Bristol Myers Squibb (BMY) 10-K risk factor changes: FY2022 vs FY2021

[removed: *Our products continue to be subject to increasing pressures 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 in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which negatively impact our] [added: Our future] revenues and profit [removed: margins,] [added: margins could be negatively affected,] including [removed: from] [added: as a result of] (i) [removed: U.S. federal and state] [added: changes in] laws and regulations [removed: aimed at further regulating] [added: relating to] the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of inflation, new discounts to fund a redesign of the Medicare Part D benefit, [removed: and] government negotiations/price controls that may establish a maximum allowed price/reimbursement rate), as well as other changes [removed: in laws and regulations for] [added: relating to] federal healthcare [removed: programs such as Medicare and Medicaid,] [added: programs,] such as modifying the federal Anti-Kickback statute discount safe [removed: harbor, accelerating generic drug approval processes] [added: harbor] and [removed: granting] [added: 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 eliminates the Medicaid Prescription Drug Rebate cap starting January 1, 2024), [removed: (ii)] [added: (iv)] expanded utilization under the 340B Drug Pricing Program [removed: (“340B”); (iii) the] [added: ("340B program"), (v)] competition related to placements on applicable commercial and Medicare Part D formularies; [removed: (iv) changes in U.S. income tax laws resulting in an increase to our income tax expense, including through increased taxation of our international operations; (v) changes in trade laws around the world, including drug importation laws;] (vi) [removed: rules and practices of MCOs and institutional and governmental purchasers taking actions to control costs or shift the cost burden to manufacturers, including actions that could result in the exclusion of a product from, or the unfavorable placement of, a product on a MCO formulary; (vii)] changes to U.S. federal pharmaceutical coverage and reimbursement policies and [removed: practices (including the potential impacts from the Infrastructure Investment and Jobs Act passed by the Senate in August 2021 that, among other things, requires certain manufacturers of drugs payable under Medicare Part B to provide a rebate to the government for any discarded portion of the drug, the December 21, 2020 final rule issued by the Centers for Medicare & Medicaid Services (“CMS”) on the calculation of average manufacturer price, best price, and Medicaid rebates that addresses copay assistance and product line extensions among other topics, and a previously issued rule addressing the inclusion of sales in U.S. Territories in the calculation of average manufacturer price and best price beginning on January 1, 2023); (viii)] [added: practices, (vii)] the increased scrutiny of drug manufacturers (including any additional review of BMS or Celgene by the House Oversight and Reform [removed: Committee); (ix)] [added: Committee), (viii)] reimbursement [removed: delays; (x)] [added: delays, (ix)] government price erosion mechanisms across Europe and in other countries resulting in deflation for pharmaceutical product [removed: pricing; (xi)] [added: pricing, (x)] the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector [removed: beneficiaries; (xii)] [added: beneficiaries, (xi)] collection delays or failures to pay in government-funded public hospitals outside the [removed: U.S.; (xiii)] [added: U.S., (xii)] developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party [removed: payers;] [added: payers,] and [removed: (xiv)] [added: (xiii)] inhibited market access due to real or perceived differences in value propositions for our products compared to competing [removed: products.][added: products.*]

We expect that these market access constraints, [removed: pharmaceutical] pricing controls and discounting and other restrictions will become more acute [added: as public] and [removed: will] [added: private payers] continue to [removed: negatively affect our future revenues and profit margins.*][added: take aggressive steps to control their expenditures.]

[removed: Following the effective date,] [added: *Additionally,] manufacturers who are found to have knowingly and intentionally overcharged 340B [added: program] covered entities could be subject to significant monetary penalties.

Over the course of the past few years, Celgene had received inquiries from [removed: HRSA] [added: Human 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 Celgene Corporation) we [removed: recently] [added: had] announced that beginning March 1, 2022, we [removed: will] [added: would] recognize up to two designated 340B [added: program] contract pharmacy locations per 340B [added: program] hospital that lacks an entity-owned pharmacy.

[added: Significant changes to our sales or pricing practices with*] *regard to the distribution of drugs under the 340B program, or any material changes in our U.S. payer channel mix, could have an adverse effect on our revenues and profitability.

In addition, if we are required to pay penalties under the applicable regulations, there would be an adverse effect on our revenues and [removed: profitability.*][added: profitability.]

[removed: As a result,] [added: *result,] there is a high risk that funds we invest in research programs will not generate financial returns.

Furthermore, products or indications approved under the U.S. FDA’s Accelerated Approval Program may be contingent upon verification and description of clinical benefit in confirmatory studies and such studies may not be [removed: successful.][added: successful.*]

*Developing and commercializing new compounds and products involve 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 [added: 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; [removed: and] (vii) failure in certain markets to obtain reimbursement commensurate with the level of innovation and clinical benefit presented by the [removed: product.*][added: 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.*]

*We are also unable to predict if and when any changes to laws or regulatory policies will occur and how they will affect our business and particularly our pipeline of new [removed: products.][added: products.*]

*Regulatory approval delays are especially common when a product is expected to have a [removed: REMS] [added: Risk Evaluation and Mitigation Strategy ("REMS")] program, as required by the U.S. FDA to address significant risk/benefit issues, and we expect that certain of our future key products will be distributed in the U.S. primarily through a REMS program.

[removed: We] [added: *We] must maintain a continuous flow of successful new products and successful new indications for existing products sufficient both to cover our substantial research and development costs and to replace sales that are lost as profitable products lose market exclusivity or are displaced by competing products or therapies.

Failure to do so in the [removed: short term] [added: short-term] or [removed: long term] [added: long-term] can have a material adverse effect on our business, results of operations, cash flow, financial condition and [removed: prospects.*][added: prospects.]

[removed: The] [added: The] public announcement of data from our clinical studies, or those of our competitors, or news of any developments related to our, or our competitors’, products or late-stage compounds may cause significant volatility in our stock price and depending on the data, may result in an adverse impact on our business, financial condition or results of operations.

If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does [removed: not][added: 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.*]

We [removed: have, however,] [added: have] experienced setbacks and may continue to do [removed: so as there are further developments in our clinical studies.][added: so.*]

There [removed: is] [added: can be] no assurance that [removed: data from] our [removed: clinical studies will support filings for regulatory approval, that our] key product candidates [removed: may] [added: would] prove to be [added: safe and] effective or as [added: safe and] effective as other competing products, [added: or] that, even if approved, any such products will become commercially successful for all approved [removed: indications, or that the indications of key products approved under the U.S. FDA*’*s Accelerated Approval Program that continued approval is contingent upon verification and description of clinical benefit in confirmatory trials will be withdrawn.*][added: indications.*]

[removed: In particular,] [added: For example,] as a result of patent settlements, [removed: we expect] generic entry for Revlimid in the United Kingdom [removed: beginning] [added: began] on January 18, 2022, and in various other European countries [removed: where our Supplemental Protection Certificate is in force beginning] on February 18, 2022.

Similarly, in the U.S., following patent settlements, certain companies [removed: have been] [added: were] granted volume-limited licenses to sell generic lenalidomide in the U.S. commencing in March 2022 or thereafter.*

In addition, some countries are allowing manufacturers to manufacture and [removed: sell*][added: sell generic products, which negatively impacts the protections afforded the Company.]

*In addition, both the U.S. Congress and the U.S. FDA have taken steps to promote the development and approval of generic drugs and biosimilar [removed: biologics.][added: 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: 2021] [added: 2022] Form 10-K or that we assume when we provide our financial guidance.*

[removed: In] [added: *In] addition, we face competition from new products entering the market, particularly in IO.

Business combinations among our competitors and major third-party payers may [added: also] increase [removed: competition*][added: competition for our products.]

We could experience difficulties, delays and disruptions in [added: our supply chain as well as in] the manufacturing, distribution and sale of our products.

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 [removed: our biologics products, such as Opdivo; (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 or other business interruptions; and (ix) disruptions in supply chain continuity, including from market forces (such as the recent stress on global logistics), natural disasters (such as hurricanes), global disease outbreaks (such as 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.*][added: our*]

*In addition, manufacturing processes for novel cell-based therapies, such as [removed: CAR T] [added: CAR-T] cell therapies, are still evolving, and our processes may be more complicated or more expensive than the approaches taken by our current and future competitors.

Our ability to source raw materials and supplies used to manufacture our [removed: CAR T] [added: CAR-T] cell therapies and to develop consistent and reliable manufacturing processes and distribution networks with an attractive cost of goods could impact future anticipated revenue and gross profit for our [removed: CAR T] [added: CAR-T] cell therapies.

As a result, even slight deviations at any point in the production process for our [removed: CAR T] [added: CAR-T] cell therapies or in material used in our [removed: CAR T] [added: CAR-T] cell therapies could result in loss of product or regulatory remedial action, which could adversely affect our future anticipated revenues and/or profitability related to our [removed: CAR T] [added: CAR-T] cell therapies.*

*We and certain of our subsidiaries are, and in the future may be, involved in various legal proceedings, including patent litigation, such as claims that our patents are invalid, unenforceable and/or do not cover the product of the generic drug manufacturer or where third parties seek damages and/or injunctive relief to compensate for alleged infringement of [removed: their*][added: their patents by our commercial or other activities.]

A successful claim of patent or other intellectual property infringement could subject us to significant damages [removed: or] [added: and/or] an injunction preventing the manufacture, sale, or use of the affected product or products.

*We are currently subject to a number of government laws and regulations [removed: and] [added: and,] in the future, could become subject to new government laws and regulations.

These laws and regulations control and regulate key aspects of our business including but not limited to (i) market access, pricing controls and discounting; (ii) tax liabilities, returns and [removed: payments;(iii)] [added: payments; (iii)] imports and other trade restrictions; (iv) intellectual property protection and enforcement; (v) good practice guidelines and regulations; (vi) accounting standards; (vii) data storage and privacy, particularly in the EU and the U.S.; (viii) requirements for reporting payments and other value transfers to healthcare [removed: professionals;] [added: 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.*

Also, we anticipate continued U.S. congressional interest in modifying provisions of the [added: Patient Protection and] Affordable Care [removed: Act,] [added: Act (the “ACA”),] particularly given [added: its numerous legal challenges (such as] the [removed: ruling in Texas] [added: California] v.

[removed: The revenues] [added: *revenues] that we generate by the health insurance exchanges and Medicaid expansion under the [removed: Affordable Care Act] [added: ACA] are not material, so the impact of the change in law and similar recent administration actions is expected to be limited.

Any future replacement, modification or repeal of the [removed: Affordable Care Act] [added: ACA] may adversely affect our business and financial results, particularly if the legislation reduces incentives for employer-sponsored insurance [removed: coverage, and we cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business.*][added: coverage.]

[removed: Most recently,] [added: For example,] the Tax Cuts and Jobs Act of 2017 [added: (the "TCJA")] reduced the U.S. tax rate to 21% and introduced broad and complex changes resulting in numerous new regulations and interpretations.

The failure of any critical third party to [added: satisfactorily] meet its obligations, including for future royalty and milestone payments; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on our operations and results.

In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including the local pharmaceutical code, U.S. Foreign Corrupt [removed: Practice] [added: Practices] Act, UK Bribery Act, the EU’s General Data Protection Regulation, and other similar laws and regulations, during the performance of their obligations for us, it is possible that we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences.*

*Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls, required rebates and other discounts, in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse.

For additional information on pricing pressures and other constraints, refer to* *“Item 1.

Business—Pricing, Price Constraints and Market Access.”*

As a*

For example, following certain adverse judicial decisions in the UK and the Netherlands, generic manufacturers have begun marketing generic versions of Eliquis in the UK and Netherlands, 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 additional information, see “Item 1A.

Risk Factors—We could lose market exclusivity of a product earlier than expected.”*

We cannot predict with accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those treated by our products and product candidates.

*biologics products, such as Opdivo; (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 or other business interruptions; and (ix) disruptions in supply chain continuity, including from market forces (such as the recent stress on global logistics), 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.*

Texas case) and polarized public support.

The*

We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business.

For additional information, refer to “Item 1.

Business—Government Regulation” and “Item 1.

Business—Pricing, Price Constraints and Market Access.”*

In December 2022, the EU member states voted unanimously to adopt a Directive implementing the Pillar 2 (global minimum tax) rules giving member states until December 31, 2023 to implement the Directive into national legislation.

*Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration.

Additional clinical trials, head-to-head studies, adverse events reports following the use of our products over longer periods of time and studies that identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy) that are conducted after obtaining marketing approval for our products, and regulatory changes to standards regarding safety, efficacy or labeling, may result in product label changes or other measures that could reduce the product's market acceptance and result in declining revenues.

*In addition, if safety or efficacy concerns are raised about a third party's product in the same class as one of our products, those concerns could implicate the entire class and this, in turn, could have an adverse impact on the availability or commercial viability of our product(s) as well as other products in the class.*

A reduction in revenue from any*

For additional information, see “Item 1A.

Risk Factors—We could lose market exclusivity of a product earlier than expected.”*

*able to expand our business development capacity.

We have significant indebtedness that could have negative consequences.

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 markets could impact our growth strategy.

We may also experience delays in the initiation and enrollment of patients in our clinical trials as a consequence of any future pandemic.

*unit and functional services.

The IRA imposes a 1% excise tax on our net repurchases of shares after December 31, 2022.

