Bristol Myers Squibb (BMY) 10-K risk factor changes: FY2024 vs FY2023
The 2024-12-31 10-K against the 2023-12-31 one, compared heading by heading and sentence by sentence.
Item 1A89 rewritten41 added19 removed170 unchanged
All filing items1,424 rewritten755 added715 removed2,499 unchanged
Summary
counted, not written
- Item 1A lists 34 risk factor headings: 4 new, 8 reworded and 22 unchanged since FY2023. 4 headings from FY2023 no longer appear.
- Sentence by sentence, 755 added, 715 removed, 1,424 rewritten and 2,499 unchanged across 20 items that differ.
New Item 1A headings (4)
- Commercialization launch delays are especially common when a product is expected to have a REMS program, as required by the FDA to address significant risk/benefit issues. Certain of our future key products may be required to be distributed in the U.S. through
- Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration. Additional clinical trials, head-to-head studies, real-world data analyses, adverse events reports following the use of our products
- stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.
- Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 29% of our revenues outside of the U.S. in 2024. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth. In addition, uncertainty in the credit and capital
Removed Item 1A headings (4)
- not meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations.
- and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.
- In addition, in the U.S., most of our products are distributed through wholesalers, and if one of these wholesalers should encounter financial or other difficulties, we might be unable to timely collect the amounts that the wholesaler owes us, which could negatively impact our results of operations.
- healthcare system could impose additional burdens on clinical trials, which could increase the costs of sponsoring clinical trials or lead to additional delays or difficulties with completing clinical trials. We may also experience additional pricing pressures and/or increased governmental regulation.
Reworded Item 1A headings (8)
- We may experience difficulties or delays in the development and commercialization of new products. Our ability to replace revenue from products that lose patent protection is directly dependent on our ability to successfully [added: develop and] commercialize new products in a timely manner.
- In addition, both the U.S. Congress and the
[removed: U.S.]FDA have taken steps to promote the development and approval of generic drugs and biosimilar biologics, including by providing generic and biosimilar developers a private right of action to obtain sufficient quantities of drug samples from the reference product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products. - There is no assurance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates disclosed in this
[removed: 2023][added: 2024] Form 10-K or that we assume when we provide our financial guidance. - We face intense competition from other [added: biopharmaceutical companies and] manufacturers and expect to see increasing market penetration of lower-priced generic products.
[removed: Adverse outcomes in legal][added: Legal] matters could negatively affect our business.[removed: Increased use][added: Use] of social media platforms[removed: presents][added: can present] risks and challenges.- We are dependent on information technology
[removed: systems][added: systems, including artificial intelligence programs,] and face risk of cybersecurity incidents that could disrupt our business and result in theft of[removed: proprietary and][added: proprietary,] confidential [added: and personal] information. - Failure to attract and retain [added: a] highly qualified workforce could affect our ability to successfully develop and commercialize products.
A heading is new when no FY2023 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
24 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2024; struck-through words were in FY2023. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS.
89 rewritten, 41 added, 19 removed, 170 unchanged
Our future revenues and profit margins could be negatively affected, including as a result of (i) changes in laws and regulations relating to the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of [removed: inflation, new discounts to fund a redesign of the Medicare Part D benefit,] [added: inflation] and government negotiations/price controls that may change the determination of the "best price" and establish a maximum allowed price/reimbursement rate), as well as other changes relating to federal healthcare programs, such as modifying the federal Anti-Kickback statute discount safe harbor and the IRA, which includes a number of provisions intended to lower the costs of some drugs covered under Medicare Part D and Medicare Part B and to limit Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit, (ii) cost-cutting measures by federal healthcare programs, such as Medicare and Medicaid, MCOs and other institutional and governmental purchasers, (iii) the grant of additional authority to governmental agencies to manage drug utilization and negotiate drug prices (including the implementation of the 2020 regulation issued by the U.S. federal government authorizing states and private parties to develop and implement programs to import certain prescription drugs from Canada and sell them in the U.S., and the American Rescue Plan Act of 2021, which eliminated the Medicaid Prescription Drug Rebate cap [removed: starting] [added: as of] January 1, 2024), (iv) expanded utilization [added: and pharmaceutical company restrictions] under the 340B Drug Pricing Program ("340B program"), (v) competition related to placements on applicable commercial and Medicare Part D formularies; (vi) changes to U.S. federal pharmaceutical coverage and reimbursement policies and practices, (vii) the increased [added: purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries, (viii) the increased] scrutiny of drug manufacturers (including any additional review of BMS or Celgene by the House Oversight and Reform Committee), [removed: (viii)] [added: (ix)] reimbursement delays, [removed: (ix)] [added: (x)] government price erosion mechanisms across [removed: Europe] [added: Europe, Japan] and in other countries resulting in deflation for pharmaceutical product pricing, [removed: (x) the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries,] (xi) collection delays or failures to pay in government-funded public hospitals outside the U.S., (xii) developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers, and (xiii) inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.*
Under the IRA, the [removed: U.S Department of Health and Human Services] [added: HHS] can effectively set prices for [added: units of] certain single-source drugs and biologics reimbursed under Medicare Part [removed: B] [added: B, Medicare Advantage] and Part D.
It is possible that more of our products [removed: will] [added: could] be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.
The IRA also [added: generally] requires drug manufacturers to provide rebates for Medicare Part B and Part D medicines [removed: under certain circumstances.][added: if the price of a Part B or Part D drug increases faster than the rate of inflation.]
[removed: Beginning in] [added: As of] January 2025, under the IRA, the [added: Part D benefit redesign replaced the] 70 percent CGDP discount [removed: will be replaced by] [added: with] a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign.
Some of these state-level [removed: proposals] [added: actions] may also influence federal [removed: policy] and [added: other state policies and] legislation.
Given the [added: current] uncertainty surrounding the [removed: adoption and] [added: adoption,] timing [added: and implementation] of [added: many of] these [removed: potential legislative, policy, or administrative changes,] [added: measures, as well as pending litigation challenging such laws,] we are unable to predict their [added: full] impact on our business.
However, [removed: if enacted, these changes] [added: such measures] could modify or decrease access, coverage, or reimbursement of our products, [removed: impact our rebates,] or [removed: shift costs] [added: result in significant changes] to [removed: us,] [added: our sales or pricing practices,] which could [removed: in turn] have a material impact on our [removed: business] [added: revenues] and results of [removed: operations.*][added: operations.]
Over the course of the past few years, Celgene had received inquiries from [removed: Human] [added: the Health] Resources and Services Administration regarding the limited distribution networks for Revlimid, Pomalyst, and Thalomid and compliance with the 340B program.
As part of our broader integration strategy and alignment of our distribution model (post our acquisition of [removed: Celgene Corporation)] [added: Celgene)] we had announced that beginning March 1, 2022, we would [added: generally] recognize up to two designated 340B program contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy.
Our ability to replace revenue from products that lose patent protection is directly dependent on our ability to successfully [added: develop and] commercialize new products in a timely manner.
*As is common in the pharmaceutical industry, BMS expects that sales of its [removed: key brand] [added: branded] products like [removed: Eliquis, Revlimid, Pomalyst, Sprycel] [added: Orencia, Eliquis] and [removed: Abraxane] [added: Opdivo] will decline after the loss of market exclusivity for such products.
As a result, there is a high risk that [removed: funds we invest] [added: our investments] in research programs will not generate financial returns.
*Developing and commercializing new compounds and products [removed: involve] [added: involves] inherent risks and uncertainties, including (i) efficacy and safety concerns or findings of superior safety or efficacy of competing products; (ii) delayed or denied regulatory approvals, including as a result of difficulties in enrolling patients and completing clinical trials in a timely manner; (iii) delays or challenges with producing products on a commercial scale or excessive costs to manufacture products; (iv) failure to enter into or implement optimal alliances for the development and/or commercialization of new products; (v) changes in regulatory approval processes and policies which may cause delays or denials of new product approvals; (vi) preclusion from commercialization due to intellectual property issues or disputes with third parties; (vii) failure in certain markets to obtain reimbursement commensurate with the level of innovation and clinical benefit presented by the product; and (viii) changing clinical preferences, changing industry standards, laws and regulations, or competitors’ innovations, each of which may render new products or enhancements to existing products obsolete.*
[removed: *Regulatory approval] [added: *Commercialization launch] delays are especially common when a product is expected to have a REMS program, as required by the [removed: U.S.] FDA to address significant risk/benefit [removed: issues, and we expect that certain of our future key products will be distributed in the U.S. primarily through a REMS program.][added: issues.]
[removed: *not] [added: If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does not] meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations.*
In some countries, including certain EU member states, basic patent protections for our products may not exist because certain countries did not historically offer the right to obtain specific types of [removed: patents] [added: patents,] and/or we (or our licensors) did not file in those countries.
In addition, the patent environment can be [removed: unpredictable] [added: unpredictable,] and the validity and enforceability of patents cannot be predicted with certainty.
For example, for Eliquis, generics have challenged the composition of matter patents and related SPCs in various [removed: jurisdictions] [added: jurisdictions,] and trials have taken place, or are scheduled to take place, in certain European countries.
*Generic and biosimilar product manufacturers as well as other groups seeking financial gain are also increasingly seeking to challenge patents before they expire, and we [removed: could] [added: have faced and may continue to] face earlier-than-expected competition for any products at any time.
For example, following certain adverse judicial decisions in the [removed: UK] [added: UK, Finland] and [removed: the Netherlands,] [added: Slovakia,] generic manufacturers have begun marketing generic versions of Eliquis in [removed: the UK and Netherlands,] [added: these countries,] and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which may lead to additional infringement and invalidity actions involving Eliquis patents being filed in various countries in Europe.
For example, as a result of patent settlements, generic entry for Revlimid in the [removed: United Kingdom] [added: UK] began on January 18, 2022, and in various other European countries on February 18, 2022.
Similarly, in the U.S., following patent settlements, certain companies [removed: were granted volume-limited licenses to sell] [added: have begun marketing] generic lenalidomide [removed: in the U.S. commencing in March 2022 or thereafter.*][added: pursuant to volume-limited licenses.]
*In addition, both the U.S. Congress and the [removed: U.S.] FDA have taken steps to promote the development and approval of generic drugs and biosimilar biologics, including by providing generic and biosimilar developers a private right of action to obtain sufficient quantities of drug samples from the reference product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products.*
*In addition, in December 2023, the Biden [removed: Administration] [added: administration] released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public [removed: and therefore] [added: and, therefore,] that the government could exercise “march-in rights” and license it to a third party to manufacture.
*There is no assurance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates disclosed in this [removed: 2023] [added: 2024] Form 10-K or that we assume when we provide our financial guidance.*
We face intense competition from other [added: biopharmaceutical companies and] manufacturers and expect to see increasing market penetration of lower-priced generic products.
Competition is [removed: keen] [added: keen,] and as we lose exclusivity for some of our marketed [removed: brands] [added: brands,] lower-priced generic products will increasingly penetrate our markets.
Generic [added: or biosimilar] challenges to our products can also arise at any time, and our patents may not prevent the emergence of generic [added: or biosimilar] competition for our products.
[removed: Risk Factors—We] [added: For additional information, see “—We] could lose market exclusivity of a product earlier than expected.”*
*In addition, we face competition from new products entering the [removed: market, particularly in IO.][added: market.]
Some of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics [removed: products, such as Opdivo;] [added: products;] (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; [removed: and] (ix) [added: geopolitical factors in a specific country or region, including any new, or changes in or interpretations of existing, trade regulations, including for example, any new tariffs imposed in the jurisdictions in which we operate, or compliance requirements of other legislation; and (x)] disruptions in supply chain continuity, including from market [removed: forces (such as the recent stress on global logistics),] [added: forces,] natural disasters, global disease outbreaks or pandemics (including COVID-19), acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.*
[removed: Adverse outcomes in legal] [added: Legal] matters could negatively affect our business.
Such legal matters include (i) intellectual property disputes; (ii) adverse decisions in litigation, including product safety and liability, consumer protection and commercial cases; (iii) [added: matters related to anti-corruption or] anti-bribery regulations, such as the U.S. Foreign Corrupt Practices Act or [added: the] UK Bribery Act, including compliance with ongoing reporting obligations to the government resulting from any settlements; (iv) recalls or withdrawals of pharmaceutical products or forced closings of manufacturing plants; (v) the alleged failure to fulfill obligations under supply contracts with the government and other customers or under other agreements relating to our business; (vi) product pricing and promotional matters; (vii) lawsuits and claims asserting, or investigations into, violations of securities, antitrust, Federal and state pricing, consumer protection, data privacy and other laws and regulations; (viii) environmental, health, safety and sustainability matters, including regulatory actions in response to climate change; and (ix) tax liabilities resulting from assessments from tax authorities.*
The costs of compliance with such laws and regulations, or the negative results of non-compliance, could adversely affect our business, our operating results and [removed: the financial condition of] our [removed: Company.][added: financial condition.]
These laws and regulations control and regulate key aspects of our [removed: business including] [added: business, including,] but not limited [removed: to] [added: to:] (i) market access, pricing controls and discounting; (ii) tax liabilities, returns and payments; (iii) imports and other trade restrictions; (iv) intellectual property protection and enforcement; (v) good practice guidelines and regulations; (vi) accounting standards; (vii) [added: cybersecurity and] data [added: protection,] storage and privacy, particularly in the EU and the U.S.; (viii) requirements for reporting payments and other value transfers to healthcare professionals (such as those provided under the Federal Anti-Kickback Statute); and (ix) compliance with anti-bribery and anti-corruption practices of the U.S. and other countries.*
For example, Congress passed the Food and Drug Omnibus Reform Act in December 2022, which gave the [removed: U.S.] FDA additional authority to require confirmatory trials to be underway at the time of approval and offered an additional enforcement mechanism if sponsors do not complete such studies with due diligence.
