Bristol Myers Squibb (BMY) 10-K risk factor changes: FY2021 vs FY2020

The full extent of the impact will depend on future [removed: developments,] [added: developments] such as the ultimate duration and the severity of the spread of COVID-19 [added: and any variant strains] in the U.S. and globally, the effectiveness [added: and outreach] of [added: vaccines, the effectiveness of] federal, state, local and [removed: foreign] [added: international] governments’ mitigation actions, the pandemic’s impact on the U.S. and global economies, [added: changes in the behavior of patients and medical professionals, the timing for resumption to our normal operations,] as well as [removed: factors] [added: developments] affecting healthcare and the delivery of medicines to [removed: patients, including but not limited to those discussed above under “Part II—Item 7.][added: patients.*]

[removed: *Although] [added: *While] we [removed: currently do] [added: have] not [removed: anticipate] [added: experienced] any [removed: disruption to the] [added: significant manufacturing or] supply [removed: of our medicines to patients] [added: issues] due to COVID-19, it is possible that we could experience [removed: manufacturing or supply] [added: these] issues [removed: due to COVID-19] in the future, which [removed: would increase the negative] [added: could negatively] impact [removed: on] our business and results of operations.

For instance, we [removed: are experiencing and] may [removed: continue to] experience scarcity of certain raw materials and components as a result of the influx of COVID-19 vaccine orders receiving priority treatment from vendors.

*We have [removed: started to re-engage in] [added: restarted] in-person interactions by our customer-facing (field) personnel in health care settings in the U.S. and a number of other markets.

[removed: In addition, we could experience additional delays or difficulties enrolling patients] [added: *patients] in clinical trials and/or delays or difficulties with our ongoing, fully enrolled clinical trials, which could further negatively impact the timing of our pipeline development programs and expected future revenues and/or cash flows.

Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the approximately [removed: $53] [added: $42.5] billion of intangible assets as of December 31, [removed: 2020.][added: 2021.]

*We could face additional risks from the impact of COVID-19 on our suppliers, vendors, outsourcing partners, alliance partners and other third parties that we rely on to research, develop, manufacture, commercialize, co-promote and sell our products, manage certain marketing, selling, human resource, finance, IT and other business unit and functional [removed: services.*][added: services.]

[removed: *For] [added: For] example, if any of our third-party providers suffer from limited solvency because of the pandemic, it could negatively impact our operating model and our business.

*The COVID-19 pandemic [removed: has] [added: also] increased the volatility of the financial markets, foreign currency exchanges and interest rates.

[removed: *We] [added: In addition, we] are facing and could continue to face potential other negative consequences stemming from the COVID-19 pandemic, including but not limited to increased cyber threats to us and our partners such as phishing, social engineering and malware attacks, delays in planned integration milestones and ability to collect our receivables.

It is possible that COVID-19 could exacerbate any of the other risks described in this [removed: 2020] [added: 2021] Form 10-K as well.*

*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 revenues and profit margins, including from (i) [removed: the impact of] [added: U.S. federal and state laws and regulations aimed at further regulating] the [removed: increased] pricing [removed: pressure from Medicare Part D formularies, Medicare Part B] [added: and] reimbursement [removed: rates] [added: of pharmaceutical products] (including [removed: the] potential [removed: implementation of the pilot program by the Centers] [added: penalties] for [removed: Medicare & Medicaid Services (“CMS”) that would, among other things, set payment amounts to physicians on Part B drugs based on international drug] [added: increasing] prices [removed: and would include the Top 50 (by spending) Medicare Part B single source drugs, which would apply to many cancer medications), expanded utilization under] [added: over] the [removed: 340B Drug Pricing Program (“340B”), as well as commercial formularies in general; (ii) rules and practices] [added: rate] of [removed: MCOs and institutional and governmental purchasers taking actions to control costs or shift the cost burden] [added: inflation, new discounts] to [removed: manufacturers, including actions that could result in the exclusion of] [added: fund] a [removed: product from, or] [added: redesign of] the [removed: unfavorable placement of, a product on a MCO formulary; (iii) government administrative and policy changes] [added: Medicare Part D benefit,] and [added: government negotiations/price controls that may establish a maximum allowed price/reimbursement rate), as well as other] changes in laws and regulations for federal healthcare programs such as Medicare and Medicaid, [removed: other government actions and inquiries at the federal level that seek to amend pharmaceutical pricing and reimbursement practices] such as [removed: using international pricing indexes,] modifying the federal Anti-Kickback statute discount safe harbor, accelerating generic drug approval processes and granting 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 [removed: U.S.)] [added: U.S.,] and [removed: laws at] the [removed: state level (including] [added: American Rescue Plan Act of 2021, which eliminates the Medicaid Prescription Drug Rebate cap starting January 1, 2024), (ii) expanded utilization under the 340B Drug Pricing Program (“340B”); (iii) the competition related to placements on applicable commercial and Medicare Part D formularies; (iv) changes in U.S. income tax] laws [removed: that have been enacted] [added: resulting] in [removed: California, Vermont, Nevada and New York that are focused on] [added: 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 [added: importation laws; (vi) rules and practices of MCOs and institutional and governmental purchasers taking actions to control costs or shift the] cost [removed: transparency and/or limiting state spending on drugs); (iv)] [added: burden to manufacturers, including actions that could result in] the [removed: potential impact] [added: exclusion] of [added: 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] [added: practices (including the potential impacts] from the [added: 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 [removed: CMS] [added: 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 [removed: April] [added: January] 1, [removed: 2022); (v)] [added: 2023); (viii)] the increased scrutiny of drug manufacturers (including any additional review of [removed: the Company] [added: BMS] or Celgene by the House Oversight and Reform Committee); [removed: (vi)] [added: (ix)] reimbursement delays; [removed: (vii)] [added: (x)] government price erosion mechanisms across Europe and in other countries resulting in deflation for pharmaceutical product pricing; [removed: (viii)] [added: (xi)] the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries; [removed: (ix)] [added: (xii)] collection delays or failures to pay in government-funded public hospitals outside the U.S.; [removed: (x) the impact on pricing from parallel trade and drug importation across borders; (xi) other] [added: (xiii)] developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers; and [removed: (xii)] [added: (xiv)] inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.

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

[removed: If we are ultimately required to change our sales or pricing practices with regard to the distribution of these drugs under the 340B program, or] [added: In addition,] if we [removed: were] [added: are] required to pay penalties under the applicable regulations, there would be an adverse effect on our revenues and profitability.*

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

Additionally, we [removed: inherited] [added: 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 failure to obtain or maintain patent and other intellectual property rights, or limitations on the use or loss of such rights, could [added: result in a rapid loss of sales for any affected products which could] be material to us.

Patents covering our key products have been, and are likely to continue to be, subject to validity, enforceability and [removed: noninfringement] [added: infringement] challenges in patent litigations and post-grant review patent office proceedings.

In addition, in order to avoid the uncertainty and expense of litigation, among other reasons, we may decide to enter into settlements with generic manufacturers that permit generic [removed: competition] [added: market entry] prior to the expiration of our intellectual property rights.

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

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

This [removed: new] law has the potential to have an adverse impact on our business.*

*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: 2020] [added: 2021] Form 10-K or that we assume when we provide our financial guidance.*

We may experience difficulties or delays in the development and commercialization of new [removed: products.][added: products.]

[removed: *Compounds] [added: Compounds] or products may appear promising in development but fail to reach market within the expected or optimal timeframe, or at all.

[removed: In] [added: *In] addition, product extensions or additional indications may not be approved.

[removed: For example,] [added: This is not specific to the Company, but] in December 2020, we announced that we withdrew [removed: Opdivo’s] [added: Opdivo (nivolumab)] indication for the treatment of patients with SCLC whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy, which had been granted as an accelerated approval in 2018.

[removed: This] [added: Our] action [added: 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.*

*Developing and commercializing new compounds and products involve inherent risks and uncertainties, including (i) efficacy and safety [removed: concerns,] [added: concerns or findings of superior safety or efficacy of competing products; (ii)] delayed or denied regulatory approvals, [added: 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; [removed: (ii) inability to enroll patients and timely completion of the clinical trials; (iii)] [added: (iv)] failure to enter into or implement optimal alliances for the development and/or commercialization of new products; [removed: (iv) failure to maintain a consistent scope and variety of promising late-stage products;] (v) [removed: failure of one or more of our products to achieve or maintain commercial viability; and (vi)] changes in regulatory approval processes [added: which] may cause delays or denials of new product [removed: approvals.*][added: approvals; (vi) preclusion from commercialization due to intellectual property issues or disputes with third parties; and (vii) failure in certain markets to obtain reimbursement commensurate with the level of innovation and clinical benefit presented by the product.*]

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

[removed: While federal employees have since returned to work, a subsequent] [added: Any] extended [added: 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.*

*Regulatory approval delays are especially common when a product is expected to have a [removed: REMS,] [added: 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 [removed: U.S.*][added: U.S. primarily through a REMS program.]

*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 [removed: ide-cel,] [added: 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 [removed: communities.][added: communities.*]

[removed: Further,] [added: *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.

Furthermore, certain payment models could impact the [removed: interest] [added: financial feasibility] of [removed: appropriate treatment sites in administering] [added: making] CAR T cell [removed: therapies,] [added: therapies available in certain markets or by certain treatment sites,] thereby limiting patient access.

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 [removed: programs.*][added: programs.]

[removed: *BMS] [added: *The future growth of BMS] is dependent on the market access, uptake and expansion for marketed brands, new product introductions, new indications, product extensions and co-promotional activities with alliance [removed: partners, to deliver future growth.][added: partners.]

Some of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics 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) [removed: disruption] [added: disruptions] in supply chain continuity, including from [added: market forces (such as the recent stress on global logistics),] natural disasters (such as hurricanes), global disease outbreaks [removed: such] [added: (such] as [removed: COVID-19,] [added: COVID-19),] acts of war or terrorism or other [removed: external factors over which we have no control impacting] [added: unforeseeable or unavoidable events that materially impact] one or more of our facilities or [removed: at] a critical supplier.*

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

As part of our broader integration strategy and alignment of our distribution model (post our acquisition of Celgene Corporation) we recently announced that beginning March 1, 2022, we will recognize up to two designated 340B contract pharmacy locations per 340B hospital that lacks an entity-owned pharmacy.

Although we believe that we have complied with, and continue to comply with, all applicable legal requirements, additional legal or legislative changes with respect to the 340B program may cause us to update our approach.

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.

Our ability to replace revenue from products that lose patent protection is directly dependent on our ability to successfully commercialize new products in a timely manner.

*As is common in the pharmaceutical industry, BMS expects that sales of its key brand products like Revlimid, Pomalyst, Sprycel and Abraxane will decline after the loss of market exclusivity for such products.

Consequently, our future success is highly dependent on our pipeline of new products.

There is a high rate of failure inherent in the research and development process for new drugs.

As a result, there is a high risk that funds we invest in research programs will not generate financial returns.

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.

*We can provide no assurance when or whether any of our products under development will be approved or launched or whether any products, once launched, will be commercially successful.

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 short term or long term can have a material adverse effect on our business, results of operations, cash flow, financial condition and prospects.*

If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does not

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.

Similarly, in the U.S., following patent settlements, certain companies have been 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 sell*

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.”*

We face intense competition from other manufacturers and expect to see increasing market penetration of lower-priced generic products.

Competition is keen and as we lose exclusivity for some of our marketed brands lower-priced generic products will increasingly penetrate our markets.

Generic challenges to our products can also arise at any time, and our patents may not prevent the emergence of generic competition for 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.

In some countries, patent protection is significantly weaker than in the United States or in the EU; political and social pressure has also pushed legislation and other measures that promote the use of generic and biosimilar products.

In addition, we face competition from new products entering the market, particularly in IO.

New products may have (i) lower prices, (ii) superior efficacy (benefit) or safety (risk) profiles (whether actual or perceived), (iii) technological advantages that may make such products more convenient to use, (iv) better insurance coverage or reimbursement levels, (v) more effective marketing programs and/or other differentiating factors that make it harder for our products to compete.

