Bristol Myers Squibb (BMY) 10-K risk factor changes: FY2023 vs FY2022

Our future revenues and profit margins could be negatively affected, including as a result of (i) changes in laws and regulations relating to the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of inflation, new discounts to fund a redesign of the Medicare Part D benefit, [added: and] government negotiations/price controls that may [added: change the determination of the "best price" and] establish a maximum allowed price/reimbursement rate), as well as other changes relating to federal healthcare programs, such as modifying the federal Anti-Kickback statute discount safe harbor and the IRA, which includes a number of provisions intended to lower the costs of some drugs covered under Medicare Part D and Medicare Part B and to limit Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit, (ii) cost-cutting measures by federal healthcare programs, such as Medicare and Medicaid, MCOs and other institutional and governmental purchasers, (iii) the grant of additional authority to governmental agencies to manage drug utilization and negotiate drug prices (including the implementation of the 2020 regulation issued by the U.S. federal government authorizing states and private parties to develop and implement programs to import certain prescription drugs from Canada and sell them in the U.S., and the American Rescue Plan Act of 2021, which [removed: eliminates] [added: eliminated] the Medicaid Prescription Drug Rebate cap starting January 1, 2024), (iv) expanded utilization under the 340B Drug Pricing Program ("340B program"), (v) competition related to placements on applicable commercial and Medicare Part D formularies; (vi) changes to U.S. federal pharmaceutical coverage and reimbursement policies and practices, (vii) the increased scrutiny of drug manufacturers (including any additional review of BMS or Celgene by the House Oversight and Reform Committee), (viii) reimbursement delays, (ix) government price erosion mechanisms across Europe and in other countries resulting in deflation for pharmaceutical product pricing, (x) the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries, (xi) collection delays or failures to pay in government-funded public hospitals outside the U.S., (xii) developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers, and (xiii) inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.*

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

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

*Regulatory approval delays are especially common when a product is expected to have a [removed: Risk Evaluation and Mitigation Strategy ("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 U.S. primarily through a REMS program.

The inability to bring a product to market or a significant delay in the expected [added: regulatory] approval and related launch date of a new product could negatively impact our revenues and earnings.

[removed: If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does not] [added: *not] meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations.*

[removed: In addition,] [added: Furthermore,] manufacturers of innovative drugs as well as generic drug manufacturers may be able to design their products around our owned or licensed patents and compete with us using the resulting alternative technology.

*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: 2022] [added: 2023] Form 10-K or that we assume when we provide our financial guidance.*

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

Some of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for [removed: our*][added: 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, labor disputes or shortages, or other business interruptions; and (ix) disruptions in supply chain continuity, including from market forces (such as the recent stress on global logistics), natural disasters, global disease outbreaks or pandemics (including COVID-19), acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.*]

Resolving an intellectual property infringement [added: or other] claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms.

Business—Government [removed: Regulation” and] [added: Regulation,”] “Item 1.

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

*We rely extensively on information technology systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided [added: by] and/or used for [removed: third-parties] [added: third parties] or their vendors, to assist in conducting our business.

A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or [removed: infrastructure, by our workforce, others with authorized access to our systems] [added: leak] or [removed: unauthorized persons] [added: theft of proprietary, confidential or personal information] could negatively impact operations.

[removed: As] [added: *As] the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and due to the nature of some of these attacks, there is also a risk that they may remain undetected for a period of time.

There can be no assurance that our continuing efforts will prevent breakdowns or [removed: breaches] [added: incidents] to our or our third-party providers’ [removed: databases or] systems [added: or databases] that could adversely affect our [removed: business.*][added: business.]

[removed: *of] [added: A reduction in revenue from any of] these products due to loss of market exclusivity or other factors could adversely impact our earnings and cash flows.

Pretax income generated from royalties was approximately [removed: $2.5] [added: $2.6] billion in [removed: 2022.][added: 2023.]

Our pretax income could be adversely affected if the royalty streams decline in future [removed: periods.*][added: periods.]

Moreover, due to the substantial amount of debt that we incurred to finance the cash portion of the [removed: Celgene and] [added: Celgene,] MyoKardia [added: and Mirati] acquisitions, [added: and intend to incur in connection with the Karuna and RayzeBio acquisitions,] there can be no assurance of when we will [removed: be*][added: be able to expand our business development capacity.]

*Our acquisitions of [removed: Celgene and] [added: Celgene,] MyoKardia [added: and Mirati] increased the amount of our debt resulting in additional interest [removed: expense.][added: expense, and we intend to incur more debt to finance future acquisitions, including the Karuna and RayzeBio acquisitions.]

This could reduce our financial flexibility to continue capital investments, develop new products and declare future [removed: dividends.*][added: dividends.]

We generated approximately 30% of our revenues outside of the U.S. in [removed: 2022.][added: 2023.]

Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the [removed: $35.9] [added: $27.1] billion of [added: other] intangible assets as of December 31, [removed: 2022.*][added: 2023.*]

[removed: It is also possible that changes in the healthcare] [added: *healthcare] system could impose additional burdens on clinical trials, which could increase the costs of sponsoring clinical trials or lead to additional delays or difficulties with completing clinical trials.

*Global economic conditions or events such as wars or pandemics also create additional risks from their impact 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 [removed: business*][added: business unit and functional services.]

We could also face potential other negative consequences stemming from future pandemics or global events, including but not limited to increased cyber threats to us and our partners such as [removed: phishing, social engineering] [added: cyber attacks] and [removed: malware attacks.][added: outages.]

It is possible that global economic and political events, including any future pandemic, could exacerbate any of the other risks described in this [removed: 2022] [added: 2023] Form 10-K as well.*

*In particular, the IRA will have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact our business.

Under the IRA, the U.S Department of Health and Human Services can effectively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D.

Generally, these government prices apply nine years (for small molecule drugs) or 13 years (for biological products) following FDA approval and will be capped at a statutory ceiling price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers.

In August 2023, the U.S. Department of Health and Human Services selected Eliquis as one of the first 10 medicines subject to government-set prices beginning in 2026.

The Medicare price setting process began in February 2024 and will conclude by August 1, 2024.

On September 1, 2024, CMS will publish prices that will be applicable to the ten drugs in the Medicare program beginning January 1, 2026.

It is possible that more of our products will be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.

The IRA also requires drug manufacturers to provide rebates for Medicare Part B and Part D medicines under certain circumstances.

The Part D benefit redesign will replace the Part D CGDP with a new manufacturer discount program.

Beginning in January 2025, under the IRA, the 70 percent CGDP discount will be replaced by a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign.

Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant.

The IRA has and will continue to meaningfully impact our business strategies and those of others in the pharmaceutical industry.

The full impact of the IRA on our business and the pharmaceutical industry, including the implications to us of our or a competitor's product being selected for price setting, remains uncertain.*

*At the state level, multiple states are pursuing government actions and ballot initiatives to address or limit drug pricing and reimbursement for their Medicaid programs.

These initiatives include attempts to use the IRA's referenced drug price at the state level.

Some of these state-level proposals may also influence federal policy and legislation.

Given the uncertainty surrounding the adoption and timing of these potential legislative, policy, or administrative changes, we are unable to predict their impact on our business.

However, if enacted, these changes could modify or decrease access, coverage, or reimbursement of our products, impact our rebates, or shift costs to us, which could in turn have a material impact on our business and results of operations.*

If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does*

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

While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries and may seek to market generic versions of Eliquis in other EU countries prior to the expiration date of applicable patents and related SPCs.

*In addition, in December 2023, the Biden Administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and therefore that the government could exercise “march-in rights” and license it to a third party to manufacture.

A comment period on the proposal ran through February 6, 2024,*

*and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.*

For example, Congress passed the Food and Drug Omnibus Reform Act in December 2022, which gave the U.S. FDA additional authority to require confirmatory trials to be underway at the time of approval and offered an additional enforcement mechanism if sponsors do not complete such studies with due diligence.

Business—Pricing, Price Constraints and Market Access” and “—Adverse outcomes in legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding privacy and data protection is continuously evolving and the subject of significant attention by regulators and private parties globally.

Regulators are imposing new data privacy and security requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations.

Failure to comply with these current and future laws could result in significant penalties and reputational harm and could have a material adverse effect on our business and results of operations.*

Expectations relating to environmental, social and governance considerations and related reporting obligations expose the Company to potential liabilities, increased costs, reputational harm, and other adverse effects on the Company’s business.

*There is an increased focus by foreign, federal, state, and local regulatory and legislative bodies investors and other stakeholders regarding environmental policies relating to climate change, regulating greenhouse gas emissions, carbon taxes, emissions trading schemes, sustainability, human rights and diversity, inclusion and equity matters, and disclosure regarding the foregoing, many of which may be ambiguous, inconsistent, dynamic or conflicting.

We expect to experience increased restrictions and compliance costs, legal costs, and expenses related to such new or changing legal or regulatory requirements.

Moreover, compliance with any such legal or regulatory requirements would require us to devote substantial time and attention to these matters.

In addition, we may still be subject to penalties or potential litigation if such laws and regulations are interpreted or applied in a manner inconsistent with our practices.

Moreover, from time to time we establish and publicly announce environmental, social and governance goals and commitments.

Implementation of our environmental, social and governance goals and initiatives involves risks and uncertainties,*

*requires investments, and depends in part on third-party performance or data that is outside of our control.

In addition, some stakeholders may disagree with the Company’s environmental, social and governance goals, targets or objectives.

If we do not meet, are perceived not to meet, or if stakeholders disagree with, our environmental, social and governance goals, targets or objectives, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products or other negative impacts on our business and operations.*

Certain jurisdictions in which we operate, under the OECD/G20 Inclusive Framework, have enacted legislation that adopts a subset of such rules effective January 1, 2024, with the remaining rules becoming effective January 1, 2025.

These rules and associated legislative changes may significantly impact our tax provision and results of operations.

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

As a*

*biologics products, such as Opdivo; (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations or other business interruptions; and (ix) disruptions in supply chain continuity, including from market forces (such as the recent stress on global logistics), natural disasters, global disease outbreaks or pandemics (including COVID-19), acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.*

For example, the U.S. FDA has indicated it is undertaking an industry-wide review of indications that received accelerated approval and for which the confirmatory studies did not meet their primary endpoints.

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

Texas case) and polarized public support.

