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ALLIANCES AND COLLABORATIONS
3 Months Ended
Mar. 31, 2013
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Alliances and Collaborations [Text Block]

Note 3. ALLIANCES AND COLLABORATIONS

 

BMS enters into alliance and collaboration arrangements with third parties for the development and commercialization of certain products. Both parties are active participants in the alliance operating activities and exposed to significant risks and rewards depending on the commercial success of the activities. BMS may either in-license intellectual property owned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing, and/or commercial activities and can cover a single investigational compound or marketed product or multiple compounds and/or products in various life cycle stages.

 

When BMS is the principal in the customer sale, 100% of product sales are recognized. Otherwise, only BMS's contractual share of alliance revenue is reported in net sales.

 

Payments between collaboration partners are presented in operating results based on the nature of the arrangement, including its contractual terms, the nature of the payments and the applicable accounting guidance. Upfront and contingent milestone payments made prior to product approval are immediately expensed and those payments made after product approval are amortized over the shorter of the contractual term or estimated life of the product. Upfront and contingent milestones received are amortized over the shorter of the contractual term or estimated life of the product. Other activities between BMS and its collaboration partners are presented in operating results as follows:

 

  • Payments to BMS from collaboration partners for supply arrangements, royalties, co-promotional and collaboration fees are presented in net sales when BMS's collaboration partner is the principal in the customer sale.

     

  • Payments to collaboration partners from BMS for supply arrangements, royalties, profit sharing and distribution fees; and the amortization of upfront or contingent milestone payments made upon or after the regulatory approval date are included in cost of products sold.

     

  • Cost reimbursement payments between the parties for commercial expenses are included in marketing, selling, administrative, advertising and product promotion expenses.

     

  • Upfront and contingent milestone payments from collaboration partners to BMS prior to the regulatory approval date and cost reimbursement payments between the parties are included in research and development expenses.

     

  • The amortization of upfront and contingent milestone payments to BMS from collaboration partners, equity in net income of affiliates and other payments that are related to non-core activities are included in other (income)/expense.

 

All payments between BMS and its collaboration partners are presented in cash flows from operating activities, including profit distributions when the activities are conducted through a separate and distinct legal entity or partnership.

 

See the 2012 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.

Otsuka

 

BMS has a worldwide commercialization agreement, excluding certain Asian countries, with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to codevelop and copromote Abilify*, for the treatment of schizophrenia, bipolar mania disorder and major depressive disorder. The U.S. portion of the commercialization and manufacturing agreement was amended in 2009 and further amended in 2012, and it expires upon the expected loss of product exclusivity in April 2015. The agreement expires in all EU countries in June 2014 and in each other non-U.S. country where we have the exclusive right to sell Abilify*, the agreement expires on the later of April 20, 2015 or loss of exclusivity in any such country.

 

Otsuka is the principal in most third-party net sales. Therefore, net sales recognized for Abilify* include only BMS's contractual share of total net sales to third party customers. In the U.S., BMS's contractual share was 51.5% in 2012. Beginning January 1, 2013, BMS's contractual share changed to the percentages of total U.S. net sales set forth in the table below. BMS recognizes revenue based on the weighted-average forecast of expected annual sales (currently estimated at 35%).

 Share as a % of U.S. Net
 Sales
$0 to $2.7 billion50%
$2.7 billion to $3.2 billion20%
$3.2 billion to $3.7 billion7%
$3.7 billion to $4.0 billion2%
$4.0 billion to $4.2 billion1%
In excess of $4.2 billion20%

In the United Kingdom, Germany, France, Spain, and beginning on March 1, 2013 in Italy, BMS's contractual share of third-party net sales is 65%. 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. BMS recognizes all of the net sales in certain countries where it is the exclusive distributor for the product or has an exclusive right to sell Abilify*.

