XML 71 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
ALLIANCES AND COLLABORATIONS
6 Months Ended
Jun. 30, 2012
ALLIANCES AND COLLABORATIONS [Abstract]  
Alliances and Collaborations [Text Block]

Note 3. ALLIANCES AND COLLABORATIONS

 

BMS maintains alliances and collaborations with various third parties for the development and commercialization of certain products. Unless otherwise noted, operating results associated with the alliances and collaborations are generally treated as follows: product revenues from BMS sales are included in revenue; royalties, collaboration fees, profit sharing and distribution fees are included in cost of goods sold; post-approval milestone payments to partners are deferred and amortized over the useful life within cost of goods sold; cost sharing reimbursements offset the intended operating expense; payments to BMS attributed to upfront, milestone and other licensing payments are deferred and amortized over the estimated useful life within other income/expense; income and expenses attributed to a collaboration's non-core activities, such as supply and manufacturing arrangements and compensation for opting-out of commercialization in certain countries, are included in other income/expense; partnerships and joint ventures are either consolidated or accounted for under the equity method of accounting and related cash receipts and distributions are treated as operating cash flow.

 

See the 2011 Annual Report on Form 10-K for a more complete description of the below agreements, including termination provisions, as well as disclosures of other alliances and collaborations.

Sanofi

 

BMS has agreements with Sanofi for the codevelopment and cocommercialization of Avapro*/Avalide* and Plavix*. The worldwide alliance operates under the framework of two geographic territories; one in the Americas (principally the U.S., Canada, Puerto Rico and Latin American countries) and Australia and the other in Europe and Asia. Accordingly, two territory partnerships were formed to manage central expenses, such as marketing, research and development and royalties, and to supply finished product to the individual countries. In general, at the country level, agreements either to copromote (whereby a partnership was formed between the parties to sell each brand) or to comarket (whereby the parties operate and sell their brands independently of each other) are in place. The agreements with Sanofi expire on the later of (i) with respect to Plavix*, 2013 and, with respect to Avapro*/Avalide*, 2012 in the Americas and Australia and 2013 in Europe and Asia, and (ii) the expiration of all patents and other exclusivity rights relating to the products in the applicable territory.

 

BMS acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering the Americas and Australia and consolidates all country partnership results for this territory with Sanofi's 49.9% share of the results reflected as a noncontrolling interest. BMS recognizes net sales in this territory and in comarketing countries outside this territory (e.g. Germany, Italy for irbesartan only, Spain and Greece). Sanofi acts as the operating partner and owns a 50.1% majority controlling interest in the territory covering Europe and Asia and BMS has a 49.9% ownership interest in this territory.

 

BMS and Sanofi have a separate partnership governing the copromotion of irbesartan in the U.S. Sanofi paid BMS $350 million for their acquisition of an interest in the irbesartan license for the U.S. upon formation of the alliance.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012  2011 2012  2011
Territory covering the Americas and Australia:           
 Net sales$ 778 $ 2,045 $ 2,595 $ 4,023
 Royalty expense  141   397   508   755
 Noncontrolling interestpre-tax  249   601   854   1,174
 Profit distributions to Sanofi  (449)   (702)   (1,058)   (1,301)
             
Territory covering Europe and Asia:           
 Equity in net income of affiliates  (58)   (65)   (118)   (151)
 Profit distributions to BMS  62   67   129   127
             
Other:           
 Net sales in Europe comarketing countries and other  80   71   163   145
 Amortization (income)/expense – irbesartan license fee  (8)   (8)   (16)   (16)
 Supply activities and development and opt-out royalty (income)/expense  (39)   1   (45)   15
             
        June 30, December 31,
Dollars in Millions      2012 2011
Investment in affiliates – territory covering Europe and Asia      $ 26 $ 37
Deferred income – irbesartan license fee        13   29

The following is summarized financial information for interests in the partnerships with Sanofi for the territory covering Europe and Asia, which are not consolidated but are accounted for using the equity method:

 Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Net sales$ 319 $ 382 $ 638 $ 761
Gross profit  132   172   270   340
Net income  120   142   242   282

Otsuka

 

BMS has a worldwide commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote Abilify*, for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder, excluding certain Asia Pacific countries. The U.S. portion of the amended commercialization and manufacturing agreement expires upon the expected loss of product exclusivity in April 2015. Beginning on January 1, 2012, the contractual share of revenue recognized by BMS in the U.S. was reduced from 53.5% in 2011 to 51.5% and will be further reduced in 2013.

