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Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $134 million for 2023 and $229 million for 2022, respectively. The reductions to provisions in 2022 driven by the non-U.S. revisions in clawback amounts driven by the VAT recoverable estimates. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to higher government channel mix, which has higher GTN adjustment percentages. Non-U.S. GTN adjustments percentage increased primarily due to continued pricing pressures.
Product Revenues
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| | Year Ended December 31, | | |
| Dollars in millions | 2023 | | 2022 | | % Change |
| In-Line Products | | | | | |
| Eliquis | 12,206 | | | $ | 11,789 | | | 4 | % |
| U.S. | 8,592 | | | 7,786 | | | 10 | % |
| Non-U.S. | 3,614 | | | 4,003 | | | (10) | % |
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| Opdivo | 9,009 | | | 8,249 | | | 9 | % |
| U.S. | 5,283 | | | 4,812 | | | 10 | % |
| Non-U.S. | 3,726 | | | 3,437 | | | 8 | % |
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| Orencia | 3,601 | | | 3,464 | | | 4 | % |
| U.S. | 2,754 | | | 2,638 | | | 4 | % |
| Non-U.S. | 847 | | | 826 | | | 3 | % |
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| Pomalyst/Imnovid | 3,441 | | | 3,497 | | | (2) | % |
| U.S. | 2,357 | | | 2,438 | | | (3) | % |
| Non-U.S. | 1,084 | | | 1,059 | | | 2 | % |
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| Yervoy | 2,238 | | | 2,131 | | | 5 | % |
| U.S. | 1,388 | | | 1,304 | | | 6 | % |
| Non-U.S. | 850 | | | 827 | | | 3 | % |
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| Sprycel | 1,930 | | | 2,165 | | | (11) | % |
| U.S. | 1,446 | | | 1,497 | | | (3) | % |
| Non-U.S. | 484 | | | 668 | | | (28) | % |
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| Mature and other products | 1,895 | | | 2,045 | | | (7) | % |
| U.S. | 772 | | | 750 | | | 3 | % |
| Non-U.S. | 1,123 | | | 1,295 | | | (13) | % |
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| Total In-Line Products | 34,320 | | | 33,340 | | | 3 | % |
| U.S. | 22,592 | | | 21,225 | | | 6 | % |
| Non-U.S. | 11,728 | | | 12,115 | | | (3) | % |
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| | Year Ended December 31, | | |
| Dollars in millions | 2023 | | 2022 | | % Change |
| New Product Portfolio | | | | | |
| Reblozyl | 1,008 | | | 717 | | | 41 | % |
| U.S. | 811 | | | 591 | | | 37 | % |
| Non-U.S. | 197 | | | 126 | | | 56 | % |
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| Opdualag | 627 | | | 252 | | | * |
| U.S. | 617 | | | 252 | | | * |
| Non-U.S. | 10 | | | — | | | N/A |
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| Abecma | 472 | | | 388 | | | 22 | % |
| U.S. | 358 | | | 297 | | | 21 | % |
| Non-U.S. | 114 | | | 91 | | | 25 | % |
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| Zeposia | 434 | | | 250 | | | 74 | % |
| U.S. | 324 | | | 177 | | | 83 | % |
| Non-U.S. | 110 | | | 73 | | | 51 | % |
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| Breyanzi | 364 | | | 182 | | | 100 | % |
| U.S. | 303 | | | 151 | | | * |
| Non-U.S. | 61 | | | 31 | | | 97 | % |
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| Camzyos | 231 | | | 24 | | | * |
| U.S. | 226 | | | 24 | | | * |
| Non-U.S. | 5 | | | — | | | N/A |
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| Sotyktu | 170 | | 8 | | | * |
| U.S. | 157 | | 8 | | | * |
| Non-U.S. | 13 | | — | | | N/A |
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| Onureg | 168 | | | 124 | | | 35 | % |
| U.S. | 117 | | | 95 | | | 23 | % |
| Non-U.S. | 51 | | | 29 | | | 76 | % |
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| Inrebic | 110 | | | 85 | | | 29 | % |
| U.S. | 74 | | | 69 | | | 7 | % |
| Non-U.S. | 36 | | | 16 | | | * |
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| Augtyro | 1 | | | — | | | N/A |
| U.S. | 1 | | | — | | | N/A |
| Non-U.S. | — | | | — | | | N/A |
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| Total New Product Portfolio | 3,585 | | | 2,030 | | | 77 | % |
| U.S. | 2,988 | | | 1,664 | | | 80 | % |
| Non-U.S. | 597 | | | 366 | | | 63 | % |
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| Total In-Line Products and New Product Portfolio | 37,905 | | | 35,370 | | | 7 | % |
| U.S. | 25,580 | | | 22,889 | | | 12 | % |
| Non-U.S. | 12,325 | | | 12,481 | | | (1) | % |
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| Year Ended December 31, | | |
| Dollars in millions | 2023 | | 2022 | | % Change |
Recent LOE Products(a) | | | | | |
| Revlimid | 6,097 | | | 9,978 | | | (39) | % |
| U.S. | 5,266 | | | 8,359 | | | (37) | % |
| Non-U.S. | 831 | | | 1,619 | | | (49) | % |
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| Abraxane | 1,004 | | | 811 | | | 24 | % |
| U.S. | 709 | | | 580 | | | 22 | % |
| Non-U.S. | 295 | | | 231 | | | 28 | % |
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| Total Recent LOE Products | 7,101 | | | 10,789 | | | (34) | % |
| U.S. | 5,975 | | | 8,939 | | | (33) | % |
| Non-U.S. | 1,126 | | | 1,850 | | | (39) | % |
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| Total Revenues | 45,006 | | | 46,159 | | | (2) | % |
| U.S. | 31,555 | | | 31,828 | | | (1) | % |
| Non-U.S. | 13,451 | | | 14,331 | | | (6) | % |
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* Change in excess of 100%.
(a) Recent LOE Products include products with significant expected decline in revenue from a prior reporting period as a result of a LOE.
Eliquis (apixaban) — an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
•U.S. revenues increased 10% in 2023 primarily due to higher demand.
•International revenues decreased 10% in 2023 primarily due to lower average net selling prices and generic erosion in the UK and Canada. Excluding foreign exchange impacts, revenues decreased by 10%.
•Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe and the court decision in the UK finding the UK apixaban composition-of-matter patent and related SPC invalid, generic manufacturers have begun marketing generic versions of Eliquis in the UK and in Portugal, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which has led to additional infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe. Most recently, in France, Norway and Sweden, courts held in BMS's favor, confirming the validity of the composition of matter patent and related SPCs in those countries. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to “Item 1. Financial Statements—Note 20. Legal Proceedings and Contingencies—Intellectual Property” for further information.
Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and various gastric and esophageal cancers. There are several ongoing potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.
•U.S. revenues increased 10% in 2023 due to higher demand across multiple indications and to a lesser extent higher average net selling prices. The higher demand was related to the following indications: the Opdivo+Yervoy combinations for NSCLC, various gastric, esophageal and bladder cancers.
•International revenues increased 8% in 2023 primarily due to higher demand as a result of core indications and additional indication launches partially offset by foreign exchange impact of 3%. Excluding foreign exchange impacts, revenues increased by 11%.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
•U.S. revenues increased 4% in 2023 primarily due to higher demand.
•International revenues increased 3% in 2023 due to higher demand partially offset by foreign exchange impact of 3%. Excluding foreign exchange impacts, revenues increased by 6%.
•BMS is not aware of any Orencia biosimilars on the market in the U.S., EU or Japan. Formulation and additional patents expire in 2026 and beyond.
Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
•U.S. revenues decreased 3% in 2023 due to an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, partially offset by higher average net selling prices.
•International revenues increased 2% in 2023 due to higher demand, partially offset by lower average net selling prices and foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased by 3%.
•In the EU, the estimated minimum market exclusivity date is August 2024.
Yervoy (ipilimumab) — a CTLA4 immune checkpoint inhibitor. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.
•U.S. revenues increased 6% in 2023 due to higher average net selling prices and demand.
•International revenues increased 3% in 2023 due to higher demand as a result of additional indication launches and core indications, partially offset by lower average net selling prices and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased by 5%.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.
•U.S. revenues decreased 3% in 2023 due to lower average net selling prices driven by unfavorable GTN adjustments.
•International revenues decreased 28% in 2023 due to lower demand as a result of generic erosion, lower average net selling price and foreign exchange impact of 3%. Excluding foreign exchange impact, revenues decreased by 25%.
•In the U.S., BMS entered into settlement agreements with certain third parties to sell generic dasatinib products beginning in September 2024, or earlier in certain circumstances. In the EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent has been extended to 2024 for the treatment of non-imatinib-resistant CML, but generics have been approved for other indications.
Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products and royalty revenue and mature products.
•International revenues for mature and other products decreased 13% primarily due to lower demand as a result of continued generic erosion and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues decreased by 11%.
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status.
•U.S. revenues increased 37% in 2023 primarily due to higher demand.
Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag was launched in March 2022.
Abecma (idecabtagene vicleucel) — is a BCMA genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.
•U.S. revenues increased 21% in 2023 primarily due to higher demand enabled by additional manufacturing capacity.
Zeposia (ozanimod) — an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.
•U.S. revenues increased 83% in 2023 primarily due to higher demand.
Breyanzi (lisocabtagene maraleucel) — a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after one or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B.
•U.S. revenues doubled in sales primarily due to higher demand.
Camzyos (mavacamten) — a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Camzyos was launched in April 2022.
Sotyktu (deucravacitinib) — an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu was launched in September 2022.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
•U.S. revenues increased 23% in 2023 primarily due to higher demand.
Inrebic (fedratinib) — an oral kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) MF.
•U.S. revenues increased 7% in 2023 primarily due to higher demand.
Augtyro (repotrectinib) — a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Augtyro was launched in December 2023.
Revlimid (lenalidomide) — an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS.
•U.S. revenues decreased 37% in 2023 primarily due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, and to a lesser extent lower average net selling prices.
•International revenues decreased 49% in 2023 primarily due to generic erosion across several European countries and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues decreased by 47%.
•In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. In the EU and Japan, generic lenalidomide products have entered the market. Global revenues for Revlimid are expected to decline in the range of approximately $1.5 billion to $2.0 billion in 2024.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.
•U.S. revenues increased 22% in 2023 primarily due to higher branded sales resulting from lower authorized generic sales.
Estimated End-User Demand
Pursuant to the SEC Consent Order described under “—SEC Consent Order”, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We disclose products with levels of inventory in excess of one month on hand or expected demand, subject to certain limited exceptions. There were none as of December 31, 2023, for our U.S. distribution channels, and September 30, 2023, for our non-U.S. distribution channels.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 85% of total gross sales of U.S. products for the year ended December 31, 2023. Factors that may influence our estimates include generic erosion, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.
Camzyos is only available through a restricted program called the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos. Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS and Pomalyst REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the products’ safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.
Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the year ended December 31, 2023 is not available prior to the filing of this 2023 Form 10-K. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to certain limited exceptions, in our next quarterly report on Form 10-Q.
Expenses
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| | Year Ended December 31, | | |
| Dollar in Millions | 2023 | | 2022 | | % Change |
Cost of products sold (a) | $ | 10,693 | | | $ | 10,137 | | | 5 | % |
| Marketing, selling and administrative | 7,772 | | | 7,814 | | | (1) | % |
| Research and development | 9,299 | | | 9,509 | | | (2) | % |
| Acquired IPRD | 913 | | | 815 | | | 12 | % |
| Amortization of acquired intangible assets | 9,047 | | | 9,595 | | | (6) | % |
| Other (income)/expense, net | (1,158) | | | 576 | | | * |
| Total Expenses | $ | 36,566 | | | $ | 38,446 | | | (5) | % |
* Change in excess of 100%.
(a) Excludes amortization of acquired intangible assets.
Cost of products sold
Cost of products sold include material, internal labor and overhead costs from our owned manufacturing sites, third-party product supply costs and other supply chain costs managed by our global manufacturing and supply organization. Cost of products sold also includes royalties and profit sharing, foreign currency hedge settlement gains and losses and impairment charges, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs. Cost of products sold excludes amortization from acquired intangible assets.
Cost of products sold increased by $556 million or 5% primarily due to higher inventory costs ($388 million), driven by product mix and CAR-T cell therapy costs, higher royalties and profit sharing ($381 million), lower hedging settlement gains ($189 million), partially offset by the elimination of the Puerto Rico excise tax ($210 million) and lower inventory purchase price adjustments ($209 million).
Marketing, selling and administrative
Marketing, selling and administrative expenses primarily include salary and benefit costs, third-party professional and marketing fees, outsourcing fees, shipping and handling costs, advertising and product promotion costs, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs. Expenses are managed through regional commercialization organizations or global enabling functions such as finance, legal, information technology and human resources. Certain expenses are shared with alliance partners based upon contractual agreements.
Marketing, selling and administrative expenses decreased by $42 million or 1% primarily due to the timing of charitable giving ($215 million) and cash settlement of Turning Point unvested stock awards ($73 million) in 2022, partially offset by higher advertising and promotion costs resulting from additional new product launches ($121 million) and site exit costs ($88 million).
Research and development
Research and development activities include research and early discovery, preclinical and clinical development, drug formulation and medical support of marketed products. Expenses include salary and benefit costs, third-party grants and fees paid to clinical research organizations, supplies, IPRD impairment charges and proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, employee stock compensation costs and other appropriate costs. Certain expenses are shared with alliance partners based upon contractual agreements.
Research and development expense decreased by $210 million or 2% primarily due to costs related to the unwinding of inventory purchase price adjustments for clinical use ($130 million) and cash settlement of Turning Point unvested stock awards ($80 million) in 2022, partially offset by the purchase of a priority review voucher ($95 million) in 2023.
Acquired IPRD
Acquired IPRD expenses are comprised of upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval. Acquired IPRD charges are detailed in the table below.
| | | | | | | | | | | |
| Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 |
| Mavacamten rights buy-out (Note 4) | $ | 445 | | | $ | — | |
| Orum upfront payment (Note 4) | 100 | | | — | |
| Mavacamten royalty extinguishment (Note 4) | — | | | 295 | |
| Dragonfly milestone and opt-in license fee | — | | | 200 | |
| Evotec designation and opt-in license fees | 90 | | — | |
| BridgeBio upfront collaboration fee | — | | | 90 | |
| Prothena opt-in license fee | 55 | | | |
| Zenas upfront license fee | 50 | | | — | |
| Immatics upfront license and opt-in fee (Note 4) | 15 | | | 150 |
| Other | 158 | | | 80 | |
| Acquired IPRD | $ | 913 | | | $ | 815 | |
Refer to “Item 8. Financial Statements and Supplementary Data—Note 3. Alliances” and “—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for additional information.
Amortization of Acquired Intangible Assets
Amortization of acquired intangible assets decreased by $548 million or 6% primarily due to Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
Other (income)/expense, net
Other (income)/expense, net changed by $1.7 billion primarily due to litigation and other settlements, equity investments and other items discussed below.
| | | | | | | | | | | |
| | Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 |
| Interest expense | $ | 1,166 | | | $ | 1,232 | |
| Royalty and licensing income | (1,488) | | | (1,283) | |
| Royalty income - divestitures | (862) | | | (832) | |
| Equity investment losses/(income), net | 160 | | | 801 | |
| Integration expenses | 242 | | | 440 | |
| Loss on debt redemption | — | | | 266 | |
| Divestiture gains | — | | | (211) | |
| Litigation and other settlements | (390) | | | 178 | |
| Investment income | (449) | | | (171) | |
| Provision for restructuring | 365 | | | 75 | |
| Contingent consideration | (8) | | | (9) | |
| Other | 106 | | | 90 | |
| Other (income)/expense, net | $ | (1,158) | | | $ | 576 | |
•Interest expense decreased in 2023 due to additional debt maturities. Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements” for further information.
•Royalties increased in 2023 primarily due to higher Keytruda* royalties. Refer to “Item 8. Financial Statements and Supplementary Data—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for further information.
•Equity investments generated lower losses in 2023 compared to 2022 due to fair value adjustments for investments that have readily determinable fair value. Refer to “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements” for more information.
•Integration expenses decreased in 2023 due to lower consulting fees to implement Celgene integration initiatives related to processes and systems.
•Loss on debt redemption resulted from the early redemption of long-term debt of $6.0 billion in 2022.
•Divestiture gains resulted from certain mature product rights divested in 2022.
•Investment income increased in 2023 primarily due to higher interest rates.
•Litigation and other settlements in 2023 include $384 million of income related to the AZ settlement and $400 million of income related to the Nimbus' TYK2 program change of control provision, partially offset by $322 million expense recorded in connection with the BeiGene settlement. Litigation and other settlements in 2022 include amounts related to commercial disputes regarding licensing and supply obligation matters, intellectual property and promotional practice matters. Refer to "Item 8. Financial Statements—Note 5. Other (Income)/Expense, Net."
•Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including a new plan in 2023 discussed further in “Item 8. Financial Statements and Supplementary Data—Note 6. Restructuring.”
Income Taxes
| | | | | | | | | | | |
| Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 |
| Earnings Before Income Taxes | $ | 8,440 | | | $ | 7,713 | |
| Provision for Income Taxes | 400 | | | 1,368 | |
| Effective Tax Rate | 4.7 | % | | 17.7 | % |
| Impact of Specified Items | 10.0 | % | | (2.4) | % |
| Effective Tax Rate Excluding Specified Items | 14.7 | % | | 15.3 | % |
The effective tax rate decreased from 17.7% to 4.7% primarily due to the impact of specified items summarized in the following “—Non-GAAP Financial Measures” section. The most significant impacts included (i) a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments in 2023, (ii) $123 million higher tax benefits attributed to foreign currency on net operating loss and other carryforwards in 2023, (iii) a $193 million valuation allowance reversal related to unrealized equity investment losses in 2023, (iv) a $72 million tax benefit resulting from a revaluation of the basis of intangible and other assets internally transferred to streamline our legal entity structure after the Celgene acquisition in 2022, and (v) a $225 million tax reserve release related to the 2009 Mead Johnson split-off transaction in 2022.
Excluding the impact of specified items, the effective tax rate decreased from 15.3% to 14.7% primarily due to (i) revised guidance regarding deductibility of certain research and development expenses which reduced income taxes attributable to 2023 pre-tax income by approximately $160 million and was the primary reason for a $240 million reduction to previously estimated income taxes for 2022 upon finalization of the U.S. Federal income tax return, (ii) a favorable jurisdictional earnings mix which was partially offset by (iii) a $144 million impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax and (iv) $208 million of lower income tax reserve reversals. Income tax reserve reversals included $89 million related to the Celgene’s 2009-2011 IRS audits in 2023 and $297 million for tax positions that were effectively settled for the BMS 2008 to 2012 tax years (excluding Mead Johnson related amounts that were specified) and the lapse of statute of limitations for the Celgene 2012 to 2016 tax years in 2022. Refer to “Item 8. Financial Statements and Supplementary Data—Note 7. Income Taxes” for additional information.
In December 2022, the EU member states voted unanimously to adopt a Directive implementing the Pillar Two (global minimum tax) rules giving member states until December 31, 2023 to implement the Directive into national legislation. Certain jurisdictions in which we operate, under the OECD/G20 Inclusive Framework, have enacted legislation that adopts a subset of such rules effective January 1, 2024, with the remaining rules becoming effective January 1, 2025. These rules and associated legislative changes may significantly impact our tax provision and results of operations. The implementation of Pillar Two is currently expected to increase our effective tax rate excluding specified items by approximately 1% in 2024.
Non-GAAP Financial Measures
Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (ii) unwind of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and (xii) amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments, release of income tax reserves related to the Mead Johnson split-off transaction and internal transfers of intangible and other assets to streamline our legal entity structure subsequent to the Celgene acquisition. We also provide international revenues for our priority products excluding the impact of foreign exchange. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on February 2, 2024 and are incorporated herein by reference.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Specified items were as follows:
| | | | | | | | | | | |
| | Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 |
| Inventory purchase price accounting adjustments | $ | 84 | | | $ | 293 | |
| Intangible asset impairment | 27 | | | — | |
| Site exit and other costs | 64 | | | 63 | |
| Cost of products sold | 175 | | | 356 | |
| | | |
| Employee compensation charges | — | | | 73 | |
| Site exit and other costs | 94 | | | 6 | |
| Marketing, selling and administrative | 94 | | | 79 | |
| | | |
| IPRD impairments | 80 | | | 98 | |
| Priority review voucher | 95 | | | — | |
| Inventory purchase price accounting adjustments | — | | | 130 | |
| Employee compensation charges | — | | | 80 | |
| Site exit and other costs | 12 | | | — | |
| Research and development | 187 | | | 308 | |
| | | |
| Amortization of acquired intangible assets | 9,047 | | | 9,595 | |
| | | |
Interest expense(a) | (52) | | | (83) | |
| Equity investment losses/(gains), net | 152 | | | 799 | |
| Integration expenses | 242 | | | 440 | |
| Loss on debt redemption | — | | | 266 | |
| Divestiture gains | — | | | (211) | |
| Litigation and other settlements | (397) | | | 140 | |
| Provision for restructuring | 365 | | | 75 | |
| Other | 55 | | | 71 | |
| Other (income)/expense, net | 365 | | | 1,497 | |
| | | |
| Increase to pretax income | 9,868 | | | 11,835 | |
| | | |
| Income taxes on items above | (1,639) | | | (1,332) | |
| Income taxes attributed to internal transfer of intangible and other assets | — | | | (72) | |
| Income tax reserve release attributed to Mead Johnson | — | | | (225) | |
| Income taxes attributed to non-U.S. tax ruling | (656) | | | — | |
| Income taxes | (2,295) | | | (1,629) | |
| | | |
| Increase to net earnings | $ | 7,573 | | | $ | 10,206 | |
(a) Includes amortization of purchase price adjustments to Celgene debt.
