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 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 second quarters of 2009 and 2008 was $47.6 million and $28.4 million, respectively, and $83.3 million and $55.3 million for the six months ended June 30, 2009 and 2008, respectively.

  

REVENUE BY CATEGORY

  

Worldwide revenue by category was as follows:

  

	Three Months Ended June 30,		Six Months Ended June 30,
	2009	2008	2009	2008
	(Dollars in millions)
Net sales – to unaffiliated customers
Neurosciences............................................................	$2,185.7	$2,126.7	$   4,263.4	$4,098.1
Endocrinology.............................................................	1,389.2	1,401.8	2,715.4	2,714.4
Oncology....................................................................	762.4	715.1	1,491.6	1,388.5
Cardiovascular...........................................................	454.1	476.6	909.2	938.6
Animal health.............................................................	275.4	254.5	539.5	489.9
Other pharmaceuticals................................................	46.5	59.1	86.0	113.7
Net product sales..........................................................	5,113.3	5,033.8	10,005.1	9,743.2
Collaboration and other revenue.....................................	179.5	116.6	334.7	214.8
Total revenue................................................................	$5,292.8	$5,150.4	$10,339.8	$9,958.0

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 10K for the year ended December 31, 2008.   Certain reclassifications have been made to the December 31, 2008 consolidated condensed financial statements to conform with the June 30, 2009 presentation.     We issued our financial statements by filing with the Securities and Exchange Commission on July 31, 2009.   We have evaluated subsequent events up to the time of the filing.

The Financial Accounting Standards Board (FASB) Statement on Business Combinations was effective for us for business combinations with the acquisition date on or after January 1, 2009.   This Statement changes the way in which the acquisition method is to be applied in a business combination.   The primary revisions 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.   This Statement significantly amends other authoritative guidance on Business Combinations as well, and now requires the capitalization of research and development assets acquired in a business combination at their acquisition-date fair values, separately from goodwill.   The 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.   

  

We adopted the provisions of the FASB Statement on Consolidations relating to the accounting for noncontrolling interests on January 1, 2009.   This Statement amends previous authoritative guidance, 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 part of shareholders’ equity in our consolidated condensed statements of financial position at June 30, 2009 and reclassified the December 31, 2008 balances accordingly.   The net income attributed to the noncontrolling interest in a subsidiary for the second quarters and first six months 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 the FASB Statement on disclosures relating to Derivatives and Hedging on January 1, 2009.    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, and how derivative instruments and related hedged items affect an entity’s financial position, results of operations, and cash flows.   These disclosures are included in Note 6.  

  

We adopted the provisions of the Emerging Issues Task Force guidance related to Collaborative Arrangements on January 1, 2009. This guidance 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 guidance has been applied retrospectively to all prior periods presented for significant collaborative arrangements existing as of the effective 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 the FASB Staff Position (FSP) relating to Investments on January 1, 2009.   This FSP 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 expect to recover the entire amortized cost basis of the security.   In this situation, if the company does not 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 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 a FSP relating to Fair Value Measurements and Disclosures, as of March 31, 2009.   This FSP 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 a FSP on Financial Instruments, as of March 31, 2009.   This FSP required 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.

  

In June 2009, the FASB issued a Statement on Subsequent Events.   This Statement provides authoritative accounting literature and disclosure requirements for material events occurring subsequent to the balance sheet date and prior to the issuance of the financial statements.   This Statement is effective for us for the periods ended on and after June 30, 2009.   The implementation of this Statement was not material to our consolidated financial position or results of operations.

  

In June 2009, the FASB issued a Statement on Transfers and Servicing, an amendment of previous authoritative guidance. The most significant amendments resulting from this Statement consist of the removal of the concept of a qualifying special-purpose entity (SPE) from previous authoritative guidance, and the elimination of the exception for qualifying SPEs from the Consolidation guidance regarding variable interest entities.   This Statement is effective for us January 1, 2010 and is not expected to be material to our consolidated financial position or results of operations.