The*

*revenues that we generate by the health insurance exchanges and Medicaid expansion under the ACA are not material, so the impact of the change in law and similar recent administration actions is expected to be limited.

Any future replacement, modification or repeal of the ACA may adversely affect our business and financial results, particularly if the legislation reduces incentives for employer-sponsored insurance coverage.

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

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.*

We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.

The ever-increasing use and evolution of technology, including cloud-based computing, creates opportunities for the unintentional dissemination or intentional destruction or modification of confidential information stored in our, or our third-party providers’ systems, portable media or storage devices.

We could also experience a business interruption, theft of confidential information or reputational damage from industrial espionage attacks, malware or other cyber-attacks, which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party providers.

As the COVID-19 pandemic progressed, we observed an increase in cybersecurity incidents across the industry, predominantly ransomware and social engineering attacks.

Further, government entities have also been the subject of cyberattacks.

Although the aggregate impact of cybersecurity breaches and data leakage on our operations and financial condition have not been material to date, we have been the target of cyber-attacks and expect them to continue as cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry.

We have invested in industry-appropriate protections and monitoring practices of our data and IT to reduce these risks and continue to monitor our systems on an ongoing basis for any current or potential threats.

While we maintain cyber insurance, this insurance may not, however, be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems.

A reduction in revenue from any*

*able to expand our business development capacity.

*unit and functional services.

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: 2022] [added: 2023] Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows.

The comparison of [removed: 2021] [added: 2022] to [removed: 2020] [added: 2021] results has been omitted from this Form 10-K and is incorporated by reference from our Form 10-K for the year ended December 31, [removed: 2021] [added: 2022] “Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations” filed on February [removed: 10, 2021.][added: 14, 2023.]

Refer to the Summary of Abbreviated Terms at the end of this [removed: 2022] [added: 2023] Form 10-K for definitions of capitalized terms used throughout the document.

After adjusting for specified items, non-GAAP EPS [removed: increased $0.54] [added: decreased $0.19 primarily] as a result of lower [removed: weighted-average common shares outstanding and Acquired IPRD charges] [added: revenues] and [added: product mix, partially offset by] higher [removed: royalties] [added: royalty] and [removed: licensing income.][added: interest income and lower weighted average shares outstanding.]

[removed: Highlights][added: Financial Highlights]

| Dollars in [removed: Millions,] [added: millions,] except per share data | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | | | |

| Total Revenues | | | $ | [removed: 46,159] [added: 45,006] | | | | | $ | [removed: 46,385] [added: 46,159] | | | | | | | |

| GAAP | | | $ | [removed: 2.95] [added: 3.86] | | | | | $ | [removed: 3.12] [added: 2.95] | | | | | | | |

| Non-GAAP | | | [removed: 7.70] [added: 7.51] | | | | | | [removed: 7.16] [added: 7.70] | | | | | | | | |

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

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

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 [removed: margins”] [added: margins”, “—We could lose market exclusivity of a product earlier than expected”] and “—Changes to tax regulations could negatively impact our earnings.”

The following is a summary of the significant approvals received in [removed: 2022:][added: 2023:]

| Sotyktu | | | [removed: September 2022] [added: March 2023] | | | [removed: FDA] [added: EC] approval of *Sotyktu* for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic [removed: therapy or phototherapy.] [added: therapy.] | | |

| Breyanzi | | | [removed: June 2022] [added: May 2023] | | | [removed: FDA] [added: EC] approval of *Breyanzi* for the treatment of adult patients with [removed: relapsed or refractory] [added: diffuse] large B-cell [added: lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell] lymphoma [removed: after one line of therapy who are not eligible for transplant or] [added: and FL grade 3B,] who relapsed within 12 months [removed: of] [added: from completion of, or are refractory to,] first-line chemoimmunotherapy. | | |

| [removed: Opdivo+Yervoy] [added: Opdivo] | | | [removed: May 2022] [added: March 2023] | | | Japan's Ministry of Health, Labour and Welfare approval of *Opdivo* plus [removed: *Yervoy* as a first-line treatment] [added: chemotherapy] for [removed: adult] [added: the neoadjuvant treatment of] patients with [removed: unresectable advanced or metastatic ESCC regardless of PD-L1 status.] [added: resectable NSCLC.] | | |

[removed: | Breyanzi | | | April 2022 | | | EC approval of] *Breyanzi* [added: (lisocabtagene maraleucel) — a CD19-directed genetically modified autologous CAR-T cell therapy indicated] for the treatment of adult patients with relapsed or refractory [added: large B-cell lymphoma after one or more lines of systemic therapy, including] diffuse large B-cell [added: lymphoma not otherwise specified, high-grade B-cell] lymphoma, primary mediastinal large B-cell [removed: lymphoma] [added: lymphoma,] and [removed: follicular lymphoma] [added: FL] grade [removed: 3B after two or more lines of systemic therapy. | | |][added: 3B.]

| Opdivo | | | [removed: April 2022] [added: June 2023] | | | EC approval of *Opdivo* in combination with [removed: fluoropyrimidine- and] platinum-based chemotherapy for the [removed: first-line] [added: neoadjuvant] treatment of [added: resectable NSCLC at a high risk of recurrence in] adult patients with [removed: unresectable advanced, recurrent, or metastatic ESCC with] [added: tumor cell] PD-L1 expression \> 1%. | | |

Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in [removed: 2022] [added: 2023] and in early [removed: 2023.][added: 2024.]

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

Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following [added: five] core therapeutic areas: (i) oncology with a priority in certain tumor [removed: types;] [added: types, including diversification beyond IO;] (ii) hematology with opportunities to [removed: broaden our franchise and sustain a] [added: expand] leadership position in multiple [removed: myeloma;] [added: myeloma, as well as broaden our portfolio across leukemias, lymphomas and non-malignant hematologic diseases;] (iii) immunology with priorities in [removed: relapsing multiple sclerosis, psoriasis, psoriatic arthritis, lupus, RA] [added: strengthening presence in dermatology, rheumatology] and [removed: inflammatory bowel disease;] [added: gastrointestinal disorders, establishing new standards of care in pulmonology and rapidly advance cell therapy into immunology diseases;] (iv) cardiovascular [removed: disease (v) fibrotic disease] [added: diseases] with [removed: priorities in lung] [added: focus on cardiomyopathies, heart failures] and [removed: liver,] [added: thrombotic diseases;] and [removed: (vi)] [added: (v)] neuroscience with a focus on [added: neuropsychiatry,] neurodegenerative [removed: disease.][added: and neuroinflammation diseases.]

We are further strengthening our IO portfolio with *Opdualag* for the treatment of melanoma and potential expanded opportunities in [removed: lung, liver, CRC and adjuvant melanoma.][added: other indications.]

[added: Moreover,] *Eliquis* continues to grow, leveraging its best in class clinical profile and extensive real world data and [removed: is now] [added: remains] the number one novel oral anticoagulant in total prescriptions globally.

In [removed: immunology, the] [added: addition, our] Phase III registrational clinical trials are underway for *Sotyktu* in [removed: systemic lupus erythematosus (SLE)] [added: PsA, SLE] and [removed: psoriatic arthritis.][added: Sjögren's Syndrome.]

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

For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during [removed: 2022] [added: 2023] refer to “Item 8.

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

| Dollars in [removed: Millions] [added: millions] | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | % Change | | | | | | Foreign Exchange(b) | | |

| United States | | | $ | [removed: 31,828] [added: 31,555] | | | | | $ | [removed: 29,214] [added: 31,828] | | | | | [removed: 9] [added: (1)] | | % | | | | [removed: —] [added: N/A] | | |

| International | | | [removed: 13,497] [added: 12,752] | | | | | | [removed: 16,319] [added: 13,497] | | | | | | [removed: (17)] [added: (6)] | | % | | | | [removed: (9)] [added: (1)] | | % |

| Other(a) | | | [removed: 834] [added: 699] | | | | | | [removed: 852] [added: 834] | | | | | | [removed: (2)] [added: (16)] | | % | | | | [removed: —] [added: N/A] | | |

| Total | | | $ | [removed: 46,159] [added: 45,006] | | | | | $ | [removed: 46,385] [added: 46,159] | | | | | [removed: —] [added: (2)] | | [added: %] | | | | [removed: (3)] [added: —] | | % |

- International revenues in [removed: 2022] [added: 2023] decreased [added: 6%] primarily due to [removed: lower demand for] *Revlimid* [removed: as a result of] [added: and *Eliquis*] generic erosion, [removed: foreign exchange and] lower average net selling prices, [added: and foreign exchange impacts,] partially offset by [removed: In-Line Products] [added: an increase in demand for *Opdivo*] and New Product Portfolio.

No single country outside the U.S. contributed more than 10% of total revenues in [removed: 2022] [added: 2023] and [removed: 2021.][added: 2022.]

| | | | Year Ended December [removed: 31, 2022 | | | | | |] [added: 31,] | | | | | | | | | | | | | | |

| Prior period | | | [removed: (14)] [added: (11)] | | | | | | [removed: (2)] [added: 11] | | | | | | [removed: (213)] [added: (134)] | | | | | | [removed: (229)] [added: (134)] | | |

| Foreign currency translation and other | | | [removed: (6)] [added: (1)] | | | | | | — | | | | | | [removed: (125)] [added: 76] | | | | | | [removed: (131)] [added: 75] | | |

| Balance at [removed: December 31, 2022] [added: January 1, 2023] | | | $ | 675 | | | | | $ | 3,822 | | | | | $ | 2,880 | | | | | $ | 7,377 | |

| Dollars in [removed: Millions] [added: millions] | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | | | | | | | [removed: 2022] [added: 2023] vs. [removed: 2021] [added: 2022] | | | | | | | | |

In 2023, we received approvals for initial and additional indications for the following marketed products in major markets (the U.S., EU and Japan), which further expanded our geographical reach in immunology, hematology, oncology, and cardiovascular diseases: (i) U.S. and EU approval of *Opdivo* for treatment of completely resected stage IIB and IIC melanoma, expanding upon the existing adjuvant treatment for melanoma patients; (ii) FDA approval of *Reblozyl* in the first-line setting for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk MDS who may also require red blood cell transfusions, regardless of ring sideroblast status; and EU approval for an additional indication for anemia associated with non-transfusion-dependent beta thalassemia; (iii) approvals in Japan and in the EU of *Opdivo* in combination with chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC; (iv) approval of *Camzyos* for the treatment of symptomatic obstructive HCM in the EU; (v) approval of Breyanzi for the second-line treatment of diffuse large B-cell lymphoma in the EU; (vi) approval for *Sotyktu* for moderate-to-severe plaque psoriasis in the EU; and (vii) approval of *Augtyro* (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC) in the U.S. We continue expanding our commercial CAR-T manufacturing network through the FDA approval of our Devens, MA facility in June 2023.

