion animal product that kills fleas and prevents flea infestations on dogs, and for the first nine months of 2008, the impact~~acquisition of the ~~2007 acquisition of Ivy Animal Health, Inc.~~product in October 2008. Sales outside the ~~U.S increased 20~~U.S. decreased 13 percent, ~~and 14 percent, compared to the same periods in 2007,~~ driven primarily by ~~increased demand and~~ the ~~favorable~~unfavorable impact of foreign exchange ~~rates.~~rates, and to a lesser extent, decreased demand and lower prices.

Gross Margin, Costs, and Expenses

For the ~~third~~first quarter of ~~2008,~~2009, gross margins as a percent of ~~net sales~~total revenue increased ~~by .8~~6.9 percentage points, to ~~77.8~~83.8 percent. This increase was due to the impact on international inventories from the decline in foreign currencies compared to the U.S. dollar, resulting in a benefit to cost of sales.

Operating expenses (the aggregate of research and development and marketing, selling, and administrative expenses) increased 2 percent ~~driven by higher product prices and manufacturing expenses growing at a slower rate than sales. For~~for the first ~~nine months~~quarter of ~~2008, gross margins as a percentage~~2009 compared with the first quarter of ~~net sales decreased by .8 percentage points,~~2008. Marketing, selling, and administrative expenses declined 1 percent to ~~77.1 percent. This decrease was primarily~~$1.53 billion, due to the impact of foreign exchange rates and ~~the inclusion~~a reduction in ~~cost of sales of asset impairments at certain manufacturing facilities of $57.1 million,~~expenses related to U.S. marketing programs, partially offset by ~~manufacturing~~the impact of the ImClone acquisition and increased prasugrel pre-launch activities. Research and development expenses ~~growing at a slower rate than sales.~~

~~Marketing, selling, and administrative expenses rose 12~~increased 8 percent to ~~$1.65 billion,~~$947.3 million, due primarily to the ImClone acquisition and ~~13 percent, to $4.90 billion, for the third quarter~~increased late-stage clinical trial and ~~first nine months of 2008, respectively. This increase was due to increased marketing and sales force expenses, including prelaunch expenses for prasugrel and marketing~~discovery research costs, ~~associated with Cymbalta and Evista,~~partially offset by the impact of foreign exchange rates, and increased litigation-related expenses. Research and development expenses were $953.0 million and $2.78 billion for the third quarter and first nine months of 2008, respectively, or 18 percent of sales. Compared with the third quarter and first nine months of 2007, research and development expenses increased 13 percent and 10 percent, respectively. This increase was primarily due to increased discovery research and late-stage clinical trial costs, and for the first nine months of 2008, to a $47.0 million expense for a milestone payment made to MacroGenics, Inc. related to progress in the clinical trials of teplizumab, offset by lower prasugrel clinical trial costs. The increase in research and development expenses for the first nine months of 2008 was also offset by the first-quarter 2007 costs associated with the consequences of the FDA’s rejection of our appeal of the approvable letter for Arxxant^TM ~~and the withdrawal of the Arxxant application in Europe.~~exchanges rates.

Acquired IPR&D charges were ~~$28.0 million and $150.0~~$87.0 million in the ~~third quarter and~~ first ~~nine months of 2008, respectively, compared with no charges for the third~~ quarter of ~~2007 and $656.6 million for the first nine months of 2007, respectively.~~2008. We ~~recognized~~incurred asset impairments, restructuring (exit costs), and other special charges of ~~$1.66 and $1.89 billion~~$145.7 in the ~~third~~first quarter of ~~2008 and first nine months of 2008, respectively, as compared to $81.3 million and $204.3 million in the third quarter and first nine months of 2007, respectively.~~2008. See Notes 3 4, and 115 to the consolidated condensed financial statements for additional information.

~~Other income —~~Other— net, expense (income) decreased ~~by $47.3~~$91.0 million, to ~~$2.5~~a net expense of $70.7 million, primarily due to lower interest income and ~~by $34.8 million, to $55.1~~higher interest expense associated with the ImClone acquisition, as well as lower business development income.

We incurred tax expense of $370.3 million for the ~~third quarter and~~ first nine months of 2008, respectively. Other income — net consists of interest expense, interest income, the after-tax operating results of the Lilly ICOS joint venture prior to the 2007 ICOS acquisition, and all other miscellaneous income and expense items.

	•		Interest expense for the third quarter and first nine months of 2008 decreased $11.8 million and $21.5 million, respectively, to $44.0 million and $146.4 million, respectively, driven by lower debt balances and lower interest rates in 2008 as compared with the same periods of 2007, offset partially by lower capitalized interest due to lower construction-in-progress balances.

	•		Interest income for the third quarter of 2008 increased $3.6 million to $53.2 million, driven primarily by higher average cash balances in the third quarter of 2008 as compared to the same period in 2007, offset by lower short-term interest rates. Interest income for the first nine months of 2008 decreased $.2 million to $156.8 million, driven by lower interest rates in 2008, offset by higher cash balances in 2008.

	•		~~The Lilly ICOS joint venture income prior to the 2007 acquisition was $11.0 million. Subsequent to the acquisition, all activity related to ICOS is included in our consolidated financial results.~~

	•		Net other miscellaneous income (loss) items for the third quarter and first nine months of 2008 decreased $62.7 million, to a loss of $6.7 million, and $45.1 million, to $44.7 million, respectively, driven by lower out-licensing income and the $10.9 million write-down of certain investment securities in the third quarter of 2008, offset partially by the gains on the sale of investment securities.