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

Business combinations among our competitors and major third-party payers may increase competition*

*for our products.

*patents by our commercial or other activities.

Changes in tax laws and regulations can and do occur.

Significant judgment is required for determining the Company’s tax liabilities, and the Company’s tax returns are periodically examined by various tax authorities.

We have faced, and may continue to face, audit challenges on how we apply a tax law or regulation.

The ultimate resolution of any tax matters may result in payments greater or less than amounts accrued, which could have a negative impact on our provision for income taxes.

Notably, in July and October 2021 OECD/G20 Inclusive Framework agreed on the general rules for redefined jurisdictional taxation rights and a global minimum tax.

Further details regarding implementation of these rules are expected and if implemented could have a material impact on our tax provision and results of operations.*

The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce, which increased during the COVID-19 pandemic, greatly enhancing consumers’ ability to obtain prescriptions and other medical treatments via the internet in lieu of traditional brick and mortar pharmacies.

COVID-19 Pandemic Risks

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Economic and Market Factors”, and how quickly we can return to more normal operations, among other things.*

*Although we have restarted clinical development activities, we continue to experience delays in the initiation and enrollment of patients in our clinical trials.

Although we incurred downward adjustments to our equity investment fair values in the first quarter of 2020, the fair values have subsequently recovered.

If the U.S. dollar continues to strengthen, interest rates continue to decline, and/or stock markets continue to decline, we could see a further reduction in revenues or other income or additional charges to our equity investments, which could have a negative impact on our earnings and cash flows.*

*entities could be subject to significant monetary penalties.

Such findings could also result in negative publicity that could harm the manufacturer’s reputation or cause business disruption.

On December 10, 2020, HRSA issued the 340B Drug Pricing Program Alternative Dispute Resolution Final Rule (“ADR Final Rule”), which went into effect on January 13, 2021.

The ADR Final Rule establishes an alternative dispute resolution (“ADR”) process for certain disputes (including disputes about overcharges, duplicate discounts or diversion).

On December 30, 2020, the U.S. Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Program on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities.

We believe that we have complied with applicable legal requirements.

For example, in December 2020, we announced that CheckMate -548, a Phase 3 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) in patients with newly diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation following surgical resection of the tumor, did not meet its primary endpoint of overall survival (OS) in patients with no baseline corticosteroid use or in the overall randomized population.

For example, we did not receive a decision on our BLA for liso-cel for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies by December 31, 2020 and as a result, on January 1, 2021, the Contingent Value Rights Agreement, dated as of November 20, 2019, pursuant to which contingent value rights that we issued in connection with the Celgene transaction terminated automatically in accordance with its terms and the contingent value rights are no longer eligible for payment under the Contingent Value Rights Agreement.

*primarily through a REMS program.

We face intense competition from other manufacturers.

Competition is keen and includes (i) lower-priced generics and increasingly aggressive generic commercialization tactics, (ii) new competitive products entering the market, particularly in IO, (iii) lower prices for other companies’ products, real or perceived superior efficacy (benefit) or safety (risk) profiles or other differentiating factors, (iv) technological advances and patents attained by our competitors, (v) clinical study results from our products or a competitor’s products that affect the value proposition for our products, (vi) business combinations among our competitors and major third-party payers and (vii) competing interests for external partnerships to develop and bring new products to markets.

*If we are unable to successfully combine the businesses in an efficient, cost-effective manner within the anticipated timeframe, the projected benefits and cost savings may not be realized fully or may take longer to realize than expected and our business may be unable to grow as planned, which could materially impact our business, cash flow, financial condition or results of operations as well as adversely impact our share price.

The integration process may also result in significant expenses and charges, both cash and noncash.

The attention of certain members of our management and our resources will be at times focused on the integration of the businesses of the two companies and diverted from day-to-day business operations, which may disrupt our ongoing business.*

*manufacturing plants; (v) the alleged failure to fulfill obligations under supply contracts with the government and other customers or under other agreements relating to our business; (vi) product pricing and promotional matters; (vii) lawsuits and claims asserting, or investigations into, violations of securities, antitrust, Federal and state pricing, consumer protection, data privacy and other laws and regulations; (viii) environmental, health, safety and sustainability matters; and (ix) tax liabilities resulting from assessments from tax authorities.*

This is not specific to the Company, but in December 2020, we announced that we withdrew Opdivo’s indication for the treatment of patients with SCLC whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy, which had been granted as an accelerated approval in 2018.

We could face audit challenges on how we apply the new law that could have a negative impact on our provision for income taxes.

*impact on our operations and results.

*business or reputational losses that may result from an interruption or breach of our systems.

Our 13 prioritized brands comprised approximately 95% of revenues in 2020.

*We have acquired, or in-licensed, a number of other assets.

*services arrangements, or potential litigation, following the transaction.

Competition for qualified talent in the biopharmaceutical field is intense.

Additional cash will be required for any dividends declared due to additional shares issued in connection with the Celgene acquisition.

While we are still assessing the details of the EU-UK Trade and Cooperation Agreement (which was formally approved by the U.K. House of Commons on December 30, 2020 and is expected to be formally approved by the EU legislature in March 2021) and related impact on our UK business and other operations, we currently do not believe that these matters and other related financial effects will have a material impact on our consolidated results of operations, financial position or liquidity.*

*continue to provide LIBOR submissions to the administrator of LIBOR and whether LIBOR rates will cease to be published or supported before or after 2021.

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: 2020] [added: 2021] Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.

The comparison of [removed: 2019] [added: 2020] to [removed: 2018] [added: 2019] results has been omitted from this Form [removed: 10-K, but can be referenced in] [added: 10-K and is incorporated by reference from] our Form 10-K for the year ended December 31, [removed: 2019—“Item] [added: 2020—“Item] 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February [removed: 24, 2020.][added: 10, 2021.]

Refer to the Summary of Abbreviated Terms at the end of this [removed: 2020] [added: 2021] Form 10-K for terms used throughout the document.

[removed: Refer to “—Acquisitions,] [added: Acquisitions,] Divestitures, Licensing and Other Arrangements” for further [removed: information.][added: information on these charges.]

[removed: Although the pandemic has not had a significant impact on our results of operations, it] [added: The situation] remains [added: 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.

The [added: future financial and operational] impact [added: of the COVID-19 pandemic on BMS] will depend on future developments such as the ultimate duration and [removed: recovery from] the [removed: pandemic, government] [added: 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, [added: the pandemic's] impact on the U.S. and global economies, [removed: customer behavior] changes [added: in the behavior of patients] and [added: medical professionals and the] timing for resumption to our normal operations, [removed: among others.][added: as well as developments affecting healthcare and the delivery of medicines to patients.]

The GAAP [removed: loss per share] [added: EPS] of [removed: $3.99] [added: $3.12] in [removed: 2020] [added: 2021] as compared to the GAAP [removed: EPS] [added: loss per share] of [removed: $2.01] [added: $3.99] in [removed: 2019] [added: 2020] was primarily due to [removed: the] [added: (i)] IPRD [removed: charge] [added: and other charges] resulting from the MyoKardia asset acquisition [removed: and charges relating to the Celgene acquisition including (i) amortization of acquired intangible assets,] [added: in 2020,] (ii) [removed: the] [added: other specified items including lower] unwinding of inventory [removed: fair value] [added: purchase price] adjustments and [added: other income related to equity investments and contingent value rights and] (iii) [removed: tax charges resulting from an] internal [removed: transfer] [added: transfers] of certain intangible [removed: assets] and [removed: the *Otezla divestiture, partially offset by higher revenues and fair value adjustments] [added: other assets] to [removed: contingent value rights] [added: streamline our legal entity structure subsequent to the Celgene acquisition resulting in a tax benefit in 2021] and [removed: equity investments.][added: a tax charge in 2020.]

| Dollars in Millions, except per share data | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | | | |

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

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

| GAAP | | | $ | [removed: (3.99)] [added: 3.12] | | | | | $ | [removed: 2.01] [added: (3.99)] | | | | | | | |

| Non-GAAP | | | [removed: 6.44] [added: 7.51] | | | | | | [removed: 4.69] [added: 6.44] | | | | | | | | |

See risk factor on the Company’s risk factors [removed: resulting from the COVID-19 pandemic] [added: on these items] included under “Part I—Item 1A.

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

Risk [removed: Factors—Increased] [added: Factors—Product, Industry and Operational Risks—Increased] pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit [removed: margins.”][added: margins” and “—Changes to tax regulations could negatively impact our earnings.”]

See [removed: “Item] [added: “Part I—Item] 1A.

The following is a summary of the significant approvals received in [removed: 2020:][added: 2022:]

| Opdivo | | | November [removed: 2020] [added: 2021] | | | [removed: EC] [added: Japan’s Ministry of Health, Labour and Welfare] approval of *Opdivo* for the [added: first-line] treatment of [removed: adults with] unresectable [removed: advanced, recurrent] [added: advanced] or [removed: metastatic ESCC after prior fluoropyrimidine- and platinum-based] [added: recurrent gastric cancer in] combination [added: with] chemotherapy. | | |

| [removed: Opdivo+Yervoy] [added: Opdivo] | | | [removed: October 2020] [added: January 2021] | | | FDA approval of [removed: *Opdivo*+*Yervoy*] [added: *Opdivo* in combination with *CABOMETYX] for the first-line treatment of [removed: adult] patients with [removed: unresectable MPM.] [added: advanced RCC.] | | |

[removed: | Onureg | | | September 2020 | | | FDA approval of] *Onureg* (azacitidine) [added: — an oral hypomethylating agent that incorporates into DNA and RNA, indicated] for [removed: the] continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and [removed: who] are not able to complete intensive curative therapy. [removed: | | |]

[removed: | Reblozyl | | | April 2020 | | | FDA approval of] *Reblozyl* [added: (luspatercept-aamt) — an erythroid maturation agent indicated] for the treatment of anemia [added: in adult patients with beta thalassemia who require regular red blood cell transfusions and for the treatment of anemia] failing an [removed: erythropoiesis stimulating agent] [added: ESA] in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions. [removed: | | |]

[removed: - In January 2021, the FDA approved the use] [added: | Opdivo | | | April 2021 | | | EC approval] of *Opdivo* in combination with [removed: *Cabometyx] [added: *CABOMETYX] for the first-line treatment of patients with advanced RCC. [added: | | |]

[removed: - In] [added: | Breyanzi | | |] February [removed: 2021, the] [added: 2021 | | |] FDA [removed: approved] [added: approval of] *Breyanzi* [removed: (lisocabtagene maraleucel; liso-cel)] for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. [added: | | |]

[removed: - In] [added: | Inrebic | | |] February [removed: 2021, the] [added: 2021 | | |] EC [removed: approved] [added: approval of] *Inrebic* for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis, who are Janus Associated Kinase inhibitor naïve or have been treated with ruxolitinib. [added: | | |]

Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in [removed: 2020] [added: 2021] and in early [removed: 2021.][added: 2022.]

Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology (both solid tumors and hematology), immunology, cardiovascular and [removed: fibrosis.][added: neurology.]

We are developing new medicines in the following core therapeutic areas: (i) oncology with a priority in certain tumor types; (ii) hematology with opportunities to broaden our franchise and potentially sustain a leadership position in multiple myeloma; (iii) immunology with priorities in relapsing multiple sclerosis, psoriasis, [added: psoriatic arthritis,] lupus, RA and inflammatory bowel disease; (iv) cardiovascular disease and; (v) fibrotic disease with priorities in lung and liver.

There is a broad effort to continue to address the unmet medical need in multiple myeloma and we are working across multiple modalities and mechanisms of action such as cereblon [removed: modulator (“*CELMoD*”),] [added: modulators (“CELMoDs”),] T-cell [removed: Engager] [added: Engagers] and CAR T-cell [removed: therapy.][added: therapies.]

Beyond cancer, we continue to advance our early stage portfolio in immunology, cardiovascular and [removed: fibrotic] [added: neuroscience] diseases and strengthen our partnerships with a diverse group of companies and academic institutions in new and expanded research activities.