The imposition of the excise tax on repurchases of our shares may increase the cost to us of making repurchases and may cause our Board to reduce the number of shares repurchased pursuant to our share repurchase program.*

*Additionally, in early 2016, Health Resources and Services Administration (“HRSA”) finalized a regulation regarding the 340B pricing methodology and providing guidelines for when civil monetary penalties may be issued for “knowing and intentional” manufacturer overcharges of 340B covered entities.

The effective date of this regulation was January 1, 2019.

Significant changes to our sales or pricing practices with*

For example, in November 2021, the FDA extended its review of our NDA for mavacamten and announced a new PDUFA action date of April 28, 2022; the FDA had earlier set a PDUFA action date of January 28, 2022.*

For example, in July 2021, we announced that we voluntarily withdrew from the U.S. market the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib.

Opdivo was granted this indication in 2017 under the U.S. FDA's accelerated approval program.

Our action to withdraw the indication was taken in consultation with the U.S. FDA in accordance with its standard procedures for evaluating accelerated approvals that have not met their post-marketing requirements and as part of a broader industry-wide evaluation.*

For example, in the U.S., a partial federal government shutdown halted the work of many federal agencies and their employees from late December 2018 through late January 2019.

Any extended government shutdown could result in reductions or delays of U.S. FDA’s activities, including with respect to our ongoing clinical programs, our manufacturing of our products and product candidates and our product approvals.*

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.

*We are focusing our efforts and resources in disease areas of high unmet need.

With our more focused portfolio, investors are placing heightened scrutiny on some of our products or late-stage compounds.

For example, in October 2021, we announced that the Phase 2 LATTICE-UC study evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at Week 12, nor secondary efficacy endpoints.

Additionally, we obtained many late-stage compounds as well as prioritized brand portfolio in hematology and immunology through our acquisition of Celgene that may not meet expectations.*

*The announcement of data from our clinical studies, or those of our competitors, or news of any developments related to our, or our competitors’, products or late-stage compounds, such as Opdivo, has and will continue to cause significant volatility in our stock price and, depending on the news, may result in an adverse impact on our business, financial condition or results of operations.

Furthermore, the announcement of any negative or unexpected data or the discontinuation of development of any of our key late-stage product candidates, any delay in our anticipated timelines for filing for regulatory approval or a significant advancement of a competitor, has and will continue to cause our stock price to decline significantly and may have an adverse impact on our business, financial condition or results of operations.

For example, we expect that some generic drug companies may market generic versions of Revlimid in the major European markets before the expiration of our intellectual property rights.

*generic products, which negatively impacts the protections afforded the Company.

For example, in December 2019, the U.S. Congress enacted legislation intended to facilitate generic companies’ access to drug samples.

Section 610 of the Further Consolidated Appropriations Act, 2020, provides 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.

This law has the potential to have an adverse impact on our business.*

Certain novel approaches to the treatment of diseases, such as chimeric antigen receptor (“CAR”) T cell therapy, may present significant challenges and risks for us.

*The development of novel approaches for the treatment of diseases, such as our acquisition in November 2019 of Celgene’s and Juno’s CAR T cell therapy programs, including Breyanzi (liso-cel) and Abecma (ide-cel), presents many new challenges and risks due to the unique nature of genetic modification of patient cells ex vivo using certain viruses to reengineer these cells to ultimately treat diseases, including obtaining regulatory approval from U.S. FDA and other regulatory agencies that have limited experience with the development of cellular therapies involving genetic modification of patient cells; developing and deploying consistent and reliable processes, while limiting contamination, for engineering a patient’s cells ex vivo and infusing genetically modified cells back into the patient; developing processes for the safe administration of cellular therapies, including long-term follow-up for patients receiving cellular therapies; and sourcing additional clinical and, if approved, commercial supplies for the materials used to manufacture and process our potential CAR T products.

The use of reengineered cells as a potential cancer treatment is a recent development and may not be broadly accepted by the regulatory, patient or medical communities.*

*Further, we may not be able to satisfactorily establish the safety and efficacy or the reliability of these therapies through health authority approval, or demonstrate the potential advantages and side effects compared to existing and future therapies.

Regulatory requirements governing gene and cell therapy products have changed frequently and may continue to change in the future.

Furthermore, certain payment models could impact the financial feasibility of making CAR T cell therapies available in certain markets or by certain treatment sites, thereby limiting patient access.

To date, only a few products that involve the genetic modification of patient cells have been approved for commercial sale.

Moreover, the safety profiles of cellular therapies may adversely influence public perception and may adversely influence the willingness of subjects to participate in clinical trials, or if approved, of physicians and payers to subscribe to these novel treatment approaches.

If we fail to overcome these and other challenges, or if significant adverse events are reported from similar therapies, our development of these novel treatment approaches may be hampered or delayed, which could adversely affect our future anticipated revenues and/or profitability related to these therapeutic programs.

In addition, we could also face difficulties in manufacturing CAR T cell therapies,* *which could adversely affect our future anticipated revenues and/or profitability related to our CAR T cell therapies.* *See “*—*We could experience difficulties, delays and disruptions in the manufacturing, distribution and sale of our products.”*

For example, if we receive an adverse litigation decision in a country in the EU where our Eliquis composition of matter patents and related Supplementary Protection Certificates are being challenged (see “Item 8.

Financial Statements and Supplementary Data—Note 19.

Legal Proceedings and Contingencies”), we may not be able to prevent generic apixaban products from being introduced in such country prior to our estimated minimum market exclusivity date.

We also face intense competition for external partnerships, joint ventures and acquisition targets that can help develop and bring new products to markets.

*for our products.

We may encounter difficulties integrating ours and Celgene’s businesses and operations and, therefore, may not fully realize the projected benefits from our acquisition of Celgene.

*The ultimate success of our acquisition of Celgene and our ability to realize the anticipated benefits from the acquisition, including the expected cost savings and avoidance from synergies, innovation opportunities and operational efficiencies, depends on, among other things, how effective we are in integrating the Bristol Myers Squibb and Celgene operations, products and employees.*

*We are in the process of integrating a large number of manufacturing, operational and administrative systems to achieve consistency throughout the combined company, including with respect to human capital management, portfolio rationalization, finance and accounting systems, sales operations and product distribution, pricing systems and methodologies, cybersecurity systems, compliance programs and internal controls processes.

This integration is a complex, costly and time-consuming process.

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: 2021] [added: 2022] Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.

The comparison of [removed: 2020] [added: 2021] to [removed: 2019] [added: 2020] 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: 2020—“Item] [added: 2021 “Item] 7.

Refer to the Summary of Abbreviated Terms at the end of this [removed: 2021] [added: 2022] Form 10-K for [added: definitions of capitalized] terms used throughout the document.

In [removed: 2021,] [added: 2022,] we obtained [removed: more than 20] [added: 18] approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including [removed: regulatory approvals of *Breyanzi* and *Abecma*] [added: advancement] in [removed: hematology malignancies,] [added: oncology through FDA and EC approval of *Opdualag*,] the first [removed: approvals of our cell therapy portfolio.][added: PD-1 inhibitor and LAG-3 blocking antibody combination.]

[removed: In support] [added: We continue the expansion] of our [removed: continued investment in our] cell therapy [removed: portfolio, we are expanding our] manufacturing capabilities [added: at our existing facilities in Washington and New Jersey, as well as] through the construction of new state-of-the-art [removed: cell therapy] manufacturing facilities in [removed: Devens, Massachusetts,] [added: Massachusetts] and [added: in] Leiden, Netherlands.

| Dollars in Millions, except per share data | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | | | |

| Total Revenues | | | $ | [removed: 46,385] [added: 46,159] | | | | | $ | [removed: 42,518] [added: 46,385] | | | | | | | |

| Diluted [removed: Earnings/(Loss)] [added: Earnings] Per Share | | | | | | | | | | | | | | | | | |

| GAAP | | | $ | [removed: 3.12] [added: 2.95] | | | | | $ | [removed: (3.99)] [added: 3.12] | | | | | | | |

For a detailed listing of all specified items and further [removed: information and] [added: information,] reconciliations [removed: of] [added: and changes to our] non-GAAP financial measures refer to “—Non-GAAP Financial Measures.”

In response to the COVID-19 pandemic, international, federal, state and local public health and governmental authorities [removed: have taken, and continue to take,] [added: took] a number of actions to limit the spread of COVID-19 and address related disruptions in the U.S. and global economy.

[removed: The] [added: While the pandemic has not significantly impacted our results of operations, the] situation remains dynamic and it is difficult to reasonably assess or predict the full extent of the negative impact that the COVID-19 pandemic may have on our business, financial condition, results of operations and cash flows.

See [added: risk factors on these items included under] “Part I—Item 1A.

As the COVID-19 pandemic affected global healthcare systems as well as major economic and financial markets, we adopted several procedures focused on ensuring the continued supply of our medicines to our patients and protecting the health, wellbeing and safety of our [removed: workforce:][added: workforce.]

[removed: In addition, the OECD recently reached agreement on a global minimum tax pursuant to which] [added: Furthermore,] countries are expected to [removed: implement] [added: make] changes to their tax laws and updates to international tax [removed: treaties.][added: treaties to implement the agreement by the Organization for Economic Co-operation and Development to establish a global minimum tax.]

Significant Product [removed: and Pipeline] Approvals

| Opdivo | | | [removed: December 2021] [added: March 2022] | | | [removed: Japan’s] [added: Japan's] Ministry of Health, Labour and Welfare approval of *Opdivo* for the [added: adjuvant] treatment of [removed: cancer of unknown primary.] [added: urothelial carcinoma.] | | |

| Opdivo | | | [removed: November 2021] [added: May 2022] | | | [removed: Japan’s] [added: Japan's] Ministry of Health, Labour and Welfare approval of *Opdivo* [removed: for the] [added: in combination with fluoropyrimidine- and platinum-containing chemotherapy as a] first-line treatment [removed: of] [added: for adult patients with] unresectable advanced or [removed: recurrent gastric cancer in combination with chemotherapy.] [added: metastatic ESCC regardless of PD-L1 status.] | | |

| Opdivo | | | [removed: October 2021] [added: April 2022] | | | EC approval of *Opdivo* in combination with fluoropyrimidine- and platinum-based [removed: combination] chemotherapy for the first-line treatment of adult patients with [removed: HER2-negative advanced] [added: unresectable advanced, recurrent,] or metastatic [removed: gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1] [added: ESCC] with [removed: a combined positive score ≥ 5.] [added: PD-L1 expression \> 1%.] | | |

| Opdivo | | | [removed: August 2021] [added: April 2022] | | | [removed: FDA] [added: EC] approval of *Opdivo* for the adjuvant treatment of [removed: patients] [added: adults] with [added: muscle-invasive] urothelial carcinoma [added: with tumor cell PD-LI expression \> 1%] who are at [removed: high] risk of recurrence after undergoing radical [removed: resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.] [added: resection.] | | |

| [removed: Abecma | | | August 2021] [added: January 2022] | | | [removed: EC] [added: Announced Japan's Ministry of Health, Labour and Welfare] approval [removed: for] [added: of] *Abecma* for the treatment of adult patients with relapsed [removed: and] [added: or] refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 [removed: antibody] [added: antibody,] and have [removed: demonstrated] [added: either experienced] disease progression on the last [added: therapy or relapse after the last] therapy. [added: The approval is based on results from the Phase II BB2121-MM-001 and Phase I CRB-401 trials.] | | | [added: | | | | | |]

| Opdivo+Yervoy | | | May [removed: 2021] [added: 2022] | | | [removed: Japan’s] [added: Japan's] Ministry of Health, Labour and Welfare approval of *Opdivo* [removed: and] [added: plus] *Yervoy* [removed: in combination therapy for the] [added: as a] first-line treatment [removed: of] [added: for adult patients with] unresectable advanced or [removed: recurrent malignant pleural mesothelioma.] [added: metastatic ESCC regardless of PD-L1 status.] | | |

| [removed: Opdivo] [added: Opdivo+Yervoy] | | | April [removed: 2021] [added: 2022] | | | EC approval of *Opdivo* [removed: in combination with *CABOMETYX] [added: plus *Yervoy*] for the first-line treatment of [added: adult] patients with [removed: advanced RCC.] [added: unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression \> 1%.] | | |

[removed: | Abecma | | | March 2021 | | | FDA approval of] *Abecma* [added: (idecabtagene vicleucel) — is a B-cell maturation antigen-directed genetically modified autologous CAR–T cell therapy indicated] for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. [removed: | | |]

| Breyanzi | | | [removed: March 2021] [added: December 2022] | | | [removed: Japan’s] [added: Japan's] Ministry of Health, Labour and Welfare approval of *Breyanzi* [removed: for] [added: allowing its use in] the [added: second-line] treatment of [removed: patients with] relapsed or refractory large B-cell [removed: lymphoma and relapsed or refractory follicular lymphoma.] [added: lymphoma, regardless of whether autologous hematopoietic stem-cell transplantation is intended.] | | |

| Breyanzi | | | [removed: February 2021] [added: April 2022] | | | [removed: FDA] [added: EC] approval of *Breyanzi* for the treatment of adult patients with relapsed or refractory [added: diffuse] large B-cell [added: lymphoma, primary mediastinal large B-cell] lymphoma [added: and follicular lymphoma grade 3B] after two or more lines of systemic therapy. | | |

[removed: - In] [added: | Abecma | | |] January [removed: 2022, Japan's] [added: 2022 | | | Japan’s] Ministry of Health, Labour and Welfare [removed: approved] [added: approval of] *Abecma* for the treatment of adult patients with relapsed or refractory multiple [removed: myeloma,] [added: myeloma] who have received at least three prior therapies. [added: | | |]

Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in [removed: 2021] [added: 2022] and in early [removed: 2022.][added: 2023.]