~~We recorded income tax expense of $232.8 million for the third~~ quarter of ~~2008 despite a net loss before income taxes, due to the uncertainty of the tax treatment of the Zyprexa charges. We recorded income tax expense of $472.3 million, an~~2009. The effective tax rate ~~of 23.3 percent, for the first nine months of 2008, down from 25.7 percent for the first nine months of 2007.~~was 22.0 percent. In the first quarter of 2008, we ~~recognized a discrete~~reported an aggregate income tax benefit of $8.0 million due to the recognition of $210.3 million ~~which was~~discrete benefit as a result of the resolution of a substantial portion of the IRS audit of our federal income tax returns for ~~the~~ years 2001 through 2004. ~~This item reduced~~

FINANCIAL CONDITION

As of March 31, 2009, cash, cash equivalents, and short-term investments totaled $3.51 billion compared with $5.93 billion at December 31, 2008. The decrease in cash is driven by a net reduction in short-term borrowings of $4.24 billion and dividends paid of $536.8 million, partially offset by proceeds of long-term debt issuances of $2.40 billion. Cash flow from operations was $87.9 million, which included payments related to the ~~effective tax rate~~EDPA settlement of $1.06 billion.

Total debt as of March 31, 2009 decreased by $1.99 billion, to $8.47 billion, reflecting the pay down of our commercial paper that was issued to finance our acquisition of ImClone and to fund payments required in connection with the EDPA settlements, partially offset by $2.40 billion of long- term debt we issued in March 2009. Our current debt ratings from Standard & Poor’s and Moody’s remain at AA and A1, respectively.

In the past several months, global economic conditions have deteriorated, triggered by the liquidity crisis in the capital markets, resulting in higher unemployment and declines in real consumer spending. In addition, many financial institutions tightened lines of credit, reducing funding available for ~~the first nine months of 2008. Furthermore, the in-process research and development charges~~near-term economic growth. Pharmaceutical consumption has traditionally been relatively unaffected by economic downturns; however, an extended downturn could lead to a decline in ~~2007 associated~~overall prescriptions corresponding with the growth of the

2930

~~acquisitions of ICOS~~uninsured and ~~Hypnion were not deductible, resulting~~underinsured population in ~~higher effective tax rates for 2007.~~

~~FINANCIAL CONDITION~~

~~As of September 30, 2008, cash, cash equivalents,~~the U.S. In addition, both private and short-term investments totaled $6.12 billion compared with $4.83 billion at December 31, 2007. Cash flows from operations of $4.92 billion during the first nine months of 2008 were offset by dividends paid of $1.54 billion, net purchases of property and equipment of $671.5 million, and net purchases of noncurrent investments of $641.9 million.

~~Total debt at September 30, 2008, was $4.61 billion, a decrease of $395.1 million from December 31, 2007. Subsequent~~public health care payers are facing heightened fiscal challenges due to the ~~announcement~~economic slowdown and are taking aggressive steps to reduce the costs of care, including pressures for increased pharmaceutical discounts and rebates and efforts to drive greater use of generic drugs. We continue to monitor the ~~proposed acquisition~~potential near-term impact of ~~ImClone, Standard & Poor’s affirmed~~prescription trends, the creditworthiness of our ~~AA/A+ long-term rating~~wholesalers and ~~our A-1 short-term rating. Moody’s Investors Service placed our Aa3 long-term rating under review for possible downgrade, but affirmed our Prime-1 short-term rating.~~other customers and suppliers, the decline of health insurance coverage in the overall population, and the federal government’s involvement in the economic crisis.

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, costs associated with litigation and government investigations, and dividends ~~and taxes~~ in ~~2008.~~2009. We ~~approved a definitive merger agreement under which we will acquire ImClone~~believe that amounts accessible through ~~an all-cash tender offer of $70 per share, or approximately $6.5 billion. We intend~~existing commercial paper markets should be adequate to fund ~~the acquisition, as well as any payments required in connection with the EDPA investigation, with cash and cash equivalents on hand and~~ short-term borrowings through the issuance of commercial paper. We have $1.25 billion of unused committed bank credit facilities, $1.2 billion of which backs our commercial paper program. Additionally, we have obtained commitments to provide a short-term revolving credit facility in the amount of $4.0 billion as back-up, alternative financing.borrowings. Our access to credit markets has not been adversely affected by the ~~recent~~ illiquidity in the market ~~due to~~because of the high credit quality of our short- and long-term ~~debt; however, long-term borrowing costs~~debt. In the remainder of 2009, we intend to fund the remaining payments required in connection with the EDPA settlements, and to further reduce outstanding commercial paper with cash and cash equivalents on hand, and cash generated from operations. We currently have ~~increased.~~$1.24 billion of unused committed bank credit facilities, $1.20 billion of which backs our commercial paper program. Various risks and uncertainties, including those discussed in the Financial Expectations for ~~2008~~2009 section, may affect our operating results and cash generated from operations.

LEGAL AND REGULATORY MATTERS

We are a party to various legal actions and government investigations. The most significant of these are described below. While it is not possible to determine the outcome of these matters, we believe that, except as specifically noted below, 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 our consolidated results of operations in any one accounting period.

