On February 2, 2024 Bristol Myers Squibb (NYSE: BMY) reported results for the fourth quarter and full year of 2023, which reflect strong pipeline acceleration, continued portfolio diversification, and momentum in our business (Press release, Bristol-Myers Squibb, FEB 2, 2024, View Source [SID1234639815]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We saw good performance in the fourth quarter from our in-line and new products and took several actions to strengthen the company and build a foundation for sustainable growth," said Christopher Boerner, Ph.D., chief executive officer, Bristol Myers Squibb. "In 2024, our focus is on delivering strong commercial execution and accelerating opportunities that enhance our growth profile in the middle of the decade and beyond."
Fourth Quarter
Full Year
$ in millions, except per share amounts
2023
2022
Change
Change Excl.
F/X**
2023
2022
Change
Change Excl.
F/X**
Total Revenues
$11,477
$11,406
1%
1%
$45,006
$46,159
(2)%
(2)%
EPS — GAAP*
0.87
0.95
(8)%
N/A
3.86
2.95
31%
N/A
EPS — Non-GAAP*
1.70
1.82
(7)%
N/A
7.51
7.70
(2)%
N/A
Acquired IPRD charge and Licensing Income Net Impact (Decrease)/Increase
(0.20)
(0.01)
N/A
N/A
(0.28)
(0.24)
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 2022 unless otherwise stated.
Bristol Myers Squibb posted fourth quarter revenues of $11.5 billion, an increase of 1% both on a reported and when adjusted for foreign exchange basis, primarily due to higher sales of new product portfolio, as well as Eliquis and Opdivo, partially offset by lower sales of Revlimid.
U.S. revenues increased 1% to $8.0 billion primarily due to higher sales of new product portfolio, Eliquis and Opdivo, partially offset by lower sales of Revlimid.
International revenues remained relatively flat at $3.5 billion, primarily due to lower sales of Revlimid, offset by higher sales ofnew product portfolio and Opdivo.
On a GAAP basis, gross margin decreased from 77.3% to 76.1% and on a non-GAAP basis, gross margin decreased from 77.9% to 76.4% primarily due to product mix and lower hedge settlement gains.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 9% to $2.1 billion primarily due to timing of spend.
On a GAAP and non-GAAP basis, research and development expenses remained relatively flat at $2.5 billion.
On a GAAP and non-GAAP basis, Acquired IPRD increased to $600 million from $52 million primarily due to the reacquired mavacamten rights of $445 million in China and certain other Asian territories. On a GAAP and non-GAAP basis, licensing income was $67 million compared to $16 million during the same period a year ago.
On a GAAP basis, amortization of acquired intangible assets decreased 3% to $2.3 billion primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
On a GAAP basis, income tax benefit was $88 million despite pre-tax earnings of $1.7 billion primarily due to a valuation allowance reversal related to unrealized equity investment losses and foreign currency. In 2022, the income tax benefit was $166 million despite pre-tax earnings of $1.9 billion primarily due to the release of income tax reserves. On a non-GAAP basis, the effective tax rate changed from 10.9% to 14.9%, primarily due to release of income tax reserves in 2022.
The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $1.8 billion, or $0.87 per share, compared to $2.0 billion, or $0.95 per share, for the same period a year ago. In addition to the items above, the decrease in GAAP EPS was driven by lower losses in equity investments. The company reported on a non-GAAP basis net earnings attributable to Bristol Myers Squibb of $3.5 billion, or $1.70 per share, compared to $3.9 billion, or $1.82 per share, for the same period a year ago. The EPS results in the fourth quarter of 2023 also include the impact of lower weighted-average common shares outstanding.