Our commercial model has been successful with revenues from our [removed: prioritized] [added: key] brands continuing to grow, which demonstrates strong execution of our strategy.

We are building on the continued success of our other [removed: prioritized] [added: key] brands and remain strongly committed to *Orencia* and *Sprycel*.

We are also optimistic on the future growth and near-term opportunities of *Reblozyl*, [removed: a first-in-class medicine,] *Inrebic*, [removed: *Zeposia*] [added: *Zeposia*, *Onureg*, *Breyanzi*] and [removed: *Onureg*.][added: *Abecma*.]

Our operating model continues to evolve and we have been successful in focusing commercial, R&D and manufacturing resources on [removed: prioritized] [added: key] brands and markets, strengthening our R&D capabilities in tumor biology, patient selection and new biomarkers, delivering leaner administrative functions and streamlining our manufacturing network to reflect the importance of biologics in our current and future portfolio.

Through our Celgene acquisition restructuring activities, we expect to realize [added: approximately] $3.0 billion of synergies resulting from cost savings and avoidance through 2022 and our integration efforts across general and administrative, manufacturing, R&D, procurement and streamlining the Company's pricing and information technology infrastructure.

Looking ahead, we will continue to implement our biopharma strategy by driving the growth of [removed: prioritized] [added: key] brands, executing product launches, investing in our diverse and innovative pipeline, aided by strategic business development, focusing on prioritized markets, increasing investments in our biologics manufacturing capabilities and maintaining a culture of continuous improvement.

Significant acquisitions, divestitures, licensing and other arrangements during [removed: 2020] [added: 2021] are summarized below.

| | | | Year Ended December 31, | | | | | | | | | | | | [removed: 2020] [added: 2021] vs. [removed: 2019] [added: 2020] | | | | | | | | |

| Dollars in Millions | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | % Change | | | | | | Foreign Exchange(b) | | |

| United States | | | $ | [removed: 26,577] [added: 29,214] | | | | | $ | [removed: 15,342] [added: 26,577] | | | | | [removed: 73] [added: 10] | | % | | | | — | | |

In 2021, we obtained more than 20 approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including regulatory approvals of *Breyanzi* and *Abecma* in hematology malignancies, the first approvals of our cell therapy portfolio.

In support of our continued investment in our cell therapy portfolio, we are expanding our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts, and Leiden, Netherlands.

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.

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.

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

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.

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 workforce:

*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.

We completed the Celgene transaction on November 20, 2019.

Our consolidated financial statements for 2020 include a full year of Celgene operations.

On November 17, 2020, we completed our acquisition of MyoKardia for approximately $13.1 billion in cash.

We expect that our acquisitions of Celgene and MyoKardia will further position us as a leading biopharmaceutical company, expanding our oncology, hematology, immunology and cardiovascular portfolios with several near-term assets and additional external partnerships.

The COVID-19 pandemic is resulting in significant risks and disruptions to the health and welfare of the global population and economy.

Refer to “—Economic and Market Factors” for further information.

In 2020, we received 13 approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including multiple regulatory milestone achievements for *Opdivo* and *Opdivo*+*Yervoy* combinations and have over 50 unique compounds in clinical development.

We are investigating *Opdivo* alone and in combination with *Yervoy* and other anti-cancer agents for a wide array of tumor types.

We continue to expand in the field of hematology, where we have the leading presence, through in-line assets *Revlimid* and *Pomalyst*.

In 2020, we received regulatory approvals for *Zeposia* and *Onureg* and received EMA validation for liso-cel for the treatment of large B-cell lymphoma.

Additionally, our pipeline shows significant added promise in hematology malignancies through our *CELMoD* agents (iberdomide and CC-92480), multiple modalities targeting B-Cell Maturation Antigen (“BCMA”) and the next generation of cell therapy agents.

We are expanding our portfolio in immunology with a near term launch opportunity for deucravacitinib, our TYK2 inhibitor.

Additionally in the cardiovascular space, *Eliquis* is a leading oral anti-coagulant drug, and we continue to experience growth in both the *Eliquis* brand and market while also advancing our Factor XIa inhibitor program.

With the acquisition of MyoKardia, we bolstered our leading cardiovascular franchise and added exceptional scientific capabilities, mavacamten a potentially transformative new medicine with significant commercial potential and a promising pipeline of candidates.

In 2020, our revenues increased 63% as a result of the Celgene acquisition, which contributed $15.7 billion of revenues or 60% of the growth, and higher demand for *Eliquis*.

After adjusting for specified items, non-GAAP EPS increased $1.75 as result of the Celgene acquisition.

The COVID-19 pandemic continues to affect global healthcare systems as well as major economic and financial markets.

Virtually all industries are facing challenges associated with the economic conditions resulting from efforts to address this pandemic.

For example, many entities in certain industries have seen sharp declines in revenues due to regulatory and organizational mandates (e.g., “shelter in place” mandates, non-essential business and school closures) and voluntary changes in consumer behavior (e.g., “physical distancing”).

Many entities continue to experience conditions often associated with a sudden and severe economic downturn.

Such conditions may include financial market volatility, erosion of market value, deteriorating credit, liquidity concerns, further increases in government intervention, increasing unemployment, broad declines in consumer discretionary spending, increasing inventory levels, reductions in production because of decreased demand and supply constraints, layoffs and furloughs and other restructuring activities.

We continue to monitor the impact on our business resulting from wider restrictions in select states and non-U.S. countries.

This is a dynamically changing environment and we continue to react to outbreaks throughout the world by re-enforcing our directives to keep our workforce safe in order to provide our patients with life-sustaining medicines.

Continued escalating infection rates could negatively affect our planned recovery, pressuring demand from less patient visits and channel mix if unemployment data trends remain unfavorable.

We have not incurred and do not anticipate disruptions to the supply of our medicines for patients due to the COVID-19 pandemic.

However, we are experiencing scarcity of certain raw materials and components as a result of the influx of COVID-19 vaccine orders receiving priority treatment from vendors.

All of our internal manufacturing facilities and key contract manufacturers are operating with proper measures taken to help ensure employee safety.

We have increased the number of our lab workers where it is safe to do so.

We have implemented a number of measures to protect the health and safety of our workforce, including, where needed, a mandatory work-from-home policy for our global workforce who can perform their jobs from home as well as restrictions on business travel, and workplace and in-person meetings.

Depending on local conditions, field-based personnel began in-person customer interactions in healthcare settings where it is safe to do so and approved by the government.

The remote engagement model has continued to support healthcare professionals, patient care and access to our medicines.

Although certain field-based sales teams have begun in person engagement in selected states and non-U.S. regions, the majority of interactions remain remote.

The situation remains dynamic and challenging to assess the potential impact on our operations such as the ability and willingness of patients to access treatment centers or obtain a prescription and changes in prescribing patterns that may potentially affect our operations in the long-term.

Certain changes in buying patterns have occurred, including payers implementing policies to encourage larger prescription sizes and earlier refills to help patients avoid trips to the pharmacy.

However, fewer patient office visits are resulting in lower than previously expected new patient starts.

Although it is difficult to estimate the impact of these factors, we do not believe that they had a significant impact on our revenues during 2020.

The timing of specific product launches depends on the relevant facts and circumstances for each situation.

For example, we delayed the commercialization of *Zeposia* in the U.S. based on the best health interest of our patients, customers and workforce.

In contrast, *Reblozyl* was available for MDS patients following its approval for this additional indication in April 2020 and *Onureg* was available for patients with AML in September 2020.

Our expanded U.S. patient assistance programs provided certain covered BMS medicines free to eligible patients that lost employment and health insurance due to COVID-19.

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 forward contracts by [removed: $742] [added: $678] million and [removed: $358] [added: $742] million at December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019,] [added: 2020,] respectively, reducing earnings over the remaining life of the contracts.

Non-U.S. dollar borrowings are used to hedge the foreign currency exposures of our net investment in certain [removed: foreign] [added: international] affiliates and are designated as hedges of net investments.

In this sensitivity analysis, if there were a 100 basis point increase in short-term or long-term interest rates as of December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019,] [added: 2020,] the expected adverse impact on our earnings would not be material.

We estimate that an increase of 100 basis points in long-term interest rates at December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019] [added: 2020] would decrease the fair value of long-term debt by [removed: $4.7] [added: $3.8] billion and [removed: $3.8] [added: $4.7] billion, respectively.

We [removed: are] [added: continue to operate in one segment] engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.

We expect that our acquisitions of Celgene [added: in 2019] and MyoKardia [added: in 2020] will further position us as a leading biopharmaceutical company, expanding our oncology, hematology, immunology 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: 2020] [added: 2021] Form 10-K for 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: oncology (both solid tumors and hematology), immunology, cardiovascular and [removed: fibrosis.][added: neurology.]

| Dollars in Millions | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| United States | | | 63 | | % | | | | [removed: 59] [added: 63] | | % | | | | [removed: 56] [added: 59] | | % |

| Europe | | | 23 | | % | | | | [removed: 24] [added: 23] | | % | | | | [removed: 25] [added: 24] | | % |

| Rest of the World | | | [removed: 14] [added: 12] | | % | | | | [removed: 17] [added: 13] | | % | | | | [removed: 19] [added: 15] | | % |

| Total Revenues | | | $ | [removed: 42,518] [added: 46,385] | | | | | $ | [removed: 26,145] [added: 42,518] | | | | | $ | [removed: 22,561] [added: 26,145] | |

Acquisitions, divestitures and [added: other] licensing arrangements allow us to focus our resources behind growth opportunities that drive the greatest long-term value.

[removed: Additional] [added: For additional] information relating to our acquisitions, [removed: divestitures and] [added: divestitures,] licensing [added: and other] arrangements [removed: is contained in] [added: refer to] “Item [removed: 8.][added: 7.]

[removed: Our pharmaceutical products include chemically-synthesized or small molecule drugs and products produced from biological processes, called “biologics.”] Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well.

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

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

*Orencia®* *Orencia* (abatacept), a biological product, is a fusion protein indicated for adult patients with moderately to severely active RA and [removed: PsA and is also indicated] [added: PsA,] for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular [removed: JIA.][added: JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.]

*Reblozyl®* *Reblozyl* [removed: (luspatercept-aamt)] [added: (luspatercept-aamt), a biological product,] is an erythroid maturation agent indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell [added: 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.

*Inrebic®* *Inrebic* (fedratinib) is [removed: a] [added: an oral] kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

*Zeposia®* *Zeposia* (ozanimod) is an oral immunomodulatory drug used to treat [added: moderately to severely active UC and] relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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

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

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

[removed: In addition to patent protection, certain innovative pharmaceutical products] [added: Both types of applications] can receive [added: certain] periods of regulatory exclusivity.

An NDA [added: or a BLA for a compound] that is designated as an orphan drug can receive seven years of exclusivity for [removed: the] [added: an] orphan [added: drug] indication.

During this [removed: time] period, [removed: neither NDAs nor aNDAs] [added: the FDA generally may not approve another application] for the same drug product [removed: can be approved] for the same orphan use.

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

An innovative chemical pharmaceutical product is entitled to five years of [removed: RDP] [added: regulatory data protection] 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 aNDA after the fourth year of the five-year [removed: RDP] [added: regulatory data protection] 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: RDP] [added: regulatory data protection] 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 regulatory [removed: exclusivity,] [added: data protection,] meaning that the FDA may not approve a biosimilar version until 12 years after the innovative biological product was first approved by the FDA.

For products that were filed prior to October/November 2005, there is a 10-year period of [added: 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).

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

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

The following chart shows our key products together with the year in which the earliest basic exclusivity loss (patent rights or data exclusivity) [removed: occurred or] is currently estimated to occur in the U.S., the EU and [removed: Japan.][added: Japan (the “estimated minimum market exclusivity date”).]

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 [added: regulatory] data [removed: exclusivity.][added: protection.]

We estimate the [added: minimum] market exclusivity [removed: period] [added: date] for each of our products for the purpose of business planning only.