  

In June 2009, the FASB issued a Statement which amends the previous Consolidations guidance regarding variable interest entities and addresses the effects of eliminating the qualifying special-purpose entity concept from the guidance on Transfers and Servicing.   This Statement responds to concerns about the application of certain key provisions of the previous guidance on Consolidations regarding variable interest entities, including concerns over the transparency of enterprises’ involvement with variable interest entities.   This Statement is effective for us January 1, 2010 and is not expected to be material to our consolidated financial position or results of operations.

During 2008 we acquired several businesses.   These acquisitions were accounted for as business combinations under the purchase method of accounting.   Under the purchase method of accounting, the assets acquired and liabilities assumed were recorded at their respective fair 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.   The results of operations of these acquisitions are included in our consolidated financial statements from the date of acquisition.  

  

Most of these acquisitions included in-process research and development (IPR&D), which represented compounds, new indications, or line extensions under development that had not yet achieved regulatory approval for marketing.   There are several methods that can be used to determine the estimated fair value of the IPR&D acquired 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.   Pursuant to the existing rules, 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 or second quarters 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 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.  

  

	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

  

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.

  

All of the estimated fair value of the acquired IPR&D is attributable to oncology-related products in development, including $1.33 billion to line extensions for Erbitux.   A significant portion (81 percent) of the remaining value of acquired IPR&D is attributable to one compound in Phase III clinical testing and two compounds in Phase II clinical testing, all targeted to treat various forms of cancers.   The discount rate we used in valuing the acquired IPR&D projects was 13.5 percent, and the charge for acquired IPR&D of $4.69 billion recorded in the fourth quarter of 2008 was not deductible for tax purposes.

  

Posilac®

  

On October 1, 2008, we acquired the worldwide rights to the dairy cow supplement Posilac, 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 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 allocated $204.3 million to identifiable intangible assets related to Posilac, $167.6 million to inventories, and $99.5 million of the purchase price to property and equipment.   We also assumed $67.5 million of liabilities.   Substantially all of the identifiable intangible assets are being amortized over their estimated remaining useful lives of 20 years.   The amount allocated to each of the intangible assets acquired is deductible for tax purposes.

  

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 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 was deductible for tax purposes.

  

In January 2008, our agreement with BioMS Medical Corp. to acquire the rights to its compound for the treatment of multiple sclerosis became 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.   In July 2009, data from the Phase III clinical trials showed there were no statistically significant differences between dirucotide and placebo on the primary or secondary endpoints of the study, and ongoing clinical trials were discontinued.   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 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.

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. The following table summarizes the revenue recognized with respect to Erbitux:  

  

	Three Months Ended June 30, 2009	Six Months Ended June 30, 2009
	(Dollars in millions)
Net product sales...........................................	$ 23.9	$     50.0
Collaboration and other revenue......................	75.8	143.9
Total revenue.................................................	$ 99.7	$ 193.9

  

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 have 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 and ImClone 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 royalty 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® (exenatide injection) and other forms of exenatide such as exenatide once weekly. Byetta 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.   The following table summarizes the revenue recognized with respect to Byetta:

  

  

	Three Months Ended June 30,		Six Months Ended June 30,
	2009	2008	2009	2008
	(Dollars in millions)
Net product sales...........................................	$     34.7	$     22.7	$    62.1	$     39.1
Collaboration and other revenue......................	79.9	78.5	150.2	144.8
Total revenue.................................................	$ 114.6	$ 101.2	$ 212.3	$ 183.9

  

  

  

  

  

  

  

  

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.

  

A New Drug Application has been submitted to the U.S. Food and Drug Administration (FDA) for exenatide once weekly.   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.   We have also agreed in principle to cooperate with Amylin in the development, manufacturing, and marketing of exenatide once weekly in a dual-chamber cartridge pen configuration.   We will contribute 60 percent of the total initial capital costs of the project, our portion of which will be approximately $130 million.