Business—Pricing, Price Constraints and Market Access” and [removed: “—Adverse outcomes in legal] [added: “—Legal] matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding [removed: privacy and] [added: cybersecurity,] data [removed: protection] [added: protection, storage and privacy] is continuously evolving and the subject of significant attention by regulators and private parties globally.
[removed: Regulators are imposing new data privacy] [added: *protection, storage] and [removed: security] [added: privacy] requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations.
Failure to comply with these [removed: current and future] laws could result in significant [removed: penalties] [added: penalties, including potential exclusion from federal healthcare programs,] and reputational harm and could have a material adverse effect on our business and results of operations.*
In August 2024, as part of the first round of government price setting pursuant to the IRA, the HHS announced the "maximum fair price" for a 30-day equivalent supply of Eliquis, which applies to the U.S. Medicare channel effective January 1, 2026.
In January 2025, the HHS selected Pomalyst as a medicine subject to "negotiation" for government-set prices beginning in 2027.
Failure to comply with requirements under the price setting process is subject to an excise tax and/or a civil monetary penalty.
*At the state level, multiple states have passed, are pursuing or are considering government action via legislation or regulations to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service Act drug pricing program, etc.).
With respect to the Federal Public Health Service Act drug pricing program, certain states have enacted laws regulating manufacturer pricing obligations under the program to date.
Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.
Further, commercial payers often consider Medicare coverage policy and payment limitations when setting their own payment rates.
Any reduction in cost or other containment measures may similarly be adopted by commercial plans.
Coverage policies and reimbursement rates for commercial plans may change at any time.*
We then updated this policy effective July 1, 2024, to generally recognize up to four contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy.
Multiple states have enacted laws generally prohibiting manufacturer policies restricting recognition of contract pharmacy arrangements and provide for certain penalties for violations.
Such laws have been subject to legal challenges.
Whether or how such laws may impact our business remains uncertain.
Certain of our future key products may be required to be distributed in the U.S. through*
*a REMS program.
We may also choose to no longer pursue certain programs from time to time as we periodically review our research and development programs and seek to prioritize our pipeline investments.
This may result in further uncertainty as to when potential new products will be approved and commercialized.
The licenses will no longer be volume-limited beginning on January 31, 2026.*
We cannot predict whether the Trump administration will finalize the draft framework or if the government will propose other drug pricing policy changes.
If pursued and finalized, these policies could reduce prices and reimbursement for certain of our products and could significantly impact our business and consolidated results of operations*.
Additionally, pharmacy benefit manager practices have come under increased scrutiny from U.S. policymakers at the federal and state level, who have proposed legislation intended to address concerns regarding the impact that these intermediaries have on drug pricing and patients’ out of pocket costs.
If promulgated, such legislation could have resultant implications, costs or consequences for our business and how we*
*interact with these entities.
Regulators are imposing new cybersecurity and data*
This includes Pillar Two legislation that has been enacted pursuant to the OECD/G20 Inclusive Framework in various jurisdictions in which we operate.
Additional clinical trials, head-to-head studies, real-world data analyses, adverse events reports following the use of our products*
For example, in November 2023, the FDA announced that it was investigating the risk of T-cell malignancies in patients who received treatment with CAR-T cell therapy, noting that the overall benefits of CAR-T cell therapy products continue to outweigh their potential risks for their approved uses.
In January 2024, the FDA determined that safety labeling changes were needed for approved CAR-T cell therapies, including a “boxed warning” about the possible risk of T-cell malignancies in patients treated with CAR-T cell therapy.
*As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and due*
Further, although we maintain insurance coverage designed to transfer certain cybersecurity incident costs, there is a risk this insurance would be insufficient to cover the costs of the incident, including due to coverage limits or insurance exclusions.*
*In addition, we face certain risks as we seek to leverage artificial intelligence programs and machine learning (“AI”) to optimize productivity and efficiency in various aspects of the organization.
For example, flawed algorithms and/or biased, incomplete or inaccurate data used in AI programs may result in deficient AI-generated content.
The regulatory landscape related to AI remains uncertain, and we may be required to devote significant resources to comply with developing laws and address ethical concerns.
Our competitors may also develop or adopt more effective AI technologies, resulting in more efficient operations and putting us at a competitive disadvantage.
These risks may result in an adverse impact on our business, financial condition or results of operations.*
For additional information, see “—We could lose market exclusivity of a product earlier than expected.”*
We expect that consolidation and integration of pharmacy chains, wholesalers and pharmacy benefit managers will increase competitive and pricing pressures on pharmaceutical manufacturers, including us.*
*stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.*
Additionally, we periodically adjust our personnel needs in response to changing macroeconomic conditions, market opportunities, management changes, acquisitions, cost levels and other internal and external considerations, which may adversely impact our workplace culture and ability to retain and incentivize employees.
*markets could impact our growth strategy.
In August 2023, the U.S. Department of Health and Human Services selected Eliquis as one of the first 10 medicines subject to government-set prices beginning in 2026.
The Medicare price setting process began in February 2024 and will conclude by August 1, 2024.
On September 1, 2024, CMS will publish prices that will be applicable to the ten drugs in the Medicare program beginning January 1, 2026.
The Part D benefit redesign will replace the Part D CGDP with a new manufacturer discount program.
*At the state level, multiple states are pursuing government actions and ballot initiatives to address or limit drug pricing and reimbursement for their Medicaid programs.
These initiatives include attempts to use the IRA's referenced drug price at the state level.
If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does*
A comment period on the proposal ran through February 6, 2024,*
*and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.*
For additional information, see “Item 1A.
Moreover, compliance with any such legal or regulatory requirements would require us to devote substantial time and attention to these matters.
*requires investments, and depends in part on third-party performance or data that is outside of our control.
Notably, in July and October 2021 OECD/G20 Inclusive Framework agreed on the general rules for redefined jurisdictional taxation rights and a global minimum tax.
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.
The implementation of Pillar Two is currently expected to increase our effective tax rate excluding specified items by approximately 1% in 2024.*
In particular, the exit of the UK from the EU, which occurred on January 31, 2020, created uncertainties affecting our business operations in the UK and the EU and may have an impact on our research, commercial and general business operations in the UK and the EU, including the approval and supply of our products and may require changes to our legal entity structure in the UK and the EU.*
For example, there is potential for a shift in the U.S. payer channel mix due to changes in patient coverage from the current economic crisis, but we are not able to reliably estimate what the impact would be on our results of operations given the highly variable and uncertain situation.
It is also possible that changes in the*
An excerpt. Shown here: 40 of 89 rewritten, 40 of 41 added and all 19 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS. in the FY2024 filing and the FY2023 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
251 rewritten, 256 added, 200 removed, 499 unchanged
Management’s discussion and analysis of financial condition and results of operations is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this [removed: 2023] [added: 2024] Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.
The comparison of [removed: 2022] [added: 2023] to [removed: 2021] [added: 2022] results has been omitted from this Form 10-K and is incorporated by reference from our Form 10-K for the year ended December 31, [removed: 2022] [added: 2023] “Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February [removed: 14, 2023.][added: 13, 2024.]
Refer to the Summary of Abbreviated Terms at the end of this [removed: 2023] [added: 2024] Form 10-K for definitions of capitalized terms used throughout the document.
Financial Statements and Supplementary Data—Note [removed: 3.][added: 5.]
| | | | Year Ended December 31, | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]
| Dollars in millions, except per share data | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | | | |
| Total Revenues | | | $ | [removed: 45,006] [added: 48,300] | | | | | $ | [removed: 46,159] [added: 45,006] | | | | | | | |
| Diluted [removed: Earnings] [added: (Loss)/Earnings] Per Share | | | | | | | | | | | | | | | | | |
| GAAP | | | $ | [removed: 3.86] [added: (4.41)] | | | | | $ | [removed: 2.95] [added: 3.86] | | | | | | | |
| Non-GAAP | | | [removed: 7.51] [added: 1.15] | | | | | | [removed: 7.70] [added: 7.51] | | | | | | | | |
[removed: Our products continue to be subject to increasing] [added: These] pressures [removed: across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions in the U.S., the EU and other regions around the world that result] [added: have resulted] in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which can negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility.
[removed: For example, on August 16, 2022, President Biden signed the] [added: The] IRA [removed: into law which provides for] [added: directs] (i) the [added: federal] government to [removed: negotiate] [added: “negotiate”] prices for select high-cost Medicare Part D (beginning in 2026) and Part B [removed: drugs] (beginning in 2028) [added: drugs] that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their [added: initial] FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation [removed: beginning in 2022 for Part D] and [removed: 2023 for Part B, and] (iii) [removed: Medicare] [added: the formation of the] Part D [removed: redesign] [added: Manufacturer Program] which [removed: replaces] [added: replaced] the [removed: current] Part D CGDP and [removed: establishes] [added: established] a $2,000 cap for out-of-pocket [removed: limits] costs for Medicare beneficiaries [removed: beginning in] [added: as of January] 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.
In addition, in December 2023, the Biden [removed: Administration] [added: administration] released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public [removed: and therefore] [added: and, therefore,] that the government could exercise “march-in rights” and license it to a third party to manufacture.
[removed: The effect of reducing] [added: If pursued and finalized, these policies could reduce] prices and reimbursement for certain of our products [removed: would] [added: and could] significantly impact our business and consolidated results of operations.
Additionally, in connection with the [removed: IRA] [added: IRA,] the following changes have been made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock [removed: repurchases, to be applied to] repurchases [removed: beginning in 2023.][added: after December 31, 2022.]
We continue to evaluate the impact of the IRA [removed: legislation] on our results of [removed: operations] [added: operations,] and it is possible that these changes may result in a material impact on our business and results of operations.
Furthermore, countries are [removed: expected to make] [added: in the process of enacting] changes to their tax laws [removed: and updates] to [removed: international tax treaties to] implement the agreement by the OECD to establish a global minimum tax.
The following is a summary of the significant approvals [removed: received in 2023:][added: received:]
| [removed: Opdivo] [added: Augtyro] | | | [removed: March 2023] [added: September 2024] | | | Japan's Ministry of Health, Labour and Welfare approval of [removed: *Opdivo* plus chemotherapy] [added: *Augtyro*] for the [removed: neoadjuvant] treatment of patients with [removed: resectable] [added: ROS1 fusion-positive, unresectable advanced or recurrent] NSCLC. | | |
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in [removed: 2023] [added: 2024] and in early [removed: 2024.][added: 2025.]
Together with our proven track record, rapidly advancing pipeline and [removed: growth with marketed products,] [added: increasing use of artificial intelligence,] we [removed: increased and sustained] [added: are increasing] our R&D [removed: productivity] [added: productivity,] enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.
[removed: *Reblozyl* is advancing into new indications with] [added: We have] an ongoing registrational trial [removed: for] [added: to potentially expand into] chronic anemia associated with myelofibrosis.
For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during [removed: 2023] [added: 2024] refer to “Item 8.
| Dollars in millions | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | % Change | | | | | | Foreign [removed: Exchange(b)] [added: Exchange(c)] | | |
| [removed: Other(a)] [added: Other revenues(b)] | | | [removed: 699] [added: 996] | | | | | | [removed: 834] [added: 699] | | | | | | [removed: (16)] [added: 42] | | % | | | | N/A | | |
| Total [added: Revenues] | | | $ | [removed: 45,006] [added: 48,300] | | | | | $ | [removed: 46,159] [added: 45,006] | | | | | [removed: (2)] [added: 7] | | % | | | | [removed: —] [added: (2)] | | % |
[removed: (a)] [added: (b)] Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
[removed: (b)] [added: (c)] Foreign exchange impacts were derived by applying the prior period average currency rates to the current period revenues.
- U.S. revenues [removed: in 2023] decreased [removed: 1%] [added: 4% in 2024] primarily due to [removed: lower *Revlimid* sales driven by the previously disclosed] generic erosion and [removed: an increase in] [added: lower average net selling prices partially offset by the prior year impact of] patients receiving free drug product [removed: for *Revlimid*, and to a lesser extent, *Pomalyst*,] from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates [removed: product*,* partially offset by an increase in demand for our In-Line Products and New Product Portfolio.][added: products.]
Average net selling prices [removed: remained flat] [added: decreased by 1%] in [removed: 2023] [added: 2024] compared to [removed: 2022.][added: 2023.]
- International revenues [removed: in 2023] decreased [removed: 6%] [added: 23% in 2024] primarily due to [removed: *Revlimid* and *Eliquis*] [added: lower demand driven by] generic erosion, lower average net selling [removed: prices,] [added: prices] and foreign exchange [removed: impacts, partially offset by an increase in demand for *Opdivo* and New Product Portfolio.][added: impacts of 1%.]
No single country outside the U.S. contributed more than 10% of total revenues in [removed: 2023] [added: 2024] and [removed: 2022.][added: 2023.]
| Prior period | | | [removed: (11)] [added: (8)] | | | | | | [removed: 11] [added: (91)] | | | | | | [removed: (134)] [added: (60)] | | | | | | [removed: (134)] [added: (159)] | | |
| Foreign currency translation and other | | | [removed: (1)] [added: (2)] | | | | | | [removed: —] [added: 1] | | | | | | [removed: 76] [added: (146)] | | | | | | [removed: 75] [added: (147)] | | |
| Balance at [removed: December 31, 2023] [added: January 1, 2024] | | | $ | 646 | | | | | $ | 4,445 | | | | | $ | 3,237 | | | | | $ | 8,328 | |
| Dollars in millions | | | [removed: 2023 | | | | | | 2022 | | | | | | | | | | | | 2023 vs. 2022] [added: 2024] | | | | | | [added: 2023] | | |
| Gross product sales | | | $ | [removed: 73,679] [added: 83,671] | | | | | $ | [removed: 69,633] [added: 73,679] | | | | | | | | | | | [removed: 6] [added: 14] | | % | | | | | | |
| Charge-backs and cash discounts | | | [removed: (9,144)] [added: (11,510)] | | | | | | [removed: (7,469)] [added: (9,144)] | | | | | | | | | | | | [removed: 22] [added: 26] | | % | | | | | | |
| Medicaid and Medicare rebates | | | [removed: (13,411)] [added: (16,551)] | | | | | | [removed: (11,362)] [added: (13,411)] | | | | | | | | | | | | [removed: 18] [added: 23] | | % | | | | | | |
In 2024, we achieved multiple clinical and regulatory milestones across our portfolio including (i) approvals for *Breyanzi* in the U.S. and Japan for adults with relapsed or refractory FL and in the U.S. for adults with relapsed or refractory CLL/SLL and MCL; (ii) *Reblozyl's* expanded approval to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS in the EU and Japan; (iii) FDA approval of *Opdivo* *Qvantig* injection for subcutaneous use in most previously approved adult solid tumor *Opdivo* indications; (iv) FDA approval of *Opdivo* for the treatment of adult patients with resectable NSCLC, in combination with platinum-doublet chemotherapy, followed by single-agent *Opdivo* as adjuvant treatment after surgery; and (v) FDA approval and subsequent launch of *Cobenfy* for the treatment of schizophrenia in adults.