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

| *Revlimid* [removed: (lenalidomide)(a)] [added: (lenalidomide)(h)] | | | ^^ | | | | | | [removed: 2022] [added: ^^] | | | | | | 2022 | | |

| *Orencia* [removed: (abatacept)(c)] [added: (abatacept)(e)] | | | [removed: 2021] [added: ^^] | | | | | | [removed: 2021] [added: ^^] | | | | | | ^^ | | |

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

We remain committed to reducing our debt and returning capital to shareholders.

| Other(a) | | | 2 | | % | | | | 1 | | % | | | | 2 | | % |

(a) Other revenues include royalties and alliance-related revenues for products not sold by BMS’s regional commercial organizations.

Management's Discussion and Analysis of Financial Condition and Results of Operations—Acquisitions, Divestitures, Licensing and Other Arrangements” and “Item 8.

Our pharmaceutical products include chemically-synthesized or small molecule drugs, products produced from biological processes, called “biologics” and chimeric antigen receptor (CAR) T-cell therapies.

CAR T-cell therapies are administered to patients by intravenous infusion.

*Abecma®* *Abecma* (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.

The type of application filed can affect regulatory data protection exclusivity rights as discussed below.

Our marketed biologic products include *Opdivo*, *Yervoy*, *Orencia,* *Reblozyl* and *Empliciti*.

| | | | Estimated Minimum Market Exclusivity Date | | | | | | | | | | | | | | |

| *Abecma* (idecabtagene vicleucel) | | | 2036 | | | | | | 2035 | | | | | | 2035 | | |

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

The remaining generic companies appealed, and in September 2021 the U.S. Court of Appeals for the Federal Circuit upheld the decision with respect to both patents.

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 U.S., Accord Healthcare Inc. has challenged the formulation patent, which is listed in the FDA Orange Book, and litigation is ongoing.

In the EU, three formulation patents (EP 2,299,984; EP 2,695,609; and EP 3,692,983) cover *Onureg*, and two of these patents (EP 2,299,984 and EP 2,695,609) are in pending opposition proceedings.

The EPO Opposition Division recently found one of these formulation patents (EP 2,299,984) invalid, and the decision is being appealed.

(f) For *Pomalyst* in the U.S., we currently do not expect generic entry prior to the first quarter of 2026.

For Japan, the estimated minimum market exclusivity date is 2026 based on a method of use patent.

Certain other generic companies have been granted volume-limited licenses to sell generic lenalidomide in the U.S. beginning on confidential dates that are sometime after the March 2022 volume-limited license date provided to Natco.

In Japan, the composition of matter patent has been extended to 2024 for the treatment of non-imatinib-resistant CML, and there is a patent covering the monohydrate form of dasatinib that expires in 2025.

In the EU, the estimated minimum market exclusivity date is based on regulatory data protection exclusivity.

Our drug discovery and development work takes place across a network of state-of-the-art facilities worldwide.

We have continued our investment in our existing sites and the expansion of our manufacturing capabilities.

In addition, in support of our continued investment in our cell therapy portfolio, we are expanding our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts and Leiden, Netherlands.

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

| Opdivo + Yervoy | | | CRPC | | | CM-7DX | | | 2023/24 | | | | | | 3L+ Follicular Lymphoma | | | TRANSCEND-FL | | | 2023/24 | | | | | |

| Opdivo + Yervoy | | | Adj. HCC | | | CM-9DX | | | 2023/24 | | | | | | Reblozyl | | | 1L MDS (ESA naïve) | | | COMMANDS | | | 2023/24 | | |

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

| Opdivo | | | Peri-adjuvant MIBC | | | CM-078 | | | 2023/24 | | | | | | | | | | | | | | | | | |

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

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

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

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

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

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

Refer to “Item 8.

Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins.”

- In August 2020, BMS and the Bristol Myers Squibb Foundation each announced that they would independently invest $150 million over the next five years as part of a series of commitments around health equity, diversity and inclusion currently focused on five key priorities: 1) addressing health disparities, 2) increasing clinical trial diversity, 3) expanding our supplier diversity program, 4) expanding our U.S. & Puerto Rico Employee Giving Program and 5) increasing our workforce diversity at the executive levels.

We completed the Celgene transaction on November 20, 2019.

On November 17, 2020, we completed our acquisition of MyoKardia for approximately $13.1 billion in cash.

We continue to operate in one segment—Biopharmaceuticals.

For additional information about our business segment, refer to “Item 8.

Financial Statements and Supplementary Data—Note 1.

Accounting Policies and Recently Issued Accounting Standards.” Commencing from the Celgene acquisition date, our consolidated financial statements include the assets, liabilities, operating results and cash flows of Celgene.

Our four strategic priorities are to drive enterprise performance, maximize the value of our commercial portfolio, ensure the long-term sustainability of our pipeline through combined internal and external innovation and establish our new culture and embed our people strategy.

While we are committed to reducing our debt, we plan to remain focused on broadening our portfolio of marketed medicines and pipeline assets.

Our significant business development activities include:

- In November 2020, we completed our acquisition of MyoKardia.

- In October 2020, we obtained a global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002.

- In September 2020, we completed our acquisition of Forbius.

*Vidaza®* *Vidaza* (azacitidine for injection) is a pyrimidine nucleoside analog that has been shown to reverse the effects of deoxyribonucleic acid hypermethylation and promote subsequent gene re-expression and is indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia (CMMoL).

*Baraclude®* *Baraclude* (entecavir) is an oral antiviral agent for the treatment of chronic hepatitis B.

The type of application filed affects RDP exclusivity rights.

In many instances, the basic exclusivity loss date listed below is the expiration date of the patent that claims the active ingredient of the drug or the method of using the drug for the approved indication, if there is only one approved indication.

In some instances, the basic exclusivity loss date listed in the chart is the expiration date of the data exclusivity period.

| | | | Estimated LOE | | | | | | | | | | | | | | |

The remaining generic companies have appealed the Delaware court decision and the final decision in this case could determine when generic versions of Eliquis will come on the market.

While we cannot predict the outcome of this pending litigation, these are the alternatives that might occur:

- If the formulation patent is held invalid or not infringed in the current appeal, the settled generic companies and the remaining generic companies would be permitted to launch on November 21, 2026; or

- If both patents are held invalid or not infringed in the current appeal, the settled generic companies and the remaining generic companies could launch immediately upon such an adverse decision.

In addition, both patents may be subject to subsequent challenges by parties other than the remaining generic companies.

If this were to occur, depending on the outcome of the subsequent challenge, the potential launch by generic companies, including challengers, if successful, could occur on timelines similar to those discussed above.

(c) For *Orencia*, in the U.S. and EU, estimated LOE dates are based on method of use patents that expire in 2021.

Actual LOE may extend beyond these dates for the aforementioned reasons.

(d) For *Pomalyst*, in the U.S. refer to “Item 8.

BMS initiated patent litigation against Dr. Reddy’s Laboratories (October 2019) and Lupin (June 2020), and the decision in these cases could determine when generics will come on the market.

(f) For *Abraxane* in the U.S., as part of the settlement with Actavis LLC, Actavis was granted a license to certain patents required to sell a generic paclitaxel protein-bound particles for injectable suspension product in the U.S. beginning on March 31, 2022.

As part of our operating model evolution, our R&D geographic footprint will significantly transform to foster speed and innovation in the future.

The transformation involves the closing of our Hopewell, New Jersey site in 2020 accompanied by additional investment in the expansion and opening of others.

In addition, with the acquisition of Celgene in 2019, we added R&D facilities in strategic locations around the U.S. and Europe, including San Diego, California; Seattle, Washington; Cambridge, Massachusetts; Summit, New Jersey; San Francisco, California; and Boudry, Switzerland.

| Opdivo + relatlimab | | | Melanoma | | | CA224-047 | | | 2021 | | | | | | iberdomide | | | 4L+ Multiple Myeloma | | | CC-220-MM-001 | | | 2021 | | |

| Opdivo + Yervoy | | | HCC | | | CM-9DW | | | 2022/23 | | | | | | 2L TNE Diffuse Large B-cell Lymphoma | | | PILOT | | | 2021 | | | | | |

| Opdivo + Yervoy | | | Neo-adjuvant NSCLC | | | CM-816 | | | 2022/23 | | | | | | 2L TE Diffuse Large B-cell Lymphoma | | | TRANSFORM | | | 2021 | | | | | |

| Opdivo + Yervoy | | | Peri-adjuvant NSCLC | | | CM-77T | | | 2022/23 | | | | | | 3L+ Follicular Lymphoma | | | TRANSCEND-FL | | | 2022/23 | | | | | |

| | | | | | | | | | | | | | | | 3L+ Multiple Myeloma | | | KarMMa-3 | | | 2022/23 | | | | | |

| Immunology | | | | | | | | | | | | | | | Reblozyl | | | 1L MDS (ESA naïve) | | | COMMANDS | | | 2022/23 | | |

Risk Factors.”

- BMS and the Bristol Myers Squibb Foundation announced in August 2020 a combined investment of $300 million as part of a series of commitments designed to address health disparities, increase clinical trial diversity and increase the amount of business that we do with diverse suppliers.

For the fiscal year ended December 31, [removed: 2020][added: 2021]

The aggregate market value of the [removed: 2,252,423,640] [added: 2,220,639,863] 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: $132,442,510,032.][added: $148,383,155,646.]

Bristol-Myers Squibb [added: Company] has no non-voting common equity.

At February 1, [removed: 2021,] [added: 2022,] there were [removed: 2,240,475,153] [added: 2,179,712,820] 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: 2020] [added: 2021] 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.

| | | | [Item [removed: 1.](#i41f64878d2784d5ea6ffaae4477d4823_13)] [added: 1.](#ibe77cac30ec34febb3568b00c7b1dcde_13)] | | | [removed: [Business](#i41f64878d2784d5ea6ffaae4477d4823_13)] [added: [Business](#ibe77cac30ec34febb3568b00c7b1dcde_13)] | | | [removed: [1](#i41f64878d2784d5ea6ffaae4477d4823_13)] [added: [1](#ibe77cac30ec34febb3568b00c7b1dcde_13)] | | |

| | | | | | | [Acquisitions, Divestitures and Licensing [removed: Arrangements](#i41f64878d2784d5ea6ffaae4477d4823_16)] [added: Arrangements](#ibe77cac30ec34febb3568b00c7b1dcde_16)] | | | [removed: [2](#i41f64878d2784d5ea6ffaae4477d4823_16)] [added: [2](#ibe77cac30ec34febb3568b00c7b1dcde_16)] | | |

| | | | | | | [Products, Intellectual Property and Product [removed: Exclusivity](#i41f64878d2784d5ea6ffaae4477d4823_19)] [added: Exclusivity](#ibe77cac30ec34febb3568b00c7b1dcde_19)] | | | [removed: [2](#i41f64878d2784d5ea6ffaae4477d4823_19)] [added: [2](#ibe77cac30ec34febb3568b00c7b1dcde_19)] | | |

| | | | | | | [Research and [removed: Development](#i41f64878d2784d5ea6ffaae4477d4823_25)] [added: Development](#ibe77cac30ec34febb3568b00c7b1dcde_22)] | | | [removed: [7](#i41f64878d2784d5ea6ffaae4477d4823_25)] [added: [8](#ibe77cac30ec34febb3568b00c7b1dcde_22)] | | |

| | | | | | | [Marketing, Distribution and [removed: Customers](#i41f64878d2784d5ea6ffaae4477d4823_40)] [added: Customers](#ibe77cac30ec34febb3568b00c7b1dcde_40)] | | | [removed: [13](#i41f64878d2784d5ea6ffaae4477d4823_40)] [added: [15](#ibe77cac30ec34febb3568b00c7b1dcde_40)] | | |

| | | | | | | [Pricing, Price Constraints and Market [removed: Access](#i41f64878d2784d5ea6ffaae4477d4823_46)] [added: Access](#ibe77cac30ec34febb3568b00c7b1dcde_46)] | | | [removed: [15](#i41f64878d2784d5ea6ffaae4477d4823_46)] [added: [16](#ibe77cac30ec34febb3568b00c7b1dcde_46)] | | |