 

In the UK, Germany, France and Spain, BMS receives 65% of third-party net sales. In these countries and the U.S., third-party customers are invoiced by BMS on behalf of Otsuka and alliance revenue is recognized when Abilify* is shipped and all risks and rewards of ownership have been transferred to third-party customers. In certain countries where BMS is presently the exclusive distributor for the product or has an exclusive right to sell Abilify*, BMS recognizes all of the net sales.

 

BMS purchases the product from Otsuka and performs finish manufacturing for sale to third-party customers by BMS or Otsuka. Under the terms of the amended agreement, BMS paid Otsuka $400 million, which is amortized as a reduction of net sales through the expected loss of U.S. exclusivity in April 2015. The unamortized balance is included in other assets. Otsuka receives a royalty based on 1.5% of total U.S. net sales. Otsuka is responsible for 30% of the U.S. expenses related to the commercialization of Abilify* from 2010 through 2012. BMS also reimburses Otsuka for its contractual share of the annual pharmaceutical company fee related to Abilify*.

 

BMS and Otsuka also have an oncology collaboration for Sprycel and Ixempra (ixabepilone) (the “Oncology Products”) in the U.S., Japan and the top five markets in the EU. The Company pays a collaboration fee to Otsuka equal to 30% of the first $400 million annual net sales of the Oncology Products in the Oncology Territory, 5% of annual net sales between $400 million and $600 million, and 3% of annual net sales between $600 million and $800 million with additional trailing percentages of annual net sales over $800 million. Otsuka contributes 20% of the first $175 million of certain commercial operational expenses relating to the Oncology Products in the Oncology Territory and 1% of such costs in excess of $175 million.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Abilify* net sales, including amortization of extension payment$ 711 $ 706 $ 1,332 $ 1,330
Oncology Products collaboration fee expense  35   37   67   70
Royalty expense  20   18   37   35
Commercialization expense reimbursement to/(from) Otsuka (19)   (11)  (32)   (22)
Amortization (income)/expense extension payment  17   17   33   33
Amortization (income)/expense – upfront, milestone and other            
licensing payments  2   2   4   4
             
        June 30, December 31,
Dollars in Millions      2012 2011
Other assets - extension payment      $ 186 $ 219
Other intangible assets - upfront, milestone and other licensing payments        1   5

Lilly

 

BMS has an Epidermal Growth Factor Receptor (EGFR) commercialization agreement with Eli Lilly and Company (Lilly) through Lilly's November 2008 acquisition of ImClone Systems Incorporated (ImClone) for the codevelopment and promotion of Erbitux* and necitumumab (IMC-11F8) in the U.S. which expires as to Erbitux* in September 2018. BMS also has codevelopment and copromotion rights to both products in Canada and Japan. Erbitux* is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. Under the EGFR agreement, with respect to Erbitux* sales in North America, Lilly receives a distribution fee based on a flat rate of 39% of net sales in North America plus reimbursement of certain royalties paid by Lilly.

 

In Japan, BMS shares rights to Erbitux* under an agreement with Lilly and Merck KGaA and receives 50% of the pre-tax profit from Merck KGaA's net sales of Erbitux* in Japan which is further shared equally with Lilly.

 

With respect to necitumumab, the companies will share in the cost of developing and potentially commercializing necitumumab in the U.S., Canada and Japan. Lilly maintains exclusive rights to necitumumab in all other markets. BMS will fund 55% of development costs for studies that will be used only in the U.S., 50% for Japan studies and 27.5% for global studies.

 

BMS is amortizing $500 million of license acquisition costs associated with the EGFR commercialization agreement through 2018.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Net sales$ 179 $ 173 $ 358 $ 338
Distribution fees and royalty expense  75   71   149   140
Research and development expense reimbursement to Lilly – necitumumab   7   4   8   6
Amortization (income)/expense upfront, milestone and other            
 licensing payments  9   9   19   19
Commercialization expense reimbursements to/(from) Lilly  (6)   (2)   (10)   (3)
Japan commercialization profit sharing (income)/expense  (13)   (6)   (19)   (15)
             
        June 30, December 31,
Dollars in Millions      2012 2011
Other intangible assets – upfront, milestone and other licensing payments      $ 230 $ 249

Gilead

 

BMS and Gilead Sciences, Inc. (Gilead) have a joint venture to develop and commercialize Atripla* (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen for the treatment of human immunodeficiency virus (HIV) infection, combining Sustiva, a product of BMS, and Truvada* (emtricitabine and tenofovir disoproxil fumarate), a product of Gilead, in the U.S., Canada and Europe.