In 2024, we completed the following acquisitions: (i) Karuna, a biopharmaceutical company in the area of developing and delivering medicines, including *Cobenfy,* for psychiatric and neurological conditions; (ii) RayzeBio, a clinical-stage radiopharmaceutical therapeutics company with a pipeline of potentially first-in-class and/or best-in-class drug development programs; and (iii) Mirati, a commercial stage targeted oncology company, with a commercialized medicine, *Krazati*, and clinical programs in development.
We also entered into a strategic collaboration with SystImmune, to co-develop and co-commercialize izalontamab brengitecan (iza-bren or BL-B01D1), a bispecific topoisomerase inhibitor-based anti-body drug conjugate.
Revenues increased by 7%, primarily driven by the Growth Portfolio and *Eliquis*, partially offset by generic erosion in the Legacy Portfolio.
We expect continued generic erosion within our Legacy Portfolio in 2025 primarily due to *Revlimid*, *Sprycel* and for *Pomalyst* outside the U.S.
The $8.27 decrease in GAAP EPS in 2024 was primarily driven by a one-time, non-deductible Acquired IPRD charge resulting from the Karuna asset acquisition and SystImmune collaboration, which impacted full-year GAAP EPS by approximately $6.28 and the impact of certain specified items, primarily intangible asset impairments.
After adjusting for specified items, the $6.36 decrease in non-GAAP EPS was primarily due to the aforementioned Acquired IPRD charges and higher interest expense partially offset by higher revenues.
As regulators continue to focus on prescription drugs, our products are facing increased pressures across the portfolio.
These pressures stem from legislative and policy changes, including price controls, pharmaceutical market access, discounting, changes to tax and importation laws and other restrictions in the U.S., EU and other regions around the world.
In August 2024, as part of the first round of government price setting pursuant to the IRA, the HHS announced the "maximum fair price" for a 30-day equivalent supply of *Eliquis*, which applies to the U.S. Medicare channel effective January 1, 2026.
In January 2025, the HHS selected *Pomalyst* as a medicine subject to "negotiation" for government-set prices beginning in 2027.
We cannot predict whether the Trump administration will finalize the draft framework or if the government will propose other drug pricing policy changes.
At the state level, multiple states have passed, are pursuing or are considering government action via legislation or regulations to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service Act drug pricing program, etc.).
Some of these state-level actions may also influence federal and other state policies and legislation.
Given the current uncertainty surrounding the adoption, timing and implementation of many of these measures, as well as pending litigation challenging such laws, we are unable to predict their full impact on our business.
However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations.
With respect to the Federal Public Health Service Act drug pricing program, certain states have enacted laws regulating manufacturer pricing obligations under the program to date.
Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.
| Augtyro | | | January 2025 | | | EC approval for *Augtyro* as a treatment for adult patients with ROS1-positive NSCL and for adult and pediatric patients 12 years of age and older with NTRK-positive solid tumors. | | |
| Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) | | | December 2024 | | | FDA approval for *Opdivo* *Qvantig* injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase, in most previously approved adult, solid tumor *Opdivo* indications as monotherapy, monotherapy maintenance following completion of *Opdivo* plus *Yervoy* combination therapy, or in combination with chemotherapy or cabozantinib. | | |
| Opdivo | | | December 2024 | | | Japan’s Ministry of Health, Labour and Welfare approval of *Opdivo* for the treatment of radically unresectable urothelial carcinoma. | | |
| Zeposia | | | December 2024 | | | Japan’s Ministry of Health, Labour and Welfare approval of *Zeposia* for the treatment of moderate to severe UC in patients who have had an inadequate response to conventional therapies. | | |
| Opdivo+Yervoy | | | December 2024 | | | EC approval of *Opdivo* plus *Yervoy* for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer. | | |
| Opdivo | | | October 2024 | | | FDA approval of *Opdivo* for the treatment of adult patients with resectable (tumors ≥ 4 cm or node positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent *Opdivo* as adjuvant treatment after surgery. | | |
| Cobenfy | | | September 2024 | | | FDA approval of *Cobenfy* for the treatment of schizophrenia in adults. | | |
| Breyanzi | | | August 2024 | | | Japan's Ministry of Health, Labour and Welfare approval of *Breyanzi* for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy. | | |
| Krazati | | | June 2024 | | | FDA accelerated approval for *Krazati* in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C\-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. | | |
| | | | | | | | | |
| Augtyro | | | June 2024 | | | FDA accelerated approval of *Augtyro* for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. | | |
| | | | | | | | | |
| Opdivo | | | May 2024 | | | EC approval of *Opdivo* in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. | | |
| | | | | | | | | |
| Breyanzi | | | May 2024 | | | FDA approval of *Breyanzi* for the treatment of adult patients with relapsed or refractory MCL who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. | | |
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| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Product | | | Date | | | Approval | | |
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Breyanzi | | | May 2024 | | | FDA accelerated approval of *Breyanzi* for the treatment of adult patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy. | | |
| | | | | | | | | |
In 2023, we received approvals for initial and additional indications for the following marketed products in major markets (the U.S., EU and Japan), which further expanded our geographical reach in immunology, hematology, oncology, and cardiovascular diseases: (i) U.S. and EU approval of *Opdivo* for treatment of completely resected stage IIB and IIC melanoma, expanding upon the existing adjuvant treatment for melanoma patients; (ii) FDA approval of *Reblozyl* in the first-line setting for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk MDS who may also require red blood cell transfusions, regardless of ring sideroblast status; and EU approval for an additional indication for anemia associated with non-transfusion-dependent beta thalassemia; (iii) approvals in Japan and in the EU of *Opdivo* in combination with chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC; (iv) approval of *Camzyos* for the treatment of symptomatic obstructive HCM in the EU; (v) approval of Breyanzi for the second-line treatment of diffuse large B-cell lymphoma in the EU; (vi) approval for *Sotyktu* for moderate-to-severe plaque psoriasis in the EU; and (vii) approval of *Augtyro* (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC) in the U.S. We continue expanding our commercial CAR-T manufacturing network through the FDA approval of our Devens, MA facility in June 2023.
In January 2024, we acquired Mirati, a commercial stage targeted oncology company with a pipeline of commercial, clinical and pre-clinical stage oncology medicines and assets.
With the Mirati acquisition, we obtained rights to *Krazati, a best-in-class inhibitor of KRASG12C mutation, approved by the FDA as a second-line treatment for patients with NSCLC; and MRTX1719, a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase I development, among others.
In addition, during the fourth quarter of 2023, we entered into definitive merger agreements to acquire Karuna and RayzeBio and also entered into strategic collaboration with SystImmune.
Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions.
RayzeBio is a clinical-stage radiopharmaceutical therapeutics company with an innovation-leading position in actinium-based radiopharmaceutical therapeutics and a pipeline of potentially first-in-class and best-in-class drug development programs.
Refer to “Item 8.
The goal of the collaboration with SystImmune is to co-develop and co-commercialize 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.
Alliances” for further information.
The Company has the potential to increase its registrational portfolio from six to up to twelve potentially first-in-class/best-in-class assets.
In addition to its growing registrational portfolio, the Company has more than 25 indication expansion opportunities on the horizon.
Taken together, this leads to increased depth across the Company’s therapeutic areas, including oncology, hematology, immunology, cardiovascular and a growing presence in neuroscience.
| | | | | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
In 2023, our revenues decreased by 2%, primarily due to lower *Revlimid* sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for *Revlimid*, and to a lesser extent, *Pomalyst*, from the Bristol Myers Squibb Patient Assistance Foundation, partially offset by higher sales of our New Product Portfolio and In-Line Products (primarily *Opdivo*).
The $0.91 increase in GAAP EPS in 2023 was primarily driven by the impact of certain specified items, including deferred income tax benefit related to a non-U.S. tax ruling, lower losses on equity investments, amortization of intangible assets, as well as litigation and other settlement income, partially offset by lower revenues and product mix.
After adjusting for specified items, non-GAAP EPS decreased $0.19 primarily as a result of lower revenues and product mix, partially offset by higher royalty and interest income and lower weighted average shares outstanding.
In August 2023, the U.S. Department of Health and Human Services selected *Eliquis* as one of the first 10 medicines subject to government-set prices beginning in 2026.
A comment period on the proposal ran through February 6, 2024, and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.
Other proposals, such as those relating to the calculation of best price as well as potential executive orders focused on drug pricing are still being debated.
| Augtyro (repotrectinib) | | | November 2023 | | | FDA approval of *Augtyro* for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. | | |
| Opdivo | | | October 2023 | | | 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. | | |
| Reblozyl | | | August 2023 | | | 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. | | |
| Opdivo | | | August 2023 | | | 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. | | |
| Opdivo | | | June 2023 | | | 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%. | | |
| Camzyos | | | June 2023 | | | EC approval of *Camzyos* for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM. | | |
| Breyanzi | | | May 2023 | | | 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. | | |
| Sotyktu | | | March 2023 | | | EC approval of *Sotyktu* for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. | | |
| Reblozyl | | | March 2023 | | | EC approval of *Reblozyl* for the treatment in adult patients of anemia associated with non-transfusion-dependent beta thalassemia. | | |
Our priorities are (i) to continue to renew and diversify our portfolio through launching new medicines, (ii) advancing our early, mid and late-stage pipeline and (iii) executing disciplined business development.
As we undergo a period of renewal, our strategy will be focused on driving near-term growth, minimizing the impact of a transition period that follows and delivering growth in the late 2020s by accelerating opportunities that enhance productivity and efficiency, advance our pipeline, and drive strong commercial execution that move our business forward.
We remain committed to a strategic business development and maintaining a strong investment grade credit rating, growing the dividend and reducing additional debt that will be issued in support of recent transactions.
Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following five core therapeutic areas: (i) oncology with a priority in certain tumor types, including diversification beyond IO; (ii) hematology with opportunities to expand leadership position in multiple myeloma, as well as broaden our portfolio across leukemias, lymphomas and non-malignant hematologic diseases; (iii) immunology with priorities in strengthening presence in dermatology, rheumatology and gastrointestinal disorders, establishing new standards of care in pulmonology and rapidly advance cell therapy into immunology diseases; (iv) cardiovascular diseases with focus on cardiomyopathies, heart failures and thrombotic diseases; and (v) neuroscience with a focus on neuropsychiatry, neurodegenerative and neuroinflammation diseases.
We are working towards expanding our pipeline of registrational assets from six to up to twelve.
In addition, we are positioned to support continued innovation and expand treatment options across several different diseases based on our differentiated research platforms.
We have a broad portfolio and pipeline when it comes to autologous CAR-T cell therapies.
We have two approved cell therapies against two distinct targets and are continuing to build our leadership in this space.
We are expanding manufacturing capacity, exploring innovative technologies such as dual-targeting CAR-Ts and allogenic approaches, advancing multiple next-generation assets including new targets and rapidly expanding into immunology, including lupus and multiple sclerosis.
We also have a strong position in the protein degradation field and have been advancing our pipeline with an expansive library of assets with two in registrational trials, an additional five in clinical phase studies and more than fifteen being studied pre-clinically.
This growing platform has potential across several diseases and is positioned to deliver approximately four INDs each year.
An excerpt. Shown here: 40 of 251 rewritten, 40 of 256 added and 40 of 200 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. in the FY2024 filing and the FY2023 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
5 rewritten, 0 added, 0 removed, 30 unchanged
Foreign currency forward and purchased local currency put option contracts are used to manage risk primarily arising from certain intercompany [added: sales, third party] sales and purchases transactions.
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 [removed: $409] [added: $455] million and [removed: $782] [added: $409] million as of December 31, [removed: 2023] [added: 2024] and December 31, [removed: 2022,] [added: 2023,] respectively, reducing earnings over the remaining life of the contracts.
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 [removed: $46] [added: $49] million as of December 31, [removed: 2023] [added: 2024] and [removed: decrease] [added: increase] by [removed: $73] [added: $46] million as of December 31, [removed: 2022,] [added: 2023,] respectively.
In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, [removed: 2023] [added: 2024] and December 31, [removed: 2022,] [added: 2023,] 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, [removed: 2023] [added: 2024] and December 31, [removed: 2022] [added: 2023] would decrease the fair value of long-term debt by [removed: $3.0] [added: $3.6] billion and [removed: $2.6] [added: $3.0] billion, respectively.
Item 1. BUSINESS.
125 rewritten, 60 added, 105 removed, 447 unchanged
Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology, hematology, immunology, [removed: cardiovascular] [added: cardiovascular, neuroscience] and [removed: neuroscience.][added: other areas where we can also deliver attractive returns for shareholders.]
