On February 6, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the fourth quarter and full year of 2024 (Press release, Bristol-Myers Squibb, FEB 6, 2025, View Source [SID1234650081]).
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"We made good progress in 2024, which was capped by a fourth quarter of strong topline growth driven by key products and important pipeline advancements. We also achieved the landmark U.S. approval of Cobenfy last year for the treatment of schizophrenia in adults, and we expect this medicine to have a meaningful impact on patients and the company as a new growth driver," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "Our collective focus on execution has established a solid foundation to navigate the multi-year journey toward achieving top-tier sustainable growth and long-term shareholder returns."
Fourth Quarter
$ in millions, except per share amounts 2024 2023 Change Change Excl. F/X**
Total Revenues $12,342 $11,477 8 % 9 %
Earnings Per Share – GAAP*
0.04 0.87 (95) % N/A
Earnings Per Share – Non-GAAP*
1.67 1.70 (2) % N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share 0.01 (0.20) 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".
Full Year
$ in millions, except per share amounts 2024 2023 Change Change Excl. F/X**
Total Revenues $48,300 $45,006 7 % 9 %
(Loss)/Earnings Per Share – GAAP*
(4.41) 3.86 N/A N/A
Earnings Per Share – Non-GAAP*
1.15 7.51 (85) % N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share (6.39) (0.28) 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".
FOURTH QUARTER RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
•Bristol Myers Squibb posted fourth quarter revenues of $12.3 billion, an increase of 8%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for Eliquis, partially offset by the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst.
◦U.S. revenues increased 9% to $8.6 billion, primarily driven by higher demand for the Growth Portfolio and Eliquis, partially offset by the impact of generics within the Legacy Portfolio.
◦International revenues increased 5% to $3.7 billion, or 9% when adjusted for foreign exchange impacts, primarily driven by higher demand for the Growth Portfolio, partially offset by the impact of generics within the Legacy Portfolio.
•On a GAAP basis, gross margin decreased from 76.1% to 61.0%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.4% to 74.0%, primarily due to product mix.
•On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $2.1 billion.
•On a GAAP basis, research and development expenses increased 29% to $3.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 13% to $2.8 billion, primarily due to the impact of recent acquisitions.
•On a GAAP and non-GAAP basis, Acquired IPRD decreased to $30 million from $600 million. On a GAAP and non-GAAP basis, licensing income was $48 million compared to $67 million.
•On a GAAP basis, amortization of acquired intangible assets decreased 26% to $1.7 billion, primarily due to lower amortization expense related to Revlimid, partially offset by the RayzeBio acquisition in 2024.
•On a GAAP basis, the effective tax rate was 56.6%, primarily due to the impact of intangible asset impairments and amortization of acquired intangible assets. In 2023, the income tax benefit was $88 million despite pre-tax earnings of $1.7 billion, primarily due to a valuation allowance reversal and foreign currency. On a non-GAAP basis, the effective tax rate changed from 14.9% to 19.9%, primarily due to jurisdictional earnings mix.
•On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $72 million, or $0.04 per share, during the fourth quarter of 2024 compared to net earnings of $1.8 billion, or $0.87 per share, for the same period a year ago. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.4 billion, or $1.67 per share, during the fourth quarter of 2024 compared to $3.5 billion, or $1.70 per share, for the same period a year ago.
