Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s discussion and analysis of results of operations and financial condition is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related footnotes included elsewhere in this Quarterly Report on Form 10-Q to enhance the understanding of our results of operations, financial condition and cash flows.
EXECUTIVE SUMMARY
Our principal strategy is to combine the resources, scale and capability of a large pharmaceutical company with the speed, agility and focus on innovation typically found in the biotech industry. Our priorities are to continue to renew and diversify our portfolio through launching new medicines, advancing our early, mid and late-stage pipeline, and executing disciplined business development. Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following core therapeutic areas: (i) oncology with a priority in certain tumor types; (ii) hematology with opportunities to broaden our franchise and sustain a leadership position in multiple myeloma; (iii) immunology with priorities in relapsing multiple sclerosis, psoriasis, psoriatic arthritis, lupus, RA and inflammatory bowel disease, liver and lung; (iv) cardiovascular disease; and (v) neuroscience with a focus on neurodegenerative disease. We are working on accelerating our drug development and delivery of our innovative medicines to patients, enhancing our commercial operating model, as well as enhancing flexibility and reliability of our manufacturing network. We are committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We remain committed to maintaining a strong investment grade credit rating and returning capital to shareholders. For further information on our strategy, see "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations—Executive Summary—Strategy" in our 2022 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.
In 2023, we received approvals for initial and/or additional indications or formulations for the following marketed products both in the EU and Japan, which further expanded our geographical reach in immunology and hematology, including: (i) approvals in Japan and by the EC of Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC (ii) EC approval of Camzyos for the treatment of symptomatic obstructive HCM; (iii) EC approval of Breyanzi for the treatment of diffuse large B-cell lymphoma; (iv) EC approval for Sotyktu for moderate-to-severe plaque psoriasis; and (v) EC approval for an additional indication for anemia associated with non-transfusion-dependent beta thalassemia for Reblozyl. In addition, we continue expanding our commercial CAR-T manufacturing network through the FDA approval of our Devens, MA facility in June 2023.
Our revenues decreased by 4% for the six months ended June 30, 2023 due to lower Revlimid sales and 1% foreign exchange impact, partially offset by In-Line Products (primarily Opdivo and Eliquis) and New Product Portfolio (primarily Opdualag, Abecma and Reblozyl). The $0.81 increase in GAAP EPS primarily resulted from a deferred income tax benefit related to a non-U.S. tax ruling, lower equity investment losses in 2023, lower Acquired IPRD charges, partially offset by lower revenues. After adjusting for specified items, non-GAAP EPS decreased $0.09 as a result of lower revenues, partially offset by lower Acquired IPRD charges, lower weighted-average common shares outstanding, higher interest income and royalties.
Our revenues decreased by 6% during the three months ended June 30, 2023 primarily due to lower Revlimid sales driven by generic erosion and an increase in patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product.
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in millions, except per share data | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
| Total Revenues | $ | 11,226 | $ | 11,887 | $ | 22,563 | $ | 23,535 | |||||||||||||||
| Diluted earnings per share | |||||||||||||||||||||||
| GAAP | $ | 0.99 | $ | 0.66 | $ | 2.06 | $ | 1.25 | |||||||||||||||
| Non-GAAP | 1.75 | 1.93 | 3.80 | 3.89 |
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For further information and reconciliations relating to our non-GAAP financial measures refer to "—Non-GAAP Financial Measures."
Economic and Market Factors
Governmental Actions
Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which can negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility. For example, some of the provisions of the IRA signed into law in August 2022, were as follows: (i) the government requires pharmaceutical manufacturers like BMS, under the threat of significant penalties, to sell certain innovative Medicare Part D and Part B medicines at government-set discounted prices, (ii) manufacturers are to pay an inflation-based rebate for Medicare Part B and Part D medicines, and (iii) Medicare Part D redesign. In addition, there were changes made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations, and a (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in 2023. Implementation of this legislation is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which is uncertain. We continue to evaluate the impact of the IRA on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations. See "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Other Litigation" for further information. Furthermore, countries are expected to make changes to their tax laws and updates to international tax treaties to implement the agreement by the Organization for Economic Co-operation and Development to establish a global minimum tax. See risk factors on these items included under "Part I—Item 1A. Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins" and "—Changes to tax regulations could negatively impact our earnings" in our 2022 Form 10-K.
Significant Product and Pipeline Approvals
The following is a summary of the significant approvals received in 2023 as of July 27, 2023:
| Product | Date | Approval |
| Opdivo | June 2023 | EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%. |
| Camzyos | June 2023 | EC approval of Camzyos for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM. |
| Breyanzi | May 2023 | EC approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. |
| Opdivo | March 2023 | Japan's Ministry of Health, Labour and Welfare approval of Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC. |
| Sotyktu | March 2023 | EC approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. |
| Reblozyl | March 2023 | EC approval of Reblozyl for the treatment in adult patients of anemia associated with non-transfusion-dependent beta thalassemia. |
Refer to "—Product and Pipeline Developments" for the developments in our marketed products and late-stage pipeline since the start of the second quarter of 2023.
Divestitures, Licensing and Other Arrangements
Refer to "Item 1. Financial Statements—Note 3. Alliances" and "—Note 4. Divestitures, Licensing and Other Arrangements" for information on significant divestitures, licensing and other arrangements.