The reconciliations from GAAP to Non-GAAP were as follows:
| | | | | | | | | | | |
|
| Net earnings attributable to BMS | | | |
| GAAP | $ | 8,025 | | | $ | 6,327 | |
| Specified Items | 7,573 | | | 10,206 | |
| Non-GAAP | $ | 15,598 | | | $ | 16,533 | |
| | | |
| Weighted-average common shares outstanding – diluted | 2,078 | | | 2,146 | |
| | | |
| Diluted earnings per share attributable to BMS | | | |
| GAAP | $ | 3.86 | | | $ | 2.95 | |
| Specified items | 3.65 | | | 4.75 | |
| Non-GAAP | $ | 7.51 | | | $ | 7.70 | |
Financial Position, Liquidity and Capital Resources
Our net debt position was as follows:
| | | | | | | | | | | |
| December 31, |
| Dollars in millions | 2023 | | 2022 |
| Cash and cash equivalents | $ | 11,464 | | | $ | 9,123 | |
| Marketable debt securities – current | 816 | | | 130 | |
| Marketable debt securities – non-current | 364 | | | — | |
| Total cash, cash equivalents and marketable debt securities | 12,644 | | | 9,253 | |
| Short-term debt obligations | (3,119) | | | (4,264) | |
| Long-term debt | (36,653) | | | (35,056) | |
| Net debt position | $ | (27,128) | | | $ | (30,067) | |
Liquidity and Capital Resources
We regularly assess our anticipated working capital needs, debt and leverage ratio levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in order to maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions. We also regularly evaluate our capital structure to ensure financial risks, adequate liquidity access and lower cost of capital are efficiently managed, which may lead to the issuance of additional debt securities, the repurchase of debt securities prior to maturity or the issuance or repurchase of common stock.
We believe that our existing cash, cash equivalents and marketable debt securities together with cash generated from operations in the next few years, and, if required, from the issuance of commercial paper, will be sufficient to satisfy our anticipated cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, repurchase of common stock, and debt maturities of approximately $10.3 billion through 2028, as well as any debt repurchases through redemptions or tender offers. As of December 31, 2023, our net debt position decreased by $2.9 billion primarily driven by $13.9 billion of cash provided by operations partially offset by $9.9 billion of dividend payments and common stock repurchases and $1.2 billion of capital expenditures.
In February 2024, we entered into a $10.0 billion 364-day senior unsecured delayed draw term loan facility to provide bridge financing for the planned acquisitions of Karuna and RayzeBio. This facility would be drawn only if these acquisitions close prior to our planned issuance of debt securities and, if drawn, would be repaid following the issuance of such securities. No amounts were outstanding as of February 13, 2024. For more information on planned acquisitions, refer to “Item 8. Financial Statements and Supplementary Data — Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements”.
In 2023, we issued an aggregate principal amount of $4.5 billion of debt. We used the net proceeds for the acquisition of Mirati in January 2024 and general corporate purposes. In addition, $3.9 billion of debt matured and was repaid. Refer to “Item 8. Financial Statements and Supplementary Data —Note 10. Financing Arrangements” for further information.
We have a share repurchase program, authorized by our Board of Directors, allowing for repurchases of BMS common stock shares, effected in the open market or through privately negotiated transactions in compliance with Rule 10b-18 under the Exchange Act, including through Rule 10b5-1 trading plans. The share repurchase program does not obligate us to repurchase any specific number of shares nor does it have a specific expiration date and may be suspended or discontinued at any time. In 2023, we repurchased approximately 87 million shares of our common stock for $5.2 billion, including approximately 70 million shares for $4.0 billion through our ASR agreements. In December 2023, the Board of Directors approved an increase of $3.0 billion to the share repurchase authorization for BMS's common stock. The remaining share repurchase capacity under the BMS share repurchase program was $5.0 billion as of December 31, 2023. Refer to “Item 8. Financial Statements and Supplementary Data—Note 17. Equity” for additional information.
Dividend payments were $4.7 billion in 2023 and $4.6 billion in 2022. Dividend paid per common share was $0.57 during each quarter of 2023. Dividends are authorized on a quarterly basis by our Board of Directors.
Under our commercial paper program, we may issue a maximum of $7.0 billion unsecured notes that have maturities of not more than 365 days from the date of issuance. There were no commercial paper borrowings outstanding as of December 31, 2023.
As of December 31, 2023, we had a five-year $5.0 billion revolving credit facility expiring in January 2028, which is extendable annually by one year with the consent of the lenders. In January 2024, we extended the credit facility to January 2029. Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings. No borrowings were outstanding under any revolving credit facility as of December 31, 2023 or 2022.
Our investment portfolio includes marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 8. Financial Statements and Supplementary Data—Note 10. Financing Arrangements” for further information.
Capital Expenditures
Annual capital expenditures were approximately $1.1 billion in 2023 and 2022, $970 million in 2021 and are expected to be approximately $1.4 billion in 2024 and 2025. We continue to make capital expenditures in connection with the expansion of our cell therapy and other manufacturing capabilities, research and development and other facility-related activities.
Contractual Obligations and Off-Balance Sheet Arrangements
In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations relating to debt, income taxes and lease arrangements are provided in “Item 8. Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards”, “—Note 10. Financing Arrangements”, “—Note 7. Income Taxes” and “—Note 14. Leases”, respectively.
We are committed to an aggregate $20.0 billion of potential contingent future research and development milestone payments to third parties for in-licensing, asset acquisitions and development programs including early-stage milestones of $6.5 billion (milestones achieved through Phase III clinical studies) and late-stage milestones of $13.5 billion (milestones achieved post Phase III clinical studies). Payments generally are due and payable only upon achievement of certain developmental and regulatory milestones for which the specific timing cannot be predicted. Certain agreements also provide for sales-based milestones aggregating to $14.6 billion that we would be obligated to pay upon achievement of certain sales levels in addition to royalties. We also have certain manufacturing, development and commercialization obligations in connection with alliance arrangements. It is not practicable to estimate the amount of these obligations. Refer to “Item 8. Financial Statements and Supplementary Data—Note 3. Alliances” and "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.
We do not have any off-balance sheet arrangements that are material or reasonably likely to become material to our financial condition or results of operations.
Credit Ratings
In December 2023, following our announcements to acquire Karuna and RayzeBio, Standard & Poor's downgraded BMS's long-term credit rating to A from A+ (with a stable long-term credit outlook). There were no changes to our short-term Standard & Poor credit rating (A1). The downgrade to long-term credit ratings reflects Standard & Poor's anticipation of a higher debt leverage following the announced acquisitions, partially offset by improvements in business strengths. In February 2024, Moody's confirmed BMS's long-term (A2) and short-term (Prime-1) ratings (with a negative long-term credit outlook).
Collectively, the current long-term credit ratings reflect the agencies’ opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. The short-term credit ratings reflect the agencies’ opinion that we have good to extremely strong capacity for timely repayment. Any credit rating downgrade may affect the interest rate of any debt we may incur, the fair market value of existing debt and our ability to access the capital markets generally.
Cash Flows
The following is a discussion of cash flow activities:
| | | | | | | | | | | |
| Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 |
| Cash flow provided by/(used in): | | | |
| Operating activities | $ | 13,860 | | | $ | 13,066 | |
| Investing activities | (2,295) | | | (1,062) | |
| Financing activities | (9,416) | | | (16,962) | |
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements from all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; customer discounts and rebates; and tax payments in the ordinary course of business.
The $794 million increase in cash flow provided by operating activities compared to 2022 resulted from $1.1 billion of lower U.S. income tax payments, primarily due to revised guidance regarding deductibility of certain research and development expenses, and $900 million of higher non-customer collections, primarily due to royalties, interest, litigation and other settlements. These impacts were partially offset by $900 million of lower net customer collections (net of rebates and discounts) and $300 million of higher payments, primarily due to additional inventory requirements.
Investing Activities
Cash requirements from investing activities include cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketable securities with original maturities greater than 90 days at the time of purchase, proceeds from business divestitures (including royalties), the sale and maturity of marketable securities, sale of equity investments, as well as upfront and contingent milestones payments from licensing arrangements.
The $1.2 billion increase in cash flow used in investing activities compared to 2022 resulted from $3.9 billion of changes in the amount of marketable debt securities held and $396 million of lower divestiture proceeds, partially offset by the acquisition of Turning Point ($3.2 billion net of cash acquired) in 2022.
Financing Activities
Cash requirements from financing activities include cash used to pay dividends, repurchase common stock and repay long-term debt and other borrowings, as well as proceeds from the exercise of stock options and issuance of long-term debt and other borrowings.
The $7.5 billion decrease in cash used in financing activities compared to 2022 resulted from $5.8 billion of changes in net debt position, primarily due to the $4.5 billion issuance of debt in connection with the acquisition of Mirati and lower debt maturities of $871 million, and $2.8 billion of lower share repurchases, partially offset by $957 million of lower proceeds from stock option exercises.
Recently Issued Accounting Standards
For recently issued accounting standards, refer to “Item 8. Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards.”
SEC Consent Order
As previously disclosed, on August 4, 2004, we entered into a final settlement with the SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters. The settlement was reached through a Consent, a copy of which was attached as Exhibit 10 to our quarterly report on Form 10-Q for the period ended September 30, 2004.
Under the terms of the Consent, we agreed, subject to certain defined exceptions, to limit sales of all products sold to our direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice. We also agreed in the Consent to certain measures that we have implemented including: (a) establishing a formal review and certification process of our annual and quarterly reports filed with the SEC; (b) establishing a business risk and disclosure group; (c) retaining an outside consultant to comprehensively study and help re-engineer our accounting and financial reporting processes; (d) publicly disclosing any sales incentives offered to direct customers for the purpose of inducing them to purchase products in excess of expected demand; and (e) ensuring that our budget process gives appropriate weight to inputs that come from the bottom to the top, and not just from the top to the bottom, and adequately documenting that process.
We have established a company-wide policy concerning our sales to direct customers for the purpose of complying with the Consent, which includes the adoption of various procedures to monitor and limit sales to direct customers in accordance with the terms of the Consent. These procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis.
We maintain DSAs with our U.S. pharmaceutical wholesalers, which account for nearly 100% of our gross U.S. revenues. Under the current terms of the DSAs, our wholesaler customers provide us with weekly information with respect to months on hand product-level inventories and the amount of out-movement of products. The three largest wholesalers currently account for approximately 85% of our gross U.S. revenues. The inventory information received from our wholesalers, together with our internal information, is used to estimate months on hand product level inventories at these wholesalers. We estimate months on hand product inventory levels for our U.S. business’s wholesaler customers other than the three largest wholesalers by extrapolating from the months on hand calculated for the three largest wholesalers. In contrast, our non-U.S. business has significantly more direct customers, limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. Accordingly, we rely on a variety of methods to estimate months on hand product level inventories for these business units.
We believe the above-described procedures provide a reasonable basis to ensure compliance with the Consent.
Critical Accounting Policies
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly affect our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates.
Revenue Recognition
Our accounting policy for revenue recognition has a substantial impact on reported results and relies on certain estimates. Revenue is recognized following a five-step model: (i) identify the customer contract; (ii) identify the contract’s performance obligation; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation; and (v) recognize revenue when or as a performance obligation is satisfied. Revenue is also reduced for GTN sales adjustments discussed below, all of which involve significant estimates and judgment after considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix (e.g. Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel. Estimates are assessed each period and adjusted as required to revise information or actual experience.
The following categories of GTN adjustments involve significant estimates, judgments and information obtained from external sources. Refer to “Item 8. Financial Statements and Supplementary Data—Note 2. Revenue” for further discussion and analysis of each significant category of GTN sales adjustments.
Charge-backs and cash discounts
Our U.S. business participates in programs with government entities, the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and other parties, including covered entities under the 340B program, whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower program price and the wholesalers then charge us the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale (typically within a two to four week time lag).
In the U.S. and certain other countries, customers are offered cash discounts as an incentive for prompt payment, generally approximating 2% of the invoiced sales price. Accounts receivable is reduced for the estimated amount of cash discount at the time of sale and the discount is typically taken by the customer within one month.
Medicaid and Medicare rebates
Our U.S. business participates in state government Medicaid programs and other qualifying Federal and state government programs requiring discounts and rebates to participating state and local government entities. All discounts and rebates provided through these programs are included in our Medicaid rebate accrual. Medicaid rebates have also been extended to drugs used in managed Medicaid plans. The estimated amount of unpaid or unbilled rebates is presented as a liability.
Rebates and discounts are offered to managed healthcare organizations in the U.S. managing prescription drug programs and Medicare Advantage prescription drug plans covering the Medicare Part D drug benefit. We also pay a 70% point of service discount to the CMS when the Medicare Part D beneficiaries are in the coverage gap. The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability.
Other rebates, returns, discounts and adjustments
Other GTN sales adjustments include sales returns and all other programs based on applicable laws and regulations for individual non-U.S. countries as well as rebates offered to managed healthcare organizations in the U.S. to a lesser extent. The non-U.S. programs include several different pricing schemes such as cost caps, volume discounts, outcome-based pricing schemes and pricing claw-backs that are based on sales of individual companies or an aggregation of all companies participating in a specific market. The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability.
Estimated returns for established products are determined after considering historical experience and other factors including levels of inventory in the distribution channel, estimated shelf life, product recalls, product discontinuances, price changes of competitive products, introductions of generic products, introductions of competitive new products and lower demand following the loss of market exclusivity. Estimated returns for new products are determined after considering historical sales return experience of similar products, such as those within the same product line, similar therapeutic area and/or similar distribution model and estimated levels of inventory in the distribution channel and projected demand. The estimated amount for product returns is presented as a liability.
Use of information from external sources
Information from external sources is used to estimate GTN adjustments. Our estimate of inventory at the wholesalers is based on the projected prescription demand-based sales for our products and historical inventory experience, as well as our analysis of third-party information, including written and oral information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and third-party market research data, and our internal information. The inventory information received from wholesalers is a product of their recordkeeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals.
We have also continued the practice of combining retail and mail prescription volume on a retail-equivalent basis. We use this methodology for internal demand forecasts. We also use information from external sources to identify prescription trends, patient demand and average selling prices. Our estimates are subject to inherent limitations of estimates that rely on third-party information, as certain third-party information was itself in the form of estimates, and reflect other limitations including lags between the date as of which third-party information is generated and the date on which we receive third-party information.
Acquisition and Intangible Assets Valuations
We make certain judgments to determine whether transactions should be accounted for as acquisitions of assets or as business combinations. If it is determined that substantially all of the fair value of gross assets acquired in a transaction is concentrated in a single asset (or a group of similar assets), the transaction is treated as an acquisition of assets. We evaluate the inputs, processes, and outputs associated with the acquired set of activities and assets. If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business.
We account for business combinations using the acquisition method of accounting, which requires that assets acquired and liabilities assumed generally be recorded at their fair values as of the acquisition date. Excess of consideration over the fair value of net assets acquired is recorded as goodwill. Estimating fair value requires us to make significant judgments and assumptions.
In transactions accounted for as acquisitions of assets, no goodwill is recorded and contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally is not recognized at the acquisition date. In an asset acquisition, upfront payments allocated to IPRD projects at the acquisition date are expensed unless there is an alternative future use. In addition, product development milestones are expensed upon achievement.
We have identifiable intangible assets that are measured at their respective fair values as of the acquisition date. Generally, we engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date. The fair value of these assets is estimated using discounted cash flow models. These models required the use of the following significant estimates and assumptions among others:
•Identification of product candidates with sufficient substance requiring separate recognition;
•Estimates of revenues and operating profits related to commercial products or product candidates;
•Eligible patients, pricing and market share used in estimating future revenues;
•Probability of success for unapproved product candidates and additional indications for commercial products;
•Resources required to complete the development and approval of product candidates;
•Timing of regulatory approvals and exclusivity;
•Appropriate discount rate by products;
•Market participant income tax rates; and
•Allocation of expected synergies to products.
We believe the fair value used to record intangible assets acquired are based upon reasonable estimates and assumptions considering the facts and circumstances as of the acquisition date.
Impairment and Amortization of Long-lived Assets, including Intangible Assets
Long-lived assets include intangible assets and property, plant and equipment and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or at least annually for IPRD. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products or IPRD. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include changes in competitive landscape, earlier than expected loss of market exclusivity, pricing reductions, adverse regulatory changes or clinical study results, delay or failure to obtain regulatory approval for initial or follow on indications and unanticipated development costs, inability to achieve expected synergies resulting from cost savings and avoidance, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. If the carrying value of long-lived assets exceeds its fair value, then the asset is written-down to its fair value. Expectations of future cash flows are subject to change based upon the near and long-term production volumes and margins generated by the asset as well as any potential alternative future use. The estimated useful lives of long-lived assets is subjective and requires significant judgment regarding patent lives, future plans and external market factors. Long-lived assets are also periodically reviewed for changes in facts or circumstances resulting in a reduction to the estimated useful life of the asset, requiring the acceleration of depreciation or amortization. Impairment charges included in Cost of products sold and Research and development expense were $136 million in 2023, $101 million in 2022 and $1.2 billion in 2021. Refer to “Item 8. Financial Statements and Supplementary Data—Note 15. Goodwill and Other Intangible Assets” for further discussion and analysis of these impairment charges.
Income Taxes
Valuation allowances are recognized to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including long-range forecasts of future taxable income and evaluation of tax planning initiatives. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made. Our deferred tax assets were $7.3 billion at December 31, 2023 (net of valuation allowance of $764 million) and $4.1 billion at December 31, 2022 (net of valuation allowance of $873 million).
The U.S. federal net operating loss carryforwards were $420 million at December 31, 2023. These carryforwards were acquired as a result of certain acquisitions and are subject to limitations under Section 382 of the Internal Revenue Code. The net operating loss carryforwards expire in varying amounts beginning in 2024. The foreign and state net operating loss carryforwards expire in varying amounts beginning in 2024 (certain amounts have unlimited lives).
Liabilities are established for possible assessments by tax authorities resulting from known tax exposures including, but not limited to, transfer pricing matters, tax credits and deductibility of certain expenses. Such liabilities represent a reasonable provision for taxes ultimately expected to be paid and may need to be adjusted over time as more information becomes known.
For discussions on income taxes, refer to “Item 8. Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards—Income Taxes” and “—Note 7. Income Taxes.”
Contingencies
In the normal course of business, we are subject to contingencies, such as legal proceedings and claims arising out of our business, that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters. We recognize accruals for such contingencies when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. These estimates are subject to uncertainties that are difficult to predict and, as such, actual results could vary from these estimates.
For discussions on contingencies, refer to “Item 8. Financial Statements and Supplementary Data—Note 1. Accounting Policies and Recently Issued Accounting Standards—Contingencies,” “—Note 7. Income Taxes” and “—Note 20. Legal Proceedings and Contingencies.”
Product and Pipeline Developments
Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. Spending on these programs represents approximately 46% of our annual R&D expenses in the last three years. Opdivo was the only investigational compound or marketed product that represented approximately 10% of our R&D expenses in the last three years. Our late-stage development programs could potentially have an impact on our revenue and earnings within the next few years if regulatory approvals are obtained and products are successfully commercialized. The following are the late-stage new indication developments in our marketed products, as well as developments in our late-stage pipeline through February 2, 2024:
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| Product | Indication | Date | Developments |
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Opdivo | Bladder | December 2023 | Ono, our alliance partner for Opdivo in Japan, announced that it has submitted a supplemental application of Opdivo Intravenous Infusion, a human anti-human PD-1 monoclonal antibody in Japan, to expand its use for the treatment of unresectable urothelial carcinoma, for a partial change in approved items of the manufacturing and marketing approval. The application is based on the results from the sub-study of the Phase III CheckMate -901 trial. |
| December 2023 | Announced that the FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The application is based on results from the Phase III CheckMate -901 trial. The FDA granted the application Priority Review status and assigned a PDUFA goal date of April 5, 2024.
