Results Reflect Continued Strength of In-Line
and New Products, Pipeline Execution and Business Development
Activity, Supporting Growth Momentum into 2024
- Reports Fourth Quarter Revenues of $11.5 Billion; GAAP EPS
of $0.87 and Non-GAAP EPS of $1.70
- In-Line and New Product Portfolio Revenues Increased 9% to
$9.8 Billion
- Reports Full-Year Revenues of $45.0 Billion; GAAP EPS of
$3.86 and Non-GAAP EPS of $7.51
- In-Line and New Product Portfolio Revenues Increased 7% to
$37.9 Billion
- Strengthens Long-Term Growth Profile Through Multiple
Transactions, Including Planned Acquisitions of Karuna Therapeutics
and RayzeBio and Strategic Collaboration with SystImmune; Completes
Purchase of Mirati Therapeutics
- Advances Research Pipeline Including U.S. Approval of
Augtyro and FDA Acceptance of sBLAs for Breyanzi in Follicular
Lymphoma and Mantle Cell Lymphoma for Priority Review
- Provides 2024 Guidance with Revenues Increasing by Low
Single-Digits; Non-GAAP EPS Range $7.10 to $7.40, Excludes Impact
of Pending Transactions
Bristol Myers Squibb (NYSE: BMY) today reports results for the
fourth quarter and full year of 2023, which reflect strong pipeline
acceleration, continued portfolio diversification, and momentum in
our business.
“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 of new 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
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 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.
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, Twitter, YouTube, Facebook, and
Instagram.
corporatefinancial-news
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, 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 expense 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, unwind 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, release of income
tax reserves related to the Mead Johnson split-off transaction and
internal transfers of intangible and other assets to streamline our
legal entity structure subsequent 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 a 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, 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, 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 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 or that the company
will be able to complete any pending acquisitions and realize the
benefits of these acquisitions.
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 product's 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 including as a result of the Russian
Federation-Ukraine conflict; 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, 2022, as updated by the company’s subsequent Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and other filings
with the Securities and Exchange Commission. 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
FOR THE THREE AND TWELVE
MONTHS ENDED DECEMBER 31, 2023 AND 2022
(Unaudited, dollars and shares
in millions except per share data)
Three Months Ended December
31,
Twelve Months Ended December
31,
2023
2022
2023
2022
Net product sales
$
11,168
$
11,065
$
43,778
$
44,671
Alliance and other revenues
309
341
1,228
1,488
Total Revenues
11,477
11,406
45,006
46,159
Cost of products sold(a)
2,745
2,593
10,693
10,137
Marketing, selling and administrative
2,073
2,266
7,772
7,814
Research and development
2,478
2,510
9,299
9,509
Acquired IPRD
600
52
913
815
Amortization of acquired intangible
assets
2,278
2,343
9,047
9,595
Other (income)/expense, net
(371)
(217)
(1,158)
576
Total Expenses
9,803
9,547
36,566
38,446
Earnings Before Income Taxes
1,674
1,859
8,440
7,713
Provision for Income Taxes
(88)
(166)
400
1,368
Net Earnings
1,762
2,025
8,040
6,345
Noncontrolling Interest
—
3
15
18
Net Earnings Attributable to
BMS
$
1,762
$
2,022
$
8,025
$
6,327
Weighted-Average Common Shares
Outstanding:
Basic
2,027
2,108
2,069
2,130
Diluted
2,033
2,124
2,078
2,146
Earnings per Common Share:
Basic
$
0.87
$
0.96
$
3.88
$
2.97
Diluted
0.87
0.95
3.86
2.95
Other (income)/expense, net
Interest expense(b)
$
316
$
294
$
1,166
$
1,232
Royalty and licensing income
(420)
(316)
(1,488)
(1,283)
Royalty income - divestitures
(239)
(235)
(862)
(832)
Equity investment (gains)/losses
(53)
(165)
160
801
Integration expenses
62
97
242
440
Loss on debt redemption