Patent Litigation

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):

Cymbalta: We have received notice that at least four generic drug manufacturers have submitted Abbreviated New Drug Applications (ANDAs) seeking permission to market generic versions of Cymbalta prior to the expiration of our relevant U.S. patents (the earliest of which expires in 2013) and alleging that these patents are either invalid or not infringed. We are currently reviewing the allegations and will take appropriate action to seek rulings that the patents are valid and infringed.

~~Gemzar: Sicor Pharmaceuticals, Inc. (Sicor), Mayne Pharma (USA) Inc. (Mayne), and Sun~~

	•		Cymbalta: Sixteen generic drug manufacturers have submitted ANDAs seeking permission to market generic versions of Cymbalta prior to the expiration of our relevant U.S. patents (the earliest of which expires in 2013). Of these challengers, all allege non-infringement of the patent claims directed to the commercial formulation, and eight allege invalidity of the patent claims directed to the active ingredient duloxetine. Of the eight challengers to the compound patent claims, one further alleges invalidity of the claims directed to the use of Cymbalta for treating fibromyalgia, and one alleges the patent having claims directed to the active ingredient is unenforceable. Lawsuits have been filed in U.S. District Court for the Southern District of Indiana against Activis Elizabeth LLC; Aurobindo Pharma Ltd.; Cobalt Laboratories, Inc.; Impax Laboratories, Inc.; Lupin Limited; Sandoz Inc.; Sun Pharma Global, Inc.; and Wockhardt Limited, seeking rulings that the patents are valid, infringed, and enforceable. The cases have been consolidated and are proceeding.

	•		Gemzar: Sicor Pharmaceuticals, Inc. (Sicor), Mayne Pharma (USA) Inc. (Mayne), and Sun Pharmaceutical Industries Inc. (Sun) each submitted an ~~Abbreviated New Drug Application (ANDA)~~ANDA seeking permission to market generic versions of Gemzar prior to the expiration of our relevant U.S. patents (compound patent expiring in 2010 and ~~method of use~~method-of-use patent expiring in 2013), and alleging that these patents are invalid. We filed lawsuits in the U.S. District Court for the Southern District of Indiana against Sicor (February 2006) and Mayne (October 2006 and January 2008), seeking rulings that these patents are valid and are being infringed. The suit against Sicor has been scheduled for trial in ~~July~~September 2009. ~~The statutory stay barring final approval of~~ Sicor’s ANDAs ~~has expired;~~have been approved by the FDA; however, Sicor must provide 90 days notice prior to marketing generic Gemzar ~~upon receipt of final approval by the FDA~~ to allow time for us to seek a preliminary injunction. Both suits against Mayne have been administratively closed, and the parties have agreed to be bound by the results of the Sicor suit. In November 2007, Sun filed a declaratory judgment action in the United States District Court for the Eastern District of Michigan, seeking rulings that our method-of-use and compound patents are invalid or unenforceable, or would not be infringed by the sale of Sun’s generic product. This trial is scheduled for December 2009.

	•		Alimta: Teva Parenteral Medicines, Inc. (Teva) ~~and~~, APP Pharmaceuticals, LLC (APP), and Barr Laboratories, Inc. (Barr) each submitted ANDAs seeking approval to market generic versions of Alimta prior to the expiration of the relevant U.S. patent (licensed from the Trustees of Princeton University and expiring in 2016), and alleging the patent is invalid. We, along with Princeton, filed lawsuits in the U.S. District Court for the District of Delaware against Teva, APP, and ~~APP,~~Barr seeking rulings that the compound patent is valid and infringed. ~~The court has not set a date~~Trial is scheduled for ~~trial in either case.~~November 2010 against Teva and APP.

	•		Evista: 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 Pharmaceuticals USA, Inc. (Teva) has also submitted an ANDA seeking permission to market a generic version of Evista. In June 2006, we filed a similar lawsuit against Teva in the U.S. District Court for the Southern District of Indiana. The lawsuit against Teva is currently scheduled for trial beginning March 9, 2009, while no trial date has been set in the lawsuit against Barr. In April 2008, the FDA granted Teva tentative approval of its ANDA, but Teva’s ability to market a generic product before a decision at trial is subject to a statutory stay that expires on March 9, 2009.

	•		Strattera: Actavis Elizabeth LLC (Actavis), Glenmark Pharmaceuticals Inc., USA (Glenmark), Sun Pharmaceutical Industries Limited (Sun), Sandoz Inc. (Sandoz), Mylan Pharmaceuticals Inc. (Mylan), Teva Pharmaceuticals USA, Inc. (Teva), Apotex Inc. (Apotex), Aurobindo Pharma Ltd. (Aurobindo), Synthon Laboratories, Inc. (Synthon), and Zydus Pharmaceuticals, USA, Inc. (Zydus) each submitted an ANDA seeking permission to market generic versions of Strattera prior to the expiration of our relevant U.S. patent (expiring in 2017), and alleging that this patent is invalid. We filed a lawsuit against Actavis in the United States District Court for the District of New Jersey in August 2007, and added Glenmark, Sun, Sandoz, Mylan, Teva, Apotex, Aurobindo, Synthon, and Zydus as defendants in September 2007. In December 2007, Zydus agreed to entry of a consent judgment in which Zydus conceded the validity and enforceability of the patent and agreed to a permanent injunction. In June 2008, Glenmark agreed to entry of a permanent injunction, enjoining it from selling a generic product prior to the expiration of the U.S. patent. Also in June 2008, Synthon notified us that it has withdrawn its ANDA and agreed to a stipulated dismissal of all outstanding claims. For the remaining defendants, trial is anticipated as early as December 2009.