RESULTS OF OPERATIONS
Regional Revenues
The composition of the changes in revenues was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | Foreign Exchange**(b)** | 2023 | 2022 | % Change | Foreign Exchange**(b)** | |||||||||||||||||||||||||||||||||||||||
| United States | $ | 7,891 | $ | 8,268 | (5) | % | — | $ | 15,924 | $ | 15,962 | — | — | ||||||||||||||||||||||||||||||||||
| International | 3,160 | 3,427 | (8) | % | (2) | % | 6,309 | 7,154 | (12) | % | (3) | % | |||||||||||||||||||||||||||||||||||
| Other(a) | 175 | 192 | (9) | % | — | 330 | 419 | (21) | % | — | |||||||||||||||||||||||||||||||||||||
| Total | $ | 11,226 | $ | 11,887 | (6) | % | (1) | % | $ | 22,563 | $ | 23,535 | (4) | % | (1) | % |
(a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.
United States
- U.S. revenues decreased 5% during the second quarter of 2023 primarily due to lower Revlimid sales driven by generic erosion and an increase in patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product*,* partially offset by our New Product Portfolio and In-Line Products*.* Year-to-date, lower Revlimid sales was fully offset by New Product Portfolio and In-Line Products*.* Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.
International
- International revenues decreased 8% during the second quarter of 2023 and 12% year-to-date primarily due to Revlimid and Eliquis generic erosion, lower average net selling prices and foreign exchange, partially offset by Opdivo and New Product Portfolio.
No single country outside the U.S. contributed more than 10% of total revenues during the six months ended June 30, 2023 and 2022. Our business is typically not seasonal.
GTN Adjustments
The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||||||||||||||||||||||||||
| Gross product sales | $ | 18,111 | $ | 17,299 | 5 | % | $ | 35,399 | $ | 33,949 | 4 | % | |||||||||||||||||||||||
| GTN adjustments | |||||||||||||||||||||||||||||||||||
| Charge-backs and cash discounts | (2,279) | (1,750) | 30 | % | (4,370) | (3,513) | 24 | % | |||||||||||||||||||||||||||
| Medicaid and Medicare rebates | (3,143) | (2,624) | 20 | % | (5,625) | (4,708) | 19 | % | |||||||||||||||||||||||||||
| Other rebates, returns, discounts and adjustments | (1,772) | (1,440) | 23 | % | (3,439) | (2,935) | 17 | % | |||||||||||||||||||||||||||
| Total GTN adjustments | (7,194) | (5,814) | 24 | % | (13,434) | (11,156) | 20 | % | |||||||||||||||||||||||||||
| Net product sales | $ | 10,917 | $ | 11,485 | (5) | % | $ | 21,965 | $ | 22,793 | (4) | % | |||||||||||||||||||||||
| GTN adjustments percentage | 40 | % | 34 | % | 6 | % | 38 | % | 33 | % | 5 | % | |||||||||||||||||||||||
| U.S. | 45 | % | 38 | % | 7 | % | 43 | % | 38 | % | 5 | % | |||||||||||||||||||||||
| Non-U.S. | 20 | % | 16 | % | 4 | % | 19 | % | 16 | % | 3 | % |
Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $11 million and $98 million for the three and six months ended June 30, 2023 and $123 million and $197 million for the three and six months ended June 30, 2022, respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to product mix and higher government channel rebates.
Product Revenues
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||||||||||||||||||||||||||
| In-Line Products | |||||||||||||||||||||||||||||||||||
| Eliquis | $ | 3,204 | $ | 3,235 | (1) | % | $ | 6,627 | $ | 6,446 | 3 | % | |||||||||||||||||||||||
| U.S. | 2,340 | 2,192 | 7 | % | 4,894 | 4,339 | 13 | % | |||||||||||||||||||||||||||
| Non-U.S. | 864 | 1,043 | (17) | % | 1,733 | 2,107 | (18) | % | |||||||||||||||||||||||||||
| Opdivo | 2,145 | 2,063 | 4 | % | 4,347 | 3,986 | 9 | % | |||||||||||||||||||||||||||
| U.S. | 1,230 | 1,205 | 2 | % | 2,520 | 2,304 | 9 | % | |||||||||||||||||||||||||||
| Non-U.S. | 915 | 858 | 7 | % | 1,827 | 1,682 | 9 | % | |||||||||||||||||||||||||||
| Pomalyst/Imnovid | 847 | 908 | (7) | % | 1,679 | 1,734 | (3) | % | |||||||||||||||||||||||||||
| U.S. | 570 | 616 | (7) | % | 1,115 | 1,173 | (5) | % | |||||||||||||||||||||||||||
| Non-U.S. | 277 | 292 | (5) | % | 564 | 561 | 1 | % | |||||||||||||||||||||||||||
| Orencia | 927 | 876 | 6 | % | 1,691 | 1,668 | 1 | % | |||||||||||||||||||||||||||
| U.S. | 707 | 654 | 8 | % | 1,269 | 1,246 | 2 | % | |||||||||||||||||||||||||||
| Non-U.S. | 220 | 222 | (1) | % | 422 | 422 | — | ||||||||||||||||||||||||||||
| Sprycel | 458 | 544 | (16) | % | 887 | 1,027 | (14) | % | |||||||||||||||||||||||||||
| U.S. | 328 | 372 | (12) | % | 623 | 677 | (8) | % | |||||||||||||||||||||||||||
| Non-U.S. | 130 | 172 | (24) | % | 264 | 350 | (25) | % | |||||||||||||||||||||||||||
| Yervoy | 585 | 525 | 11 | % | 1,093 | 1,040 | 5 | % | |||||||||||||||||||||||||||