 

BMS purchases the active pharmaceutical ingredient from Otsuka and completes the manufacture of the product for sale to third-party customers by BMS or Otsuka. Under the terms of the 2009 U.S. amendment, BMS paid Otsuka $400 million in 2009, 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, which is included in cost of products sold. Otsuka was responsible for 30% of the U.S. expenses related to the commercialization of Abilify* from 2010 through 2012. Under the 2012 U.S. amendment, Otsuka assumed responsibility for providing and funding all sales force efforts effective January 2013. In consideration, BMS paid Otsuka $27 million in January 2013, and will be responsible for funding certain operating expenses up to $82 million in 2013, $56 million in 2014 and $8 million in 2015. In the EU, Otsuka reimbursed BMS for the sales force effort it provided through March 31, 2013. Otsuka assumed responsibility for providing and funding sales force efforts in the EU effective April 2013.

 

BMS and Otsuka also have an oncology collaboration for Sprycel and Ixempra (ixabepilone) (the “Oncology Products”) in the U.S., Japan and the EU (the Oncology Territory). A collaboration fee, included in cost of products sold, is paid to Otsuka based on the following percentages of annual net sales of Sprycel and Ixempra

 % of Net Sales
 2010 - 2012 2013 - 2020
$0 to $400 million30% 65%
$400 million to $600 million5% 12%
$600 million to $800 million3% 3%
$800 million to $1.0 billion2% 2%
In excess of $1.0 billion1% 1%

During these periods, 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 March 31,
Dollars in Millions 2013  2012
Abilify*net sales, net of amortization of extension payment$ 522 $ 621
Oncology Products collaboration fee expense  70   32
Royalty expense  17   17
Reimbursement of operating expenses to/(from) Otsuka  (6)   (24)
Amortization (income)/expense extension payment  16   16
Amortization (income)/expense – upfront, milestone and other licensing payments  -   2
       
  March 31, December 31,
Dollars in Millions2013 2012
Other assets - extension payment$ 137 $ 153

AstraZeneca

 

BMS and AstraZeneca have a diabetes alliance consisting of three worldwide codevelopment and commercialization agreements. One collaboration covers Onglyza, Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release), and Komboglyze (saxagliptin and metformin immediate-release marketed in the EU); a second collaboration covers Forxiga; and a third collaboration, entered into during August 2012, covers Amylin's portfolio of products (Bydureon*, Byetta*, Symlin* (pramlintide acetate) and metreleptin, which is currently in development). The agreements for saxagliptin exclude Japan. In this document unless specifically noted, we refer to both Kombiglyze and Komboglyze as Kombiglyze. Onglyza and Forxiga were discovered by BMS. Kombiglyze was codeveloped with AstraZeneca. Bydureon*, Byetta*, Symlin* and metreleptin were discovered by Amylin, LLC (Amylin), a wholly-owned subsidiary of BMS since August 2012.

 

BMS is the principal in third party customer net sales. 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, with the exception of Forxiga development costs in Japan, which are borne by AstraZeneca.

 

In 2012, BMS received preliminary proceeds of $3.6 billion from AstraZeneca as consideration for entering into the Amylin-related collaboration including $73 million included in accrued expenses that is expected to be reimbursed back to AstraZeneca in the second quarter of 2013. The remaining $3.5 billion is accounted for as deferred income and amortized as a reduction to cost of products sold on a pro-rata basis over the estimated useful lives of the related long-lived assets assigned in the purchase price allocation (primarily intangible assets with a weighted-average estimated useful life of 12 years and property, plant and equipment with a weighted-average estimated useful life of 15 years). The net proceeds that BMS received from AstraZeneca as consideration for entering into the collaboration are subject to certain adjustments including the right to receive an additional $135 million when AstraZeneca exercises its option for equal governance rights over certain key strategic and financial decisions regarding the collaboration, which it has indicated it intends to do pending required anti-trust approvals in certain international markets. BMS is entitled to reimbursements for 50% of capital expenditures related to Amylin. BMS and AstraZeneca agreed to share in certain tax attributes related to the Amylin collaboration. The preliminary proceeds of $3.6 billion that BMS received from AstraZeneca included $207 million related to sharing of certain tax attributes.