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions) Quarter Ended December 31, 2024 % Change from Quarter Ended December 31, 2023 % Change from Quarter Ended December 31, 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 $ 1,423 $ 1,056 $ 2,479 2 % 7 % 4 % 15 % 7 %
Orencia 750 250 1,000 (1) % 9 % 2 % 15 % 3 %
Yervoy 428 247 675 26 % 9 % 19 % 15 % 22 %
Reblozyl 445 102 547 65 % 104 % 71 % 110 % 72 %
Opdualag 233 21 254 25 % >200% 34 % >200% 34 %
Breyanzi 209 54 263 146 % >200% 160 % >200% 162 %
Camzyos 201 22 223 142 % >200% 153 % >200% 153 %
Zeposia 115 43 158 15 % 30 % 19 % 33 % 20 %
Abecma 59 46 105 5 % 5 % 5 % 5 % 5 %
Sotyktu 64 19 83 14 % 171 % 32 % 171 % 32 %
Krazati 36 3 39 N/A N/A N/A N/A N/A
Augtyro 13 2 15 >200% N/A >200% N/A >200%
Cobenfy 10 — 10 N/A N/A N/A N/A N/A
Other Growth Products(a)
186 326 512 13 % 104 % 58 % 106 % 59 %
Total Growth Portfolio
4,172 2,191 6,363 19 % 24 % 21 % 31 % 23 %
Legacy Portfolio
Eliquis 2,221 974 3,195 19 % (3) % 11 % (2) % 11 %
Revlimid 1,169 170 1,339 (6) % (17) % (8) % (15) % (7) %
Pomalyst/Imnovid 685 138 823 9 % (48) % (8) % (47) % (7) %
Sprycel 135 63 198 (67) % (45) % (62) % (41) % (61) %
Abraxane 91 83 174 (48) % 17 % (30) % 28 % (26) %
Other Legacy Products(b)
123 127 250 46 % (14) % 8 % (15) % 7 %
Total Legacy Portfolio
4,424 1,555 5,979 — % (14) % (4) % (12) % (3) %
Total Revenues $ 8,596 $ 3,746 $ 12,342 9 % 5 % 8 % 9 % 9 %
** 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).
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $6.4 billion compared to $5.3 billion in the prior year period, representing growth of 21% on a reported basis, or 23% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily due to higher demand for Reblozyl, Breyanzi, Camzyos, Yervoy and Opdualag.
Legacy Portfolio
Revenues for the Legacy Portfolio in the fourth quarter were $6.0 billion compared to $6.2 billion in the prior year period, representing a decline of 4% on a reported basis and 3% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were lower primarily due to the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst, partially offset by higher demand for Eliquis.
PRODUCT AND PIPELINE UPDATE
Neuroscience
Category Asset Milestone
Clinical & Research
CobenfyTM (xanomeline and trospium chloride)
Long-term data from the Phase 3 EMERGENT-4 and EMERGENT-5 trials evaluating Cobenfy in adults with schizophrenia showed that Cobenfy was generally well tolerated over 52 weeks, with continued improvements in symptoms and a side effect profile consistent with prior trials of the treatment in this indication.
Oncology
Category Asset Milestone
Regulatory
Opdivo (nivolumab) + Yervoy (ipilimumab)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo + Yervoy for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma. The recommendation is based on results of the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
AugtyroTM (repotrectinib)*
The EC approved Augtyro, a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The approval is based on results from the TRIDENT-1 and CARE trials.
*Approval received on January 13, 2025, and announced today by the company.
Opdivo QvantigTM (nivolumab and hydaluronidase-nyhy)
The U.S. Food and Drug Administration (FDA) approved Opdivo Qvantig injection for subcutaneous use in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance after completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The approval is based on results from the Phase 3 randomized, open-label CheckMate -67T trial.
Opdivo + Yervoy
The EC approved Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer (mCRC). The approval is based on results from the CheckMate -8HW trial.
Clinical & Research
Opdivo + Yervoy
Results from an analysis of the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy versus Opdivo monotherapy across all lines of therapy for microsatellite instability-high/mismatch repair-deficient mCRC demonstrated a statistically significant and clinically meaningful improvement at a median follow up of 47 months in the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review.
Hematology
Category Asset Milestone
Clinical & Research
Breyanzi (lisocabtagene maraleucel)
Five-year overall survival data from the Phase 1 TRANSCEND NHL 001 study supported deep and durable responses of Breyanzi in patients with relapsed or refractory large B-cell lymphoma (LBCL) with median overall survival (OS) of 27.5 months and an estimated OS rate at five years of 38 percent. Breyanzi continued to demonstrate an established safety profile with no new safety signals.
In addition, new circulating tumor DNA (ctDNA) from the Phase 3 TRANSFORM study supported the superiority of Breyanzi to achieve deeper responses over the former standard of care in second-line LBCL.