| U.S. | 369 | 326 | 13 | % | 683 | 637 | 7 | % | |||||||||||||||||||||||||||
| Non-U.S. | 216 | 199 | 9 | % | 410 | 403 | 2 | % | |||||||||||||||||||||||||||
| Mature and other products | 472 | 512 | (8) | % | 939 | 1,049 | (10) | % | |||||||||||||||||||||||||||
| U.S. | 197 | 194 | 2 | % | 379 | 374 | 1 | % | |||||||||||||||||||||||||||
| Non-U.S. | 275 | 318 | (14) | % | 560 | 675 | (17) | % | |||||||||||||||||||||||||||
| Total In-Line Products | 8,638 | 8,663 | — | 17,263 | 16,950 | 2 | % | ||||||||||||||||||||||||||||
| U.S. | 5,741 | 5,559 | 3 | % | 11,483 | 10,750 | 7 | % | |||||||||||||||||||||||||||
| Non-U.S. | 2,897 | 3,104 | (7) | % | 5,780 | 6,200 | (7) | % | |||||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||||||||||||||||||||||||||
| New Product Portfolio | |||||||||||||||||||||||||||||||||||
| Reblozyl | 234 | 172 | 36 | % | 440 | 328 | 34 | % | |||||||||||||||||||||||||||
| U.S. | 179 | 144 | 24 | % | 337 | 278 | 21 | % | |||||||||||||||||||||||||||
| Non-U.S. | 55 | 28 | 96 | % | 103 | 50 | * | ||||||||||||||||||||||||||||
| Abecma | 132 | 89 | 48 | % | 279 | 156 | 79 | % | |||||||||||||||||||||||||||
| U.S. | 115 | 72 | 60 | % | 233 | 128 | 82 | % | |||||||||||||||||||||||||||
| Non-U.S. | 17 | 17 | — | 46 | 28 | 64 | % | ||||||||||||||||||||||||||||
| Opdualag | 154 | 58 | * | 271 | 64 | * | |||||||||||||||||||||||||||||
| U.S. | 152 | 58 | * | 268 | 64 | * | |||||||||||||||||||||||||||||
| Non-U.S. | 2 | — | N/A | 3 | — | N/A | |||||||||||||||||||||||||||||
| Zeposia | 100 | 66 | 52 | % | 178 | 102 | 75 | % | |||||||||||||||||||||||||||
| U.S. | 75 | 48 | 56 | % | 127 | 69 | 84 | % | |||||||||||||||||||||||||||
| Non-U.S. | 25 | 18 | 39 | % | 51 | 33 | 55 | % | |||||||||||||||||||||||||||
| Breyanzi | 100 | 39 | * | 171 | 83 | * | |||||||||||||||||||||||||||||
| U.S. | 83 | 33 | * | 141 | 74 | 91 | % | ||||||||||||||||||||||||||||
| Non-U.S. | 17 | 6 | * | 30 | 9 | * | |||||||||||||||||||||||||||||
| Onureg | 44 | 32 | 38 | % | 78 | 55 | 42 | % | |||||||||||||||||||||||||||
| U.S. | 31 | 25 | 24 | % | 56 | 44 | 27 | % | |||||||||||||||||||||||||||
| Non-U.S. | 13 | 7 | 86 | % | 22 | 11 | 100 | % | |||||||||||||||||||||||||||
| Inrebic | 27 | 23 | 17 | % | 52 | 41 | 27 | % | |||||||||||||||||||||||||||
| U.S. | 19 | 20 | (5) | % | 36 | 35 | 3 | % | |||||||||||||||||||||||||||
| Non-U.S. | 8 | 3 | * | 16 | 6 | * | |||||||||||||||||||||||||||||
| Camzyos | 46 | 3 | * | 75 | 3 | * | |||||||||||||||||||||||||||||
| U.S. | 46 | 3 | * | 75 | 3 | * | |||||||||||||||||||||||||||||
| Non-U.S. | — | — | N/A | — | — | N/A | |||||||||||||||||||||||||||||
| Sotyktu | 25 | — | N/A | 41 | — | N/A | |||||||||||||||||||||||||||||
| U.S. | 24 | — | N/A | 39 | — | N/A | |||||||||||||||||||||||||||||
| Non-U.S. | 1 | — | N/A | 2 | — | N/A | |||||||||||||||||||||||||||||
| Total New Product Portfolio | 862 | 482 | 79 | % | 1,585 | 832 | 91 | % | |||||||||||||||||||||||||||
| U.S. | 724 | 403 | 80 | % | 1,312 | 695 | 89 | % | |||||||||||||||||||||||||||
| Non-U.S. | 138 | 79 | 75 | % | 273 | 137 | 99 | % | |||||||||||||||||||||||||||
| Total In-Line Products and New Product Portfolio | 9,500 | 9,145 | 4 | % | 18,848 | 17,782 | 6 | % | |||||||||||||||||||||||||||
| U.S. | 6,465 | 5,962 | 8 | % | 12,795 | 11,445 | 12 | % | |||||||||||||||||||||||||||
| Non-U.S. | 3,035 | 3,183 | (5) | % | 6,053 | 6,337 | (4) | % | |||||||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||||||||||||||||||||||||||
| Recent LOE Products(a) | |||||||||||||||||||||||||||||||||||
| Revlimid | 1,468 | 2,501 | (41) | % | 3,218 | 5,298 | (39) | % | |||||||||||||||||||||||||||
| U.S. | 1,237 | 2,130 | (42) | % | 2,778 | 4,168 | (33) | % | |||||||||||||||||||||||||||
| Non-U.S. | 231 | 371 | (38) | % | 440 | 1,130 | (61) | % | |||||||||||||||||||||||||||
| Abraxane | 258 | 241 | 7 | % | 497 | 455 | 9 | % | |||||||||||||||||||||||||||
| U.S. | 189 | 176 | 7 | % | 351 | 349 | 1 | % | |||||||||||||||||||||||||||
| Non-U.S. | 69 | 65 | 6 | % | 146 | 106 | 38 | % | |||||||||||||||||||||||||||
| Total Recent LOE Products | 1,726 | 2,742 | (37) | % | 3,715 | 5,753 | (35) | % | |||||||||||||||||||||||||||
| U.S. | 1,426 | 2,306 | (38) | % | 3,129 | 4,517 | (31) | % | |||||||||||||||||||||||||||
| Non-U.S. | 300 | 436 | (31) | % | 586 | 1,236 | (53) | % | |||||||||||||||||||||||||||
| Total Revenues | $ | 11,226 | $ | 11,887 | (6) | % | 22,563 | 23,535 | (4) | % | |||||||||||||||||||||||||
| U.S. | 7,891 | 8,268 | (5) | % | 15,924 | 15,962 | — | ||||||||||||||||||||||||||||
| Non-U.S. | 3,335 | 3,619 | (8) | % | 6,639 | 7,573 | (12) | % |
- Change in excess of 100%.
