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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________
FORM 8-K
_____________________________
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 31, 2024
_____________________________
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
_____________________________
| | | | | | | | |
| Delaware | 001-01136 | 22-0790350 |
(State or other jurisdiction of
incorporation or organization) | (Commission File Number) | (I.R.S Employer
Identification No.) |
Route 206 & Province Line Road, Princeton, New Jersey 08543
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, including area code): (609) 252-4621
_____________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.10 Par Value | BMY | New York Stock Exchange |
| 1.000% Notes due 2025 | BMY25 | New York Stock Exchange |
| 1.750% Notes due 2035 | BMY35 | New York Stock Exchange |
| Celgene Contingent Value Rights | CELG RT | New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| | |
| Item 2.02 Results of Operations and Financial Condition. |
On October 31, 2024, Bristol-Myers Squibb Company (the “Company”) issued a press release (the “Earnings Press Release”) announcing its financial results for the third quarter of 2024. A copy of the Earnings Press Release is furnished pursuant to this Item 2.02 as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein in its entirety.
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| Item 7.01 Regulation FD Disclosure. |
On October 31, 2024, the Company posted on its website at www.bms.com a presentation (the “Bristol Myers Presentation”) on certain financial and operating initiatives available for viewing during the Company’s conference call and webcast announcing its financial results for the third quarter of 2024 at 8:00 a.m. Eastern time. A copy of the Bristol Myers Presentation is furnished pursuant to this Item 7.01 as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein in its entirety. The Earnings Press Release and the Bristol Myers Presentation include references to non-GAAP financial information. Reconciliations between the non-GAAP financial measures and the comparable GAAP financial measures and the reasons for the presentation of such non-GAAP financial measures, are available in the Earnings Press Release which is included as Exhibit 99.1 hereto. The Bristol Myers Presentation should be read in conjunction with the Earnings Press Release. The Company reserves the right to discontinue availability of the Bristol Myers Presentation from its website at any time.
Pursuant to General Instruction B.2. to Form 8-K, the information set forth in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be incorporated by reference into future filings by the Company under the Exchange Act or under the Securities Act of 1933, as amended, except to the extent specifically provided in any such filing. Additionally, the submission of the information set forth in this Item 7.01 is not deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely by Regulation FD.
| | |
| Item 9.01 Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are furnished as part of this Current Report on Form 8-K:
| | | | | | | | |
| | |
Exhibit
No. | | Description |
| |
| 99.1 | | |
| 99.2 | | |
| 104 | | The cover page from this Current Report on Form 8-K formatted in Inline XBRL (included as Exhibit 101). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | | | | | | | | | | | | | | | | |
| | BRISTOL-MYERS SQUIBB COMPANY | |
| | | |
Dated: October 31, 2024 | | By: | | /s/ Amy Fallone | |
| | Name: | | Amy Fallone | |
| | Title: | | Corporate Secretary | |
| | | | | |
Bristol Myers Squibb Reports Third Quarter Financial Results for 2024
Performance Reflects Continued Focus on Near-Term Execution and Building a Foundation for Long-Term Sustainable Growth
•Third Quarter Revenues were $11.9 Billion, increasing 8% (+10% Adjusting for Foreign Exchange)
•Growth Portfolio Revenues were $5.8 Billion, increasing 18% (+20% Adjusting for Foreign Exchange)
•GAAP EPS was $0.60 and Non-GAAP EPS was $1.80; Includes Net Impact of $(0.09) Per Share for GAAP EPS and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
•Achieved U.S. Approval of Cobenfy, the First New Pharmacological Approach to Treat Schizophrenia in Decades
•Raising 2024 Revenue Guidance to Approximately +5% (+6% Adjusting for Foreign Exchange), Non-GAAP EPS Range Increased to $0.75 to $0.95
(PRINCETON, N.J., October 31, 2024) – Bristol Myers Squibb (NYSE: BMY) today reports results for the third quarter of 2024.
“We made important strides in the third quarter with the landmark U.S. approval of Cobenfy in schizophrenia, continued sales momentum, strong cash flow generation and key pipeline achievements,” said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. “We're focused on closing out the year with strong execution as we deliver on our Growth Portfolio, prioritize high-growth opportunities and continue delivering transformational results for patients."
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Third Quarter | | |
$ in millions, except per share amounts | 2024 | | 2023 | | Change | | Change Excl. F/X** | | | | | | | | |
| Total Revenues | $11,892 | | | $10,966 | | | 8 | % | | 10 | % | | | | | | | | |
Earnings Per Share — GAAP* | 0.60 | | | 0.93 | | | (35) | % | | N/A | | | | | | | | |
Earnings Per Share — Non-GAAP* ** | 1.80 | | | 2.00 | | | (10) | % | | N/A | | | | | | | | |
| Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share | (0.09) | | | (0.03) | | | N/A | | N/A | | | | | | | | |
*GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".
THIRD QUARTER RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
•Bristol Myers Squibb posted third quarter revenues of $11.9 billion, an increase of 8%, or 10% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and Eliquis, partially offset by generic erosion of Sprycel due to the loss of exclusivity.
•U.S. revenues increased 9% to $8.2 billion, and International revenues increased 7% to $3.7 billion, primarily due to the Growth Portfolio and higher demand for Eliquis, partially offset by generic erosion of Sprycel due to the loss of exclusivity. The negative impact from foreign exchange on International revenues was 4%.
•On a GAAP basis, gross margin decreased from 77.1% to 75.1%, and on a non-GAAP basis decreased from 77.3% to 76.0%, primarily due to product mix.
•On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $2.0 billion.
•On a GAAP basis, research and development expenses increased 6%, and 8% on a non-GAAP basis, to $2.4 billion, primarily due to recent acquisitions.
•On a GAAP and non-GAAP basis, Acquired IPRD increased to $262 million from $80 million. On a GAAP and non-GAAP basis, licensing income was $25 million compared to $12 million.
•On a GAAP basis, amortization of acquired intangible assets increased 7% to $2.4 billion, primarily due to the RayzeBio acquisition in 2024 and approval of Augtyro in the fourth quarter of 2023.
•On a GAAP basis, the effective tax rate increased from 9.5% to 27.5%, and on a non-GAAP basis, increased from 11.6% to 18.5%, primarily due to jurisdictional earnings mix and adjustments in 2023 to reflect IRS income tax guidance issued in 2023 regarding deductibility of certain non-U.S. research and development expenses.
•On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $1.2 billion, or $0.60 per share, during the third quarter of 2024 compared to $1.9 billion, or $0.93 per share, for the same period a year ago. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.7 billion, or $1.80 per share, during the third quarter of 2024 compared to $4.1 billion, or $2.00 per share, for the same period a year ago. In addition to the items above, GAAP and non-GAAP earnings per share were impacted by higher interest expense.
