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.--(BUSINESS WIRE)--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. | ||
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 |
| % Change from Quarter |
| % Change from | |||||||||||||
|
| U.S. |
| Int’l (c) |
| WW(d) |
| U.S. |
| Int’l(c) |
| WW(d) |
| Int’l(c) |
| WW(d) | |||
Growth Portfolio |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
| $ | 1,366 |
| $ | 994 |
| $ | 2,360 |
| 2% |
| 7% |
| 4% |
| 16% |
| 7% | |
|
| 706 |
|
| 230 |
|
| 936 |
| —% |
| 6% |
| 1% |
| 13% |
| 3% | |
|
| 399 |
|
| 243 |
|
| 642 |
| 11% |
| 10% |
| 11% |
| 17% |
| 13% | |
|
| 358 |
|
| 89 |
|
| 447 |
| 79% |
| 85% |
| 80% |
| 90% |
| 81% | |
|
| 216 |
|
| 17 |
|
| 233 |
| 33% |
| >200% |
| 40% |
| >200% |
| 40% | |
|
| 77 |
|
| 47 |
|
| 124 |
| 12% |
| 96% |
| 33% |
| 100% |
| 34% | |
|
| 105 |
|
| 42 |
|
| 147 |
| 11% |
| 50% |
| 20% |
| 46% |
| 19% | |
|
| 173 |
|
| 51 |
|
| 224 |
| 125% |
| >200% |
| 143% |
| >200% |
| 143% | |
|
| 135 |
|
| 21 |
|
| 156 |
| 101% |
| >200% |
| 129% |
| >200% |
| 129% | |
|
| 51 |
|
| 15 |
|
| 66 |
| (18)% |
| >200% |
| —% |
| >200% |
| —% | |
|
| 10 |
|
| — |
|
| 10 |
| N/A |
| N/A |
| N/A |
| N/A |
| N/A | |
|
| 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
|
| 2,045 |
|
| 957 |
|
| 3,002 |
| 15% |
| 3% |
| 11% |
| 2% |
| 11% | |
|
| 1,212 |
|
| 200 |
|
| 1,412 |
| —% |
| (9)% |
| (1)% |
| (6)% |
| (1)% | |
|
| 697 |
|
| 201 |
|
| 898 |
| 15% |
| (24)% |
| 3% |
| (24)% |
| 3% | |
|
| 225 |
|
| 65 |
|
| 290 |
| (44)% |
| (45)% |
| (44)% |
| (42)% |
| (43)% | |
|
| 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 | 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 & | Camzyos® | 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® | 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 + | 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 & | 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 + | 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 + | 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® | 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 & | Zeposia® | 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 | October |
Total Revenues | Upper end of low single- | ~5% increase |
Total Revenues | Upper end of low single- | ~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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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.
Contacts
For more information, contact:
Media Relations: media@bms.com
Investor Relations: investor.relations@bms.com