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| October 2023 | Announced that the EMA validated its type II variation application of Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The application is based on results from the Phase III CheckMate -901 trial. Application validation confirms the submission is complete and begins the EMA's centralized review procedure. |
| Melanoma | October 2023 | Announced FDA approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma. The approval is based on the Phase III CheckMate -76K trial. |
| August 2023 | Announced EC approval of Opdivo as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection. The approval is based on results from the Phase III CheckMate -76K trial. |
Malignant Mesothelioma | November 2023 | Ono, our alliance partner for Opdivo in Japan, announced that they have received supplemental approval of Opdivo Intravenous Infusion, a human anti-human PD-1 monoclonal antibody in Japan, for expanded use for the treatment of malignant mesothelioma (excluding malignant pleural mesothelioma), for a partial change in approved items of the manufacturing and marketing approval. The supplemental approval is based on results from the investigator-initiated clinical Phase II VIOLA trial. |
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| Product | Indication | Date | Developments |
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Opdivo | NSCLC | October 2023 | Announced follow-up results from the Phase III CheckMate -816 trial, demonstrating sustained event-free survival and promising overall survival trends with three cycles of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC, regardless of PD-L1 expression levels. Neoadjuvant Opdivo with chemotherapy also showed improvements in pathologic complete response and major pathologic response over chemotherapy alone in PD-L1>1% and <1% patient populations. The safety profile of the Opdivo-based regimen was consistent across all PD-L1 subgroups. |
| October 2023 | Announced that the first disclosure of data from the Phase III CheckMate -77T trial evaluating perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC showed statistically significant and clinically meaning improvement in the primary efficacy endpoint of event-free survival as assessed by Blinded Independent Central Review compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. |
NSCLC | June 2023 | Announced EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%. The approval is based on results from the Phase III CheckMate -816 trial. |
| March 2023 | Ono, our alliance partner for Opdivo in Japan, announced the Japan's Ministry of Health, Labour and Welfare's supplemental approval of Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC. The approval is based on results from the Phase III CheckMate -816 trial. |
| Prostate Cancer | July 2023 | Announced that results from the Phase III CheckMate -7DX trial evaluating Opdivo in combination with docetaxel in patients with advanced or metastatic castration-resistant prostate cancer did not meet the primary endpoints of radiographic progressive free survival at final analysis, nor overall survival at an interim analysis. No safety concerns were reported. Based on the recommendation from the DMC, the Company has decided to discontinue the study. |
| RCC | January 2024 | Announced data from the Phase III CheckMate -67T trial, evaluating subcutaneous nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell RCC who have received prior systemic therapy, demonstrated non-inferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed non-inferior objective response rate as assessed by Blinded Independent Central Review versus intravenous Opdivo. |
| January 2024 | Announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with Cabometyx* (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic RCC continued to show superior progression-free survival and objective response rates in patients treated with Opdivo plus Cabometyx* over sunitinib, regardless of risk classification based on IMDC scores. Superior overall survival was also observed in patients treated with the combination. |
| October 2023 | Announced that the Phase III CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo co-formulated with Halozyme Therapeutics’ proprietary recombinant human hyaluronidase (rHPuH20) ("subcutaneous nivolumab") compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint. Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate as assessed by Blinded Independent Central Review vs. IV Opdivo, a key secondary endpoint. The safety profile of subcutaneous nivolumab was consistent with the IV formulation. |
| UC | February 2023 | Announced three-year results from the Phase III CheckMate -274 trial demonstrating significant sustained clinical benefits with Opdivo for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive UC and continuous improvement in disease-free survival, non-urothelial tract recurrence-free survival, distant metastasis-free survival and second progression-free survival compared to placebo across all-randomized patients and in patients whose tumor cells express PD-L1 ≥1%. |
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| Product | Indication | Date | Developments |
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| Opdivo+Yervoy | RCC | January 2024 | Announced that eight-year data from the Phase III CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients. |
Metastatic Colorectal Cancer | January 2024 | Announced that the Phase III CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at a pre-specific interim analysis. The study is ongoing to assess the second dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints.
In addition, data from the Phase III CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) compared to chemotherapy. |
| NSCLC | September 2023 | Announced six-year results from the Phase III CheckMate -227 trial demonstrating long-term, durable survival benefits of Opdivo plus Yervoy compared to chemotherapy in the first-line treatment of patients with metastatic NSCLC, regardless of PD-L1 expression levels. |
| June 2023 | Announced four-year follow-up results from the Phase III CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic NSCLC. |
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| Reblozyl | MDS | January 2024 | Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Reblozyl for MDS-related anemia. The approval is based on the results of the global Phase III COMMANDS trial and the Phase III MEDALIST study, as well as a Japanese Phase II study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients. |
| December 2023 | Announced updated results from the primary analysis of the Phase III COMMANDS trial, comparing Reblozyl versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes who may require red blood cell transfusions, which confirmed positive outcome of the interim analysis with superior efficacy and durability compared to ESAs. |
| August 2023 | Announced FDA approval of Reblozyl for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may require regular red blood cell transfusions. The approval is based on the Phase III COMMANDS trial. |
| Beta Thalassemia | March 2023 | Announced EC approval of Reblozyl for the treatment in adult patients of anemia associated with non-transfusion-dependent beta thalassemia. The approval is based on results from the Phase II BEYOND study. |
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Opdualag | Colorectal Cancer | December 2023 | The Phase III RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns. |
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Abecma | Multiple Myeloma | January 2024 | Announced that the CHMP of the EMA has recommended the approval of Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the EU. Recommendation for approval was based on Phase III KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improved progression-free survival and a well-established safety profile with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity. |
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| Product | Indication | Date | Developments |
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Abecma | Multiple Myeloma | December 2023 | Announced results from the preplanned final progression-free survival analysis of the pivotal Phase III, open-label, global, randomized controlled KarMMa-3 study demonstrated a significantly improved PFS maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death. |
| December 2023 | Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on the interim analysis from the Phase III KarMMa-3 study. |
| April 2023 | Announced with our alliance partner, 2seventy bio, that the FDA accepted the sBLA for Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. |
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Zeposia | Multiple Sclerosis | October 2023 | Announced data from the Phase III DAYBREAK and RADIANCE trials showing that after eight years of follow-up, 76% of patients treated with Zeposia for relapsing multiple sclerosis were free of six-month confirmed disability progression. Findings also demonstrated treatment with Zeposia resulted in low rates of progression independent relapse activity and relapse-associated worsening, key drivers of disease progression and permanent disability in multiple sclerosis.
Also announced that first interim readout from the Phase IIIb ENLIGHTEN trial showing clinically meaningful improvement in cognitive functioning compared to baseline after one year of Zeposia treatment in almost half of patients with early relapsing multiple sclerosis. |
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Breyanzi | Lymphoma | January 2024 | Announced the FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.
In addition, Japan's Ministry of Health, Labour and Welfare has also accepted the company's supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.
In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study. |
| December 2024 | Announced first disclosure of primary analysis results from the high-risk, second-line cohort of the Phase II TRANSCEND FL study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma (FL) demonstrated 95.7% complete response for patients with high-risk relapsed or refractory FL treated in the second-line setting. |
| November 2024 | Announced that the FDA accepted the sBLA for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA granted the application Priority Review and assigned a PDUFA goal date of March 14, 2024. |
| May 2023 | Announced EC approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The approval is based on results from the Phase III TRANSFORM trial. |
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| Product | Indication | Date | Developments |
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| Sotyktu | Plaque Psoriasis | October 2023 | Announced results from the POETYK PSO LTE trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis. Clinical response rates were maintained with continuous treatment with modified nonresponder imputation responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75 with 3 years of continuous Sotyktu treatment. Sotyktu had a consistent safety profile with no increases in adverse events or serious adverse events and no new safety signals. |
| March 2023 | Announced EC approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval was based on Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials as well as additional data from the POETYK PSO long-term extension trial. |
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| Camzyos | Obstructive HCM | August 2023 | Announced long-term follow-up results from the Phase III VALOR-HCM LTE trial demonstrating the consistent impact of oral treatment for severely symptomatic obstructive HCM patients by showing that nearly 9 out of 10 patients treated with Camzyos have continued in the trial without septal reduction therapy at either 40 or 56 weeks of treatment.
Also announced results from the Phase III EXPLORER-LTE trial showing treatment with Camzyos demonstrated sustained improvements in left ventricular outflow tract obstruction, symptoms and NT-proBNP levels in patients with symptomatic obstructive HCM. No new safety signals were observed. |
| June 2023 | Announced EC approval of Camzyos for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM in adult patients. The approval is based on results from the Phase III EXPLORER-HCM and VALOR-HCM trials. |
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Augtyro (repotrectinib) | NSCLC | November 2023 | Announced FDA approval of Augtyro for the treatment of patients with ROS1-positive locally advanced or metastatic NSCLC. The approval is based on the Phase I/II TRIDENT-1 trial. |
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repotrectinib | NSCLC | January 2024 | The EMA validated the marketing authorization application for repotrectinib as a treatment for ROS1 tyrosine kinase inhibitor (TKI)-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase I/II TRIDENT-1 trial and CARE study. |
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| milvexian | Thrombosis | May 2023 | Announced with our alliance partner Janssen Pharmaceuticals Inc., a Johnson & Johnson company, that all three prospective indications for milvexian, an investigational oral factor XIa inhibitor, have been granted Fast Track Designation by the FDA. The designations cover all three indication-seeking studies within the Phase III Librexia development program: Librexia STROKE, Librexia ACS and Librexia AF, which are all dosing patients.
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BMS-986278 (LPA1) | Progressive Pulmonary Fibrosis | October 2023 | Announced that the FDA has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF). The Breakthrough Therapy Designation is based on results from the global, randomized Phase II study that assessed the safety and efficacy of BMS-986278 treatment versus placebo in people living with idiopathic pulmonary fibrosis (IPF) and PPF. Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed. |
Special Note Regarding Forward-Looking Statements
This 2023 Form 10-K (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on our current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions, alliances and other business development activities, the impact of any pandemic or epidemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug prices, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products, and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. We have included important factors in the cautionary statements included in this 2023 Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.
Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this 2023 Form 10-K not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this 2023 Form 10-K.
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| Item 7A. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. |
We are exposed to market risk resulting from changes in currency exchange rates and interest rates. Certain derivative financial instruments are used when available on a cost-effective basis to hedge our underlying economic exposure. All of our financial instruments, including derivatives, are subject to counterparty credit risk considered as part of the overall fair value measurement. Derivative financial instruments are not used for trading purposes.
Foreign Exchange Risk
Significant amounts of our revenues, earnings and cash flow are exposed to changes in foreign currency rates. Our primary net foreign currency translation exposures are the euro and Japanese yen. Foreign currency forward and purchased local currency put option contracts are used to manage risk primarily arising from certain intercompany sales and purchases transactions.
We are also exposed to foreign exchange transaction risk arising from non-functional currency denominated assets and liabilities and earnings denominated in non-U.S. dollar currencies. Foreign currency forward contracts are used to offset these exposures but are not designated as hedges. Foreign currency forward contracts are also used to hedge the foreign currency exposures of our net investment in certain international affiliates and are designated as hedges of net investments.
We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would decrease the fair value of foreign exchange contracts by $409 million and $782 million as of December 31, 2023 and December 31, 2022, respectively, reducing earnings over the remaining life of the contracts.
Cross-currency swap contracts are used to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries. We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would increase the fair value of cross-currency swap contracts by $46 million as of December 31, 2023 and decrease by $73 million as of December 31, 2022, respectively.
For additional information, refer to “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.”
Interest Rate Risk
We use fixed-to-floating interest rate swap contracts designated as fair value hedges to provide an appropriate balance of fixed and floating rate debt. We use cross-currency swap contracts designated to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries. The fair values of these contracts as well as our marketable debt securities are analyzed at year-end to determine their sensitivity to interest rate changes. In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, 2023 and December 31, 2022, the expected adverse impact on our earnings would not be material.
We estimate that an increase of 1% in long-term interest rates as of December 31, 2023 and December 31, 2022 would decrease the fair value of long-term debt by $3.0 billion and $2.6 billion, respectively.
Credit Risk
We monitor our investments with counterparties with the objective of minimizing concentrations of credit risk. Our investment policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity of investments with any individual counterparty. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards.
The use of derivative instruments exposes us to credit risk if the counterparty fails to perform when the fair value of a derivative instrument contract is positive. If the counterparty fails to perform, collateral is not required by any party whether derivatives are in an asset or liability position. We have a policy of diversifying derivatives with counterparties to mitigate the overall risk of counterparty defaults. For additional information, refer to “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements.”
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| Item 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. |
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
Dollars in millions, except per share data
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| | Year Ended December 31, |
| EARNINGS | 2023 | | 2022 | | 2021 |
| Net product sales | $ | | | | $ | | | | $ | | |
| Alliance and other revenues | | | | | | | | |
| Total Revenues | | | | | | | | |
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Cost of products sold(a) | | | | | | | | |
| Marketing, selling and administrative | | | | | | | | |
| Research and development | | | | | | | | |
| Acquired IPRD | | | | | | | | |
| Amortization of acquired intangible assets | | | | | | | | |
| Other (income)/expense, net | () | | | | | | () | |
| Total Expenses | | | | | | | | |
| | | | | |
| Earnings Before Income Taxes | | | | | | | | |
| Provision for Income Taxes | | | | | | | | |
| Net Earnings | | | | | | | | |
| Noncontrolling Interest | | | | | | | | |
| Net Earnings Attributable to BMS | $ | | | | $ | | | | $ | | |
| | | | | |
| Earnings per Common Share | | | | | |
| Basic | $ | | | | | | | $ | | |
| Diluted | | | | | | | | |
(a)
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
Dollars in millions
| | | | | | | | | | | | | | | | | |
| | Year Ended December 31, |
COMPREHENSIVE INCOME | 2023 | | 2022 | | 2021 |
| Net Earnings | $ | | | | $ | | | | $ | | |
| Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings: | | | | | |
| Derivatives qualifying as cash flow hedges | () | | | | | | | |
| Pension and postretirement benefits | () | | | | | | | |
| Marketable debt securities | | | | () | | | () | |
| Foreign currency translation | | | | () | | | () | |
| Total Other Comprehensive Income/(Loss) | () | | | () | | | | |
| | | | | |
Comprehensive Income | | | | | | | | |
| Comprehensive Income Attributable to Noncontrolling Interest | | | | | | | | |
Comprehensive Income Attributable to BMS | $ | | | | $ | | | | $ | | |
The accompanying notes are an integral part of these consolidated financial statements.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED BALANCE SHEETS
Dollars in millions, except share and per share data
| | | | | | | | | | | |
| | December 31, |
| ASSETS | 2023 | | 2022 |
| Current Assets: | | | |
| Cash and cash equivalents | $ | | | | $ | | |
Marketable debt securities | | | | | |
| Receivables | | | | | |
| Inventories | | | | | |
| Other current assets | | | | | |
| Total Current assets | | | | | |
| Property, plant and equipment | | | | | |
| Goodwill | | | | | |
| Other intangible assets | | | | | |
| Deferred income taxes | | | | | |
Marketable debt securities | | | | | |
| Other non-current assets | | | | | |
| Total Assets | $ | | | | $ | | |
| | | |
| LIABILITIES | | | |
| Current Liabilities: | | | |
| Short-term debt obligations | $ | | | | $ | | |
| Accounts payable | | | | | |
| Other current liabilities | | | | | |
| Total Current liabilities | | | | | |
| Deferred income taxes | | | | | |
| Long-term debt | | | | | |
| Other non-current liabilities | | | | | |
| Total Liabilities | | | | | |
| | | |
| Commitments and contingencies | | | |
| | | |
| EQUITY | | | |
| Bristol-Myers Squibb Company Shareholders’ Equity: | | | |
Preferred stock, $ convertible series, par value $ per share: Authorized million shares; issued and outstanding in 2023 and in 2022, liquidation value of $ per share | | | | | |
Common stock, par value of $ per share: Authorized billion shares; billion issued in 2023 and 2022 | | | | | |
| Capital in excess of par value of stock | | | | | |
| Accumulated other comprehensive loss | () | | | () | |
| Retained earnings | | | | | |
Less cost of treasury stock — million common shares in 2023 and million common shares in 2022 | () | | | () | |
Total BMS Shareholders’ Equity | | | | | |
| Noncontrolling interest | | | | | |
| Total Equity | | | | | |
| Total Liabilities and Equity | $ | | | | $ | | |
The accompanying notes are an integral part of these consolidated financial statements.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Dollars in millions
| | | | | | | | | | | | | | | | | |
| | Year Ended December 31, |
| | 2023 | | 2022 | | 2021 |
| Cash Flows From Operating Activities: | | | | | |
| Net earnings | $ | | | | $ | | | | $ | | |
| Adjustments to reconcile net earnings/(loss) to net cash provided by operating activities: | | | | | |
| Depreciation and amortization, net | | | | | | | | |
| Deferred income taxes | () | | | () | | | () | |
| Stock-based compensation | | | | | | | | |
| Impairment charges | | | | | | | | |
| | | |
| Divestiture gains and royalties | () | | | () | | | () | |
| Acquired IPRD | | | | | | | | |
| Equity investment losses/(gains), net | | | | | | | () | |
| Contingent consideration fair value adjustments | () | | | () | | | () | |
| Other adjustments | | | | | | | | |
| Changes in operating assets and liabilities: | | | | | |
| Receivables | () | | | () | | | () | |
| Inventories | () | | | () | | | | |
| Accounts payable | | | | | | | | |
| Rebates and discounts | | | | | | | | |
| Income taxes payable | () | | | () | | | () | |
| Other | () | | | () | | | () | |
| Net Cash Provided by Operating Activities | | | | | | | | |
| Cash Flows From Investing Activities: | | | | | |
| Sale and maturities of marketable debt securities | | | | | | | | |
| Purchase of marketable debt securities | () | | | () | | | () | |
| Proceeds from sales of equity investment securities | | | | | | | | |
| Capital expenditures | () | | | () | | | () | |
| Divestiture and other proceeds | | | | | | | | |
| Acquisition and other payments, net of cash acquired | () | | | () | | | () | |
| Net Cash Used in Investing Activities | () | | | () | | | () | |
| Cash Flows From Financing Activities: | | | | | |
| Short-term debt obligations, net | () | | | | | | () | |
| Issuance of long-term debt | | | | | | | | |
| Repayment of long-term debt | () | | | () | | | () | |
| Repurchase of common stock | () | | | () | | | () | |
| Dividends | () | | | () | | | () | |
| Stock option proceeds and other, net | | | | | | | | |
| Net Cash Used in Financing Activities | () | | | () | | | () | |
| Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | | | | () | | | () | |
Increase/(Decrease) in Cash, Cash Equivalents and Restricted Cash | | | | () | | | () | |
| Cash, Cash Equivalents and Restricted Cash at Beginning of Year | | | | | | | | |
| Cash, Cash Equivalents and Restricted Cash at End of Year | $ | | | | $ | | | | $ | | |
The accompanying notes are an integral part of these consolidated financial statements.
Note 1.
to years for buildings and to years for machinery, equipment and fixtures.
.
| | $ | | | | $ | | |
| In-license arrangements and other (Note 4) | | | | | | | | |
| Acquired IPRD | $ | | | | $ | | | | $ | | |
Advertising and product promotion costs are included in Marketing, selling and administrative expenses and were approximately $ billion in 2023 and $ billion in 2022 and 2021.
Note 2.
| | $ | | | | $ | | | | Alliance revenues | | | | | | | | |
| Other revenues | | | | | | | | |
| Total Revenues | $ | | | | $ | | | | $ | | |
Net product sales represent more than % of total revenues for all periods presented. Products are sold principally to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies. Customer orders are generally fulfilled within a few days of receipt resulting in minimal order backlog. Contractual performance obligations are usually limited to transfer of control of the product to the customer. The transfer occurs either upon shipment, upon receipt of the product after considering when the customer obtains legal title to the product, or upon infusion for cell therapies and when BMS obtains a right of payment. At these points, customers are able to direct the use of and obtain substantially all of the remaining benefits of the product.
% | | | % | | | % | Cencora, Inc. (formerly known an AmerisourceBergen Corporation) | | % | | | % | | | % |
| Cardinal Health, Inc. | | % | | | % | | | % |
| | $ | | | | $ | | | GTN adjustments(a) | | | | | |
| Charge-backs and cash discounts | () | | | () | | | () | |
| Medicaid and Medicare rebates | () | | | () | | | () | |
| Other rebates, returns, discounts and adjustments | () | | | () | | | () | |
| Total GTN adjustments | () | | | () | | | () | |
| Net product sales | $ | | | | $ | | | | $ | | |
million in 2023, $ million in 2022, and $ million in 2021.
| | $ | | | | $ | | | | Opdivo | | | | | | | | |
| Orencia | | | | | | | | |
| Pomalyst/Imnovid | | | | | | | | |
| Yervoy | | | | | | | | |
| Sprycel | | | | | | | | |
| Mature and other brands | | | | | | | | |
| Total In-Line Products | | | | | | | | |
| New Product Portfolio | | | | | |
| Reblozyl | | | | | | | | |
| Opdualag | | | | | | | | |
| Abecma | | | | | | | | |
| Zeposia | | | | | | | | |
| Breyanzi | | | | | | | | |
| Camzyos | | | | | | | | |
| Sotyktu | | | | | | | | |
| Onureg | | | | | | | | |
| Inrebic | | | | | | | | |
| Augtyro | | | | | | | | |
| Total New Product Portfolio | | | | | | | | |
| Total In-Line Products and New Product Portfolio | | | | | | | | |
Recent LOE Products(a) | | | | | |
| Revlimid | | | | | | | | |
| Abraxane | | | | | | | | |
| Total Recent LOE Products | | | | | | | | |
| Total revenues | $ | | | | $ | | | | $ | | |
| | | | | |
| United States | $ | | | | $ | | | | $ | | |
| International | | | | | | | | |
Other(b) | | | | | | | | |
| Total revenues | $ | | | | $ | | | | $ | | |
(a) Recent LOE Products include products with significant expected decline in revenue from the prior reporting period as a result of a LOE.