| | | | | | | [Government [removed: Regulation](#i41f64878d2784d5ea6ffaae4477d4823_49)] [added: Regulation](#ibe77cac30ec34febb3568b00c7b1dcde_49)] | | | [removed: [16](#i41f64878d2784d5ea6ffaae4477d4823_49)] [added: [17](#ibe77cac30ec34febb3568b00c7b1dcde_49)] | | |

| | | | | | | [Sources and Availability of Raw [removed: Materials](#i41f64878d2784d5ea6ffaae4477d4823_52)] [added: Materials](#ibe77cac30ec34febb3568b00c7b1dcde_52)] | | | [removed: [17](#i41f64878d2784d5ea6ffaae4477d4823_52)] [added: [19](#ibe77cac30ec34febb3568b00c7b1dcde_52)] | | |

| | | | | | | [Manufacturing and Quality [removed: Assurance](#i41f64878d2784d5ea6ffaae4477d4823_55)] [added: Assurance](#ibe77cac30ec34febb3568b00c7b1dcde_55)] | | | [removed: [18](#i41f64878d2784d5ea6ffaae4477d4823_55)] [added: [20](#ibe77cac30ec34febb3568b00c7b1dcde_55)] | | |

| | | | | | | [Environmental [removed: Regulation](#i41f64878d2784d5ea6ffaae4477d4823_58)] [added: Regulation](#ibe77cac30ec34febb3568b00c7b1dcde_58)] | | | [removed: [19](#i41f64878d2784d5ea6ffaae4477d4823_58)] [added: [21](#ibe77cac30ec34febb3568b00c7b1dcde_58)] | | |

| | | | | | | [Human Capital Management and [removed: Resources](#i41f64878d2784d5ea6ffaae4477d4823_61)] [added: Resources](#ibe77cac30ec34febb3568b00c7b1dcde_61)] | | | [removed: [19](#i41f64878d2784d5ea6ffaae4477d4823_61)] [added: [21](#ibe77cac30ec34febb3568b00c7b1dcde_61)] | | |

| | | | | | | [Foreign [removed: Operations](#i41f64878d2784d5ea6ffaae4477d4823_64)] [added: Operations](#ibe77cac30ec34febb3568b00c7b1dcde_64)] | | | [removed: [21](#i41f64878d2784d5ea6ffaae4477d4823_64)] [added: [23](#ibe77cac30ec34febb3568b00c7b1dcde_64)] | | |

| | | | | | | [removed: [Bristol-Myers] [added: [Bristol](#ibe77cac30ec34febb3568b00c7b1dcde_67) [](#ibe77cac30ec34febb3568b00c7b1dcde_67)[Myers] Squibb [removed: Website](#i41f64878d2784d5ea6ffaae4477d4823_67)] [added: Website](#ibe77cac30ec34febb3568b00c7b1dcde_67)] | | | [removed: [21](#i41f64878d2784d5ea6ffaae4477d4823_67)] [added: [23](#ibe77cac30ec34febb3568b00c7b1dcde_67)] | | |

| | | | [Item [removed: 1A.](#i41f64878d2784d5ea6ffaae4477d4823_70)] [added: 1A.](#ibe77cac30ec34febb3568b00c7b1dcde_70)] | | | [Risk [removed: Factors](#i41f64878d2784d5ea6ffaae4477d4823_70)] [added: Factors](#ibe77cac30ec34febb3568b00c7b1dcde_70)] | | | [removed: [22](#i41f64878d2784d5ea6ffaae4477d4823_70)] [added: [24](#ibe77cac30ec34febb3568b00c7b1dcde_70)] | | |

| | | | [Item [removed: 1B.](#i41f64878d2784d5ea6ffaae4477d4823_73)] [added: 1B.](#ibe77cac30ec34febb3568b00c7b1dcde_73)] | | | [Unresolved Staff [removed: Comments](#i41f64878d2784d5ea6ffaae4477d4823_73)] [added: Comments](#ibe77cac30ec34febb3568b00c7b1dcde_73)] | | | [removed: [33](#i41f64878d2784d5ea6ffaae4477d4823_73)] [added: [36](#ibe77cac30ec34febb3568b00c7b1dcde_73)] | | |

| | | | [Item [removed: 2.](#i41f64878d2784d5ea6ffaae4477d4823_76)] [added: 2.](#ibe77cac30ec34febb3568b00c7b1dcde_76)] | | | [removed: [Properties](#i41f64878d2784d5ea6ffaae4477d4823_76)] [added: [Properties](#ibe77cac30ec34febb3568b00c7b1dcde_76)] | | | [removed: [33](#i41f64878d2784d5ea6ffaae4477d4823_76)] [added: [36](#ibe77cac30ec34febb3568b00c7b1dcde_76)] | | |

| | | | [Item [removed: 3.](#i41f64878d2784d5ea6ffaae4477d4823_79)] [added: 3.](#ibe77cac30ec34febb3568b00c7b1dcde_79)] | | | [Legal [removed: Proceedings](#i41f64878d2784d5ea6ffaae4477d4823_79)] [added: Proceedings](#ibe77cac30ec34febb3568b00c7b1dcde_79)] | | | [removed: [33](#i41f64878d2784d5ea6ffaae4477d4823_79)] [added: [38](#ibe77cac30ec34febb3568b00c7b1dcde_79)] | | |

| | | | [Item [removed: 4.](#i41f64878d2784d5ea6ffaae4477d4823_82)] [added: 4.](#ibe77cac30ec34febb3568b00c7b1dcde_82)] | | | [Mine Safety [removed: Disclosures](#i41f64878d2784d5ea6ffaae4477d4823_82)] [added: Disclosures](#ibe77cac30ec34febb3568b00c7b1dcde_82)] | | | [removed: [33](#i41f64878d2784d5ea6ffaae4477d4823_82)] [added: [36](#ibe77cac30ec34febb3568b00c7b1dcde_82)] | | |

| [PART [removed: IA](#i41f64878d2784d5ea6ffaae4477d4823_85)] [added: IA](#ibe77cac30ec34febb3568b00c7b1dcde_85)] | | | | | | [Information about our Executive [removed: Officers](#i41f64878d2784d5ea6ffaae4477d4823_85)] [added: Officers](#ibe77cac30ec34febb3568b00c7b1dcde_85)] | | | [removed: [34](#i41f64878d2784d5ea6ffaae4477d4823_85)] [added: [37](#ibe77cac30ec34febb3568b00c7b1dcde_85)] | | |

| | | | [Item [removed: 5.](#i41f64878d2784d5ea6ffaae4477d4823_91)] [added: 5.](#ibe77cac30ec34febb3568b00c7b1dcde_91)] | | | [Market for the Registrant's Common Stock and Other Stockholder [removed: Matters](#i41f64878d2784d5ea6ffaae4477d4823_91)] [added: Matters](#ibe77cac30ec34febb3568b00c7b1dcde_91)] | | | [removed: [35](#i41f64878d2784d5ea6ffaae4477d4823_91)] [added: [38](#ibe77cac30ec34febb3568b00c7b1dcde_91)] | | |

| | | | [Item [removed: 6.](#i41f64878d2784d5ea6ffaae4477d4823_94)] [added: 6.](#ibe77cac30ec34febb3568b00c7b1dcde_94)] | | | [Selected Financial [removed: Data](#i41f64878d2784d5ea6ffaae4477d4823_94)] [added: Data](#ibe77cac30ec34febb3568b00c7b1dcde_94)] | | | [removed: [37](#i41f64878d2784d5ea6ffaae4477d4823_94)] [added: [39](#ibe77cac30ec34febb3568b00c7b1dcde_94)] | | |

| | | | [Item [removed: 7.](#i41f64878d2784d5ea6ffaae4477d4823_97)] [added: 7.](#ibe77cac30ec34febb3568b00c7b1dcde_97)] | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i41f64878d2784d5ea6ffaae4477d4823_97)] [added: Operations](#ibe77cac30ec34febb3568b00c7b1dcde_97)] | | | [removed: [38](#i41f64878d2784d5ea6ffaae4477d4823_97)] [added: [40](#ibe77cac30ec34febb3568b00c7b1dcde_97)] | | |

| | | | [Item [removed: 7A.](#i41f64878d2784d5ea6ffaae4477d4823_196)] [added: 7A.](#ibe77cac30ec34febb3568b00c7b1dcde_190)] | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i41f64878d2784d5ea6ffaae4477d4823_196)] [added: Risk](#ibe77cac30ec34febb3568b00c7b1dcde_190)] | | | [removed: [68](#i41f64878d2784d5ea6ffaae4477d4823_196)] [added: [71](#ibe77cac30ec34febb3568b00c7b1dcde_190)] | | |

| | | | [Item [removed: 8.](#i41f64878d2784d5ea6ffaae4477d4823_199)] [added: 8.](#ibe77cac30ec34febb3568b00c7b1dcde_193)] | | | [Financial Statements and Supplementary [removed: Data](#i41f64878d2784d5ea6ffaae4477d4823_199)] [added: Data](#ibe77cac30ec34febb3568b00c7b1dcde_193)] | | | [removed: [70](#i41f64878d2784d5ea6ffaae4477d4823_199)] [added: [73](#ibe77cac30ec34febb3568b00c7b1dcde_193)] | | |

| | | | | | | [Consolidated Statements of Earnings and Comprehensive [removed: (Loss)/Income](#i41f64878d2784d5ea6ffaae4477d4823_202)] [added: (Loss)/Income](#ibe77cac30ec34febb3568b00c7b1dcde_196)] | | | [removed: [70](#i41f64878d2784d5ea6ffaae4477d4823_202)] [added: [73](#ibe77cac30ec34febb3568b00c7b1dcde_196)] | | |

| | | | | | | [Consolidated Balance [removed: Sheets](#i41f64878d2784d5ea6ffaae4477d4823_205)] [added: Sheets](#ibe77cac30ec34febb3568b00c7b1dcde_199)] | | | [removed: [71](#i41f64878d2784d5ea6ffaae4477d4823_205)] [added: [74](#ibe77cac30ec34febb3568b00c7b1dcde_199)] | | |

| | | | | | | [Consolidated Statements of Cash [removed: Flows](#i41f64878d2784d5ea6ffaae4477d4823_211)] [added: Flows](#ibe77cac30ec34febb3568b00c7b1dcde_202)] | | | [removed: [72](#i41f64878d2784d5ea6ffaae4477d4823_211)] [added: [75](#ibe77cac30ec34febb3568b00c7b1dcde_202)] | | |

| | | | | | | [Notes to the Financial [removed: Statements](#i41f64878d2784d5ea6ffaae4477d4823_214)] [added: Statements](#ibe77cac30ec34febb3568b00c7b1dcde_205)] | | | [removed: [73](#i41f64878d2784d5ea6ffaae4477d4823_214)] [added: [76](#ibe77cac30ec34febb3568b00c7b1dcde_205)] | | |

| | | | [Item [removed: 9.](#i41f64878d2784d5ea6ffaae4477d4823_334)] [added: 9.](#ibe77cac30ec34febb3568b00c7b1dcde_319)] | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i41f64878d2784d5ea6ffaae4477d4823_334)] [added: Disclosure](#ibe77cac30ec34febb3568b00c7b1dcde_319)] | | | [removed: [126](#i41f64878d2784d5ea6ffaae4477d4823_334)] [added: [127](#ibe77cac30ec34febb3568b00c7b1dcde_319)] | | |

| | | | [Item [removed: 9A.](#i41f64878d2784d5ea6ffaae4477d4823_337)] [added: 9A.](#ibe77cac30ec34febb3568b00c7b1dcde_322)] | | | [Controls and [removed: Procedures](#i41f64878d2784d5ea6ffaae4477d4823_337)] [added: Procedures](#ibe77cac30ec34febb3568b00c7b1dcde_322)] | | | [removed: [126](#i41f64878d2784d5ea6ffaae4477d4823_337)] [added: [127](#ibe77cac30ec34febb3568b00c7b1dcde_322)] | | |