In January 2024, we acquired Mirati, a commercial stage targeted oncology company with a pipeline of commercial, clinical and pre-clinical stage oncology medicines and assets.

With the Mirati acquisition, we obtained rights to *Krazati, a best-in-class inhibitor of KRASG12C mutation, approved by the FDA as a second-line treatment for patients with NSCLC; and MRTX1719, a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase I development, among others.

In addition, during the fourth quarter of 2023, we entered into definitive merger agreements to acquire Karuna and RayzeBio and also entered into strategic collaboration with SystImmune.

Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions.

RayzeBio is a clinical-stage radiopharmaceutical therapeutics company with an innovation-leading position in actinium-based radiopharmaceutical therapeutics and a pipeline of potentially first-in-class and best-in-class drug development programs.

The goal of the collaboration with SystImmune is to co-develop and co-commercialize BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate which targets both EGFR and HER3 and is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC.

The Company has the potential to increase its registrational portfolio from six to up to twelve potentially first-in-class/best-in-class assets.

In addition to its growing registrational portfolio, the Company has more than 25 indication expansion opportunities on the horizon.

Taken together, this leads to increased depth across the Company’s therapeutic areas, including oncology, hematology, immunology, cardiovascular and a growing presence in neuroscience.

In 2023, our revenues decreased by 2%, primarily due to lower *Revlimid* sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for *Revlimid*, and to a lesser extent, *Pomalyst*, from the Bristol Myers Squibb Patient Assistance Foundation, partially offset by higher sales of our New Product Portfolio and In-Line Products (primarily *Opdivo*).

The $0.91 increase in GAAP EPS in 2023 was primarily driven by the impact of certain specified items, including deferred income tax benefit related to a non-U.S. tax ruling, lower losses on equity investments, amortization of intangible assets, as well as litigation and other settlement income, partially offset by lower revenues and product mix.

In August 2023, the U.S. Department of Health and Human Services selected *Eliquis* as one of the first 10 medicines subject to government-set prices beginning in 2026.

It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.

In addition, in December 2023, the Biden Administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and therefore that the government could exercise “march-in rights” and license it to a third party to manufacture.

A comment period on the proposal ran through February 6, 2024, and we are not able to predict whether a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products.

Other proposals, such as those relating to the calculation of best price as well as potential executive orders focused on drug pricing are still being debated.

The effect of reducing prices and reimbursement for certain of our products would significantly impact our business and consolidated results of operations.

| Augtyro (repotrectinib) | | | November 2023 | | | FDA approval of *Augtyro* for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. | | |

| Opdivo | | | October 2023 | | | FDA approval of *Opdivo* for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma. | | |

| Reblozyl | | | August 2023 | | | FDA approval of *Reblozyl* for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS. | | |

| Opdivo | | | August 2023 | | | EC approval of *Opdivo* as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection. | | |

| Camzyos | | | June 2023 | | | EC approval of *Camzyos* for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM. | | |

As we undergo a period of renewal, our strategy will be focused on driving near-term growth, minimizing the impact of a transition period that follows and delivering growth in the late 2020s by accelerating opportunities that enhance productivity and efficiency, advance our pipeline, and drive strong commercial execution that move our business forward.

We remain committed to a strategic business development and maintaining a strong investment grade credit rating, growing the dividend and reducing additional debt that will be issued in support of recent transactions.

We are working towards expanding our pipeline of registrational assets from six to up to twelve.

In addition, we are positioned to support continued innovation and expand treatment options across several different diseases based on our differentiated research platforms.

We have a broad portfolio and pipeline when it comes to autologous CAR-T cell therapies.

We have two approved cell therapies against two distinct targets and are continuing to build our leadership in this space.

We are expanding manufacturing capacity, exploring innovative technologies such as dual-targeting CAR-Ts and allogenic approaches, advancing multiple next-generation assets including new targets and rapidly expanding into immunology, including lupus and multiple sclerosis.

We also have a strong position in the protein degradation field and have been advancing our pipeline with an expansive library of assets with two in registrational trials, an additional five in clinical phase studies and more than fifteen being studied pre-clinically.

This growing platform has potential across several diseases and is positioned to deliver approximately four INDs each year.

Together with our proven track record, rapidly advancing pipeline and growth with marketed products, we increased and sustained our R&D productivity enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.

Specifically, our ambition is to: (i) deliver approximately ten INDs per year; (ii) increase success rates from first-in-human trials to approval to approximately 20%; (iii) reduce timelines to achieve a median of 6.5 years from first-in-human trials to approval.

Our R&D strategy will help ensure we maintain a strong legacy of scientific innovation, bringing first-in class and/or best-in-class treatments to patients at an accelerated speed.

We are encouraged that our investigational subcutaneous formulation for *Opdivo* has the potential to bring enhanced benefits to patients into the next decade, with positive registrational data now in-house.

We are growing a differentiated NSCLC portfolio, which includes the launch of *Augtyro* and includes *Krazati*, (acquired through Mirati), which demonstrates a strategic fit into our oncology portfolio.

We are also strengthening our neuroscience portfolio with the planned acquisition of Karuna.

*Camzyos* continues to demonstrate benefits as shared through our long-term follow-up data from two Phase III studies.

In immunology, *Sotyktu* is the key growth driver for BMS and we continue to make further investments to accelerate the launch through direct to consumer advertising and adding field force support.

In 2022, we obtained 18 approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including advancement in oncology through FDA and EC approval of *Opdualag*, the first PD-1 inhibitor and LAG-3 blocking antibody combination.

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

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

We continue the expansion of our cell therapy manufacturing capabilities at our existing facilities in Washington and New Jersey, as well as through the construction of new state-of-the-art manufacturing facilities in Massachusetts and in Leiden, Netherlands.

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

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

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

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

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

The following table summarizes our financial information:

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

COVID-19

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

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.

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

| | | | | | | | | |

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

| Product | | | Date | | | Approval | | |

| Breyanzi | | | December 2022 | | | Japan's Ministry of Health, Labour and Welfare approval of *Breyanzi* allowing its use in the second-line treatment of relapsed or refractory large B-cell lymphoma, regardless of whether autologous hematopoietic stem-cell transplantation is intended. | | |

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

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

| Opdivo | | | May 2022 | | | Japan's Ministry of Health, Labour and Welfare approval of *Opdivo* in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for adult patients with unresectable advanced or metastatic ESCC regardless of PD-L1 status. | | |

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

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

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

| Opdivo+Yervoy | | | April 2022 | | | EC approval of *Opdivo* plus *Yervoy* for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression \> 1%. | | |

| Opdivo | | | April 2022 | | | EC approval of *Opdivo* for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-LI expression \> 1% who are at risk of recurrence after undergoing radical resection. | | |

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

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

| Opdivo | | | March 2022 | | | Japan's Ministry of Health, Labour and Welfare approval of *Opdivo* for the adjuvant treatment of urothelial carcinoma. | | |

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

We remain committed to maintaining a strong investment grade credit rating and returning capital to shareholders.

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

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

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

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

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

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

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

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

We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would decrease the fair value of foreign exchange contracts by [removed: $782] [added: $409] million and [removed: $678] [added: $782] million as of December 31, [removed: 2022] [added: 2023] and December 31, [removed: 2021,] [added: 2022,] respectively, reducing earnings over the remaining life of the contracts.

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

We estimate that a 10% appreciation in the underlying currencies being hedged from their levels against the U.S. dollar (with all other variables held constant) would [removed: decrease] [added: increase] the fair value of cross-currency [removed: interest] swap contracts by [removed: $73 million and $58] [added: $46] million as of December 31, [removed: 2022] [added: 2023] and [added: decrease by $73 million as of] December 31, [removed: 2021.][added: 2022, respectively.]

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

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

In this sensitivity analysis, if there was a 1% increase in short-term or long-term interest rates as of December 31, [removed: 2022] [added: 2023] and December 31, [removed: 2021,] [added: 2022,] the expected adverse impact on our earnings would not be material.

We estimate that an increase of 1% in long-term interest rates as of December 31, [removed: 2022] [added: 2023] and December 31, [removed: 2021] [added: 2022] would decrease the fair value of long-term debt by [removed: $2.6] [added: $3.0] billion and [removed: $3.8] [added: $2.6] billion, respectively.

We are also exposed to translation risk on non-U.S. dollar-denominated net assets.

The effective portion of foreign exchange gains or losses on these hedges is included in the foreign currency translation component of Accumulated other comprehensive loss.

If our net investment decreases below the equivalent value of the non-U.S. debt borrowings, the change in the remeasurement basis of the debt would be subject to recognition in income as changes occur.

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

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

We have significant manufacturing operations in the U.S., Puerto Rico, [removed: Ireland] [added: Switzerland, Ireland,] and [removed: Switzerland.][added: the Netherlands.]

| Dollars in [removed: Millions] [added: millions] | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| United States | | | [removed: 69] [added: 70] | | % | | | | [removed: 63] [added: 69] | | % | | | | 63 | | % |

| International | | | [removed: 29] [added: 28] | | % | | | | [removed: 35] [added: 29] | | % | | | | [removed: 36] [added: 35] | | % |

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

| Total Revenues | | | $ | [removed: 46,159] [added: 45,006] | | | | | $ | [removed: 46,385] [added: 46,159] | | | | | $ | [removed: 42,518] [added: 46,385] | |

Refer to the Summary of Abbreviated Terms at the end of this [removed: 2022] [added: 2023] Form 10-K for definitions of capitalized terms used throughout the document.

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

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

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

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

*Opdivo®* *Opdivo* [removed: (nivolumab),] [added: (nivolumab) is] a biological [removed: product, is] [added: product and] a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells.

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

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

*Sprycel®* *Sprycel* (dasatinib) is an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic [removed: phase,] [added: phase and] the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including *Gleevec (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.

*Yervoy®* *Yervoy* [removed: (ipilimumab),] [added: (ipilimumab) is] a biological product [removed: that] [added: and] is a CTLA4 immune checkpoint inhibitor.