Court for the Southern District of Indiana, seeking a ruling that these patents are valid, enforceable, and being infringed by Barr. The lawsuit against Barr was administratively closed and, as a result, no trial date has been set.

In 2006, Teva Pharmaceuticals USA, Inc. (Teva) submitted an ANDA seeking permission to market a generic version of Evista. In June 2006, we filed a lawsuit, similar to the Barr lawsuit, against Teva in the U.S. District Court for the Southern District of Indiana. The trial against Teva was completed in March 2009. In April 2008, the FDA granted Teva tentative approval of its ANDA; however, Teva’s ability to market a generic product is subject to a preliminary injunction that prevents Teva from launching its generic raloxifene product until the Court issues a final judgment. Teva has announced its intent to appeal the preliminary injunction.

We believe each of these Hatch-Waxman challenges is without merit and expect to prevail in this litigation. However, it is not possible to determine the outcome of this litigation, and accordingly, we can provide no assurance that we will prevail. An unfavorable outcome in any of these cases could have a material adverse impact on our future consolidated results of operations, liquidity, and financial position.

We have received challenges to Zyprexa patents in a number of countries outside the U.S.:

	•		In Canada, several generic pharmaceutical manufacturers have challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In April 2007, the Canadian Federal Court ruled against the first challenger, Apotex Inc. (Apotex), and that ruling was affirmed on appeal in February 2008. In June 2007, the Canadian Federal Court held that an invalidity allegation of a second challenger, Novopharm Ltd. (Novopharm), was justified and denied our request that Novopharm be prohibited from receiving marketing approval for generic olanzapine in Canada. Novopharm began selling generic olanzapine in Canada in the third quarter of 2007. We ~~have~~ sued Novopharm for patent infringement, and the trial ~~is scheduled for November 2008.~~was completed in April 2009. We anticipate a decision in the second half of 2009. In November 2007, Apotex filed an action seeking a declaration of the invalidity of our Zyprexa compound and method-of-use patents, and no trial date has been set. We ~~have brought~~are involved in similar actions against Pharmascience (August 2007), Sandoz (July 2007), Nu-Pharm (June 2008), ~~and~~ Genpharm (June 2008)~~; none of~~ and Cobalt (January 2009). By agreement between the parties, or due to scheduling by the court, no substantive developments are expected in these suits ~~has been scheduled for trial. Pharmascience has agreed~~prior to ~~be bound by~~ the ~~outcome of~~decision in the Novopharm suit, and, pending the outcome of the lawsuit, we have agreed not to take any further steps to prevent them from coming to market with generic olanzapine tablets, subject to a contingent damages obligation should we be successful against Novopharm.suit.

	•		In Germany, generic pharmaceutical manufacturers Egis-Gyogyszergyar and Neolab Ltd. challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In June 2007, the German Federal Patent Court held that our patent is invalid. ~~We are appealing the decision to the German Supreme Court, which has scheduled a hearing for December 2008.~~ Generic olanzapine was launched by competitors in Germany in the fourth quarter of 2007. ~~Notwithstanding~~We appealed the decision to the German Federal Supreme Court and following a hearing in December 2008, the Supreme Court reversed the Federal Patent Court ~~ruling, we have sought preliminary injunctions against all~~and found the patent to be valid. Following the decision of the Supreme Court, the generic companies who are marketing generic olanzapine products in Germany. In May 2008 the Court of Appeal in Düsseldorf granted an injunction against the first of these generic companies, STADApharm GmbH, as a result of which STADA has had to withdraw its generic olanzapine product from the German market. Preliminary injunction actions against other generic companies in Germany were denied. We continue to pursue these companies in main actions for infringement.

	•		We have received challenges in a number of other countries, including Spain, the United Kingdom (UK), and several smaller European countries. In Spain, we have been successful at both the trial and appellate court levels in defeating the generic manufacturers’ challenge, but we anticipate further legal challenges from generic manufacturers. In the UK, the generic pharmaceutical manufacturer Dr. Reddy’s Laboratories (UK) Limited has challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In October, 2008, the Patents Court in the High Court, London ruled that our patent was valid. We anticipate that Dr. Reddy’s will appeal this decision.either

agreed to withdraw from the market or were subject to preliminary injunction. We are pursuing these companies for damages arising from infringement.

We have received challenges in a number of other countries, including Spain, the United Kingdom (U.K.), France, and several smaller European countries. In Spain, we have been successful at both the trial and appellate court levels in defeating the generic manufacturers’ challenges, but further legal challenge is now pending before the Commercial Court in Madrid. In the U.K., the generic pharmaceutical manufacturer Dr. Reddy’s Laboratories (UK) Limited has challenged the validity of our Zyprexa compound and method-of-use patent (expiring in 2011). In October 2008, the Patents Court in the High Court, London ruled that our patent was valid. Dr. Reddy’s appealed this decision, and a hearing date for the appeal has been set for November 2009.