THIRD QUARTER PRODUCT REVENUE HIGHLIGHTS
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ($ amounts in millions) | | Quarter Ended September 30, 2024 | | % Change from Quarter Ended September 30, 2023 | | % Change from Quarter Ended September 30, 2023 Ex-F/X** |
| | | U.S. | | Int'l (c) | | WW(d) | | U.S. | | Int'l(c) | | WW(d) | | Int'l(c) | | WW(d) |
Growth Portfolio | | | | | | | | | | | | | | | | |
| Opdivo | | $ | 1,366 | | | $ | 994 | | | $ | 2,360 | | | 2 | % | | 7 | % | | 4 | % | | 16 | % | | 7 | % |
| Orencia | | 706 | | | 230 | | | 936 | | | — | % | | 6 | % | | 1 | % | | 13 | % | | 3 | % |
| Yervoy | | 399 | | | 243 | | | 642 | | | 11 | % | | 10 | % | | 11 | % | | 17 | % | | 13 | % |
| Reblozyl | | 358 | | | 89 | | | 447 | | | 79 | % | | 85 | % | | 80 | % | | 90 | % | | 81 | % |
| Opdualag | | 216 | | | 17 | | | 233 | | | 33 | % | | >200% | | 40 | % | | >200% | | 40 | % |
| Abecma | | 77 | | | 47 | | | 124 | | | 12 | % | | 96 | % | | 33 | % | | 100 | % | | 34 | % |
| Zeposia | | 105 | | | 42 | | | 147 | | | 11 | % | | 50 | % | | 20 | % | | 46 | % | | 19 | % |
| Breyanzi | | 173 | | | 51 | | | 224 | | | 125 | % | | >200% | | 143 | % | | >200% | | 143 | % |
| Camzyos | | 135 | | | 21 | | | 156 | | | 101 | % | | >200% | | 129 | % | | >200% | | 129 | % |
| Sotyktu | | 51 | | | 15 | | | 66 | | | (18) | % | | >200% | | — | % | | >200% | | — | % |
| Augtyro | | 10 | | | — | | | 10 | | | N/A | | N/A | | N/A | | N/A | | N/A |
| Krazati | | 32 | | | 2 | | | 34 | | | N/A | | N/A | | N/A | | N/A | | N/A |
Other Growth Products(a) | | 172 | | | 261 | | | 433 | | | 15 | % | | 61 | % | | 39 | % | | 64 | % | | 41 | % |
Total Growth Portfolio | | 3,800 | | | 2,012 | | | 5,812 | | | 15 | % | | 22 | % | | 18 | % | | 29 | % | | 20 | % |
Legacy Portfolio | | | | | | | | | | | | | | | | |
| Eliquis | | 2,045 | | | 957 | | | 3,002 | | | 15 | % | | 3 | % | | 11 | % | | 2 | % | | 11 | % |
| Revlimid | | 1,212 | | | 200 | | | 1,412 | | | — | % | | (9) | % | | (1) | % | | (6) | % | | (1) | % |
| Pomalyst/Imnovid | | 697 | | | 201 | | | 898 | | | 15 | % | | (24) | % | | 3 | % | | (24) | % | | 3 | % |
| Sprycel | | 225 | | | 65 | | | 290 | | | (44) | % | | (45) | % | | (44) | % | | (42) | % | | (43) | % |
| Abraxane | | 151 | | | 102 | | | 253 | | | (15) | % | | 24 | % | | (3) | % | | 37 | % | | 1 | % |
Other Legacy Products(b) | | 102 | | | 123 | | | 225 | | | 17 | % | | (18) | % | | (5) | % | | (19) | % | | (5) | % |
Total Legacy Portfolio | | 4,432 | | | 1,648 | | | 6,080 | | | 4 | % | | (7) | % | | 1 | % | | (6) | % | | 1 | % |
| Total Revenues | | $ | 8,232 | | | $ | 3,660 | | | $ | 11,892 | | | 9 | % | | 7 | % | | 8 | % | | 11 | % | | 10 | % |
** See "Use of Non-GAAP Financial Information".
(a) Includes Nulojix, Onureg, Inrebic, Empliciti and royalty revenue.
(b) Includes other mature brands.
(c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d) Worldwide (WW) includes U.S. and International (Int'l).
THIRD QUARTER PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $5.8 billion compared to $4.9 billion in the prior year period, representing growth of 18% on a reported basis or 20% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Reblozyl, Breyanzi, Camzyos and Opdualag.
Legacy Portfolio
Revenues for the Legacy Portfolio in the third quarter were $6.1 billion compared to $6.0 billion in the prior year period, representing growth of 1% on a reported basis and when adjusted for foreign
exchange impacts. Legacy Portfolio revenues were primarily driven by higher demand for Eliquis, partially offset by a decline in demand for Sprycel due to generic erosion.
PRODUCT AND PIPELINE UPDATE
Bristol Myers Squibb recently achieved several important clinical and regulatory milestones, including the U.S. approval of Cobenfy and the disclosure of long-term cardiovascular and oncology data that underscore the strength of the company's science.
With Cobenfy, the company is re-establishing its presence in neuroscience and introducing the first new pharmacological approach to treat schizophrenia in decades.
Today, the company is providing an update on data from two Phase 3 oncology trials, CheckMate -8HW and CheckMate -901. Please see the table below for more information.
Neuroscience
| | | | | | | | |
| Category | Asset | Milestone |
| Regulatory | CobenfyTM (xanomeline and trospium chloride) | The U.S. Food and Drug Administration (FDA) approved Cobenfy, previously referred to as KarXT, for the treatment of schizophrenia in adults, with a mechanism of action distinct from current therapies. The approval is based on data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of Cobenfy for up to one year. |
Cardiovascular | | | | | | | | |
| Category | Asset | Milestone |
| Clinical & Research | Camzyos® (mavacamten) | Long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study evaluating Camzyos in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy demonstrated that patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years of continuous treatment.
Patients experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes. The safety profile of Camzyos for up to 3.5 years remained consistent with the established safety profile and no new safety signals were identified. |
Oncology
| | | | | | | | |
| Category | Asset | Milestone |
Regulatory | Opdivo® (nivolumab) | The FDA approved Opdivo for the treatment of adult patients with resectable (tumors ≥ 4cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery. The approval is based on results from the Phase 3 randomized CheckMate -77T trial. |
| Opdivo + Yervoy® (ipilimumab) | The FDA accepted the supplemental Biologics License Application for Opdivo plus Yervoy as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma. The acceptance is based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a Prescription Drug User Fee Act goal date of April 21, 2025. |
| Clinical & Research | Opdivo | The Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to Opdivo monotherapy across all lines of therapy as a treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review at a pre-specified interim analysis. Previously, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy. Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Opdivo monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival (OS). The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified. |
| Opdivo | The Phase 3 CheckMate -901 trial evaluating Opdivo plus Yervoy versus standard-of-care non-cisplatin-based chemotherapy in patients with unresectable or metastatic urothelial carcinoma (UC) who are ineligible for cisplatin-based chemotherapy did not meet its primary endpoint of OS. The safety profile for Opdivo and Yervoy was consistent with previously reported data, with no new safety signals identified. Opdivo has previously shown clinical benefit across various stages of UC. These results do not impact those data or approved indications. |
| nivolumab + relatlimab high dose | The company announced plans to initiate a Phase 3 trial evaluating the fixed-dose combination of nivolumab and high-dose relatlimab plus chemotherapy as a first-line treatment for stage IV or recurrent non-squamous NSCLC with tumor cell PD-L1 expression of 1 to 49%. The decision was supported by findings from the Phase 2 RELATIVITY-104 trial. |
| Opdivo + Yervoy | 10-year follow-up data from the Phase 3 CheckMate -067 trial showed continued durable improvement in survival with first-line Opdivo plus Yervoy therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma. With a minimum follow up of 10 years, median OS was 71.9 months with Opdivo plus Yervoy, the longest reported median OS in a Phase 3 advanced melanoma trial. |
Hematology | | | | | | | | |
| Category | Asset | Milestone |
| Regulatory | Breyanzi® (lisocabtagene maraleucel) | The European Medicines Agency (EMA) validated the Type II variation application to expand the indication for Breyanzi to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The application is supported by data from the Phase 2 TRANSCEND FL study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
In addition, Japan's Ministry of Health, Labour and Welfare approved the supplemental New Drug Application for Breyanzi for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy. |
Immunology
| | | | | | | | |
| Category | Asset | Milestone |
| Clinical & Research | Zeposia® (ozanimod) | Data from the Phase 3 DAYBREAK trial demonstrated that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia for relapsing forms of multiple sclerosis.
A separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events, with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia. |
Financial Guidance
Bristol Myers Squibb is raising its 2024 line-item guidance as noted below.
2024 Line-Item Guidance
| | | | | | | | |
| Non-GAAP2
|
| July
(Prior) | October
(Updated) |
| Total Revenues | Upper end of low single-digit range | ~5% increase |
Total Revenues (excl. F/X) | Upper end of low single-digit range | ~6% increase |
| Gross Margin % | Between ~74% and ~75% | Between ~74.5% and ~75% |
Operating Expenses1 | Low single-digit increase | ~4% to ~5% increase |
| Other income/(expense) | ~($50M) | ~$125M |
| Effective tax rate | ~66% | ~60% |
| Diluted EPS | $0.60 - $0.90 | $0.75 - $0.95 |
1 Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets.
2 See "Use of Non-GAAP Financial Information."
The 2024 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the "Investors" section. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.
A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."