*Reblozyl®* *Reblozyl* [removed: (luspatercept-aamt),] [added: (luspatercept-aamt) is] a biological product, [added: and] is an erythroid maturation agent indicated for the treatment of anemia in [added: i)] adult patients with transfusion dependent and non-transfusion dependent beta thalassemia [removed: and for the treatment of anemia failing an erythropoiesis stimulating agent (“ESA”) in] [added: who require regular red blood cell transfusions, ii)] adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require [removed: RBC transfusions.][added: red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status.]

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

*Zeposia®* *Zeposia* (ozanimod) is an oral immunomodulatory drug used to treat [removed: 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 [added: adults and to treat moderately to severely active UC in] adults.

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

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

[removed: The U.S., EU and Japan each provide] [added: Market exclusivity is also sometimes provided by] RDP, a period of time after the approval of a new drug during which the regulatory agency may not rely upon the innovator’s data to approve a competitor’s generic copy.

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

A significant portion of a product’s patent life, however, is lost during the time it takes an [removed: innovative] [added: innovator] company to develop and obtain regulatory approval of a new drug.

Our marketed chemical products include *Eliquis, Pomalyst, Sprycel, Zeposia, Onureg, Inrebic, [removed: Camzyos,*] [added: Camzyos, Sotyktu*,] and [removed: *Sotyktu.*][added: *Augtyro* (repotrectinib).]

[removed: The] U.S. healthcare legislation enacted in 2010 created an approval pathway for biosimilar versions of innovative biological [removed: products that did not previously exist.][added: products.]

[removed: Under the new regulatory mechanism, the] [added: The] FDA can approve products that are similar to (but not generic copies of) innovative biologics on the basis of less extensive data than is required by a full BLA.

As a result of [removed: all of] these developments, among others, it is not possible to predict the length of market exclusivity for a particular product with certainty based solely on the expiration of the relevant patent(s) or the current forms of regulatory exclusivity.

Our marketed biologic products include *Opdivo*, *Orencia,* *Yervoy*, [removed: *Empliciti, Reblozyl,] [added: *Reblozyl,] Abecma, [removed: Opdualag] [added: Opdualag*] and [removed: Breyanzi.*][added: *Breyanzi.*]

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

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

[removed: As in the U.S.,] [added: In Japan,] patents [removed: in Japan] [added: on pharmaceutical products are enforceable and] may be extended to compensate for the patent term lost during the regulatory review process.

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

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

| | | | U.S. | | | | | | [removed: EU(o)] [added: EU(p)] | | | | | | Japan | | |

| *Breyanzi* (lisocabtagene [removed: maraleucel)(b)] [added: maraleucel)(c)] | | | 2033 | | | | | | 2033 | | | | | | 2033 | | |

| *Camzyos* [removed: (mavacamten)(c)] [added: (mavacamten)(d)] | | | 2034 | | | | | | [removed: ++] [added: 2034] | | | | | | ++ | | |

| *Eliquis* [removed: (apixaban)(d)] [added: (apixaban)(e)] | | | 2026 | | | | | | ^^ | | | | | | 2026 | | |

We expect that our planned acquisitions of Karuna and RayzeBio, announced during the fourth quarter of 2023, as well as the Mirati (2024) and the Turning Point (2022) acquisitions, will continue to position us as a leading biopharmaceutical company, expanding our targeted oncology portfolio, as well as other therapeutic areas, including neuroscience.

Our significant business development activities in 2023 included: (i) the acquisition of Mirati, which was

completed in January 2024; (ii) the planned acquisitions of Karuna and RayzeBio, which were announced in December 2023; and (iii) a global strategic collaboration agreement with SystImmune, which was announced in December 2023.

Alliances”, and “Item 8.

In-Line Products

The *Opdivo*+*Yervoy* regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.

New Product Portfolio

*Augtyro®* *Augtyro* (repotrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Recent LOE Products

| *Augtyro* (repotrectinib)(b) | | | 2035 | | | | | | ++ | | | | | | ++ | | |

(a) For *Abraxane* in the U.S. and EU generics have entered the market.

For Japan, the estimated minimum market exclusivity date was June 2023 and we are not aware of any generics entering the market as of December 31, 2023.

In the EU, SPC applications are pending and, if granted, the estimated patent expiry would be 2038.

| * | | | Japan only | | | | | |

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

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

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

| Oncology | | | | | | | | | | | | Immunology | | | | | | | | |

| Krazati | | | 1L NSCLC TPS<50% | | | KRYSTAL-17 | | | | | | cendakimab | | | EoE | | | IM042-P04 | | |

| Krazati | | | 2L CRC | | | KRYSTAL-10 | | | | | | Sotyktu | | | PsA | | | POETYK-PsA-1 | | |

| Krazati | | | 2L+ Mutated NSCLC | | | KRYSTAL-12* | | | | | | Sotyktu | | | PsA | | | POETYK-PsA-2 | | |

| Opdivo | | | Adjuvant HCC | | | CM-9DX | | | | | | Zeposia | | | Crohn's Disease | | | YELLOWSTONE (Induction -1) | | |

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| Asset | | | Disease | | | Trial | | | | | | Asset | | | Disease | | | Trial | | |

| Breyanzi | | | Relapsed/Refractory MZL | | | TRANSCEND | | | | | | Camzyos | | | nHCM | | | ODYSSEY-HCM | | |

| Reblozyl | | | 1L TD MF Associated Anemia | | | INDEPENDENCE | | | | | | | | | | | | | | |

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* Confirmatory trial

For further discussion on the IRA, refer to “Item 1.

These PBMs control nearly 80% of the prescription market and are owned by payers UnitedHealthcare, Aetna, and Cigna, respectively.

Prices are often reevaluated and further restricted throughout the life of the medicine.

In recent years, several legislative and policy proposals have been introduced in the U.S. to lower drug prices.

In August 2023, the U.S. Department of Health and Human Services selected *Eliquis* as one of the first 10 medicines subject to government-set prices beginning in 2026.

It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.

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

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

*Empliciti* is a humanized monoclonal antibody for the treatment of multiple myeloma.

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

In certain markets where patent protection and other forms of market exclusivity may have expired, RDP can be of particular importance.

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

Prior to that time, innovative biologics had essentially unlimited regulatory exclusivity.

Patents on pharmaceutical products are enforceable.

| *Empliciti* (elotuzumab) | | | 2029 | | | | | | 2029 | | | | | | 2029 | | |

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

Refer to “Item 8.

Legal Proceedings and Contingencies” for more information.

(j) For *Reblozyl* in the U.S. and Europe, the estimated minimum market exclusivity date is based on RDP exclusivity.

In the EU, licenses have been granted to third parties to market generic lenalidomide products prior to expiry of our patent and supplementary protection certificate (“SPC”) rights in the UK beginning on January 18, 2022, and in various other major market European countries (e.g., France, Germany, Italy and Spain) where our SPC is in force beginning on February 18, 2022.

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

In 2020, Acquired IPRD included an $11.4 billion charge resulting from the MyoKardia acquisition.

*Opdivo* is the only individual investigational compound or marketed product to represent 10% or more of our R&D expenses in 2022.

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

FIBROTIC DISEASES

| | | | | | | | | | PHASE II | | | | | | | | | | | | | | | | | |

| | | | | | | | | | Investigational Compounds HSP47ª \--Non-Alcoholic Steatohepatitis LPA1 Antagonist \--Pulmonary Fibrosis | | | | | | | | | | | | | | | | | |

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

| Opdivo + Yervoy | | | 1L+ MSI High CRC | | | CM-8HW | | | 2024/25 | | | | | | 3L+ Follicular Lymphoma | | | TRANSCEND-FL | | | 2023 | | | | | |

| Opdivo + Yervoy | | | Adj. HCC | | | CM-9DX | | | 2024/25 | | | | | | Reblozyl | | | 1L Myelofibrosis | | | INDEPENDENCE | | | 2024/25 | | |

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

| Opdivo | | | Peri-adjuvant MIBC | | | CM-078 | | | 2024/25 | | | | | | Immunology | | | | | | | | | | | |

| Opdivo | | | 1L mCRPC | | | CM-7DX | | | 2023 | | | | | | Asset | | | Disease | | | Trial | | | Timing | | |

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

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

* Partner Run Study

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

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Executive Summary.”

For example, the FDA approved our large scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts in May 2012 and we continue to make capital investments in this facility.

For example, we completed our new large-scale biologics manufacturing facility in Cruiserath, Ireland, which was approved by the FDA in December 2019 and by the EU in January 2020.

- The ongoing investment in our People and Business Resource Groups ("PBRGs") represent one key lever that we use to enable our Global Inclusion & Diversity strategy.

- We remain committed to achieving our I&D and health equity goals set in 2020 which include: 1) addressing health disparities, 2) increasing clinical trial diversity, 3) enhancing our supplier diversity program, 4) investing in our U.S. and Puerto Rico Employee Giving Program and 5) increasing our workforce diversity at the executive levels.

We prioritized the health and safety of our employees during the COVID-19 pandemic, while continuing the supply of medicines to our patients and driving strong business performance.

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

Vaccinations are required for generally all of our employees in the U.S. and Puerto Rico subject to any local regulation which limit or restrict vaccine mandates.

For the fiscal year ended December 31, [removed: 2022][added: 2023]

The aggregate market value of the [removed: 2,133,779,907] [added: 2,087,551,048] 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: $164,301,052,839.][added: $133,498,889,520.]

At February [removed: 7, 2023,] [added: 6, 2024,] there were [removed: 2,098,775,978] [added: 2,022,193,411] 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: 2022] [added: 2023] with the U.S. Securities and Exchange Commission pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent described therein.