| | | | [Item [removed: 9B.](#i41f64878d2784d5ea6ffaae4477d4823_340)] [added: 9B.](#ibe77cac30ec34febb3568b00c7b1dcde_325)] | | | [Other [removed: Information](#i41f64878d2784d5ea6ffaae4477d4823_340)] [added: Information](#ibe77cac30ec34febb3568b00c7b1dcde_325)] | | | [removed: [126](#i41f64878d2784d5ea6ffaae4477d4823_340)] [added: [127](#ibe77cac30ec34febb3568b00c7b1dcde_325)] | | |

| | | | [Item [removed: 10.](#i41f64878d2784d5ea6ffaae4477d4823_349)] [added: 10.](#ibe77cac30ec34febb3568b00c7b1dcde_334)] | | | [Directors and Executive Officers of the [removed: Registrant](#i41f64878d2784d5ea6ffaae4477d4823_349)] [added: Registrant](#ibe77cac30ec34febb3568b00c7b1dcde_334)] | | | [removed: [128](#i41f64878d2784d5ea6ffaae4477d4823_349)] [added: [129](#ibe77cac30ec34febb3568b00c7b1dcde_334)] | | |

| | | | [Item [removed: 11.](#i41f64878d2784d5ea6ffaae4477d4823_352)] [added: 11.](#ibe77cac30ec34febb3568b00c7b1dcde_337)] | | | [Executive [removed: Compensation](#i41f64878d2784d5ea6ffaae4477d4823_352)] [added: Compensation](#ibe77cac30ec34febb3568b00c7b1dcde_337)] | | | [removed: [128](#i41f64878d2784d5ea6ffaae4477d4823_352)] [added: [129](#ibe77cac30ec34febb3568b00c7b1dcde_337)] | | |

| | | | [Item [removed: 12.](#i41f64878d2784d5ea6ffaae4477d4823_355)] [added: 12.](#ibe77cac30ec34febb3568b00c7b1dcde_340)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i41f64878d2784d5ea6ffaae4477d4823_355)] [added: Matters](#ibe77cac30ec34febb3568b00c7b1dcde_340)] | | | [removed: [128](#i41f64878d2784d5ea6ffaae4477d4823_355)] [added: [129](#ibe77cac30ec34febb3568b00c7b1dcde_340)] | | |

| | | | [Item [removed: 13.](#i41f64878d2784d5ea6ffaae4477d4823_358)] [added: 13.](#ibe77cac30ec34febb3568b00c7b1dcde_343)] | | | [Certain Relationships and Related [removed: Transactions](#i41f64878d2784d5ea6ffaae4477d4823_358)] [added: Transactions](#ibe77cac30ec34febb3568b00c7b1dcde_343)] | | | [removed: [128](#i41f64878d2784d5ea6ffaae4477d4823_358)] [added: [129](#ibe77cac30ec34febb3568b00c7b1dcde_343)] | | |

December 31, 2021

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

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

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

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

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

| [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) | | |

December 31, 2020

| [PART I](#i41f64878d2784d5ea6ffaae4477d4823_10) | | | | | | | | | | | |

| | | | | | | [Alliances](#i41f64878d2784d5ea6ffaae4477d4823_37) | | | [12](#i41f64878d2784d5ea6ffaae4477d4823_37) | | |

| | | | | | | [Competition](#i41f64878d2784d5ea6ffaae4477d4823_43) | | | [14](#i41f64878d2784d5ea6ffaae4477d4823_43) | | |

| [PART II](#i41f64878d2784d5ea6ffaae4477d4823_88) | | | | | | | | | | | |

| [PART III](#i41f64878d2784d5ea6ffaae4477d4823_346) | | | | | | | | | | | |

| [PART IV](#i41f64878d2784d5ea6ffaae4477d4823_364) | | | | | | | | | | | |

| [SIGNATURES](#i41f64878d2784d5ea6ffaae4477d4823_373) | | | | | | | | | [130](#i41f64878d2784d5ea6ffaae4477d4823_373) | | |

| [SUMMARY OF ABBREVIATED TERMS](#i41f64878d2784d5ea6ffaae4477d4823_376) | | | | | | | | | [132](#i41f64878d2784d5ea6ffaae4477d4823_376) | | |

| [EXHIBIT INDEX](#i41f64878d2784d5ea6ffaae4477d4823_379) | | | | | | | | | [133](#i41f64878d2784d5ea6ffaae4477d4823_379) | | |

We own or lease manufacturing, R&D, administration, storage and distribution facilities at approximately [removed: 210] [added: 195] sites worldwide.

Our significant manufacturing and R&D locations by geographic area were as follows at December 31, [removed: 2020:][added: 2021:]

| United States | | | [removed: 5] [added: 6] | | | | | | [removed: 11] [added: 10] | | |

| Total | | | [removed: 7] [added: 8] | | | | | | [removed: 12] [added: 11] | | |

Listed below is information on our executive officers as of February [removed: 10, 2021.][added: 9, 2022.]

| Giovanni Caforio, M.D. *Chairman of the Board and Chief Executive Officer* *Member of the Leadership Team* | | | [removed: 56] [added: 57] | | | [removed: 2014 to] 2015 [removed: – Chief Operating Officer and Director of the Company 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: 50] [added: 51] | | | [removed: 2014 to] 2015 [removed: – Executive Vice President, Seattle Genetics 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 [removed: Commercial] [added: Commercialization] Officer | | |

| [removed: Joseph E. Eid,] [added: Samit Hirawat,] M.D. [removed: *Senior] [added: *Executive] Vice [removed: President and Head of Global] [added: President, Chief] Medical [removed: Affairs*] [added: Officer, Global Drug Development*] *Member of the Leadership Team* | | | 53 | | | [removed: 2014 to] 2017 [added: to 2019] – [added: Executive] Vice President, Head of Oncology [removed: Global Medical Affairs, Merck 2017 to] [added: Development, Novartis] 2019 [removed: – Head of Global Medical 2017] to present – [removed: Senior] [added: Executive] Vice [removed: President and Head of Global] [added: President, Chief] Medical [removed: Affairs] [added: Officer, Global Drug Development] | | |

| David V. Elkins *Executive Vice President and Chief Financial Officer* *Member of the Leadership Team* | | | [removed: 52] [added: 53] | | | 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 Devices and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene 2019 to present – Executive Vice President and Chief Financial Officer | | |

| [removed: Samit Hirawat, M.D.] [added: Ann M. Powell] *Executive Vice President, Chief [removed: Medical Officer, Global Drug Development*] [added: Human Resources Officer*] *Member of the Leadership Team* | | | [removed: 52] [added: 56] | | | [removed: 2012 to] 2016 [removed: – Senior Vice President & Global Program Head, Novartis 2017] to 2019 – [removed: Executive] [added: Senior] Vice President, [removed: Head of Oncology Development, Novartis] [added: Chief Human Resources Officer] 2019 to present – Executive Vice President, Chief [removed: Medical Officer, Global Drug Development] [added: Human Resources Officer] | | |

| Sandra Leung *Executive Vice President, General Counsel* *Member of the Leadership Team* | | | [removed: 60] [added: 61] | | | [removed: 2007 to 2014 – General Counsel and Corporate Secretary 2014 to] 2015 [removed: – Executive Vice President, General Counsel and Corporate Secretary 2015] to present – Executive Vice President, General Counsel | | |

| Elizabeth A. Mily *Executive Vice President, Strategy & Business Development* *Member of the Leadership Team* | | | [removed: 53] [added: 54] | | | 2010 to 2020 – Managing Director, Barclays Investment Bank 2020 to present – Executive Vice President, Strategy & Business Development | | |

| [removed: Ann M. Powell] [added: Paul von Autenried] *Executive Vice President, Chief [removed: Human Resources] [added: Information] Officer* *Member of the Leadership Team* | | | [removed: 55] [added: 60] | | | [removed: 2009 to 2013 – Chief Human Resources Officer, Shire Pharmaceuticals 2013 to] 2016 [removed: – Senior Vice President, Global Human Resources 2016] to 2019 – Senior Vice President, Chief [removed: Human Resources] [added: Information] Officer 2019 to present – Executive Vice President, Chief [removed: Human Resources] [added: Information] Officer | | |

| Karen Santiago *Senior Vice President and Corporate Controller* | | | [removed: 50] [added: 51] | | | [removed: 2012 to 2015 – Vice President Finance, Global Manufacturing and Supply 2015 to] 2016 [removed: – Vice President Finance, U.S. Commercial and Global Capability Hub 2016] to 2018 – Lead, Enabling Functions and Finance Transformation 2018 to present – Senior Vice President and Corporate Controller | | |

| Louis S. Schmukler *Executive Vice President and President, Global Product Development and Supply* *Member of the Leadership Team* | | | [removed: 65] [added: 66] | | | 2011 to 2017 – President, Global Product Development and Supply 2017 to 2019 – Senior Vice President and President, Global Product Development and Supply 2019 to present – Executive Vice President and President, Global Product Development and Supply | | |

| Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil. *Executive Vice President, Research and Early Development* *Member of the Leadership Team* | | | [removed: 56] [added: 57] | | | 2015 to 2019 – President of Research and Early Development, Celgene 2019 to present – Executive Vice President, Research and Early Development | | |

| Greg Meyers *Executive Vice President, Chief Digital and Technology Officer* *Member of the Leadership Team* | | | 49 | | | 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 | | |

| Michelle Weese *Executive Vice President, Corporate Affairs* *Member of the Leadership Team* | | | 51 | | | 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 | | |

| Adam Dubow *Senior Vice President, Chief Compliance and Ethics Officer Member of the Leadership Team* | | | 54 | | | 2013 to 2015 – Vice President and Assistant General Counsel, China, Japan and Intercon Region and EMAC Region 2015 to 2018 – Vice President and Associate General Counsel, Research and Development 2018 to present – Senior Vice President, Chief Compliance and Ethics Officer | | |

| Paul von Autenried *Executive Vice President, Chief Information Officer* *Member of the Leadership Team* | | | 59 | | | 2012 to 2016 – Senior Vice President, Enterprise Services and Chief Information Officer 2016 to 2019 – Senior Vice President, Chief Information Officer 2019 to present – Executive Vice President, Chief Information Officer | | |

[removed: Bristol-Myers] [added: Bristol Myers] Squibb common stock is traded on the New York Stock Exchange (Symbol: BMY).

The number of record holders of our common stock at January 31, [removed: 2021] [added: 2022] was [removed: 36,187.][added: 34,417.]

Information required by this item will be contained in our [removed: 2021] [added: 2022] Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive Officers-Equity Compensation Plan Information,” which information is incorporated herein by reference.

The following graph compares the cumulative total stockholders’ returns of our common shares with the cumulative total stockholders’ returns of the companies listed in the Standard & Poor’s 500 Index [added: ("S&P 500 Index")] and a composite peer group of major pharmaceutical companies comprised of AbbVie, Amgen, AstraZeneca, Biogen, Gilead, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck, Novartis, Pfizer, Roche and Sanofi.

The graph assumes $100 investment on December 31, [removed: 2015] [added: 2016] 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: 2016,] 2017, 2018, [removed: 2019] [added: 2019, 2020] and [removed: 2020.][added: 2021.]

[removed: ][added: ]

| | | | [removed: 2015] [added: 2016] | | | | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | |

The following table summarizes the surrenders of our equity securities during the three months ended December 31, [removed: 2020:][added: 2021:]

The remaining share repurchase capacity under the program was approximately [removed: $4.4] [added: $15.2] billion as of December 31, [removed: 2020.][added: 2021.]