(b) Other include royalties and alliance-related revenues for products not sold by BMS’s regional commercial organizations.
Contract assets are primarily estimated future royalties and termination fees not eligible for the licensing exclusion and therefore recognized under ASC 606 and ASC 610. Contract assets are reduced and receivables are increased in the period the underlying sales occur. Cumulative catch-up adjustments to revenue affecting contract assets or contract liabilities were not material during the years ended December 31, 2023, 2022 and 2021. Revenue recognized from performance obligations satisfied in prior periods was $ million in 2023, $ million in 2022, and $ million in 2021 consisting primarily of revised estimates for GTN adjustments related to prior period sales and royalties from out-licensing arrangements.
Sales commissions and other incremental costs of obtaining customer contracts are expensed as incurred as the amortization periods would be less than one year.
Note 3.
| | $ | | | | $ | | | | Alliance revenues | | | | | | | | |
| Total Revenues | $ | | | | $ | | | | $ | | |
| | | | | |
| Payments to/(from) alliance partners: | | | | | |
| Cost of products sold | $ | | | | $ | | | | $ | | |
| Marketing, selling and administrative | () | | | () | | | () | |
| Research and development | | | | | | | | |
| Acquired IPRD | | | | | | | | |
| Other (income)/expense, net | () | | | () | | | () | |
| | | | | | | | | | | |
| Selected alliance balance sheet information: | December 31, |
| Dollars in millions | 2023 | | 2022 |
| Receivables – from alliance partners | $ | | | | $ | | |
| Accounts payable – to alliance partners | | | | | |
Deferred income from alliances(a) | | | | | |
(a) Includes unamortized upfront and milestone payments.
Specific information pertaining to significant alliances is discussed below, including their nature and purpose; the significant rights and obligations of the parties; specific accounting policy elections; and the statements of earnings classification of and amounts attributable to payments between the parties.
SystImmune
In December 2023, BMS and SystImmune, Inc. (SystImmune) announced a global strategic collaboration for the co-development and co-commercialization of BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate which targets both EGFR and HER3 and is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC.
The parties will jointly develop and commercialize BL-B01D1 in the U.S. Profits, research and development and commercialization costs are shared in the U.S. SystImmune will be responsible for the development, commercialization and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for outside of Mainland China, where BMS will receive a royalty on net sales. BMS will be responsible for development and commercialization in the rest of the world, where SystImmune will receive a royalty on net sales.
The transaction became effective in February 2024 and included an upfront payment of $ million, which will be included in Acquired IPRD during the first quarter of 2024. BMS is also obligated to pay up to $ billion upon the achievement of contingent development, regulatory and sales-based milestones.
Pfizer
BMS and Pfizer jointly develop and commercialize Eliquis, an anticoagulant discovered by BMS. Pfizer funds between % and % of all development costs depending on the study. Profits and losses are shared equally on a global basis except in certain countries where Pfizer commercializes Eliquis and pays BMS a sales-based fee.
| | $ | | | | $ | | | | Alliance revenues | | | | | | | | |
| Total revenues | $ | | | | $ | | | | $ | | |
| | | | | |
| Payments to/(from) Pfizer: | | | | | |
| Cost of products sold – profit sharing | | | | | | | | |
| Other (income)/expense, net – amortization of deferred income | () | | | () | | | () | |
| | | | | | | | | | | |
| Selected alliance balance sheet information: | December 31, |
| Dollars in millions | 2023 | | 2022 |
| Receivables | $ | | | | $ | | |
| Accounts payable | | | | | |
| Deferred income | | | | | |
Ono
BMS and Ono jointly develop and commercialize Opdivo, Yervoy and several BMS investigational compounds in Japan, South Korea and Taiwan. BMS is responsible for supply of the products. Profits, losses and development costs are shared equally for all combination therapies involving compounds of both parties. Otherwise, sharing is % and % for activities involving only one of the party’s compounds.
BMS and Ono also jointly develop and commercialize Orencia in Japan. BMS is responsible for the order fulfillment and distribution of the intravenous formulation and Ono is responsible for the subcutaneous formulation. Both formulations are jointly promoted by both parties with assigned customer accounts and BMS is responsible for the product supply. A co-promotion fee of % is paid when a sale is made to the other party’s assigned customer.
| | $ | | | | $ | | | | Alliance revenues | | | | | | | | |
| Total Revenues | $ | | | | $ | | | | $ | | |
BMS is the principal in the end customer product sales and has the exclusive right to develop, manufacture and commercialize Opdivo worldwide except in Japan, South Korea and Taiwan. Ono is entitled to receive royalties of % in North America and % in all territories excluding the three countries listed above, subject to customary adjustments.
million which was expensed to Acquired IPRD. BridgeBio is eligible to receive contingent development, regulatory and sales-based milestones up to $ million, as well as royalties on global net sales, excluding certain markets. BridgeBio is responsible for funding and completing ongoing BBP-398 Phase I monotherapy and combination therapy trials. BMS will lead and fund all other development and commercial activities. BridgeBio has an option to co-develop BBP-398 and receive higher royalties in the U.S.
2seventy bio
BMS and 2seventy bio jointly develop and commercialize novel disease-altering gene therapy product candidates targeting BCMA. The collaboration includes (i) a right for BMS to license any anti-BCMA products resulting from the collaboration, (ii) a right for 2seventy bio to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and profit share in the U.S. in exchange for a reduction of milestone payments, and (iii) sales-based milestones and royalties payable to 2seventy bio upon the commercialization of any licensed products resulting from the collaboration should 2seventy bio decline to exercise their co-development and profit sharing rights.
BMS exercised its option to license idecabtagene vicleucel (Abecma) in 2016 and 2seventy bio elected to participate in development and commercialization of Abecma in the U.S. in 2018. The terms of the collaboration have since been amended to transfer substantially all manufacturing obligations to BMS and eliminate ex-U.S. milestones and royalties payable to 2seventy bio for Abecma.
In 2021, the FDA approved Abecma for the treatment of relapsed or refractory multiple myeloma. Net product sales of Abecma in the U.S. were $ million, $ million and $ million; and the related profit sharing costs were $ million, $ million and $ million in 2023, 2022 and 2021, respectively. Cost reimbursements were not material.
Eisai
In 2021, BMS and Eisai commenced an exclusive global strategic collaboration for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers. MORAb-202 is currently in Phase I/II clinical trials for solid tumors.
The parties jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Russia, Japan, China and certain other countries in the Asia-Pacific region (the “collaboration territory”). Eisai is responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS is responsible for development and commercialization outside of the collaboration territory and will pay a royalty on those sales.
A $ million upfront collaboration fee was expensed to Acquired IPRD in 2021. BMS is also obligated to pay up to $ billion upon the achievement of contingent development, regulatory and sales-based milestones. Cost reimbursements were not material.
Note 4.
per share in an all-cash transaction for a total consideration of $ billion or $ billion, net of estimated cash acquired. Mirati stockholders will also receive non-tradeable contingent value right for each share of Mirati common stock held, potentially worth $ per share in cash for a total value of approximately $ billion. The payout of the contingent value right is subject to the FDA acceptance of an NDA for MRTX1719 for the treatment of specific indications within of the closing of the transaction. The transaction will be accounted for as a business combination in which all assets acquired and liabilities assumed will be recognized at fair value as of the acquisition date. The purchase price allocation of the consideration transferred to the assets acquired and liabilities assumed has not yet been finalized. The acquisition was funded through a combination of cash on hand and debt proceeds.
Karuna
In December 2023, BMS entered into a definitive merger agreement to acquire Karuna, a clinical-stage biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions. The acquisition will provide BMS with rights to Karuna's lead asset, KarXT (xanomeline-trospium). KarXT is an antipsychotic with a novel mechanism of action and differentiated efficacy and safety, is currently under review by the FDA for the treatment of schizophrenia in adults with a PDUFA date of September 26, 2024. KarXT is also in registrational trials for both adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease.
BMS will acquire all of the issued and outstanding shares of Karuna's common stock for $ per share in an all-cash transaction for a total consideration of $ billion. The accounting treatment as a business combination or asset acquisition will be determined in the period the transaction closes. The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of regulatory approvals. The acquisition will be funded primarily with future debt proceeds.
RayzeBio
In December 2023, BMS entered into a definitive merger agreement to acquire RayzeBio, a clinical-stage radiopharmaceutical therapeutics (RPT) company with actinium-based RPTs for solid tumors. The acquisition will provide BMS with rights to RayzeBio’s actinium-based radiopharmaceutical platform and lead asset, RYZ101, which is in Phase III development for treatment of gastroenteropancreatic neuroendocrine tumors.
BMS will acquire all of the issued and outstanding shares of RayzeBio's common stock for $ per share in an all-cash transaction for a total consideration of $ billion. The transaction is expected to be accounted for as a business combination and is anticipated to close in the first half of 2024, subject to fulfillment of customary closing conditions, including receipt of required regulatory approvals. The acquisition will be funded primarily with future debt proceeds.
Orum
In November 2023, BMS acquired the rights to Orum's ORM-6151 program, which is in preclinical development. ORM-6151 is a anti-CD33 antibody-enabled GSPT1 degrader that has received the FDA’s clearance for Phase I for the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. The consideration included an upfront payment of $ million, as well as contingent development milestone payments up to $ million. The upfront payment was expensed to Acquired IPRD.
Turning Point
In 2022, BMS acquired Turning Point for $ billion of cash (or $ billion net of cash acquired). Turning Point was a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the common mutations and alterations that drive cancer growth. The acquisition provided BMS rights to Turning Point's lead asset, repotrectinib, and other clinical and pre-clinical stage assets. Repotrectinib was approved by the FDA in November 2023 and is marketed under the brand name Augtyro.
The transaction was accounted for as a business combination in which all assets acquired and liabilities assumed were recognized at fair value as of the acquisition date.
| | Cash consideration for equity awards | | |
| Consideration paid | | |
Less: unvested stock awards (a) | | |
| Total consideration allocated | $ | | |
(a) Included unvested equity awards of $ million expensed in Marketing, selling, and administrative and $ million expensed in Research and development in 2022.
| | Other current assets | | |
Intangible assets (a) | | |
| Deferred income tax assets | | |
| Other non-current assets | | |
| Deferred income tax liabilities | () | |
| Other current liabilities | () | |
| Identifiable net assets acquired | $ | | |
Goodwill (b) | | |
| Total consideration allocated | $ | | |
(a) Intangible assets included $ billion of IPRD allocated to repotrectinib (Augtyro). The estimated fair value of IPRD assets was determined using income approach valuation method.
(b) Goodwill resulted primarily from the recognition of deferred tax liabilities and is not deductible for tax purposes.
The results of Turning Point's operations were included in the consolidated financial statements commencing August 18, 2022, and were not material. Historical financial results of the acquired entity were not significant.
| | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | () | | Mature products and other(a) | | | | | | | | | | | | | () | | | () | | | | | | () | | | () | |
| Total | $ | | | | $ | | | | $ | | | | $ | | | | $ | () | | | $ | () | | | $ | () | | | $ | () | | | $ | () | |
million and a divestiture gain of $ million related to the sale of several mature products of Cheplapharm in 2022.
Diabetes Business
In 2014, BMS and AstraZeneca terminated their diabetes business alliance agreements and BMS sold to AstraZeneca substantially all of the diabetes business comprising the alliance. Consideration for the transaction included tiered royalty payments ranging from % to % based on net sales through 2025. Royalties were $ million in 2023, $ million in 2022 and $ million in 2021.
million in 2023, $ million in 2022 and $ million in 2021.
Mature Products and Other
Manufacturing Operations
In 2022, BMS agreed to sell its manufacturing facility in Syracuse, New York to LOTTE Corporation and accounted for the business as held-for-sale, which resulted in a $ million impairment charge recorded to Cost of products sold. Assets and liabilities reclassified to held-for-sale were included within Other current assets and Other current liabilities and were $ million and $ million, respectively, as of December 31, 2022. In January 2023, BMS completed the sale resulting in cash proceeds of $ million, which was received in December 2022.
Licensing and Other Arrangements
Royalty and Licensing Income
) | | $ | () | | | $ | () | | Tecentriq* royalties | () | | | () | | | () | |
| Upfront licensing fees | | | | | | | () | |
| Contingent milestone income | () | | | () | | | () | |
| Amortization of deferred income | () | | | () | | | () | |
| Biohaven sublicense income | | | | () | | | | |
| Other royalties | () | | | () | | | () | |
| Total | $ | () | | | $ | () | | | $ | () | |
LianBio (mavacamten)
In October 2023, BMS reacquired the rights for mavacamten in China and certain other Asian territories from LianBio. The transaction resulted in a $ million Acquired IPRD charge which included the cash transferred of $ million and the carrying value of previously established License intangible asset.
Keytruda* Patent License Agreement
BMS and Ono are parties to a global patent license agreement with Merck related to Merck's PD-1 antibody Keytruda*. Under the agreement, Merck was obligated to pay ongoing royalties on global sales of Keytruda* of % through December 31, 2023, and will pay % from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a / percent allocation, respectively after adjusting for each parties' legal fees.
Tecentriq* Patent License Agreement
BMS and Ono are parties to a global patent license agreement with Roche Group related to Tecentriq*, Roche’s anti-PD-L1 antibody. Under the agreement, Roche is obligated to pay single-digit royalties on worldwide net sales of Tecentriq* through December 31, 2026. The royalties are shared between BMS and Ono consistent with existing agreements.
million which was expensed to Acquired IPRD in 2022. Immatics is eligible to receive contingent development, regulatory and sales-based milestones up to $ million, as well as royalties on global net sales.
Agenus
In 2021, BMS obtained a global exclusive license to Agenus’ proprietary AGEN1777 bispecific antibody program that blocks TIGIT and an additional target. AGEN1777 is being studied in oncology. BMS is responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. The transaction included a payment of $ million which was expensed to Acquired IPRD in 2021. In addition, Agenus is eligible to receive contingent development, regulatory and sales-based milestones up to $ billion as well as royalties on global net sales.
Dragonfly
In 2020, BMS obtained a global exclusive license to Dragonfly’s interleukin-12 ("IL-12") investigational immunotherapy program. In 2022, a Phase I development milestone for IL-12 was achieved resulting in a $ million payment to Dragonfly which was expensed to Acquired IPRD. In 2023, BMS notified Dragonfly that it was terminating the global exclusive license that relates to Dragonfly’s IL-12 program and all rights were reverted back to Dragonfly.
Other
In 2022, BMS amended the terms of a license arrangement and paid a third party $ million to extinguish a future royalty obligation related to Camzyos (mavacamten), prior to its FDA approval in April 2022, resulting in an Acquired IPRD charge.
Note 5.
| | $ | | | | $ | | | | Royalty and licensing income (Note 4) | () | | | () | | | () | |
| Royalty income - divestitures (Note 4) | () | | | () | | | () | |
Equity investment losses/(gains), net (Note 9) | | | | | | | () | |
| Integration expenses (Note 6) | | | | | | | | |
Loss on debt redemption (Note 10) | | | | | | | | |
| Divestiture gains (Note 4) | | | | () | | | () | |
| Litigation and other settlements | () | | | | | | | |
| Investment income | () | | | () | | | () | |
| Provision for restructuring (Note 6) | | | | | | | | |
| Contingent consideration | () | | | () | | | () | |
| Other | | | | | | | () | |
| Other (income)/expense, net | $ | () | | | $ | | | | $ | () | |
million of BeiGene ordinary shares of common stock held under a share subscription agreement back to BeiGene resulting in $ million of expense that was included in Other (income)/expense, net in 2023. The expense was determined based on the closing price of the shares on the date of the transfer. In addition, the remaining BeiGene ordinary shares owned by BMS under the share subscription agreement were converted to American Depository Shares, which were subsequently sold in 2023.
AstraZeneca Settlement
In 2023, BMS entered into an agreement with AstraZeneca to settle all outstanding claims between the parties in the CTLA-4 litigation and the PD-L1 antibody litigations, as further described in "—Note 20. Legal Proceedings and Contingencies." AstraZeneca will pay an aggregate of $ million to BMS in payments through September 2026, which will be subject to sharing arrangements with Ono and Dana-Farber. BMS's share is approximately $ million, of which the net present value of $ million was reflected in Other (income)/expense in 2023.
Nimbus Change of Control Income
In 2022, BMS and Nimbus entered into a settlement resolving all legal claims and business interests pertaining to Nimbus' TYK2 inhibitor resulting in $ million of income included in Other (income)/expense. The settlement also provides for BMS to receive additional amounts for contingent development, regulatory approval and sales-based milestones and % of any change in control proceeds received by Nimbus related to its TYK2 inhibitor. In 2023, Takeda acquired % ownership of Nimbus' TYK2 inhibitor for approximately $ billion in upfront proceeds plus contingent sales-based milestones aggregating up to $ billion. As a result, $ million of income related to the change of control provision was included in Other (income)/expense in 2023.
Contingent Consideration
Contingent consideration in 2021 included $ million of fair value adjustments resulting from the change in the traded price of contingent value rights issued with the Celgene acquisition. The contractual obligation to pay the contingent value rights terminated in January 2021 because the FDA did not approve liso-cel (JCAR017) by December 31, 2020.
Note 6.
billion are expected to be incurred through 2025, consisting primarily of employee termination costs and to a lesser extent site exit costs, including impairment and accelerated depreciation of property, plant and equipment.
Celgene and Other Acquisition Plans
Restructuring and integration plans were initiated to realize expected cost synergies resulting from cost savings and avoidance from the acquisition of Celgene (2019), MyoKardia (2020) and Turning Point (2022). As part of these plans, the Company expects to incur charges of approximately $ billion. Cumulative charges of approximately $ billion have been recognized to date including integration planning and execution expenses, employee termination benefit costs and accelerated stock-based compensation, contract termination costs and other shutdown costs associated with site exits. The remaining charges are primarily related to Celgene's IT system integration.
| | $ | | | | $ | | | | Celgene and Other Acquisition Plans | | | | | | | | |
| Total charges | $ | | | | $ | | | | $ | | |
| | | | | |
| Employee termination costs | $ | | | | $ | | | | $ | | |
| Other termination costs | | | | | | | | |
| Provision for restructuring | | | | | | | | |
| Integration expenses | | | | | | | | |
| Accelerated depreciation | | | | | | | | |
| Asset impairments | | | | | | | | |
| Other shutdown costs, net | | | | | | | () | |
| Total charges | $ | | | | $ | | | | $ | | |
| | | | | |
| Cost of products sold | $ | | | | $ | | | | $ | | |
| Marketing, selling and administrative | | | | | | | | |
| Research and development | | | | | | | | |
| Other (income)/expense, net | | | | | | | | |
| Total charges | $ | | | | $ | | | | $ | | |
| | $ | | | Provision for restructuring(a) | | | | | |
| Payments | () | | | () | |
| Foreign currency translation and other | | | | () | |
| Liability at December 31 | $ | | | | $ | | |
(a) Includes reductions to the liability resulting from changes in estimates of $ million in 2023 and $ million in 2022.
Note 7.
| | $ | | | | $ | | | | Non-U.S. | | | | | | | | |
| Total current | | | | | | | | |
| Deferred: | | | | | |
| U.S. | () | | | () | | | () | |
| Non-U.S. | () | | | | | | () | |
| Total deferred | () | | | () | | | () | |
| Total Provision for Income Taxes | $ | | | | $ | | | | $ | | |
| | | | $ | () | | | | | $ | | | | | | Non-U.S. | | | | | | | | | | | | | | |
| Total | | | | | | | | | | | | | | |
| U.S. statutory rate | | | | | % | | | | | | % | | | | | | % |
| GILTI, net of foreign derived intangible income deduction | | | | | % | | | | | | % | | | | | | % |
| Foreign tax effect of certain operations in Ireland, Puerto Rico and Switzerland | () | | | () | % | | () | | | () | % | | () | | | () | % |
Non-U.S. tax ruling | () | | | () | % | | | | | | % | | | | | | % |
| Internal transfers of intangible and other assets | | | | | % | | () | | | () | % | | () | | | () | % |
U.S. Federal valuation allowance | () | | | () | % | | | | | | % | | | | | | % |
| U.S. Federal, state and foreign contingent tax matters | | | | | % | | () | | | () | % | | | | | | % |
| U.S. Federal research-based credits | () | | | () | % | | () | | | () | % | | () | | | () | % |
| Charitable contributions of inventory | () | | | () | % | | () | | | () | % | | () | | | () | % |
| Contingent value rights | | | | | % | | | | | | % | | () | | | () | % |
| Puerto Rico excise tax credit | | | | | % | | () | | | () | % | | () | | | () | % |
| State and local taxes (net of valuation allowance) | | | | | % | | | | | | % | | | | | | % |
| Foreign and other | | | | | % | | | | | | % | | | | | | % |
| Total Provision for Income Taxes | $ | | | | | % | | $ | | | | | % | | $ | | | | | % |
GILTI, net of foreign derived intangible income deduction includes a benefit of approximately $ million due to the revised 2023 guidance regarding the deductibility of certain research and development expenses.