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| | | | [Item [removed: 9C.](#ib63d400e46fb4076ada7bde6dec75444_292)] [added: 9C.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_277)] | | | [Disclosure Regarding Foreign Jurisdictions That Prevent [removed: Inspections](#ib63d400e46fb4076ada7bde6dec75444_292)] [added: Inspections](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_277)] | | | [removed: [117](#ib63d400e46fb4076ada7bde6dec75444_292)] [added: [123](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_277)] | | |

| | | | [Item [removed: 10.](#ib63d400e46fb4076ada7bde6dec75444_301)] [added: 10.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_286)] | | | [Directors, Executive Officers and Corporate [removed: Governance](#ib63d400e46fb4076ada7bde6dec75444_301)] [added: Governance](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_286)] | | | [removed: [119](#ib63d400e46fb4076ada7bde6dec75444_301)] [added: [125](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_286)] | | |

| | | | [Item [removed: 11.](#ib63d400e46fb4076ada7bde6dec75444_304)] [added: 11.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_289)] | | | [Executive [removed: Compensation](#ib63d400e46fb4076ada7bde6dec75444_304)] [added: Compensation](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_289)] | | | [removed: [119](#ib63d400e46fb4076ada7bde6dec75444_304)] [added: [125](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_289)] | | |

| | | | [Item [removed: 12.](#ib63d400e46fb4076ada7bde6dec75444_307)] [added: 12.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#ib63d400e46fb4076ada7bde6dec75444_307)] [added: Matters](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] | | | [removed: [119](#ib63d400e46fb4076ada7bde6dec75444_307)] [added: [125](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_292)] | | |

| | | | [Item [removed: 13.](#ib63d400e46fb4076ada7bde6dec75444_310)] [added: 13.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_295)] | | | [Certain Relationships and Related [removed: Transactions](#ib63d400e46fb4076ada7bde6dec75444_310)] [added: Transactions](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_295)] | | | [removed: [119](#ib63d400e46fb4076ada7bde6dec75444_310)] [added: [125](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_295)] | | |

Route 206 & Province Line Road, Princeton, New Jersey 08543

(609) 252-4621

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

December 31, 2023

| [PART I](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_13) | | | | | | | | | | | |

| | | | | | | [Alliances](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_37) | | | [13](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_37) | | |

| | | | | | | [Competition](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_43) | | | [14](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_43) | | |

| | | | [Item 1C.](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_1099511630475) | | | [Cybersecurity](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_1099511630475) | | | [33](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_1099511630475) | | |

| [PART II](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_88) | | | | | | | | | | | |

| [PART III](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_283) | | | | | | | | | | | |

| [PART IV](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_301) | | | | | | | | | | | |

| [SIGNATURES](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_310) | | | | | | | | | [127](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_310) | | |

| [SUMMARY OF ABBREVIATED TERMS](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_313) | | | | | | | | | [129](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_313) | | |

| [EXHIBIT INDEX](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316) | | | | | | | | | [130](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316) | | |

430 E.

29th Street, 14FL, New York, NY 10016

(212) 546-4200

December 31, 2022

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

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

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

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

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

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

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

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

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

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

Risk Management and Strategy

The Company manages cybersecurity risk as part of our overall enterprise risk management strategy, which is overseen by the Audit Committee and the Board.

The Company employs robust cybersecurity and data privacy programs that are largely aligned to, among others, the U.S. National Institute of Standards and Technology Cybersecurity Framework to assess, identify and manage material risks from cybersecurity threats.

We are constantly evolving our cyber defenses to minimize impacts from cyber threats by using a multi-pronged approach that helps safeguard our assets and data.

We are particularly focused on addressing emerging cybersecurity risks, including human risk, as phishing attacks remain one of the most common causes of data breaches; third-party supply chain risks, as threat actors continue to target supply chains to compromise a greater number of victims; and geopolitical risk, as tensions and conflicts around the world are often accompanied by an increase in sabotage, espionage and cyber attacks.

As threat actors frequently target employees to gain access to information and systems, we have a comprehensive global human risk management program that educates our workforce on threats they face as a first line of defense, and includes elements addressing phishing, malware, data handling, device security, cybersecurity education, password security, internet browsing and defenses to physical threats.

Our employees are exposed to data-driven cybersecurity awareness campaigns and training in order to keep pace with industry standards, evolving challenges and innovative solutions with respect to information security, data privacy, and cybersecurity risks to the organization.

Additionally, we employ a multi-layered approach in our application of cybersecurity technologies to help safeguard our systems, networks, and data from potential cybersecurity threats.

For companies that we acquire, our integration plans include, where appropriate, workable timelines for alignment on information security, data privacy, cybersecurity and employee education.

To support our preparedness, we have a cybersecurity incident response plan (“CIRP”) that we regularly update as business needs and the security landscapes change.

In the event of a cybersecurity incident, our incident response team refers to our CIRP and existing management internal controls and disclosure processes.

Pursuant to this process, designated personnel are responsible for assessing the severity of the incident and any associated threats, containing and resolving the incident as quickly as possible, managing any damage to the Company’s systems and networks, minimizing the impact on the Company’s stakeholders, analyzing and executing upon internal reporting obligations, escalating information about the incident to senior management, as appropriate, and performing post-incident analysis and program enhancements, as needed.

We perform periodic tabletop exercises annually to test our incident response procedures, identify gaps and improvement opportunities and exercise team preparedness.

We engage with third parties to separately conduct cyber assessments on a recurring basis and assist with containment and remediation efforts.

In addition, third-party technology and analytics are utilized to identify potential vulnerabilities.

We recognize that third parties that provide services to the Company can be subject to cybersecurity incidents that could impact the Company.

To manage third-party risk, we maintain a third-party risk management program, which is designed to assess the security controls of our third parties.

The assessment methodology is based on risk and relies on the data, access, connectivity, and criticality of the services that the third-party offers.

As noted, we also conduct tabletop exercises to identify gaps in our supply chain resilience so we can implement improvements.

We maintain relationships with law enforcement, government agencies, forensic investigators, and legal counsel to inform our cybersecurity and data privacy programs.

As of December 31, 2023, and through the date of this filing, we are not aware of any material cybersecurity incidents that have impacted the Company.

However, we have been the target of cyber attacks and expect them to continue as cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry.

We face risks of incidents, whether through cyber attacks or cyber intrusions through the Cloud, the Internet, phishing attempts, ransomware and other forms of malware, computer viruses, email attachments, extortion, and other scams.

Although we make efforts to maintain the security and integrity of our information technology systems, these systems and the proprietary, confidential and personal information that resides on or is transmitted through them, are subject to the risk of a cybersecurity incident or disruption, and there can be no assurance that our security efforts and measures, and those of our third-party vendors, will prevent breakdowns or incidents to our or our third-party vendors’ systems that could adversely affect our business.

For a discussion of these risks, see “Item 1A—Risk Factors—Information Technology and Cybersecurity Risks—We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity incidents and data leakage.”

Governance

The Company’s cybersecurity and data privacy programs are implemented and overseen by the Company’s Chief Information Security Officer (“CISO”), the Executive Vice President, Chief Digital and Technology Officer, and senior management.

The information security team responsible for managing and implementing the Company’s cybersecurity and data privacy programs has many years of valuable business experience managing risks from cybersecurity threats and data privacy breaches and developing and implementing cybersecurity and data privacy policies and procedures.

Our Audit Committee, which consists solely of independent directors, oversees the Company’s overall enterprise risk assessment and risk management policies and guidelines, including risks related to cybersecurity matters.

Our Audit Committee reviews, discusses with management and oversees the Company’s information security and data protection programs.

In particular, the Audit Committee receives periodic updates from the CISO, internal audit function and other members of management on significant cybersecurity and data privacy threats to our systems and the potential impact on the Company’s business, financial results, operations, and reputation, risk management strategies, including information governance and security policies and programs, program assessments, planned improvements, major legislative and regulatory developments that could materially impact the Company’s cybersecurity and data privacy policies and programs, and status of information security initiatives, including an appropriate threat assessment relating to information technology risks.

After each such update, the Chair of the Audit Committee updates the full Board.

The Board also receives similar cybersecurity updates directly from the CISO and other members of management at least annually, and as needed from time to time.

| | | | | | |

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

We own or lease manufacturing, R&D, administration, storage and distribution facilities at approximately [removed: 190] [added: 130] sites worldwide.

Our significant manufacturing and R&D locations by geographic area were as follows at December 31, [removed: 2022:][added: 2023:]

| United States | | | [removed: 7] [added: 6] | | | | | | [removed: 9] [added: 8] | | |

| Total | | | [removed: 8] [added: 7] | | | | | | [removed: 10] [added: 9] | | |

Our principal executive offices are located at Route 206 & Province Line Road, Princeton, NJ.

Our principal executive offices are located at 430 East 29th Street, 14th Floor, New York, NY.

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

Listed below is information on our executive officers as of February [removed: 14, 2023.][added: 13, 2024.]

| Giovanni Caforio, M.D. [removed: *Chairman] [added: *Executive Chairman] of the [removed: Board and Chief Executive Officer*] [added: Board*] *Member of the Leadership Team* | | | [removed: 58] [added: 59] | | | 2015 to 2017 – Chief Executive Officer and Director of the Company 2017 to [removed: present] [added: 2023] – Chairman of the Board and Chief Executive Officer [added: 2023 to present – Executive Chairman of the Board] | | |

| Christopher Boerner, Ph.D. [removed: *Executive Vice President, Chief Commercialization Officer Member] [added: *Chief Executive Officer* *Member] of the Leadership Team* | | | [removed: 52] [added: 53] | | | 2015 to 2017 – President and Head of U.S. Commercial 2017 to 2018 – President and Head, International Markets 2018 to [removed: present] [added: 2023] – Executive Vice President, Chief Commercialization Officer [added: 2023 to 2023 – Executive Vice President, Chief Operating Officer 2023 to present – Chief Executive Officer] | | |

| David V. Elkins *Executive Vice President and Chief Financial Officer* *Member of the Leadership Team* | | | [removed: 54] [added: 55] | | | 2014 to 2017 – Group Vice President and Chief Financial Officer, Consumer and Consumer Medicines, Johnson & Johnson 2017 to 2018 – Worldwide Vice President and Chief Financial Officer, Consumer Products, Medical Development and Corporate Functions, Johnson & Johnson 2018 to 2019 – Chief Financial Officer, Celgene Corporation 2019 to present – Executive Vice President and Chief Financial Officer | | |

| Sharon Greenlees *Senior Vice President, Corporate Controller* | | | [removed: 51] [added: 52] | | | 2016 to 2018 – Vice President of Investor Relations, AbbVie Inc. 2018 to 2020 – Head of Pricing, U.S. Commercial, AbbVie Inc. 2020 to 2021 – Head of Supply Chain Finance, AbbVie Inc. 2021 to 2022 – Vice President and Controller, R&D Finance and Operations, AbbVie Inc. 2022 to present – Senior Vice President, Corporate Controller | | |