Our principal strategy is to combine the resources, scale and capability of a [added: large] pharmaceutical company with the [removed: speed] [added: speed, agility] and focus on innovation [removed: of] [added: typically found in] the biotech industry.

Our priorities are to continue to renew and diversify our portfolio through launching [removed: our] new [removed: product portfolio,] [added: medicines,] advancing our early, mid and late-stage pipeline, and executing disciplined business development.

We remain committed to [removed: reducing our debt] [added: maintaining a strong investment grade credit rating] and returning capital to shareholders.

[removed: We are] [added: Our focus is on discovering,] developing [removed: new] [added: and delivering transformational] medicines [added: for patients facing serious diseases] in the following core therapeutic areas: (i) oncology with a priority in certain tumor types; (ii) hematology with opportunities to broaden our franchise and [removed: potentially] sustain a leadership position in multiple myeloma; (iii) immunology with priorities in relapsing multiple sclerosis, psoriasis, psoriatic arthritis, lupus, RA and inflammatory bowel disease; (iv) cardiovascular disease [removed: and;] (v) fibrotic disease with priorities in lung and [removed: liver.][added: liver, and (vi) neuroscience with a focus on neurodegenerative disease.]

We are further strengthening our IO portfolio with [removed: another opportunity of relatlimab in a fixed dose combination with nivolumab] [added: *Opdualag*] for the treatment of melanoma and [added: potential] expanded opportunities in [removed: adjuvant melanoma,] lung, [removed: liver] [added: liver, CRC] and [removed: CRC.][added: adjuvant melanoma.]

[removed: There] [added: For hematology, there] is a broad effort to continue [removed: to address] [added: addressing] the unmet medical [removed: need] [added: needs] in multiple [removed: myeloma] [added: myeloma, lymphoma,] and [added: anemia (e.g., MDS and MF associated anemia) and] we are working across multiple modalities and mechanisms of action such as cereblon modulators (“CELMoDs”), [added: ADCs,] T-cell Engagers and [removed: CAR T-cell] [added: CAR-T] therapies.

Our commercial model has been successful with revenues from our [removed: key] [added: in-line] brands [added: and new product portfolio] continuing to grow, which demonstrates strong execution of our strategy.

We are able to leverage our leading capabilities in hematological malignancies and our robust pipeline to provide opportunities for long-term growth to offset the impact of [added: current and] future patent expires for *Revlimid* and *Pomalyst*.

We expect the growth [removed: in] [added: of] our in-line and new product portfolio will enable us to more than offset the expected decline in *Revlimid, Abraxane* and other products revenues due to their loss of market exclusivity through 2025.

[removed: Significant] [added: For detailed information on significant] acquisitions, divestitures, [added: collaborations,] licensing and other arrangements during [removed: 2021 are summarized below.][added: 2022 refer to “Item 8.]

| | | | Year Ended December 31, | | | | | | | | | | | | [removed: 2021] [added: 2022] vs. [removed: 2020] [added: 2021] | | | | | | | | |

| Dollars in Millions | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | % Change | | | | | | Foreign Exchange(b) | | |

Additionally, in the U.S., EU and Japan, two *Opdivo* based regimens as first-line treatments for unresectable advanced or metastatic ESCC were approved.

We continue to advance and invest in our cell therapy portfolio through the approval of *Abecma* in Japan for the treatment of multiple myeloma for patients with at least three prior therapies, and approvals of *Breyanzi* for the relapsed or refractory diffuse large B-cell lymphoma, with second-line treatments in the U.S. and Japan, and third-line treatments in the EU.

The approvals for *Sotyktu* (deucravacitinib) in the U.S. and Japan for the treatment of moderate to severe plaque psoriasis expanded our portfolio in immunology.

Within cardiovascular, we broadened our New Product Portfolio with the FDA approval of *Camzyos* (mavacamten) for patients with symptomatic obstructive HCM.

In addition, in August 2022, we acquired Turning Point, a precision oncology company, with the goal of expanding our solid tumor portfolio with the addition of repotrectinib.

In 2022, our revenues remained consistent with the prior year due to growth in our In-Line Products (primarily *Eliquis* and *Opdivo*) and New Product Portfolio (primarily *Opdualag, Abecma* and *Reblozyl*), offset by Recent LOE Products (primarily *Revlimid*) and the impact of foreign exchange.

The $0.17 decrease in GAAP EPS in 2022 was primarily due to changes to equity investment and contingent consideration fair value adjustments, partially offset by lower impairment charges and weighted-average common shares outstanding.

After adjusting for specified items, non-GAAP EPS increased $0.54 as a result of lower weighted-average common shares outstanding and Acquired IPRD charges and higher royalties and licensing income.

| Non-GAAP | | | 7.70 | | | | | | 7.16 | | | | | | | | |

For example, on August 16, 2022, President Biden signed the IRA which provides for (i) the government to negotiate prices for select high-cost Medicare Part D (beginning in 2026) and Part B drugs (beginning in 2028) that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation beginning in 2022 for Part D and 2023 for Part B, and (iii) Medicare Part D redesign which replaces the current coverage gap provisions and establishes a $2,000 cap for out-of-pocket limits costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached.

Implementation of this legislation is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which is uncertain.

Additionally, in connection with the 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 repurchases, to be applied to repurchases beginning in 2023.

We continue to evaluate the impact of the IRA legislation on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations.

| Sotyktu | | | September 2022 | | | Japan's Ministry of Health, Labour and Welfare approval of *Sotyktu* for treatment of plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis, for patients who have had an inadequate response to conventional therapies. | | |

| Sotyktu | | | September 2022 | | | FDA approval of *Sotyktu* for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. | | |

| Opdualag | | | September 2022 | | | EC approval of *Opdualag* for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. | | |

| Breyanzi | | | June 2022 | | | FDA approval of *Breyanzi* for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after one line of therapy who are not eligible for transplant or who relapsed within 12 months of first-line chemoimmunotherapy. | | |

| Opdivo+Yervoy | | | May 2022 | | | FDA approval of *Opdivo* plus *Yervoy* as a first-line treatment for adult patients with unresectable advanced or metastatic ESCC regardless of PD-L1 status. | | |

| Opdivo | | | May 2022 | | | FDA approval of *Opdivo* in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic ESCC regardless of PD-LI status. | | |

| Camzyos | | | April 2022 | | | FDA approval of *Camzyos* for the treatment of adults with symptomatic obstructive HCM. | | |

| Opdualag | | | March 2022 | | | FDA approval of *Opdualag,* a fixed-dose combination of nivolumab and relatlimab, for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma. | | |

| Opdivo | | | March 2022 | | | FDA approval of *Opdivo* in combination with platinum-doublet chemotherapy for adult patients with resectable NSCLC in the neoadjuvant setting. | | |

We continue to advance the next wave of innovative medicines by investing significantly in our oncology, hematology (with alnuctamab in multiple myeloma), immunology (with LPA1 antagonist in pulmonary fibrosis) and cardiovascular portfolios with our alliance partnership with Janssen where we are advancing a next-generation antithrombotic medicine milvexian.

We have expanded our oncology portfolio, including a precision oncology asset repotrectinib in ROS-1 mutated NSCLC.

For immunology, the Phase III clinical trials are underway for cendakimab in eosinophilic esophagitis.

In 2022, we have launched three first-in-class medicines with blockbuster potential across three therapeutic areas: *Opdualag* in first line melanoma, *Camzyos* in oHCM, *Sotyktu* in moderate to severe psoriasis.

In immunology, the Phase III registrational clinical trials are underway for *Sotyktu* in systemic lupus erythematosus (SLE) and psoriatic arthritis.

Through our Celgene acquisition restructuring activities, we realized at least $3.0 billion of synergies annually resulting from cost savings and avoidance.

The achieved synergies were across general and administrative, manufacturing, R&D, and procurement, and also resulted in streamlining the Company's pricing and information technology infrastructure.

Our strategy extends well beyond the discovery, development and delivery of transformative medicines that help patients prevail over serious diseases.

We believe that driving long-term business value is at the heart of living our purpose, from improving access and affordability to advancing inclusion and diversity and health equity in all areas of medicine to supporting a healthy planet in order to sustain lives and communities everywhere.

Our Environmental, Social and Governance (ESG) strategy is integrated into our company’s core strategy, as the opportunities and potential impacts of ESG issues are directly connected to our business.

Our ESG strategy focuses on (i) operating with effective governance and the highest ethical standards, and seeking transparency and dialogue with our stakeholders to improve our understanding of their needs, (ii) fostering an environment of inclusion and belonging and build a globally diverse workforce to drive equitable advancement and outcomes for all, (iii) around the globe, improve access to our innovative therapies and promote health equity to improve health outcomes for populations disproportionately affected by serious diseases and (iv) understand our responsibility to create a maximum positive impact while minimizing our environmental footprint while leveraging sustainability to drive innovation, build resiliency and manage nonfinancial risks.

Acquisitions, Divestitures, Licensing and Other Arrangements.”

| International | | | 13,497 | | | | | | 16,319 | | | | | | (17) | | % | | | | (9) | | % |

- U.S. revenues in 2022 increased primarily due to *Eliquis,* New Product Portfolio, and *Opdivo,* partially offset by our Recent LOE Products.

International

- International revenues in 2022 decreased primarily due to lower demand for *Revlimid* as a result of generic erosion, foreign exchange and lower average net selling prices, partially offset by In-Line Products and New Product Portfolio.

| Current period | | | 7,483 | | | | | | 11,364 | | | | | | 6,344 | | | | | | 25,191 | | |

| Prior period | | | (14) | | | | | | (2) | | | | | | (213) | | | | | | (229) | | |

We continue to see momentum in our immuno-oncology portfolio with additional approvals for both *Opdivo* and *Opdivo*+*Yervoy* in various indications (e.g. adjuvant bladder, gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma and RCC) and the return to growth of *Opdivo*.

Our portfolio in immunology has expanded with the FDA approval of *Zeposia* for the treatment of adults with moderately to severely active UC and we have an important opportunity for deucravacitinib, our TYK2 inhibitor, for the treatment of psoriasis and other immune-mediated diseases.

We bolstered our leading cardiovascular franchise by adding mavacamten with the acquisition of MyoKardia in 2020.

In 2021, the FDA accepted the NDA for mavacamten for patients with symptomatic obstructive HCM and assigned a revised PDUFA goal date of April 28, 2022.

In 2021, our revenues increased 9%, due to *Eliquis, Opdivo*/*Yervoy*, our recently launched new products, *Revlimid* and foreign exchange.

The GAAP EPS of $3.12 in 2021 as compared to the GAAP loss per share of $3.99 in 2020 was primarily due to (i) IPRD and other charges resulting from the MyoKardia asset acquisition in 2020, (ii) other specified items including lower unwinding of inventory purchase price adjustments and other income related to equity investments and contingent value rights and (iii) internal transfers of certain intangible and other assets to streamline our legal entity structure subsequent to the Celgene acquisition resulting in a tax benefit in 2021 and a tax charge in 2020.

After adjusting for specified items, non-GAAP EPS increased $1.07 due to higher revenues, partially offset by higher expenses to support product launches and the overall portfolio.

| Non-GAAP | | | 7.51 | | | | | | 6.44 | | | | | | | | |

While we continue to experience impacts on revenues from COVID-19 primarily due to lower new patient starts and patient visits, the pandemic has not significantly impacted our results of operations.

The future financial and operational impact of the COVID-19 pandemic on BMS will depend on future developments such as the ultimate duration and the severity of the spread of COVID-19 and any variant strains in the U.S. and globally, the effectiveness and outreach of vaccines, the effectiveness of federal, state, local and international government's mitigation actions, the pandemic's impact on the U.S. and global economies, changes in the behavior of patients and medical professionals and the timing for resumption to our normal operations, as well as developments affecting healthcare and the delivery of medicines to patients.

Risk Factors—General Risks—The COVID-19 pandemic is affecting our business and could have a material adverse effect on us.”

*Workplace and Community*

- We are maintaining our steadfast commitment to protecting our workforce, communities and patients, and ensuring the continued supply of life-saving medicines.

*•*As a science-based company, we have a social responsibility to help reduce the spread of the virus.

Vaccinations are required for generally all of our employees in the U.S. and Puerto Rico subject to any local regulations which limit or restrict vaccine mandates, and we are encouraged that as of January 5, 2022 approximately 99% of our employees in these regions are vaccinated against COVID-19.

Requests for medical or religious accommodations are also considered on an individual basis.

Although local regulations and conditions in other ex-U.S. jurisdictions may limit or restrict vaccine mandates, we are committed to implementing similar requirements in other markets wherever possible.

- As we return workers to the office, we will continue to assess the need to require weekly asymptomatic testing, mask wearing, and physical distancing of all colleagues onsite at our facilities in the U.S. and Puerto Rico.