Regulatory
Breyanzi
The CHMP of the EMA recommended approval of Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The recommendation is based on data from the Phase 2 TRANSCEND FL study. The CHMP opinion will now be reviewed by the EC.
Cardiovascular
Category Asset Milestone
Clinical & Research
Camzyos (mavacamten)
In Europe, following an opinion from the CHMP of the EMA, Camzyos received a label update to reduce the frequency of required echocardiography monitoring once a patient treated for obstructive hypertrophic cardiomyopathy is on a stable dose.
In addition, the company is today announcing the receipt of an April Prescription Drug User Fee Act (PDUFA) goal date from the FDA in the same setting.
Immunology
Category Asset Milestone
Clinical & Research
Sotyktu (deucravacitinib)
Results from the Phase 3 POETYK PsA-1 and POETYK PsA-2 trials evaluating the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA) met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving at least a 20 percent improvement in signs and symptoms of disease after 16 weeks of treatment compared with placebo.
In addition, both trials met secondary endpoints across PsA disease activity at Week 16. In both studies, Sotyktu was well-tolerated and demonstrated safety consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials.
FULL-YEAR FINANCIAL RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
•Bristol Myers Squibb posted revenues of $48.3 billion, an increase of 7%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for Eliquis, partially offset by the impact of generics on Sprycel, Revlimid and Abraxane.
◦U.S. revenues increased 9% to $34.1 billion, primarily due to higher demand for the Growth Portfolio and Eliquis, partially offset by the impact of generics on Sprycel, Revlimid and Abraxane.
◦International revenues increased 3% to $14.2 billion, or 8.0% when adjusted for foreign exchange impacts, primarily due to demand for Growth Portfolio products, partially offset by the impact of generics within the Legacy Portfolio.
•On a GAAP basis, gross margin decreased from 76.2% to 71.1%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.6% to 75.3%, primarily due to product mix.
•On a GAAP and non-GAAP basis, marketing, selling and administrative expenses increased 8% to $8.4 billion and 4% to $8.0 billion, respectively. The increase is primarily due to the timing of spend and the impact of recent acquisitions.
•On a GAAP basis, research and development expenses increased 20% to $11.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 7% to $9.8 billion, primarily due to the impact of recent acquisitions.
•On a GAAP and non-GAAP basis, Acquired IPRD increased from $913 million to $13.4 billion driven by a one-time Acquired IPRD charge from the Karuna asset acquisition and SystImmune collaboration. On a GAAP and non-GAAP basis, licensing income was $122 million during the year compared to $142 million in 2023.
•On a GAAP basis, amortization of acquired intangible assets decreased 2% to $8.9 billion, primarily due to lower amortization expense related to Revlimid, partially offset by the RayzeBio acquisition in 2024.
•On a GAAP basis, income tax expense was $554 million despite a pre-tax loss of $8.4 billion, primarily due to a $12.1 billion non-tax deductible charge for the Karuna acquisition. The 2023 GAAP effective tax rate was impacted by a non-U.S. tax ruling on statutory impairment deductibility, changes in tax reserves, valuation allowances, and IRS guidance on non-U.S. R&D expense deductibility. On a non-GAAP basis, the effective tax rate increased from 14.7% to 56.8%, primarily due to the non-tax deductible charge.
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•The company reported on a GAAP basis net loss attributable to Bristol Myers Squibb of $8.9 billion, or $(4.41) per share, compared to earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share for the same period a year ago. On a non-GAAP basis the company reported net earnings attributable to Bristol Myers Squibb of $2.3 billion, or $1.15 per share, compared to earnings attributable to Bristol Myers Squibb of $15.6 billion, or $7.51 per share for the same period a year ago. In addition to the non-GAAP drivers noted above, non-GAAP EPS was impacted by higher interest expense.