| Samit Hirawat, M.D. *Executive Vice President, Chief Medical Officer, [removed: Global Drug] [added: Head of] Development* *Member of the Leadership Team* | | | [removed: 54] [added: 55] | | | 2017 to 2019 – Executive Vice President, Head of Oncology Development, Novartis 2019 to [removed: present] [added: 2023] – Executive Vice President, Chief Medical Officer, Global Drug Development [added: 2023 to present – Executive Vice President, Chief Medical Officer, Head of Development] | | |

| Sandra Leung *Executive Vice President, General Counsel* *Member of the Leadership Team* | | | [removed: 62] [added: 63] | | | 2015 to present – Executive Vice President, General Counsel | | |

| Greg Meyers *Executive Vice President, Chief Digital and Technology Officer* *Member of the Leadership Team* | | | [removed: 50] [added: 51] | | | 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 | | |

| [removed: Ann M. Powell] [added: Adam Lenkowsky] *Executive Vice President, Chief [removed: Human Resources] [added: Commercialization] Officer* *Member of the Leadership Team* | | | [removed: 57] [added: 52] | | | 2016 to 2019 – [added: Head of US Oncology 2019 to 2022 –] Senior Vice President, [removed: Chief Human Resources Officer 2019] [added: General Manager of U.S. Oncology, Immunology & Cardiovascular 2022] to [added: 2023 Senior Vice President, Head of Major Markets 2023 to] present – Executive Vice President, Chief [removed: Human Resources] [added: Commercialization] Officer | | |

| Karin Shanahan *Executive Vice President, Global Product Development & Supply* *Member of the Leadership Team* | | | [removed: 58] [added: 59] | | | 2013 to 2018 – Senior Vice President and Chief Operating Officer, Global Operations, Teva Pharmaceuticals 2018 to 2022 – Senior Vice President, Global Biologics & Sterile Operations, Merck 2022 to present – Executive Vice President, Global Product Development & Supply | | |

| Cari Gallman *Executive Vice President, Corporate Affairs* *Member of the Leadership Team* | | | 44 | | | 2015 to 2018 – Senior Counsel, US Legal 2018 to 2019 – Assistant General Counsel, Oncology Legal 2019 to 2021 – Vice President, Assistant General Counsel, Worldwide Oncology 2021 to 2023 – Senior Vice President, Chief Compliance Officer 2023 to present – Executive Vice President, Corporate Affairs | | |

| Lynelle Hoch *President, Cell Therapy Organization* *Member of the Leadership Team* | | | 51 | | | 2016 to 2019– Vice President, Immuno-Oncology Marketing 2019 to 2021 – General Manager, Ireland & UK, Major Markets 2021 to 2023 – Senior Vice President, Global Cell Therapy Franchise Lead 2023 to present – President, Cell Therapy Organization | | |

| Robert Plenge, M.D., Ph.D. *Executive Vice President, Chief Research Officer, Head of Research* *Member of the Leadership Team* | | | 53 | | | 2017 to 2019 – Vice President Inflammation and Immunology, Thematic Center of Excellence Unit, Celgene Corporation 2019 to 2021 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center 2021 to 2023 – Senior Vice President, Immunology, Cardiovascular & Fibrosis, Thematic Research Center, and Head of Translational Medicine 2023 to 2023 – Senior Vice President and Head of Discovery and Translational Sciences 2023 to present – Executive Vice President, Chief Research Officer, Head of Research | | |

| Amanda Poole *Executive Vice President, Chief Human Resources Officer* *Member of the Leadership Team* | | | 49 | | | 2017 to 2019 – Vice President, Head of Human Resources, Global Product Development & Supply 2019 to 2020 – Vice President, Head of BMS/Celgene Integration 2020 to 2022 – Senior Vice President, Head of Human Resources, Commercialization 2022 to 2024 – Senior Vice President, People Strategy, Solutions & Services 2024 to present – Executive Vice President, Chief Human Resources Officer | | |

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

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

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

The number of record holders of our common stock at January 31, [removed: 2023] [added: 2024] was [removed: 32,895.][added: 31,207.]

Information required by this item will be contained in our [removed: 2023] [added: 2024] Proxy Statement under the heading “Items to be Voted Upon—Item 2—Advisory Vote to Approve the Compensation of our Named Executive Officers—Equity Compensation Plan Information,” which information is incorporated herein by reference.

The graph assumes $100 investment on December 31, [removed: 2017] [added: 2018] 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: 2018,] 2019, 2020, [removed: 2021] [added: 2021, 2022] and [removed: 2022.][added: 2023.]

[removed: ][added: ]

| | | | [removed: 2017] | | | [removed: | | | 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | |

The following table summarizes the surrenders of our equity securities during the three months ended December 31, [removed: 2022:][added: 2023:]

Following this authorization, the Board subsequently approved additional authorizations, including most recently, in February 2020, January [added: and December] 2021 and December [removed: 2021,] [added: 2023,] in the amount $5.0 billion, $2.0 [added: billion, $15.0] billion and [removed: $15.0] [added: $3.0] billion, respectively, to the share repurchase authorization.

The remaining share repurchase capacity under the program was [removed: approximately $7.2] [added: $5.0] billion as of December 31, [removed: 2022.][added: 2023.]

Refer to “Item [removed: 1.][added: 8.]

Financial [removed: Statements—Note] [added: Statements and Supplementary Data—Note] 17.

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

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

| Bristol Myers Squibb | | | | | | $ | 127.74 | | | | | $ | 128.26 | | | | | $ | 131.95 | | | | | $ | 157.00 | | | | | $ | 115.95 | |

| S&P 500 | | | | | | 131.49 | | | | | | 155.68 | | | | | | 200.37 | | | | | | 164.08 | | | | | | 207.21 | | |

| Peer Group | | | | | | 117.27 | | | | | | 119.64 | | | | | | 147.25 | | | | | | 163.08 | | | | | | 166.38 | | |

| October 1 to 31, 2023 | | | 68,146 | | | | | | $ | 57.26 | | | | | — | | | | | | $ | 2,014 | |

| November 1 to 30, 2023 (c) | | | 13,875,165 | | | | | | | | | | | | 13,853,518 | | | | | | 2,014 | | |

| December 1 to 31, 2023 | | | 36,099 | | | | | | 50.36 | | | | | | — | | | | | | 5,014 | | |

| Three months ended December 31, 2023 | | | 13,979,410 | | | | | | | | | | | | 13,853,518 | | | | | | | | |

(c) Represents approximately 14 million of shares, under the ASR, settled and transferred into treasury stock.

The completed repurchases pursuant to the ASR had an average repurchase price of $57.19.

Refer to “Item 8.

Financial Statements and Supplementary Data—Note 17.

Equity” for further information.

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

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

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

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

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

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

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

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

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

| EARNINGS | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Net product sales | | | $ | [removed: 44,671] [added: 43,778] | | | | | $ | [removed: 45,055] [added: 44,671] | | | | | $ | [removed: 41,321] [added: 45,055] | |

| Alliance and other revenues | | | [removed: 1,488] [added: 1,228] | | | | | | [removed: 1,330] [added: 1,488] | | | | | | [removed: 1,197] [added: 1,330] | | |

| Total Revenues | | | [removed: 46,159] [added: 45,006] | | | | | | [removed: 46,385] [added: 46,159] | | | | | | [removed: 42,518] [added: 46,385] | | |

| Cost of products sold(a) | | | [removed: 10,137] [added: 10,693] | | | | | | [removed: 9,940] [added: 10,137] | | | | | | [removed: 11,773] [added: 9,940] | | |

| Marketing, selling and administrative | | | [removed: 7,814] [added: 7,772] | | | | | | [removed: 7,690] [added: 7,814] | | | | | | [removed: 7,661] [added: 7,690] | | |

| Research and development | | | [removed: 9,509] [added: 9,299] | | | | | | [removed: 10,195] [added: 9,509] | | | | | | [removed: 10,048] [added: 10,195] | | |

| Acquired IPRD | | | [removed: 815] [added: 913] | | | | | | [removed: 1,159] [added: 815] | | | | | | [removed: 12,533] [added: 1,159] | | |

| Amortization of acquired intangible assets | | | [removed: 9,595] [added: 9,047] | | | | | | [removed: 10,023] [added: 9,595] | | | | | | [removed: 9,688] [added: 10,023] | | |

| Other (income)/expense, net | | | [removed: 576] [added: (1,158)] | | | | | | [removed: (720)] [added: 576] | | | | | | [removed: (2,314)] [added: (720)] | | |

| Total Expenses | | | [removed: 38,446] [added: 36,566] | | | | | | [removed: 38,287] [added: 38,446] | | | | | | [removed: 49,389] [added: 38,287] | | |

| [removed: Earnings/(Loss)] [added: Earnings] Before Income Taxes | | | [removed: 7,713] [added: 8,440] | | | | | | [removed: 8,098] [added: 7,713] | | | | | | [removed: (6,871)] [added: 8,098] | | |

| Provision for Income Taxes | | | [removed: 1,368] [added: 400] | | | | | | [removed: 1,084] [added: 1,368] | | | | | | [removed: 2,124] [added: 1,084] | | |

| Net [removed: Earnings/(Loss)] [added: Earnings] | | | [removed: 6,345] [added: 8,040] | | | | | | [removed: 7,014] [added: 6,345] | | | | | | [removed: (8,995)] [added: 7,014] | | |

| Noncontrolling Interest | | | [removed: 18] [added: 15] | | | | | | [removed: 20] [added: 18] | | | | | | 20 | | |

| Net [removed: Earnings(Loss)] [added: Earnings] Attributable to BMS | | | $ | [removed: 6,327] [added: 8,025] | | | | | $ | [removed: 6,994] [added: 6,327] | | | | | $ | [removed: (9,015)] [added: 6,994] | |

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

| Basic | | | $ | [removed: 2.97] [added: 3.88] | | | | | [removed: $] [added: 2.97] | [removed: 3.15] | | | | | $ | [removed: (3.99)] [added: 3.15] | |

| Diluted | | | [removed: 2.95] [added: 3.86] | | | | | | [removed: 3.12] [added: 2.95] | | | | | | [removed: (3.99)] [added: 3.12] | | |