(a) Recent LOE Products includes products with significant decline in revenue from a prior reporting period as a result of a loss of exclusivity.
In-Line Products
Eliquis (apixaban) — an oral Factor Xa inhibitor, indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
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U.S. revenues increased 7% during the second quarter of 2023 and primarily due to higher demand, partially offset by lower average net selling prices, including GTN adjustments in 2023.
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U.S. revenues increased 13% year-to-date primarily due to higher demand. Eliquis growth rates were lower in the second quarter of 2023 compared to year-to-date primarily due to lower average net selling prices resulting from changes in payer channel mix. A majority of Eliquis patients enter the coverage gap during the third and fourth quarters which is expected to result in lower revenues during the second half of the year.
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International revenues decreased 17% during the second quarter of 2023 and 18% year-to-date primarily due to lower average net selling price and generic erosion in Canada and the UK. Year-to-date was also impacted by foreign exchange of 3%. Excluding foreign exchange impacts, revenues decreased by 17% and 15%, respectively.
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Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe, and court decisions in (i) the United Kingdom finding the UK apixaban composition of matter patent and related SPC invalid and (ii) the Netherlands denying a BMS request for a preliminary injunction that would have prevented an at-risk generic launch, generic manufacturers have begun marketing generic versions of Eliquis in the UK and the Netherlands, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which has led to additional infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe. Most recently, in France, Norway and Sweden, courts held in BMS's favor, confirming the validity of the composition of matter patent and related SPCs in those countries. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Intellectual Property" for further information.
Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells that has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and various gastric and esophageal cancers. There are several ongoing potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.
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U.S. revenues increased 2% during the second quarter of 2023 primarily due to higher average net selling prices.
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U.S. revenues increased 9% year-to-date due to higher demand across multiple indications and to a lesser extent higher average net selling prices. The higher demand was related to the following indications: the Opdivo+Yervoy combinations for NSCLC, various gastric, esophageal and bladder cancers. Opdivo growth rates were lower during the second quarter of 2023 compared to year-to-date primarily due to customer buying patterns.
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International revenues increased 7% during the second quarter of 2023 and 9% year-to-date due to higher demand as a result of additional indication launches and core indications partially offset by foreign exchange impacts of 3% and 5%, respectively, and lower average net selling prices. Excluding foreign exchange impacts, revenues increased 10% and 14%, respectively.
Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
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U.S. revenues decreased 7% during the second quarter of 2023 and 5% year-to-date due to an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, partially offset by higher average net selling prices.
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International revenues decreased 5% during the second quarter of 2023 primarily due to lower average net selling prices and foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues decreased by 4%.
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International revenues increased 1% year-to-date primarily due to higher demand partially offset by lower average net selling prices and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased by 4%.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA.
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U.S. revenues increased 8% during the second quarter of 2023 and 2% year-to-date primarily due to higher demand partially offset by lower average net selling prices.
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International revenues decreased 1% during the second quarter of 2023 due to lower average net selling prices and foreign exchange impacts of 3%, partially offset by higher demand. Excluding foreign exchange impacts, revenues increased by 2%.
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International revenues remained constant year-to-date with higher demand being offset by foreign exchange impacts of 6% and lower average net selling prices. Excluding foreign exchange impacts, revenues increased by 6%.
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BMS is not aware of any Orencia biosimilars on the market in the U.S., EU and Japan. Formulation and additional patents expire in 2026 and beyond.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic 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.
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U.S. revenues decreased 12% during the second quarter of 2023 and 8% year-to-date primarily due to lower average net selling prices.
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International revenues decreased 24% during the second quarter of 2023 and 25% year-to-date primarily due to lower demand as a result of generic erosion and foreign exchange impacts of 2% and 5%, respectively. Excluding foreign exchange impacts, revenues decreased by 22% and 20%, respectively.
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In the U.S., BMS entered into settlement agreements with certain third parties to sell generic dasatinib products beginning in September 2024, or earlier in certain circumstances. In the EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent has been extended to 2024 for the treatment of non-imatinib-resistant CML, but generics have been approved for other indications.
Yervoy (ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.
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U.S. revenues increased 13% during the second quarter of 2023 and 7% year-to-date due to higher demand.
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International revenues increased 9% during the second quarter of 2023 and 2% year-to-date primarily due to higher demand as a result of additional indication launches and core indications, partially offset by lower average net selling prices and foreign exchange impacts of 2% and 5%, respectively. Excluding foreign exchange impacts, revenues increased by 11% and 7%, respectively.
Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products, royalty revenue and mature products.
- International revenues decreased 14% during the second quarter of 2023 and 17% year-to-date primarily due to continued generic erosion, lower average net selling prices and foreign exchange impacts of 2% and 3%, respectively. Excluding foreign exchange impacts, revenues decreased by 12% and 14%, respectively.
New Product Portfolio
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions and for the treatment of anemia failing an ESA in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions. Reblozyl was launched in November 2019.
- U.S. revenues increased 24% during the second quarter of 2023 and 21% year-to-date primarily due to higher demand.