In January [added: and December] 2021, the Board of Directors approved an increase of $2.0 billion [added: and $15.0 billion, respectively,] to the share repurchase [removed: authorization for our common stock.][added: authorization.]

| 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 | | |

Issuer Purchases of Equity Securities

| 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 | | | | | | | | |

| Bristol-Myers Squibb | | | $ | 100.00 | | | | | $ | 86.51 | | | | | $ | 93.18 | | | | | $ | 81.16 | | | | | $ | 103.67 | | | | | $ | 104.10 | |

| S&P 500 | | | 100.00 | | | | | | 111.96 | | | | | | 136.40 | | | | | | 130.42 | | | | | | 171.49 | | | | | | 203.04 | | |

| Peer Group | | | 100.00 | | | | | | 99.45 | | | | | | 114.61 | | | | | | 126.10 | | | | | | 147.87 | | | | | | 150.86 | | |

Unregistered Sales of Equity Securities and Use of Proceeds

| October 1 to 31, 2020 | | | 9,489,912 | | | | | | $ | 59.95 | | | | | 8,901,702 | | | | | | $ | 5,385 | |

| November 1 to 30, 2020 | | | 7,355,624 | | | | | | 63.02 | | | | | | 7,333,449 | | | | | | 4,923 | | |

| December 1 to 31, 2020 | | | 8,529,764 | | | | | | 61.63 | | | | | | 8,359,055 | | | | | | 4,408 | | |

| Three months ended December 31, 2020 | | | 25,375,300 | | | | | | | | | | | | 24,594,206 | | | | | | | | |

The following table sets forth our selected historical consolidated financial information for each of the five periods indicated.

This information should be read together with “Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations” and with the consolidated financial statements and related notes included elsewhere in this 2020 Form 10-K including disclosures related to the November 20, 2019 acquisition of Celgene.

The selected historical financial information as of and for the years ended December 31, 2020, 2019, 2018, 2017 and 2016 are derived from our audited consolidated financial statements and related notes.

Five Year Financial Summary

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

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

| Amounts in Millions, except per share data | | | 2020 | | | | | | 2019 | | | | | | 2018 | | | | | | 2017 | | | | | | 2016 | | |

| Income Statement Data: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Total Revenues | | | $ | 42,518 | | | | | $ | 26,145 | | | | | $ | 22,561 | | | | | $ | 20,776 | | | | | $ | 19,427 | |

| Net (Loss)/Earnings | | | (8,995) | | | | | | 3,460 | | | | | | 4,947 | | | | | | 975 | | | | | | 4,507 | | |

| Net (Loss)/Earnings Attributable to: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Noncontrolling Interest | | | 20 | | | | | | 21 | | | | | | 27 | | | | | | (32) | | | | | | 50 | | |

| BMS | | | (9,015) | | | | | | 3,439 | | | | | | 4,920 | | | | | | 1,007 | | | | | | 4,457 | | |

| Net (Loss)/Earnings per Common Share Attributable to BMS: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Basic | | | $ | (3.99) | | | | | $ | 2.02 | | | | | $ | 3.01 | | | | | $ | 0.61 | | | | | $ | 2.67 | |

| Diluted | | | (3.99) | | | | | | 2.01 | | | | | | 3.01 | | | | | | 0.61 | | | | | | 2.65 | | |

| Weighted average common shares outstanding: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Basic | | | 2,258 | | | | | | 1,705 | | | | | | 1,633 | | | | | | 1,645 | | | | | | 1,671 | | |

| Diluted | | | 2,258 | | | | | | 1,712 | | | | | | 1,637 | | | | | | 1,652 | | | | | | 1,680 | | |

| Cash dividends paid on BMS common and preferred stock | | | $ | 4,075 | | | | | $ | 2,679 | | | | | $ | 2,613 | | | | | $ | 2,577 | | | | | $ | 2,547 | |

| Cash dividends declared per common share | | | $ | 1.84 | | | | | $ | 1.68 | | | | | $ | 1.61 | | | | | $ | 1.57 | | | | | $ | 1.53 | |

| Financial Position Data at December 31: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Cash and cash equivalents | | | $ | 14,546 | | | | | $ | 12,346 | | | | | $ | 6,911 | | | | | $ | 5,421 | | | | | $ | 4,237 | |

| Marketable debt securities(a)(b) | | | 1,718 | | | | | | 3,814 | | | | | | 3,623 | | | | | | 3,739 | | | | | | 4,724 | | |

| Total Assets | | | 118,481 | | | | | | 129,944 | | | | | | 34,986 | | | | | | 33,551 | | | | | | 33,707 | | |

| Long-term debt(a) | | | 50,336 | | | | | | 46,150 | | | | | | 6,895 | | | | | | 6,975 | | | | | | 6,465 | | |

| Equity | | | 37,882 | | | | | | 51,698 | | | | | | 14,127 | | | | | | 11,847 | | | | | | 16,347 | | |

(a)Includes current and non-current portion.

(b)Prior period amounts were conformed to current period presentation.

| EARNINGS | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Net product sales | | | $ | [removed: 41,321] [added: 45,055] | | | | | $ | [removed: 25,174] [added: 41,321] | | | | | $ | [removed: 21,581] [added: 25,174] | |

| Alliance and other revenues | | | [removed: 1,197] [added: 1,330] | | | | | | [removed: 971] [added: 1,197] | | | | | | [removed: 980] [added: 971] | | |

| Total Revenues | | | [removed: 42,518] [added: 46,385] | | | | | | [removed: 26,145] [added: 42,518] | | | | | | [removed: 22,561] [added: 26,145] | | |

| Cost of products sold(a) | | | [removed: 11,773] [added: 9,940] | | | | | | [removed: 8,078] [added: 11,773] | | | | | | [removed: 6,467] [added: 8,078] | | |

| Marketing, selling and administrative | | | [removed: 7,661] [added: 7,690] | | | | | | [removed: 4,871] [added: 7,661] | | | | | | [removed: 4,551] [added: 4,871] | | |

| Research and development | | | [removed: 11,143] [added: 11,354] | | | | | | [removed: 6,148] [added: 11,143] | | | | | | [removed: 6,332] [added: 6,148] | | |

| IPRD charge - MyoKardia acquisition | | | [removed: 11,438] [added: —] | | | | | | [removed: —] [added: 11,438] | | | | | | — | | |

| Amortization of acquired intangible assets | | | [removed: 9,688] [added: 10,023] | | | | | | [removed: 1,135] [added: 9,688] | | | | | | [removed: 97] [added: 1,135] | | |

| Other (income)/expense, net | | | [removed: (2,314)] [added: (720)] | | | | | | [removed: 938] [added: (2,314)] | | | | | | [removed: (854)] [added: 938] | | |

| Total Expenses | | | [removed: 49,389] [added: 38,287] | | | | | | [removed: 21,170] [added: 49,389] | | | | | | [removed: 16,593] [added: 21,170] | | |

| [removed: (Loss)/Earnings] [added: Earnings/(Loss)] Before Income Taxes | | | [removed: (6,871)] [added: 8,098] | | | | | | [removed: 4,975] [added: (6,871)] | | | | | | [removed: 5,968] [added: 4,975] | | |

| Provision for Income Taxes | | | [removed: 2,124] [added: 1,084] | | | | | | [removed: 1,515] [added: 2,124] | | | | | | [removed: 1,021] [added: 1,515] | | |

| Net [removed: (Loss)/Earnings] [added: Earnings/(Loss)] | | | [removed: (8,995)] [added: 7,014] | | | | | | [removed: 3,460] [added: (8,995)] | | | | | | [removed: 4,947] [added: 3,460] | | |

| Noncontrolling Interest | | | 20 | | | | | | [removed: 21] [added: 20] | | | | | | [removed: 27] [added: 21] | | |

| Net [removed: (Loss)/Earnings] [added: Earnings(Loss)] Attributable to BMS | | | $ | [removed: (9,015)] [added: 6,994] | | | | | $ | [removed: 3,439] [added: (9,015)] | | | | | $ | [removed: 4,920] [added: 3,439] | |

| [removed: (Loss)/Earnings] [added: Earnings/(Loss)] per Common Share | | | | | | | | | | | | | | | | | |

| Basic | | | $ | [removed: (3.99)] [added: 3.15] | | | | | $ | [removed: 2.02] [added: (3.99)] | | | | | $ | [removed: 3.01] [added: 2.02] | |

| Diluted | | | [removed: (3.99)] [added: 3.12] | | | | | | [removed: 2.01] [added: (3.99)] | | | | | | [removed: 3.01] [added: 2.01] | | |

CONSOLIDATED STATEMENTS OF COMPREHENSIVE [removed: (LOSS)/INCOME][added: INCOME/(LOSS)]

| COMPREHENSIVE [removed: (LOSS)/INCOME] [added: INCOME/(LOSS)] | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

| Net [removed: (Loss)/Earnings] [added: Earnings/(Loss)] | | | $ | [removed: (8,995)] [added: 7,014] | | | | | $ | [removed: 3,460] [added: (8,995)] | | | | | $ | [removed: 4,947] [added: 3,460] | |

| Other Comprehensive [removed: (Loss)/Income,] [added: Income/(Loss),] net of taxes and reclassifications to earnings: | | | | | | | | | | | | | | | | | |

| Derivatives qualifying as cash flow hedges | | | [removed: (256)] [added: 415] | | | | | | [removed: (32)] [added: (256)] | | | | | | [removed: 70] [added: (32)] | | |

| Pension and postretirement benefits | | | [removed: (75)] [added: 206] | | | | | | [removed: 1,203] [added: (75)] | | | | | | [removed: 53] [added: 1,203] | | |

| Foreign currency translation | | | [removed: 7] [added: (41)] | | | | | | [removed: 35] [added: 7] | | | | | | [removed: (254)] [added: 35] | | |

| Total Other Comprehensive [removed: (Loss)/Income] [added: Income/(Loss)] | | | [removed: (319)] [added: 571] | | | | | | [removed: 1,242] [added: (319)] | | | | | | [removed: (156)] [added: 1,242] | | |

| Comprehensive [removed: (Loss)/Income] [added: Income/(Loss)] | | | [removed: (9,314)] [added: 7,585] | | | | | | [removed: 4,702] [added: (9,314)] | | | | | | [removed: 4,791] [added: 4,702] | | |

| Comprehensive Income Attributable to Noncontrolling Interest | | | 20 | | | | | | [removed: 21] [added: 20] | | | | | | [removed: 27] [added: 21] | | |

| Comprehensive [removed: (Loss)/Income] [added: Income/(Loss)] Attributable to BMS | | | $ | [removed: (9,334)] [added: 7,565] | | | | | $ | [removed: 4,681] [added: (9,334)] | | | | | $ | [removed: 4,764] [added: 4,681] | |

| ASSETS | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Cash and cash equivalents | | | $ | [removed: 14,546] [added: 13,979] | | | | | $ | [removed: 12,346] [added: 14,546] | |

| Marketable debt securities | | | [removed: 1,285] [added: 2,987] | | | | | | [removed: 3,047] [added: 1,285] | | |

| Receivables | | | [removed: 8,501] [added: 9,369] | | | | | | [removed: 7,685] [added: 8,501] | | |

| Inventories | | | [removed: 2,074] [added: 2,095] | | | | | | [removed: 4,293] [added: 2,074] | | |

| Other current assets | | | [removed: 3,786] [added: 4,832] | | | | | | [removed: 1,983] [added: 3,786] | | |

| Total Current Assets | | | [removed: 30,192] [added: 33,262] | | | | | | [removed: 29,354] [added: 30,192] | | |

| Property, plant and equipment | | | [removed: 5,886] [added: 6,049] | | | | | | [removed: 6,252] [added: 5,886] | | |

| Goodwill | | | [removed: 20,547] [added: 20,502] | | | | | | [removed: 22,488] [added: 20,547] | | |

| Other intangible assets | | | [removed: 53,243] [added: 42,527] | | | | | | [removed: 63,969] [added: 53,243] | | |

| Rebates and discounts | | | 863 | | | | | | 1,189 | | | | | | 591 | | |

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

| Proceeds from sales of equity investment securities | | | 2,579 | | | | | | 129 | | | | | | 167 | | |

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.

The tax effects of global intangible low-taxed income from certain foreign subsidiaries is recognized in the income tax provision in the period the tax arises.

*Income Taxes*

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.