We compete with other [removed: worldwide] [added: global] research-based [removed: drug] [added: biopharmaceutical] companies, smaller research companies and generic drug manufacturers.
| Dollars in millions | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |
| United States | | | [removed: 70] [added: 71] | | % | | | | 69 | | % | | | | [removed: 63] [added: 68] | | % |
| International [added: (a)] | | | [removed: 28] [added: 27] | | % | | | | 29 | | % | | | | [removed: 35] [added: 30] | | % |
| [removed: Other(a)] [added: Other (b)] | | | 2 | | % | | | | 2 | | % | | | | 2 | | % |
| Total Revenues | | | $ | [removed: 45,006] [added: 48,300] | | | | | $ | [removed: 46,159] [added: 45,006] | | | | | $ | [removed: 46,385] [added: 46,159] | |
[removed: (a)] [added: (b)] Other revenues include royalties and alliance-related revenues for products not sold by BMS’s regional commercial organizations.
Refer to the Summary of Abbreviated Terms at the end of this [removed: 2023] [added: 2024] Form 10-K for definitions of capitalized terms used throughout the document.
Our [removed: pharmaceutical products include] [added: platforms are comprised of] chemically-synthesized or small molecule [removed: drugs, products] [added: drugs including protein degraders; drugs] produced from biological processes, called [removed: “biologics” and chimeric antigen receptor (CAR-T)] [added: “biologics”; ADCs, CAR-T] cell [removed: therapies.][added: therapies, and radiopharmaceutical therapeutics.]
Small molecule drugs are typically administered orally in the form of a tablet or capsule, although other drug delivery mechanisms are [removed: used as well.][added: also used.]
Biologics are typically administered [removed: to patients] through injections or by intravenous infusion.
CAR-T [added: cell] therapies are administered [removed: to patients] by intravenous infusion.
The *Opdivo*+*Yervoy* regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and various gastric and esophageal [removed: cancers.][added: cancers..]
[removed: *Orencia®* *Orencia* (abatacept) is a biological product, is a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated] [added: It has indications] for [added: (i)] reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and [added: (ii)] for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
*Reblozyl®* *Reblozyl* (luspatercept-aamt) is a biological product, and is an erythroid maturation agent indicated for the treatment of anemia in [removed: i)] [added: (i)] adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, [removed: ii)] [added: (ii)] adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as [removed: iii)] [added: (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 [removed: ring sideroblast] [added: RS] status.
*Abecma®* *Abecma* (idecabtagene vicleucel) is a BCMA genetically modified autologous [removed: CAR–T] [added: 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.
*Zeposia®* *Zeposia* (ozanimod) is an oral immunomodulatory drug used to treat relapsing forms of [removed: multiple sclerosis,] [added: MS,] 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.
*Breyanzi®* *Breyanzi* (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory [removed: large B-cell lymphoma] [added: LBCL] after one or more lines of systemic therapy, including [removed: diffuse large B-cell lymphoma] [added: DLBCL] not otherwise specified, high-grade B-cell lymphoma, primary mediastinal [removed: large B-cell lymphoma,] [added: LBCL, grade 3B FL] and [added: relapsed or refractory] FL [removed: grade 3B.][added: after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL, and relapsed or refractory MCL in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.]
*Camzyos®* *Camzyos* (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic [removed: obstructive HCM] [added: oHCM] to improve functional capacity and symptoms.
Market exclusivity is also sometimes provided by [removed: RDP,] [added: regulatory exclusivity,] a period of time after the approval of a new drug during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic [added: or biosimilar] copy.
[removed: These incentives] [added: Regulatory exclusivity] can provide a market exclusivity period on a product that expires beyond the patent term.
Specific aspects of the law governing market patent protection and [removed: RDP] [added: regulatory exclusivity] for pharmaceuticals vary from country to country.
Both types of applications can receive certain periods of regulatory [removed: exclusivity.][added: exclusivity as discussed below.]
Medicines [removed: approved under an NDA] can also receive several types of [removed: RDP.][added: regulatory exclusivity.]
An innovative chemical pharmaceutical product is entitled to five years of [removed: RDP] [added: regulatory exclusivity] in the U.S., during which the FDA cannot approve generic substitutes.
If an innovator’s patent is challenged, [removed: as described above,] a generic manufacturer may file its ANDA after the fourth year of the five-year [removed: RDP] [added: regulatory exclusivity] period.
Our marketed chemical products include *Eliquis, [added: Revlimid,] Pomalyst, Sprycel, Zeposia, [removed: Onureg, Inrebic,] Camzyos, Sotyktu*, [added: *Augtyro, Krazati,*] and [removed: *Augtyro* (repotrectinib).][added: *Cobenfy*.]
[removed: However, although an application for approval of a biosimilar version may be filed four years after approval of the innovator product, qualified] [added: Qualified] innovative biological products [removed: will] receive 12 years of [removed: RDP,] [added: regulatory exclusivity,] meaning that the FDA may not approve a biosimilar version until 12 years after the innovative biological product was first approved by the FDA.
Our marketed biologic products include *Opdivo*, [added: *Opdivo Qvantig,*] *Orencia,* [removed: *Yervoy*, *Reblozyl, Abecma, Opdualag*] [added: *Yervoy, Reblozyl, Opdualag, Breyanzi, Abecma*] and [removed: *Breyanzi.*][added: *Abraxane.*]
First, generic companies have increasingly sought to challenge innovators’ [removed: basic] patents covering major pharmaceutical products.
[removed: Patents] [added: In Japan, patents] on pharmaceutical products are [removed: generally] enforceable [removed: in the EU and, as in the U.S.,] [added: and] may be extended [added: for up] to [added: five years to] compensate for the patent term lost during the regulatory review process.
Throughout the EU, all products for which marketing authorizations have been filed after October and November 2005 are subject to an “8+2+1” [removed: RDP] [added: regulatory exclusivity] regime.
In general, EU law treats [removed: chemically-synthesized] [added: chemically synthesized] drugs and [removed: biologically-derived] [added: biologically derived] drugs the same with respect to intellectual property and [removed: RDP.][added: regulatory exclusivity.]
[removed: In Japan, patents] [added: Patents] on pharmaceutical products are [added: generally] enforceable [removed: and] [added: in the EU and, as in the U.S.,] may be extended [added: for up] to [added: five years to] compensate for the patent term lost during the regulatory review [removed: process.][added: process, provided that the extension cannot cause the patent to be in effect for more than 15 years from the date of drug approval.]
Medicines of new chemical entities are generally afforded eight years of [removed: RDP] [added: regulatory exclusivity] for approved indications and dosage.
Generic copies can receive regulatory approval after [removed: RDP] [added: regulatory exclusivity] and patent expirations.
In general, Japanese law treats [removed: chemically-synthesized] [added: chemically synthesized] and [removed: biologically-derived] [added: biologically derived] drugs the same with respect to intellectual property and [removed: market] [added: regulatory] exclusivity.
In countries outside of the U.S., the EU and Japan, there [removed: is] [added: are] a [removed: wide] variety of legal systems with respect to intellectual property and [removed: market] [added: regulatory] exclusivity of pharmaceuticals.
The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or [removed: RDP] [added: regulatory] exclusivity) is currently estimated to occur in the U.S., the EU and Japan (the “estimated minimum market exclusivity date”).
Our priorities are to focus on transformational medicines where we have a competitive advantage, drive operational excellence and strategically allocate capital for long-term growth and shareholder returns.
Management's Discussion and Analysis of Financial Condition and Results of Operations—Strategy.” In addition, we expect that our acquisitions of Karuna, RayzeBio and Mirati in 2024 will allow us to expand in neuroscience and oncology, and continue to position us as a leading biopharmaceutical company across our core therapeutic areas.
(a) Beginning in 2024, Puerto Rico revenues are presented as part of International revenues to align with management's review of the Company's financial results.
Prior period amounts have been recast to conform to the current presentation.
Our significant business development activities in 2024 included acquisitions of Karuna, RayzeBio and Mirati in addition to a global strategic collaboration agreement with SystImmune.
Our differentiated research platforms support long-term growth across therapeutic areas.
Growth Portfolio
*Opdivo QvantigTM* *Opdivo Qvantig* (nivolumab and hyaluronidase-nvhy) is a subcutaneously administered PD-1 inhibitor indicated for most previously approved adult, solid tumor *Opdivo* indications as monotherapy, monotherapy maintenance following completion of *Opdivo* plus *Yervoy* combination therapy, or in combination with chemotherapy or cabozantinib.
*Orencia®* *Orencia* (abatacept) is a biological product and a fusion protein indicated for adult patients with moderate to severe active RA and PsA.
*Krazati®* *Krazati* (adagrasib) is a highly selective and potent oral small-molecule inhibitor of the KRASG12C mutation, indicated for the treatment of adult patients with KRASG12C\-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRASG12C\-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
*Augtyro®* *Augtyro* (repotrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
*CobenfyTM* *Cobenfy* (xanomeline and trospium chloride) is a combination M1/M4 muscarinic receptor agonist and muscarinic antagonist indicated for the treatment of schizophrenia in adults.
Legacy Portfolio
In the U.S., medicines (chemically synthesized or biologically derived) may also receive an additional six months of market exclusivity (added to certain patent terms and regulatory exclusivities) if certain agreed-upon pediatric studies are completed by the applicant.
The EU provides an additional six months of exclusivity added to the extended patent term if certain pediatric studies are completed by the applicant.
This regulatory exclusivity could be extended if certain pediatric studies are completed by the applicant.
| *Cobenfy* (xanomeline and trospium chloride) (e) | | | ^^ | | | | | | ++ | | | | | | ++ | | |
| *Krazati* (adagrasib) | | | 2037 | | | | | | 2038 | | | | | | ++ | | |
| *Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)(g)* | | | ^^ | | | | | | ++ | | | | | | ++ | | |
(e) For *Cobenfy* in the U.S., we have been granted patents covering the combination of active ingredients in *Cobenfy*, which expire in 2030.
(f) For *Eliquis*, in the U.S., multiple generic companies challenged the two patents listed in the FDA Orange Book.
(g) For *Opdivo Qvantig,* the estimated minimum market exclusivity date of 2028 is based on the expiry of the COM patent for *Opdivo* and does not include any potential exclusivity resulting from pending patent applications relating to the *Opdivo* *Qvantig* formulation and its use.
In France, Italy and Spain, SPC and PED are granted and the estimated patent expiry is 2038.
In Europe, generics have entered the market.
In the U.S., PTR on a method of treatment patent was granted, and the estimated patent expiry is 2033.
The licenses will no longer be volume-limited beginning on January 31, 2026.
(n) For *Sprycel,* in the U.S., EU and Japan, generics have entered the market.
We concentrate our R&D efforts in the following disease areas with significant unmet medical needs: oncology and hematology with novel modalities in cell therapies, protein degraders, ADCs and radiopharmaceuticals; immunology with a focus on establishing new standards of care in pulmonology, rapidly advancing cell therapy into immunology diseases and transformational programs to control inflammation, reset immune memory and promote homeostasis in dermatology and rheumatology disorders; cardiovascular diseases by leveraging deep expertise across thrombotic diseases, heart failures and cardiomyopathies; and neuroscience with a focus on developing new treatments in neuropsychiatry and neurodegeneration.
R&D expenses are comprised of the following main categories: (i) research, which includes costs to support the discovery and development of new molecular entities through pre-clinical studies; (ii) drug development, which includes costs to support clinical development of potential new products, including expansion of indications for existing products through Phase I, Phase II and Phase III clinical studies and (iii) Other, which includes costs to support manufacturing development of pre-approved products, medical support of marketed products, IPRD impairment charges, acquisition-related charges and proportionate allocations of enterprise-wide costs including facilities, information technology, and other appropriate costs.
Acquired IPRD expenses in 2024 included $12.1 billion related to the acquisition of Karuna, as further described in “Item 8.
Acquisitions, Divestitures, Licensing and Other Arrangements."
| | | | | | | | | | PHASE II | | | | | | PHASE III | | | | | | APPROVED INDICATIONS | | | | | |
| ª | | | Development Partnerships: *AUGTYRO:* Zai Lab; BMS-986495: Prothena; *COBENFY*: Zai Lab; iza-bren (EGFRxHER3 ADC): SystImmune; *KRAZATI*: Zai Lab; milvexian: Johnson & Johnson; obexelimab: Zenas BioPharma; *OPDIVO*, *YERVOY*, *OPDUALAG,* nivolumab + relatlimab HD, Anti-CCR8 + nivolumab: Ono; PKCθ Inhibitor: Exscientia; *REBLOZYL*: Merck; rHuPH20: Halozyme | | | | | |
| | | | | | | | | |
| Opdivo | | | Adjuvant HCC | | | CheckMate -9DX | | | | | | Sotyktu | | | SLE | | | POETYK SLE-1 | | |
| Opdivo | | | Peri-adjuvant MIUC | | | CA017-078 | | | | | | Sotyktu | | | SLE | | | POETYK SLE-2 | | |
| Opdualag | | | Adjuvant Stage III/IV Melanoma | | | RELATIVITY-098 | | | | | | admilparant | | | IPF | | | ALOFT-IPF | | |
| Opdualag | | | 1L Melanoma SC | | | RELATIVITY-127 | | | | | | obexelimab | | | IgG4-Related Disease | | | INDIGO | | |
| RYZ101 | | | 2L+ SSTR2+ GEP-NETs | | | ACTION-1 | | | | | | Asset | | | Disease | | | Trial | | |
| | | | | | | | | | | | | Camzyos | | | nHCM | | | ODYSSEY-HCM | | |
We expect that our planned acquisitions of Karuna and RayzeBio, announced during the fourth quarter of 2023, as well as the Mirati (2024) and the Turning Point (2022) acquisitions, will continue to position us as a leading biopharmaceutical company, expanding our targeted oncology portfolio, as well as other therapeutic areas, including neuroscience.
Our priorities are to continue renewing and diversifying our portfolio, advancing our early, mid and late-stage pipeline, and executing disciplined business development.
We remain committed to strengthening our balance sheet and returning capital to shareholders.
Management's Discussion and Analysis of Financial Condition and Results of Operations—Strategy.”
Most of our revenues come from products in the following therapeutic classes: hematology, oncology, cardiovascular and immunology.
