Item 6. EXHIBITS
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Item 6. EXHIBITS
Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
| Exhibit No. | Description | |||||||
| 31a. | Section 302 Certification Letter. | |||||||
| 31b. | Section 302 Certification Letter. | |||||||
| 32a. | Section 906 Certification Letter. | |||||||
| 32b. | Section 906 Certification Letter. | |||||||
| 101.INS | XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document. | |||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | |||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
- Indicates, in this Quarterly Report on Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Gleevec is a trademark of Novartis AG; Keytruda is a trademark of Merck Sharp & Dohme Corp; Krazati is a trademark Mirati, Therapeutics, Inc.; Onglyza is a trademark of AstraZeneca AB; Otezla is a trademark of Amgen Inc.; and Plavix is a trademark of Sanofi; Tecentriq is a trademark of Genentech, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.
SUMMARY OF ABBREVIATED TERMS
Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q, unless the context otherwise indicates. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:
| 2022 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2022 | LPA1 | lysophosphatidic acid receptor 1 | ||||||||
| ANDA | Abbreviated New Drug Application | MDL | multi-district litigation | ||||||||
| AstraZeneca | AstraZeneca PLC | MDS | myelodysplastic syndromes | ||||||||
| ASR | accelerated share repurchase | Mirati Therapeutics | Mirati Therapeutics, Inc. | ||||||||
| BCMA | B-cell maturation antigen-directed | MPM | malignant pleural mesothelioma | ||||||||
| CAR-T | chimeric antigen receptor T-cell | MyoKardia | MyoKardia, Inc. | ||||||||
| Celgene | Celgene Corporation | NDA | New Drug Application | ||||||||
| Celgene and Other Acquisition Plans | Restructuring and integration plan implemented as a result of the acquisition of Celgene in 2019, MyoKardia in 2020 and Turning Point in 2022 | NSCLC | non-small cell lung cancer | ||||||||
| CERCLA | U.S. Comprehensive Environmental Response, Compensation and Liability Act | Nimbus | Nimbus Therapeutics | ||||||||
| Cheplapharm | Cheplapharm Arzneimittel GmbH | OTC | over-the-counter | ||||||||
| CML | chronic myeloid leukemia | Otsuka | Otsuka Pharmaceutical Co., Ltd. | ||||||||
| CRC | colorectal carcinoma | PD-1 | programmed cell death protein 1 | ||||||||
| Dragonfly | Dragonfly Therapeutics, Inc. | PD-L1 | programmed death-ligand 1 | ||||||||
| EC | European Commission | PDUFA | Prescription Drug User Fee Act | ||||||||
| EPS | earnings per share | PPF | progessive pulmonary fibrosis | ||||||||
| ESA | erythropoiesis stimulating agent | Quarterly Report on Form 10-Q | Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 | ||||||||
| EU | European Union | R&D | research and development | ||||||||
| Exchange Act | the Securities Exchange Act of 1934 | RA | rheumatoid arthritis | ||||||||
| FASB | Financial Accounting Standards Board | RCC | renal cell carcinoma | ||||||||
| FDA | U.S. Food and Drug Administration | REMS | risk evaluation and mitigation strategy | ||||||||
| GAAP | generally accepted accounting principles | Sanofi | Sanofi S.A. | ||||||||
| GTN | gross-to-net | SEC | U.S. Securities and Exchange Commission | ||||||||
| HCM | hypertrophic cardiomyopathy | Section 174 | Guidance on amortization of specified research or experimental expenditures under Section 174 Notice 2023-63 | ||||||||
| Immatics | Immatics Biotechnologies GmbH. | SPC | Supplementary Protection Certificate | ||||||||
| IPF | idiopathic pulmonary fibrosis | Takeda | Takeda Pharmaceutical Company Limited | ||||||||
| IPRD | in-process research and development | Turning Point | Turning Point Therapeutics, Inc. | ||||||||
| IRA | Inflation Reduction Act of 2022 | UC | ulcerative colitis | ||||||||
| IRS | Internal Revenue Service | UK | United Kingdom | ||||||||
| IV | intravenous | U.S. | United States | ||||||||
| Juno | Juno Therapeutics, Inc. | USPTO | U.S. Patent and Trademark Office | ||||||||
| LTE | long-term extension | VAT | value added tax | ||||||||
| LOE | loss of exclusivity |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BRISTOL-MYERS SQUIBB COMPANY (REGISTRANT) | |||||||||||
| Date: | October 26, 2023 | By: | /s/ Giovanni Caforio, M.D. | ||||||||
| Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer | |||||||||||
| Date: | October 26, 2023 | By: | /s/ David V. Elkins | ||||||||
| David V. Elkins Chief Financial Officer |
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