Xigrisand Evista:In June 2002, Ariad Pharmaceuticals, Inc. (Ariad), 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 sued us, alleging that sales

Government Investigations and Related Litigation

In March 2004, the Office of the U.S. Attorney for the Eastern District of Pennsylvania (EDPA) advised us that it had commenced an 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 ~~November 2007, we received a grand jury subpoena from the EDPA for a broad range of documents related to Zyprexa. In~~ addition, the State Medicaid Fraud Control Units of more than 30 states ~~are coordinating~~coordinated with the EDPA in its investigation of any Medicaid-related claims relating to our marketing and promotion of Zyprexa. Twelve other states (Arkansas, Connecticut, Idaho, Louisiana, Minnesota, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia) have filed lawsuits over Zyprexa and are not participating in the coordinated investigation. In ~~October 2008,~~January 2009, we announced that we ~~are~~reached resolution of this matter, and on January 30, 2009, the court approved the settlement. As part of the resolution, we pled guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act for the off-label promotion of Zyprexa in ~~advanced discussions~~elderly populations as treatment for dementia, including Alzheimer’s dementia, between September 1999 and March 2001. In connection with the federal criminal and civil settlements, in the first quarter of 2009, we paid $1.06 billion. We also agreed to ~~resolve the ongoing investigations led by the EDPA, and we~~make

available a maximum amount of approximately $362.0 million for payment to those states that agree to settle. We recorded a charge of $1.42 billion. The charge reflects our currently estimable exposure with respect to these matters. If the ongoing discussions are successfully concluded, we expect that they would settle the Zyprexa-related federal claims, as well as similar Medicaid-related claims of states participatingbillion for this matter in the ~~settlement.~~

~~In October 2005,~~third quarter of 2008. As part of the ~~EDPA advised that it is also conducting an inquiry regarding certain rebate agreements~~settlement, we have entered into ~~with~~ a pharmacy benefit manager covering Axid, Evista, Humalog, Humulin, Prozac, and Zyprexa. The inquiry includes a review of our Medicaid best price reporting related to the product sales covered by the rebate agreements.

~~Beginning in August 2006, we received civil investigative demands or subpoenas from the attorneys general of a number of states under various state consumer protection laws. Most of these~~

Product Liability and Related Litigation

	•		In ~~June~~ 2005, we ~~reached an agreement in principle (and in September 2005 a final agreement) to settle~~settled and paid more than 8,000 claims for $690.0 million, plus $10.0 million to cover administration of the settlement.

	•		In ~~January~~ 2007, we ~~reached agreements with a number of plaintiffs’ attorneys to settle~~settled and paid more than 18,000 claims for approximately $500 million.

~~The 2005 settlement totaling $700.0 million was paid during 2005. The January 2007 settlements were paid during 2007.~~

We are prepared to continue our vigorous defense of Zyprexa in all remaining claims. The U.S. Zyprexa product liability claims not subject to these agreements include approximately ~~180~~120 lawsuits in the U.S. covering approximately ~~1,615~~140 plaintiffs, of which about ~~130~~90 cases covering about ~~305~~100 plaintiffs are part of the MDL. ~~The MDL cases~~No trials have been scheduled ~~for trial in groups, with the earliest trial scheduled~~related to ~~begin March 16, 2009.~~these claims.

	•		The cost of the Zyprexa product liability settlements to date; and

	•		Reserves for product liability exposures and defense costs regarding the known Zyprexa product liability claims and expected future claims to the extent we could formulate a reasonable estimate of the probable number and cost of the claims.

FINANCIAL EXPECTATIONS FOR ~~2008~~2009

~~Our full-year~~We reconfirm our 2009 financial guidance, as set forth in our Management’s Discussion and Analysis in our 2008 ~~earnings guidance on a GAAP basis is now $2.44 to $2.49 per share. The change from earlier guidance~~Form 10-K. For the full year of ~~$3.79 to $3.94~~2009, we expect earnings per share ~~results from~~to be in the previously mentioned third-quarter 2008 significant items totaling $1.47 per share that are reflected in our financial results, as well as from improved financial performance. Our full-year 2008 guidance does not reflect any impact relatedrange of $4.00 to ~~the proposed acquisition of ImClone Systems, Inc., including any potential charges associated with the purchase.~~

$4.25. We ~~have also revised other aspects of our previously-issued 2008 full-year financial guidance. Specifically, guidance for~~expect mid-single digit sales growth. We expect gross margin as a percent of net sales ~~other income and deductions, and~~to increase substantially, driven by the ~~effective tax rate has been revised. All other line-item guidance remains unchanged. Sales are still expected to grow~~strengthening dollar. This increase could be more pronounced in the ~~high-single to low-double digits. As a result~~first half of the weakening of foreign currencies, we now expect significant improvement in gross margin as a percent of sales, an increase from prior guidance that gross margin would remain essentially flat. The sum of marketing, selling, and administrative expenses and research and development expenses is still expected to grow in the high-single digits.2009. Marketing, selling, and administrative expenses are ~~still~~ expected to show flat to low-single digit growth. Research and development expenses are projected to grow in the ~~high-single digits, and research and development expenses are still expected to grow in the high-single to~~ low-double digits. Other income and deductions are now expected to contribute approximately $50 million, a reduction from our previous guidance of less than $100 million. As a result of the Zyprexa charges, the effective tax rate—net, expense (income) is ~~now~~ expected to be a net loss of between $200.0 million and $250.0 million. Capital expenditures are expected to remain level at approximately ~~23 percent.~~$1.1 billion, and we expect continued strong operating cash flow.

We caution investors that any forward-looking statements or projections made by us, including those above, are based on management’s 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 ~~restructuring~~acquisitions of compounds under development resulting in acquired IPR&D charges; ~~acquisitions and business development transactions;~~ foreign exchange rates and global

Item 4. Controls and Procedures

(a)		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 company’s “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.