Abecma (idecabtagene vicleucel) — is a B-cell maturation antigen-directed genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma was launched in May 2021.
- U.S. revenues increased 60% during the second quarter of 2023 and 82% year-to-date primarily due to higher demand enabled by additional manufacturing capacity.
Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag was launched in March 2022.
Zeposia (ozanimod) — an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults. Zeposia was launched in June 2020.
Breyanzi (lisocabtagene maraleucel) — is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with certain types of relapsed or refractory large B-cell lymphoma after one or more lines of systemic therapy. Breyanzi was launched in April 2021.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg was launched in September 2020.
Inrebic (fedratinib) — an oral kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Inrebic was launched in August 2019.
Camzyos (mavacamten) — a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Camzyos was launched in April 2022.
Sotyktu (deucravacitinib) — an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu was launched in September 2022.
Recent LOE Products
Revlimid (lenalidomide) — an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant.
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U.S. revenues decreased 42% during the second quarter of 2023 and 33% year-to-date primarily due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, and to a lesser extent lower average net selling prices.
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International revenues decreased 38% during the second quarter of 2023 and 61% year-to-date primarily due to generic erosion across several European countries and to a lesser extent lower average net selling prices, as well as foreign exchange impacts of 2% in the second quarter and year-to-date. Excluding foreign exchange impacts, revenues decreased by 36% and 59%, respectively.
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In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. In the EU, generic lenalidomide products have entered the market. Global revenues for Revlimid are expected to decline to approximately $5.5 billion in 2023.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.
- U.S. revenues increased 7% during the second quarter of 2023 primarily due to higher branded sales resulting from lower authorized generic sales during the second quarter of 2023. U.S. revenues year-over-year remained relatively flat.
Estimated End-User Demand
Pursuant to the SEC Consent Order described under "— SEC Consent Order" in our 2022 Form 10-K, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. There were no products in the U.S. wholesaler distribution channel with estimated levels of inventory in excess of one month as of June 30, 2023. Estimated levels of inventory outside of the U.S. in the direct distribution channel in excess of one month on hand were not material to our results of operations as of March 31, 2023.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which accounted for approximately 85% of total gross sales of U.S. products during the six months ended June 30, 2023. Factors that may influence our estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.
Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS (Revlimid) and Pomalyst REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities' specifications to provide for the products' safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.
Camzyos is only available through a restricted program called the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos.
Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business during the six months ended June 30, 2023 is not available prior to the filing of this Quarterly Report on Form 10-Q. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in our next quarterly report on Form 10-Q.
Expenses
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||||||||||||||||||||||||||
| Cost of products sold(a) | $ | 2,876 | $ | 2,720 | 6 | % | $ | 5,442 | $ | 5,191 | 5 | % | |||||||||||||||||||||||
| Marketing, selling and administrative | 1,934 | 1,787 | 8 | % | 3,696 | 3,618 | 2 | % | |||||||||||||||||||||||||||
| Research and development | 2,258 | 2,321 | (3) | % | 4,579 | 4,581 | — | ||||||||||||||||||||||||||||
| Acquired IPRD | 158 | 400 | (61) | % | 233 | 733 | (68) | % | |||||||||||||||||||||||||||
| Amortization of acquired intangible assets | 2,257 | 2,417 | (7) | % | 4,513 | 4,834 | (7) | % | |||||||||||||||||||||||||||
| Other (income)/expense, net | (116) | 284 | * | (529) | 933 | * | |||||||||||||||||||||||||||||
| Total Expenses | $ | 9,367 | $ | 9,929 | (6) | % | $ | 17,934 | $ | 19,890 | (10) | % |
- In excess of +/- 100%.
(a) Excludes amortization of acquired intangible assets.
Cost of Products Sold
Cost of products sold increased by $156 million in the second quarter of 2023 primarily due to product mix and higher CAR-T cell therapy inventory charges, partially offset by lower inventory purchase price adjustments and the elimination of the Puerto Rico excise tax.
Cost of products sold increased by $251 million year-to-date, primarily due to product mix, higher CAR-T cell therapy inventory charges, higher profit sharing and royalties ($212 million year-to-date) partially offset by lower inventory purchase price adjustments and the elimination of the Puerto Rico excise tax and foreign exchange.
Marketing, Selling and Administrative
Marketing, selling and administrative expense increased by $147 million in the second quarter of 2023 primarily due to higher advertising, promotion and sales force costs to support new product launches, as well as higher consulting costs supporting corporate initiatives.
Marketing, selling and administrative expense increased $78 million year-to-date primarily due to higher advertising, promotion and sales force costs to support new product launches and higher consulting costs supporting corporate initiatives, partially offset by timing of charitable giving ($150 million).
Research and Development
Research and development expense decreased by $63 million in the second quarter of 2023 and $2 million year-to-date.
Acquired IPRD
Acquired IPRD charges resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights were as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
| Mavacamten royalty extinguishment | $ | — | $ | 295 | $ | — | $ | 295 | |||||||||||||||
| Dragonfly milestone | — | — | — | 175 | |||||||||||||||||||
| Prothena opt-in license fee | 55 | — | 55 | — | |||||||||||||||||||
| Immatics upfront license fee | 15 | — | 15 | 150 | |||||||||||||||||||
| Evotec designation and opt-in license fees | 40 | — | 90 | — | |||||||||||||||||||
| BridgeBio upfront license fee | — | 90 | — | 90 | |||||||||||||||||||
| Other | 48 | 15 | 73 | 23 | |||||||||||||||||||
| Acquired IPRD charges | $ | 158 | $ | 400 | $ | 233 | $ | 733 |
Amortization of Acquired Intangible Assets
Amortization of acquired intangible assets decreased by $160 million in the second quarter of 2023 and $321 million year-to-date primarily due to Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
Other (Income)/Expense, Net
Other (income)/expense, net changed by $400 million in the second quarter of 2023 and $1.5 billion year-to-date primarily due to equity investments, litigation and other settlements and other items discussed below.