Foreign tax effect of certain operations in Ireland, Puerto Rico and Switzerland includes the impact of earnings mix and a $ million benefit from the impact of foreign currency on net operating loss and other carryforwards in 2023.
The Non-U.S. tax ruling includes a $ million deferred income tax benefit regarding the deductibility of a statutory impairment of subsidiary investments in 2023.
Internal transfers of intangible and other assets to streamline our legal entity structure subsequent to the Celgene acquisition resulted in a tax benefit in 2022 and 2021.
U.S. Federal valuation allowance includes a $ million reversal related to unrealized equity investment losses in 2023.
U.S. Federal, state and foreign contingent tax matters include tax benefits related to lapse of statute and effectively settled contingent tax matters of $ million in 2023 and $ million in 2022.
U.S. Federal research-based credits includes credits both on research and development as well as orphan drug. The credits in 2023 include revised estimates upon finalization of prior year tax returns.
Fair value adjustments for contingent value rights are not taxable or tax deductible.
Puerto Rico imposed an excise tax on the gross company purchase price of goods sold from BMS’s manufacturer in Puerto Rico. The excise tax was recognized in Cost of products sold when the intra-entity sale occurred. For U.S. income tax purposes, the excise tax was not deductible but resulted in foreign tax credits that were generally recognized in BMS’s provision for income taxes when the excise tax was incurred. As of December 31, 2022, BMS amended its existing Puerto Rico decree, eliminating the excise tax and increasing its Puerto Rico tax rate to % effective for the tax year beginning January 1, 2023, and extending BMS’s tax grants an additional 15 years to 2038.
| | $ | | | | State net operating loss and credit carryforwards | | | | | |
U.S. Federal capital loss, net operating loss and tax credit | | | | | |
| Milestone payments and license fees | | | | | |
| Capitalized research expenditures | | | | | |
| Other | | | | | |
| Total deferred tax assets | | | | | |
| Valuation allowance | () | | | () | |
| Deferred tax assets net of valuation allowance | $ | | | | $ | | |
| | | |
| Deferred tax liabilities | | | |
| Acquired intangible assets | $ | () | | | $ | () | |
| Goodwill and other | () | | | () | |
| Total deferred tax liabilities | $ | () | | | $ | () | |
| | | |
Deferred tax assets/(liabilities), net | $ | | | | $ | () | |
| | | |
| Recognized as: | | | |
| Deferred income taxes assets – non-current | $ | | | | $ | | |
| Deferred income taxes liabilities – non-current | () | | | () | |
| Total | $ | | | | $ | () | |
BMS is not indefinitely reinvested with respect to its undistributed earnings from foreign subsidiaries and has provided a deferred tax liability for foreign and state income and withholding tax that would apply. BMS remains indefinitely reinvested with respect to its financial statement basis in excess of tax basis of its foreign subsidiaries. A determination of the deferred tax liability with respect to this basis difference is not practicable.
Foreign net operating loss and other carryforwards includes the impact of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments.
The U.S. Federal net operating loss carryforwards were $ million at December 31, 2023. These carryforwards were acquired as a result of certain acquisitions and are subject to limitations under Section 382 of the Internal Revenue Code. The net operating loss carryforwards expire in varying amounts beginning in 2024. The foreign and state net operating loss carryforwards expire in varying amounts beginning in 2024 (certain amounts have unlimited lives).
At December 31, 2023, a valuation allowance of $ million exists for the following items: $ million primarily for foreign net operating loss and tax credit carryforwards, $ million for state deferred tax assets including net operating loss and tax credit carryforwards and $ million for U.S. Federal deferred tax assets including equity investment fair value adjustments and U.S. Federal net operating loss carryforwards.
| | $ | | | | $ | | | | Provision | () | | | | | | | |
| Utilization | () | | | () | | | () | |
| Foreign currency translation | () | | | () | | | () | |
| Acquisitions/(dispositions)/(liquidations), net | | | | () | | | () | |
Non-U.S. rate change | | | | | | | | |
| Balance at end of year | $ | | | | $ | | | | $ | | |
billion in 2023, $ billion in 2022 and $ billion in 2021.
In connection with the enactment of the TCJA, we were required to pay a one-time transition tax and elected to pay over a period of eight years as permitted under the TCJA. The remaining amounts payable are as follows: $ million in 2024; $ billion in 2025; and $ million in 2026.
Business is conducted in various countries throughout the world and is subject to tax in numerous jurisdictions. A significant number of tax returns that are filed are subject to examination by various federal, state and local tax authorities. Tax examinations are often complex, as tax authorities may disagree with the treatment of items reported requiring several years to resolve. Liabilities are established for possible assessments by tax authorities resulting from known tax exposures including, but not limited to, transfer pricing matters, tax credit deductibility of certain expenses, and deemed repatriation transition tax. Such liabilities represent a reasonable provision for taxes ultimately expected to be paid and may need to be adjusted over time as more information becomes known. The effect of changes in estimates related to contingent tax liabilities is included in the effective tax rate reconciliation above.
| | $ | | | | $ | | | | Gross additions to tax positions related to current year | | | | | | | | |
| Gross additions to tax positions related to prior years | | | | | | | | |
| Gross additions to tax positions assumed in acquisitions | | | | | | | | |
| Gross reductions to tax positions related to prior years | () | | | () | | | () | |
| Settlements | () | | | () | | | () | |
| Reductions to tax positions related to lapse of statute | () | | | () | | | () | |
| Cumulative translation adjustment | | | | () | | | () | |
| Balance at end of year | $ | | | | $ | | | | $ | | |
| | $ | | | | $ | | | | Accrued interest | | | | | | | | |
| Accrued penalties | | | | | | | | |
| Interest and penalties expense/(benefit) | | | | () | | | | |
Accrued interest and penalties payable for unrecognized tax benefits are included in either current or non-current income taxes payable. Interest and penalties related to unrecognized tax benefits are included in income tax expense. These amounts reflect the beneficial impacts of various tax settlements, including the settlement discussed below.
BMS is currently under examination by a number of tax authorities that proposed or are considering proposing material adjustments to tax positions for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. As previously disclosed, BMS received several notices of proposed adjustments from the IRS related to transfer pricing and other tax issues for the 2008 to 2012 tax years. BMS disagrees with the IRS’s positions and continues to work cooperatively with the IRS to resolve these issues. In 2022, BMS entered the IRS administrative appeals process to resolve these matters. Timing of the final resolution of these complex matters is uncertain and could have a material impact on BMS’s financial statements. Tax positions for these years unrelated to matters that entered the administrative appeals process are considered effectively settled.
It is reasonably possible that new issues will be raised by tax authorities that may increase unrecognized tax benefits; however, an estimate of such increases cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.
million to $ million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits may result in the payment of additional taxes, adjustment of certain deferred taxes and/or recognition of tax benefits.
Note 8.
| | $ | | | | $ | | | | | | | | |
| Weighted-average common shares outstanding - basic | | | | | | | | |
| Incremental shares attributable to share-based compensation plans | | | | | | | | |
| Weighted-average common shares outstanding - diluted | | | | | | | | |
| | | | | |
| Earnings per common share | | | | | |
| Basic | $ | | | | $ | | | | $ | | |
| Diluted | | | | | | | | |
The total number of potential shares of common stock excluded from the diluted earnings per share computation because of the antidilutive impact was not material in 2023, 2022 and 2021.
Note 9.
| | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | Marketable debt securities | | | | | | | | | | | |
| Certificates of deposit | | | | | | | | | | | | | | | | | |
| Commercial paper | | | | | | | | | | | | | | | | | |
| Corporate debt securities | | | | | | | | | | | | | | | | | |
| U.S. Treasury securities | | | | | | | | | | | | | | | | | |
| Derivative assets | | | | | | | | | | | | | | | | |
| Equity investments | | | | | | | | | | | | | | | | | |
| Derivative liabilities | | | | | | | | | | | | | | | | | |
| Contingent consideration liability | | | | | | | | | | | |
| Contingent value rights | | | | | | | | | | | | | | | | | |
| Other acquisition related contingent consideration | | | | | | | | | | | | | | | | | |
Marketable Debt Securities
The amortized cost for marketable debt securities approximates its fair value and these securities mature within as of December 31, 2023, and as of December 31, 2022.
| | $ | | | | Equity investments without readily determinable fair values | | | | | |
| Limited partnerships and other equity method investments | | | | | |
| Total equity investments | $ | | | | $ | | |
| | $ | | | | $ | | | Net (gain) recognized on investments sold | () | | | () | | | () | |
| Net unrealized loss recognized on investments still held | | | | | | | | |
| | | | | |
| Equity investments without readily determinable fair values | | | | | |
| Upward adjustments | () | | | () | | | () | |
| Impairments and downward adjustments | | | | | | | | |
| Equity in net (income)/loss of affiliates | | | | | | | () | |
| | | | | |
Total equity investment losses/(gains) | | | | | | | () | |
Cumulative upwards adjustments and cumulative impairments and downward adjustments based on observable price changes in equity investments without readily determinable fair values still held as of December 31, 2023 were $ million and $ million, respectively.
million into Cost of products sold for our foreign exchange contracts out of AOCL during the next 12 months. The notional amount of outstanding foreign currency exchange contracts was primarily $ billion for the euro contracts and $ billion for Japanese yen contracts as of December 31, 2023.
BMS also enters into cross-currency swap contracts to hedge exposure to foreign currency exchange rate risk associated with its long-term debt denominated in euros. These contracts convert interest payments and principal repayment of the long-term debt to U.S. dollars from euros and are designated as cash flow hedges. The unrealized gains and losses on these contracts are reported in AOCL and reclassified to Other (income)/expense, net, in the same periods during which the hedged debt affects earnings. The notional amount of cross-currency interest rate swap contracts associated with long-term debt denominated in euros was $ billion as of December 31, 2023.
million as of December 31, 2023 are designated to hedge currency exposure of BMS's net investment in its foreign subsidiaries. Contract fair value changes are recorded in the foreign currency translation component of AOCL with a related offset in derivative asset or liability in the consolidated balance sheets. The notional amount of outstanding cross-currency swap and foreign currency forward contracts was primarily attributed to the Japanese yen of $ million and euro of $ million as of December 31, 2023.
During the years ended December 31, 2023, 2022 and 2021, the amortization of gains related to the portion of our net investment hedges that was excluded from the assessment of effectiveness was not material.
Fair Value Hedges
Fixed to floating interest rate swap contracts are designated as fair value hedges and used as an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The contracts and underlying debt for the hedged benchmark risk are recorded at fair value. Gains or losses resulting from changes in fair value of the underlying debt attributable to the hedged benchmark interest rate risk are recorded in interest expense with an associated offset to the carrying value of debt. Since the specific terms and notional amount of the swap are intended to align with the debt being hedged, all changes in fair value of the swap are recorded in interest expense with an associated offset to the derivative asset or liability on the consolidated balance sheet. As a result, there was no net impact in earnings. If the underlying swap is terminated prior to maturity, then the fair value adjustment to the underlying debt is amortized as a reduction to interest expense over the remaining term of the debt.
Derivative cash flows, with the exception of net investment hedges, are principally classified in the operating section of the consolidated statements of cash flows, consistent with the underlying hedged item. Cash flows related to net investment hedges are classified in investing activities.
| | | | | | | | () | | | | | | | | | | | | () | | | Cross-currency swap contracts | | | | | | | | | | | | | | | | | | | | | | () | |
| Designated as net investment hedges | | | | | | | | | | | | | | | |
| Foreign exchange contracts | | | | | | | | | | () | | | | | | | | | | | | | |
| Cross-currency swap contracts | | | | | | | | | | () | | | | | | | | | | | | () | |
| Designated as fair value hedges | | | | | | | | | | | | | | | |
| Interest rate swap contracts | | | | | | | | | | () | | | | | | | | | | | | () | |
| Not designated as hedges | | | | | | | | | | | | | | | |
| Foreign currency exchange contracts | | | | | | | | | | () | | | | | | | | | | | | () | |
Total return swap contracts(c) | | | | | | | | | | | | | | | | | | | | | | () | |
(a) Included in Other current assets and Other non-current assets.
(b) Included in Other current liabilities and Other non-current liabilities.
(c) Total return swap contracts were entered into to hedge changes in fair value of certain deferred compensation liabilities.
| | $ | () | | | $ | | | | $ | () | | | $ | | | | $ | () | | | Cross-currency swap contracts | | | | () | | | | | | () | | | | | | () | |
| Foreign exchange contracts | () | | | () | | | () | | | () | | | | | | () | |
The following table summarizes the effect of derivative and non-derivative instruments designated as hedging instruments in Other Comprehensive Income/(Loss):
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| Dollars in millions | 2023 | | 2022 | | 2021 |
| Derivatives qualifying as cash flow hedges | | | | | |
| Foreign exchange contracts gain/(loss): | | | | | |
| Recognized in Other Comprehensive Income/(Loss) | $ | | | | $ | | | | $ | | |
| Reclassified to Cost of products sold | () | | | () | | | | |
| Cross-currency swap contracts gain/(loss): | | | | | |
| Recognized in Other Comprehensive Income | | | | () | | | | |
| Reclassified to Other (income)/expense, net | () | | | () | | | | |
| Forward starting interest rate swap contract loss: | | | | | |
| Reclassified to Other (income)/expense, net | | | | () | | | | |
| | | |
| | | |
| | | | | |
| Derivatives qualifying as net investment hedges | | | | | |
| Cross-currency swap contracts gain/(loss): | | | | | |
| Recognized in Other Comprehensive Income/(Loss) | | | | | | | | |
| Foreign Exchange contracts gain/(loss): | | | | | |
| Recognized in Other Comprehensive Income/(Loss) | () | | | | | | | |
| | | | | |
| Non-derivatives qualifying as net investment hedges | | | | | |
Non-U.S. dollar borrowings gain/(loss): | | | | | |
Recognized in Other Comprehensive Income/(Loss) (a) | () | | | | | | | |
(a) In 2023, the Company de-designated its remaining net investment hedge in debt denominated in euros of € million, and the amount represents the effective portion of foreign exchange loss on the remeasurement of the debt.
Note 10.
| | $ | | | | Current portion of long-term debt | | | | | |
| Other | | | | | |
| Total | $ | | | | $ | | |
% Notes due 2023 | | | | | % Notes due 2023 | | | | | |
% Notes due 2023 | | | | | |
% Notes due 2023 | | | | | |
% Notes due 2023 | | | | | |
% Notes due 2024 | | | | | |
% Notes due 2024 | | | | | |
% Notes due 2025 | | | | | |
% Euro Notes due 2025 | | | | | |
% Notes due 2025 | | | | | |
% Notes due 2026 | | | | | |
% Notes due 2026 | | | | | |
% Notes due 2027 | | | | | |
% Notes due 2027 | | | | | |
% Notes due 2027 | | | | | |
% Notes due 2028 | | | | | |
% Notes due 2029 | | | | | |
% Notes due 2030 | | | | | |
% Notes due 2031 | | | | | |
% Notes due 2032 | | | | | |
% Notes due 2033 | | | | | |
% Euro Notes due 2035 | | | | | |
% Notes due 2036 | | | | | |
% Notes due 2038 | | | | | |
% Notes due 2039 | | | | | |
% Notes due 2040 | | | | | |
% Notes due 2040 | | | | | |
% Notes due 2042 | | | | | |
% Notes due 2042 | | | | | |
% Notes due 2043 | | | | | |
% Notes due 2044 | | | | | |
% Notes due 2044 | | | | | |
% Notes due 2045 | | | | | |
% Notes due 2047 | | | | | |
% Notes due 2048 | | | | | |
% Notes due 2049 | | | | | |
% Notes due 2050 | | | | | |
% Notes due 2052 | | | | | |
% Notes due 2053 | | | | | |
% Notes due 2062 | | | | | |
% Notes due 2063 | | | | | |
% Notes due 2097 | | | | | |
% Convertible debt due 2023 | | | | | |
| Total | $ | | | | $ | | |
| | $ | | | | | | |
| Adjustments to Principal Value: | | | |
| Fair value of interest rate swap contracts | () | | | () | |
| Unamortized basis adjustment from swap terminations | | | | | |
| Unamortized bond discounts and issuance costs | () | | | () | |
| Unamortized purchase price adjustments of Celgene debt | | | | | |
| Total | $ | | | | $ | | |
| | | |
| Current portion of long-term debt | $ | | | | $ | | |
| Long-term debt | | | | | |
| Total | $ | | | | $ | | |
The fair value of long-term debt was $ billion and $ billion at December 31, 2023 and 2022, respectively, valued using Level 2 inputs which are based upon the quoted market prices for the same or similar debt instruments. The fair value of short-term borrowings approximates the carrying value due to the short maturities of the debt instruments.
In February 2024, we entered into a $ billion senior unsecured delayed draw term loan facility to provide bridge financing for the planned acquisitions of Karuna and RayzeBio. This facility would be drawn only if these acquisitions close prior to our planned issuance of debt securities and, if drawn, would be repaid following the issuance of such securities. amounts were outstanding as of February 13, 2024.
In 2023, BMS issued an aggregate principal amount of $ billion of fixed rate unsecured senior notes. The Company used the net proceeds of the offering to finance the acquisition of Mirati in January 2024 and for other general corporate purposes. In 2022, BMS issued an aggregate principal amount of $ billion of fixed rate unsecured senior notes with net proceeds of $ billion.
The notes rank equally in right of payment with all of BMS’s existing and future senior unsecured indebtedness and are redeemable at any time, in whole, or in part, at varying specified redemption prices plus accrued and unpaid interest.
In 2022, BMS purchased aggregate principal amount of $ billion of certain of its debt securities for $ billion of cash in a series of tender offers and “make whole” redemptions. In connection with these transactions, a $ million loss on debt redemption was recognized based on the carrying value of the debt and included in Other (income)/expense, net.
In 2021, BMS purchased aggregate principal amount of $ billion of certain of its debt securities for approximately $ billion of cash in a series of tender offers and “make whole” redemptions. In connection with these transactions, a $ million loss on debt redemption was recognized based on the carrying value of the debt and included in Other (income)/expense, net.
Repayment of notes at maturity aggregated $ billion in 2023, $ billion in 2022 and $ billion in 2021. Interest payments were $ billion in 2023, $ billion in 2022 and $ billion in 2021.
The aggregate maturities of long-term debt for each of the next five years are as follows: $ billion in 2024; $ billion in 2025; $ billion in 2026; $ billion in 2027; and $ billion in 2028. Interest payments related to long-term debt for each of the next five years are as follows: $ billion in 2024; $ billion in 2025; $ billion in 2026; $ billion in 2027; and $ billion in 2028.
Credit Facilities
As of December 31, 2023, BMS had a $ billion revolving credit facility expiring in January 2028, which is extendable annually by with the consent of the lenders. In January 2024, we extended the credit facility to January 2029. Additionally, in February 2024, we entered into a $ billion revolving credit facility. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for BMS’ commercial paper borrowings. borrowings were outstanding under any revolving credit facility as of December 31, 2023 or 2022.
Available financial guarantees provided in the form of bank overdraft facilities, stand-by letters of credit and performance bonds were $ billion as of December 31, 2023. Stand-by letters of credit and guarantees are issued through financial institutions in support of various obligations, including sale of products to hospitals and foreign ministries of health, bonds for customs, and duties and VAT.
Note 11.
| | $ | | | | Less charge-backs and cash discounts | () | | | () | |
| Less allowance for expected credit loss | () | | | () | |
| Net trade receivables | | | | | |
| Alliance, royalties, VAT and other | | | | | |
| Receivables | $ | | | | $ | | |
Non-U.S. receivables sold on a nonrecourse basis were $ billion in 2023, $ billion in 2022 and $ billion in 2021. In the aggregate, receivables from pharmaceutical wholesalers in the U.S. represented approximately % and % of total trade receivables at December 31, 2023 and 2022, respectively.
| | $ | | | | $ | | | Provision(a) | | | | | | | | |
| Utilization | () | | | () | | | () | |
| Other | | | | () | | | () | |
| Balance at end of year | $ | | | | $ | | | | $ | | |
(a) Includes provision for expected credit loss of $ million in 2023, $ million in 2022 and $ million in 2021.