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

| COMPREHENSIVE [removed: INCOME/(LOSS)] [added: INCOME] | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Net [removed: Earnings/(Loss)] [added: Earnings] | | | $ | [removed: 6,345] [added: 8,040] | | | | | $ | [removed: 7,014] [added: 6,345] | | | | | $ | [removed: (8,995)] [added: 7,014] | |

| Derivatives qualifying as cash flow hedges | | | [removed: 54] [added: (230)] | | | | | | [removed: 415] [added: 54] | | | | | | [removed: (256)] [added: 415] | | |

| Pension and postretirement benefits | | | [removed: 145] [added: (115)] | | | | | | [removed: 206] [added: 145] | | | | | | [removed: (75)] [added: 206] | | |

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

| Foreign currency translation | | | [removed: (210)] [added: 78] | | | | | | [removed: (41)] [added: (210)] | | | | | | [removed: 7] [added: (41)] | | |

| Total Other Comprehensive Income/(Loss) | | | [removed: (13)] [added: (265)] | | | | | | [removed: 571] [added: (13)] | | | | | | [removed: (319)] [added: 571] | | |

| Comprehensive [removed: Income/(Loss)] [added: Income] | | | [removed: 6,332] [added: 7,775] | | | | | | [removed: 7,585] [added: 6,332] | | | | | | [removed: (9,314)] [added: 7,585] | | |

| Comprehensive Income Attributable to Noncontrolling Interest | | | [removed: 18] [added: 15] | | | | | | [removed: 20] [added: 18] | | | | | | 20 | | |

| Comprehensive [removed: Income/(Loss)] [added: Income] Attributable to BMS | | | $ | [removed: 6,314] [added: 7,760] | | | | | $ | [removed: 7,565] [added: 6,314] | | | | | $ | [removed: (9,334)] [added: 7,565] | |

| ASSETS | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Cash and cash equivalents | | | $ | [removed: 9,123] [added: 11,464] | | | | | $ | [removed: 13,979] [added: 9,123] | |

| Marketable debt securities | | | [removed: 130] [added: 816] | | | | | | [removed: 2,987] [added: 130] | | |

| Receivables | | | [removed: 9,886] [added: 10,921] | | | | | | [removed: 9,369] [added: 9,886] | | |

| Inventories | | | [removed: 2,339] [added: 2,662] | | | | | | [removed: 2,095] [added: 2,339] | | |

| Other current assets | | | [removed: 5,795] [added: 5,907] | | | | | | [removed: 4,832] [added: 5,795] | | |

| Total Current [removed: Assets] [added: assets] | | | [removed: 27,273] [added: 31,770] | | | | | | [removed: 33,262] [added: 27,273] | | |

| Property, plant and equipment | | | [removed: 6,255] [added: 6,646] | | | | | | [removed: 6,049] [added: 6,255] | | |

| Goodwill | | | [removed: 21,149] [added: 21,169] | | | | | | [removed: 20,502] [added: 21,149] | | |

| Other intangible assets | | | [removed: 35,859] [added: 27,072] | | | | | | [removed: 42,527] [added: 35,859] | | |

| Total BMS Shareholders’ Equity | | | 29,430 | | | | | | 31,061 | | |

| Net earnings | | | $ | 8,040 | | | | | $ | 6,345 | | | | | $ | 7,014 | |

| Inventories | | | (751) | | | | | | (69) | | | | | | 13 | | |

| Acquired IPRD | | | $ | 913 | | | | | $ | 815 | | | | | $ | 1,159 | |

Recently Adopted Accounting Standards

The guidance was adopted on January 1, 2023 and the adoption did not have an impact to the consolidated financial statements.

The guidance was adopted on January 1, 2023 and the adoption did not have an impact to the consolidated financial statements.

*Income Taxes*

In December 2023, the FASB issued amended guidance on income tax disclosures.

The guidance is intended to provide additional disaggregation to the effective income tax rate reconciliation and income tax payment disclosures.

The amended guidance is effective for annual periods beginning January 2025 and should be applied on a prospective basis.

Early adoption is permitted.

*Segment Reporting*

In November 2023, the FASB issued amended guidance for improvements to reportable segment disclosures.

The revised guidance requires that a public entity disclose significant segment expenses regularly reviewed by the chief operating decision maker (CODM), including public entities with a single reportable segment.

The amended guidance is effective for fiscal years beginning January 2024 and interim periods beginning January 2025 on a retrospective basis.

Early adoption is permitted.

| Net product sales | | | $ | 43,778 | | | | | $ | 44,671 | | | | | $ | 45,055 | |

| Cencora, Inc. (formerly known an AmerisourceBergen Corporation) | | | 29 | | % | | | | 25 | | % | | | | 25 | | % |

| Net product sales | | | $ | 43,778 | | | | | $ | 44,671 | | | | | $ | 45,055 | |

| Total In-Line Products | | | 34,320 | | | | | | 33,340 | | | | | | 31,300 | | |

| *Augtyro* | | | 1 | | | | | | — | | | | | | — | | |

| Total New Product Portfolio | | | 3,585 | | | | | | 2,030 | | | | | | 1,083 | | |

| Total In-Line Products and New Product Portfolio | | | 37,905 | | | | | | 35,370 | | | | | | 32,383 | | |

| Total Recent LOE Products | | | 7,101 | | | | | | 10,789 | | | | | | 14,002 | | |

| Total revenues | | | $ | 45,006 | | | | | $ | 46,159 | | | | | $ | 46,385 | |

| Total revenues | | | $ | 45,006 | | | | | $ | 46,159 | | | | | $ | 46,385 | |

| Alliance revenues | | | 608 | | | | | | 742 | | | | | | 716 | | |

| Dollars in millions | | | 2023 | | | | | | 2022 | | |

SystImmune

In December 2023, BMS and SystImmune, Inc. (SystImmune) announced a global strategic collaboration for the co-development and co-commercialization of BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate which targets both EGFR and HER3 and is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC.

The parties will jointly develop and commercialize BL-B01D1 in the U.S. Profits, research and development and commercialization costs are shared in the U.S. SystImmune will be responsible for the development, commercialization and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for outside of Mainland China, where BMS will receive a royalty on net sales.

The transaction became effective in February 2024 and included an upfront payment of $800 million, which will be included in Acquired IPRD during the first quarter of 2024.

BMS is also obligated to pay up to $7.6 billion upon the achievement of contingent development, regulatory and sales-based milestones.

| Dollars in millions | | | 2023 | | | | | | 2022 | | |

BMS exercised its option to license idecabtagene vicleucel (*Abecma*) in 2016 and 2seventy bio elected to participate in development and commercialization of *Abecma* in the U.S. in 2018.

The terms of the collaboration have since been amended to transfer substantially all manufacturing obligations to BMS and eliminate ex-U.S. milestones and royalties payable to 2seventy bio for *Abecma*.

*Mirati*

In January 2024, BMS acquired Mirati, a commercial stage targeted oncology company with a pipeline of clinical and commercial oncology medicines.

Through this acquisition, BMS has added commercialized lung cancer medicine *Krazati,* as well as several clinical assets, including MRTX1719.

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

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

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

| Total Bristol-Myers Squibb Company Shareholders’ Equity | | | 31,061 | | | | | | 35,946 | | |

| Inventories | | | (69) | | | | | | 13 | | | | | | 2,672 | | |

Reclassifications

Certain reclassifications were made to conform the prior period consolidated financial statements to the current period presentation.

Upfront and contingent milestone charges in connection with asset acquisitions or licensing of third-party intellectual property rights previously presented in Research and development are now presented in Acquired IPRD in the consolidated statements of earnings.

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

| Asset acquisitions (Note 4) | | | — | | | | | | — | | | | | | 11,616 | | |

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

| AmerisourceBergen Corporation | | | 25 | | % | | | | 25 | | % | | | | 25 | | % |

| *Empliciti* | | | 296 | | | | | | 334 | | | | | | 381 | | |

Nektar

In 2022, BMS and Nektar discontinued the global clinical development program for bempegaldesleukin (NKTR-214) in combination with *Opdivo* based on results from pre-planned analyses of three late-stage clinical studies in RCC and bladder cancer.

These studies and all other ongoing studies in the program are being discontinued.

Research and development cost reimbursements were not material in 2022, 2021 and 2020.

The option to license idecabtagene vicleucel (*Abecma*) was exercised in 2016.

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.

BMS paid $200 million to extinguish its obligation for future ex-U.S. milestones and royalties on ide-cel, which was expensed to Acquired IPRD in 2020.

(a) Intangible assets primarily consist of IPRD allocated to repotrectinib ($2.8 billion), a potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers in NSCLC and other advanced solid tumors.

Repotrectinib is currently in registrational Phase II study in adults and a Phase I/II study in pediatric patients.

*MyoKardia*

In November 2020, BMS acquired MyoKardia for $13.1 billion, including cash settlements of equity stock awards.

MyoKardia was a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious cardiovascular diseases.

The acquisition provided BMS with rights to MyoKardia’s lead asset, mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy.

BMS funded the transaction through a combination of cash on hand from its operations and net proceeds received in connection with the 2020 senior unsecured notes offering.

The transaction was accounted for as an asset acquisition since mavacamten represented substantially all of the fair value of the gross assets acquired (excluding cash and deferred income taxes).

As a result, $11.4 billion was expensed to Acquired IPRD during 2020.

Additionally, in connection with this acquisition, BMS recorded approximately $1.4 billion of assets primarily consisting of cash, deferred income taxes, licenses; liabilities assumed were $226 million.

Total consideration paid also included $482 million of unvested stock awards expensed to Marketing, selling and administrative ($241 million) and Research and development ($241 million).

*Forbius*

In 2020, BMS acquired all of the outstanding shares of Forbius for $185 million and contingent development, regulatory and sales-based milestone payments up to $815 million.

Forbius was a privately held, clinical-stage protein engineering company that designed and developed biotherapeutics for the treatment of cancer and fibrotic diseases.

The acquisition provided BMS with full rights to Forbius' TGF-beta program, including the program’s lead investigational asset, AVID200, which was in Phase I development.

BMS accounted for the transaction as an asset acquisition since AVID200 represented substantially all of the fair value of the gross assets acquired.

As a result, $178 million was expensed to Acquired IPRD and $7 million was allocated to deferred tax assets.

(a) Includes proceeds from royalties received subsequent to the related sale of the asset or business.

As of December 31, [removed: 2022,] [added: 2023,] management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by this [removed: 2022] [added: 2023] Form 10-K.