Environmental, Social & Governance (ESG)
As a leading biopharmaceutical company, Bristol Myers Squibb's passion for making an impact extends beyond the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. To learn more about our priorities and goals, please visit our latest ESG report.
Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, October 31, 2024, at 8:00 a.m. ET, during which company executives will review quarterly financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.
Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.
A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on October 31, 2024, through 11:30 a.m. ET on November 14, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 9624003.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X (formerly Twitter), YouTube, Facebook, and Instagram.
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For more information, contact:
Media Relations: media@bms.com
Investor Relations: investor.relations@bms.com
Use of Non-GAAP Financial Information
In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company's baseline performance, supplement or enhance management's, analysts' and investors' overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expenses excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expenses excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding
certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results.
This earnings release and the accompanying tables also provide certain revenues and expenses, as well as non-GAAP measures, excluding the impact of foreign exchange ("Ex-Fx"). 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. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results.
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 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 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, unwinding of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and 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 and release of income tax reserves relating to the Celgene acquisition.
Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are 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 financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at www.bms.com. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and earnings per share amounts presented are calculated from the underlying amounts.
A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.
Website Information
We routinely post important information for investors on our website, BMS.com, in the “Investors” section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, Securities and Exchange Commission ("SEC") filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.
Cautionary Statement Regarding Forward-Looking Statements
This earnings release and the related attachments (as well as the oral statements made with respect to information contained in this release and the attachments) contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the company’s 2024 financial guidance, plans and strategy, including its business development and capital allocation strategy, ESG priorities and goals, anticipated developments in the company’s pipeline, expectations with respect to the company’s future market position and the projected benefits of the company’s alliances and other business development activities. These statements may be identified by the fact that 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, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed and there is no assurance that the company will achieve its financial guidance and long-term targets, that the company’s future clinical studies will support the data described in this release, that the company’s product candidates will receive necessary clinical and manufacturing regulatory approvals, that the company’s pipeline products will prove to be commercially successful, that clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes, or that contractual milestones will be achieved.
Forward-looking statements are based on current expectations and projections about the company’s 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, that are difficult to predict, may be beyond the company’s control and could cause the company’s future financial results, goals, plans and
objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; market actions taken by private and government payers to manage drug utilization and contain costs; the company’s ability to retain patent exclusivity of certain products; regulatory changes that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; the company’s ability to obtain and maintain regulatory approval for its product candidates; the company’s ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the possibility of difficulties and delays in product introduction and commercialization; increasing industry competition; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; failure to complete, or delays in completing, collaborations, acquisitions, divestitures, alliances and other portfolio actions and the failure to achieve anticipated benefits from such transactions and actions; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions or investigations; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; the impact of counterfeit or unregistered versions of the company’s products and from stolen products; product label changes or other measures that could reduce the market acceptance for the company's products and result in declining sales; safety or efficacy concerns regarding the company’s products or any product in the same class as the company’s products; the risk of cyber-attacks on the company’s information systems or products and unauthorized disclosure of trade secrets or other confidential data; the company’s ability to execute its financial, strategic and operational plans; the company’s dependency on several key products; any decline in the company’s future royalty streams; the company’s ability to attract and retain key personnel; the impact of the company’s significant indebtedness; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; risks relating to the use of social media platforms; the impact of our exclusive forum provision in our by-laws for certain lawsuits on our stockholders’ ability to obtain a judicial forum that they find favorable for such lawsuits; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics.
Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the company’s business and market, particularly those identified in the cautionary statement and risk factors discussion in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by the company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
(Unaudited, dollars and shares in millions except per share data)
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | | | | | | |
| Net product sales | $ | 11,483 | | | $ | 10,645 | | | $ | 34,967 | | | $ | 32,610 | |
| Alliance and other revenues | 409 | | | 321 | | | 991 | | | 919 | |
| Total Revenues | 11,892 | | | 10,966 | | | 35,958 | | | 33,529 | |
| | | | | | | |
Cost of products sold(a) | 2,957 | | | 2,506 | | | 9,156 | | | 7,948 | |
| Marketing, selling and administrative | 1,983 | | | 2,003 | | | 6,278 | | | 5,699 | |
| Research and development | 2,374 | | | 2,242 | | | 7,968 | | | 6,821 | |
| Acquired IPRD | 262 | | | 80 | | | 13,343 | | | 313 | |
| Amortization of acquired intangible assets | 2,406 | | | 2,256 | | | 7,179 | | | 6,769 | |
| Other (income)/expense, net | 234 | | | (258) | | | 588 | | | (787) | |
| Total Expenses | 10,216 | | | 8,829 | | | 44,512 | | | 26,763 | |
| | | | | | | |
(Loss)/Earnings Before Income Taxes | 1,676 | | | 2,137 | | | (8,554) | | | 6,766 | |
| Provision for Income Taxes | 461 | | | 203 | | | 455 | | | 488 | |
Net (Loss)/Earnings | 1,215 | | | 1,934 | | | (9,009) | | | 6,278 | |
| Noncontrolling Interest | 4 | | | 6 | | | 11 | | | 15 | |
Net (Loss)/Earnings Attributable to BMS | $ | 1,211 | | | $ | 1,928 | | | $ | (9,020) | | | $ | 6,263 | |
| | | | | | | |
| Weighted-Average Common Shares Outstanding: | | | | | | | |
| Basic | 2,028 | | | 2,057 | | | 2,026 | | | 2,083 | |
| Diluted | 2,031 | | | 2,064 | | | 2,026 | | | 2,093 | |
| | | | | | | |
(Loss)/Earnings per Common Share: | | | | | | | |
| Basic | $ | 0.60 | | | $ | 0.94 | | | $ | (4.45) | | | $ | 3.01 | |
| Diluted | 0.60 | | | 0.93 | | | (4.45) | | | 2.99 | |
| | | | | | | |
| Other (income)/expense, net | | | | | | | |
Interest expense(b) | $ | 505 | | | $ | 280 | | | $ | 1,451 | | | $ | 850 | |
| Royalty and licensing income | (180) | | | (365) | | | (532) | | | (1,068) | |
| Royalty income - divestitures | (284) | | | (217) | | | (820) | | | (623) | |
Equity investment (gains)/losses | (12) | | | — | | | (221) | | | 213 | |
| Integration expenses | 69 | | | 54 | | | 214 | | | 180 | |
| | | | | | | |
| | | | | | | |
Intangible asset impairments | 47 | | | 29 | | | 47 | | | 29 | |
| Litigation and other settlements | — | | | (61) | | | 71 | | | (393) | |
| Investment income | (94) | | | (107) | | | (364) | | | (304) | |
| Provision for restructuring | 78 | | | 141 | | | 558 | | | 321 | |
| Acquisition expense | — | | | — | | | 50 | | | — | |
| Other | 105 | | | (12) | | | 134 | | | 8 | |
| Other (income)/expense, net | $ | 234 | | | $ | (258) | | | $ | 588 | | | $ | (787) | |
(a) Excludes amortization of acquired intangible assets.