Note 12.
| | $ | | | | Work in process | | | | | |
| Raw and packaging materials | | | | | |
| Total Inventories | $ | | | | $ | | |
| | | |
| Inventories | $ | | | | $ | | |
| Other non-current assets | | | | | |
Total inventories include fair value adjustments resulting from the Celgene acquisition of approximately $ million as of December 31, 2022.
Note 13.
| | $ | | | | Buildings | | | | | |
| Machinery, equipment and fixtures | | | | | |
| Construction in progress | | | | | |
| Gross property, plant and equipment | | | | | |
| Less accumulated depreciation | () | | | () | |
| Property, plant and equipment | $ | | | | $ | | |
| | | |
| United States | $ | | | | $ | | |
| International | | | | | |
| Total | $ | | | | $ | | |
| | Depreciation expense was $ million in 2023, $ million in 2022 and $ million in 2021.
Note 14.
% of the total lease obligation. Lease terms vary based on the nature of operations and the market dynamics in each country; however, all leased facilities are classified as operating leases with remaining lease terms between and years. Most leases contain specific renewal options for periods ranging between and years where notice to renew must be provided in advance of lease expiration or automatic renewals where no advance notice is required. Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. Certain leases also contain termination options that provide the flexibility to terminate the lease ahead of its expiration with sufficient advance notice. Periods covered by an option to terminate the lease were included in the non-cancellable lease term when exercise of the option was determined not to be reasonably certain. Judgment is required in assessing whether renewal and termination options are reasonably certain to be exercised. Factors are considered such as contractual terms compared to current market rates, leasehold improvements expected to have significant value, costs to terminate a lease and the importance of the facility to operations. Costs determined to be variable and not based on an index or rate were not included in the measurement of real estate lease liabilities. These variable costs include real estate taxes, insurance, utilities, common area maintenance and other operating costs. As the implicit rate on most leases is not readily determinable, an incremental borrowing rate was applied on a portfolio approach to discount its real estate lease liabilities.
The remaining lease obligations are comprised of vehicles and a research and development facility operated by a third party under management’s direction. Vehicle lease terms vary by country with terms generally between and .
| | $ | | | | $ | | |
| Variable lease cost | | | | | | | | |
| Short-term lease cost | | | | | | | | |
| Sublease income | () | | | () | | | () | |
| Total operating lease expense | $ | | | | $ | | | | $ | | |
| | $ | | | | | | |
| Other current liabilities | $ | | | | $ | | |
| Other non-current liabilities | | | | | |
| Total liabilities | $ | | | | $ | | |
| 2025 | | |
2026 | | |
2027 | | |
2028 | | |
| Thereafter | | |
| Total future lease payments | | |
| |
| Less imputed interest | () | |
| Total lease liability | $ | | |
million in 2023. Right-of-use assets impairment charge was $ million in 2023. Cash paid for amounts included in the measurement of operating lease liabilities was $ million in 2023, $ million in 2022 and $ million in 2021.
Undiscounted lease obligations for operating leases not yet commenced were $ million as of December 31, 2023. The obligation primarily relates to a research and development facility that is being constructed by the lessor and is expected to be ready for use in 2025.
years | years | | Weighted average discount rate | | % | | | % |
Note 15.
| | $ | | | | Turning Point acquisition | | | | | |
| Currency translation and other adjustments | | | | () | |
| Ending balance | $ | | | | $ | | |
Other Intangible Assets
– years | $ | | | | $ | () | | | $ | | | | $ | | | | $ | () | | | $ | | | | Acquired marketed product rights | – years | | | | | () | | | | | | | | | () | | | | |
| Capitalized software | – years | | | | | () | | | | | | | | | () | | | | |
| IPRD | | | | | | — | | | | | | | | | — | | | | |
| Total | | | $ | | | | $ | () | | | $ | | | | $ | | | | $ | () | | | $ | | |
In November 2023, $ billion of IPRD, previously allocated to repotrectinib (Augtyro), was transferred to Acquired marketed product rights upon obtaining FDA approval. Refer to “—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for further information related to the Turning Point acquisition.
In December 2023, BMS agreed to pay $ million to the former shareholders of Impact Biomedicines to extinguish all remaining contingent milestone obligations, which was recorded to Acquired marketed product rights for Inrebic in the amount of $ million (after establishing the applicable deferred tax liability). The $ million was paid in January 2024.
Amortization expense of Other intangible assets was $ billion in 2023, $ billion in 2022 and $ billion in 2021. Future annual amortization expense of Other intangible assets is expected to be approximately $ billion in 2024, $ billion in 2025, $ billion in 2026, $ billion in 2027 and $ billion in 2028.
Other intangible asset impairment charges were $ million in 2023, $ million in 2022 and $ billion in 2021.
The impairment charges in 2023 and 2022 primarily resulted from decisions to discontinue development of investigational compounds in connection with the prioritization of current pipeline opportunities.
million IPRD impairment charge for an investigational compound was recorded in Research and development expense primarily resulting from changes in clinical timelines, expected launch dates and competitive landscape. The compound is being studied as a potential treatment for hematologic diseases and was acquired in the acquisition of Celgene. The charge represented a partial write-down of its carrying value based on the estimated fair value determined using discounted cash flow projections.
In 2021, a $ million IPRD impairment charge was recorded in Research and development expense following a decision to discontinue development of an investigational compound in connection with the prioritization of pipeline opportunities. The compound was being studied as a potential treatment for fibrotic diseases and was acquired in the acquisition of Celgene. The charge represented a full write-down based on the estimated fair value determined using discounted cash flow projections.
In 2021, Inrebic EU regulatory approval milestones of $ million were achieved resulting in a $ million increase to the acquired marketed product rights intangible asset, after establishing the applicable deferred tax liability. An impairment charge of $ million was recognized in Cost of products sold as the carrying value of this asset exceeded the projected undiscounted cash flows of the asset. The charge was equal to the excess of the asset's carrying value over its estimated fair value using discounted cash flow projections.
Note 16.
| | $ | | | | Research and development | | | | | |
| Contract assets | | | | | |
Restricted cash(a) | | | | | |
| Other | | | | | |
| Other current assets | $ | | | | $ | | |
| | $ | | | Operating leases | | | | | |
Inventories | | | | | |
Pension and postretirement | | | | | |
Research and development | | | | | |
Restricted cash(a) | | | | | |
| Receivables and convertible notes | | | | | |
| Other | | | | | |
| Other non-current assets | | | | | |
(a) Restricted cash consists of funds restricted for annual Company contributions to the defined contribution plan in the U.S. and escrow for litigation settlements. Cash is restricted when withdrawal or general use is contractually or legally restricted.
| | $ | | | | Income taxes | | | | | |
| Employee compensation and benefits | | | | | |
| Research and development | | | | | |
| Dividends | | | | | |
| Interest | | | | | |
| Royalties | | | | | |
| Operating leases | | | | | |
| Other | | | | | |
| Other current liabilities | $ | | | | $ | | |
| | $ | | | | Pension and postretirement | | | | | |
| Operating leases | | | | | |
| Deferred income | | | | | |
| Deferred compensation | | | | | |
| Other | | | | | |
| Other non-current liabilities | $ | | | | $ | | |
Note 17.
| | $ | | | | $ | | | | $ | () | | | $ | | | | | | | $ | () | | | $ | | | Net earnings | — | | | — | | | — | | | — | | | | | | — | | | — | | | | |
| Other Comprehensive Income/(Loss) | — | | | — | | | — | | | | | | — | | | — | | | — | | | — | |
Cash dividends declared(a) | — | | | | | — | | | — | | | () | | | — | | | — | | | — | |
Share repurchases | — | | | — | | | — | | | — | | | — | | | | | | () | | | — | |
| Stock compensation | — | | | — | | | | | | — | | | — | | | () | | | | | | — | |
| Distributions | — | | | — | | | — | | | — | | | — | | | — | | | — | | | () | |
| Balance at December 31, 2021 | | | | | | | | | | () | | | | | | | | | () | | | | |
| Net earnings | — | | | — | | | — | | | — | | | | | | — | | | — | | | | |
| Other Comprehensive Income/(Loss) | — | | | — | | | — | | | () | | | — | | | — | | | — | | | — | |
Cash dividends declared(a) | — | | | — | | | — | | | — | | | () | | | — | | | — | | | — | |
Share repurchases | — | | | — | | | — | | | — | | | — | | | | | | () | | | — | |
| Stock compensation | — | | | — | | | | | | — | | | — | | | () | | | | | | — | |
| Distributions | — | | | — | | | — | | | — | | | — | | | — | | | — | | | () | |
| Balance at December 31, 2022 | | | | | | | | | | () | | | | | | | | | () | | | | |
| Net earnings | — | | | — | | | — | | | — | | | | | | — | | | — | | | | |
| Other Comprehensive Income/(Loss) | — | | | — | | | — | | | () | | | — | | | — | | | — | | | — | |
Cash dividends declared(a) | — | | | — | | | — | | | — | | | () | | | — | | | — | | | — | |
Share repurchases | — | | | — | | | | | | — | | | — | | | | | | () | | | — | |
| Stock compensation | — | | | — | | | | | | — | | | — | | | () | | | | | | — | |
Convertible debt | — | | | — | | | | | | — | | | — | | | — | | | | | | — | |
| Distributions | — | | | — | | | — | | | — | | | — | | | — | | | — | | | () | |
| Balance at December 31, 2023 | | | | $ | | | | $ | | | | $ | () | | | $ | | | | | | | $ | () | | | $ | | |
(a) Cash dividends declared per common share were $ in 2023, $ in 2022 and $ in 2021.
BMS has a share repurchase program, authorized by its Board of Directors, allowing for repurchases of its shares, effected in the open market or through privately negotiated transactions in compliance with Rule 10b-18 under the Exchange Act, including through Rule 10b5-1 trading plans. The share repurchase program does not obligate us to repurchase any specific number of shares, does not have a specific expiration date and may be suspended or discontinued at any time. Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method and are generally funded by cash on hand. In December 2023, the Board of Directors approved an increase of $ billion to the share repurchase authorization for BMS's common stock. The remaining share repurchase capacity under the BMS share repurchase program was $ billion as of December 31, 2023.
In 2021, BMS repurchased approximately million shares of common stock for $ billion.
In 2022, BMS entered into ASR agreements and repurchased million shares of common stock for $ billion. In addition, as part of its share repurchase program, BMS repurchased million shares of its common stock for $ billion.
In 2023, BMS entered into ASR agreements and repurchased million shares of common stock for $ billion. In addition, as part of its share repurchase program, BMS repurchased million shares of its common stock for $ billion.
| | $ | () | | | $ | | | | $ | | | | $ | () | | | $ | | | | $ | | | | $ | () | | | $ | | | Reclassified to net earnings(a) | () | | | | | | () | | | () | | | | | | () | | | | | | () | | | | |
| Derivatives qualifying as cash flow hedges | () | | | | | | () | | | | | | () | | | | | | | | | () | | | | |
| | | | | | | | | | | | | | | | | |
| Pension and postretirement benefits: | | | | | | | | | | | | | | | | | |
| Actuarial gains/(losses) | () | | | | | | () | | | | | | () | | | | | | | | | () | | | | |
Amortization(b) | | | | | | | | | | | | | () | | | | | | | | | () | | | | |
Settlements(b) | | | | | | | | | | | | | () | | | | | | () | | | | | | () | |
| Pension and postretirement benefits | () | | | | | | () | | | | | | () | | | | | | | | | () | | | | |
| | | | | | | | | | | | | | | | | |
| Marketable debt securities: | | | | | | | | | | | | | | | | | |
Unrealized (losses)/gains | | | | () | | | | | | () | | | | | | () | | | () | | | | | | () | |
| | | | | | | | | | | | | | | | | |
| Foreign currency translation | | | | () | | | | | | () | | | () | | | () | | | () | | | () | | | () | |
| | | | | | | | | | | | | | | | | |
Other comprehensive income/(loss) | $ | () | | | $ | | | | $ | () | | | $ | | | | $ | () | | | $ | () | | | $ | | | | $ | () | | | $ | | |
(a) Included in Cost of products sold and Other (income)/expense, net. Refer to “—Note 9. Financial Instruments and Fair Value Measurements“ for further information.
(b) Included in Other (income)/expense, net.
| | $ | | | | Pension and postretirement benefits | () | | | () | |
| Marketable debt securities | | | | | |
Foreign currency translation(a) | () | | | () | |
| Accumulated other comprehensive loss | $ | () | | | $ | () | |
(a) Included in foreign currency are net investment hedges gains of $ million and $ million as of December 31, 2023 and December 31, 2022, respectively.
Note 18.
million, $ million, and $ million during the years ended December 31, 2023, 2022 and 2021, respectively.
| | $ | | | | Service cost—benefits earned during the year | | | | | |
| Interest cost | | | | | |
| Settlements and curtailments | () | | | () | |
| Actuarial (gains)/losses | | | | () | |
| Benefits paid | () | | | () | |
| Foreign currency and other | | | | () | |
| Benefit obligations at end of year | $ | | | | $ | | |
| | | |
| Fair value of plan assets at beginning of year | $ | | | | $ | | |
| Actual return on plan assets | | | | () | |
| Employer contributions | | | | | |
| Settlements | () | | | () | |
| Benefits paid | () | | | () | |
| Foreign currency and other | | | | () | |
| Fair value of plan assets at end of year | $ | | | | $ | | |
| | | |
| Funded status | $ | () | | | $ | | |
| | | |
| Assets/(Liabilities) recognized: | | | |
| Other non-current assets | $ | | | | $ | | |
| Other current liabilities | () | | | () | |
| Other non-current liabilities | () | | | () | |
| Funded status | $ | () | | | $ | | |
| | | |
| Recognized in Accumulated other comprehensive loss: | | | |
| Net actuarial losses | $ | | | | $ | | |
| Prior service credit | () | | | () | |
| Total | $ | | | | $ | | |
The accumulated benefit obligation for defined benefit pension plans was $ billion and $ billion at December 31, 2023 and 2022, respectively.
| | $ | | | | Fair value of plan assets | | | | | |
Pension plans with accumulated benefit obligations in excess of plan assets: | | | |
| Accumulated benefit obligation | | | | | |
| Fair value of plan assets | | | | | |
Actuarial Assumptions
% | | | % | | Rate of compensation increase | | % | | | % |
| Interest crediting rate | | % | | | % |
% | | | % | | | % | | Expected long-term return on plan assets | | % | | | % | | | % |
| Rate of compensation increase | | % | | | % | | | % |
| Interest crediting rate | | % | | | % | | | % |
The yield on high quality corporate bonds matching the duration of the benefit obligations is used in determining the discount rate. The FTSE Pension Discount Curve is used in developing the discount rate for the U.S. plans.
The expected return on plan assets assumption for each plan is based on management’s expectations of long-term average rates of return to be achieved by the underlying investment portfolio. Several factors are considered in developing the expected return on plan assets, including long-term historical returns and input from external advisors. Individual asset class return forecasts were developed based upon market conditions, for example, price-earnings levels and yields and long-term growth expectations. The expected long-term rate of return is the weighted-average of the target asset allocation of each individual asset class.
Actuarial gains and losses resulted from changes in actuarial assumptions (such as changes in the discount rate and revised mortality rates) and from differences between assumed and actual experience (such as differences between actual and expected return on plan assets). Actuarial gains and losses related to plan benefit obligations primarily resulted from changes in discount rates.
Postretirement Benefit Plans
Comprehensive medical and group life benefits are provided for substantially all BMS U.S. retirees electing to participate in comprehensive medical and group life plans and to a lesser extent certain benefits for non-U.S. employees. The medical plan is contributory. Contributions are adjusted periodically and vary by date of retirement. The life insurance plan is noncontributory. Postretirement benefit plan obligations were $ million and $ million at December 31, 2023 and 2022, respectively. The weighted-average discount rate used to determine benefit obligations was % and % at December 31, 2023 and 2022, respectively. The net periodic benefit credits were not material.
Plan Assets
| | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | Equity funds | | | | | | | | | | | | | | | | | | | | | | | |
| Fixed income funds | | | | | | | | | | | | | | | | | | | | | | | |
| Corporate debt securities | | | | | | | | | | | | | | | | | | | | | | | |
| U.S. Treasury and agency securities | | | | | | | | | | | | | | | | | | | | | | | |
| Insurance contracts | | | | | | | | | | | | | | | | | | | | | | | |
| Cash and cash equivalents | | | | | | | | | | | | | | | | | | | | | | | |
| Other | | | | | | | | | | | | | | | | | | | | | | | |
| Plan assets subject to leveling | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | | | $ | | |
| | | | | | | | | | | | | | | |
| Plan assets measured at NAV as a practical expedient | | | | | | | | | | | | | | | | |
| Net plan assets | | | | | | | $ | | | | | | | | | | $ | | |
%), debt securities (%) and other investments (%).
Contributions and Estimated Future Benefit Payments
The Company's estimated annual contributions and future benefits payments are not expected to be material.
Savings Plans
The principal defined contribution plan is the Bristol-Myers Squibb Savings and Investment Program. The contributions are based on employee contributions and the level of Company match. The U.S. defined contribution plan expense was approximately $ million in 2023, $ million in 2022 and $ million in 2021.
Note 19.
million shares to be authorized for grants plus shares recaptured upon forfeitures or other terminations of awards under our previous equity awards plans, subject to adjustments in accordance with the terms of the 2021 Plan. As of December 31, 2023, million shares were available for award and million equity awards were outstanding (stock options, RSUs, MSUs and PSUs). Shares generally are issued from treasury stock to satisfy BMS’s obligations under the 2021 Plan and our prior equity award plans.
Under the 2021 Plan, executive officers and other employees may be granted options to purchase common stock at no less than the market price on the date the option is granted. Options generally become exercisable ratably over and have a maximum term of years. The 2021 Plan provides for the granting of SARs whereby the grantee may surrender exercisable rights and receive common stock and/or cash measured by the excess of the market price of the common stock over the award's exercise price. BMS did not grant stock options or SARs during the years ended December 31, 2023, 2022 and 2021. Options that were outstanding during those years generally vested ratably over (some options granted as replacements for options held by Celgene option holders upon the acquisition of Celgene in 2019 provided for cliff vesting and/or longer or shorter vesting periods).
period from grant date, subject to accelerated vesting in specified circumstances. A stock unit is a right to receive stock at the end of the specified vesting and/or deferral period; stock units have no voting rights. BMS grants non-forfeitable stock units to its non-employee directors.
MSUs are granted to executive officers. Vesting is conditioned upon continuous employment and occurs ratably over , subject to accelerated vesting in specified circumstances. The number of shares issued upon vesting of MSUs is determined based on a specified payout factor requiring that the market price per share at a specified measurement date be at least % of the grant-date share price (market condition) for awards granted in 2023 (% prior to 2022). Attainment of a higher payout factor, calculated as the share price on measurement date divided by share price on award date, results in a higher percentage payout of MSUs, up to a maximum of % of the target number of MSUs for awards granted in 2023 (% prior to 2022). The share price used in the payout factor is calculated using an average of the closing prices on the grant date or measurement date, and the nine trading days immediately preceding the grant date or measurement date.
PSUs are granted to executive officers, have a performance cycle and are granted as a target number of stock units subject to adjustment. The number of shares issued when PSUs vest is determined based on the achievement of specified performance goals (a performance condition) and based on BMS’s relative total shareholder return compound annual growth rate relative to a peer group of companies (a market condition) for awards granted in 2023 ( total shareholder return relative to a peer group of companies prior to 2023) and can range from % to a maximum of % of the target number of PSUs. Vesting is conditioned upon continuous employment and occurs on the third anniversary of the grant date, subject to accelerated vesting in specified circumstances.
Stock-based compensation expense for awards ultimately expected to vest is recognized over the vesting period. Forfeitures are estimated based on historical experience at the time of grant and revised in subsequent periods if actual forfeitures differ from those estimates.
| | $ | | | | $ | | | | Marketing, selling and administrative | | | | | | | | |
| Research and development | | | | | | | | |
| Other (income)/expense, net | | | | | | | | |
| Total stock-based compensation expense | $ | | | | $ | | | | $ | | |
| | | | | |
Income tax benefit(a) | $ | | | | $ | | | | $ | | |
(a) Income tax benefit excludes excess tax benefits from share-based compensation awards that were vested or exercised of $ million in 2023, $ million in 2022 and $ million in 2021.
| | $ | | | | | | | $ | | | | | | | $ | | | | | | | $ | | | | Granted | | | | | | | | | | | | | | | | | | | | | | | |
| Released/Exercised | () | | | | | | () | | | | | | () | | | | | | () | | | | |
| Adjustments for actual payout | | | | | | | | | | | | | | | | | | | | | | | |
| Forfeited/Canceled | () | | | | | | () | | | | | | () | | | | | | () | | | | |
| Balance at December 31, 2023 | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| Expected to vest | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| Dollars in millions | Restricted Stock Units | | Market Share Units | | Performance Share Units |
| Unrecognized compensation cost | $ | | | | $ | | | | $ | | |
| Expected weighted-average period in years of compensation cost to be recognized | | | | | |
| | | $ | | | | MSUs | | | | | | |
| PSUs | | | | | | |
| | | | | |
| Fair value of awards that vested: | | | | | |
| RSUs - replacement awards | $ | | | | $ | | | | $ | | |
| RSUs | | | | | | | | |
| MSUs | | | | | | | | |
| PSUs | | | | | | | | |
| | | | | |
| Total intrinsic value of stock options exercised | | | | | | | | |
The fair value of RSUs approximates the closing market price of BMS’s common stock on the grant date after adjusting for the units not eligible for accrual of dividend equivalents. The fair value of MSUs is estimated as of the grant date using a Monte Carlo simulation. The fair value of PSUs is estimated as of the grant date for the portion related to the relative total shareholder return measure, using a Monte Carlo simulation and, for the remaining portion, based on the closing market price of BMS’s common stock on the grant date after adjusting for the units not eligible for accrual of dividend equivalents, and taking into account the probability of satisfying the performance condition as of the grant date.