We also keep our workforce safe by conducting regular deep cleaning of our sites.

- Our manufacturing sites have remained open throughout the pandemic supported by on site personnel.

We have taken a thoughtful and phased approach to bringing the rest of our workforce back to our 195 plus sites around the world, guided by the following principles:

◦Serving the needs of our patients and customers

◦Prioritizing health and safety

◦Following medical advice and government direction

◦Leading with compassion and flexibility

◦Modeling key learnings

- No single approach fits for every site or market – our timelines and circumstances have varied across the globe.

We are monitoring local conditions and government direction closely and adjusting our plans as appropriate.

*Supply of Our Medicines and Support to Patients, Physicians and Advocacy Groups*

- An important element of keeping our promise to patients, their families and our healthcare providers is to ensure that our supply chain is robust and carefully managed.

Our clinical and commercial supply chain teams have proactively used mitigation plans to ensure our products reach our markets, clinical sites and patients over the past months.

Thanks to these efforts, we have not seen any significant disruptions in our clinical or commercial supply chain due to the pandemic.

- We recognize this remains a challenging time for everyone, and we know patients may be facing additional hardships.

Our existing patient support programs are available to help eligible patients in the U.S. who have been prescribed a Bristol Myers Squibb medicine and have lost employment and health insurance due to the COVID-19 pandemic.

Under these programs, eligible patients are provided certain Bristol Myers Squibb medicines for free.

- All of our U.S. and Puerto Rico personnel are currently required to be vaccinated to interact with customers, vendors and people at our clinical trial sites.

We are also continuing to employ remote interactions as appropriate to ensure continued support for healthcare professionals, patient care, and access to our medicines across our global markets.

*Our Clinical Trials and Research*

- We are working with health authorities and investigators to protect our trial participants and personnel at BMS and our clinical trial sites, while ensuring regulatory compliance and the integrity of our science.

- We have provided clinical trial investigators with overarching principles and guidance regarding the conduct of BMS clinical trials worldwide in light of COVID-19, and are taking into account guidance from health authorities, where applicable.

[removed: Foreign currency forward contracts are used to manage risk primarily arising from certain intercompany sales and purchases transactions; we] [added: We] are also exposed to foreign exchange transaction risk arising from non-functional currency denominated assets and liabilities and earnings denominated in non-U.S. dollar currencies.

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 [removed: forward] contracts by [removed: $678] [added: $782] million and [removed: $742] [added: $678] million [removed: at] [added: as of] December 31, [removed: 2021] [added: 2022] and December 31, [removed: 2020,] [added: 2021,] respectively, reducing earnings over the remaining life of the contracts.

We use cross-currency interest rate swap contracts designated to [added: manage risk arising from long-term debt denominated in euros and to] hedge the Company's net investment in its [removed: Japan subsidiary.][added: foreign subsidiaries.]

In this sensitivity analysis, if there [removed: were] [added: was] a [removed: 100 basis point] [added: 1%] increase in short-term or long-term interest rates as of December 31, [removed: 2021] [added: 2022] and December 31, [removed: 2020,] [added: 2021,] the expected adverse impact on our earnings would not be material.

We estimate that an increase of [removed: 100 basis points] [added: 1%] in long-term interest rates [removed: at] [added: as of] December 31, [removed: 2021] [added: 2022] and December 31, [removed: 2020] [added: 2021] would decrease the fair value of long-term debt by [removed: $3.8] [added: $2.6] billion and [removed: $4.7] [added: $3.8] billion, respectively.

Foreign currency forward and purchased local currency put option contracts are used to manage risk primarily arising from certain intercompany sales and purchases transactions.

Cross-currency interest rate swap contracts are used to manage risk arising from long-term debt denominated in euros and to hedge the Company's net investment in its foreign subsidiaries.

We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would decrease the fair value of cross-currency interest swap contracts by $73 million and $58 million as of December 31, 2022 and December 31, 2021.

Bristol-Myers Squibb Company [added: ("we", the "Company", or "BMS")] was incorporated under the laws of the State of Delaware in August 1933 under the name Bristol-Myers Company, as successor to a New York business started in 1887.

We expect that our acquisitions of [removed: Celgene in 2019 and] MyoKardia in 2020 [added: and Turning Point in 2022] will further position us as a leading biopharmaceutical company, expanding our [removed: oncology, hematology, immunology] [added: precision oncology] and cardiovascular portfolios with several near-term assets and additional external partnerships.

Refer to the Summary of Abbreviated Terms at the end of this [removed: 2021] [added: 2022] Form 10-K for [added: definitions of capitalized] terms used throughout the document.

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: [removed: oncology (both solid tumors and hematology),] [added: oncology, hematology,] immunology, cardiovascular and [removed: neurology.][added: neuroscience.]

We remain committed to [removed: reducing] [added: strengthening] our [removed: debt] [added: balance sheet] and returning capital to shareholders.

We [removed: manufacture products in the U.S. and Puerto Rico and] have significant manufacturing operations in [removed: two foreign countries.][added: the U.S., Puerto Rico, Ireland and Switzerland.]

| Dollars in Millions | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| United States | | | [removed: 63] [added: 69] | | % | | | | 63 | | % | | | | [removed: 59] [added: 63] | | % |

| Other(a) | | | 2 | | % | | | | [removed: 1] [added: 2] | | % | | | | [removed: 2] [added: 1] | | % |

| Total Revenues | | | $ | [removed: 46,385] [added: 46,159] | | | | | $ | [removed: 42,518] [added: 46,385] | | | | | $ | [removed: 26,145] [added: 42,518] | |

Acquisitions, [removed: Divestitures and] [added: Divestitures,] Licensing [added: and Other] Arrangements

Small molecule drugs are typically administered [removed: orally, e.g.,] [added: orally] in the form of a [removed: pill] [added: tablet] or [removed: tablet,] [added: capsule,] although other drug delivery mechanisms are used as well.

[removed: CAR T-cell] [added: CAR-T] therapies are administered to patients by intravenous infusion.

*Opdivo* has received approvals for several anti-cancer indications including bladder, blood, [removed: colon,] [added: CRC,] head and neck, [removed: kidney, liver,] [added: RCC, HCC,] lung, melanoma, [removed: mesothelioma] [added: MPM, stomach] and [removed: stomach.][added: esophageal cancer.]

The *Opdivo*+*Yervoy* regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, [removed: mesothelioma,] [added: MPM,] RCC, [added: CRC] and [removed: CRC.][added: various gastric and esophageal cancers.]

[removed: *Yervoy®*] *Yervoy* [removed: (ipilimumab), a biological product,] is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma.

*Reblozyl®* *Reblozyl* (luspatercept-aamt), a biological product, is an erythroid maturation agent indicated for the treatment of anemia in adult patients with [added: transfusion dependent and non-transfusion dependent] beta thalassemia [removed: who require regular red blood cell transfusions] and for the treatment of anemia failing an erythropoiesis stimulating agent (“ESA”) in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions.

[removed: *Empliciti®*] *Empliciti* [removed: (elotuzumab), a biological product,] is a humanized monoclonal antibody for the treatment of multiple myeloma.

*Abecma®* *Abecma* (idecabtagene vicleucel) is a B-cell maturation antigen-directed 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-CD38 monoclonal antibody.

*Breyanzi®* *Breyanzi* (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous [removed: CAR T] [added: CAR-T] cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after [removed: two] [added: one] or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Market exclusivity is also sometimes influenced by regulatory data protection [added: ("RDP")] exclusivity rights.

The U.S., EU and Japan each provide [removed: regulatory data protection,] [added: RDP,] 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 copy.

In certain markets where patent protection and other forms of market exclusivity may have expired, [removed: regulatory data protection] [added: RDP] can be of particular importance.

However, most regulatory forms of exclusivity do not prevent a competitor from gaining regulatory approval prior to the expiration of [removed: regulatory data protection] [added: RDP] exclusivity on the basis of the competitor’s own safety and efficacy data on its drug, even when that drug is identical to that marketed by the innovator.

For further discussion of the impact of generic [removed: competition] [added: medicines] on our business, refer to “—Competition” below.

Specific aspects of the law governing market exclusivity and [removed: data regulatory protection] [added: RDP] for pharmaceuticals vary from country to country.

The type of application filed [added: (NDA or BLA)] can affect [removed: regulatory data protection] [added: RDP] exclusivity rights as discussed below.

Medicines approved under an NDA can also receive several types of [removed: regulatory data protection.][added: RDP.]

An innovative chemical pharmaceutical product is entitled to five years of [removed: regulatory data protection] [added: RDP] in the U.S., during which the FDA cannot approve generic substitutes.

If an innovator’s patent is challenged, as described above, a generic manufacturer may file its [removed: aNDA] [added: ANDA] after the fourth year of the five-year [removed: regulatory data protection] [added: RDP] period.

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 [removed: regulatory data protection] [added: RDP] for that formulation, route of administration, or indication.

However, although an application for approval of a biosimilar version may be filed four years after approval of the innovator product, qualified innovative biological products will receive 12 years of [removed: regulatory data protection,] [added: RDP,] 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*, [removed: *Yervoy*,] *Orencia,* [removed: *Reblozyl*] [added: *Yervoy*, *Empliciti, Reblozyl, Abecma, Opdualag] and [removed: *Empliciti*.][added: Breyanzi.*]

Throughout the EU, all products for which marketing authorizations have been filed after October/November 2005 are subject to an “8+2+1” [added: RDP] regime.

Generic versions of pharmaceutical products can be approved after [removed: data protection] [added: RDP] expires, regardless of whether the innovator holds patents covering its drug.

In general, EU law treats chemically-synthesized drugs and biologically-derived drugs the same with respect to intellectual property and [removed: data protection.][added: RDP.]

In Japan, medicines of new chemical entities are generally afforded eight years of [removed: regulatory data protection] [added: RDP] for approved indications and dosage.

Generic copies can receive regulatory approval after [removed: regulatory data protection] [added: RDP] and patent expirations.

Generally, the estimated minimum market exclusivity date in the table below pertain to the end of [removed: regulatory data protection] [added: RDP] or the Composition of Matter (“COM”) patent expiration for the respective products and patent term restoration (“PTR”) if granted.

In situations where there is only data exclusivity without patent protection, a competitor could seek regulatory approval by submitting its own clinical study data to obtain marketing approval prior to the expiration of [removed: regulatory data protection.][added: RDP.]

| International | | | 29 | | % | | | | 35 | | % | | | | 36 | | % |

*Yervoy®* *Yervoy* (ipilimumab), a biological product that is a CTLA4 immune checkpoint inhibitor.

*Empliciti®* *Empliciti* (elotuzumab), a biological product that targets the SLAMF7 protein expressed on natural killer cells (NKC) and myeloma cells.

*Opdualag®* *Opdualag* (nivolumab and relatlimab-rmbw) is a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

*Camzyos®* *Camzyos* (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms.

*Sotyktu®* *Sotyktu* (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Our marketed chemical products include *Eliquis, Pomalyst, Sprycel, Zeposia, Onureg, Inrebic, Camzyos,* and *Sotyktu.*

*Biologic products (includes CAR-T cell therapy products)*

| *Camzyos* (mavacamten)(c) | | | 2034 | | | | | | ++ | | | | | | ++ | | |

| *Opdualag* (nivolumab and relatlimab-rmbw)(g) | | | 2034 | | | | | | 2033 | | | | | | ++ | | |

| *Sotyktu* (deucravacitinib)(l) | | | 2033 | | | | | | ++ | | | | | | 2033 | | |

(a) For *Abraxane* in the U.S., based on settlements, certain generics were permitted to enter the market in 2022.

(b) For *Breyanzi* in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2034.

(c) For *Camzyos* in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.

In the EU, the apixaban composition of matter patents and related Supplementary Protection Certificates (“SPCs”) expire in 2026.

Generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries.

While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of *Eliquis* in the UK and the Netherlands and may seek to market generic versions of *Eliquis* in other European countries prior to the expiration date of apixaban patents and related SPCs.

Financial Statements and Supplementary Data—Note 20.

(g) For *Opdualag* in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.

In the EU, an SPC application is pending and, if granted, the estimated patent expiry will be 2037.

Financial Statements and Supplementary Data—Note 20.

Natco and certain other generics have begun marketing generic lenalidomide products in the U.S. pursuant to those volume-limited licenses.

In Japan, the composition of matter patent expired in July 2022, however BMS is not aware of any generic approvals.

Financial Statements and Supplementary Data—Note 20.

(l) For *Sotyktu* in the U.S., a PTR application is pending and, if granted, the estimated patent expiry will be 2036.

In Japan, a PTR application is also pending and, if granted, the estimated patent expiry will be 2037.

Lawsuits filed by BMS are pending against other companies that filed 505(b)(2) NDA applications containing paragraph IV certifications seeking approval of dasatinib products in the U.S. In the EU, the EPO’s Opposition Division upheld the validity of the patent directed to the use of dasatinib to treat CML, which expires in 2024; however, further to settlement agreements certain generics have already launched generic dasatinib for all approved indications.

Financial Statements and Supplementary Data—Note 20.

In the EU, the estimated minimum market exclusivity date is based on RDP exclusivity.

The R&D process (i.e., target identification to major market approval) typically takes about fourteen years.

Acquired IPRD include upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval.