Our significant business development activities in 2023 included: (i) the acquisition of Mirati, which was
completed in January 2024; (ii) the planned acquisitions of Karuna and RayzeBio, which were announced in December 2023; and (iii) a global strategic collaboration agreement with SystImmune, which was announced in December 2023.
In-Line Products
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.
New Product Portfolio
*Onureg®* *Onureg* (azacitidine) is 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.
*Inrebic®* *Inrebic* (fedratinib) is 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.
*Augtyro®* *Augtyro* (repotrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.
Recent LOE Products
Many developed countries provide certain non-patent incentives for the development of medicines.
For example, in the U.S., EU, Japan and certain other countries, RDP exclusivity rights are offered as incentives for research on medicines for rare diseases, or orphan drugs, and on medicines useful in treating pediatric patients.
The type of application filed (NDA or BLA) can affect RDP exclusivity rights as discussed below.
A pharmaceutical drug product that contains an active ingredient that has been previously approved in an NDA, but is approved in, for example, a new formulation or a new route of administration, but not for the drug itself, or for a new indication on the basis of new clinical studies, may receive three years of RDP for that formulation, route of administration, or indication.
U.S. healthcare legislation enacted in 2010 created an approval pathway for biosimilar versions of innovative biological products.
The FDA can approve products that are similar to (but not generic copies of) innovative biologics on the basis of less extensive data than is required by a full BLA.
After an innovator has marketed its product for four years, any manufacturer may file an application for approval of a “biosimilar” version of the innovator product.
The law also provides a mechanism for innovators to enforce the patents that protect innovative biological products and for biosimilar applicants to challenge the patents.
Such patent litigation may begin as early as four years after the innovative biological product is first approved by the FDA.
It is also possible for new chemical products to obtain marketing authorization in the EU through a “mutual recognition procedure,” in which an application is made to a single member state, and if the member state approves the pharmaceutical product under a national procedure, then the applicant may submit that approval to the mutual recognition procedure of some or all other member states.
Also, the European patent system has an opposition procedure in which generic manufacturers may challenge the validity of patents covering innovator products within nine months of grant.
In addition to the relevant legislation and annexes related to biologic medicinal products, the EMA has issued guidelines that outline the additional information to be provided for biosimilar products, also known as generic biologics, in order to review an application for marketing approval.
| *Inrebic* (fedratinib)(f) | | | 2031 | | | | | | 2031 | | | | | | ++ | | |
| *Onureg* (azacitidine)(g) | | | 2027 | | | | | | ^^ | | | | | | ++ | | |
For Japan, the estimated minimum market exclusivity date was June 2023 and we are not aware of any generics entering the market as of December 31, 2023.
(e) For *Eliquis*, in the U.S., two patents listed in the FDA Orange Book, the composition of matter patent claiming apixaban specifically (expiring 2026) and a formulation patent (expiring 2031), were challenged by numerous generic companies.
In August 2020, the U.S. District Court for the District of Delaware decided that the two challenged *Eliquis* patents are both valid and infringed by the remaining generic companies.
The remaining generic companies appealed, and in September 2021 the U.S. Court of Appeals for the Federal Circuit upheld the decision with respect to both patents.
Refer to “Item 8.
Legal Proceedings and Contingencies” for more information.
(g) For *Onureg* in the U.S., the estimated minimum market exclusivity date of 2027 is based on seven years of orphan drug exclusivity.
Formulation patents covering *Onureg* expire in 2029 and 2030 in the U.S., and in 2029 in the EU and Japan.
In the EU, we have four formulation patents (EP 2,299,984; EP 2,695,609; EP 3,692,983; and EP 3,782,611) that cover *Onureg* and they are in pending opposition proceedings.
The EPO Opposition Division found three of these formulation patents invalid, and the decisions are being or will be appealed.
For Europe, the estimated minimum market exclusivity date is August 2024 based on RDP exclusivity.
(k) For *Reblozyl* in the U.S. and Europe, the estimated minimum market exclusivity date is based on RDP exclusivity.
An excerpt. Shown here: 40 of 125 rewritten, 40 of 60 added and 40 of 105 removed. The counts are complete. For every sentence, read Item 1. BUSINESS. in the FY2024 filing and the FY2023 filing.
Cover and table of contents
45 rewritten, 10 added, 10 removed, 72 unchanged
For the fiscal year ended December 31, [removed: 2023][added: 2024]
The aggregate market value of the [removed: 2,087,551,048] [added: 2,026,400,768] shares of voting common equity held by non-affiliates of the registrant, computed by reference to the closing price as reported on the New York Stock Exchange, as of the last business day of the registrant’s most recently completed second fiscal quarter was approximately [removed: $133,498,889,520.][added: $84,156,423,913.]
At February 6, [removed: 2024,] [added: 2025,] there were [removed: 2,022,193,411] [added: 2,029,312,023] shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE: Portions of the definitive proxy statement for the registrant’s Annual Meeting of Shareholders to be filed within 120 days after the conclusion of the registrant's fiscal year ended December 31, [removed: 2023] [added: 2024] with the U.S. Securities and Exchange Commission pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent described therein.
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| | | | | | | [Acquisitions, [removed: Divestitures and] [added: Divestitures,] Licensing [removed: Arrangements](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_19)] [added: and Other Arrangements](#i108122c74c1d499c8dfc549b508b40bd_19)] | | | [removed: [2](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_19)] [added: [2](#i108122c74c1d499c8dfc549b508b40bd_19)] | | |
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| [PART [removed: IA](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_85)] [added: IA](#i108122c74c1d499c8dfc549b508b40bd_85)] | | | | | | [Information about our Executive [removed: Officers](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_85)] [added: Officers](#i108122c74c1d499c8dfc549b508b40bd_85)] | | | [removed: [35](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_85)] [added: [37](#i108122c74c1d499c8dfc549b508b40bd_85)] | | |
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| | | | | | | [Consolidated Statements of Earnings and Comprehensive [removed: Income](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] [added: (Loss)/Income](#i108122c74c1d499c8dfc549b508b40bd_202)] | | | [removed: [71](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] [added: [75](#i108122c74c1d499c8dfc549b508b40bd_202)] | | |
| | | | | | | [Consolidated Balance [removed: Sheets](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] [added: Sheets](#i108122c74c1d499c8dfc549b508b40bd_205)] | | | [removed: [72](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] [added: [76](#i108122c74c1d499c8dfc549b508b40bd_205)] | | |
| | | | | | | [Consolidated Statements of Cash [removed: Flows](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] [added: Flows](#i108122c74c1d499c8dfc549b508b40bd_208)] | | | [removed: [73](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] [added: [77](#i108122c74c1d499c8dfc549b508b40bd_208)] | | |
| | | | | | | [Notes to the Financial [removed: Statements](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] [added: Statements](#i108122c74c1d499c8dfc549b508b40bd_211)] | | | [removed: [74](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] [added: [78](#i108122c74c1d499c8dfc549b508b40bd_211)] | | |
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| | | | [Item [removed: 12.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] [added: 12.](#i108122c74c1d499c8dfc549b508b40bd_325)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] [added: Matters](#i108122c74c1d499c8dfc549b508b40bd_325)] | | | [removed: [125](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] [added: [128](#i108122c74c1d499c8dfc549b508b40bd_325)] | | |
December 31, 2024
| [PART I](#i108122c74c1d499c8dfc549b508b40bd_13) | | | | | | | | | | | |
| | | | | | | [Alliances](#i108122c74c1d499c8dfc549b508b40bd_34) | | | [14](#i108122c74c1d499c8dfc549b508b40bd_34) | | |
| | | | | | | [Competition](#i108122c74c1d499c8dfc549b508b40bd_40) | | | [15](#i108122c74c1d499c8dfc549b508b40bd_40) | | |
| [PART II](#i108122c74c1d499c8dfc549b508b40bd_88) | | | | | | | | | | | |
| [PART III](#i108122c74c1d499c8dfc549b508b40bd_316) | | | | | | | | | | | |
| [PART IV](#i108122c74c1d499c8dfc549b508b40bd_334) | | | | | | | | | | | |
| [SIGNATURES](#i108122c74c1d499c8dfc549b508b40bd_343) | | | | | | | | | [130](#i108122c74c1d499c8dfc549b508b40bd_343) | | |
| [SUMMARY OF ABBREVIATED TERMS](#i108122c74c1d499c8dfc549b508b40bd_346) | | | | | | | | | [132](#i108122c74c1d499c8dfc549b508b40bd_346) | | |
| [EXHIBIT INDEX](#i108122c74c1d499c8dfc549b508b40bd_349) | | | | | | | | | [133](#i108122c74c1d499c8dfc549b508b40bd_349) | | |
December 31, 2023
| [PART I](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_13) | | | | | | | | | | | |
| | | | | | | [Alliances](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_37) | | | [13](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_37) | | |
| | | | | | | [Competition](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_43) | | | [14](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_43) | | |
| [PART II](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_88) | | | | | | | | | | | |
| [PART III](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_283) | | | | | | | | | | | |
| [PART IV](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_301) | | | | | | | | | | | |
| [SIGNATURES](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_310) | | | | | | | | | [127](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_310) | | |
| [SUMMARY OF ABBREVIATED TERMS](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_313) | | | | | | | | | [129](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_313) | | |
| [EXHIBIT INDEX](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316) | | | | | | | | | [130](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316) | | |
An excerpt. Shown here: 40 of 45 rewritten, all 10 added and all 10 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2024 filing and the FY2023 filing.
Item 1C. CYBERSECURITY
6 rewritten, 6 added, 1 removed, 28 unchanged
The Company employs robust cybersecurity and data privacy programs that are [removed: largely aligned to, among others, the U.S. National Institute of Standards and Technology Cybersecurity Framework] [added: designed] to assess, identify and manage material risks from cybersecurity threats.
Our employees are exposed to data-driven cybersecurity awareness campaigns and [added: annual] training in order to keep pace with industry standards, evolving challenges and innovative solutions with respect to information security, data privacy, and cybersecurity risks to the organization.
As noted, we also conduct tabletop exercises to identify [removed: gaps] [added: improvement opportunities] in our supply chain [removed: resilience so we can implement improvements.][added: resilience.]
[removed: As] [added: While we and our third-party vendors are regularly subject to cybersecurity attacks and incidents, as] of December 31, [removed: 2023,] [added: 2024] and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the [removed: Company.][added: Company in the last three years.]
[removed: The] [added: Our CISO has led our enterprise-wide cybersecurity risk management, strategy, policy, standards and processes since 2018, and the] information security team responsible for managing and implementing the Company’s cybersecurity and data privacy programs has many years of valuable business experience [removed: managing risks from] [added: effectively addressing] cybersecurity [removed: threats and data privacy breaches] [added: risks] and developing [removed: and implementing cybersecurity and data privacy] [added: related robust] policies and procedures.
Our Audit Committee reviews, discusses with management [added: at least annually] and oversees the Company’s information security and data protection programs.
These programs are independently assessed every three years against the U.S. National Institute of Standards and Technology Cybersecurity Framework ("NIST").
In many regions, our employees receive a monthly snapshot of their cyber behaviors and are given a rating for their cyber vigilance.
We perform multiple tabletop exercises across various levels of the Company each year to test our incident response procedures, enhance our resiliency by seeking to ensure business continuity during potential extended digital outages, identify improvement opportunities and increase employee awareness and preparedness.
These tabletop exercises focus on various aspects of cybersecurity events, including patient and employee impact, operational resilience and effectiveness and communication coordination.
The CISO reports to the Chief Digital & Technology Officer, who in turn reports to the CEO.
Collectively, our CISO and senior management team have extensive experience in information security and information technology risk management, including cybersecurity.
We perform periodic tabletop exercises annually to test our incident response procedures, identify gaps and improvement opportunities and exercise team preparedness.
Item 2. PROPERTIES.
4 rewritten, 1 added, 1 removed, 10 unchanged
We also believe that none of our properties [removed: is] [added: are] subject to any material encumbrance, easement or other restriction that would detract materially from [removed: its] [added: their] value or impair [removed: its] [added: their] use in the operation of the business.
Our significant manufacturing and R&D locations by geographic area were as follows at December 31, [removed: 2023:][added: 2024:]
| United States | | | [removed: 6] [added: 4] | | | | | | 8 | | |
| Total | | | [removed: 7] [added: 6] | | | | | | [removed: 9] [added: 10] | | |
| International | | | 2 | | | | | | 2 | | |
| Europe | | | 1 | | | | | | 1 | | |
Item 4. MINE SAFETY DISCLOSURES.