		Our management, with the participation of John C. Lechleiter, ~~Ph.D.,~~chairman, president, 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, 2008,~~March 31, 2009, and concluded that they are effective.

(b)

Changes in Internal ~~Controls.~~Controls. During the ~~third~~first quarter of ~~2008,~~2009, 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, Management’s Discussion and Analysis, “Legal and Regulatory Matters,” for information on various legal proceedings, including but not limited to:

	•		The U.S. patent ~~matters~~litigation involving Cymbalta, Gemzar, Alimta, Evista, ~~Strattera,~~ and Xigris

	•		The patent litigation outside the U.S. involving Zyprexa

	•		The investigation by the U.S. Attorney for the Eastern District of Pennsylvania and various state attorneys general relating to our U.S. sales, marketing, and promotional practices

	•		The Zyprexa product liability and related litigation, including claims brought on behalf of state Medicaid agencies and private healthcare payors, as well as product liability litigation related to DES and thimerosal

That information is incorporated into this Item by reference.

Other Patent Litigation

Cialis: In July 2005, Vanderbilt University filed a lawsuit in the United States District Court in Delaware against ICOS Corporation seeking to add three of its scientists as co-inventors on the Cialis compound and method-of-use patents. In January 2009, the district court judge ruled in our favor, declining to add any of these scientists as an inventor on either patent. The plaintiff

has appealed this ruling. We believe these claims are without legal merit and expect to prevail in any appeal of this litigation; however, it is not possible to determine the outcome. An unfavorable final outcome could have a material adverse impact on our consolidated results of operations, liquidity, and financial position.

Other Product Liability Litigation

We refer to Part I, Item 3, of our Form ~~10-K/A~~10-K annual report for ~~2007~~2008 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 7050 suits involving approximately ~~125~~75 claimants. In the thimerosal litigation, we have been named as a defendant in approximately 210 suits involving approximately 285 claimants.

Other Marketing Practices Litigation

In August 2003, we received notice that the staff of the SEC is conducting an investigation into the compliance by Polish subsidiaries of certain pharmaceutical companies, including us, with ~~approximately 280 claimants.~~the U.S. Foreign Corrupt Practices Act of 1977. The staff issued subpoenas to us requesting production of documents related to the investigation. In connection with that matter, staffs of the SEC and the Department of Justice (DOJ) have asked us to voluntarily provide additional information related to certain activities of our affiliates in a number of other countries. The SEC staff has also recently issued a subpoena related to activities in these countries. We are cooperating with the SEC and the DOJ in this investigation.

Employee Litigation

In April 2006, three former employees and one current employee filed a putative class action against the company in the U.S. District Court for the Southern District of Indiana (Welch, et al. v. Eli Lilly and Company, filed April 20, 2006) alleging racial discrimination. Plaintiffs have since amended their complaint twice, adding to the lawsuit a total of 154 individual plaintiffs as well as the national and local chapters of the National Association for the Advancement of Colored People (NAACP). Under the current schedule, the plaintiffs are to file their class certification motion in March 2009. The company believes this lawsuit is without merit and is prepared to defend against it vigorously.

~~We have also been named as a defendant in a lawsuit filed in the U.S. District Court for the Northern District of New York (~~~~Schaefer-LaRose, et al~~., filed November 14, 2006) claiming that our pharmaceutical sales representatives should have been categorized as “non-exempt” rather than “exempt” employees, and claiming that the company owes them back wages for overtime worked, as well as penalties, interest, and attorneys fees. Other pharmaceutical industry

participants face identical lawsuits. The case was transferred to the U.S. District Court for the Southern District of Indiana in August 2007. In February 2008, the Indianapolis court conditionally certified a nationwide opt-in collective action under the Fair Labor Standards Act of all current and former employees who served as a Lilly pharmaceutical sales representative at any time from November 2003 to the present. As of the close of the opt-in period, fewer than 400 of the over 7,500 potential plaintiffs elected to participate in the lawsuit. We believe this lawsuit is without merit and are prepared to defend against it vigorously.

~~ImClone Shareholder Litigation~~Other Environmental Matters

~~In October 2008,~~We have been named in a ~~class action complaint was~~lawsuit brought by the Labor Attorney for 15th Region in the Labor Court of Paulinia, State of Sao Paulo, Brazil, alleging possible harm to employees and former employees caused by exposure to heavy metals. We have also been named in approximately 50 lawsuits filed in the Supreme Court of the State of New York, purportedly on behalf of all shareholders of ImClone Systems, Inc. (ImClone), against us, ImClone, and the members of its board of directors. The complaint alleges, among other things, that the members of ImClone’s board of directors breached their fiduciary duties to ImClone’s shareholders in connection with the transactions contemplatedsame court by the merger agreement and failed to provide ImClone’s shareholders with material information to make an informed decision as to whether to tender their shares in the offer. In addition, the complaint alleges that Lilly knowingly aided and abetted the alleged wrongdoing of ImClone’s board of directors. The complaint seeks, among other relief, injunctive relief preliminarily and permanently enjoining the defendants from proceeding with the offer; a judgment enjoining the defendants from consummating the offer and the merger until certain additional information is provided; and an award to plaintiffs of the costs of the action, including reasonable attorneys’ and experts’ fees.individual former employees making similar claims. We ~~believe that the complaint is without merit and intend to vigorously defend the action.~~