- $ | | | | | $ | | | | $ | | | $ - $ | | | | | | | | | | |
$ - $ | | | | | | | | | | |
$ + | | | | | | | | | | |
| Outstanding | | | | | | | | | $ | | |
| Exercisable | | | | | | | | | $ | | |
The aggregate intrinsic value in the preceding table represents the total pretax intrinsic value, based on the closing stock price of $ on December 29, 2023, which was the last trading day of 2023.
Note 20.
million AUD ($ million), plus interest, which would be split between BMS and Sanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. BMS and Sanofi dispute that the Australian government is entitled to any damages. A trial was concluded in September 2017. In April 2020, the Federal Court issued a decision dismissing the Australian government's claim for damages. In May 2020, the Australian government appealed the Federal Court's decision and an appeal hearing concluded in February 2021. On June 26, 2023, the appeal court issued a ruling in BMS and Sanofi's favor, upholding the lower court's decision. In December 2023, the Australian government was granted leave to appeal the decision to the High Court of Australia.
FDA Orange Book-listed monohydrate form patents expiring in 2025 and 2026. In February 2022, BMS filed a patent infringement action against Xspray in the U.S. District Court for the District of New Jersey. In May 2022, BMS filed a patent infringement action against Nanocopoeia in the U.S. District Court for the District of Minnesota. In November 2022, BMS filed a patent infringement action against Handa in the U.S. District Court for the Northern District of California. On March 24, 2023, the Minnesota court denied a motion that Nanocopoeia had filed seeking a judgment based on the pleadings. On June 16, 2023, BMS entered into a confidential settlement agreement with Handa, settling all outstanding claims in the litigation. On September 13, 2023, BMS entered into a confidential settlement agreement with XSpray, settling all outstanding claims in the litigation. On October 10, 2023, BMS entered into a confidential settlement agreement with Nanocopoeia, settling all outstanding claims in the litigation. In October 2023, BMS filed a patent infringement action against Zydus in the U.S. District Court for the District of New Jersey.
Zeposia - U.S.
On October 15, 2021, Actelion Pharmaceuticals LTD and Actelion Pharmaceuticals US, INC ("Actelion") filed a complaint for patent infringement in the United States District Court for the District of New Jersey against BMS and Celgene for alleged infringement of U.S. Patent No. 10,251,867 (the "'867 Patent"). The Complaint alleges that the sale of Zeposia infringes certain claims of the '867 Patent and Actelion is seeking damages. No trial date has been scheduled.
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION
Plavix* State Attorneys General Lawsuits
BMS and certain Sanofi entities are defendants in a consumer protection action brought by the attorney general of Hawaii relating to the labeling, sales and/or promotion of Plavix*. In February 2021, a Hawaii state court judge issued a decision against Sanofi and BMS, imposing penalties in the total amount of $ million, with $ million attributed to BMS. Sanofi and BMS appealed the decision. On March 15, 2023, the Hawaii Supreme Court issued its decision, reversing in part and affirming in part the trial court decision, vacating the penalty award and remanding the case for a new trial and penalty determination. A new bench trial concluded on October 16, 2023, and a decision is pending.
PRODUCT LIABILITY LITIGATION
BMS is a party to various product liability lawsuits. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. As previously disclosed, in addition to lawsuits, BMS also faces unfiled claims involving its products.
Abilify*
BMS and Otsuka are co-defendants in product liability litigation related to Abilify*. Plaintiffs allege Abilify* caused them to engage in compulsive gambling and other impulse control disorders. Cases were filed in state and federal courts in the United States. Pursuant to a previously disclosed master settlement agreement and settlement related court orders, the vast majority of the cases in the United States. were resolved or dismissed. inactive cases remain pending in state courts in New Jersey. There are also cases pending in Canada ( class actions and individual injury claims), of which are active (the certified class actions in Quebec and Ontario).
putative class actions were filed against Celgene and certain of its officers in the U.S. District Court for the District of New Jersey (the "Celgene Securities Class Action"). The complaints allege that the defendants violated federal securities laws by making misstatements and/or omissions concerning (1) trials of GED-0301, (2) Celgene's 2020 outlook and projected sales of Otezla*, and (3) the NDA for Zeposia. The Court consolidated the actions and appointed a lead plaintiff, lead counsel, and co-liaison counsel for the putative class. In February 2019, the defendants filed a motion to dismiss plaintiffs' amended complaint in full. In December 2019, the Court denied the motion to dismiss in part and granted the motion to dismiss in part (including all claims arising from alleged misstatements regarding GED-0301). Although the Court gave the plaintiff leave to re-plead the dismissed claims, it elected not to do so, and the dismissed claims are now dismissed with prejudice. In November 2020, the Court granted class certification with respect to the remaining claims. In March 2023, the Court granted the defendants leave to file a motion for summary judgment, the briefing for which was completed in June 2023. On September 8, 2023, the Court granted in part and denied in part defendants' motion for summary judgment as to the claims regarding statements made by the remaining officer defendants. As to the claims regarding Celgene’s corporate statements, the Court denied the defendants’ motion without prejudice and granted the defendants leave to re-raise the issue. On October 27, 2023, the defendants filed a motion for partial summary judgment as to Celgene’s corporate statements.
In April 2020, certain Schwab management investment companies on behalf of certain Schwab funds filed an individual action in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action against the same remaining defendants in that action (the "Schwab Action"). In July 2020, the defendants filed a motion to dismiss the plaintiffs' complaint in full. In March 2021, the Court granted in part and denied in part defendants' motion to dismiss consistent with its decision in the Celgene Securities Class Action.
The California Public Employees' Retirement System in April 2021 (the "CalPERS Action"); DFA Investment Dimensions Group Inc., on behalf of certain of its funds; and American Century Mutual Funds, Inc., on behalf of certain of its funds, in July 2021 (respectively the "DFA Action" and the "American Century Action"), and GIC Private Limited in September 2021 (the "GIC Action"), filed separate individual actions in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action and the Schwab individual action against the same remaining defendants in those actions. In October 2021, these actions were consolidated for pre-trial proceedings with the Schwab Action. The Court also consolidated any future direct actions raising common questions of law and fact with the Schwab Action (the "Consolidated Schwab Action"). On October 2, 2023, defendants filed a motion for partial summary judgment in the Consolidated Schwab Action.
No trial dates have been scheduled in any of the above Celgene Securities Litigations.
Contingent Value Rights Litigations
In June 2021, an action was filed against BMS in the U.S. District Court for the Southern District of New York asserting claims of alleged breaches of a Contingent Value Rights Agreement ("CVR Agreement") entered into in connection with the closing of BMS's acquisition of Celgene Corporation in November 2019. An entity claiming to be the successor trustee under the CVR Agreement alleges that BMS breached the CVR Agreement by allegedly failing to use "diligent efforts" to obtain FDA approval of liso-cel (Breyanzi) before a contractual milestone date, thereby allegedly avoiding a $ billion potential obligation to holders of the contingent value rights governed by the CVR Agreement and by allegedly failing to permit inspection of records in response to a request by the alleged successor trustee. The plaintiff seeks damages in an amount to be determined at trial and other relief, including interest and attorneys' fees. BMS disputes the allegations. BMS filed a motion to dismiss the alleged successor trustee's complaint for failure to state a claim upon which relief can be granted, which was denied on June 24, 2022. On February 2, 2024, BMS filed a motion to dismiss the complaint for lack of subject matter jurisdiction.
separate putative classes, of acquirers of CVRs and of acquirers of BMS common stock, for violations of sections 11(a), 12(a)(2), and 15 of the Securities Act. The complaint alleges that the registration statement filed in connection with the proposed merger transaction between Celgene and BMS was materially false or misleading because it failed to disclose that allegedly BMS had no intention at the time to obtain FDA approval for liso-cel (Breyanzi) by the contractual milestone date. The complaint asserts claims against BMS, the members of its board of directors at the time of the joint proxy statement, certain BMS officers who signed the registration statement and Celgene's former chairman and chief executive officer. Defendants moved to stay the action pending resolution of the federal action and, in the alternative, to dismiss the complaint. On February 17, 2023, the Court granted defendants' motion to stay and declined to reach the merits of defendants' motion to dismiss. On October 9, 2023, the plaintiff filed a motion to vacate the stay.
No trial dates have been scheduled in any of the above CVR Litigations.
OTHER LITIGATION
IRA Litigation
On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA. That program requires pharmaceutical companies, like BMS, under the threat of significant penalties, to sell certain of their medicines at government-dictated prices. On August 29, 2023, the government selected Eliquis for this program. In its lawsuit, BMS argues that this program violates the Fifth Amendment, which requires the government to pay just compensation if it takes property for public use, by requiring pharmaceutical manufacturers to provide medicines to third parties at prices set by the government that necessarily fall below fair market value. BMS also argues that this program violates the First Amendment right to free speech by requiring manufacturers to state that they agree that the price set by the government is the medicine's "maximum fair price" as determined by negotiation, even though there is no true negotiation. On August 16, 2023, BMS filed a motion for summary judgment. On October 16, 2023, the government filed an opposition to BMS’s motion for summary judgment and a cross-motion for summary judgment.
of Molina’s claims, which Molina later reasserted in the District of New Jersey as described above, and stayed the remaining claims. No activity is expected in this case until disposition of the New Jersey actions.
Certain other entities that opted out of the now‑settled class action have also filed summonses related to actions in the Philadelphia County Court of Common Pleas in connection with the allegations made by Humana and other opt‑out entities. Those actions have been placed in deferred status pending further developments in the above opt‑out cases.
In November 2022, certain specialty pharmacies filed an action as direct purchasers against Celgene, BMS, and certain generic manufacturers in the U.S. District Court for the District of New Jersey. The action makes largely the same claims and allegations against Celgene and BMS as were made with respect to Revlimid in the now settled class action litigation, and seek injunctive relief and damages under the Sherman Antitrust Act. Also in November 2022, a putative class of end-payor plaintiffs filed an action against Celgene, BMS, and certain generic manufacturers in the U.S. District Court for the District of New Jersey. The class complaint brings claims based on Celgene's allegedly anticompetitive settlements of Revlimid patent litigation, seeking damages under state antitrust and consumer protection laws and injunctive relief under federal antitrust law. Celgene, BMS and the generic defendants have filed consolidated motions to dismiss these actions. The motions were fully briefed in May 2023 and administratively terminated in November 2023 pending a ruling on Celgene and BMS's motion to dismiss the Humana amended complaint. No trial dates have been scheduled.
healthcare systems—the Mayo Clinic, LifePoint Corporate Services, G.P. and Intermountain Health, Inc.—filed new lawsuits against Celgene, BMS and certain generic manufacturers making largely the same claims and allegations against Celgene and BMS as were made with respect to Revlimid in the now-settled class action litigation, and seeking injunctive relief and damages under the Sherman Antitrust Act and parallel state laws. Those actions are pending in the U.S. District Court for the District of New Jersey. No trial dates have been scheduled.
MSK Contract Litigation
On April 1, 2022, Memorial Sloan Kettering Cancer Center and Eureka Therapeutics, Inc. (collectively, "Plaintiffs") filed a complaint against BMS, Celgene and Juno (collectively, "Defendants"). In June 2022, Plaintiffs filed an amended complaint. Plaintiffs allege that Defendants breached a license agreement by allegedly failing to use commercially reasonable efforts to develop, manufacture, and commercialize a certain chimeric antigen receptor product and by failing to pay Plaintiffs a running royalty of at least % of worldwide sales of Abecma allegedly owed to Plaintiffs under the license agreement. Defendants disagree with plaintiffs' claims, and filed a motion to dismiss the amended complaint in July 2022. On January 24, 2024, the Court granted Defendants’ motion to dismiss as to BMS and Celgene, removing them from the case. The case against Juno will continue. No trial date has been scheduled.
Pomalyst Antitrust Class Action
In September 2023, certain health plan entities filed an action on behalf of a putative class of end-payor plaintiffs against Celgene, BMS, and certain generic pharmaceutical manufacturers in the U.S. District Court for the Southern District of New York. The class complaint asserts claims under federal antitrust law and state antitrust, consumer protection, and unjust enrichment laws based on allegations that Celgene and BMS engaged in anticompetitive conduct related to pomalidomide in the U.S., including by allegedly engaging in fraud before the USPTO in the acquisition of patents related to the use of pomalidomide, by filing alleged sham patent litigations against generic pharmaceutical companies seeking to market generic pomalidomide, and by entering into allegedly unlawful patent litigation settlements with certain generic pharmaceutical companies seeking to market generic pomalidomide. In December 2023, the plaintiffs filed an amended complaint that added individual Pomalyst patient as a plaintiff, removed the generic manufacturer defendants, and added individuals as defendants. No trial date has been scheduled.
GOVERNMENT INVESTIGATIONS
Like other pharmaceutical companies, BMS and certain of its subsidiaries are subject to extensive regulation by national, state and local authorities in the U.S. and other countries in which BMS operates. As a result, BMS, from time to time, is subject to various governmental and regulatory inquiries and investigations as well as threatened legal actions and proceedings. It is possible that criminal charges, substantial fines and/or civil penalties, could result from government or regulatory investigations.
ENVIRONMENTAL PROCEEDINGS
As previously reported, BMS is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreign laws, including CERCLA, for certain costs of investigating and/or remediating contamination resulting from past industrial activity at BMS's current or former sites or at waste disposal or reprocessing facilities operated by third parties.
CERCLA and Other Remediation Matters
With respect to CERCLA and other remediation matters for which BMS is responsible under various state, federal and international laws, BMS typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other "potentially responsible parties," and BMS accrues liabilities when they are probable and reasonably estimable. BMS estimated its share of future costs for these sites to be $ million as of December 31, 2023, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties). The amount includes the estimated costs for any additional probable loss associated with the previously disclosed North Brunswick Township High School Remediation Site.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Bristol-Myers Squibb Company
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Bristol-Myers Squibb Company and subsidiaries (the "Company") as of December 31, 2023 and 2022, the related consolidated statements of earnings, comprehensive income, and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 12, 2024, expressed an unqualified opinion on the Company's internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Gross-to-Net U.S. Rebate Accruals for U.S. Medicaid, Medicare Part D, and managed healthcare — Refer to “Note 2 – Revenue” to the financial statements
Critical Audit Matter Description
As more fully disclosed in Note 2 to the financial statements, the Company reduces gross product sales from list price at the time revenue is recognized for expected charge-backs, discounts, rebates, sales allowances and product returns, which are referred to as gross-to-net (“GTN”) adjustments. These reductions are attributed to various commercial arrangements, managed healthcare organizations, and government programs that mandate various reductions from list price. Charge-backs and cash discounts are reflected as a reduction to receivables and settled through the issuance of credits to the customer. All other rebates, discounts and adjustments, are reflected as a liability and settled through cash payments.
Certain of the GTN liabilities related to U.S. Medicaid, Medicare Part D, and managed healthcare organizations rebate programs (the “GTN U.S. rebate accruals”) involve the use of significant assumptions and judgments in their calculation. These significant assumptions and judgments include consideration of legal interpretations of applicable laws and regulations, historical claims experience, payer channel mix, current contract prices, unbilled claims, claims submission time lags, and inventory levels in the distribution channel.
Given the complexity involved in determining the significant assumptions used in calculating certain GTN U.S. rebate accruals, auditing these estimates involved especially subjective judgment.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to GTN U.S. rebate accruals included the following, among others:
◦We evaluated the appropriateness and consistency of the Company’s methods and assumptions used to calculate GTN U.S. rebate accruals.
◦We tested the effectiveness of internal controls over the review of the Company’s estimation model, including underlying assumptions and key inputs into the Company’s process to calculate GTN U.S. rebate accruals.
◦We tested the mathematical accuracy of GTN U.S. rebate accruals.
◦We tested significant assumptions and key inputs used to calculate GTN U.S. rebate accruals.
◦We evaluated the Company’s ability to estimate GTN U.S. rebate accruals accurately by comparing actual amounts incurred for GTN U.S. rebate accruals to historical estimates.
◦We tested the overall reasonableness of the GTN U.S. rebate accruals recorded at period end by developing an expectation for comparison to actual recorded balances.
◦We involved audit professionals with industry and quantitative analytics experience to assist us in performing our auditing procedures.
Taxes — Unrecognized Tax Benefit Liabilities for U.S. Transfer Pricing — Refer to “Note 7- Income Taxes” to the financial statements
Critical Audit Matter Description
As more fully disclosed in Note 7 to the financial statements, the Company recognizes certain income tax benefits associated with transactions between its U.S. operating companies and related foreign affiliates. These income tax benefits are estimated based on transfer pricing agreements, third-party transfer pricing studies, and the Company’s judgment as to whether it is more-likely-than-not the benefits will be realized. Tax benefits that may not ultimately be realized by the Company, as determined by its judgment, are accrued for as unrecognized tax benefit liabilities. The amounts recognized as unrecognized tax benefit liabilities related to U.S. transfer pricing may be significantly affected in subsequent periods due to various factors, such as changes in tax law, identification of additional relevant facts, or a change in the Company’s judgment regarding measurement of the tax benefits upon ultimate settlement with the taxing authorities.
Given the complexity associated with significant assumptions used and judgments made to calculate unrecognized tax benefit liabilities related to U.S. transfer pricing auditing these estimates involved especially subjective judgment.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to unrecognized tax benefit liabilities related to U.S. transfer pricing included the following, among others:
◦We evaluated the appropriateness and consistency of the Company’s methods and assumptions used in the identification, recognition, measurement, and disclosure of unrecognized tax benefit liabilities.
◦We tested the effectiveness of internal controls over the review of the underlying assumptions and key inputs into the Company’s process to calculate unrecognized tax benefit liabilities.
◦We obtained an understanding of the Company’s related party transactions and transfer pricing policies.
◦We tested the mathematical accuracy of the unrecognized tax benefit liabilities.
◦We tested the completeness of unrecognized tax benefit liabilities.
◦We tested the reasonableness of the underlying tax positions and amounts accrued for a selection of unrecognized tax benefit liabilities by reviewing the Company’s evaluation of the relevant facts and tax law associated with the tax position, and testing the significant assumptions and inputs used to calculate the unrecognized tax benefit liabilities by reference to third party data, information produced by the entity, our understanding of transfer pricing principles and tax laws, and inquires of management.
◦We evaluated whether the Company had appropriately considered new information that could significantly change the recognition, measurement or disclosure of the unrecognized tax benefit liabilities.
◦We involved income tax specialists and audit professionals with industry experience to assist us in performing our auditing procedures.
/s/
February 12, 2024
We have served as the Company's auditor since 2006.
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| Item 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. |
None.
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| Item 9A. | CONTROLS AND PROCEDURES. |
Evaluation of Disclosure Controls and Procedures
As of December 31, 2023, management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by this 2023 Form 10-K. Based on this evaluation, management has concluded that as of December 31, 2023, such disclosure controls and procedures were effective.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of management, including the chief executive officer and chief financial officer, management assessed the effectiveness of internal control over financial reporting as of December 31, 2023 based on the framework in “Internal Control—Integrated Framework” (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on that assessment, management has concluded that the Company’s internal control over financial reporting was effective at December 31, 2023 to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of its financial statements for external purposes in accordance with United States generally accepted accounting principles. Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Deloitte & Touche LLP, an independent registered public accounting firm, has audited the Company’s financial statements included in this report on this 2023 Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, 2023, which is included herein.
Changes in Internal Control Over Financial Reporting
There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, 2023 that have materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
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| Item 9B. | OTHER INFORMATION. |
During the fourth quarter of 2023, no director or officer of the Company or an active "Rule 10b5-1 trading
arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.