FULL-YEAR PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions) Year Ended December 31, 2024 % Change from Year Ended December 31, 2023 % Change from Year Ended December 31, 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 $ 5,350 $ 3,954 $ 9,304 2 % 5 % 3 % 14 % 7 %
Orencia 2,770 912 3,682 2 % 2 % 2 % 10 % 4 %
Yervoy 1,599 931 2,530 16 % 8 % 13 % 15 % 16 %
Reblozyl 1,444 329 1,773 80 % 61 % 76 % 65 % 77 %
Opdualag 870 58 928 41 % >200% 48 % >200% 48 %
Breyanzi 591 156 747 95 % 156 % 105 % 162 % 106 %
Camzyos 543 59 602 141 % >200% 161 % >200% 161 %
Zeposia 403 163 566 26 % 42 % 30 % 42 % 30 %
Abecma 242 164 406 (32) % 44 % (14) % 47 % (13) %
Sotyktu 190 56 246 21 % >200% 45 % >200% 46 %
Krazati 118 8 126 N/A N/A N/A N/A N/A
Augtyro 36 2 38 >200% N/A >200% N/A >200%
Cobenfy 10 — 10 N/A N/A N/A N/A N/A
Other Growth Products(a)
674 931 1,605 9 % 58 % 33 % 61 % 34 %
Total Growth Portfolio 14,840 7,723 22,563 17 % 16 % 17 % 24 % 19 %
Legacy Portfolio
Eliquis 9,631 3,702 13,333 14 % (1) % 9 % — % 9 %
Revlimid 4,999 774 5,773 (4) % (14) % (5) % (11) % (5) %
Pomalyst/Imnovid 2,695 850 3,545 15 % (23) % 3 % (22) % 3 %
Sprycel 983 303 1,286 (31) % (40) % (33) % (36) % (32) %
Abraxane 541 334 875 (23) % 11 % (13) % 25 % (8) %
Other Legacy Products(b)
416 509 925 25 % (19) % (4) % (18) % (3) %
Total Legacy Portfolio 19,265 6,472 25,737 4 % (10) % — % (8) % 1 %
Total Revenues $ 34,105 $ 14,195 $ 48,300 9 % 3 % 7 % 8 % 9 %
** 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).
FULL-YEAR PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $22.6 billion compared to $19.4 billion in the prior year period, representing growth of 17% on a reported basis, or 19% 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 remained relatively flat at $25.7 billion compared to $25.6 billion in the prior year period, and increased 1% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were primarily driven by higher demand for Eliquis, offset by the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst.
Update on Strategic Productivity Initiative
Bristol Myers Squibb is expanding its existing strategic productivity initiative to include approximately $2 billion in additional annualized cost savings by the end of 2027.
Under this expanded initiative, savings will be driven by changes in organizational design and efforts to enhance operational efficiency. These savings will be removed from our cost structure to contribute to a leaner, more efficient company while investing behind growth brands and promising areas of science.
Financial Guidance
Bristol Myers Squibb is providing key 2025 non-GAAP line-item guidance assumptions as outlined below.
We estimate total revenues to be approximately $45.5 billion, reflecting, as previously expected, the near-term impact of generics across Revlimid, Pomalyst, Sprycel and Abraxane, which we expect to result in a revenue decline of approximately 18-20% of the Legacy Portfolio. This is expected to be partially offset by the continued strength of our Growth Portfolio. This guidance also reflects an approximate $500 million expected negative impact to revenue due to foreign exchange.
2025 Non-GAAP1 Line-Item Guidance
Total Revenues
(Reported & Ex-F/X)
~$45.5 billion
Gross Margin %
~72%
Operating Expenses2
~$16 billion
Other Income/(Expense)
~$30 million
Tax Rate
~18%
Diluted EPS
$6.55-$6.85
1See "Use of Non-GAAP Financial Information."
2Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets.
The 2025 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."
Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, February 6, 2025, at 8:00 a.m. ET, during which company executives will review quarterly and annual 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 View Source." target="_blank" title="View Source." rel="nofollow">View Source
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 View Source prior to the start of the conference call.
A replay of the webcast will be available at View Source 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 February 6, 2025, through 11:30 a.m. ET on February 20, 2025, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 5943651.