~~Other Matters~~

~~During 2004 we,~~have also been named, along with several other ~~pharmaceutical companies, were named in one consolidated case in California state court brought on behalf of consumers alleging that the conduct of pharmaceutical~~ companies, in ~~preventing commercial importation~~a lawsuit filed by certain of ~~prescription drugs from outside the United States violated antitrust laws. The case sought restitution~~these individuals in U.S. District Court for ~~alleged overpayments for pharmaceuticals~~Southern District of Indiana on April 21, 2009, alleging possible harm caused by exposure to pesticides related to our former agricultural chemical manufacturing facility in Cosmopolis, Brazil. We believe these lawsuits are without merit and ~~an injunction~~are prepared to defend against the allegedly violative conduct. Summary judgment was granted to us and the other defendants. In July 2008, the California Court of Appeals affirmed that decision. Plaintiffs have petitioned the California Supreme Court to accept a further appeal.them vigorously.

While it is not possible to predict or determine the outcome of the patent, product liability, or other legal actions brought against us or the ultimate cost of environmental matters, we believe that, except as noted above, the resolution of all such matters will not have a material adverse effect on our consolidated financial position or liquidity but could possibly be material to the consolidated results of operations in any one accounting period.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

The following table summarizes the activity related to repurchases of our equity securities during the ~~three-month period~~three months ended ~~September 30, 2008:~~March 31, 2009:

Total Number of Approximate Dollar
Shares Purchased as Value of Shares
Part of Publicly that May Yet Be
Total Number of Average Price Paid Announced Plans or Purchased Under the
Shares Purchased per Share Programs Plans or Programs
Period (a) (b) (c) (d)
(in thousands) (in thousands) (in millions)

July 2008 — — — $ 419.2
August 2008 — — — 419.2
September 2008 — — — 419.2

Total — — —

Total Number

of Shares

Approximate

Purchased as

Dollar Value of

Part of

Shares that

Total

Publicly

May Yet Be

Number of

Average Price

Announced

Purchased

Paid per

Plans or

Under the Plans

Purchased

Programs

or Programs

Period

(a)

(b)

(c)

(d)

(in thousands)

(in millions)

January 2009

39.55

—

419.2

February 2009

36.84

—

419.2

March 2009

33.17

—

419.2

Total

125

—

The amounts presented in columns (a) and (b) above represent purchases of common stock related to our stock-based compensation programs. 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, 2008,~~March 31, 2009, we have purchased $2.58 billion related to this program. During the first ~~nine~~three months of ~~2008,~~2009, no shares were repurchased pursuant to this program and we do not expect to purchase any shares under this program during the remainder of ~~2008.~~2009.

On February 10, 2009, the company issued and sold 10 million shares of its common stock to National City Bank, not in its individual or corporate capacity, but solely in its capacity as Trustee of the Eli Lilly Compensation Trust (the “Trust”). The Trust is an employee benefit trust that provides a source of funds to assist the company in meeting its obligations under various employee compensation and benefit plans. The shares were sold in exchange for a promissory note from the Trustee in its capacity as Trustee of the Trust in the aggregate principal amount of $378.2 million (the“Note”). The Note bears interest at 2 percent above the prime rate of interest charged by JPMorgan Chase bank, and is compounded annually. The Note is repayable on the earliest of (i) demand by the company, (ii) early termination of the Trust, or (iii) April 17, 2025, the final termination date of the Trust.

This funding of the Trust had no net impact on shareholders’ equity as we consolidate the Trust. Any dividends paid on the shares in the Trust are used to repay indebtedness under the Note and are therefore eliminated. Lilly common stock held by the Trust is not considered outstanding in the computation of earnings per share. The sale of common stock was exempt from the registration requirements of the Securities Act of 1933 by virtue of the exemption provided by Section 4(2) as a transaction by an issuer not involving a public offering.

Item 4. Submission of Matters to a Vote of Security Holders

We held our annual meeting of shareholders on April 20, 2009. The following is a summary of the matters voted on at the meeting:

(a)

The four nominees for director were elected to serve three-year terms ending in 2012, as follows:


Nominee	For		Withhold Vote
Martin S. Feldstein, Ph.D.		731,639,675		299,782,047
J. Erik Fyrwald		736,330,112		295,091,610
Ellen R. Marram		728,714,901		302,706,821
Douglas R. Oberhelman		1,009,116,635		22,305,087

(b)

The appointment of Ernst & Young LLP as our principal independent auditors was ratified by the following shareholder vote:

(c)

By the following vote, the shareholders did not approve the proposal (proposal required the vote of 80 percent of outstanding shares) to amend the company’s articles of incorporation to provide for annual election of directors:

(d)

By the following vote, the shareholders approved the material terms of the performance goals for the Eli Lilly and Company Bonus Plan:

(e)

By the following vote, the shareholders approved a shareholder proposal regarding amending the company’s articles of incorporation to eliminate all supermajority voting provisions from the company’s articles of incorporation and bylaws:

(f)

By the following vote, the shareholders did not approve a shareholder proposal regarding amending the company’s articles of incorporation to allow shareholders to amend the bylaws by majority vote:

(g)

By the following vote, the shareholders did not approve a shareholder proposal regarding adopting a policy of asking shareholders to ratify the compensation of named executive officers at the annual meeting of shareholders:


	Estimated Fair
	Value
	at November 24,
	2008

Cash and short-term investments	$	982.9
Inventories		136.2
Developed product technology (Erbitux®)¹		1,057.9
Goodwill		419.5
Property and equipment		339.8
Debt assumed		(600.0	)
Deferred taxes		(315.0	)
Deferred income		(127.7	)
Other assets and liabilities — net		(72.1	)
Acquired in-process research and development		4,685.4