R&D expenses were $9.5 billion in 2022, $10.2 billion in 2021 and $10.0 billion in 2020.

Acquired IPRD expenses were $815 million, $1.2 billion and $12.5 billion in 2022, 2021 and 2020, respectively.

| ª | | | Development Partnerships: *ABECMA* (ide-cel): 2seventy bio; AHR: Ikena Oncology; Anti-Tau: Prothena; *CAMZYOS* in China, Singapore, Thailand, Macau, HK, Taiwan: LianBio; Claudin 18.2 ADC: LaNova Medicines; CD3xPSCA: Avencell; eIF2b Activator: Evotec; *ELIQUIS*: Pfizer; *EMPLICITI*: AbbVie; farletuzumab ecteribulin: Eisai; HSP47: Nitto Denko Corporation; rHuPH20: Halozyme; *IDHIFA*: Servier; MAGEA4/8 TCER: Immatics; milvexian: Janssen Pharmaceuticals, Inc.; *OPDIVO*, *YERVOY*, *OPDUALAG*: Ono; *REBLOZYL*: Merck; SHP2 Inhibitor: BridgeBio Pharma; TIGIT Bispecific: Agenus; PKCθ Inhibitor: Exscientia | | | | | |

| Oncology | | | | | | | | | | | | | | | Hematology | | | | | | | | | | | |

| Opdivo + Yervoy | | | 1L HCC | | | CM-9DW | | | 2024/25 | | | | | | Breyanzi | | | 3L+ CLL | | | TRANSCEND-CLL | | | 2023 | | |

| Opdivo + Yervoy | | | Stage III Unresectable NSCLC | | | CM-73L | | | 2024/25 | | | | | | | | | | | | | | | | | |

| Opdivo | | | Peri-adjuvant NSCLC | | | CM-77T | | | 2024/25 | | | | | | Zeposia | | | Moderate to Severe Crohn’s Disease | | | YELLOWSTONE | | | 2024/25 | | |

| Opdivo | | | Stage IB-IIIA Adjuvant NSCLC | | | ANVIL* | | | 2024/25 | | | | | | Sotyktu | | | PsA | | | IM011-054/-055 | | | 2024/25 | | |

| Opdualag | | | 2L+ MSS mCRPC | | | RELATIVITY-123 | | | 2024/25 | | | | | | cendakimab | | | EoE | | | IM042-P04 | | | 2024/25 | | |

| Europe | | | 23 | | % | | | | 23 | | % | | | | 24 | | % |

| Rest of the World | | | 12 | | % | | | | 13 | | % | | | | 15 | | % |

*Biologic products*

For products that were filed prior to October/November 2005, there is a 10-year period of regulatory data protection under the centralized procedures and a period of either six or 10 years under the mutual recognition procedure (depending on the member state).

(a) For *Abraxane* in the U.S., based on settlements reached we anticipate generic entry on or after March 31, 2022.

In the EU, Sandoz Limited (“Sandoz”) and Teva Pharmaceutical Industries Ltd. (“Teva Limited”), respectively, filed lawsuits in the United Kingdom, France, Italy, the Netherlands, Portugal, the Republic of Ireland, and Sweden seeking revocation of the composition of matter patent and related Supplementary Protection Certificates, and trials are scheduled to begin in early 2022.

In the EU, the EPO’s Opposition Division upheld the validity of the patent directed to the use of dasatinib to treat CML, which expires in 2024; however, generics have already entered the market for some indications and may enter the market for all indications prior to 2024.

The R&D process typically takes about fourteen years, with approximately two and a half years spent in Phase III, or late-stage, development.

On average, only about one in 10,000 molecules discovered by pharmaceutical industry researchers proves to be both medically effective and safe enough to become an approved medicine.

R&D expenses were $11.4 billion in 2021, $11.1 billion in 2020 and $6.1 billion in 2019, including license and asset acquisition charges of approximately $1.0 billion, $1.0 billion and $25 million in 2021, 2020 and 2019, respectively.

R&D expenses in 2020 include a full year of expense resulting from the Celgene acquisition which occurred in November 2019.

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

COVID-19

| | | | PHASE I | | | | | | PHASE II | | | | | | | | | | | | | | | | | |

| | | | | | | | | | Investigational Compounds SARS-CoV-2 mAb Duoª \--COVID-19 Therapy or Prevention# ORENCIA \--COVID-19 treatment | | | | | | | | | | | | | | | | | |

| | | | ª Development Partnership: OPDIVO, YERVOY, Relatlimab: Ono (our collaboration with Ono also includes other early stage compounds); EMPLICITI: AbbVie; bempegaldesleukin: Nektar; cabozantinib: Exelixis, Inc.; ELIQUIS: Pfizer; Factor XIa Inhibitor: Janssen Pharmaceuticals, Inc.; HSP47: Nitto Denko Corporation; CD3xPSCA: GeMoaB Monoclonals GmbH; ABECMA (ide-cel): 2seventy bio; REBLOZYL: Merck; AHR: Ikena Oncology; CD22 ADC: TriPhase Accelerator; Immune Tolerance: Anokion SA; SARS-CoV-2 mAb Duo: Rockefeller University; TIGIT Bispecific: Agenus; farletuzumab-eribulin ADC: Eisai; rHuPH20: Halozyme; Anti-Tau: Prothena Corporation PLC; eIF2b Activator: Evotec SE; MAGE A4/8 TCE Bispecific: Immatics. | | | | | |

| Opdivo/Yervoy | | | | | | | | | | | | | | | Hematology | | | | | | | | | | | |

| Opdivo + Yervoy | | | HCC | | | CM-9DW | | | 2023/24 | | | | | | Abecma | | | 3L+ Multiple Myeloma | | | KarMMa-3 | | | 2023/24 | | |

| Opdivo + Yervoy | | | Peri-adjuvant NSCLC | | | CM-77T | | | 2023/24 | | | | | | Breyanzi | | | 3L+ Chronic Lymphocytic Leukemia | | | TRANSCEND-CLL-004 | | | 2023/24 | | |

| Opdivo | | | Adj. RCC | | | CM-914 | | | 2023/24 | | | | | | Myelofibrosis | | | INDEPENDENCE | | | 2023/24 | | | | | |

| Opdivo | | | Adj. NSCLC | | | ANVIL | | | 2023/24 | | | | | | | | | | | | | | | | | |

| bempegal-desleukin | | | RCC, Melanoma, Bladder | | | *Opdivo* + NKTR-214 | | | 2022 | | | | | | | | | | | | | | | | | |

| bempegal-desleukin | | | Neo-adj, CIS-ineligible MIBC | | | CA045-009 | | | 2023/24 | | | | | | | | | | | | | | | | | |

| Immunology | | | | | | | | | | | | | | | Cardiovascular | | | | | | | | | | | |

| Zeposia | | | Moderate to Severe Crohn’s Disease | | | YELLOWSTONE | | | 2023/24 | | | | | | mavacamten | | | SRT | | | VALOR | | | 2022 | | |

| deucravacitinib | | | PsA | | | IM011-054/-055 | | | 2023/24 | | | | | | | | | | | | | | | | | |

| cendakimab | | | EoE | | | CC-93538-EE001 | | | 2023/24 | | | | | | | | | | | | | | | | | |

As a result of HR 3590 (Affordable Care Act) and the reconciliation bill containing a package of changes to the healthcare bill, we have and will continue to experience additional financial costs and certain other changes to our business.

For example, we are required to provide a 70% discount on our brand-name drugs to patients who fall within the Medicare Part D coverage gap, also referred to as the “donut hole”, and pay an annual non-tax-deductible fee to the federal government based on an allocation of our market share of branded drug sales to certain government programs including Medicare, Medicaid, Department of Veterans Affairs, Department of Defense and TRICARE.

The amount of the annual fee imposed on pharmaceutical manufacturers as a whole is $2.8 billion for 2019 and thereafter.

To maintain a stable supply of these products, we take a variety of actions including inventory management and maintenance of additional quantities of materials, when possible, that are designed to provide for a reasonable level of these ingredients to be held by the third-party supplier, us or both, so that our manufacturing operations are not interrupted.

*People Strategy*: Our people are the heart and soul of our globally unified culture.

Our People Strategy is designed to inspire individuals and encourage teams to work together for our patients and our communities.

We invest in our workforce through the extensive programs, policies and initiatives described below to accelerate personal development and collaboration in service to our patients and we believe that these investments are a competitive advantage in recruiting our future workforce.

To accelerate innovation, we strive to match the diverse knowledge, skills and capabilities of our talented employee community to our business needs.

The following programs, policies and initiatives encompass some of the objectives and measures that we continue to focus on as part of our People Strategy

- *Diversity, Equity and Inclusion*: Through a culture of inclusion, we foster a diverse mosaic of people that seek to mirror our patients and communities worldwide and create an agile and responsive work environment.

The diversity of our people and their unique perspectives and experiences help us achieve our patient-focused mission and business objectives.

We believe that our inclusive culture encourages all to pursue innovative ideas, develop leadership capabilities and gain valuable experiences to shape exciting careers.

We have implemented measures that provide accountability for continually increasing our diversity.

Financial Statements and Supplementary Data—Note [removed: 19.][added: 20.]

For the fiscal year ended December 31, [removed: 2021][added: 2022]

(212) [removed: 546-4000][added: 546-4200]

The aggregate market value of the [removed: 2,220,639,863] [added: 2,133,779,907] 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: $148,383,155,646.][added: $164,301,052,839.]

At February [removed: 1, 2022,] [added: 7, 2023,] there were [removed: 2,179,712,820] [added: 2,098,775,978] 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: 2021] [added: 2022] 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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| | | | [Item [removed: 5.](#ibe77cac30ec34febb3568b00c7b1dcde_91)] [added: 5.](#ib63d400e46fb4076ada7bde6dec75444_88)] | | | [Market for the Registrant's Common [removed: Stock and Other] [added: Equity,](#ib63d400e46fb4076ada7bde6dec75444_88) [Related] Stockholder [removed: Matters](#ibe77cac30ec34febb3568b00c7b1dcde_91)] [added: Matters and Issuer Purchases of Equity Securities](#ib63d400e46fb4076ada7bde6dec75444_88)] | | | [removed: [38](#ibe77cac30ec34febb3568b00c7b1dcde_91)] [added: [34](#ib63d400e46fb4076ada7bde6dec75444_88)] | | |

| | | | [Item [removed: 7.](#ibe77cac30ec34febb3568b00c7b1dcde_97)] [added: 7.](#ib63d400e46fb4076ada7bde6dec75444_97)] | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#ibe77cac30ec34febb3568b00c7b1dcde_97)] [added: Operations](#ib63d400e46fb4076ada7bde6dec75444_97)] | | | [removed: [40](#ibe77cac30ec34febb3568b00c7b1dcde_97)] [added: [36](#ib63d400e46fb4076ada7bde6dec75444_97)] | | |

| | | | [Item [removed: 7A.](#ibe77cac30ec34febb3568b00c7b1dcde_190)] [added: 7A.](#ib63d400e46fb4076ada7bde6dec75444_187)] | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#ibe77cac30ec34febb3568b00c7b1dcde_190)] [added: Risk](#ib63d400e46fb4076ada7bde6dec75444_187)] | | | [removed: [71](#ibe77cac30ec34febb3568b00c7b1dcde_190)] [added: [64](#ib63d400e46fb4076ada7bde6dec75444_187)] | | |

| | | | [Item [removed: 8.](#ibe77cac30ec34febb3568b00c7b1dcde_193)] [added: 8.](#ib63d400e46fb4076ada7bde6dec75444_190)] | | | [Financial Statements and Supplementary [removed: Data](#ibe77cac30ec34febb3568b00c7b1dcde_193)] [added: Data](#ib63d400e46fb4076ada7bde6dec75444_190)] | | | [removed: [73](#ibe77cac30ec34febb3568b00c7b1dcde_193)] [added: [66](#ib63d400e46fb4076ada7bde6dec75444_190)] | | |

| | | | | | | [Consolidated Statements of Earnings and Comprehensive [removed: (Loss)/Income](#ibe77cac30ec34febb3568b00c7b1dcde_196)] [added: (Loss)/Income](#ib63d400e46fb4076ada7bde6dec75444_193)] | | | [removed: [73](#ibe77cac30ec34febb3568b00c7b1dcde_196)] [added: [66](#ib63d400e46fb4076ada7bde6dec75444_193)] | | |

| | | | | | | [Consolidated Balance [removed: Sheets](#ibe77cac30ec34febb3568b00c7b1dcde_199)] [added: Sheets](#ib63d400e46fb4076ada7bde6dec75444_196)] | | | [removed: [74](#ibe77cac30ec34febb3568b00c7b1dcde_199)] [added: [67](#ib63d400e46fb4076ada7bde6dec75444_196)] | | |

| | | | | | | [Consolidated Statements of Cash [removed: Flows](#ibe77cac30ec34febb3568b00c7b1dcde_202)] [added: Flows](#ib63d400e46fb4076ada7bde6dec75444_199)] | | | [removed: [75](#ibe77cac30ec34febb3568b00c7b1dcde_202)] [added: [68](#ib63d400e46fb4076ada7bde6dec75444_199)] | | |