  

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 and receives a commission based upon net product sales.   According to this agreement, Quintiles’ obligation to promote Cymbalta expires in 2009, and we will pay a lower rate on net product sales for three years after completion of the promotion efforts specified in this agreement.   The commissions paid to Quintiles are recorded in marketing, selling, and administrative expenses.  

Effient™

  

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. Prasugrel was also approved for marketing by the FDA under the tradename Effient in July 2009, and we and D-S plan to launch by early August.   Within this arrangement, we and D-S 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.   The parties share approximately 50/50 in the profits, as well as in the costs of development and marketing in the co-promotion territories.   A third-party manufactures bulk product, and we produce the finished product for our exclusive and co-promotion territories.   We record product sales in the co-promotion and exclusive territories.   In our exclusive territories, we will pay D-S a royalty specific to these territories.   Profit share payments made to D-S are recorded as marketing, selling, and administrative expenses.   All royalties paid to D-S and the third-party manufacturer are recorded in cost of sales.   Due to the short period of time since European approval and the time required to obtain pricing and reimbursement approval in each country in Europe, sales are not significant to date.

  

TPG-Axon Capital

  

In 2008, we entered into an agreement with an affiliate of TPG-Axon Capital (TPG) for the Phase III development of a gamma-secretase inhibitor and an A-beta antibody, our two lead molecules for the treatment of mild to moderate Alzheimer’s disease.   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 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. Reimbursements received from TPG for its portion of research and development costs incurred related to the Alzheimer’s treatments are recorded as a reduction to the research and development expense line item on the consolidated condensed statements of income.   The 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 $84.6 million and $75.8 million in the quarters ended June 30, 2009 and 2008, respectively, and $162.2 million and $142.4 million in the six months ended June 30, 2009 and 2008, respectively.

The components of the charges included in asset impairments, restructuring, and other special charges in our consolidated condensed statements of income are described below.

  

In the second quarter, we incurred other special charges of $105.0 million.   We are in advanced discussions with the attorneys general for several states that were not part of the Eastern District of Pennsylvania settlement, seeking to resolve their Zyprexa®-related claims, and we have reached settlement with the state of West Virginia.   The charge represents the currently probable and estimable exposures in connection with the states’ claims.   Refer to Note 12 for additional information.

  

In the second quarter of 2008, we recognized restructuring and other special charges of $88.9 million. In addition, we recognized non-cash charges of $57.1 million for the write down of impaired manufacturing assets that had no future use, which were included in cost of sales.   In April 2008, we announced a voluntary exit program that was offered to employees primarily in manufacturing.   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 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 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 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 an estimate of Alkermes’ wind-down costs for which we were contractually obligated.   The wind-down activities and patient programs 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.

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 this concentration is mitigated by our ongoing credit review procedures and insurance.   Major financial institutions represent the largest component of our investments in corporate debt securities.   In accordance with documented corporate policies, we limit the 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 June 30, 2009, we did not hold any foreign currency option contracts.   At June 30, 2009, we had outstanding foreign currency forward commitments to purchase 394 million British pounds and sell 466 million euro, and commitments to purchase 667 million U.S. dollars and sell 478 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 June 30, 2009, approximately 84 percent of our total debt is at a fixed rate.   We have converted approximately 50 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

  

Both the gains on the hedged fixed-rate debt and the offsetting losses on the related interest rate swaps for the second quarter of 2009 were $171.5 million.   Both the gains on the hedged fixed-rate debt and the offsetting losses on the related interest rate swaps for the first six months of 2009 were $311.0 million.   All of these amounts net to zero and were included in othernet, expense (income).

  

We expect to reclassify an estimated $11.4 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.