Total purchase price	$	6,506.9


	Retiree Health Benefit Plans
	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2008			2007			2008			2007
	(Dollars in millions)
Components of net periodic benefit cost
Service cost	$	15.5		$	17.6		$	46.6		$	54.3
Interest cost		26.5			25.3			79.4			76.0
Expected return on plan assets		(29.1	)		(25.3	)		(88.3	)		(77.0	)
Amortization of prior service cost		(9.0	)		(3.9	)		(27.0	)		(11.7	)
Recognized actuarial loss		15.7			23.8			47.1			70.9

Net periodic benefit cost	$	19.6		$	37.5		$	57.8		$	112.5


~~EXHIBIT 10.1~~		~~2002~~
EXHIBIT 10.		The Eli Lilly ~~Stock~~and Company Bonus Plan, as amended effective January 1, 2009

~~EXHIBIT 10.2~~		~~Lilly Directors Deferral Plan, as amended effective October 20, 2008~~

~~EXHIBIT 10.3~~		~~The Lilly Deferred Compensation Plan, as amended effective January 1, 2009~~

~~EXHIBIT 10.4~~		~~2007 Change In Control Severance Pay Plan for Select Employees, as amended effective January 1, 2009~~

~~EXHIBIT 10.5~~		~~2007 Change In Control Severance Pay Plan for Select Employees, as amended effective October 20, 2010~~

EXHIBIT 11.		Statement re: Computation of Earnings per Share

EXHIBIT 12.		Statement re: Computation of Ratio of Earnings to Fixed Charges

EXHIBIT 31.1		Rule 13a-14(a) Certification of John C. Lechleiter, ~~Ph.D.,~~Chairman, President, and Chief Executive Officer

EXHIBIT 31.2		Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President and Chief Financial Officer

EXHIBIT 32.		Section 1350 Certification


	ELI LILLY AND COMPANY (Registrant)
~~Date November 3, 2008~~Date: April 30, 2009	s/ James B. Lootens
	James B. Lootens
	Secretary and Deputy General Counsel


~~Date November 3, 2008~~Date: April 30, 2009	s/ Arnold C. Hanish
	Arnold C. Hanish
	~~Executive Director, Finance,~~Vice President and Chief Accounting Officer


EXHIBIT ~~10.1~~10.		~~2002~~The Eli Lilly ~~Stock~~and Company Bonus Plan, as amended effective January 1, 2009

~~EXHIBIT 10.2~~		~~Lilly Directors Deferral Plan, as amended effective October 20, 2008~~

~~EXHIBIT 10.3~~		~~The Lilly Deferred Compensation Plan, as amended effective January 1, 2009~~

~~EXHIBIT 10.4~~		~~2007 Change In Control Severance Pay Plan for Select Employees, as amended effective January 1, 2009~~

~~EXHIBIT 10.5~~		~~2007 Change In Control Severance Pay Plan for Select Employees, as amended effective October 20, 2010~~

EXHIBIT 11.		Statement re: Computation of Earnings per Share

EXHIBIT 12.		Statement re: Computation of Ratio of Earnings to Fixed Charges

EXHIBIT 31.1		Rule 13a-14(a) Certification of John C. Lechleiter, ~~Ph.D.,~~Chairman, President, and Chief Executive Officer

EXHIBIT 31.2		Rule 13a-14(a) Certification of Derica W. Rice, Senior Vice President and Chief Financial Officer

EXHIBIT 32.		Section 1350 Certification


	Estimated Fair
	Value
	at January 29,
	2007

Cash and short-term investments	$	197.7
Developed product technology (Cialis)¹		1,659.9
Acquired in-process research and development		303.5
Tax benefit of net operating losses		404.1
Goodwill		646.7
Other assets and liabilities — net		(32.1	)
Deferred taxes		(583.5	)
Long-term debt assumed		(275.6	)

Total purchase price	$	2,320.7


¹		This intangible asset will be amortized on a straight-line basis through 2023 in the U.S. and 2018 in the rest of the world.


	Defined Benefit Pension Plans												Defined Benefit Pension Plans						Retiree Health Benefit Plans
	Three Months Ended						Nine Months Ended						Three Months Ended						Three Months Ended
	September 30,						September 30,						March 31,						March 31,
	2008			2007			2008			2007			2009			2008			2009			2008
	(Dollars in millions)												(Dollars in millions)
Components of net periodic benefit cost
Service cost	$	61.4		$	62.9		$	186.8		$	194.9		$	60.7		$	64.3		$	16.3		$	14.4
Interest cost		102.7			86.5			308.5			258.9			103.4			102.9			28.7			26.5
Expected return on plan assets		(151.3	)		(134.6	)		(455.0	)		(403.1	)		(142.3	)		(151.5	)		(29.5	)		(29.4	)
Amortization of prior service cost		1.8			1.4			5.3			4.0			1.8			1.8			(9.0	)		(9.0	)
Recognized actuarial loss		19.2			30.9			57.8			93.1			21.6			19.2			17.2			16.5

Net periodic benefit cost	$	33.8		$	47.1		$	103.4		$	147.8		$	45.2		$	36.7		$	23.7		$	19.0


¹		U.S. ~~sales include sales~~revenue includes revenue in Puerto Rico.

1,008,276,202