13 rewritten, 2 added, 2 removed, 10 unchanged
Listed below is information on our executive officers as of February [removed: 13, 2024.][added: 12, 2025.]
| Name and Current Position | | | Age | | | Employment [removed: History for the Past 5 Years] [added: History] | | |
| Christopher Boerner, Ph.D. [removed: *Chief] [added: *Chair of the Board and Chief] Executive Officer* *Member of the Leadership Team* | | | [removed: 53] [added: 54] | | | 2015 to 2017 – President and Head of U.S. Commercial 2017 to 2018 – President and Head, International Markets 2018 to 2023 – Executive Vice President, Chief Commercialization Officer 2023 to 2023 – Executive Vice President, Chief Operating Officer 2023 to [added: 2024 – Chief Executive Officer 2024 to] present – [added: Chair of the Board and] Chief Executive Officer | | |
| David V. Elkins *Executive Vice President and Chief Financial Officer* *Member of the Leadership Team* | | | [removed: 55] [added: 56] | | | 2014 to 2017 – Group Vice President and Chief Financial Officer, Consumer and Consumer Medicines, Johnson & Johnson 2017 to 2018 – Worldwide Vice President and Chief Financial Officer, Consumer Products, Medical Development and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene Corporation 2019 to present – Executive Vice President and Chief Financial Officer | | |
| Cari Gallman *Executive Vice President, Corporate Affairs* *Member of the Leadership Team* | | | [removed: 44] [added: 45] | | | 2015 to 2018 – Senior Counsel, US Legal 2018 to 2019 – Assistant General Counsel, Oncology Legal 2019 to 2021 – Vice President, Assistant General Counsel, Worldwide Oncology 2021 to 2023 – Senior Vice President, Chief Compliance Officer 2023 to present – Executive Vice President, Corporate Affairs | | |
| Samit Hirawat, M.D. *Executive Vice President, Chief Medical Officer, Head of Development* *Member of the Leadership Team* | | | [removed: 55] [added: 56] | | | 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to 2023 – Executive Vice President, Chief Medical Officer, Global Drug Development 2023 to present – Executive Vice President, Chief Medical Officer, Head of Development | | |
| Lynelle Hoch *President, Cell Therapy Organization* *Member of the Leadership Team* | | | [removed: 51] [added: 52] | | | 2016 to 2019– Vice President, Immuno-Oncology Marketing 2019 to 2021 – General Manager, Ireland & UK, Major Markets 2021 to 2023 – Senior Vice President, Global Cell Therapy Franchise Lead 2023 to present – President, Cell Therapy Organization | | |
| Adam Lenkowsky *Executive Vice President, Chief Commercialization Officer* *Member of the Leadership Team* | | | [removed: 52] [added: 53] | | | 2016 to 2019 – Head of US Oncology 2019 to 2022 – Senior Vice President, General Manager of U.S. Oncology, Immunology & Cardiovascular 2022 to 2023 Senior Vice President, Head of Major Markets 2023 to present – Executive Vice President, Chief Commercialization Officer | | |
| Sandra Leung *Executive Vice President, General Counsel* *Member of the Leadership Team* | | | [removed: 63] [added: 64] | | | 2015 to present – Executive Vice President, General Counsel | | |
| Greg Meyers *Executive Vice President, Chief Digital and Technology Officer* *Member of the Leadership Team* | | | [removed: 51] [added: 52] | | | 2014 to 2018 – Corporate Vice President and Chief Information Officer, Motorola Solutions 2018 to 2022 – Group Chief Information and Digital Officer, Syngenta Group 2022 to present – Executive Vice President, Chief Digital and Technology Officer | | |
| Robert Plenge, M.D., Ph.D. *Executive Vice President, Chief Research Officer, Head of Research* *Member of the Leadership Team* | | | [removed: 53] [added: 54] | | | 2017 to 2019 – Vice President Inflammation and Immunology, Thematic Center of Excellence Unit, Celgene Corporation 2019 to 2021 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center 2021 to 2023 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center, and Head of Translational Medicine 2023 to 2023 – Senior Vice President and Head of Discovery and Translational Sciences 2023 to present – Executive Vice President, Chief Research Officer, Head of Research | | |
| Amanda Poole *Executive Vice President, Chief [removed: Human Resources] [added: People] Officer* *Member of the Leadership Team* | | | [removed: 49] [added: 50] | | | 2017 to 2019 – Vice President, Head of Human Resources, Global Product Development & Supply 2019 to 2020 – Vice President, Head of BMS/Celgene Integration 2020 to 2022 – Senior Vice President, Head of Human Resources, Commercialization 2022 to 2024 – Senior Vice President, People Strategy, Solutions & Services 2024 to present – Executive Vice President, Chief [removed: Human Resources] [added: People] Officer | | |
| Karin Shanahan *Executive Vice President, Global Product Development & Supply* *Member of the Leadership Team* | | | [removed: 59] [added: 60] | | | 2013 to 2018 – Senior Vice President and Chief Operating Officer, Global Operations, Teva Pharmaceuticals 2018 to 2022 – Senior Vice President, Global Biologics & Sterile Operations, Merck 2022 to present – Executive Vice President, Global Product Development & Supply | | |
| Benjamin Hickey *President, RayzeBio Organization* *Member of the Leadership Team* | | | 50 | | | 2014 to 2016 – Vice President, Commercial, Immuno-Oncology 2016 to 2018 – General Manager, UK & Ireland 2018 to 2020 – Senior Vice President, Chief Commercial Officer, Halozyme Therapeutics 2020 to 2024 – Chief Commercial Officer, Head of Business Development, Mirati Therapeutics 2024 to present – President, RayzeBio Organization, Bristol-Myers Squibb Company | | |
| Phil Holzer *Senior Vice President & Controller* | | | 49 | | | 2015 to 2018 – Chief Audit Officer 2018 to 2019 – Vice President & Head of Finance, Research & Development 2019 to 2021 – Senior Vice President, Enterprise Integration Management 2021 to 2024 – Senior Vice President, Finance, Tax & Treasury 2024 to present – Senior Vice President & Controller | | |
| Giovanni Caforio, M.D. *Executive Chairman of the Board* *Member of the Leadership Team* | | | 59 | | | 2015 to 2017 – Chief Executive Officer and Director of the Company 2017 to 2023 – Chairman of the Board and Chief Executive Officer 2023 to present – Executive Chairman of the Board | | |
| Sharon Greenlees *Senior Vice President, Corporate Controller* | | | 52 | | | 2016 to 2018 – Vice President of Investor Relations, AbbVie Inc. 2018 to 2020 – Head of Pricing, U.S. Commercial, AbbVie Inc. 2020 to 2021 – Head of Supply Chain Finance, AbbVie Inc. 2021 to 2022 – Vice President and Controller, R&D Finance and Operations, AbbVie Inc. 2022 to present – Senior Vice President, Corporate Controller | | |
Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
8 rewritten, 7 added, 12 removed, 21 unchanged
The number of record holders of our common stock at January 31, [removed: 2024] [added: 2025] was [removed: 31,207.][added: 29,685.]
Information required by this item will be contained in our [removed: 2024] [added: 2025] Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive Officers—Equity Compensation Plan Information,” which information is incorporated herein by reference.
The graph assumes $100 investment on December 31, [removed: 2018] [added: 2019] in each of our common shares, the S&P 500 Index and the stock of our peer group companies, including reinvestment of dividends, for the years ended December 31, [removed: 2019,] 2020, 2021, [removed: 2022] [added: 2022, 2023] and [removed: 2023.][added: 2024.]
[removed: ][added: ]
| | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2023] [added: 2024] | | |
The following table summarizes the surrenders of our equity securities during the three months ended December 31, [removed: 2023:][added: 2024:]
(a) Includes shares [removed: repurchased as part] of [removed: publicly announced programs and shares of] common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive program.
The remaining share repurchase capacity under the program was $5.0 billion as of December 31, [removed: 2023.][added: 2024.]
| Bristol Myers Squibb | | | | | | $ | 100.41 | | | | | $ | 103.30 | | | | | $ | 122.91 | | | | | $ | 90.77 | | | | | $ | 105.12 | |
| S&P 500 | | | | | | 118.40 | | | | | | 152.39 | | | | | | 124.79 | | | | | | 157.59 | | | | | | 197.02 | | |
| Peer Group | | | | | | 102.02 | | | | | | 125.57 | | | | | | 139.06 | | | | | | 141.88 | | | | | | 153.64 | | |
| October 1 to 31, 2024 | | | 79,154 | | | | | | $ | 53.57 | | | | | — | | | | | | $ | 5,014 | |
| November 1 to 30, 2024 | | | 28,401 | | | | | | 54.41 | | | | | | — | | | | | | 5,014 | | |
| December 1 to 31, 2024 | | | 27,385 | | | | | | 58.28 | | | | | | — | | | | | | 5,014 | | |
| Three months ended December 31, 2024 | | | 134,940 | | | | | | | | | | | | — | | | | | | | | |
| Bristol Myers Squibb | | | | | | $ | 127.74 | | | | | $ | 128.26 | | | | | $ | 131.95 | | | | | $ | 157.00 | | | | | $ | 115.95 | |
| S&P 500 | | | | | | 131.49 | | | | | | 155.68 | | | | | | 200.37 | | | | | | 164.08 | | | | | | 207.21 | | |
| Peer Group | | | | | | 117.27 | | | | | | 119.64 | | | | | | 147.25 | | | | | | 163.08 | | | | | | 166.38 | | |
| October 1 to 31, 2023 | | | 68,146 | | | | | | $ | 57.26 | | | | | — | | | | | | $ | 2,014 | |
| November 1 to 30, 2023 (c) | | | 13,875,165 | | | | | | | | | | | | 13,853,518 | | | | | | 2,014 | | |
| December 1 to 31, 2023 | | | 36,099 | | | | | | 50.36 | | | | | | — | | | | | | 5,014 | | |
| Three months ended December 31, 2023 | | | 13,979,410 | | | | | | | | | | | | 13,853,518 | | | | | | | | |
Refer to “Item 8.
Financial Statements and Supplementary Data—Note 17.
(c) Represents approximately 14 million of shares, under the ASR, settled and transferred into treasury stock.
The completed repurchases pursuant to the ASR had an average repurchase price of $57.19.
Equity” for further information.
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
698 rewritten, 343 added, 332 removed, 941 unchanged
| [removed: EARNINGS] | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |
| Net product sales | | | $ | [removed: 43,778] [added: 46,778] | | | | | $ | [removed: 44,671] [added: 43,778] | | | | | $ | [removed: 45,055] [added: 44,671] | |
| Alliance and other revenues | | | [removed: 1,228] [added: 1,522] | | | | | | [removed: 1,488] [added: 1,228] | | | | | | [removed: 1,330] [added: 1,488] | | |
| Total Revenues | | | [removed: 45,006] [added: 48,300] | | | | | | [removed: 46,159] [added: 45,006] | | | | | | [removed: 46,385] [added: 46,159] | | |
| Cost of products sold(a) | | | [removed: 10,693] [added: 13,968] | | | | | | [removed: 10,137] [added: 10,693] | | | | | | [removed: 9,940] [added: 10,137] | | |
| Marketing, selling and administrative | | | [removed: 7,772] [added: 8,414] | | | | | | [removed: 7,814] [added: 7,772] | | | | | | [removed: 7,690] [added: 7,814] | | |
| Research and development | | | [removed: 9,299] [added: 11,159] | | | | | | [removed: 9,509] [added: 9,299] | | | | | | [removed: 10,195] [added: 9,509] | | |
| Acquired IPRD | | | [removed: 913] [added: 13,373] | | | | | | [removed: 815] [added: 913] | | | | | | [removed: 1,159] [added: 815] | | |
| Amortization of acquired intangible assets | | | [removed: 9,047] [added: 8,872] | | | | | | [removed: 9,595] [added: 9,047] | | | | | | [removed: 10,023] [added: 9,595] | | |
| Other (income)/expense, net | | | [removed: (1,158)] [added: 893] | | | | | | [removed: 576] [added: (1,158)] | | | | | | [removed: (720)] [added: 576] | | |
| Total Expenses | | | [removed: 36,566] [added: 56,679] | | | | | | [removed: 38,446] [added: 36,566] | | | | | | [removed: 38,287] [added: 38,446] | | |
| [removed: Earnings Before Income Taxes] [added: (Loss)/earnings before income taxes] | | | [removed: 8,440] [added: (8,379)] | | | | | | [removed: 7,713] [added: 8,440] | | | | | | [removed: 8,098] [added: 7,713] | | |
| [removed: Provision for] Income [removed: Taxes] [added: tax provision] | | | [removed: 400] [added: 554] | | | | | | [removed: 1,368] [added: 400] | | | | | | [removed: 1,084] [added: 1,368] | | |
| Net [removed: Earnings] [added: (loss)/earnings] | | | [removed: 8,040] [added: (8,933)] | | | | | | [removed: 6,345] [added: 8,040] | | | | | | [removed: 7,014] [added: 6,345] | | |
| Noncontrolling Interest | | | 15 | | | | | | [removed: 18] [added: 15] | | | | | | [removed: 20] [added: 18] | | |
| Net [removed: Earnings Attributable] [added: (loss)/earnings attributable] to BMS | | | $ | [removed: 8,025] [added: (8,948)] | | | | | $ | [removed: 6,327] [added: 8,025] | | | | | $ | [removed: 6,994] [added: 6,327] | |
| [removed: Earnings] [added: (Loss)/Earnings] per [removed: Common Share] [added: common share:] | | | | | | | | | | | | | | | | | |
| Basic | | | $ | [removed: 3.88] [added: (4.41)] | | | | | [removed: 2.97] [added: $] | [added: 3.88] | | | | | $ | [removed: 3.15] [added: 2.97] | |
| Diluted | | | [removed: 3.86] [added: (4.41)] | | | | | | [removed: 2.95] [added: 3.86] | | | | | | [removed: 3.12] [added: 2.95] | | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE [removed: INCOME][added: (LOSS)/INCOME]
| Net [removed: Earnings] [added: (loss)/earnings] | | | $ | [removed: 8,040] [added: (8,933)] | | | | | $ | [removed: 6,345] [added: 8,040] | | | | | $ | [removed: 7,014] [added: 6,345] | |
| Derivatives qualifying as cash flow hedges | | | [removed: (230)] [added: 374] | | | | | | [removed: 54] [added: (230)] | | | | | | [removed: 415] [added: 54] | | |
| Pension and postretirement benefits | | | [removed: (115)] [added: 90] | | | | | | [removed: 145] [added: (115)] | | | | | | [removed: 206] [added: 145] | | |
| Marketable debt securities | | | [removed: 2] [added: —] | | | | | | [removed: (2)] [added: 2] | | | | | | [removed: (9)] [added: (2)] | | |
| Foreign currency translation | | | [removed: 78] [added: (156)] | | | | | | [removed: (210)] [added: 78] | | | | | | [removed: (41)] [added: (210)] | | |
| Total [removed: Other Comprehensive Income/(Loss)] [added: other comprehensive income/(loss)] | | | [removed: (265)] [added: 308] | | | | | | [removed: (13)] [added: (265)] | | | | | | [removed: 571] [added: (13)] | | |
| Comprehensive [removed: Income] [added: (loss)/income] | | | [removed: 7,775] [added: (8,625)] | | | | | | [removed: 6,332] [added: 7,775] | | | | | | [removed: 7,585] [added: 6,332] | | |
| Comprehensive [removed: Income Attributable] [added: income attributable] to [removed: Noncontrolling Interest] [added: noncontrolling interest] | | | 15 | | | | | | [removed: 18] [added: 15] | | | | | | [removed: 20] [added: 18] | | |
| Comprehensive [removed: Income Attributable] [added: (loss)/income attributable] to BMS | | | $ | [removed: 7,760] [added: (8,640)] | | | | | $ | [removed: 6,314] [added: 7,760] | | | | | $ | [removed: 7,565] [added: 6,314] | |
| ASSETS | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |
| Cash and cash equivalents | | | $ | [removed: 11,464] [added: 10,346] | | | | | $ | [removed: 9,123] [added: 11,464] | |
| Marketable debt securities | | | [removed: 816] [added: 513] | | | | | | [removed: 130] [added: 816] | | |
| Receivables | | | [removed: 10,921] [added: 10,747] | | | | | | [removed: 9,886] [added: 10,921] | | |
| Inventories | | | [removed: 2,662] [added: 2,557] | | | | | | [removed: 2,339] [added: 2,662] | | |
| Other current assets | | | [removed: 5,907] [added: 5,617] | | | | | | [removed: 5,795] [added: 5,907] | | |
| Total Current assets | | | [removed: 31,770] [added: 29,780] | | | | | | [removed: 27,273] [added: 31,770] | | |
| Property, plant and equipment | | | [removed: 6,646] [added: 7,136] | | | | | | [removed: 6,255] [added: 6,646] | | |
| Goodwill | | | [removed: 21,169] [added: 21,719] | | | | | | [removed: 21,149] [added: 21,169] | | |
| Other intangible assets | | | [removed: 27,072] [added: 23,307] | | | | | | [removed: 35,859] [added: 27,072] | | |
| Deferred income taxes | | | [removed: 2,768] [added: 4,236] | | | | | | [removed: 1,344] [added: 2,768] | | |
| Net (loss)/earnings | | | $ | (8,933) | | | | | $ | 8,040 | | | | | $ | 6,345 | |
| Other adjustments | | | 94 | | | | | | 300 | | | | | | 223 | | |
| Proceeds from issuance of short-term debt obligations | | | 2,987 | | | | | | — | | | | | | — | | |
| Repayments of short-term debt obligations | | | (3,000) | | | | | | — | | | | | | — | | |
The following table represents the significant segment expenses regularly provided to the CEO:
| Research (a) | | | $ | 1,522 | | | | | $ | 1,557 | | | | | $ | 1,553 | |
| Drug Development (b) | | | 4,495 | | | | | | 3,835 | | | | | | 3,824 | | |
| Other (c) | | | 5,142 | | | | | | 3,907 | | | | | | 4,132 | | |
| Research and development | | | $ | 11,159 | | | | | $ | 9,299 | | | | | $ | 9,509 | |
(a) Includes costs to support the discovery and development of new molecular entities through pre-clinical studies.