| | | | | | | [Notes to the Financial [removed: Statements](#ibe77cac30ec34febb3568b00c7b1dcde_205)] [added: Statements](#ib63d400e46fb4076ada7bde6dec75444_202)] | | | [removed: [76](#ibe77cac30ec34febb3568b00c7b1dcde_205)] [added: [69](#ib63d400e46fb4076ada7bde6dec75444_202)] | | |

| | | | [Item [removed: 9.](#ibe77cac30ec34febb3568b00c7b1dcde_319)] [added: 9.](#ib63d400e46fb4076ada7bde6dec75444_283)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#ibe77cac30ec34febb3568b00c7b1dcde_319)] [added: Disclosure](#ib63d400e46fb4076ada7bde6dec75444_283)] | | | [removed: [127](#ibe77cac30ec34febb3568b00c7b1dcde_319)] [added: [117](#ib63d400e46fb4076ada7bde6dec75444_283)] | | |

| | | | [Item [removed: 9A.](#ibe77cac30ec34febb3568b00c7b1dcde_322)] [added: 9A.](#ib63d400e46fb4076ada7bde6dec75444_286)] | | | [Controls and [removed: Procedures](#ibe77cac30ec34febb3568b00c7b1dcde_322)] [added: Procedures](#ib63d400e46fb4076ada7bde6dec75444_286)] | | | [removed: [127](#ibe77cac30ec34febb3568b00c7b1dcde_322)] [added: [117](#ib63d400e46fb4076ada7bde6dec75444_286)] | | |

| | | | [Item [removed: 9B.](#ibe77cac30ec34febb3568b00c7b1dcde_325)] [added: 9B.](#ib63d400e46fb4076ada7bde6dec75444_289)] | | | [Other [removed: Information](#ibe77cac30ec34febb3568b00c7b1dcde_325)] [added: Information](#ib63d400e46fb4076ada7bde6dec75444_289)] | | | [removed: [127](#ibe77cac30ec34febb3568b00c7b1dcde_325)] [added: [117](#ib63d400e46fb4076ada7bde6dec75444_289)] | | |

| | | | [Item [removed: 11.](#ibe77cac30ec34febb3568b00c7b1dcde_337)] [added: 11.](#ib63d400e46fb4076ada7bde6dec75444_304)] | | | [Executive [removed: Compensation](#ibe77cac30ec34febb3568b00c7b1dcde_337)] [added: Compensation](#ib63d400e46fb4076ada7bde6dec75444_304)] | | | [removed: [129](#ibe77cac30ec34febb3568b00c7b1dcde_337)] [added: [119](#ib63d400e46fb4076ada7bde6dec75444_304)] | | |

| | | | [Item [removed: 12.](#ibe77cac30ec34febb3568b00c7b1dcde_340)] [added: 12.](#ib63d400e46fb4076ada7bde6dec75444_307)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ibe77cac30ec34febb3568b00c7b1dcde_340)] [added: Matters](#ib63d400e46fb4076ada7bde6dec75444_307)] | | | [removed: [129](#ibe77cac30ec34febb3568b00c7b1dcde_340)] [added: [119](#ib63d400e46fb4076ada7bde6dec75444_307)] | | |

| | | | [Item [removed: 13.](#ibe77cac30ec34febb3568b00c7b1dcde_343)] [added: 13.](#ib63d400e46fb4076ada7bde6dec75444_310)] | | | [Certain Relationships and Related [removed: Transactions](#ibe77cac30ec34febb3568b00c7b1dcde_343)] [added: Transactions](#ib63d400e46fb4076ada7bde6dec75444_310)] | | | [removed: [129](#ibe77cac30ec34febb3568b00c7b1dcde_343)] [added: [119](#ib63d400e46fb4076ada7bde6dec75444_310)] | | |

| | | | [Item [removed: 15.](#ibe77cac30ec34febb3568b00c7b1dcde_352)] [added: 15.](#ib63d400e46fb4076ada7bde6dec75444_319)] | | | [Exhibits and Financial Statement [removed: Schedule](#ibe77cac30ec34febb3568b00c7b1dcde_352)] [added: Schedule](#ib63d400e46fb4076ada7bde6dec75444_319)] | | | [removed: [130](#ibe77cac30ec34febb3568b00c7b1dcde_352)] [added: [120](#ib63d400e46fb4076ada7bde6dec75444_319)] | | |

| | | | [Item [removed: 16.](#ibe77cac30ec34febb3568b00c7b1dcde_355)] [added: 16.](#ib63d400e46fb4076ada7bde6dec75444_322)] | | | [Form 10-K [removed: Summary](#ibe77cac30ec34febb3568b00c7b1dcde_355)] [added: Summary](#ib63d400e46fb4076ada7bde6dec75444_322)] | | | [removed: [130](#ibe77cac30ec34febb3568b00c7b1dcde_355)] [added: [120](#ib63d400e46fb4076ada7bde6dec75444_322)] | | |

December 31, 2022

| [PART I](#ib63d400e46fb4076ada7bde6dec75444_10) | | | | | | | | | | | |

| | | | | | | [Alliances](#ib63d400e46fb4076ada7bde6dec75444_34) | | | [13](#ib63d400e46fb4076ada7bde6dec75444_34) | | |

| | | | | | | [Competition](#ib63d400e46fb4076ada7bde6dec75444_40) | | | [14](#ib63d400e46fb4076ada7bde6dec75444_40) | | |

| [PART II](#ib63d400e46fb4076ada7bde6dec75444_82) | | | | | | | | | | | |

| | | | [Item 6.](#ib63d400e46fb4076ada7bde6dec75444_91) | | | [\[Reserved\]](#ib63d400e46fb4076ada7bde6dec75444_91) | | | [35](#ib63d400e46fb4076ada7bde6dec75444_91) | | |

| | | | [Item 9C.](#ib63d400e46fb4076ada7bde6dec75444_292) | | | [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](#ib63d400e46fb4076ada7bde6dec75444_292) | | | [117](#ib63d400e46fb4076ada7bde6dec75444_292) | | |

| [PART III](#ib63d400e46fb4076ada7bde6dec75444_298) | | | | | | | | | | | |

| | | | [Item 10.](#ib63d400e46fb4076ada7bde6dec75444_301) | | | [Directors, Executive Officers and Corporate Governance](#ib63d400e46fb4076ada7bde6dec75444_301) | | | [119](#ib63d400e46fb4076ada7bde6dec75444_301) | | |

| | | | [Item 14.](#ib63d400e46fb4076ada7bde6dec75444_313) | | | [Principal Accountant Fees and Services](#ib63d400e46fb4076ada7bde6dec75444_313) | | | [119](#ib63d400e46fb4076ada7bde6dec75444_313) | | |

| [PART IV](#ib63d400e46fb4076ada7bde6dec75444_316) | | | | | | | | | | | |

| [SIGNATURES](#ib63d400e46fb4076ada7bde6dec75444_325) | | | | | | | | | [121](#ib63d400e46fb4076ada7bde6dec75444_325) | | |

| [SUMMARY OF ABBREVIATED TERMS](#ib63d400e46fb4076ada7bde6dec75444_328) | | | | | | | | | [123](#ib63d400e46fb4076ada7bde6dec75444_328) | | |

| [EXHIBIT INDEX](#ib63d400e46fb4076ada7bde6dec75444_331) | | | | | | | | | [124](#ib63d400e46fb4076ada7bde6dec75444_331) | | |

December 31, 2021

| [PART I](#ibe77cac30ec34febb3568b00c7b1dcde_10) | | | | | | | | | | | |

| | | | | | | [Alliances](#ibe77cac30ec34febb3568b00c7b1dcde_34) | | | [14](#ibe77cac30ec34febb3568b00c7b1dcde_34) | | |

| | | | | | | [Competition](#ibe77cac30ec34febb3568b00c7b1dcde_43) | | | [15](#ibe77cac30ec34febb3568b00c7b1dcde_43) | | |

| [PART II](#ibe77cac30ec34febb3568b00c7b1dcde_88) | | | | | | | | | | | |

| | | | [Item 6.](#ibe77cac30ec34febb3568b00c7b1dcde_94) | | | [Selected Financial Data](#ibe77cac30ec34febb3568b00c7b1dcde_94) | | | [39](#ibe77cac30ec34febb3568b00c7b1dcde_94) | | |

| [PART III](#ibe77cac30ec34febb3568b00c7b1dcde_331) | | | | | | | | | | | |

| | | | [Item 10.](#ibe77cac30ec34febb3568b00c7b1dcde_334) | | | [Directors and Executive Officers of the Registrant](#ibe77cac30ec34febb3568b00c7b1dcde_334) | | | [129](#ibe77cac30ec34febb3568b00c7b1dcde_334) | | |

| | | | [Item 14.](#ibe77cac30ec34febb3568b00c7b1dcde_346) | | | [Auditor Fees](#ibe77cac30ec34febb3568b00c7b1dcde_346) | | | [129](#ibe77cac30ec34febb3568b00c7b1dcde_346) | | |

| [PART IV](#ibe77cac30ec34febb3568b00c7b1dcde_349) | | | | | | | | | | | |

| [SIGNATURES](#ibe77cac30ec34febb3568b00c7b1dcde_358) | | | | | | | | | [131](#ibe77cac30ec34febb3568b00c7b1dcde_358) | | |

| [SUMMARY OF ABBREVIATED TERMS](#ibe77cac30ec34febb3568b00c7b1dcde_361) | | | | | | | | | [133](#ibe77cac30ec34febb3568b00c7b1dcde_361) | | |

| [EXHIBIT INDEX](#ibe77cac30ec34febb3568b00c7b1dcde_364) | | | | | | | | | [134](#ibe77cac30ec34febb3568b00c7b1dcde_364) | | |

We own or lease manufacturing, R&D, administration, storage and distribution facilities at approximately [removed: 195] [added: 190] sites worldwide.

Our significant manufacturing and R&D locations by geographic area were as follows at December 31, [removed: 2021:][added: 2022:]

| United States | | | [removed: 6] [added: 7] | | | | | | [removed: 10] [added: 9] | | |

| Europe | | | [removed: 2] [added: 1] | | | | | | 1 | | |

| Total | | | 8 | | | | | | [removed: 11] [added: 10] | | |

Listed below is information on our executive officers as of February [removed: 9, 2022.][added: 14, 2023.]

| Giovanni Caforio, M.D. *Chairman of the Board and Chief Executive Officer* *Member of the Leadership Team* | | | [removed: 57] [added: 58] | | | 2015 to 2017 – Chief Executive Officer and Director of the Company 2017 to present – Chairman of the Board and Chief Executive Officer | | |

| Christopher Boerner, Ph.D. *Executive Vice President, Chief Commercialization Officer Member of the Leadership Team* | | | [removed: 51] [added: 52] | | | 2015 to 2017 – President and Head of U.S. Commercial 2017 to 2018 – President and Head, International Markets 2018 to present – Executive Vice President, Chief Commercialization Officer | | |

| David V. Elkins *Executive Vice President and Chief Financial Officer* *Member of the Leadership Team* | | | [removed: 53] [added: 54] | | | 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 [removed: Devices] [added: Development] and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene [added: Corporation] 2019 to present – Executive Vice President and Chief Financial Officer | | |

| Samit Hirawat, M.D. *Executive Vice President, Chief Medical Officer, Global Drug Development* *Member of the Leadership Team* | | | [removed: 53] [added: 54] | | | 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to present – Executive Vice President, Chief Medical Officer, Global Drug Development | | |

| Sandra Leung *Executive Vice President, General Counsel* *Member of the Leadership Team* | | | [removed: 61] [added: 62] | | | 2015 to present – Executive Vice President, General Counsel | | |

| Greg Meyers *Executive Vice President, Chief Digital and Technology Officer* *Member of the Leadership Team* | | | [removed: 49] [added: 50] | | | 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 | | |

| Elizabeth A. Mily *Executive Vice President, Strategy & Business Development* *Member of the Leadership Team* | | | [removed: 54] [added: 55] | | | 2010 to 2020 – Managing Director, Barclays Investment Bank 2020 to present – Executive Vice President, Strategy & Business Development | | |

| Ann M. Powell *Executive Vice President, Chief Human Resources Officer* *Member of the Leadership Team* | | | [removed: 56] [added: 57] | | | 2016 to 2019 – Senior Vice President, Chief Human Resources Officer 2019 to present – Executive Vice President, Chief Human Resources Officer | | |

| [removed: Louis S. Schmukler] [added: Karin Shanahan] *Executive Vice [removed: President and] President, Global Product Development [removed: and] [added: &] Supply* *Member of the Leadership Team* | | | [removed: 66] [added: 58] | | | [removed: 2011] [added: 2013] to [removed: 2017] [added: 2018] – [removed: President, Global Product Development] [added: Senior Vice President] and [removed: Supply 2017] [added: Chief Operating Officer, Global Operations, Teva Pharmaceuticals 2018] to [removed: 2019] [added: 2022] – Senior Vice [removed: President and] President, Global [removed: Product Development and Supply 2019] [added: Biologics & Sterile Operations, Merck 2022] to present – Executive Vice [removed: President and] President, Global Product Development [removed: and] [added: &] Supply | | |

| Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil. *Executive Vice [removed: President, Research] [added: President] and [removed: Early Development*] [added: President, Research*] *Member of the Leadership Team* | | | [removed: 57] [added: 58] | | | 2015 to 2019 – President of Research and Early Development, Celgene [added: Corporation] 2019 to [removed: present] [added: 2022] – Executive Vice [added: President and] President, Research and Early Development [added: 2022 to present – Executive Vice President and President, Research] | | |

| Michelle Weese *Executive Vice President, Corporate Affairs* *Member of the Leadership Team* | | | [removed: 51] [added: 52] | | | 2009 to 2018 – Founder/Chief Executive Officer, Strat-igence, Inc. 2018 to 2021 – General Secretary, North America, Danone 2021 to present – Executive Vice President, Corporate Affairs | | |

| Sharon Greenlees *Senior Vice President, Corporate Controller* | | | 51 | | | 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 | | |

| Karen Santiago *Senior Vice President and Corporate Controller* | | | 51 | | | 2016 to 2018 – Lead, Enabling Functions and Finance Transformation 2018 to present – Senior Vice President and Corporate Controller | | |

| Paul von Autenried *Executive Vice President, Chief Information Officer* *Member of the Leadership Team* | | | 60 | | | 2016 to 2019 – Senior Vice President, Chief Information Officer 2019 to present – Executive Vice President, Chief Information Officer | | |

The number of record holders of our common stock at January 31, [removed: 2022] [added: 2023] was [removed: 34,417.][added: 32,895.]