 

With respect to the other collaborations, BMS has received $300 million in upfront, milestone and other licensing payments related to saxagliptin to date and could receive up to an additional $300 million for sales-based milestones. BMS has also received $250 million in upfront, milestone and other licensing payments related to dapagliflozin to date, and could potentially receive up to an additional $150 million for development and regulatory milestones and up to an additional $390 million for sales-based milestones.

 

Summarized financial information related to these alliances is as follows:

  Three Months Ended March 31,
Dollars in Millions2013 2012
Net sales$ 358 $ 161
Profit sharing expense  146   73
Commercialization expense reimbursements to/(from) AstraZeneca  (57)   (12)
Research and development expense reimbursements to/(from) AstraZeneca  (17)   4
Amortization (income)/expense – upfront, milestone and other licensing receipts recognized in:     
 Cost of products sold  (75)   -
 Other (income)/expense  (7)   (10)
       
Upfront, milestone and other licensing receipts:     
 Dapagliflozin  80   -
       
  March 31, December 31,
Dollars in Millions2013 2012
Deferred income – upfront, milestone and other licensing receipts     
 Amylin-related products$ 3,352 $ 3,423
 Saxagliptin  204   208
 Dapagliflozin  203   206

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 recognized for Atripla* include only the bulk efavirenz component of Atripla*. They are deferred until the combined product is sold to third-party customers and 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 March 31,
Dollars in Millions 2013 2012
Net sales $ 324 $ 322
Equity in net loss of affiliates   4   4

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* 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. BMS is the principal in third party customer sales. 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.

 

In March 2013, the Company and Lilly terminated the global codevelopment and cocommercialization arrangement for necitumumab (IMC-11F8), with all rights returning to Lilly. Discovered by ImClone, necitumumab is a fully human monoclonal antibody being investigated as an anticancer treatment and was part of the alliance between the Company and Lilly.

 

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 March 31,
Dollars in Millions2013 2012
Net sales$ 162 $ 179
Distribution fees and royalty expense  67   74
Research and development expense reimbursement to Lilly – necitumumab   -   1
Amortization (income)/expense upfront, milestone and other licensing payments  9   10
Japan commercialization fee (income)/expense  (4)   (6)
      
 March 31, December 31,
Dollars in Millions2013 2012
Other intangible assets – upfront, milestone and other licensing payments$ 202 $ 211

Prior to BMS's acquisition of Amylin on August 8, 2012, Amylin had entered into a settlement and termination agreement with Lilly regarding their collaboration for the global development and commercialization of Byetta* and Bydureon* (exenatide products) under which the parties agreed to transition full responsibility of these products to Amylin. The transition of the U.S. operations was completed by the time of the acquisition. The transition of non-U.S. operations of the exenatide products in a majority of markets was completed on April 1, 2013 terminating Lilly's exclusive right to non-U.S. commercialization of the exenatide products. BMS is responsible for any non-U.S. losses incurred by Lilly during 2012 and 2013 up to a maximum of $60 million.

Sanofi

 

In September 2012, BMS and Sanofi restructured the terms of the codevelopment and cocommercialization agreements for Plavix*, a platelet aggregation inhibitor, and Avapro*/Avalide*, an angiotension II receptor antagonist indicated for the treatment of hypertension and diabetic nephropathy. Effective January 1, 2013, Sanofi assumed essentially all of the worldwide operations of the alliance with the exception of Plavix* in the U.S. and Puerto Rico. The alliance for Plavix* in these two markets will continue unchanged through December 2019 under the same terms as in the original alliance arrangements described below. In exchange for the rights being assumed by Sanofi, BMS will receive quarterly royalties from January 1, 2013 until December 31, 2018 and a terminal payment from Sanofi of $200 million at the end of 2018.

 

Beginning in 2013, all royalties received from Sanofi in the territory covering the Americas and Australia, opt-out markets, and former comarketing countries discussed below are presented in net sales, including $51 million in the three months ended March 31, 2013. Development and opt-out royalties were recognized in other (income)/expense in 2012. Royalties attributed to the territory covering Europe and Asia continue to be earned by the territory partnership and are included in equity in net income of affiliates. Additionally, equity in net income of affiliates for the three months ended March 31, 2013 includes $22 million of profit that was deferred prior to the restructuring of the agreement. Net sales attributed to the supply of irbesartan active pharmaceutical ingredient to Sanofi were $18 million and $38 million for the three months ended March 31, 2013 and 2012, respectively. The supply arrangement expires in 2015.