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
| Interest expense | $ | 282 | $ | 313 | $ | 570 | $ | 639 | |||||||||||||||
| Royalty and licensing income | (340) | (287) | (703) | (593) | |||||||||||||||||||
| Royalty income - divestitures | (218) | (221) | (406) | (392) | |||||||||||||||||||
| Equity investment losses | 58 | 308 | 213 | 952 | |||||||||||||||||||
| Integration expenses | 59 | 124 | 126 | 229 | |||||||||||||||||||
| (Gain)/Loss on debt redemption | — | (9) | — | 266 | |||||||||||||||||||
| Divestiture gains | — | — | — | (211) | |||||||||||||||||||
| Litigation and other settlements | (7) | 25 | (332) | (12) | |||||||||||||||||||
| Investment income | (95) | (27) | (197) | (37) | |||||||||||||||||||
| Provision for restructuring | 113 | 20 | 180 | 43 | |||||||||||||||||||
| Other | 32 | 38 | 20 | 49 | |||||||||||||||||||
| Other (income)/expense, net | $ | (116) | $ | 284 | $ | (529) | $ | 933 |
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Interest expense decreased in the second quarter of 2023 and year-to-date compared to 2022 due to additional debt maturities. Refer to "Item 1. Financial Statements and Supplementary Data—Note 10. Financing Arrangements" for further information.
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Royalties increased in the second quarter of 2023 and year-to-date primarily due to higher Keytruda* and diabetes business divestiture royalties. Refer to "Item 8. Financial Statements and Supplementary Data—Note 4. Divestitures, Licensing and Other Arrangements" for further information.
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Equity investments generated lower losses in the second quarter of 2023 and year-to-date compared to 2022 primarily driven by fair value adjustments for investments that have readily determinable fair value. Refer to "Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements" for more information.
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Integration expenses decreased in the second quarter of 2023 and year-to-date primarily due to lower consulting fees to implement Celgene integration initiatives related to processes and systems.
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(Gain)/Loss on debt redemption resulted from the early redemption of long-term debt during the first six months ended June 30, 2022, as further discussed in "Item 1. Financial Statements and Supplementary Data—Note 10. Financing Arrangements".
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Divestiture gains resulted from the divestiture of product rights for several mature products during the first quarter of 2022.
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Litigation and other settlements include $400 million of income related to the Nimbus' TYK2 program change of control provision and additional settlement costs related to commercial disputes regarding intellectual property matters during the first six months of 2023.
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Investment income increased during the second quarter of 2023 and year-to-date primarily due to higher interest rates.
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Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including a new plan in 2023 discussed further in "Item 1. Financial Statements and Supplementary Data—Note 6. Restructuring".
Income Taxes
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||||
| Earnings before income taxes | $ | 1,859 | $ | 1,958 | $ | 4,629 | $ | 3,645 | ||||||||||||||||||
| Income tax (benefit)/provision | (218) | 529 | 285 | 933 | ||||||||||||||||||||||
| Effective tax rate | (11.7) | % | 27.0 | % | 6.2 | % | 25.6 | % | ||||||||||||||||||
| Impact of specified items | (28.6) | % | 10.0 | % | (10.0) | % | 9.2 | % | ||||||||||||||||||
| Effective tax rate excluding specified items | 16.9 | % | 17.0 | % | 16.2 | % | 16.4 | % |
Provision for income taxes in interim periods are determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The effective tax rate during the second quarter of 2023 was primarily impacted by a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments. In addition, the effective tax rate during the first six months of 2023 was impacted by jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and other settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audits, partially offset by the impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax. Additional changes to the effective tax rate may occur in future periods due to various reasons, including changes to the estimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code.
The changes in the non-GAAP effective tax rate were due to the changes in the aforementioned Puerto Rico tax decree, jurisdictional earnings mix and the tax reserve releases in the first quarter of 2023.
Non-GAAP Financial Measures
Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (ii) unwind of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and (xii) amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments. We also provide international revenues for our priority products excluding the impact of foreign exchange. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on July 27, 2023 and are incorporated herein by reference.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors' overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our consolidated financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Specified items were as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in millions | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
| Inventory purchase price accounting adjustments | $ | 31 | $ | 102 | $ | 84 | $ | 154 | |||||||||||||||
| Site exit and other costs | 36 | 43 | 37 | 43 | |||||||||||||||||||
| Cost of products sold | 67 | 145 | 121 | 197 | |||||||||||||||||||
| Site exit and other costs | 20 | 4 | 20 | 6 | |||||||||||||||||||
| Marketing, selling and administrative | 20 | 4 | 20 | 6 | |||||||||||||||||||
| IPRD impairments | — | — | 20 | 40 | |||||||||||||||||||
| Priority review voucher | — | — | 95 | — | |||||||||||||||||||
| Inventory purchase price accounting adjustments | — | 21 | — | 108 | |||||||||||||||||||
| Site exit and other costs | 6 | — | 6 | — | |||||||||||||||||||
| Research and development | 6 | 21 | 121 | 148 | |||||||||||||||||||
| Amortization of acquired intangible assets | 2,257 | 2,417 | 4,513 | 4,834 | |||||||||||||||||||
| Interest expense(a) | (13) | (21) | (27) | (48) | |||||||||||||||||||
| Equity investment losses | 58 | 307 | 208 | 950 | |||||||||||||||||||
| Integration expenses | 59 | 124 | 126 | 229 | |||||||||||||||||||
| (Gains)/loss on debt redemption | — | (9) | — | 266 | |||||||||||||||||||
| Divestiture gains | — | — | — | (211) | |||||||||||||||||||
| Litigation and other settlements | — | — | (335) | (40) | |||||||||||||||||||
| Provision for restructuring | 113 | 20 | 180 | 43 | |||||||||||||||||||
| Other | — | 42 | (5) | 42 | |||||||||||||||||||
| Other (income)/expense, net | 217 | 463 | 147 | 1,231 | |||||||||||||||||||
| Increase to pretax income | 2,567 | 3,050 | 4,922 | 6,416 | |||||||||||||||||||
| Income taxes on items above | (311) | (321) | (604) | (719) | |||||||||||||||||||
| Income taxes attributed to non-U.S. tax ruling | (656) | — | (656) | — | |||||||||||||||||||
| Income taxes | (967) | (321) | (1,260) | (719) | |||||||||||||||||||
| Increase to net earnings | $ | 1,600 | $ | 2,729 | $ | 3,662 | $ | 5,697 |
(a) Includes amortization of purchase price adjustments to Celgene debt.