(b) Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited, dollars in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | Change vs. 2023 |
| | | 2024 | | 2023 | | GAAP | | Excl. F/X** |
| | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) |
Growth Portfolio | | | | | | | | | | | | | | | | | | | | | | | | |
| Opdivo | | $ | 1,366 | | | $ | 994 | | | $ | 2,360 | | | $ | 1,343 | | | $ | 932 | | | $ | 2,275 | | | 2 | % | | 7 | % | | 4 | % | | 2 | % | | 16 | % | | 7 | % |
| Orencia | | 706 | | | 230 | | | 936 | | | 708 | | | 217 | | | 925 | | | — | % | | 6 | % | | 1 | % | | — | % | | 13 | % | | 3 | % |
| Yervoy | | 399 | | | 243 | | | 642 | | | 359 | | | 220 | | | 579 | | | 11 | % | | 10 | % | | 11 | % | | 11 | % | | 17 | % | | 13 | % |
| Reblozyl | | 358 | | | 89 | | | 447 | | | 200 | | | 48 | | | 248 | | | 79 | % | | 85 | % | | 80 | % | | 79 | % | | 90 | % | | 81 | % |
| Opdualag | | 216 | | | 17 | | | 233 | | | 162 | | | 4 | | | 166 | | | 33 | % | | >200% | | 40 | % | | 33 | % | | >200% | | 40 | % |
| Abecma | | 77 | | | 47 | | | 124 | | | 69 | | | 24 | | | 93 | | | 12 | % | | 96 | % | | 33 | % | | 12 | % | | 100 | % | | 34 | % |
| Zeposia | | 105 | | | 42 | | | 147 | | | 95 | | | 28 | | | 123 | | | 11 | % | | 50 | % | | 20 | % | | 11 | % | | 46 | % | | 19 | % |
| Breyanzi | | 173 | | | 51 | | | 224 | | | 77 | | | 15 | | | 92 | | | 125 | % | | >200% | | 143 | % | | 125 | % | | >200% | | 143 | % |
| Camzyos | | 135 | | | 21 | | | 156 | | | 67 | | | 1 | | | 68 | | | 101 | % | | >200% | | 129 | % | | 101 | % | | >200% | | 129 | % |
| Sotyktu | | 51 | | | 15 | | | 66 | | | 62 | | | 4 | | | 66 | | | (18) | % | | >200% | | — | % | | (18) | % | | >200% | | — | % |
| Augtyro | | 10 | | | — | | | 10 | | | — | | | — | | | — | | | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
| Krazati | | 32 | | | 2 | | | 34 | | | — | | | — | | | — | | | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
Other Growth Products(a) | | 172 | | | 261 | | | 433 | | | 149 | | | 162 | | | 311 | | | 15 | % | | 61 | % | | 39 | % | | 15 | % | | 64 | % | | 41 | % |
Total Growth Portfolio | | 3,800 | | | 2,012 | | | 5,812 | | | 3,291 | | | 1,655 | | | 4,946 | | | 15 | % | | 22 | % | | 18 | % | | 15 | % | | 29 | % | | 20 | % |
Legacy Portfolio | | | | | | | | | | | | | | | | | | | | | | | | |
| Eliquis | | 2,045 | | | 957 | | | 3,002 | | | 1,772 | | | 933 | | | 2,705 | | | 15 | % | | 3 | % | | 11 | % | | 15 | % | | 2 | % | | 11 | % |
| Revlimid | | 1,212 | | | 200 | | | 1,412 | | | 1,209 | | | 220 | | | 1,429 | | | — | % | | (9) | % | | (1) | % | | — | % | | (6) | % | | (1) | % |
| Pomalyst/Imnovid | | 697 | | | 201 | | | 898 | | | 606 | | | 266 | | | 872 | | | 15 | % | | (24) | % | | 3 | % | | 15 | % | | (24) | % | | 3 | % |
| Sprycel | | 225 | | | 65 | | | 290 | | | 399 | | | 118 | | | 517 | | | (44) | % | | (45) | % | | (44) | % | | (44) | % | | (42) | % | | (43) | % |
| Abraxane | | 151 | | | 102 | | | 253 | | | 178 | | | 82 | | | 260 | | | (15) | % | | 24 | % | | (3) | % | | (15) | % | | 37 | % | | 1 | % |
Other Legacy Products(b) | | 102 | | | 123 | | | 225 | | | 87 | | | 150 | | | 237 | | | 17 | % | | (18) | % | | (5) | % | | 17 | % | | (19) | % | | (5) | % |
Total Legacy Portfolio | | 4,432 | | | 1,648 | | | 6,080 | | | 4,251 | | | 1,769 | | | 6,020 | | | 4 | % | | (7) | % | | 1 | % | | 4 | % | | (6) | % | | 1 | % |
| Total Revenues | | $ | 8,232 | | | $ | 3,660 | | | $ | 11,892 | | | $ | 7,542 | | | $ | 3,424 | | | $ | 10,966 | | | 9 | % | | 7 | % | | 8 | % | | 9 | % | | 11 | % | | 10 | % |
** See "Use of Non-GAAP Financial Information".
(a) Includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
(b) Includes other mature brands.
(c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d) Worldwide (WW) includes U.S. and International (Int'l).
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited, dollars in millions)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | Change vs. 2023 |
| | | 2024 | | 2023 | | GAAP | | Excl. F/X** |
| | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) | | U.S. | | Int'l (c) | | WW (d) |
Growth Portfolio | | | | | | | | | | | | | | | | | | | | | | | | |
| Opdivo | | $ | 3,927 | | | $ | 2,898 | | | $ | 6,825 | | | $ | 3,845 | | | $ | 2,777 | | | $ | 6,622 | | | 2 | % | | 4 | % | | 3 | % | | 2 | % | | 14 | % | | 7 | % |
| Orencia | | 2,020 | | | 662 | | | 2,682 | | | 1,954 | | | 662 | | | 2,616 | | | 3 | % | | — | % | | 3 | % | | 3 | % | | 8 | % | | 5 | % |
| Yervoy | | 1,171 | | | 684 | | | 1,855 | | | 1,039 | | | 633 | | | 1,672 | | | 13 | % | | 8 | % | | 11 | % | | 13 | % | | 15 | % | | 14 | % |
| Reblozyl | | 999 | | | 227 | | | 1,226 | | | 534 | | | 154 | | | 688 | | | 87 | % | | 47 | % | | 78 | % | | 87 | % | | 50 | % | | 79 | % |
| Opdualag | | 637 | | | 37 | | | 674 | | | 429 | | | 8 | | | 437 | | | 48 | % | | >200% | | 54 | % | | 48 | % | | >200% | | 54 | % |
| Abecma | | 183 | | | 118 | | | 301 | | | 302 | | | 70 | | | 372 | | | (39) | % | | 69 | % | | (19) | % | | (39) | % | | 74 | % | | (18) | % |
| Zeposia | | 288 | | | 120 | | | 408 | | | 219 | | | 82 | | | 301 | | | 32 | % | | 46 | % | | 36 | % | | 32 | % | | 45 | % | | 35 | % |
| Breyanzi | | 382 | | | 102 | | | 484 | | | 218 | | | 45 | | | 263 | | | 75 | % | | 127 | % | | 84 | % | | 75 | % | | 131 | % | | 85 | % |
| Camzyos | | 342 | | | 37 | | | 379 | | | 142 | | | 1 | | | 143 | | | 141 | % | | >200% | | 165 | % | | 141 | % | | >200% | | 165 | % |
| Sotyktu | | 126 | | | 37 | | | 163 | | | 101 | | | 6 | | | 107 | | | 25 | % | | >200% | | 52 | % | | 25 | % | | >200% | | 54 | % |
| Augtyro | | 23 | | | — | | | 23 | | | — | | | — | | | — | | | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
| Krazati | | 82 | | | 5 | | | 87 | | | — | | | — | | | — | | | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
Other Growth Products(a) | | 488 | | | 605 | | | 1,093 | | | 455 | | | 431 | | | 886 | | | 7 | % | | 40 | % | | 23 | % | | 7 | % | | 44 | % | | 25 | % |
Total Growth Portfolio | | 10,668 | | | 5,532 | | | 16,200 | | | 9,238 | | | 4,869 | | | 14,107 | | | 15 | % | | 14 | % | | 15 | % | | 15 | % | | 22 | % | | 18 | % |
Legacy Portfolio | | | | | | | | | | | | | | | | | | | | | | | | |
| Eliquis | | 7,410 | | | 2,728 | | | 10,138 | | | 6,610 | | | 2,722 | | | 9,332 | | | 12 | % | | — | % | | 9 | % | | 12 | % | | 1 | % | | 9 | % |
| Revlimid | | 3,830 | | | 604 | | | 4,434 | | | 3,951 | | | 696 | | | 4,647 | | | (3) | % | | (13) | % | | (5) | % | | (3) | % | | (9) | % | | (4) | % |
| Pomalyst/Imnovid | | 2,010 | | | 712 | | | 2,722 | | | 1,712 | | | 839 | | | 2,551 | | | 17 | % | | (15) | % | | 7 | % | | 17 | % | | (14) | % | | 7 | % |
| Sprycel | | 848 | | | 240 | | | 1,088 | | | 1,011 | | | 393 | | | 1,404 | | | (16) | % | | (39) | % | | (23) | % | | (16) | % | | (35) | % | | (21) | % |
| Abraxane | | 450 | | | 251 | | | 701 | | | 526 | | | 231 | | | 757 | | | (14) | % | | 9 | % | | (7) | % | | (14) | % | | 24 | % | | (3) | % |
Other Legacy Products(b) | | 293 | | | 382 | | | 675 | | | 250 | | | 481 | | | 731 | | | 17 | % | | (21) | % | | (8) | % | | 17 | % | | (19) | % | | (6) | % |
Total Legacy Portfolio | | 14,841 | | | 4,917 | | | 19,758 | | | 14,060 | | | 5,362 | | | 19,422 | | | 6 | % | | (8) | % | | 2 | % | | 6 | % | | (6) | % | | 2 | % |
| Total Revenues | | $ | 25,509 | | | $ | 10,449 | | | $ | 35,958 | | | $ | 23,298 | | | $ | 10,231 | | | $ | 33,529 | | | 9 | % | | 2 | % | | 7 | % | | 9 | % | | 7 | % | | 9 | % |
** See "Use of Non-GAAP Financial Information".
(a) Includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
(b) Includes other mature brands.