 

Net sales of the bulk efavirenz component of Atripla* are deferred until the combined product is sold to third-party customers. Net sales for the efavirenz component are based on the relative ratio of the average respective net selling prices of Truvada* and Sustiva.

 

Summarized financial information related to this alliance is as follows:

 Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Net sales$ 323 $ 298 $ 645 $ 569
Equity in net loss of affiliates  4   3   8   8

AstraZeneca

 

BMS maintains two worldwide codevelopment and cocommercialization agreements with AstraZeneca PLC (AstraZeneca) for Onglyza, Kombiglyze (excluding Japan), Komboglyze and Forxiga (dapagliflozin). Onglyza, Kombiglyze (saxagliptin and metformin hydrochloride extended-release) and Komboglyze (saxagliptin and metformin immediate-release marketed in the EU) are indicated for use in the treatment of diabetes. In this document unless specifically noted, we refer to both Kombiglyze and Komboglyze as Kombiglyze. Forxiga is currently being studied for the treatment of diabetes. Onglyza and Forxiga were discovered by BMS. Kombiglyze was codeveloped with AstraZeneca. Both companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits and losses equally on a global basis and also share in development costs. BMS manufactures both products. BMS has opted to decline involvement in cocommercialization in certain countries not in the BMS global commercialization network and instead receive compensation based on net sales recorded by AstraZeneca in these countries. Opt-out compensation recorded by BMS was not material in the three and six months ended June 30, 2012.

 

BMS received $300 million in upfront, milestone and other licensing payments related to saxagliptin as of June 30, 2012 and $170 million in upfront, milestone and other licensing payments related to dapagliflozin as of June 30, 2012.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Net sales$ 172 $ 112 $ 333 $ 193
Profit sharing expense  77   52   150   90
Commercialization expense reimbursements to/(from) AstraZeneca  (7)   (10)   (19)   (19)
Research and development expense reimbursements to/(from) AstraZeneca  6   15   10   29
Amortization (income)/expense upfront, milestone and other            
 licensing payments  (11)   (10)   (21)   (18)
             
        June 30, December 31,
Dollars in Millions      2012 2011
Deferred income upfront, milestone and other licensing payments           
 Saxagliptin      $ 217 $ 230
 Dapagliflozin        134   142

Following the completion of BMS's planned acquisition of Amylin Pharmaceuticals, Inc. (Amylin) (see “—Note 4. Acquisitions” for further information), BMS and AstraZeneca Pharmaceuticals LP, a wholly-owned subsidiary of AstraZeneca will enter into collaboration arrangements, based on the framework of the existing diabetes alliance agreements, regarding the development and commercialization of Amylin's portfolio of products and AstraZeneca will make a payment to Amylin, as a wholly-owned subsidiary of BMS, in the amount of approximately $3.4 billion in cash. Profits and losses arising from the collaboration will be shared equally. In addition, AstraZeneca has the option, exercisable at its sole discretion following the closing of the acquisition, to establish equal governance rights over certain key strategic and financial decisions regarding the collaboration, upon the payment to BMS of an additional $135 million.

Pfizer

 

BMS and Pfizer Inc. (Pfizer) maintain a worldwide codevelopment and cocommercialization agreement for Eliquis, an anticoagulant discovered by BMS for the prevention and treatment of atrial fibrillation and other arterial thrombotic conditions. Pfizer funds 60% of all development costs under the initial development plan effective January 1, 2007. The companies jointly develop the clinical and marketing strategy and share commercialization expenses and profits equally on a global basis. In certain countries not in the BMS global commercialization network, Pfizer will commercialize Eliquis alone and will pay a royalty to BMS. BMS manufactures the product globally.

 

BMS has received $559 million in upfront, milestone and other licensing payments for Eliquis as of June 30, 2012.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions2012 2011 2012 2011
Net sales$ 1 $ - $ 1 $ -
Commercialization expense reimbursement to/(from) Pfizer  (3)   (2)   (8)   (3)
Research and development reimbursements to/(from) Pfizer  9   (27)   11   (56)
Amortization (income)/expense – upfront, milestone and other            
 licensing payments  (9)   (8)   (19)   (16)
             
        June 30, December 31,
Dollars in Millions      2012 2011
Deferred income upfront, milestone and other licensing payments      $ 415 $ 434