  

Other-net, expense (income) for the second quarter and first six months of 2009 includes the effective portion of losses on interest rate contracts in designated cash flow hedging relationships reclassified from accumulated other comprehensive loss into income of $2.6 million and $5.1 million, respectively, and the gains (losses) on foreign exchange contracts not designated as hedging instruments recognized in income of $(3.0) million and $33.6 million, respectively.   The effective portions of net gains on interest rate contracts in designated cash flow hedging relationships recorded in other comprehensive income for the first six months of 2009 was $37.8 million; no such amounts were recorded in the second quarter.

  

During the second quarter and first six months of 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 of Financial Instruments

  

The following tables summarize certain fair value information at June 30, 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
Description	Carrying Amount	Amortized Cost	Quoted Prices in Active Markets for Identical Assets (Level 1)	Significant Other Observable Inputs (Level 2)	Significant Unobservable Inputs (Level 3)	Fair Value
June 30, 2009
Short-term investments
Corporate debt securities...........	$   108.3	$   110.6	$      -	$108.3	$     -	$   108.3
U.S. government and agencies....	41.2	41.2	41.2	-	- -	41.2
Other securities........................	18.6	17.9	- -	18.6	- -	18.6
	$   168.1	$   169.7
Noncurrent investments
Corporate debt securities...........	$   333.0	$   363.4	$      -	$   333.0	$    -	$   333.0
Mortgage-backed......................	250.7	356.3	-	250.7	-	250.7
Asset-backed...........................	126.2	152.1	-	126.2	-	126.2
U.S. government and agencies....	55.0	53.6	55.0	- -	-	55.0
Other debt securities.................	36.9	14.3	-	3.6	33.3	36.9
Marketable equity.....................	300.2	181.7	300.2	-	- -	300.2
Equity method and other investments.............................	137.0	137.0				NA
	$1,239.0	$1,258.4
Long-term debt, including    current portion..........................	$(6,707.9)	NA	$      -	$(6,801.3)	$   - -	$(6,801.3)
Risk-management instruments
Interest rate contracts    designated as hedging instruments
Sundry...................................	$   187.2	NA	$      -	$   187.2	$   -	$   187.2
Foreign exchange contracts not designated as hedging instruments
Prepaid expenses...................	2.0	NA	-	2.0	-	2.0
Other current liabilities............	(13.7)	NA	-	(13.7)	-	(13.7)
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
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.   Approximately $480 million of our investments in debt securities will mature within 5 years.

  

A summary of the fair value of 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:  

  

	June 30, 2009	December 31, 2008
Unrealized gross gains..................................................	$     156.3	$      69.9
Unrealized gross losses................................................	177.3	239.0
Fair value of securities in an unrealized gain position........	624.6	767.5
Fair value of securities in an unrealized loss position........	622.4	1,046.1

  

The total other-than-temporary impairment losses for the second quarter and first six months of 2009 were $3.3 million and $21.2 million, respectively, of which $1.0 million and $13.6 million, respectively, were recognized in other comprehensive income resulting in net charges of $2.3 million and $7.6 million, respectively.   These charges relate to credit losses on certain mortgage-backed securities.   The amount of credit losses represents the difference between the present value of 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 are comprised of 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 63 percent of the securities in a loss position are investment-grade debt 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 do not intend to sell and it is not more likely than not we will be required to sell the securities in a loss position before the market values recover or the underlying cash flows have been received, and we have concluded that no additional other-than-temporary loss is required to be charged to earnings as of June 30, 2009.   The fair values of our auction rate securities and collateralized debt obligations were determined using Level 3 inputs.   We did not hold securities issued by structured investment vehicles at June 30, 2009.  

  

Activity related to our available-for-sale investment portfolio was as follows:

  

	Three Months Ended June 30, 2009	Six Months Ended June 30, 2009
Proceeds from sales.....................................................	$   313.0	$   600.6
Realized gross gains on sales........................................	12.4	17.3
Realized gross losses on sales......................................	0.3	1.0

  

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.