Information required by this item will be contained in our [removed: 2022] [added: 2023] Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive [removed: Officers-Equity] [added: Officers—Equity] Compensation Plan Information,” which information is incorporated herein by reference.

The graph assumes $100 investment on December 31, [removed: 2016] [added: 2017] 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: 2017,] 2018, 2019, [removed: 2020] [added: 2020, 2021] and [removed: 2021.][added: 2022.]

[removed: ][added: ]

| | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | |

The following table summarizes the surrenders of our equity securities during the three months ended December 31, [removed: 2021:][added: 2022:]

(b) In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common [removed: stock and in June 2012 increased its authorization for the repurchase of our common stock by an additional $3.0 billion.][added: stock.]

[removed: In] [added: Following this authorization, the Board subsequently approved additional authorizations, including most recently, in February 2020,] January [added: 2021] and December 2021, [added: in] the [removed: Board of Directors approved an increase of] [added: amount $5.0 billion,] $2.0 billion and $15.0 billion, respectively, to the share repurchase authorization.

The remaining share repurchase capacity under the program was approximately [removed: $15.2] [added: $7.2] billion as of December 31, [removed: 2021.][added: 2022.]

Financial [removed: Statements-Note 16.][added: Statements—Note 17.]

| Bristol Myers Squibb | | | $ | 100.00 | | | | | $ | 87.10 | | | | | $ | 111.27 | | | | | $ | 111.72 | | | | | $ | 114.94 | | | | | $ | 136.75 | |

| S&P 500 | | | 100.00 | | | | | | 95.62 | | | | | | 125.72 | | | | | | 148.85 | | | | | | 191.58 | | | | | | 156.88 | | |

| Peer Group | | | 100.00 | | | | | | 110.03 | | | | | | 129.02 | | | | | | 131.63 | | | | | | 162.01 | | | | | | 179.43 | | |

| October 1 to 31, 2022 | | | 11,337,688 | | | | | | $ | 70.51 | | | | | 11,329,164 | | | | | | $ | 8,669 | |

| November 1 to 30, 2022 | | | 13,988,212 | | | | | | 78.23 | | | | | | 13,963,667 | | | | | | 7,577 | | |

| December 1 to 31, 2022 | | | 5,150,025 | | | | | | 79.98 | | | | | | 5,095,948 | | | | | | 7,169 | | |

| Three months ended December 31, 2022 | | | 30,475,925 | | | | | | | | | | | | 30,388,779 | | | | | | | | |

| Bristol Myers Squibb | | | $ | 100.00 | | | | | $ | 107.71 | | | | | $ | 93.82 | | | | | $ | 119.84 | | | | | $ | 120.33 | | | | | $ | 123.80 | |

| S&P 500 | | | 100.00 | | | | | | 121.83 | | | | | | 116.49 | | | | | | 153.17 | | | | | | 181.35 | | | | | | 233.41 | | |

| Peer Group | | | 100.00 | | | | | | 115.24 | | | | | | 126.80 | | | | | | 148.69 | | | | | | 151.70 | | | | | | 186.71 | | |

| October 1 to 31, 2021 | | | 820,228 | | | | | | $ | 58.48 | | | | | — | | | | | | $ | 2,919 | |

| November 1 to 30, 2021 | | | 27,082,219 | | | | | | 58.35 | | | | | | 26,993,376 | | | | | | 1,344 | | |

| December 1 to 31, 2021 | | | 20,925,321 | | | | | | 56.77 | | | | | | 20,706,814 | | | | | | 15,169 | | |

| Three months ended December 31, 2021 | | | 48,827,768 | | | | | | | | | | | | 47,700,190 | | | | | | | | |

In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of our common stock and in November 2019 further increased its authorization for the repurchase of our common stock by approximately $7.0 billion.

In February 2020, the Board of Directors approved an increase of $5.0 billion to the total outstanding share repurchase authorization.

| [added: Type of transaction] | | | Year [removed: Ended] [added: ended] December 31, | | | | | | | | | | | | | | |

| EARNINGS | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net product sales | | | $ | [removed: 45,055] [added: 44,671] | | | | | $ | [removed: 41,321] [added: 45,055] | | | | | $ | [removed: 25,174] [added: 41,321] | |

| Alliance and other revenues | | | [removed: 1,330] [added: 1,488] | | | | | | [removed: 1,197] [added: 1,330] | | | | | | [removed: 971] [added: 1,197] | | |

| Total Revenues | | | [removed: 46,385] [added: 46,159] | | | | | | [removed: 42,518] [added: 46,385] | | | | | | [removed: 26,145] [added: 42,518] | | |

| Cost of products sold(a) | | | [removed: 9,940] [added: 10,137] | | | | | | [removed: 11,773] [added: 9,940] | | | | | | [removed: 8,078] [added: 11,773] | | |

| Marketing, selling and administrative | | | [removed: 7,690] [added: 7,814] | | | | | | [removed: 7,661] [added: 7,690] | | | | | | [removed: 4,871] [added: 7,661] | | |

| Research and development | | | [removed: 11,354] [added: 49] | | | | | | [removed: 11,143] [added: 42] | | | | | | [removed: 6,148] [added: 91] | | |

| Amortization of acquired intangible assets | | | [removed: 10,023] [added: 9,595] | | | | | | [removed: 9,688] [added: 10,023] | | | | | | [removed: 1,135] [added: 9,688] | | |

| Other (income)/expense, net | | | [removed: (720)] [added: 576] | | | | | | [removed: (2,314)] [added: (720)] | | | | | | [removed: 938] [added: (2,314)] | | |

| Total Expenses | | | [removed: 38,287] [added: 38,446] | | | | | | [removed: 49,389] [added: 38,287] | | | | | | [removed: 21,170] [added: 49,389] | | |

| Earnings/(Loss) Before Income Taxes | | | [removed: 8,098] [added: 7,713] | | | | | | [removed: (6,871)] [added: 8,098] | | | | | | [removed: 4,975] [added: (6,871)] | | |

| Provision for Income Taxes | | | [removed: 1,084] [added: 1,368] | | | | | | [removed: 2,124] [added: 1,084] | | | | | | [removed: 1,515] [added: 2,124] | | |

| Net Earnings/(Loss) | | | [removed: 7,014] [added: 6,345] | | | | | | [removed: (8,995)] [added: 7,014] | | | | | | [removed: 3,460] [added: (8,995)] | | |

| Noncontrolling Interest | | | [removed: 20] [added: 18] | | | | | | 20 | | | | | | [removed: 21] [added: 20] | | |

| Net Earnings(Loss) Attributable to BMS | | | $ | [removed: 6,994] [added: 6,327] | | | | | $ | [removed: (9,015)] [added: 6,994] | | | | | $ | [removed: 3,439] [added: (9,015)] | |

| Basic | | | $ | [removed: 3.15] [added: 2.97] | | | | | $ | [removed: (3.99)] [added: 3.15] | | | | | $ | [removed: 2.02] [added: (3.99)] | |

| Diluted | | | [removed: 3.12] [added: 2.95] | | | | | | [removed: (3.99)] [added: 3.12] | | | | | | [removed: 2.01] [added: (3.99)] | | |

| COMPREHENSIVE INCOME/(LOSS) | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Net Earnings/(Loss) | | | $ | [removed: 7,014] [added: 6,345] | | | | | $ | [removed: (8,995)] [added: 7,014] | | | | | $ | [removed: 3,460] [added: (8,995)] | |

| Derivatives qualifying as cash flow hedges | | | [removed: 415] [added: 54] | | | | | | [removed: (256)] [added: 415] | | | | | | [removed: (32)] [added: (256)] | | |

| Pension and postretirement benefits | | | [removed: 206] [added: 145] | | | | | | [removed: (75)] [added: 206] | | | | | | [removed: 1,203] [added: (75)] | | |

| Marketable debt securities | | | [removed: (9)] [added: (2)] | | | | | | [removed: 5] [added: (9)] | | | | | | [removed: 36] [added: 5] | | |

| Foreign currency translation | | | [removed: (41)] [added: (210)] | | | | | | [removed: 7] [added: (41)] | | | | | | [removed: 35] [added: 7] | | |

| Total Other Comprehensive Income/(Loss) | | | [removed: 571] [added: (13)] | | | | | | [removed: (319)] [added: 571] | | | | | | [removed: 1,242] [added: (319)] | | |

| Comprehensive Income/(Loss) | | | [removed: 7,585] [added: 6,332] | | | | | | [removed: (9,314)] [added: 7,585] | | | | | | [removed: 4,702] [added: (9,314)] | | |

| Comprehensive Income Attributable to Noncontrolling Interest | | | [removed: 20] [added: 18] | | | | | | 20 | | | | | | [removed: 21] [added: 20] | | |

| Comprehensive Income/(Loss) Attributable to BMS | | | $ | [removed: 7,565] [added: 6,314] | | | | | $ | [removed: (9,334)] [added: 7,565] | | | | | $ | [removed: 4,681] [added: (9,334)] | |

| ASSETS | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Cash and cash equivalents | | | $ | [removed: 13,979] [added: 9,123] | | | | | $ | [removed: 14,546] [added: 13,979] | |

| Marketable debt securities | | | [removed: 2,987] [added: 130] | | | | | | [removed: 1,285] [added: 2,987] | | |

| Receivables | | | [removed: 9,369] [added: 9,886] | | | | | | [removed: 8,501] [added: 9,369] | | |

| Inventories | | | [removed: 2,095] [added: 2,339] | | | | | | [removed: 2,074] [added: 2,095] | | |

| Other current assets | | | [removed: 4,832] [added: 5,795] | | | | | | [removed: 3,786] [added: 4,832] | | |

| Total Current Assets | | | [removed: 33,262] [added: 27,273] | | | | | | [removed: 30,192] [added: 33,262] | | |

| Property, plant and equipment | | | [removed: 6,049] [added: 6,255] | | | | | | [removed: 5,886] [added: 6,049] | | |

| Goodwill | | | [removed: 20,502] [added: 21,149] | | | | | | [removed: 20,547] [added: 20,502] | | |

| Other intangible assets | | | [removed: 42,527] [added: 35,859] | | | | | | [removed: 53,243] [added: 42,527] | | |

| Deferred income taxes | | | [removed: 1,439] [added: 1,344] | | | | | | [removed: 1,161] [added: 1,439] | | |

| Marketable debt securities | | | [added: (2) | | | | | |] — | | | | | | [removed: 433] [added: (2)] | | | [added: | | | (11) | | | | | | 2 | | | | | | (9) | | | | | | 6 | | | | | | (1) | | | | | | 5 | | |]

| Research and development | | | 9,509 | | | | | | 10,195 | | | | | | 10,048 | | |

| Acquired IPRD | | | 815 | | | | | | 1,159 | | | | | | 12,533 | | |

| Net earnings/(loss) | | | $ | 6,345 | | | | | $ | 7,014 | | | | | $ | (8,995) | |

| Acquired IPRD | | | 815 | | | | | | 1,159 | | | | | | 12,533 | | |

| Other adjustments | | | 232 | | | | | | 183 | | | | | | (134) | | |

| Other | | | (610) | | | | | | (265) | | | | | | (111) | | |

| Stock option proceeds and other, net | | | 984 | | | | | | 641 | | | | | | 542 | | |

Bristol-Myers Squibb Company (“BMS”, or “the Company”) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Revenue.”

BMS holds investments in limited partnerships, which primarily invest in early-stage life sciences companies.

Such limited partnership investments are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient.

These investments are typically redeemable only through distributions upon liquidation of the underlying assets.

In addition, in an asset acquisition, acquired in-process research and development ("IPRD") assets with no alternative future use are charged to Acquired IPRD.

Derivatives

All derivative instruments are recognized as either assets or liabilities at fair value on the consolidated balance sheets and are classified as current or long-term based on the scheduled maturity of the instrument.

The changes in fair value of a derivative designated as a fair value hedge and of the hedged item attributable to the hedged risk are recognized in earnings immediately.

The effective portions of changes in the fair value of a derivative designated as a cash flow hedge are reported in Accumulated other comprehensive loss and are subsequently recognized in earnings consistent with the underlying hedged item.