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Quarter Ended December
31, 2023
% Change from Quarter
Ended December 31,
2022
% Change from
Quarter Ended
December 31,
2022 Ex-F/X**
U.S.(c)
Int’l
WW(d)
U.S.(c)
Int’l
WW(d)
Int’l
WW(d)
In-Line Products
Eliquis
$
1,899
$
975
$
2,874
11%
1%
7%
(3)%
6%
Opdivo
1,411
976
2,387
12%
3%
8%
4%
8%
Orencia
766
219
985
8%
8%
8%
11%
9%
Pomalyst/Imnovid
632
258
890
1%
2%
1%
—%
1%
Yervoy
343
223
566
(1)%
—%
— %
1%
—%
Sprycel
417
109
526
—%
(32)%
(9)%
(31)%
(9)%
Mature and other products (a)
202
278
480
9%
(6)%
—%
(5)%
1%
Total In-Line Products
5,670
3,038
8,708
8%
(1) %
5 %
(1)%
5%
New Product Portfolio
Reblozyl
274
46
320
75%
10%
61%
5%
60%
Opdualag
187
3
190
80%
N/A
83%
N/A
83%
Abecma
56
44
100
(40)%
42%
(20)%
39%
(21)%
Zeposia
101
32
133
74%
52%
68%
43%
66%
Breyanzi
85
16
101
*
23%
84%
23%
84%
Camzyos
84
4
88
*
N/A
*
N/A
*
Sotyktu
56
7
63
*
N/A
*
N/A
*
Onureg
31
16
47
15%
60%
27%
50%
24%
Inrebic
19
10
29
12%
67%
26%
67%
26%
Augtyro
1
—
1
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
894
178
1,072
71%
45%
66%
39%
65%
Total In-Line and New Product Portfolio
6,564
3,216
9,780
13%
1%
9%
1%
9%
Recent LOE Products (b)
Revlimid
1,262
188
1,450
(38)%
(21)%
(36)%
(20)%
(36)%
Abraxane
177
70
247
53%
11%
38%
22%
42%
Total Recent LOE Products
1,439
258
1,697
(33)%
(15)%
(30)%
(11)%
(30)%
Total Revenues
$
8,003
$
3,474
$
11,477
1%
—%
1%
—%
1%
*
In excess of +100%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes over-the-counter (OTC) products, royalty revenue and mature products.
(b)
Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c)
Includes Puerto Rico.
(d)
Worldwide (WW) includes U.S. and International (Int’l).
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products in the fourth quarter were $8.7 billion compared to $8.3 billion in the prior year period. In-line products revenue was largely driven by:
Eliquis worldwide revenues increased 7%, or 6% when adjusted for foreign exchange impacts. U.S. revenues were $1.9 billion compared to $1.7 billion in the prior year period, representing an increase of 11% primarily due to higher demand, partially offset by GTN adjustments in 2023. International revenues were $975 million compared to $970 million in the prior year period, representing an increase of 1%, or a decrease of 3% when adjusted for foreign exchange impacts, primarily driven by lower average net selling prices and generic erosion in several European countries.
Opdivo worldwide revenues increased 8% both on a reported and when adjusted for foreign exchange basis. U.S. revenues increased 12% to $1.4 billion compared to $1.3 billion in the prior year period primarily due to higher demand. International revenues were $976 million compared to $951 million in the prior year period, representing an increase of 3%, or 4% when adjusted for foreign exchange impacts, primarily due to higher demand as a result of launches for new indications and core indications.
New Product Portfolio
New product portfolio worldwide revenues increased to $1.1 billion compared to $645 million in the prior year period, representing a growth of 66%, or 65% when adjusted for foreign exchange impacts, primarily driven by higher demand across the portfolio, including for Reblozyl, Opdualag, Camzyos, Sotyktu, Zeposia and Breyanzi.
Recent LOE Products
Revlimid worldwide revenues declined to $1.5 billion compared to $2.3 billion in the prior year period, representing a decline of 36%, both on a reported and when adjusted for foreign exchange basis, primarily due to generic erosion.
PRODUCT AND PIPELINE UPDATE
The company recently achieved several important regulatory and clinical milestones. In November 2023, Augtyro received U.S. regulatory approval in non-small cell lung cancer. The U.S. Food and Drug Administration (FDA) also accepted supplemental Biologics License Applications (sBLAs) for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma.
Oncology
Category
Asset
Milestone
Regulatory
KRAZATI
(adagrasib)
The European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.
repotrectinib
The European Medicines Agency (EMA) validated the marketing authorization application for repotrectinib as a treatment for ROS1 tyrosine kinase inhibitor (TKI)-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI naïve- and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on the registrational Phase 1/2 TRIDENT-1 trial and CARE study. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.
Opdivo
(nivolumab)
The FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.
In addition, the EMA validated the type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.
The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -901 trial.
AugtyroTM
(repotrectinib)
The FDA approved Augtyro, a TKI, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on results from the pivotal TRIDENT-1 study.
Clinical &
Research
Subcutaneous
nivolumab
Data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate as assessed by Blinded Independent Central Review (BICR) versus intravenous Opdivo.
Opdivo
Four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) continued to show superior progression-free survival (PFS) and objective response rates in patients treated with Opdivo plus CABOMETYX over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. Superior overall survival (OS) was also observed in patients treated with the combination.