(c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d) Worldwide (WW) includes U.S. and International (Int'l).
BRISTOL-MYERS SQUIBB COMPANY
INTERNATIONAL REVENUES(a)
FOREIGN EXCHANGE IMPACT (%)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2024 | | Nine Months Ended September 30, 2024 |
| Revenue Change % | | F/X % Favorable/ (Unfavorable) ** | | Revenue Change % Ex- F/X ** | | Revenue Change % | | F/X % Favorable/ (Unfavorable) ** | | Revenue Change % Ex- F/X ** |
Growth Portfolio | | | | | | | | | | | |
| Opdivo | 7% | | (9)% | | 16% | | 4% | | (10)% | | 14% |
| Orencia | 6% | | (7)% | | 13% | | —% | | (8)% | | 8% |
| Yervoy | 10% | | (7)% | | 17% | | 8% | | (7)% | | 15% |
| Reblozyl | 85% | | (5)% | | 90% | | 47% | | (3)% | | 50% |
| Opdualag | >200% | | NM | | >200% | | >200% | | NM | | >200% |
| Abecma | 96% | | (4)% | | 100% | | 69% | | (5)% | | 74% |
| Zeposia | 50% | | 4% | | 46% | | 46% | | 1% | | 45% |
| Breyanzi | >200% | | NM | | >200% | | 127% | | (4)% | | 131% |
| Camzyos | >200% | | NM | | >200% | | >200% | | NM | | >200% |
| Sotyktu | >200% | | NM | | >200% | | >200% | | NM | | >200% |
| Augtyro | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
| Krazati | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
Other Growth Products(b) | 61% | | (3)% | | 64% | | 40% | | (4)% | | 44% |
Total Growth Portfolio | 22% | | (7)% | | 29% | | 14% | | (8)% | | 22% |
Legacy Portfolio | | | | | | | | | | | |
| Eliquis | 3% | | 1% | | 2% | | —% | | (1)% | | 1% |
| Revlimid | (9)% | | (3)% | | (6)% | | (13)% | | (4)% | | (9)% |
| Pomalyst/Imnovid | (24)% | | —% | | (24)% | | (15)% | | (1)% | | (14)% |
| Sprycel | (45)% | | (3)% | | (42)% | | (39)% | | (4)% | | (35)% |
| Abraxane | 24% | | (13)% | | 37% | | 9% | | (15)% | | 24% |
Other Legacy Products(c) | (18)% | | 1% | | (19)% | | (21)% | | (2)% | | (19)% |
Total Legacy Portfolio | (7)% | | (1)% | | (6)% | | (8)% | | (2)% | | (6)% |
| Total Revenues | 7% | | (4)% | | 11% | | 2% | | (5)% | | 7% |
NM Not meaningful
** See "Use of Non-GAAP Financial Information".
(a) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(b) Includes Onureg, Nulojix, Empliciti and royalty revenues.
(c) Includes other mature brands.
BRISTOL-MYERS SQUIBB COMPANY
WORLDWIDE REVENUES(a)
FOREIGN EXCHANGE IMPACT (%)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2024 | | Nine Months Ended September 30, 2024 |
| Revenue Change % | | F/X % Favorable/ (Unfavorable) ** | | Revenue Change % Ex- F/X ** | | Revenue Change % | | F/X % Favorable/ (Unfavorable) ** | | Revenue Change % Ex- F/X ** |
Growth Portfolio | | | | | | | | | | | |
| Opdivo | 4% | | (3)% | | 7% | | 3% | | (4)% | | 7% |
| Orencia | 1% | | (2)% | | 3% | | 3% | | (2)% | | 5% |
| Yervoy | 11% | | (2)% | | 13% | | 11% | | (3)% | | 14% |
| Reblozyl | 80% | | (1)% | | 81% | | 78% | | (1)% | | 79% |
| Opdualag | 40% | | —% | | 40% | | 54% | | —% | | 54% |
| Abecma | 33% | | (1)% | | 34% | | (19)% | | (1)% | | (18)% |
| Zeposia | 20% | | 1% | | 19% | | 36% | | 1% | | 35% |
| Breyanzi | 143% | | —% | | 143% | | 84% | | (1)% | | 85% |
| Camzyos | 129% | | —% | | 129% | | 165% | | —% | | 165% |
| Sotyktu | —% | | —% | | —% | | 52% | | (2)% | | 54% |
| Augtyro | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
| Krazati | N/A | | N/A | | N/A | | N/A | | N/A | | N/A |
Other Growth Products(b) | 39% | | (2)% | | 41% | | 23% | | (2)% | | 25% |
Total Growth Portfolio | 18% | | (2)% | | 20% | | 15% | | (3)% | | 18% |
Legacy Portfolio | | | | | | | | | | | |
| Eliquis | 11% | | —% | | 11% | | 9% | | —% | | 9% |
| Revlimid | (1)% | | —% | | (1)% | | (5)% | | (1)% | | (4)% |
| Pomalyst/Imnovid | 3% | | —% | | 3% | | 7% | | —% | | 7% |
| Sprycel | (44)% | | (1)% | | (43)% | | (23)% | | (2)% | | (21)% |
| Abraxane | (3)% | | (4)% | | 1% | | (7)% | | (4)% | | (3)% |
Other Legacy Products(c) | (5)% | | —% | | (5)% | | (8)% | | (2)% | | (6)% |
Total Legacy Portfolio | 1% | | —% | | 1% | | 2% | | —% | | 2% |
| Total Revenues | 8% | | (2)% | | 10% | | 7% | | (2)% | | 9% |
** See "Use of Non-GAAP Financial Information".
(a) Worldwide (WW) includes U.S. and International (Int'l).
(b) Includes Onureg, Nulojix, Empliciti and royalty revenues.