The reconciliations from GAAP to Non-GAAP were as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| Dollars in millions, except per share data | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||
| Net earnings attributable to BMS | |||||||||||||||||||||||
| GAAP | $ | 2,073 | $ | 1,421 | $ | 4,335 | $ | 2,699 | |||||||||||||||
| Specified items | 1,600 | 2,729 | 3,662 | 5,697 | |||||||||||||||||||
| Non-GAAP | $ | 3,673 | $ | 4,150 | $ | 7,997 | $ | 8,396 | |||||||||||||||
| Weighted-average common shares outstanding – diluted | 2,102 | 2,149 | 2,107 | 2,157 | |||||||||||||||||||
| Diluted earnings per share attributable to BMS | |||||||||||||||||||||||
| GAAP | $ | 0.99 | $ | 0.66 | $ | 2.06 | $ | 1.25 | |||||||||||||||
| Specified items | 0.76 | 1.27 | 1.74 | 2.64 | |||||||||||||||||||
| Non-GAAP | $ | 1.75 | $ | 1.93 | $ | 3.80 | $ | 3.89 |
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
Our net debt position was as follows:
| Dollars in Millions | June 30, 2023 | December 31, 2022 | |||||||||
| Cash and cash equivalents | $ | 8,372 | $ | 9,123 | |||||||
| Marketable debt securities – current | 358 | 130 | |||||||||
| Total cash, cash equivalents and marketable debt securities | 8,730 | 9,253 | |||||||||
| Short-term debt obligations | (3,020) | (4,264) | |||||||||
| Long-term debt | (34,656) | (35,056) | |||||||||
| Net debt position | $ | (28,946) | $ | (30,067) |
We believe that our existing cash, cash equivalents and marketable debt securities, together with our ability to generate cash from operations and our access to short-term and long-term borrowings, are sufficient to satisfy our existing and anticipated cash needs, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, business development, business combinations, asset acquisitions, repurchase of common stock, debt maturities, as well as any debt repurchases through redemptions or tender offers. During the first six months of 2023, our net debt position decreased by $1.1 billion primarily driven by $4.9 billion of cash provided by operations partially offset by $3.5 billion of dividend payments and common stock repurchases.
During the first six months of 2023, $1.9 billion of debt matured and was repaid including $750 million 2.750% Notes, $890 million 3.250% Notes and $239 million 7.150% Notes.
Under our share repurchase program, we repurchased 17 million shares of common stock for $1.2 billion during the six months ended June 30, 2023. The remaining share repurchase capacity under the share repurchase program was $6.0 billion as of June 30, 2023. A $4.0 billion accelerated share repurchase program was announced in July 2023, which is expected to be executed during the third quarter of 2023.
Dividends payments were $2.4 billion during the six months ended June 30, 2023. Dividend paid per common share was $0.57 during the first and second quarters of 2023. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.
Annual capital expenditures are expected to be approximately $1.2 billion and $1.5 billion in 2023 and 2024, respectively. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities, research and development and other facility-related activities.
There were no borrowings outstanding under our $5.0 billion revolving credit facility as of June 30, 2023 and December 31, 2022.
Under our commercial paper program, we may issue a maximum of $5.0 billion unsecured notes that have maturities of not more than 366 days from the date of issuance. There were no commercial paper borrowings outstanding as of June 30, 2023.
Cash Flows
The following is a discussion of cash flow activities:
| Six Months Ended June 30, | |||||||||||
| Dollars in millions | 2023 | 2022 | |||||||||
| Cash flow provided by/(used in): | |||||||||||
| Operating activities | $ | 4,857 | $ | 6,073 | |||||||
| Investing activities | (539) | (194) | |||||||||
| Financing activities | (5,223) | (9,173) |
Operating Activities
The $1.2 billion decrease in cash provided by operating activities compared to 2022 was primarily due to lower cash collections of $1.1 billion (net of rebates and discounts) and higher tax payments ($400 million), partially offset by lower nonrefundable advance payments for research and development services ($400 million).
Investing Activities
The $345 million increase in cash used in investing activities compared to 2022 was primarily due to changes in the amount of marketable debt securities held ($724 million), lower divestitures proceeds ($173 million) partially offset by lower Acquired IPRD payments and other investments (647 million).
Financing Activities
The $4.0 billion decrease in cash used in financing activities compared to 2022 was primarily due to lower repurchases of common stock ($3.8 billion), lower net debt borrowings ($954 million), partially offset by lower proceeds from stock option exercises ($791 million).