Based on this evaluation, management has concluded that as of December 31, [removed: 2022,] [added: 2023,] 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: 2022] [added: 2023] based on the framework in “Internal Control—Integrated Framework” (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on that assessment, management has concluded that the Company’s internal control over financial reporting was effective at December 31, [removed: 2022] [added: 2023] to provide reasonable assurance regarding the reliability of its financial reporting and the preparation of its financial statements for external purposes in accordance with United States generally accepted accounting principles.

Deloitte & Touche LLP, an independent registered public accounting firm, has audited the Company’s financial statements included in this report on this [removed: 2022] [added: 2023] Form 10-K and issued its report on the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] which is included herein.

There were no changes in the Company’s internal control over financial reporting during the quarter ended December 31, [removed: 2022] [added: 2023] that have materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

During the fourth quarter of 2023, no director or officer of the Company adopted or terminated an active "Rule 10b5-1 trading

arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K.

None.

We have audited the internal control over financial reporting of Bristol-Myers Squibb Company and subsidiaries (the “Company”) as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in *Internal Control — Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in *Internal Control — Integrated Framework (2013)* issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, [removed: 2022,] [added: 2023,] of the Company and our report dated February [removed: 14, 2023,] [added: 12, 2024,] expressed an unqualified opinion on those financial statements.

February 12, 2024

February 14, 2023

(a)Reference is made to our [removed: 2023] [added: 2024] Proxy Statement [added: section "Who We Are: 2024 Director Nominees"] with respect to [added: information relating to] our Directors, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

(b)The information required by Item 10 with respect to our Executive Officers has been included in Part IA of this [removed: 2022] [added: 2023] Form 10-K in reliance on General Instruction G of Form 10-K and Instruction 3 to Item 401(b) of Regulation S-K, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

(c)Reference is made to our 2024 Proxy Statement section “How We Govern and Are Governed – Codes of Conduct” with respect to our code of ethics, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

(d)Reference is made to our 2024 Proxy Statement section “How We Are Selected and Elected – Director Succession Planning and Identification of Board Candidates – Shareholder Nominations for Director” with respect to procedures by which shareholders can recommend nominees to our board of directors, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

(e)Reference is made to our 2024 Proxy Statement section “How We Are Organized – Committees of Our Board” with respect to our audit committee, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.

[removed: Reference] [added: (a)Reference] is made to our [removed: 2023] [added: 2024] Proxy Statement [removed: with respect to Executive Compensation,] [added: section “Executive Compensation,”] which is incorporated herein by reference and made a part hereof in response to the information required by Item [removed: 11.][added: 11, except that the information under “Executive Compensation – Pay Versus Performance” will not be deemed to be incorporated by reference herein.]

[removed: Reference] [added: (a)Reference] is made to our [removed: 2023] [added: 2024] Proxy Statement [added: “Voting Securities and Principal Holders – Common Stock Ownership by Directors and Executive Officers”] with respect to the security ownership of certain beneficial owners and management, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.

(b)Reference is made to our 2024 Proxy Statement section “Items To Be Voted Upon – Equity Compensation Plan Information” with respect to the securities authorized for issuance under equity compensation plans, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.

[removed: Reference] [added: (a)Reference] is made to our [removed: 2023] [added: 2024] Proxy Statement [added: section “How We Govern and Are Governed – Related Party Transactions”] with respect to certain relationships and related transactions, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.

(b)Reference is made to our 2024 Proxy Statement section “How We Are Selected and Elected – Director Independence” with respect to director independence, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.

Reference is made to our [removed: 2023] [added: 2024] Proxy Statement [added: sections “Items To Be Voted Upon – Audit and Non-Audit Fees” and “Items To Be Voted Upon – Pre-Approval Policy for Services Provided by our Independent Registered Public Accounting Firm”] with respect to the aggregate fees billed to us [added: and services provided] by our principal accountant, Deloitte & Touche LLP (PCAOB ID No. 34), which [removed: is] [added: are] 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](#ib63d400e46fb4076ada7bde6dec75444_193)] [added: Income](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] | | | [removed: [66](#ib63d400e46fb4076ada7bde6dec75444_193)] [added: [71](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_193)] | | |

| | | | [Consolidated Balance [removed: Sheets](#ib63d400e46fb4076ada7bde6dec75444_196)] [added: Sheets](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] | | | [removed: [67](#ib63d400e46fb4076ada7bde6dec75444_196)] [added: [72](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_196)] | | |

| | | | [Consolidated Statements of Cash [removed: Flows](#ib63d400e46fb4076ada7bde6dec75444_199)] [added: Flows](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] | | | [removed: [68](#ib63d400e46fb4076ada7bde6dec75444_199)] [added: [73](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_199)] | | |

| | | | [Notes to Consolidated Financial [removed: Statements](#ib63d400e46fb4076ada7bde6dec75444_202)] [added: Statements](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] | | | [removed: [69](#ib63d400e46fb4076ada7bde6dec75444_202)] [added: [74](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_202)] | | |

| | | | [Report of Independent Registered Public Accounting [removed: Firm](#ib63d400e46fb4076ada7bde6dec75444_280)] [added: Firm](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_265)] | | | [removed: [114](#ib63d400e46fb4076ada7bde6dec75444_280)] [added: [120](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_265)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this [removed: 2022] [added: 2023] Form 10-K.

| (b) | | | [Exhibits Required to be filed by Item 601 of Regulation [removed: S-K](#ib63d400e46fb4076ada7bde6dec75444_331)] [added: S-K](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316)] | | | [removed: [124](#ib63d400e46fb4076ada7bde6dec75444_331)] [added: [130](#ib0240e90e00e4c13ab1ad83b4bbe5b5e_316)] | | |

The information called for by this Item is incorporated herein by reference to the Exhibit Index in this 2023 Form 10-K.

| [removed: By] [added: (Giovanni Caforio, M.D.)] | | | | | | [removed: /s/ GIOVANNI CAFORIO, M.D.] | | | [added: | | | | | |]

| | | | | | | [removed: Chairman of the Board and Chief] [added: Chief] Executive Officer | | |

| Date: February [removed: 14, 2023] [added: 13, 2024] | | | | | | | | |

| /s/ GIOVANNI CAFORIO, M.D. | | | | | | [added: Executive] Chairman of the Board [removed: and Chief Executive Officer] | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ DAVID V. ELKINS | | | | | | Chief Financial Officer | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ SHARON GREENLEES | | | | | | Senior Vice President and Corporate Controller | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ PETER J. ARDUINI | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ DEEPAK L. BHATT. M.D. MPH | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ JULIA A. HALLER, M.D. | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ MANUEL HIDALGO MEDINA, M.D., Ph.D. | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ PAULA A. PRICE | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ DERICA W. RICE | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ THEODORE R. SAMUELS | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ GERALD L. STORCH | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ KAREN H. VOUSDEN, Ph.D. | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

| /s/ PHYLLIS R. YALE | | | | | | Director | | | | | | February [removed: 14, 2023] [added: 13, 2024] | | |

Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol Myers Squibb, BMS, the Company, we, our or us in this [removed: 2022] [added: 2023] Form 10-K, unless the context otherwise indicates.

Throughout this [removed: 2022] [added: 2023] Form 10-K, we have used terms which are defined below:

| [removed: 2022] [added: 2023] Form 10-K | | | Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2022] [added: 2023] | | | [removed: LIBOR] [added: MAA] | | | [removed: London Interbank Offered Rate] [added: Marketing Authorization Application] | | |

| 2021 Plan | | | 2021 Stock Award and Incentive Plan | | | [removed: Lilly] [added: MCOs] | | | [removed: Eli Lilly and Company] [added: Managed Care Organizations] | | |

| aGVHD | | | acute graft-versus-host disease | | | [removed: Mead Johnson] [added: MSI-H] | | | [removed: Mead Johnson Nutrition Company] [added: high microsatellite instability] | | |

| [removed: Amgen] [added: AbbVie] | | | [removed: Amgen] [added: AbbVie] Inc. | | | MF | | | myelofibrosis | | |

| [removed: Amylin] [added: Agenus] | | | [removed: Amylin Pharmaceuticals,] [added: Agenus] Inc. | | | MPM | | | Malignant Pleural Mesothelioma | | |

| ANDA | | | abbreviated New Drug Application | | | [removed: MSI-H] [added: Mirati] | | | [removed: high microsatellite instability] [added: Mirati Therapeutics, Inc.] | | |

| [removed: Biogen] [added: ASR] | | | [removed: Biogen, Inc.] [added: Accelerated Share Repurchase] | | | NDA | | | New Drug Application | | |

| Biohaven | | | Biohaven Pharmaceutical Holding Company Ltd. | | | [removed: Nektar] [added: Novartis] | | | [removed: Nektar Therapeutics] [added: Novartis Pharmaceutical Corporation] | | |

| [removed: bluebird] [added: Biogen] | | | [removed: bluebird bio, inc.] [added: Biogen, Inc.] | | | Nimbus | | | Nimbus Therapeutics, LLC | | |

| [removed: CAR-T] [added: BLA] | | | [removed: Chimeric Antigen Receptor T cells] [added: Biologics License Application] | | | NSCLC | | | non-small cell lung cancer | | |

| CERCLA | | | U.S. Comprehensive Environmental Response, Compensation and Liability Act | | | [removed: OCE] [added: OIG] | | | [removed: Oncology Center] [added: Office] of [removed: Excellence] [added: Inspector General of the U.S. Department of Health and Human Services] | | |

| CML | | | chronic myeloid leukemia | | | [removed: Ono] [added: Otsuka] | | | [removed: Ono] [added: Otsuka] Pharmaceutical Co., Ltd. | | |

| COSO | | | Committee of Sponsoring Organizations of the Treadway Commission | | | [removed: OTC] [added: PBRGs] | | | [removed: over-the-counter] [added: People and Business Resource Groups] | | |

| [removed: DSA] [added: CRC] | | | [removed: Distribution Services Agreement] [added: colorectal cancer] | | | PCAOB | | | Public Company Accounting Oversight Board | | |

| EGFR | | | estimated glomerular filtration rate | | | [removed: PDMA] [added: Prothena] | | | [removed: Prescription Drug Marketing Act] [added: Prothena Corporation] | | |

| [removed: Eisai] [added: DSA] | | | [removed: Eisai Co., Ltd.] [added: Distribution Services Agreement] | | | PDUFA | | | Prescription Drug User Fee Act | | |