(c) Includes other mature brands.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT *
(Unaudited, dollars in millions)
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| THREE MONTHS | | 2024 | | 2023 | | Change $ | | Change % | | Favorable / (Unfavorable) F/X $ ** | | 2024 Excl. F/X ** | | Favorable / (Unfavorable) F/X % ** | | % Change Excl. F/X ** |
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| Revenues | | $ | 11,892 | | | $ | 10,966 | | | $ | 926 | | | 8 | % | | $ | (135) | | | $ | 12,027 | | | (2) | % | | 10 | % |
| Gross profit | | 8,935 | | | 8,460 | | | 475 | | | 6 | % | | N/A | | N/A | | N/A | | N/A |
Gross profit excluding specified items(a) | | 9,036 | | | 8,476 | | | 560 | | | 7 | % | | N/A | | N/A | | N/A | | N/A |
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Gross margin(b) | | 75.1 | % | | 77.1 | % | | | | | | | | | | | | |
| Gross margin excluding specified items | | 76.0 | % | | 77.3 | % | | | | | | | | | | | | |
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| Marketing, selling and administrative | | 1,983 | | | 2,003 | | | (20) | | | (1) | % | | 15 | | | 1,998 | | | 1 | % | | — | % |
Marketing, selling and administrative excluding specified items(a) | | 1,976 | | | 1,938 | | | 38 | | | 2 | % | | 15 | | | 1,991 | | | 1 | % | | 3 | % |
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| Research and development | | 2,374 | | | 2,242 | | | 132 | | | 6 | % | | 8 | | | 2,382 | | | — | % | | 6 | % |
Research and development excluding specified items(a) | | 2,353 | | | 2,178 | | | 175 | | | 8 | % | | 8 | | | 2,361 | | | — | % | | 8 | % |
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Operating margin(c) | | 38.5 | % | | 38.4 | % | | | | | | | | | | | | |
Operating margin excluding specified items | | 39.6 | % | | 39.8 | % | | | | | | | | | | | | |
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| NINE MONTHS | | 2024 | | 2023 | | Change $ | | Change % | | Favorable / (Unfavorable) F/X $ ** | | 2024 Excl. F/X ** | | Favorable / (Unfavorable) F/X % ** | | % Change Excl. F/X ** |
| Revenues | | $ | 35,958 | | | $ | 33,529 | | | $ | 2,429 | | | 7 | % | | $ | (512) | | | $ | 36,470 | | | (2) | % | | 9 | % |
| Gross profit | | 26,802 | | | 25,581 | | | 1,221 | | | 5 | % | | N/A | | N/A | | N/A | | N/A |
Gross profit excluding specified items(a) | | 27,221 | | | 25,718 | | | 1,503 | | | 6 | % | | N/A | | N/A | | N/A | | N/A |
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Gross margin(b) | | 74.5 | % | | 76.3 | % | | | | | | | | | | | | |
| Gross margin excluding specified items | | 75.7 | % | | 76.7 | % | | | | | | | | | | | | |
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| Marketing, selling and administrative | | 6,278 | | | 5,699 | | | 579 | | | 10 | % | | 68 | | | 6,346 | | | 1 | % | | 11 | % |
Marketing, selling and administrative excluding specified items(a) | | 5,887 | | | 5,614 | | | 273 | | | 5 | % | | 68 | | | 5,955 | | | 1 | % | | 6 | % |
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| Research and development | | 7,968 | | | 6,821 | | | 1,147 | | | 17 | % | | 32 | | | 8,000 | | | — | % | | 17 | % |
Research and development excluding specified items(a) | | 6,994 | | | 6,636 | | | 358 | | | 5 | % | | 32 | | | 7,026 | | | 1 | % | | 6 | % |
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Operating margin(c) | | 34.9 | % | | 39.0 | % | | | | | | | | | | | | |
Operating margin excluding specified items | | 39.9 | % | | 40.2 | % | | | | | | | | | | | | |
* Foreign exchange impacts were derived 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.
** See "Use of Non-GAAP Financial Information".
(a) Refer to the Specified Items schedule below for further details.
(b) Represents gross profit as a percentage of Revenues.
(c) Operating margin represents gross profit less marketing, selling and administrative expenses and research and development expenses, as a percentage of Revenues.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
(Unaudited, dollars in millions)
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
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| Inventory purchase price accounting adjustments | $ | 13 | | | $ | — | | | $ | 34 | | | $ | 84 | |
| Intangible asset impairment | — | | | — | | | 280 | | | — | |
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| Site exit and other costs | 88 | | | 16 | | | 105 | | | 53 | |
| Cost of products sold | 101 | | | 16 | | | 419 | | | 137 | |
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Acquisition related charges(a) | — | | | — | | | 372 | | | — | |
| Site exit and other costs | 7 | | | 65 | | | 19 | | | 85 | |
| Marketing, selling and administrative | 7 | | | 65 | | | 391 | | | 85 | |
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| IPRD impairments | — | | | 60 | | | 590 | | | 80 | |
| Priority review voucher | — | | | — | | | — | | | 95 | |
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Acquisition related charges(a) | — | | | — | | | 348 | | | — | |
| Site exit and other costs | 21 | | | 4 | | | 36 | | | 10 | |
| Research and development | 21 | | | 64 | | | 974 | | | 185 | |
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| Amortization of acquired intangible assets | 2,406 | | | 2,256 | | | 7,179 | | | 6,769 | |
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Interest expense(b) | (12) | | | (12) | | | (37) | | | (39) | |
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Equity investment (gain)/losses | (13) | | | (2) | | | (222) | | | 206 | |
Acquisition expenses | — | | | — | | | 50 | | | — | |
| Integration expenses | 69 | | | 54 | | | 214 | | | 180 | |
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| Litigation and other settlements | — | | | (62) | | | 61 | | | (397) | |
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| Provision for restructuring | 78 | | | 141 | | | 558 | | | 321 | |
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| Intangible asset impairment | 47 | | | 29 | | | 47 | | | 29 | |
| Other | 106 | | | (1) | | | 116 | | | (6) | |
| Other (income)/expense, net | 275 | | | 147 | | | 787 | | | 294 | |
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| Increase to Earnings before income taxes | 2,810 | | | 2,548 | | | 9,750 | | | 7,470 | |
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| Income taxes on items above | (371) | | | (340) | | | (1,296) | | | (944) | |
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Income tax reserve releases | — | | | — | | | (502) | | | — | |
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| Income taxes attributed to a non-U.S. tax ruling | — | | | — | | | — | | | (656) | |
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| Income taxes | (371) | | | (340) | | | (1,798) | | | (1,600) | |
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| Increase to net earnings | $ | 2,439 | | | $ | 2,208 | | | $ | 7,952 | | | $ | 5,870 | |
(a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions of Karuna, RayzeBio and Mirati.
(b) Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS
(Unaudited, dollars and shares in millions except per share data)
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| Three Months Ended September 30, 2024 | | Nine Months Ended September 30, 2024 |
| GAAP | | Specified Items(a) | | Non-GAAP | | GAAP | | Specified Items(a) | | Non-GAAP |
| Gross profit | $ | 8,935 | | | $ | 101 | | | $ | 9,036 | | | $ | 26,802 | | | $ | 419 | | | $ | 27,221 | |
| Marketing, selling and administrative | 1,983 | | | (7) | | | 1,976 | | | 6,278 | | | (391) | | | 5,887 | |
| Research and development | 2,374 | | | (21) | | | 2,353 | | | 7,968 | | | (974) | | | 6,994 | |
| Amortization of acquired intangible assets | 2,406 | | | (2,406) | | | — | | | 7,179 | | | (7,179) | | | — | |
| Other (income)/expense, net | 234 | | | (275) | | | (41) | | | 588 | | | (787) | | | (199) | |
| Earnings/(Loss) before income taxes | 1,676 | | | 2,810 | | | 4,486 | | | (8,554) | | | 9,750 | | | 1,196 | |
| Provision for income taxes | 461 | | | 371 | | | 832 | | | 455 | | | 1,798 | | | 2,253 | |
| Net earnings/(loss) attributable to BMS used for diluted EPS calculation | $ | 1,211 | | | $ | 2,439 | | | $ | 3,650 | | | $ | (9,020) | | | $ | 7,952 | | | $ | (1,068) | |
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| Weighted-average common shares outstanding—diluted | 2,031 | | | 2,031 | | | 2,031 | | | 2,026 | | | 2,026 | | | 2,026 | |
| Diluted earnings/(loss) per share | $ | 0.60 | | | $ | 1.20 | | | $ | 1.80 | | | $ | (4.45) | | | $ | 3.92 | | | $ | (0.53) | |
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| Effective tax rate | 27.5 | % | | (9.0) | % | | 18.5 | % | | (5.3) | % | | 193.7 | % | | 188.4 | % |
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| Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 |
| GAAP | | Specified Items(a) | | Non-GAAP | | GAAP | | Specified Items(a) | | Non-GAAP |
| Gross profit | $ | 8,460 | | | $ | 16 | | | $ | 8,476 | | | $ | 25,581 | | | $ | 137 | | | $ | 25,718 | |
| Marketing, selling and administrative | 2,003 | | | (65) | | | 1,938 | | | 5,699 | | | (85) | | | 5,614 | |
| Research and development | 2,242 | | | (64) | | | 2,178 | | | 6,821 | | | (185) | | | 6,636 | |
| Amortization of acquired intangible assets | 2,256 | | | (2,256) | | | — | | | 6,769 | | | (6,769) | | | — | |
| Other (income)/expense, net | (258) | | | (147) | | | (405) | | | (787) | | | (294) | | | (1,081) | |
| Earnings before income taxes | 2,137 | | | 2,548 | | | 4,685 | | | 6,766 | | | 7,470 | | | 14,236 | |
| Provision for income taxes | 203 | | | 340 | | | 543 | | | 488 | | | 1,600 | | | 2,088 | |
| Net earnings attributable to BMS used for diluted EPS calculation | $ | 1,928 | | | $ | 2,208 | | | $ | 4,136 | | | $ | 6,263 | | | $ | 5,870 | | | $ | 12,133 | |
| | | | | | | | | | | |
| Weighted-average common shares outstanding—diluted | 2,064 | | | 2,064 | | | 2,064 | | | 2,093 | | | 2,093 | | | 2,093 | |
| Diluted earnings per share | $ | 0.93 | | | $ | 1.07 | | | $ | 2.00 | | | $ | 2.99 | | | $ | 2.81 | | | $ | 5.80 | |
| | | | | | | | | | | |
| Effective tax rate | 9.5 | % | | 2.1 | % | | 11.6 | % | | 7.2 | % | | 7.5 | % | | 14.7 | % |
(a) Refer to the Specified Items schedule above for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate.