 

Prior to the restructuring, BMS's worldwide alliance with Sanofi for the codevelopment and cocommercialization of Avapro*/Avalide* and Plavix* operated 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. These two territory partnerships managed central expenses, such as marketing, research and development and royalties, and supply of finished product to individual countries. BMS acted as the operating partner and owned 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 also recognized net sales in comarketing countries outside this territory (e.g., Germany, Italy for irbesartan only, Spain and Greece). Sanofi acted as the operating partner and owned a 50.1% majority controlling interest in the territory covering Europe and Asia and BMS has a 49.9% ownership interest in this territory.

 

Summarized financial information related to this alliance is as follows:

  Three Months Ended March 31,
Dollars in Millions2013  2012
Net sales$ 137 $ 1,900
Royalty expense  2   367
Equity in net income of affiliates  (40)   (60)
Other (income)/expense  (10)   (14)
Noncontrolling interestpre-tax  24   605
       
Distributions to Sanofi  -   609
Distributions to BMS  31   67
       
  March 31, December 31,
Dollars in Millions2013 2012
Investment in affiliates – territory covering Europe and Asia$ 18 $ 9
Noncontrolling interest  (6)   (30)

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 March 31,
Dollars in Millions2013 2012
Net sales$ 49 $ 319
Gross profit  37   138
Net income  36   122

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. Eliquis was approved in the European Union in November 2012 and in the U.S. and Japan in December 2012 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). 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 BMS compensation based on a percentage of net sales. BMS manufactures the product and is the principal in third party customer sales.

 

BMS received $684 million in upfront, milestone and other licensing payments for Eliquis to date, and could receive up to an additional $200 million for development and regulatory milestones.

 

Summarized financial information related to this alliance is as follows:

 Three Months Ended March 31,
Dollars in Millions2013 2012
Net sales$ 22 $ -
Profit sharing expense  10   -
Commercialization expense reimbursement to/(from) Pfizer  (12)   (5)
Research and development reimbursements to/(from) Pfizer  7   2
Amortization (income)/expense – upfront, milestone and other licensing receipts  (10)   (10)
      
Upfront, milestone and other licensing receipts  125   -
      
 March 31, December 31,
Dollars in Millions2013 2012
Deferred income upfront, milestone and other licensing receipts$ 512 $ 397

The Medicines Company

 

In February 2013, BMS and The Medicines Company entered into a two year collaboration for Recothrom, a recombinant thrombin for use as a topical hemostat to control non-arterial bleeding during surgical procedures (previously acquired by BMS in connection with its acquisition of ZymoGenetics in 2010). Net sales of Recothrom were $67 million in 2012. In connection with the collaboration, The Medicines Company received the right to sell, distribute and market Recothrom on a global basis for two years, and will have certain responsibilities related to regulatory matters. During the collaboration term, BMS will exclusively supply Recothrom to The Medicines Company pursuant to a supply agreement at cost plus a markup and will also receive royalties equal to a tiered percentage of net sales of Recothrom. Certain employees directly attributed to the business and certain assets were transferred to The Medicines Company at the start of the collaboration period, including the Recothrom Biologics License Application and related regulatory assets. BMS retained all other assets related to Recothrom including the patents, trademarks and inventory.

 

As part of the agreement, BMS granted The Medicines Company an option to acquire the patents, trademarks, inventory and certain other assets exclusively related to Recothrom at a price determined based on a multiple of sales plus the cost of any remaining inventory held by BMS at that time. If the option is not exercised, all assets previously transferred to The Medicines Company during the collaboration period revert back to BMS. The option may be exercised by The Medicines Company between February and August 2014, with closing to occur in February 2015.