Opdivo+Yervoy
Eight-year data from the Phase 3 CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.
The Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) met the dual primary endpoint of PFS as assessed by BICR at a pre-specified interim analysis. The study is ongoing to assess the other dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints, including overall survival.
In addition, data from the Phase 3 CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with MSI-H/dMMR mCRC compared to chemotherapy. Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy in MSI-H/dMMR mCRC.
OpdualagTM
(nivolumab and
relatlimab)
The Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns.
Hematology
Category
Asset
Milestone
Regulatory
Abecma
(idecabtagene
vicleucel)
The Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.
Reblozyl
(luspatercept-
aamt)
Japan’s Ministry of Health, Labour and Welfare (MHLW) granted manufacturing and marketing approval for Reblozyl 25 mg/75 mg injection for subcutaneous use indicated for myelodysplastic syndrome (MDS)-related anemia. The approval is based on the results of the global Phase 3 COMMANDS trial and the Phase 3 MEDALIST study, as well as a Japanese Phase 2 study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.
Breyanzi
(lisocabtagene
maraleucel)
The FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.
In addition, Japan’s MHLW has also accepted the company’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.
In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.
Abecma
Japan’s MHLW granted manufacturing and marketing approval of the sNDA for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on the interim analysis from the KarMMa-3 trial.
Breyanzi
The FDA accepted the sBLA for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA granted the application Priority Review and assigned a PDUFA goal date of March 14, 2024.
Clinical &
Research
Abecma
Results from the preplanned final progression-free survival (PFS) analysis of the pivotal Phase 3, open-label, global, randomized controlled KarMMa-3 trial demonstrated a significantly improved PFS maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death.
Breyanzi
First disclosure of primary analysis results from the high-risk, second-line cohort of the Phase 2 TRANSCEND FL trial evaluating Breyanzi in patients with relapsed or refractory FL demonstrated 95.7% complete response for patients with high-risk relapsed or refractory FL treated in a second-line setting.
Reblozyl
Updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes who may require red blood cell transfusions, confirmed positive outcome of the interim analysis with superior efficacy and durability compared to ESAs.
FULL YEAR FINANCIAL RESULTS
All comparisons are made versus the same period in 2022 unless otherwise stated.
Bristol Myers Squibb posted revenues of $45.0 billion, a decrease of 2%, both on a reported and when adjusted for foreign exchange basis, primarily due to lower sales of Revlimid, partially offset by higher sales of our new product portfolio and Opdivo.
U.S. revenues decreased 1%to$31.6 billion due to lower sales of Revlimid resulting from generic erosion and, as previously disclosed, an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was partially offset by an increase in demand for Opdivo, Eliquis and new product portfolio.
International revenues decreased 6% to $13.5 billion, or 5% when adjusted for foreign exchange impacts, primarily due to lower sales of Revlimid and Eliquis, partially offset by an increase in demand for Opdivo and new product portfolio.
On a GAAP basis, gross margin decreased from 78.0% to 76.2% and on a non-GAAP basis, gross margin decreased from 78.8% to 76.6%, primarily due to product mix and lower hedge settlement gains.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 1% to $7.8 billion and $7.7 billion, respectively.
On a GAAP basis, research and development expenses decreased 2% to $9.3 billion. On a non-GAAP basis, research and development expenses decreased 1% to $9.1 billion.
On a GAAP and non-GAAP basis, Acquired IPRD increased 12% to $913 million. On a GAAP and non-GAAP basis, licensing income was $142 million during the year compared to $103 million in 2022.
On a GAAP basis, amortization of acquired intangible assets decreased 6% to $9.0 billion. The decrease was primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
On a GAAP basis, effective tax rate changed from 17.7% to 4.7% primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment and changes in income tax reserves, valuation allowances and IRS guidance regarding deductibility of certain non-U.S. research and development expenses. On a non-GAAP basis, the effective tax rate changed from 15.3% to 14.7%.
The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share, compared to $6.3 billion, or $2.95 per share. In addition to the items above, the GAAP EPS was impacted by lower losses on equity investments as well as litigation and other settlement income in 2023. On a non-GAAP basis, net earnings attributable to Bristol Myers Squibb were $15.6 billion, or $7.51 per share, compared to $16.5 billion, or $7.70 per share. In addition to the non-GAAP drivers noted above, the non-GAAP EPS was impacted by higher royalty and investment income, as well as lower weighted-average common shares outstanding.