BRISTOL-MYERS SQUIBB COMPANY
NET DEBT CALCULATION
AS OF SEPTEMBER 30, 2024 AND DECEMBER 31, 2023
(Unaudited, dollars in millions)
| | | | | | | | | | | |
| September 30,
2024 | | December 31,
2023 |
| | | |
| Cash and cash equivalents | $ | 7,890 | | | $ | 11,464 | |
| Marketable debt securities - current | 204 | | | 816 | |
| Marketable debt securities - non-current | 324 | | | 364 | |
| Cash, cash equivalents and marketable debt securities | $ | 8,418 | | | $ | 12,644 | |
| Short-term debt obligations | (1,078) | | | (3,119) | |
| Long-term debt | (48,674) | | | (36,653) | |
| Net debt position | $ | (41,334) | | | $ | (27,128) | |
Not for Product Promotional Use Q3 2024 Results October 31, 2024
Not for Product Promotional UseQ3 2024 Results Forward Looking Statements and Non-GAAP Financial Information 2 This presentation contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, anticipated clinical trials, results and regulatory approvals that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Actual results may differ materially from those expressed in, or implied by, these statements as a result of various factors, including, but not limited to: (i) new laws and regulations, (ii) our ability to obtain, protect and maintain market exclusivity rights and enforce patents and other intellectual property rights, (iii) our ability to achieve expected clinical, regulatory and contractual milestones on expected timelines or at all, (iv) difficulties or delays in the development and commercialization of new products, (v) difficulties or delays in our clinical trials and the manufacturing, distribution and sale of our products, (vi) adverse outcomes in legal or regulatory proceedings, (vii) risks relating to acquisitions, divestitures, alliances, joint ventures and other portfolio actions and (viii) political and financial instability, including changes in general economic conditions. These and other important factors are discussed in the Company’s most recent annual report on Form 10-K and reports on Forms 10-Q and 8-K. These documents are available on the U.S. Securities and Exchange Commission’s website, on the Company’s website or from Bristol-Myers Squibb Investor Relations. No forward- looking statements can be guaranteed. In addition, any forward-looking statements and clinical data included herein are presented only as of the date hereof. Except as otherwise required by applicable law, the Company undertakes no obligation to publicly update any of the provided information, whether as a result of new information, future events, changed circumstances or otherwise. This presentation includes certain non-generally accepted accounting principles (“GAAP”) financial measures that we use to describe the Company’s performance. The non-GAAP financial measures are provided as supplemental information and are presented because management has evaluated the Company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the Company’s baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. This presentation also provides certain revenues and expenses excluding the impact of foreign exchange (“Ex- FX”). 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. Ex-FX financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results. The non-GAAP information presented herein provides investors with additional useful information but should not be considered in isolation or as substitutes for the related GAAP measures. Moreover, other companies may define non-GAAP measures differently, which limits the usefulness of these measures for comparisons with such other companies. We encourage investors to review our financial statements and publicly filed reports in their entirety and not to rely on any single financial measure. An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable financial measure are available on our website at www.bms.com/investors. Also note that a reconciliation of forward-looking non-GAAP measures, including non-GAAP earnings per share (EPS), to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.
Chris Boerner, PhD Board Chair and Chief Executive Officer 3 Q3 2024 Results
Q3 2024 Results Not for Product Promotional Use Research & Development Q3 2024 performance 4 Commercial *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Not an exhaustive list of assets, programs, or indications $4.9 $5.8 $6.0 $6.1 $11.0 $11.9 Q3 2023 Q3 2024 Legacy Growth $ in billions Growth portfolio revenues: +18% or +20% Ex-FX* YoY +129% +80% Achieved multiple clinical & regulatory milestones1 +40% nivolumab + relatlimab HD +143% Re-established presence in Neuroscience
Q3 2024 Results Not for Product Promotional Use 5 Novel first-in-class schizophrenia treatment U.S. Approval: September 26, 2024 Launch now underway First new mechanism in decades • ~1.6M patients treated in the U.S.1 • ~70% of patients not well managed with current treatments Compelling efficacy with proven safety & tolerability profile • Depth & breadth of efficacy across symptom domains • No boxed warning & atypical antipsychotic class warnings & precautions Expansion opportunities2 • Expected Phase 3 data readouts: Adjunctive Schizophrenia (2025) & Alzheimer’s Psychosis (2026) • Planned registrational studies: — Alzheimer’s Agitation, Bipolar I Disorder, Alzheimer’s Cognition, & Autism Spectrum Disorder Irritability *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. DRG – Clarivate, as of July 2023; 2. Subject to positive registrational trials and regulatory approval Anticipate majority of access by 2H 2025*
Q3 2024 Results Not for Product Promotional Use Reshaping the company for long-term sustainable growth 6 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Refer to Appendix for details Focusing on transformational medicines where we have a competitive advantage Driving operational excellence throughout the organization Strategically allocating capital for long-term growth & returns • Growth portfolio led by Reblozyl, Breyanzi, Camzyos & Opdualag • 8 new oncology registrational trials1 added in past year • Focusing R&D on higher ROI programs • Realizing anticipated internal cost savings of ~$1.5B by YE 2025* • Business development remains a priority • Committed to our dividend Accelerating delivery of important medicines to more patients
Q3 2024 Results Not for Product Promotional Use 7 Near-term milestones build pipeline momentum*1 CAR T in Immunology Extending in Immuno- Oncology CD19 NEX-T Phase 1 data at ACR: November 2024 Pipeline enters catalyst-rich period starting next year2 Subcutaneous nivolumab U.S. FDA PDUFA date: December 29th *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Subject to positive registrational trials and regulatory approval; 2. Refer to Appendix for details Phase 3 PsA POETYK-PsA-I & II: data by YE Expanding in Immunology
Q3 2024 Results Not for Product Promotional Use 2024 Guidance Highlights* Total Revenues Reported Rates Expected to increase ~5% Total Revenues Ex-FX Expected to increase ~6% Non-GAAP EPS1 Increasing range to $0.75 - $0.95 Raising our 2024 revenue and EPS outlook 8 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information” 1. 2024 Guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items, and the impact of future Acquired IPRD charges and includes the net impact of Acquired IPRD and licensing income through Q3 2024
Q3 2024 Results Not for Product Promotional Use Executing on critical business priorities to build a solid foundation for sustainable growth 9 • Growth Portfolio continues to expand Focusing on commercial execution • Cobenfy U.S. approval: Multi-billion-dollar potential including LCM opportunities Re-established presence in Neuroscience • On track to deliver against productivity initiatives Maintaining P&L discipline • Near-term catalysts: CD19 NEX-T, Sotyktu, & Subcutaneous nivolumab Advancing our pipeline Strengthening the company to deliver long-term value