If a derivative is no longer highly effective as a hedge, the Company discontinues hedge accounting prospectively.

If a hedged forecasted transaction becomes probable of not occurring, any gains or losses are reclassified from Accumulated other comprehensive loss to earnings.

Derivatives that are not designated as hedges are adjusted to fair value through current earnings.

The Company also uses derivative instruments or foreign currency denominated debt to hedge its net investments in certain foreign subsidiaries and affiliates.

Realized and unrealized gains and losses from these hedges are included in foreign currency translation in Accumulated other comprehensive loss.

Derivative cash flows, with the exception of net investment hedges, are principally classified in the operating section of the consolidated statements of cash flows, consistent with the underlying hedged item.

Cash flows related to net investment hedges are classified in investing activities.

Nonrefundable advance payments for services to be received in the future for use in research and development activities are recorded as prepaid assets and expensed in the period when the services are performed.

Acquired IPRD expenses include upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval.

The Company's Acquired IPRD by type of transaction was as follows:

| Alliance (Note 3) | | | $ | 100 | | | | | $ | 730 | | | | | $ | 258 | |

| In-license arrangements and other (Note 4) | | | 715 | | | | | | 429 | | | | | | 659 | | |

| Acquired IPRD | | | $ | 815 | | | | | $ | 1,159 | | | | | $ | 12,533 | |

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 balance sheet; the nature and remaining duration of the restriction(s); and the circumstances that could cause a lapse in the restriction(s).

The amended guidance is effective January 1, 2024 on a prospective basis.

| Net product sales | | | $ | 44,671 | | | | | $ | 45,055 | | | | | $ | 41,321 | |

| Net product sales | | | $ | 44,671 | | | | | $ | 45,055 | | | | | $ | 41,321 | |

| In-Line Products | | | | | | | | | | | | | | | | | |

| New Product Portfolio | | | | | | | | | | | | | | | | | |

| *Opdualag* | | | 252 | | | | | | — | | | | | | — | | |

| IPRD charge - MyoKardia acquisition | | | — | | | | | | 11,438 | | | | | | — | | |

| | | | | | | | | | | | |

| Pension settlements and amortization | | | 35 | | | | | | 43 | | | | | | 1,688 | | |

| Asset acquisition charges | | | 1,157 | | | | | | 1,099 | | | | | | 63 | | |

| Other adjustments | | | 142 | | | | | | (177) | | | | | | (26) | | |

| Other | | | (257) | | | | | | (115) | | | | | | 228 | | |

| Other | | | 641 | | | | | | 542 | | | | | | (53) | | |

Revenue”.

Proceeds received from the sale of equity investment securities previously presented in Divestiture and other proceeds in the consolidated statements of cash flows is now presented separately in Proceeds from sales of equity investment securities.

Additionally, Rebates and discounts previously presented in Other changes in operating assets and liabilities in the consolidated statements of cash flows is now presented separately in Rebates and discounts.

Amounts allocated to investigational compounds for asset acquisitions are expensed at the date of acquisition.

Recently Adopted Accounting Standards

In December 2019, the FASB issued amended guidance on the accounting and reporting of income taxes.

The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities; clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination; and reflecting enacted changes in tax laws or rates in the annual effective tax rate.

BMS adopted the new guidance effective January 1, 2021.

The amended guidance did not have a material impact on BMS’s results of operations.

| Europe | | | 10,687 | | | | | | 9,853 | | | | | | 6,266 | | |

| Rest of World | | | 5,632 | | | | | | 5,457 | | | | | | 4,013 | | |

Co-exclusive license rights were granted to Pfizer in exchange for an up-front payment and potential milestone payments.

BMS did not allocate consideration to the rights transferred to Pfizer as such rights were not sold separately by BMS or any other party, nor could Pfizer receive any benefit for the delivered rights without the fulfillment of other ongoing obligations by BMS under the alliance agreement.

In 2019, Ono exercised the right to accept NKTR-214 into the alliance with BMS upon completion of a Phase I clinical study of *Opdivo* and NKTR-214 in the Ono Territory.

Ono partially reimbursed BMS for development costs incurred with the study and shares in certain future development costs, contingent milestone payments, profits and losses under the collaboration with Nektar.

In 2017, Ono granted BMS an exclusive license for the development and commercialization of ONO-4578, Ono’s Prostaglandin E2 receptor 4 antagonist.

In 2020, the rights were terminated by both parties.

In 2018, BMS and Nektar commenced a worldwide license and collaboration for the development and commercialization of Bempegaldesleukin (NKTR-214), Nektar’s investigational immuno-stimulatory therapy designed to selectively expand specific cancer-fighting T cells and natural killer cells directly in the tumor micro-environment.

In January 2020, the parties amended the collaboration agreement.

The *Opdivo* and NKTR-214 combination therapy is currently in Phase III clinical studies for metastatic melanoma, adjuvant melanoma, muscle-invasive bladder cancer and RCC.

A joint development plan agreed by the parties as part of the original agreement, and updated as part of the January 2020 amendment, specifies development in certain indications and tumor types with each party responsible for the supply of their own product.

BMS’s share of the development costs associated with therapies comprising a BMS medicine used in combination with NKTR-214 is 67.5%, subject to certain cost caps for Nektar.

The January 2020 amendment retains the cost sharing percentages from the original agreement.

The parties will also jointly commercialize the therapies, subject to regulatory approval.

BMS’s share of global NKTR-214 profits and losses will be 35% subject to certain annual loss caps for Nektar.

BMS paid Nektar $1.85 billion for the rights discussed above and 8.3 million shares of Nektar common stock which represented a 4.8% ownership interest.

BMS’s equity ownership is subject to certain lock-up, standstill and voting provisions for a five\-year period.

The amount of the up-front payment allocated to the equity investment was $800 million after considering Nektar’s stock price on the date of closing and current limitations on trading the securities.

The remaining $1.05 billion of the up-front payment was allocated to the rights discussed above.

BMS will also pay up to $1.8 billion upon the achievement of contingent development, regulatory and sales-based milestones over the life of the alliance period.

On November 4, 2021, bluebird completed the tax-free spin-off of its oncology programs and portfolio into 2seventy bio, Inc., an independent, publicly-traded company.

The options to license idecabtagene vicleucel (ide-cel, bb2121) and bb21217 were exercised in 2016 and 2017, respectively.

In 2022, the parties elected to not pursue further development of bb21217.

As of December 31, [removed: 2021,] [added: 2022,] 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: 2021] [added: 2022] Form 10-K.

Based on this evaluation, management has concluded that as of December 31, [removed: 2021,] [added: 2022,] 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: 2021] [added: 2022] 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: 2021] [added: 2022] 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: 2021] [added: 2022] Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] which is included herein.

There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, [removed: 2021] [added: 2022] that have materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

[removed: REPORT] [added: REPORT] OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING [removed: FIRM][added: FIRM]

We have audited the internal control over financial reporting of Bristol-Myers Squibb Company [added: and subsidiaries] (the “Company”) as of December 31, [removed: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] of the Company and our report dated February [removed: 8, 2022,] [added: 14, 2023,] expressed an unqualified opinion on those [removed: consolidated] financial statements.

[removed: Parsippany,] [added: Morristown,] New Jersey

February 14, 2023

February 8, 2022

(a)Reference is made to our [removed: 2022] [added: 2023] Proxy Statement with respect 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: 2021] [added: 2022] 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.

Reference is made to our [removed: 2022] [added: 2023] Proxy Statement with respect to Executive Compensation, which is incorporated herein by reference and made a part hereof in response to the information required by Item 11.

Reference is made to our [removed: 2022] [added: 2023] Proxy Statement 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.

Reference is made to our [removed: 2022] [added: 2023] Proxy Statement 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.

Reference is made to our [removed: 2022] [added: 2023] Proxy Statement with respect to the aggregate fees billed to us by our principal accountant, Deloitte & Touche LLP (PCAOB ID No. 34), which is incorporated herein by reference and made a part hereof in response to the information required by Item 14.

| | | | [Consolidated Statements of Earnings and Comprehensive [removed: (Loss)/Income](#ibe77cac30ec34febb3568b00c7b1dcde_196)] [added: (Loss)/Income](#ib63d400e46fb4076ada7bde6dec75444_193)] | | | [removed: [73](#ibe77cac30ec34febb3568b00c7b1dcde_196)] [added: [66](#ib63d400e46fb4076ada7bde6dec75444_193)] | | |

| | | | [Consolidated Balance [removed: Sheets](#ibe77cac30ec34febb3568b00c7b1dcde_199)] [added: Sheets](#ib63d400e46fb4076ada7bde6dec75444_196)] | | | [removed: [74](#ibe77cac30ec34febb3568b00c7b1dcde_199)] [added: [67](#ib63d400e46fb4076ada7bde6dec75444_196)] | | |

| | | | [Consolidated Statements of Cash [removed: Flows](#ibe77cac30ec34febb3568b00c7b1dcde_202)] [added: Flows](#ib63d400e46fb4076ada7bde6dec75444_199)] | | | [removed: [75](#ibe77cac30ec34febb3568b00c7b1dcde_202)] [added: [68](#ib63d400e46fb4076ada7bde6dec75444_199)] | | |

| | | | [Notes to Consolidated Financial [removed: Statements](#ibe77cac30ec34febb3568b00c7b1dcde_205)] [added: Statements](#ib63d400e46fb4076ada7bde6dec75444_202)] | | | [removed: [76](#ibe77cac30ec34febb3568b00c7b1dcde_205)] [added: [69](#ib63d400e46fb4076ada7bde6dec75444_202)] | | |

| | | | [Report of Independent Registered Public Accounting [removed: Firm](#ibe77cac30ec34febb3568b00c7b1dcde_316)] [added: Firm](#ib63d400e46fb4076ada7bde6dec75444_280)] | | | [removed: [124](#ibe77cac30ec34febb3568b00c7b1dcde_316)] [added: [114](#ib63d400e46fb4076ada7bde6dec75444_280)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this [removed: 2021] [added: 2022] Form 10-K.

| (b) | | | [Exhibits Required to be filed by Item 601 of Regulation [removed: S-K](#ibe77cac30ec34febb3568b00c7b1dcde_364)] [added: S-K](#ib63d400e46fb4076ada7bde6dec75444_331)] | | | [removed: [134](#ibe77cac30ec34febb3568b00c7b1dcde_364)] [added: [124](#ib63d400e46fb4076ada7bde6dec75444_331)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2022 Form 10-K.

| Date: February [removed: 9, 2022] [added: 14, 2023] | | | | | | | | |

| /s/ GIOVANNI CAFORIO, M.D. | | | | | | Chairman of the Board and Chief Executive Officer | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ DAVID V. ELKINS | | | | | | Chief Financial Officer | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ [removed: KAREN SANTIAGO] [added: SHARON GREENLEES] | | | | | | Senior Vice President and Corporate Controller | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| [removed: (Karen Santiago)] [added: (Sharon Greenlees)] | | | | | | (Principal Accounting Officer) | | | | | | | | |

| /s/ PETER J. ARDUINI | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ JULIA A. HALLER, M.D. | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ MANUEL HIDALGO MEDINA, M.D., Ph.D. | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ PAULA A. PRICE | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ DERICA W. RICE | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ THEODORE R. SAMUELS | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ GERALD L. STORCH | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ KAREN H. VOUSDEN, [removed: PH.D.] [added: Ph.D.] | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

| /s/ PHYLLIS R. YALE | | | | | | Director | | | | | | February [removed: 9, 2022] [added: 14, 2023] | | |

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: 2021] [added: 2022] Form 10-K, unless the context otherwise indicates.

Throughout this [removed: 2021] [added: 2022] Form 10-K, we have used terms which are defined below:

| [removed: 2021] [added: 2022] Form 10-K | | | Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2021] [added: 2022] | | | [removed: MCOs] [added: LIBOR] | | | [removed: Managed Care Organizations] [added: London Interbank Offered Rate] | | |

| Amgen | | | Amgen Inc. | | | [removed: Merck] [added: MF] | | | [removed: Merck & Co., Inc.] [added: myelofibrosis] | | |

| BCMA | | | B-cell maturation antigen | | | [removed: MyoKardia] [added: NAV] | | | [removed: MyoKardia, Inc.] [added: net asset value] | | |

| [removed: Biogen] [added: ASC] | | | [removed: Biogen, Inc.] [added: Accounting Standards Codification] | | | NASH | | | Non alcoholic steatohepatitis | | |

| CERCLA | | | U.S. Comprehensive Environmental Response, Compensation and Liability Act | | | [removed: Nektar] [added: OCE] | | | [removed: Nektar Therapeutics] [added: Oncology Center of Excellence] | | |

| [removed: Celgene] [added: Biogen] | | | [removed: Celgene Corporation] [added: Biogen, Inc.] | | | NDA | | | New Drug Application | | |

| [removed: CRC] [added: CAR-T] | | | [removed: colorectal cancer] [added: Chimeric Antigen Receptor T cells] | | | NSCLC | | | non-small cell lung cancer | | |

| [removed: EC] [added: cGMP] | | | [removed: European Commission] [added: current Good Manufacturing Practices] | | | OECD | | | [removed: Organisation] [added: Organization] for Economic Co-operation and Development | | |