(b) Includes costs to support clinical development of potential new products, including expansion of indications for existing products through Phase I, Phase II and Phase III clinical studies.
(c) Includes costs to support manufacturing development of pre-approved products, medical support of marketed products, IPRD impairment charges, acquisition-related charges and proportionate allocations of enterprise-wide costs including facilities, information technology, and other appropriate costs.
| Acquisitions (Note 4) | | | 12,122 | | | | | | — | | | | | | — | | |
| Acquired IPRD | | | $ | 13,373 | | | | | $ | 913 | | | | | $ | 815 | |
BMS adopted the new guidance for the annual period ending December 31, 2024.
*Disaggregation of Income Statement Expenses*
In November 2024, the FASB issued guidance on income statement disclosures.
The guidance aims to provide enhanced disclosures of income expense categories to improve transparency and provide financial statement users with more detailed information about the nature, amount and timing of expenses impacting financial performance.
| Net product sales | | | $ | 46,778 | | | | | $ | 43,778 | | | | | $ | 44,671 | |
| Cencora, Inc. | | | 29 | | % | | | | 29 | | % | | | | 25 | | % |
| Net product sales | | | $ | 46,778 | | | | | $ | 43,778 | | | | | $ | 44,671 | |
| Dollars in millions | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |
| Growth Portfolio | | | | | | | | | | | | | | | | | |
| *Krazati* | | | 126 | | | | | | — | | | | | | — | | |
| *Cobenfy* | | | 10 | | | | | | — | | | | | | — | | |
| Other Growth products(a) | | | 1,605 | | | | | | 1,211 | | | | | | 1,092 | | |
| Total Growth Portfolio | | | 22,563 | | | | | | 19,366 | | | | | | 16,757 | | |
| Legacy Portfolio | | | | | | | | | | | | | | | | | |
| Other Legacy products(b) | | | 925 | | | | | | 962 | | | | | | 1,162 | | |
| Total Legacy Portfolio | | | 25,737 | | | | | | 25,640 | | | | | | 29,402 | | |
| Total Revenues | | | $ | 48,300 | | | | | $ | 45,006 | | | | | $ | 46,159 | |
| United States | | | 34,105 | | | | | | 31,210 | | | | | | 31,500 | | |
| International | | | 13,199 | | | | | | 13,097 | | | | | | 13,825 | | |
| Total Revenues | | | $ | 48,300 | | | | | $ | 45,006 | | | | | $ | 46,159 | |
(a) Includes *Onureg*, *Inrebic*, *Nulojix*, *Empliciti* and royalty revenues.
(b) Includes other mature brands.
Beginning in 2024, Puerto Rico revenues are included in International revenues.
Prior period amounts have been reclassified to conform to the current presentation.
- Royalties and contingent sales based milestones payable to BMS by license partners are presented in Alliance revenues
| Dollars in millions | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |
| COMPREHENSIVE INCOME | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |
| | | | | | | | | | | | |
| Contingent consideration fair value adjustments | | | (8) | | | | | | (9) | | | | | | (542) | | |
| Other adjustments | | | 308 | | | | | | 232 | | | | | | 183 | | |
Acquisitions
*Fair Value Measurements*
In June 2022, the FASB issued amended guidance on measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security.
The guidance clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.
The guidance also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction.
The amendment requires the following disclosures for equity securities subject to contractual sale restrictions: the fair value of equity securities subject to contractual sale restrictions reflected in the consolidated balance sheets; the nature and remaining duration of the restriction(s); and the circumstances that could cause a lapse in the restriction(s).
Early adoption is permitted.
The guidance was adopted on January 1, 2023 and the adoption did not have an impact to the consolidated financial statements.
In October 2021, the FASB issued amended guidance on accounting for contract assets and contract liabilities from contracts with customers in a business combination.
The guidance is intended to address inconsistency related to recognition of an acquired contract liability and payment terms and their effect on subsequent revenue recognized.
At the acquisition date, an entity should account for the related revenue contracts in accordance with existing revenue recognition guidance generally by assessing how the acquiree applied recognition and measurement in their financial statements.
| Cencora, Inc. (formerly known an AmerisourceBergen Corporation) | | | 29 | | % | | | | 25 | | % | | | | 25 | | % |
| In-Line Products | | | | | | | | | | | | | | | | | |
| Mature and other brands | | | 1,895 | | | | | | 2,045 | | | | | | 2,234 | | |
| Total In-Line Products | | | 34,320 | | | | | | 33,340 | | | | | | 31,300 | | |
| New Product Portfolio | | | | | | | | | | | | | | | | | |
| *Onureg* | | | 168 | | | | | | 124 | | | | | | 73 | | |
| Total New Product Portfolio | | | 3,585 | | | | | | 2,030 | | | | | | 1,083 | | |
| Total In-Line Products and New Product Portfolio | | | 37,905 | | | | | | 35,370 | | | | | | 32,383 | | |
| Recent LOE Products(a) | | | | | | | | | | | | | | | | | |
| Total Recent LOE Products | | | 7,101 | | | | | | 10,789 | | | | | | 14,002 | | |
| United States | | | $ | 31,555 | | | | | $ | 31,828 | | | | | $ | 29,214 | |
| International | | | 12,752 | | | | | | 13,497 | | | | | | 16,319 | | |
(a) Recent LOE Products include products with significant expected decline in revenue from the prior reporting period as a result of a LOE.
| Revenues from Ono alliances: | | | | | | | | | | | | | | | | | |
BridgeBio
In 2022, BMS and BridgeBio commenced a collaboration to develop and commercialize BBP-398, a SHP2 inhibitor, in oncology.
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.
Cost reimbursements were not material.
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.
An excerpt. Shown here: 40 of 698 rewritten, 40 of 343 added and 40 of 332 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. in the FY2024 filing and the FY2023 filing.
Item 9A. CONTROLS AND PROCEDURES.
6 rewritten, 0 added, 0 removed, 8 unchanged
As of December 31, [removed: 2023,] [added: 2024,] 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 [removed: 2023] [added: 2024] Form 10-K.
Based on this evaluation, management has concluded that as of December 31, [removed: 2023,] [added: 2024,] such disclosure controls and procedures were effective.
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, [removed: 2023] [added: 2024] 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, [removed: 2023] [added: 2024] 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.
Deloitte & Touche LLP, an independent registered public accounting firm, has audited the Company’s financial statements included in this report on this [removed: 2023] [added: 2024] Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] which is included herein.
There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, [removed: 2023] [added: 2024] that have materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
Item 9B. OTHER INFORMATION.
1 rewritten, 0 added, 0 removed, 3 unchanged
During the fourth quarter of [removed: 2023,] [added: 2024,] no director or officer of the Company adopted or terminated an active "Rule 10b5-1 trading
Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
3 rewritten, 1 added, 1 removed, 22 unchanged
We have audited the internal control over financial reporting of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, [removed: 2023,] [added: 2024,] 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, [removed: 2023,] [added: 2024,] 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, [removed: 2023,] [added: 2024,] of the Company and our report dated February 12, [removed: 2024,] [added: 2025,] expressed an unqualified opinion on those financial statements.
February 12, 2025
February 12, 2024
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
5 rewritten, 1 added, 0 removed, 2 unchanged
(a)Reference is made to our [removed: 2024] [added: 2025] 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 [removed: 2023] [added: 2024] 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 [removed: 2024] [added: 2025] 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 [removed: 2024] [added: 2025] 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 [removed: 2024] [added: 2025] 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.
(f)Reference is made to our 2025 Proxy Statement section “How We Govern and Are Governed – Codes of Conduct” with respect to information relating to our insider trading policy, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
Item 11. EXECUTIVE COMPENSATION.
1 rewritten, 0 added, 0 removed, 2 unchanged
(a)Reference is made to our [removed: 2024] [added: 2025] 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.
Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
2 rewritten, 0 added, 0 removed, 2 unchanged
(a)Reference is made to our [removed: 2024] [added: 2025] 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 [removed: 2024] [added: 2025] 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.
Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
2 rewritten, 0 added, 0 removed, 2 unchanged
(a)Reference is made to our [removed: 2024] [added: 2025] 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 [removed: 2024] [added: 2025] 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.
Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
1 rewritten, 0 added, 0 removed, 3 unchanged
Reference is made to our [removed: 2024] [added: 2025] 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. 34), which are incorporated herein by reference and made a part hereof in response to the information required by Item 14.
Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULE.
7 rewritten, 1 added, 0 removed, 15 unchanged
| | | | [Consolidated Statements of Earnings and Comprehensive [removed: Income](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] [added: Income](#i108122c74c1d499c8dfc549b508b40bd_202)] | | | [removed: [71](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] [added: [75](#i108122c74c1d499c8dfc549b508b40bd_202)] | | |
| | | | [Consolidated Balance [removed: Sheets](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] [added: Sheets](#i108122c74c1d499c8dfc549b508b40bd_205)] | | | [removed: [72](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] [added: [76](#i108122c74c1d499c8dfc549b508b40bd_205)] | | |
| | | | [Consolidated Statements of Cash [removed: Flows](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] [added: Flows](#i108122c74c1d499c8dfc549b508b40bd_208)] | | | [removed: [73](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] [added: [77](#i108122c74c1d499c8dfc549b508b40bd_208)] | | |
| | | | [Notes to Consolidated Financial [removed: Statements](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] [added: Statements](#i108122c74c1d499c8dfc549b508b40bd_211)] | | | [removed: [74](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] [added: [78](#i108122c74c1d499c8dfc549b508b40bd_211)] | | |
| | | | [Report of Independent Registered Public Accounting [removed: Firm](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_265)] [added: Firm](#i108122c74c1d499c8dfc549b508b40bd_298)] | | | [removed: [120](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_265)] [added: [123](#i108122c74c1d499c8dfc549b508b40bd_298)] | | |
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this [removed: 2023] [added: 2024] Form 10-K.
| (b) | | | [Exhibits Required to be filed by Item 601 of Regulation [removed: S-K](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316)] [added: S-K](#i108122c74c1d499c8dfc549b508b40bd_349)] | | | [removed: [130](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316)] [added: [133](#i108122c74c1d499c8dfc549b508b40bd_349)] | | |
The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2024 Form 10-K.
Item 16. FORM 10-K SUMMARY.
152 rewritten, 26 added, 32 removed, 199 unchanged
| By | | | | | | [removed: /s/] [added: /s/] CHRISTOPHER BOERNER, [removed: Ph.D.] [added: Ph.D.] | | |
| | | | | | | [removed: Christopher] [added: Christopher] Boerner, [removed: Ph.D.] [added: Ph.D.] | | |
| | | | | | | [removed: Chief] [added: *Chair of the Board and Chief] Executive [removed: Officer] [added: Officer*] | | |
| Date: February [removed: 13, 2024] [added: 12, 2025] | | | | | | | | |
| /s/ CHRISTOPHER BOERNER, Ph.D. | | | | | | [added: Chair of the Board and] Chief Executive Officer | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ DAVID V. ELKINS | | | | | | Chief Financial Officer | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ [removed: SHARON GREENLEES] [added: PHIL M. HOLZER] | | | | | | Senior Vice President and Corporate Controller | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| [removed: (Sharon Greenlees)] [added: (Phil M. Holzer)] | | | | | | (Principal Accounting Officer) | | | | | | | | |
| /s/ PETER J. ARDUINI | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ DEEPAK L. BHATT. M.D. MPH | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ JULIA A. HALLER, M.D. | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ MANUEL HIDALGO MEDINA, M.D., Ph.D. | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ PAULA A. PRICE | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ DERICA W. RICE | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ THEODORE R. SAMUELS | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ KAREN H. VOUSDEN, Ph.D. | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
| /s/ PHYLLIS R. YALE | | | | | | Director | | | | | | February [removed: 13, 2024] [added: 12, 2025] | | |
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 [removed: 2023] [added: 2024] Form 10-K, unless the context otherwise indicates.