David Elkins Executive Vice President and Chief Financial Officer 10 Q3 2024 Results
Q3 2024 Results Not for Product Promotional Use Composition of revenue continues to transition to the Growth Portfolio 10 $4.9 $5.8 $6.0 $6.1 Q3 2023 Q3 2024 Legacy Growth Growth Portfolio Other Growth Brands1 Legacy Portfolio Other Mature Brands *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Other Growth Brands: Onureg, Inrebic, Nulojix, Empliciti, & Royalty revenues $ in billions +1% Ex-FX* +18% YoY +1% YoY +20% Ex-FX* +8% YoY, +10% Ex-FX*
Q3 2024 Results Not for Product Promotional Use Q3 2024 Oncology product summary 11 Opdivo2: • Global sales growth reflects increased volume • Subcutaneous nivolumab: U.S. FDA PDUFA date December 29, 2024 Opdualag3: • U.S. growth driven by strong demand; achieved ~30% market share4 as a SOC in 1L melanoma Krazati5: • Sales more than doubled versus prior year Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Abraxane: Anticipate increased pressure from Gx entrants on Q4 U.S. sales; 2. Opdivo: U.S. approval in periadjuvant NSCLC (CM-77T) October 2024 & 1L HCC (CM-9DW) U.S. PDUFA date April 21, 2025; 3. Opdualag: Q3 2024 U.S. sales impacted by ($10M) inventory drawdown; 4. BMS Internal Analysis; 5. Krazati: +113% YoY growth on a reported basis vs Q3 2023 WW Net Sales of ~$16M (as reported by Mirati) $M YoY % Ex-FX* % $2,360 +4% +7% $642 +11% +13% $253 (3%) +1% $233 +40% +40% $34 --- --- $10 --- --- 1
Q3 2024 Results Not for Product Promotional Use Q3 2024 Cardiovascular product summary 12 Eliquis: Best-in-class & leading OAC within category • U.S. growth driven by strong underlying demand & increasing market share • #1 OAC in key Ex-U.S. markets1 Camzyos: First-in-class myosin inhibitor • Strong increase in total treated & commercial dispensed patients in U.S. • Ex-U.S. expansion based on reimbursement timing2 Global Net Sales % $M YoY % Ex-FX* % $3,002 +11% +11% $156 +129% +129% As of Jun 30, 2024 Sept 30, 2024 Patients in hub3 ~8,900 ~10,200 Patients on commercial drug3 ~6,900 ~8,200 *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Eliquis: Q3 2024 Ex-US sales included +$20M inventory build; 2. Camzyos: Q3 2024 Ex-US sales included +$4M one-time GTN adjustment; 3. BMS internal analysis & patient figures are U.S. only
Q3 2024 Results Not for Product Promotional Use Q3 2024 Hematology product summary 13 Reblozyl: • Strong demand in 1L MDS-associated anemia • Focus on increasing market share in 1L RS negative population • Ex-U.S. growth driven by both European markets3 & recent Japanese approval Breyanzi: • Growth driven by expanded manufacturing capacity & increased demand 1 $M YoY % Ex-FX* % $1,412 (1%) (1%) $898 +3% +3% $447 +80% +81% $290 (44%) (43%) $224 +143% +143% $124 +33% +34% Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Pomalyst: In the EU, generic pomalidomide products entered the market in August 2024; 2. U.S. generic Sprycel launched Sept. 1, 2024; 3. AMNOG six-month free pricing period in Germany ended Sept. 30, 2024 1 2
Q3 2024 Results Not for Product Promotional Use Q3 2024 Immunology product summary 14 Sotyktu: First-in-class TYK2 inhibitor • ~15% sequential growth in commercially paid scripts in the U.S. • Launched in major ex-U.S. markets • Continued focus on demand growth & access improvements Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Q3 2023 sales include a clinical purchase of ~$30M; 2. Q3 2024 sales include inventory build of +$4M; 3. Symphony Health, an ICON plc Company, Metys® U.S. TRx data Q4’23 Q1’24 Q2’24 Q3’24 ~8,700 ~9,800 ~12,400 ~14,300 Sotyktu Commercially Paid Scripts3 % $M YoY % Ex-FX* % $936 +1% +3% $147 +20% +19% $661,2 0% 0%
Q3 2024 Results Not for Product Promotional Use US GAAP Non-GAAP $ in billions, except EPS Q3 2024 Q3 2023 Q3 2024 Q3 2023 Total Revenues, net 11.9 11.0 11.9 11.0 Gross Margin % 75.1% 77.1% 76.0% 77.3% Operating Expenses1 4.4 4.2 4.3 4.1 Acquired IPR&D 0.3 0.1 0.3 0.1 Amortization of Acquired Intangibles 2.4 2.3 - - Effective Tax Rate 27.5% 9.5% 18.5% 11.6% Diluted EPS 0.60 0.93 1.80 2.00 Diluted Shares Outstanding (# in millions) 2,031 2,064 2,031 2,064 Q3 2024 Financial Performance 15 US P Non- P* Diluted EPS Impact from Acquired IPR&D2 (0.09) (0.03) (0.09) (0.03) *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Operating Expenses = MS&A and R&D; 2. Represents the net impact from Acquired IPRD & Licensing income reported in Q3
Q3 2024 Results Not for Product Promotional Use Strategic approach to Capital Allocation 16 *Cash includes cash, cash equivalents and marketable debt securities; **Relative to the total debt level as of March 31, 2024; ***Subject to Board approval $B Q3 2024 Total Cash* ~$8.4 Total Debt ~$49.8 • Pursue opportunities and partnerships to diversify portfolio & strengthen long-term outlook • Maintain strong investment-grade credit rating • Planned debt pay down of ~$10B by end of 1H 2026** • Reduced total debt by ~$2.7B in Q3 (by ~$5.9B over Q2 & Q3) Business Development Balance Sheet Strength Returning Cash to Shareholders • Remain committed to our dividend*** • ~$5B in share repurchase authorization remaining as of September 30, 2024 Strong operating cash flow generation $4.8 $4.3 $2.8 $2.3 $5.6 Q3 2023 Q4 2023 Q1 2024 Q2 2024 Q3 2024 Cash flow from Operations $B
Q3 2024 Results Not for Product Promotional Use July (Prior) October (Updated) Total Revenues Reported Rates Upper end of low single-digit range ~5% increase Total Revenues Ex-FX* Upper end of low single-digit range ~6% increase Gross Margin % Between ~74% and ~75% Between ~74.5% and ~75% Operating Expenses1 Low single-digit increase ~4% to ~5% increase Other Income/ (Expense) ~($50M) ~$125M Tax Rate2 ~66% ~60% Diluted EPS2 $0.60 - $0.90 $0.75 - $0.95 Revised 2024 Guidance 17 Non-GAAP* *The Company does not reconcile forward-looking non-GAAP measures. See "Forward-Looking Statements and Non-GAAP Financial Information”; 1. Operating Expenses = MS&A and R&D, excluding Acquired IPR&D and Amortization of acquired intangibles; 2. Includes the net impact of Acquired IPRD and licensing income through Q3 2024. Guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items, and the impact of future Acquired IPRD charges Key Highlights • Raising FY Revenue & EPS guidance due to strength of results YTD • Gross Margin range narrowed due to sales mix • FY OpEx guidance reflects increased investment in Q4 to support portfolio & pipeline • OIE guidance reflects higher royalty & interest income • Underlying Tax Rate excluding Acquired IPR&D: • Q3 at ~18.8% • FY’24 estimated at ~18%
Q3 2024 Results Not for Product Promotional Use Delivered Solid Performance in Q3 18 Re-established Presence in Neuroscience Driving Sustainable Growth Q3 Performance • Topline growth: +8% or +10% Ex-FX* • Growth portfolio: +18% or +20% Ex-FX* Raising FY 2024 Revenue & EPS Non-GAAP Guidance *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Refer to Appendix for details • Focusing on transformational medicines • Driving operational excellence • Strategically allocating capital Advancing our Pipeline • 8 new oncology registrational trials added in past year1 • Near-term milestones build pipeline momentum • Cobenfy: First-in-class medicine with multi-billion-dollar potential including LCM opportunities • Launch in schizophrenia now underway; anticipate majority of access by 2H 2025
Chris Boerner, PhD Board Chair, Chief Executive Officer David Elkins Executive VP, Chief Financial Officer Samit Hirawat, MD Executive VP, Chief Medical Officer, Global Drug Development Adam Lenkowsky Executive VP, Chief Commercialization Officer 20 Q3 2024 Results Q&A
v3.24.3
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Bristol Myers Squibb (PK) (USOTC:BMYMP)
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