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| Item 9C. | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. |
Not applicable.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Bristol-Myers Squibb Company
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company and our report dated February 12, 2024, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/
February 12, 2024
PART III
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| Item 10. | DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE. |
(a)Reference is made to our 2024 Proxy Statement section "Who We Are: 2024 Director Nominees" with respect to information relating to our Directors, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
(b)The information required by Item 10 with respect to our Executive Officers has been included in Part IA of this 2023 Form 10-K in reliance on General Instruction G of Form 10-K and Instruction 3 to Item 401(b) of Regulation S-K, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
(c)Reference is made to our 2024 Proxy Statement section “How We Govern and Are Governed – Codes of Conduct” with respect to our code of ethics, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
(d)Reference is made to our 2024 Proxy Statement section “How We Are Selected and Elected – Director Succession Planning and Identification of Board Candidates – Shareholder Nominations for Director” with respect to procedures by which shareholders can recommend nominees to our board of directors, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
(e)Reference is made to our 2024 Proxy Statement section “How We Are Organized – Committees of Our Board” with respect to our audit committee, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
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| Item 11. | EXECUTIVE COMPENSATION. |
(a)Reference is made to our 2024 Proxy Statement section “Executive Compensation,” which is incorporated herein by reference and made a part hereof in response to the information required by Item 11, except that the information under “Executive Compensation – Pay Versus Performance” will not be deemed to be incorporated by reference herein.
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| Item 12. | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS. |
(a)Reference is made to our 2024 Proxy Statement “Voting Securities and Principal Holders – Common Stock Ownership by Directors and Executive Officers” with respect to the security ownership of certain beneficial owners and management, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.
(b)Reference is made to our 2024 Proxy Statement section “Items To Be Voted Upon – Equity Compensation Plan Information” with respect to the securities authorized for issuance under equity compensation plans, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.
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| Item 13. | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE. |
(a)Reference is made to our 2024 Proxy Statement section “How We Govern and Are Governed – Related Party Transactions” with respect to certain relationships and related transactions, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.
(b)Reference is made to our 2024 Proxy Statement section “How We Are Selected and Elected – Director Independence” with respect to director independence, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.
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| Item 14. | PRINCIPAL ACCOUNTANT FEES AND SERVICES. |
Reference is made to our 2024 Proxy Statement sections “Items To Be Voted Upon – Audit and Non-Audit Fees” and “Items To Be Voted Upon – Pre-Approval Policy for Services Provided by our Independent Registered Public Accounting Firm” with respect to the aggregate fees billed to us and services provided by our principal accountant, Deloitte & Touche LLP (PCAOB ID No. ), which are incorporated herein by reference and made a part hereof in response to the information required by Item 14.
PART IV
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| Item 15. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULE. |
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| (a) | | |
| | | Page Number |
| 1 | Consolidated Financial Statements | |
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| 2. | Financial Statement Schedules | |
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| All other schedules not included with this additional financial data are omitted because they are not applicable or the required information is included in the financial statements or notes thereto. |
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| 3. | Exhibits | |
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2023 Form 10-K.
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2023 Form 10-K.
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| Item 16. | FORM 10-K SUMMARY. |
None.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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BRISTOL-MYERS SQUIBB COMPANY (Registrant) |
| |
| By | | /s/ CHRISTOPHER BOERNER, Ph.D. |
| | | Christopher Boerner, Ph.D. |
| | | Chief Executive Officer |
|
Date: February 13, 2024 |
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
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| Signature | | Title | | Date |
| | | | |
/s/ CHRISTOPHER BOERNER, Ph.D. | | Chief Executive Officer | | February 13, 2024 |
(Christopher Boerner, Ph.D.) | | (Principal Executive Officer) | | |
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| /s/ DAVID V. ELKINS | | Chief Financial Officer | | February 13, 2024 |
| (David V. Elkins) | | (Principal Financial Officer) | | |
| | | | |
| /s/ SHARON GREENLEES | | Senior Vice President and Corporate Controller | | February 13, 2024 |
| (Sharon Greenlees) | | (Principal Accounting Officer) | | |
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| /s/ GIOVANNI CAFORIO, M.D. | | Executive Chairman of the Board | | February 13, 2024 |
| (Giovanni Caforio, M.D.) | | | | |
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| /s/ PETER J. ARDUINI | | Director | | February 13, 2024 |
| (Peter J. Arduini) | | | | |
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| /s/ DEEPAK L. BHATT. M.D. MPH | | Director | | February 13, 2024 |
| (Deepak L. Bhatt, M.D. MPH) | | | | |
| /s/ JULIA A. HALLER, M.D. | | Director | | February 13, 2024 |
| (Julia A. Haller, M.D.) | | | | |
| | | | |
| /s/ MANUEL HIDALGO MEDINA, M.D., Ph.D. | | Director | | February 13, 2024 |
| (Manuel Hidalgo Medina, M.D., Ph.D.) | | | | |
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| /s/ PAULA A. PRICE | | Director | | February 13, 2024 |
| (Paula A. Price) | | | | |
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| /s/ DERICA W. RICE | | Director | | February 13, 2024 |
| (Derica W. Rice) | | | | |
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| /s/ THEODORE R. SAMUELS | | Director | | February 13, 2024 |
| (Theodore R. Samuels) | | | | |
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| /s/ GERALD L. STORCH | | Director | | February 13, 2024 |
| (Gerald L. Storch) | | | | |
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| /s/ KAREN H. VOUSDEN, Ph.D. | | Director | | February 13, 2024 |
| (Karen H. Vousden, Ph.D.) | | | | |
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| /s/ PHYLLIS R. YALE | | Director | | February 13, 2024 |
| (Phyllis R. Yale) | | | | |
SUMMARY OF ABBREVIATED TERMS
Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol Myers Squibb, BMS, the Company, we, our or us in this 2023 Form 10-K, unless the context otherwise indicates. Throughout this 2023 Form 10-K, we have used terms which are defined below:
| | | | | | | | | | | |
| 2023 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2023 | MAA | Marketing Authorization Application |
| 2021 Plan | 2021 Stock Award and Incentive Plan | MCOs | Managed Care Organizations |
| 2seventy bio | 2seventy bio, Inc. | MDL | multi-district litigation |
| 340B Program | 340B Drug Pricing Program | MDS | myelodysplastic syndromes |
| AbbVie | AbbVie Inc. | MF | myelofibrosis |
| Agenus | Agenus Inc. | MPM | Malignant Pleural Mesothelioma |
| aGVHD | acute graft-versus-host disease | MSI-H | high microsatellite instability |
| Amgen | Amgen Inc. | Mead Johnson | Mead Johnson Nutrition Company |
| Amylin | Amylin Pharmaceuticals, Inc. | Merck | Merck & Co., Inc. |
| ANDA | abbreviated New Drug Application | Mirati | Mirati Therapeutics, Inc. |
| AstraZeneca | AstraZeneca PLC | MyoKardia | MyoKardia, Inc. |
| ASC | Accounting Standards Codification | NAV | net asset value |
| ASR | Accelerated Share Repurchase | NDA | New Drug Application |
| BCMA | B-cell maturation antigen | NKT | natural killer T |
| Biogen | Biogen, Inc. | Nimbus | Nimbus Therapeutics, LLC |
| Biohaven | Biohaven Pharmaceutical Holding Company Ltd. | Novartis | Novartis Pharmaceutical Corporation |
| BLA | Biologics License Application | NSCLC | non-small cell lung cancer |
| BridgeBio | BridgeBio Pharma Inc. | NVAF | non-valvular atrial fibrillation |
| CAR-T | Chimeric Antigen Receptor T cells | OCE | Oncology Center of Excellence |
| Celgene | Celgene Corporation acquired by BMS on November 20, 2019 | OECD | Organization for Economic Co-operation and Development |
| CERCLA | U.S. Comprehensive Environmental Response, Compensation and Liability Act | OIG | Office of Inspector General of the U.S. Department of Health and Human Services |
| cGMP | current Good Manufacturing Practices | Orum | Orum Therapeutics |
| Cheplapharm | Cheplapharm Arzneimittel GmbH | OTC | over-the-counter |
CHMP | Committee for Medicinal Products for Human Use | Ono | Ono Pharmaceutical Co., Ltd. |
| CML | chronic myeloid leukemia | Otsuka | Otsuka Pharmaceutical Co., Ltd. |
CLL | Chronic lymphocytic leukemia | PBMs | Pharmacy Benefit Managers |
| COSO | Committee of Sponsoring Organizations of the Treadway Commission | PBRGs | People and Business Resource Groups |
| CRC | colorectal cancer | PCAOB | Public Company Accounting Oversight Board |
| DMC | Data Monitoring Committee | PD-1 | programmed death receptor-1 |
| Dragonfly | Dragonfly Therapeutics, Inc. | PDMA | Prescription Drug Marketing Act |
| DSA | Distribution Services Agreement | PDUFA | Prescription Drug User Fee Act |
| EC | European Commission | Pfizer | Pfizer, Inc. |
| EGFR | estimated glomerular filtration rate | Prothena | Prothena Corporation |
| Eisai | Eisai Co., Ltd. | PhRMA Code | Pharmaceutical Research and Manufacturers of America’s Professional Practices Code |
| EMA | European Medicines Agency | PRP | potentially responsible party |
| EPO | European Patent Office | PsA | psoriatic arthritis |
| EPS | earnings per share | PTR | patent term restoration |
| ESA | erythoropoiesis-stimulating agent | R&D | research and development |
| Evotec | Evotec SE | RA | rheumatoid arthritis |
| EU | except as otherwise noted, EU refers to the countries that are members of the European Union plus the United Kingdom | RayzeBio | RayzeBio, Inc. |
| FASB | Financial Accounting Standards Board | RCC | renal cell carcinoma |
| FDA | U.S. Food and Drug Administration | RDP | Regulatory Data Protection |
| FL | follicular lymphoma | REMS | Risk Evaluation and Mitigation Strategy |
| GAAP | U.S. generally accepted accounting principles | ROS1 | c-ros oncogene 1 |
| Gilead | Gilead Sciences, Inc. | Roche | Roche Holding AG |
| GILTI | global intangible low taxed income | Sanofi | Sanofi S.A. |
| GlaxoSmithKline | GlaxoSmithKline PLC | sBLA | supplemental Biologics License Application |
| GTN | gross-to-net | SEC | U.S. Securities and Exchange Commission |
| Halozyme | Halozyme Therapeutics, Inc. | SLE | systemic lupus erythematosus |
| HCM | hypertrophic cardiomyopathy | SOFR | Secured Overnight Financing Rate |
IMDC | International Metastatic Renal Cell Carcinoma Database Consortium | SPC | Supplementary Protection Certificate |
| Immatics | Immatics N.V. | Takeda | Takeda Pharmaceutical Company Limited |
| IO | immuno-oncology | TCJA | the Tax Cuts and Jobs Act of 2017 |
| IPRD | in-process research and development | UC | ulcerative colitis |
| IRS | Internal Revenue Services | U.S. | United States |
| JIA | Juvenile Idiopathic Arthritis | UK | United Kingdom |
| Lilly | Eli Lilly and Company | VAT | value added tax |
| LOE | loss of exclusivity | WTO | World Trade Organization |
| Karuna | Karuna Therapeutics, Inc. | | |
| |
EXHIBIT INDEX
The Exhibits listed below are identified by numbers corresponding to the Exhibit Table of Item 601 of Regulation S-K. The Exhibits designated by the symbol ‡‡ are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15. The symbol ‡ in the Page column indicates that the Exhibit has been previously filed with the Commission and is incorporated herein by reference. Unless otherwise indicated, all Exhibits are part of Commission File Number 1-1136.
| | | | | | | | | | | | | | |
| Exhibit No. | | Description | | Page No |
| 2. | | | | ‡ |
| | | | |
| 3a. | | | | ‡ |
| | | | |
| 3b. | | | | ‡ |
| | | | |
| 3c. | | | | ‡ |
| | | | |
| 3d. | | | | ‡ |
| | | | |
| 3e. | | | | ‡ |
| | | | |
| 3f. | | | | ‡ |
| | | | |
| 4a. | | | | ‡ |
| | | | |
| 4b. | | Letter of Agreement dated March 28, 1984 (incorporated herein by reference to Exhibit 4 to the Form 10-K for the fiscal year ended December 31, 1983). | | ‡ |
| | | | |
| 4c. | | | | ‡ |
| | | | |
4d. | | | | ‡ |
| | | | |
4e. | | | | ‡ |
| | | | |
4f. | | | | ‡ |
| | | | |
4g. | | | | ‡ |
| | | | |
4h. | | | | ‡ |
| | | | |
4i. | | | | ‡ |
| | | | |
4j. | | | | ‡ |
| | | | |
4k. | | | | ‡ |
| | | | |
4l. | | | | ‡ |
| | | | |
| | | | | | | | | | | | | | |
4m. | | | | ‡ |
| | | | |
4n. | | | | ‡
|
| | | | |
4o. | | | | ‡
|
| | | | |
4p. | | | | ‡
|
| | | | |
4q. | | | | ‡
|
| | | | |
4r. | | | | ‡
|
| | | | |
4s. | | | | ‡
|
| | | | |
4t. | | | | ‡
|
| | | | |
4u. | | | | ‡
|
| | | | |
4v. | | | | ‡
|
| | | | |
4w. | | | | ‡
|
| | | | |
4x. | | | | ‡
|
| | | | |
4y. | | | | ‡
|
| | | | |
4z. | | | | ‡
|
| | | | |
4aa. | | | | ‡
|
| | | | |
4bb. | | | | ‡
|
| | | | |
4cc. | | | | ‡
|
| | | | |
4dd. | | | | ‡
|
| | | | |
4ee. | | | | ‡
|
| | | | |
4ff. | | | | ‡
|
| | | | |
4gg. | | | | ‡
|
| | | | |
4hh. | | | | ‡
|
| | | | |
4ii. | | | | ‡
|
| | | | |
| | | | | | | | | | | | | | |
4jj. | | | | ‡
|
| | | | |
4kk. | | | | ‡
|
| | | | |
4ll. | | | | ‡ |
| | | | |
4mm. | | | | ‡ |
| | | | |
4nn. | | | | ‡ |
| | | | |
4oo. | | | | ‡ |
| | | | |
4pp. | | | | ‡ |
| | | | |
4qq. | | | | ‡ |
| | | | |
4rr. | | | | ‡ |
| | | | |
4ss. | | | | ‡ |
| | | | |
4tt. | | | | ‡ |
| | | | |
4uu. | | | | ‡ |
| | | | |
4vv. | | | | ‡ |
| | | | |
4ww. | | | | ‡ |
| | | | |
4xx. | | | | ‡ |
| | | | |
4yy. | | | | ‡ |
| | | | |
4zz. | | | | ‡ |
| | | | |
4aaa. | | | | ‡ |
| | | | |
4bbb. | | | | ‡ |
| | | | |
| 10a. | | SEC Consent Order (incorporated herein by reference to Exhibit 10s to the Form 10-Q for the quarterly period ended September 30, 2004). | | ‡ |
| | | | |
| 10b. | | | | ‡ |
| | | | |
| | | | | | | | | | | | | | |
| 10c. | | | | ‡ |
| | | | |
| 10d. | | | | ‡ |
| | | | |
| ‡‡10e. | | | | ‡ |
| | | | |
‡‡10f. | | | | ‡ |
| | | | |
‡‡10g. | | | | ‡ |
| | | | |
‡‡10h. | | | | ‡ |
| | | | |
| ‡‡10i. | | | | E-10-1 |
| | | | |
| ‡‡10j. | | | | ‡ |
| | | | |
| ‡‡10k. | | | | ‡ |
| | | | |
| ‡‡10l. | | | | ‡ |
| | | | |
| ‡‡10m. | | | | ‡ |
| | | | |
| ‡‡10n. | | | | ‡ |
| | | | |
| ‡‡10o. | | | | ‡ |
| | | | |
| ‡‡10p. | | | | ‡ |
| | | | |
| ‡‡10q. | | | | ‡ |
| | | | |
| ‡‡10r. | | | | ‡ |
| | | | |
| ‡‡10s. | | | | ‡ |
| | | | |
| ‡‡10t. | | | | ‡ |
| | | | |
| | | | | | | | | | | | | | |
| ‡‡10u. | | | | ‡ |
| | | | |
‡‡10v. | | | | ‡ |
| | | | |
‡‡10w. | | | | ‡ |
| | | | |
| ‡‡10x. | | | | ‡ |
| | | | |
| ‡‡10y. | | | | ‡ |
| | | | |
| ‡‡10z. | | | | ‡ |
| | | | |
‡‡10aa. | | | | ‡ |
| | | | |
‡‡10bb. | | | | E-10-2 |
| | | | |
‡‡10cc. | | | | E-10-3 |
| | | | |
‡‡10dd. | | | | E-10-4 |
| | | | |
‡‡10ee. | | | | E-10-5 |
| | | | |
‡‡10ff. | | | | E-10-6 |
| | | | |
‡‡10gg. | | | | E-10-7 |
| | | | |
‡‡10hh. | | Bristol-Myers Squibb Company Performance Incentive Plan, as amended (as adopted, incorporated herein by reference to Exhibit 2 to the Form 10-K for the fiscal year ended December 31, 1978; as amended as of January 8, 1990, incorporated herein by reference to Exhibit 19b to the Form 10-K for the fiscal year ended December 31, 1990; as amended on April 2, 1991, incorporated herein by reference to Exhibit 19b to the Form 10-K for the fiscal year ended December 31, 1991; as amended effective January 1, 1994, incorporated herein by reference to Exhibit 10d to the Form 10-K for the fiscal year ended December 31, 1993; and as amended effective January 1, 1994, incorporated herein by reference to Exhibit 10d to the Form 10-K for the fiscal year ended December 31, 1994). | | ‡ |
| | | | |
‡‡10ii. | | Bristol-Myers Squibb Company Executive Performance Incentive Plan effective January 1, 1997 (incorporated herein by reference to Exhibit 10b to the Form 10-K for the fiscal year ended December 31, 1996). | | ‡ |
| | | | |
‡‡10jj. | | | | ‡ |
| | | | |
‡‡10kk. | | | | ‡ |
| | | | |
‡‡10ll. | | | | ‡ |
| | | | |
| | | | | | | | | | | | | | |
‡‡10mm. | | | | ‡ |
| | | | |
‡‡10nn. | | Squibb Corporation Supplementary Pension Plan, as amended (as previously amended and restated, incorporated herein by reference to Exhibit 19g to the Form 10-K for the fiscal year ended December 31, 1991; as amended as of September 14, 1993, and incorporated herein by reference to Exhibit 10g to the Form 10-K for the fiscal year ended December 31, 1993). | | ‡ |
| | | | |
‡‡10oo. | | | | ‡
|
| | | | |
‡‡10pp. | | | | ‡
|
| | | | |
‡‡10qq. | | Bristol-Myers Squibb Company Retirement Income Plan for Non-Employee Directors, as amended March 5, 1996 (incorporated herein by reference to Exhibit 10k to the Form 10-K for the fiscal year ended December 31, 1996). | | ‡ |
| | | | |
‡‡10rr. | | | | ‡ |
| | | | |
‡‡10ss. | | Bristol-Myers Squibb Company Non-Employee Directors’ Stock Option Plan, as amended (as approved by the Stockholders on May 2, 2000, incorporated herein by reference to Exhibit A to the 2000 Proxy Statement dated March 20, 2000). | | ‡ |
| | | | |
‡‡10tt. | | Squibb Corporation Deferral Plan for Fees of Outside Directors, as amended (as adopted, incorporated herein by reference to Exhibit 10e Squibb Corporation 1991 Form 10-K for the fiscal year ended December 31, 1987, File No. 1-5514; as amended effective December 31, 1991 incorporated herein by reference to Exhibit 10m to the Form 10-K for the fiscal year ended December 31, 1992). | | ‡ |
| | | | |
‡‡10uu. | | | | ‡ |
| | | | |
‡‡10vv. | | | | ‡ |
| | | | |
‡‡10ww. | | | | ‡ |
| | | | |
‡‡10xx. | | | | ‡ |
| | | | |
19. | | | | E-19-1 |
| 21. | | | | E-21-1 |
| | | | |
| 23. | | | | E-23-1 |
| | | | |
| 31a. | | | | E-31-1 |
| | | | |
| 31b. | | | | E-31-2 |
| | | | |
| 32a. | | | | E-32-1 |
| | | | |
| 32b. | | | | E-32-2 |
| | | | |
97. | | | | E-97 |
| | Compensation for Accounting Restatement | | |
| 101. | | The following financial statements from the Bristol-Myers Squibb Company Annual Report on Form 10-K for the years ended December 31, 2023, 2022 and 2021, formatted in Inline Extensible Business Reporting Language (XBRL): (i) consolidated statements of earnings, (ii) consolidated statements of comprehensive (loss)/income, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements. | | |
| | | | |
| 104. | | The cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 formatted in Inline XBRL. | | |
| | | | | |
| † | Confidential treatment has been granted for certain portions which are omitted in the copy of the exhibit electronically filed with the Commission. |
| | | | | |
| * | Indicates, in this 2023 Form 10-K, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Cabometyx is a trademark of Exelixis, Inc.; Farxiga and Onglyza are trademarks of AstraZeneca AB; Gleevec is a trademark of Novartis AG; Keytruda is a trademark of Merck Sharp & Dohme Corp.; Otezla is a trademark of Amgen Inc.; Plavix is a trademark of Sanofi; and Tecentriq is a trademark of Genentech, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries. |
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