 

As consideration for entering into the collaboration, BMS received $115 million at the start of the collaboration which was allocated to the license and other rights transferred to The Medicines Company ($80 million) and the fair value of the option to purchase the remaining assets at the end of the collaboration ($35 million). The allocation was based on the estimated fair value of the option after considering various market factors, including an analysis of any estimated excess of the fair value of the business over the potential purchase price if the option is exercised. The fair value of the option was determined using Level 3 inputs and recorded as a liability. Changes in the estimated fair value of the option liability are recognized in other (income)/expense and were not material in the three months ended March 31, 2013. The remaining $80 million will be recognized as alliance revenue throughout the term of the collaboration, of which $7 million was recognized during the three months ended March 31, 2013.

 

BMS will also recognize alliance revenue during the collaboration period for tiered royalties and supply of product. BMS will provide certain information technology, regulatory, order processing, distribution and other transitional services in exchange for a fee during a period up to six months commencing at the start of the collaboration. Alliance revenue related to tiered royalties, product supply and other services were not material in the three months ended March 31, 2013.

Valeant

 

In October 2012, BMS and PharmaSwiss SA, a wholly-owned subsidiary of Valeant Pharmaceuticals International Inc. (Valeant) entered into a collaboration for certain mature brand products in Europe. In connection with the collaboration, Valeant received the right to sell, distribute, and market the products in Europe through December 31, 2014 and will have certain responsibilities related to regulatory matters in the covered territory. During the collaboration term, BMS will exclusively supply the products to Valeant pursuant to a supply agreement at cost plus a markup.

 

As part of the agreement, BMS granted Valeant an option to acquire the trademarks and intellectual property exclusively related to the products at a price determined based on a multiple of sales. If the right is not exercised, all rights transferred to Valeant during the collaboration period revert back to BMS. The option may be exercised by Valeant between January and June 2014, with closing to occur in December 2014.

 

As consideration for entering into the collaboration, BMS received $79 million at the start of the collaboration period which was allocated to the license and other rights transferred to Valeant ($61 million) and the fair value of the option to purchase the remaining assets at the end of the collaboration ($18 million). The allocation was based on the estimated fair value of the option after considering various market factors, including an analysis of any estimated excess of the fair value of the mature brands business over the potential purchase price if the option to purchase is exercised at December 31, 2014. The fair value of the option was determined using Level 3 inputs and recorded as a liability. Changes in the estimated fair value of the option liability are recognized in other (income)/expense and were not material for the three months ended March 31, 2013. The remaining $61 million will be recognized as alliance revenue throughout the term of the collaboration of which $7 million was recognized during the three months ended March 31, 2013.

 

BMS will also recognize revenue during the collaboration period for the supply of the product, and provide certain information technology, regulatory, order processing, distribution and other transitional services in exchange for a fee during the first six months of the collaboration. Alliance revenue related to product supply and other services were not material in the three months ended March 31, 2013.

Reckitt Benckiser Group plc

 

In February 2013, BMS and Reckitt Benckiser Group plc (RBL) agreed to enter into a three year collaboration regarding several over-the-counter-products sold primarily in Mexico and Brazil. The transaction is expected to close during the second quarter of 2013, subject to customary closing conditions and regulatory approvals. Net sales of these products were approximately $100 million in 2012.

 

In connection with the collaboration, RBL will be responsible for all sales, distribution, marketing and certain regulatory matters and BMS will be responsible for the exclusive supply of the products. Certain limited assets are expected to be transferred to RBL at the start of the collaboration period, primarily the market authorizations, as well as certain employees directly attributed to the business. BMS will retain all other assets related to the business including the patents, trademarks and inventory during the collaboration period.

 

As part of the proposed agreement, BMS will grant RBL an option to acquire the patents, trademarks, inventory and certain other assets exclusively related to the products at the end of the collaboration at a price determined based on a multiple of sales (plus the cost of any remaining inventory held by BMS at the time). If the option is not exercised, all assets previously transferred to RBL during the collaboration period revert back to BMS.

 

BMS is expected to receive proceeds of $482 million at the start of the collaboration period which will be allocated to the license and other rights transferred to RBL and the fair value of the option to purchase the remaining assets at the end of the collaboration.