Product and Pipeline Developments
Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late-stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. The following are the developments in our marketed products and our late-stage pipeline since the start of the second quarter of 2023:
| Product | Indication | Date | Developments |
| Opdivo | Bladder | July 2023 | Announced results from the sub-study of the Phase III CheckMate -901 trial which showed that Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in overall survival and progression-free survival compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, no new safety concerns have been identified. | ||||||||
| Melanoma | July 2023 | Announced that the CHMP of the EMA has recommended approval of Opdivo as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage IIB or IIC melanoma. The opinion is based on results from the Phase III CheckMate -76K trial. | |||||||||
| NSCLC | June 2023 | Announced EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%. The approval is based on results from the Phase III CheckMate -816 trial. | |||||||||
| Prostate Cancer | July 2023 | Announced that results from the Phase III CheckMate -7DX trial evaluating Opdivo in combination with docetaxel in patients with advanced or metastatic castration-resistant prostate cancer did not meet the primary endpoints of radiographic progressive free survival at final analysis, nor overall survival at an interim analysis. No safety concerns were reported. Based on the recommendation from the data monitoring committee, the Company has decided to discontinue the study. |
| Opdivo+Yervoy | NSCLC | June 2023 | Announced four-year follow-up results from the Phase III CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic NSCLC. |
| Reblozyl | MDS | May 2023 | Announced that the results from the Phase III COMMANDS trial evaluating Reblozyl versus epoetin alfa, an erythropoiesis-stimulating agent (ESA) for the treatment of anemia in adult patients with very low-, low- or intermediate-risk MDS who require red blood cell transfusions and are ESA-naïve, showed that nearly twice as many patients treated with Reblozyl, achieved transfusion independence with concurrent hemoglobin increase versus epoetin alfa, including clinically relevant subgroups. Reblozyl demonstrated a durable response rate with nearly 2.5 years median transfusion independence. |
| Product | Indication | Date | Developments |
| Reblozyl | MDS | May 2023 | Announced that the FDA has accepted the sBLA and the EMA has validated the Type II Variation Application for Reblozyl to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may require red blood cell transfusions. In the U.S., the FDA has granted the application Priority Review and assigned a PDUFA goal date of August 28, 2023. The submissions are based on results from the Phase III COMMANDS trial. In addition, the Japan's Ministry of Health, Labor and Welfare has accepted our New Drug Application (JNDA) for Reblozyl as a treatment of anemia in adult patients with MDS, including myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, based on the MEDALIST trial, a Japan local Phase II trial, and the results of COMMANDS clinical trial. |
| Abecma | Multiple Myeloma | April 2023 | Announced with our alliance partner, 2seventy bio, Inc., that the FDA accepted the sBLA for Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The FDA has assigned a PDUFA goal date of December 16, 2023. The EMA has also validated our Type II variation for the extension of indication for Abecma to treat adult patients with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Validation of the application confirms the submission is complete and begins the procedure and scientific assessment. In addition, the Japan's Ministry of Health, Labour and Welfare has accepted our sNDA for Abecma in patients who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and have experienced disease progression or relapse after the last therapy. The three regulatory applications are based on results from the Phase III KarMMa-3 trial. |
| Breyanzi | Lymphoma | May 2023 | Announced results from the Phase I/II TRANSCEND CLL 004 trial evaluating Breyanzi in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma showing that Breyanzi delivered statistically significant complete response rates in 18.4% of patients in the primary efficacy analysis set. Among patients who achieved a complete response, no disease progression or deaths were observed, with median duration of response not reached. | ||||||||
| May 2023 | Announced EC approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The approval is based on results from the Phase III TRANSFORM trial. | ||||||||||
| May 2023 | Announced results from the Phase II TRANSCEND FL trial evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma (FL) and the Phase I TRANSCEND NHL trial evaluating Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma (MCL) showing both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and meaningful responses in relapsed or refractory FL and MCL. |
| Camzyos | Obstructive HCM | June 2023 | Announced EC approval of Camzyos for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM in adult patients. The approval is based on results from the Phase III EXPLORER-HCM and VALOR-HCM trials. | ||||||||
| June 2023 | Announced FDA approval of the sNDA to add positive data from the Phase III VALOR-HCM trial to the U.S. Prescribing Information for Camzyos. Data added to the label showed that treatment with Camzyos significantly reduced the composite endpoint of guideline-based eligibility for septal reduction therapy (SRT) at Week 16 or the decision to proceed with SRT to or at Week 16. |
| milvexian | Thrombosis | May 2023 | Announced with our alliance partner Janssen Pharmaceuticals Inc., that all three prospective indications for milvexian, an investigational oral factor XIa inhibitor, have been granted Fast Track Designation by the FDA. The designations cover all three indication-seeking studies within the Phase III Librexia development program: Librexia STROKE, Librexia ACS and Librexia AF, which are all dosing patients. |
| Product | Indication | Date | Developments |
| repotrectinib | NSCLC | May 2023 | Announced that the FDA accepted the NDA for repotrectinib, a next-generation tyrosine kinase inhibitor for the treatment of patients with ROS1-positive locally advanced or metastatic NSCLC. The application is based on the Phase I/II TRIDENT-1 trial. The FDA granted the application Priority Review and assigned a PDUFA goal date of November 27, 2023. |
Critical Accounting Policies
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to "Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our 2022 Form 10-K. There have been no material changes to our critical accounting policies during the six months ended June 30, 2023. For information regarding the impact of recently adopted accounting standards, refer to "Item 1. Financial Statements—Note 1. Basis of Presentation and Recently Issued Accounting Standards."
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as "should," "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on our current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions of Celgene, MyoKardia and Turning Point, the impact of the COVID-19 pandemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug prices, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. This Quarterly Report on Form 10-Q, our 2022 Form 10-K, particularly under the section "Item 1A. Risk Factors," and our other filings with the SEC, include additional information on the factors that we believe could cause actual results to differ materially from any forward-looking statement.
Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report on Form 10-Q not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this Quarterly Report on Form 10-Q.
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