Recently Issued Accounting Standards Not Yet Adopted

*Business Combinations*

In October 2021, the FASB issued amended guidance on accounting for contract assets and contract liabilities from contracts with customers in a business combination.

The guidance is intended to address inconsistency related to recognition of an acquired contract liability and payment terms and their effect on subsequent revenue recognized.

At the acquisition date, an entity should account for the related revenue contracts in accordance with existing revenue recognition guidance generally by assessing how the acquiree applied recognition and measurement in their financial statements.

The amended guidance is effective January 1, 2023 on a prospective approach.

Early adoption is permitted.

| Net product sales | | | $ | 45,055 | | | | | $ | 41,321 | | | | | $ | 25,174 | |

| Net product sales | | | $ | 45,055 | | | | | $ | 41,321 | | | | | $ | 25,174 | |

| *Abecma* | | | 164 | | | | | | — | | | | | | — | | |

| *Breyanzi* | | | 87 | | | | | | — | | | | | | — | | |

| Mature and other brands | | | 1,900 | | | | | | 2,217 | | | | | | 2,287 | | |

| Total Revenues | | | $ | 46,385 | | | | | $ | 42,518 | | | | | $ | 26,145 | |

| Total Revenues | | | $ | 46,385 | | | | | $ | 42,518 | | | | | $ | 26,145 | |

| Alliance revenues | | | 716 | | | | | | 615 | | | | | | 597 | | |

| Dollars in Millions | | | 2021 | | | | | | 2020 | | |

| Dollars in Millions | | | 2021 | | | | | | 2020 | | |

Research and development cost reimbursements were $98 million in 2021, $132 million in 2020 and $108 million in 2019.

2seventy bio (formerly bluebird)

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.

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

All profits and losses relating to developing, commercializing and manufacturing ide-cel within the U.S. are shared equally.

In 2020, terms of the collaboration were amended including certain manufacturing obligations.

Both parties were also released from future exclusivity related to BCMA-directed T cell therapies.

In 2021, the FDA approved ide-cel (“*Abecma*”*)* for the treatment of relapsed or refractory multiple myeloma.

Net product sales of Abecma within the Alliance territory were $158 million and related profit sharing costs were $42 million in 2021.

Eisai

In 2021, BMS and Eisai commenced an exclusive global strategic collaboration for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers.

MORAb-202 is currently in Phase I/II clinical trials for solid tumors.

The parties will jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Russia, Japan, China and certain other countries in the Asia-Pacific region (the “collaboration territory”).

Eisai will be responsible for the global manufacturing and supply.

| Available-for-sale securities | | | 5 | | | | | | 36 | | | | | | (25) | | |

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

| Other | | | 1,074 | | | | | | 819 | | | | | | 718 | | |

Cash payments resulting for licensing arrangements, including upfront and contingent milestones previously included in operating activities in the consolidated statements of cash flows are now presented in investing activities.

The adjustment resulted in an increase to net cash provided by operating activities and net cash used in investing activities of $143 million in 2019 and $1.1 billion in 2018.

These reclassifications did not have an impact on net assets or net earnings.

*Financial Instruments - Measurement of Credit Losses*

In June 2016, the FASB issued amended guidance for the measurement of credit losses on financial instruments.

Entities are required to use a forward-looking estimated loss model.

Available-for-sale debt security credit losses will be recognized as allowances rather than a reduction in amortized cost.

BMS adopted the amended guidance on a modified retrospective approach on January 1, 2020.

| Prioritized Brands | | | | | | | | | | | | | | | | | |

| Established Brands | | | | | | | | | | | | | | | | | |

| *Vidaza* | | | 455 | | | | | | 58 | | | | | | — | | |

| *Baraclude* | | | 447 | | | | | | 555 | | | | | | 744 | | |

| Other Brands(a) | | | 1,315 | | | | | | 1,674 | | | | | | 2,357 | | |

(a) Includes BMS and Celgene products in 2020 and 2019.

Contract assets were not material at December 31, 2020 and 2019.

Research and development expense payable under this agreement with Nektar was $132 million in 2020, $108 million in 2019 and $59 million in 2018.

bluebird

BMS is responsible for the worldwide development, including related funding after the substantial completion by bluebird of the ongoing Phase I clinical trial, and commercialization of bb21217.

bluebird has an option to co-develop, co-promote and share equally in all profits and losses in the U.S.

In 2020, BMS and bluebird amended their collaboration arrangement where, among other items, BMS is assuming the contract manufacturing agreements relating to ide-cel adherent lentiviral vector.

Over time, BMS is assuming responsibility for manufacturing ide-cel suspension lentiviral vector outside of the U.S., with bluebird responsible for manufacturing ide-cel suspension lentiviral vector in the U.S. The parties were also released from future exclusivity related to BCMA-directed T cell therapies.

Payments to Otsuka of $302 million in 2019 and $297 million in 2018, were recorded in Cost of product sold.

Financial Instruments and Fair Value Measurements.”

The measurement period adjustments reflected in 2020 primarily resulted from completing valuations of real estate and personal property, revised future cash flow estimates for certain intangible assets, changes in the estimated tax basis of certain intangible assets based upon a tax ruling which reduced deferred income tax liabilities and other changes to certain equity investments, legal contingency and income tax liabilities.

The related impact to net earnings that would have been recognized in previous periods if the adjustments were recognized as of the acquisition date was not material to the consolidated financial statements.

| Dollars in Millions | | | Amounts Recognized as of Acquisition Date (as previously reported) | | | | | | Measurement Period Adjustments | | | | | | Purchase Price Allocation | | |

| *Erbitux Business | | | 13 | | | | | | 15 | | | | | | 216 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (23) | | | | | | (145) | | |

| Manufacturing Operations | | | 10 | | | | | | 48 | | | | | | 160 | | | | | | (1) | | | | | | 1 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| *Plavix and *Avapro/*Avalide | | | 7 | | | | | | — | | | | | | 80 | | | | | | (12) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

In exchange for the transfer, BMS received an additional tiered-based royalty on *Onglyza and *Farxiga net product sales from Royalty Pharma including $165 million in 2019 and $159 million in 2018, and paid $67 million in 2020.

In October 2015, BMS transferred its rights to *Erbitux in North America to Lilly in exchange for tiered sales-based royalties through September 2018, including $145 million in 2018.

A $23 million change in estimated future royalties was included in 2019.

The divestiture included the transfer of the facility, the majority of employees at the site, inventories and certain third-party contract manufacturing obligations.

Catalent Inc. will provide certain manufacturing and packaging services for BMS for a period of time.

In 2017, BMS sold its small molecule active pharmaceutical ingredient manufacturing operations in Swords, Ireland to SK Biotek Co., Ltd. Proceeds of $160 million were received in 2018.

The transaction was accounted for as the sale of a business.

*Plavix and *Avapro/*Avalide

As of December 31, [removed: 2020,] [added: 2021,] 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: 2020] [added: 2021] Form 10-K.

Based on this evaluation, management has concluded that as of December 31, [removed: 2020,] [added: 2021,] 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: 2020] [added: 2021] 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: 2020] [added: 2021] 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: 2020] [added: 2021] Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] which is included herein.

There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, [removed: 2020] [added: 2021] that have materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the shareholders and the Board of Directors of Bristol-Myers Squibb Company

Opinion on Internal Control over Financial Reporting

We have audited the internal control over financial reporting of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, 2020, 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, 2020, 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, 2020, of the Company and our report dated February 9, 2021, expressed an unqualified opinion on those consolidated financial statements.

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

*/s/ DELOITTE & TOUCHE LLP*

Parsippany, New Jersey

February 9, 2021

PART III

Not applicable.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the shareholders and the Board of Directors of Bristol-Myers Squibb Company

Opinion on Internal Control over Financial Reporting

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

Basis for Opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

*/s/ DELOITTE & TOUCHE LLP*

Parsippany, New Jersey

February 8, 2022

PART III

| | | | | | |

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

(a)Reference is made to our [removed: 2021] [added: 2022] 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: 2020] [added: 2021] 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: 2021] [added: 2022] 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: 2021] [added: 2022] 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: 2021] [added: 2022] 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: 2021] [added: 2022] Proxy Statement with respect to [removed: auditor fees,] [added: 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](#i41f64878d2784d5ea6ffaae4477d4823_202)] [added: (Loss)/Income](#ibe77cac30ec34febb3568b00c7b1dcde_196)] | | | [removed: [70](#i41f64878d2784d5ea6ffaae4477d4823_202)] [added: [73](#ibe77cac30ec34febb3568b00c7b1dcde_196)] | | |

| | | | [Consolidated Balance [removed: Sheets](#i41f64878d2784d5ea6ffaae4477d4823_205)] [added: Sheets](#ibe77cac30ec34febb3568b00c7b1dcde_199)] | | | [removed: [71](#i41f64878d2784d5ea6ffaae4477d4823_205)] [added: [74](#ibe77cac30ec34febb3568b00c7b1dcde_199)] | | |

| | | | [Consolidated Statements of Cash [removed: Flows](#i41f64878d2784d5ea6ffaae4477d4823_211)] [added: Flows](#ibe77cac30ec34febb3568b00c7b1dcde_202)] | | | [removed: [72](#i41f64878d2784d5ea6ffaae4477d4823_211)] [added: [75](#ibe77cac30ec34febb3568b00c7b1dcde_202)] | | |

| | | | [Notes to Consolidated Financial [removed: Statements](#i41f64878d2784d5ea6ffaae4477d4823_214)] [added: Statements](#ibe77cac30ec34febb3568b00c7b1dcde_205)] | | | [removed: [73](#i41f64878d2784d5ea6ffaae4477d4823_214)] [added: [76](#ibe77cac30ec34febb3568b00c7b1dcde_205)] | | |

| | | | [Report of Independent Registered Public Accounting [removed: Firm](#i41f64878d2784d5ea6ffaae4477d4823_331)] [added: Firm](#ibe77cac30ec34febb3568b00c7b1dcde_316)] | | | [removed: [123](#i41f64878d2784d5ea6ffaae4477d4823_331)] [added: [124](#ibe77cac30ec34febb3568b00c7b1dcde_316)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this [removed: 2020] [added: 2021] Form 10-K.

| (b) | | | [Exhibits Required to be filed by Item 601 of Regulation [removed: S-K](#i41f64878d2784d5ea6ffaae4477d4823_379)] [added: S-K](#ibe77cac30ec34febb3568b00c7b1dcde_364)] | | | [removed: [133](#i41f64878d2784d5ea6ffaae4477d4823_379)] [added: [134](#ibe77cac30ec34febb3568b00c7b1dcde_364)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2021 Form 10-K.

| Date: February [removed: 10, 2021] [added: 9, 2022] | | | | | | | | |

| /s/ GIOVANNI CAFORIO, M.D. | | | | | | Chairman of the Board and Chief Executive Officer | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ DAVID V. ELKINS | | | | | | Chief Financial Officer | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ KAREN SANTIAGO | | | | | | Senior Vice President and Corporate Controller | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ PETER J. ARDUINI | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ JULIA A. HALLER, M.D. | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ PAULA A. PRICE | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ DERICA W. RICE | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ THEODORE R. SAMUELS | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ GERALD L. STORCH | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ KAREN H. VOUSDEN, PH.D. | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

| /s/ PHYLLIS R. YALE | | | | | | Director | | | | | | February [removed: 10, 2021] [added: 9, 2022] | | |

Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as [removed: Bristol-Myers] [added: Bristol Myers] Squibb, BMS, the Company, we, our or us in this [removed: 2020] [added: 2021] Form 10-K, unless the context otherwise indicates.

Throughout this [removed: 2020] [added: 2021] Form 10-K, we have used terms which are defined below:

| [removed: 2020] [added: 2021] Form 10-K | | | Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2020] [added: 2021] | | | [removed: MDL] [added: MCOs] | | | [removed: multi-district litigation] [added: Managed Care Organizations] | | |

| [removed: AbbVie] [added: Agenus] | | | [removed: AbbVie] [added: Agenus] Inc. | | | MDS | | | myelodysplastic syndromes | | |