FULL YEAR PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Year Ended December 31,
2023
% Change from Year
Ended December 31,
2022
% Change from
Year Ended
December 31,
2022 Ex-F/X**
U.S.(c)
Int’l
WW(d)
U.S.(c)
Int’l
WW(d)
Int’l
WW(d)
In-Line Products
Eliquis
$
8,592
$
3,614
$
12,206
10%
(10)%
4%
(10)%
3%
Opdivo
5,283
3,726
9,009
10%
8%
9%
11%
10%
Orencia
2,754
847
3,601
4%
3%
4%
6%
5%
Pomalyst/Imnovid
2,357
1,084
3,441
(3)%
2%
(2)%
3%
(1)%
Yervoy
1,388
850
2,238
6%
3%
5%
5%
6%
Sprycel
1,446
484
1,930
(3)%
(28)%
(11)%
(25)%
(10)%
Mature and other products (a)
772
1,123
1,895
3%
(13)%
(7)%
(11)%
(6)%
Total In-Line Products
22,592
11,728
34,320
6%
(3)%
3%
(2)%
4%
New Product Portfolio
Reblozyl
811
197
1,008
37%
56%
41%
54%
40%
Opdualag
617
10
627
*
N/A
*
N/A
*
Abecma
358
114
472
21%
25%
22%
24%
21%
Zeposia
324
110
434
83%
51%
74%
47%
72%
Breyanzi
303
61
364
*
97%
100%
*
*
Camzyos
226
5
231
*
N/A
*
N/A
*
Sotyktu
157
13
170
*
N/A
*
N/A
*
Onureg
117
51
168
23%
76%
35%
72%
35%
Inrebic
74
36
110
7%
*
29%
*
29%
Augtyro
1
—
1
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
2,988
597
3,585
80%
63%
77%
61%
76%
Total In-Line and New Product Portfolio
25,580
12,325
37,905
12%
(1)%
7%
—%
8%
Recent LOE Products (b)
Revlimid
5,266
831
6,097
(37)%
(49)%
(39)%
(47)%
(39)%
Abraxane
709
295
1,004
22%
28%
24%
39%
27%
Total Recent LOE Products
5,975
1,126
7,101
(33)%
(39)%
(34)%
(36)%
(34)%
Total Revenues
$
31,555
$
13,451
$
45,006
(1)%
(6)%
(2)%
(5)%
(2)%
*
In excess of +100%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes over-the-counter (OTC) products, royalty revenue and mature products.
(b)
Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c)
Includes Puerto Rico.
(d)
Worldwide (WW) includes U.S. and International (Int’l).
FULL YEAR PRODUCT REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products were $34.3 billion compared to $33.3 billion in the prior year period. In-line products revenue was largely driven by:
Eliquis worldwide revenues increased 4%, or 3% when adjusted for foreign exchange impacts. U.S. revenues were $8.6 billion compared to $7.8 billion in the prior year period, representing an increase of 10%, primarily due to higher demand. International revenues were $3.6 billion compared to $4.0 billion in the prior year period, representing a decrease of 10% both on a reported and when adjusted for foreign exchange basis, primarily driven by lower average net selling prices and generic erosion in Canada and the U.K.
Opdivo worldwide revenues increased 9%, or 10% when adjusted for foreign exchange impacts. U.S. revenues increased 10% to $5.3 billion compared to $4.8 billion in the prior year period, primarily due to higher demand. International revenues were $3.7 billion compared to $3.4 billion in the prior year period, representing an increase of 8%, or 11% when adjusted for foreign exchange impacts, primarily due to higher demand as a result of launches for new indications and core indications.
New Product Portfolio
New product portfolio worldwide revenues increased to $3.6 billion compared to $2.0 billion in the prior year period, representing a growth of 77%, or 76% when adjusted for foreign exchange impacts, primarily driven by higher demand across the portfolio, including for Opdualag, Reblozyl, Camzyos, Breyanzi, Zeposia and Sotyktu.
Recent LOE Products
Revlimid worldwide revenues declined by 39% both on a reported and when adjusted for foreign exchange basis, primarily due to generic erosion and, as previously disclosed, an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which the company donates products.
Business Development
The company entered into multiple transactions in December 2023, strengthening its long-term growth profile and enhancing its portfolio and pipeline.