Throughout this [removed: 2023] [added: 2024] Form 10-K, we have used terms which are defined below:
| [removed: 2023] [added: 2024] Form 10-K | | | Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2023] [added: 2024] | | | MAA | | | Marketing Authorization Application | | |
| 2021 Plan | | | 2021 Stock Award and Incentive Plan | | | [removed: MCOs] [added: MCL] | | | [removed: Managed Care Organizations] [added: mantle cell lymphoma] | | |
| aGVHD | | | acute graft-versus-host disease | | | [removed: MSI-H] [added: MPM] | | | [removed: high microsatellite instability] [added: Malignant Pleural Mesothelioma] | | |
| ANDA | | | abbreviated New Drug Application | | | [removed: Mirati] [added: MyoKardia] | | | [removed: Mirati Therapeutics,] [added: MyoKardia,] Inc. | | |
| [removed: Biogen] [added: AstraZeneca] | | | [removed: Biogen, Inc.] [added: AstraZeneca PLC] | | | Nimbus | | | Nimbus Therapeutics, LLC | | |
| [removed: BLA] [added: Biohaven] | | | [removed: Biologics License Application] [added: Biohaven Pharmaceutical Holding Company Ltd.] | | | NSCLC | | | non-small cell lung cancer | | |
| [removed: BridgeBio] [added: BLA] | | | [removed: BridgeBio Pharma Inc.] [added: Biologics License Application] | | | NVAF | | | non-valvular atrial fibrillation | | |
| [removed: CERCLA] [added: CGDP] | | | [removed: U.S. Comprehensive Environmental Response, Compensation and Liability Act] [added: Coverage Gap Discount Program] | | | OIG | | | Office of Inspector General of the U.S. Department of Health and Human Services | | |
| cGMP | | | current Good Manufacturing Practices | | | [removed: Orum] [added: Ono] | | | [removed: Orum Therapeutics] [added: Ono Pharmaceutical Co., Ltd.] | | |
| CHMP | | | Committee for Medicinal Products for Human Use | | | [removed: Ono] [added: Otsuka] | | | [removed: Ono] [added: Otsuka] Pharmaceutical Co., Ltd. | | |
| COSO | | | Committee of Sponsoring Organizations of the Treadway Commission | | | [removed: PBRGs] [added: PD-1] | | | [removed: People and Business Resource Groups] [added: programmed death receptor-1] | | |
| [removed: CRC] [added: CML] | | | [removed: colorectal cancer] [added: chronic myeloid leukemia] | | | PCAOB | | | Public Company Accounting Oversight Board | | |
| [removed: Dragonfly] [added: CRC] | | | [removed: Dragonfly Therapeutics, Inc.] [added: colorectal carcinoma] | | | PDMA | | | Prescription Drug Marketing Act | | |
| [removed: DSA] [added: DLBCL] | | | [removed: Distribution Services Agreement] [added: diffuse large B-cell lymphoma] | | | PDUFA | | | Prescription Drug User Fee Act | | |
| [removed: Eisai] [added: DSA] | | | [removed: Eisai Co., Ltd.] [added: Distribution Services Agreement] | | | PhRMA Code | | | Pharmaceutical Research and Manufacturers of America’s Professional Practices Code | | |
| [removed: EPO] [added: EMA] | | | European [removed: Patent Office] [added: Medicines Agency] | | | PsA | | | psoriatic arthritis | | |
| EU | | | except as otherwise noted, EU refers to the countries that are members of the European Union plus the United Kingdom | | | [removed: RayzeBio] [added: RA] | | | [removed: RayzeBio, Inc.] [added: rheumatoid arthritis] | | |
| FDA | | | U.S. Food and Drug Administration | | | [removed: RDP] [added: REMS] | | | [removed: Regulatory Data Protection] [added: Risk Evaluation and Mitigation Strategy] | | |
| Gilead | | | Gilead Sciences, Inc. | | | [removed: Roche] [added: RS] | | | [removed: Roche Holding AG] [added: ring sideroblast] | | |
| [removed: GTN] [added: GlaxoSmithKline] | | | [removed: gross-to-net] [added: GlaxoSmithKline PLC] | | | SEC | | | U.S. Securities and Exchange Commission | | |
| [removed: Halozyme] [added: GTN] | | | [removed: Halozyme Therapeutics, Inc.] [added: gross-to-net] | | | SLE | | | systemic lupus erythematosus | | |
| /s/ MICHAEL R. MCMULLEN | | | | | | Director | | | | | | February 12, 2025 | | |
| (Michael R. McMullen) | | | | | | | | | | | | | | |
| 2seventy bio | | | 2seventy bio, Inc. | | | MCO | | | Managed Care Organization | | |
| 2024 Senior Unsecured Notes | | | Aggregate principal amount of $13.0 billion of unsecured senior notes issued by BMS in February 2024 | | | Merck | | | Merck & Co., Inc. | | |
| ADC | | | antibody-drug conjugate | | | Mirati | | | Mirati Therapeutics, Inc. | | |
| Amgen | | | Amgen Inc. | | | MS | | | Multiple Sclerosis | | |
| Amylin | | | Amylin Pharmaceuticals, Inc. | | | MSI-High | | | microsatellite instability-high | | |
| Biogen | | | Biogen, Inc. | | | Novartis | | | Novartis Pharmaceutical Corporation | | |
| CERCLA | | | U.S. Comprehensive Environmental Response, Compensation and Liability Act | | | oHCM | | | obstructive hypertrophic cardiomyopathy | | |
| Cheplapharm | | | Cheplapharm Arzneimittel GmbH | | | Orum | | | Orum Therapeutics | | |
| EC | | | European Commission | | | PPF | | | progressive pulmonary fibrosis | | |
| Eisai | | | Eisai Co., Ltd. | | | PRP | | | potentially responsible party | | |
| Evotec | | | Evotec SE | | | RayzeBio | | | RayzeBio, Inc. | | |
| Exchange Act | | | the Securities Exchange Act o 1934 | | | RCC | | | renal cell carcinoma | | |
| FASB | | | Financial Accounting Standards Board | | | RDP | | | Regulatory Data Protection | | |
| FL | | | follicular lymphoma | | | Roche | | | Roche Holding AG | | |
| Halozyme | | | Halozyme Therapeutics, Inc. | | | SLL | | | small lymphocytic lymphoma | | |
| HCM | | | hypertrophic cardiomyopathy | | | SPC | | | Supplementary Protection Certificate | | |
| IPF | | | idiopathic pulmonary fibrosis | | | Turning Point | | | Turning Point Therapeutics, Inc. | | |
| IRA | | | Inflation Reduction Act of 2022 | | | UK | | | United Kingdom | | |
| LBCL | | | large B-cell lymphoma | | | | | | | | |
| 4yy. | | | | | | [Form of $500,000,000 Floating Rate Notes due 2026 (incorporated herein by reference to Exhibit 4.2 to the Form 8-K dated and filed on February 22, 2024).](https://www.sec.gov/Archives/edgar/data/14272/000114036124009040/ef20022028_ex4-1.htm#EXHIBITA) | | | | | | ‡ | | |
| 4ccc. | | | | | | [Form of $1,250,000,000 5.100% Notes due 2031 (incorporated herein by reference to Exhibit 4.6 to the Form 8-K dated and filed on February 22, 2024).](https://www.sec.gov/Archives/edgar/data/14272/000114036124009040/ef20022028_ex4-1.htm#EXHIBITE) | | | | | | ‡ | | |
| 4eee. | | | | | | [Form of $500,000,000 5.500% Notes due 2044 (incorporated herein by reference to Exhibit 4.8 to the Form 8-K dated and filed on February 22, 2024).](https://www.sec.gov/Archives/edgar/data/14272/000114036124009040/ef20022028_ex4-1.htm#EXHIBITG) | | | | | | ‡ | | |
| 4fff. | | | | | | [Form of $2,750,000,000 5.550% Notes due 2054 (incorporated herein by reference to Exhibit 4.9 to the Form 8-K dated and filed on February 22, 2024).](https://www.sec.gov/Archives/edgar/data/14272/000114036124009040/ef20022028_ex4-1.htm#EXHIBITH) | | | | | | ‡ | | |
| 4ggg. | | | | | | [Form of $1,750,000,000 5.650% Notes due 2064 (incorporated herein by reference to Exhibit 4.10 to the Form 8-K dated and filed on February 22, 2024).](https://www.sec.gov/Archives/edgar/data/14272/000114036124009040/ef20022028_ex4-1.htm#EXHIBITI) | | | | | | ‡ | | |
| | | | | | | | | | | | | | | |
| /s/ GIOVANNI CAFORIO, M.D. | | | | | | Executive Chairman of the Board | | | | | | February 13, 2024 | | |
| (Giovanni Caforio, M.D.) | | | | | | | | | | | | | | |
| /s/ GERALD L. STORCH | | | | | | Director | | | | | | February 13, 2024 | | |
| (Gerald L. Storch) | | | | | | | | | | | | | | |
| | | | | | | | | | | | |
| 2seventy bio | | | 2seventy bio, Inc. | | | MDL | | | multi-district litigation | | |
| Agenus | | | Agenus Inc. | | | MPM | | | Malignant Pleural Mesothelioma | | |
| Amgen | | | Amgen Inc. | | | Mead Johnson | | | Mead Johnson Nutrition Company | | |
| Amylin | | | Amylin Pharmaceuticals, Inc. | | | Merck | | | Merck & Co., Inc. | | |
| AstraZeneca | | | AstraZeneca PLC | | | MyoKardia | | | MyoKardia, Inc. | | |
| Biohaven | | | Biohaven Pharmaceutical Holding Company Ltd. | | | Novartis | | | Novartis Pharmaceutical Corporation | | |
| Cheplapharm | | | Cheplapharm Arzneimittel GmbH | | | OTC | | | over-the-counter | | |
| CML | | | chronic myeloid leukemia | | | Otsuka | | | Otsuka Pharmaceutical Co., Ltd. | | |
| DMC | | | Data Monitoring Committee | | | PD-1 | | | programmed death receptor-1 | | |
| EC | | | European Commission | | | Pfizer | | | Pfizer, Inc. | | |
| EMA | | | European Medicines Agency | | | PRP | | | potentially responsible party | | |
| Evotec | | | Evotec SE | | | RA | | | rheumatoid arthritis | | |
| FASB | | | Financial Accounting Standards Board | | | RCC | | | renal cell carcinoma | | |
| FL | | | follicular lymphoma | | | REMS | | | Risk Evaluation and Mitigation Strategy | | |
| GlaxoSmithKline | | | GlaxoSmithKline PLC | | | sBLA | | | supplemental Biologics License Application | | |
| 3e. | | | | | | [Certificate of Amendment to the Amended and Restated Certificate of Incorporation, effective as of May 4, 2021 (incorporated herein by reference to Exhibit 3a to the Form 8-K dated and filed on May 4, 2021).](https://www.sec.gov/Archives/edgar/data/14272/000114036121015721/brhc10024000_ex3a.htm) | | | | | | ‡ | | |
| 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). | | | | | | ‡ | | |
| ‡‡10bb. | | | | | | [Form of Restricted Stock Units Agreement with five year vesting under the 2021 Stock Award and Incentive Plan](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10bb.htm) [(](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10bb.htm)[filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10bb.htm) | | | | | | E-10-2 | | |
| ‡‡10cc. | | | | | | [Form of Restricted Stock Units Agreement with four year vesting under the 2021 Stock Award and Incentive Plan (filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10cc.htm) | | | | | | E-10-3 | | |
| ‡‡10dd. | | | | | | [Form of Restricted Stock Units Agreement with three year vesting under the 2021 Stock Award and Incentive Plan (filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10dd.htm) | | | | | | E-10-4 | | |
| ‡‡10ee. | | | | | | [Form of Restricted Stock Units Agreement with two-year cliff vesting with a one-year post-vest holding period under the 2021 Stock Award and Incentive Plan (filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10ee.htm) | | | | | | E-10-5 | | |
| ‡‡10ff. | | | | | | [Form of Restricted Stock Units Agreement with one-year cliff vesting with a two-year post-vest holding period under the 2021 Stock Award and Incentive Plan (filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10ff.htm) | | | | | | E-10-6 | | |
| ‡‡10gg. | | | | | | [Form of Market Share Units Agreement under the 2021 Stock Award and Incentive Plan (filed herewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit10gg.htm) | | | | | | E-10-7 | | |
| 19. | | | | | | [Standard Operating Procedure BMS-SOP-5k: Securities Trading (filed herewith)](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit19.htm) | | | | | | E-19-1 | | |
| 97. | | | | | | [Policies and Procedures for the Recoupment of](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm) [](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm)[Compensation for Accounting Restatement](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm) [effective D](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm)[ecember 1, 2023](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm) [(filed h](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm)[erewith).](https://www.sec.gov/Archives/edgar/data/14272/000001427224000044/bmy-20231231exhibit97.htm) | | | | | | E-97 | | |
| | | | | | | Compensation for Accounting Restatement | | | | | | | | |
An excerpt. Shown here: 40 of 152 rewritten, all 26 added and all 32 removed. The counts are complete. For every sentence, read Item 16. FORM 10-K SUMMARY. in the FY2024 filing and the FY2023 filing.