The company agreed to acquire Karuna Therapeutics, Inc., a clinical-stage biopharmaceutical company developing medicines for people with psychiatric and neurological conditions. Once complete, the transaction is expected to strengthen the company’s expanding position in neuroscience and add important assets, including KarXT (xanomeline-trospium), an antipsychotic with a novel mechanism of action and differentiated efficacy and safety. Karuna’s New Drug Application for KarXT for the treatment of schizophrenia in adults was accepted for review by the FDA and given a PDUFA date of September 26, 2024. The transaction is expected to close in the first half of 2024, subject to the satisfaction of customary closing conditions.
In addition, the company agreed to acquire RayzeBio, Inc., a clinical-stage radiopharmaceutical therapeutics (RPT) company with an innovation-leading position in actinium-based RPTs and a rich pipeline of potentially first-in-class and best-in-class drug development programs currently targeting solid tumors. The acquisition is expected to enhance Bristol Myers Squibb’s leading oncology franchise and add a robust engine for delivering investigational new drugs, as well as state-of-the-art radiopharmaceutical manufacturing capabilities. The transaction is expected to close in the first half of 2024, subject to the satisfaction of customary closing conditions.
The company reached an exclusive license and collaboration agreement with SystImmune for its BL-B01D1 asset, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC) currently being evaluated in a global, multi-center Phase 1 study for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer. The collaboration further diversifies Bristol Myers Squibb’s oncology portfolio and enhances the company’s presence in the ADC space. The transaction is expected to close in the first half of 2024, subject to the satisfaction of customary closing conditions.
On January 23, 2024, the company announced it had successfully completed its acquisition of Mirati Therapeutics, Inc., further diversifying Bristol Myers Squibb’s oncology portfolio and strengthening its pipeline in the latter half of the decade and beyond. Through the transaction, the company added commercialized lung cancer medicine KRAZATI to its oncology portfolio as well as several promising clinical assets, including a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development and a leading KRAS and KRAS-enabling program with two candidates in Phase 1 development.
Capital Allocation
The company takes a strategic approach to capital allocation focused on prioritizing investment for growth through business development, maintaining a strong investment grade credit rating, and returning capital to shareholders through dividends and share repurchase. Dividend decisions are subject to approval by the Board of Directors.
In December, the company announced that the Board declared a quarterly dividend of $0.60 per share on the company’s common stock, an increase of 5.3% over last year’s quarterly rate. Subject to the normal quarterly review by the Board, the annual dividend rate for fiscal year 2024 is $2.40 per share. This is the 15th consecutive year the company has increased its dividend and the 92nd consecutive year it has paid a dividend.
Also in December, the company announced that the Board authorized the repurchase of an additional $3 billion of the company’s common stock under an existing multi-year share repurchase program. With this increase, the company’s total outstanding share repurchase authorization is approximately $5 billion.
Environmental, Social & Governance (ESG)
As a leading biopharmaceutical company, we understand our responsibility extends well beyond the discovery, development and delivery of innovative medicines. Our evolving ESG strategy builds on a legacy of comprehensive and global sustainability efforts that seek to drive business value and positively impact patients, employees, communities and the planet. To learn more about our priorities and goals, please visit our latest ESG report.
Financial Guidance
Bristol Myers Squibb provides its 2024 non-GAAP EPS guidance range of $7.10 – $7.40. Key 2024 non-GAAP line-item guidance assumptions are:
Total 2024 revenues are expected to increase by low single-digits; Excluding foreign exchange, total revenues are expected to increase by low single-digits.
Non-GAAP Gross margin is expected to be approximately 74%.
Non-GAAP Operating expenses are expected to increase by low single-digits.
Other Income/(Expense) is expected to be approximately $250 million.
An effective tax rate of approximately 17.5%.
The 2024 financial guidance excludes the impact of any potential future strategic acquisitions, including the announced planned acquisitions of RayzeBio and Karuna, divestitures, specified items, 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. GAAP and non-GAAP guidance assume 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."
To better align with its go forward strategy, beginning with the first quarter of 2024, the company will update its presentation of revenues to include a Legacy Portfolio and a Growth Portfolio. Legacy Portfolio will include products such as Eliquis, Revlimid, Pomalyst, Sprycel, Abraxane and other mature brands. The Growth Portfolio will include products that comprise the remainder of our portfolio including new launches.
Conference Call Information
Bristol Myers Squibb will host a conference call today, Friday, February 2, 2024, at 8:00 a.m. ET during which company executives will review the 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 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 2, 2024, through 11:30 a.m. ET on February 16, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 1212122.