—
—
—
266
Divestiture gains
—
—
—
(211)
Litigation and other settlements
3
146
(390)
178
Investment income
(145)
(82)
(449)
(171)
Provision for restructuring
44
15
365
75
Contingent consideration
(1)
(10)
(8)
(9)
Other
62
39
106
90
Other (income)/expense, net
$
(371)
$
(217)
$
(1,158)
$
576
(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
DECEMBER 31, 2023 AND 2022
(Unaudited, dollars in
millions)
Change vs. 2022
2023
2022
GAAP
Excl. F/X**
U.S. (c)
Int'l
WW (d)
U.S. (c)
Int'l
WW (d)
U.S. (c)
Int'l
WW (d)
U.S.(c)
Int'l
WW (d)
In-Line Products
Eliquis
$
1,899
$
975
$
2,874
$
1,718
$
970
$
2,688
11%
1%
7%
11%
(3)%
6%
Opdivo
1,411
976
2,387
1,265
951
2,216
12%
3%
8%
12%
4%
8%
Orencia
766
219
985
710
203
913
8%
8%
8%
8%
11%
9%
Pomalyst/Imnovid
632
258
890
625
252
877
1%
2%
1%
1%
—%
1%
Yervoy
343
223
566
345
223
568
(1)%
—%
—%
(1)%
1%
—%
Sprycel
417
109
526
418
160
578
—%
(32)%
(9)%
—%
(31)%
(9)%
Mature and other brands(a)
202
278
480
185
297
482
9%
(6)%
—%
9%
(5)%
1%
Total In-Line Products
5,670
3,038
8,708
5,266
3,056
8,322
8%
(1)%
5%
8%
(1)%
5%
New Product Portfolio
Reblozyl
274
46
320
157
42
199
75%
10%
61%
75%
5%
60%
Opdualag
187
3
190
104
—
104
80%
N/A
83%
80%
N/A
83%
Abecma
56
44
100
94
31
125
(40)%
42%
(20)%
(40)%
39%
(21)%
Zeposia
101
32
133
58
21
79
74%
52%
68%
74%
43%
66%
Breyanzi
85
16
101
42
13
55
*
23%
84%
*
23%
84%
Camzyos
84
4
88
16
—
16
*
N/A
*
*
N/A
*
Sotyktu
56
7
63
7
—
7
*
N/A
*
*
N/A
*
Onureg
31
16
47
27
10
37
15%
60%
27%
15%
50%
24%
Inrebic
19
10
29
17
6
23
12%
67%
26%
12%
67%
26%
Augtyro
1
—
1
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
894
178
1,072
522
123
645
71%
45%
66%
71%
39%
65%
Total In-Line and New Product
Portfolio
6,564
3,216
9,780
5,788
3,179
8,967
13%
1%
9%
13%
1%
9%
Recent LOE Products(b)
Revlimid
1,262
188
1,450
2,021
239
2,260
(38)%
(21)%
(36)%
(38)%
(20)%
(36)%
Abraxane
177
70
247
116
63
179
53%
11%
38%
53%
22%
42%
Total Recent LOE Products
1,439
258
1,697
2,137
302
2,439
(33)%
(15)%
(30)%
(33)%
(11)%
(30)%
Total Revenues
$
8,003
$
3,474
$
11,477
$
7,925
$
3,481
$
11,406
1%
—%
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).
BRISTOL-MYERS SQUIBB
COMPANY
PRODUCT REVENUES
FOR THE TWELVE MONTHS ENDED
DECEMBER 31, 2023 AND 2022
(Unaudited, dollars in
millions)
Change vs. 2022
2023
2022
GAAP
Excl. F/X**
U.S. (c)
Int'l
WW (d)
U.S. (c)
Int'l
WW (d)
U.S. (c)
Int'l
WW (d)
U.S.(c)
Int'l
WW (d)
In-Line Products
Eliquis
$
8,592
$
3,614
$
12,206
$
7,786
$
4,003
$
11,789
10%
(10)%
4%
10%
(10)%
3%
Opdivo
5,283
3,726
9,009
4,812
3,437
8,249
10%
8%
9%
10%
11%
10%
Orencia
2,754
847
3,601
2,638
826
3,464
4%
3%
4%
4%
6%
5%
Pomalyst/Imnovid
2,357
1,084
3,441
2,438
1,059
3,497
(3)%
2%
(2)%
(3)%
3%
(1)%
Yervoy
1,388
850
2,238
1,304
827
2,131
6%
3%
5%
6%
5%
6%
Sprycel
1,446
484
1,930
1,497
668
2,165
(3)%
(28)%
(11)%
(3)%
(25)%
(10)%
Mature and other brands(a)
772
1,123
1,895
750
1,295
2,045
3%
(13)%
(7)%
3%
(11)%
(6)%
Total In-Line Products
22,592
11,728
34,320
21,225
12,115
33,340
6%
(3)%
3%
6%
(2)%
4%
New Product Portfolio
Reblozyl
811
197
1,008
591
126
717
37%
56%
41%
37%
54%
40%
Opdualag
617
10
627
252
—
252
*
N/A
*
*
N/A
*
Abecma
358
114
472
297
91
388
21%
25%
22%
21%
24%
21%
Zeposia
324
110
434
177
73
250
83%
51%
74%
83%
47%
72%
Breyanzi
303
61
364
151
31
182
*
97%
100%
*
*
*
Camzyos
226
5
231
24
—
24
*
N/A
*
*
N/A
*
Sotyktu
157
13
170
8
—
8
*
N/A
*
*
N/A
*
Onureg
117
51
168
95
29
124
23%
76%
35%
23%
72%
35%
Inrebic
74
36
110
69
16
85
7%
*
29%
7%
*
29%
Augtyro
1
—
1
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
2,988
597
3,585
1,664
366
2,030
80%
63%
77%
80%
61%
76%
Total In-Line and New Product
Portfolio
25,580
12,325
37,905
22,889
12,481
35,370
12%
(1)%
7%
12%
—%
8%
Recent LOE Products(b)
Revlimid
5,266
831
6,097
8,359
1,619
9,978
(37)%
(49)%
(39)%
(37)%
(47)%
(39)%
Abraxane
709
295
1,004
580
231
811
22%
28%
24%
22%
39%
27%
Total Recent LOE Products
5,975
1,126
7,101
8,939
1,850
10,789
(33)%
(39)%
(34)%
(33)%
(36)%
(34)%
Total Revenues
$
31,555
$
13,451
$
45,006
$
31,828
$
14,331
$
46,159
(1)%
(6)%
(2)%
(1)%
(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).
BRISTOL-MYERS SQUIBB
COMPANY
INTERNATIONAL REVENUES
FOREIGN EXCHANGE IMPACT
(%)
FOR THE THREE AND TWELVE
MONTHS ENDED DECEMBER 31, 2023
(Unaudited)
Three Months Ended December
31, 2023
Twelve Months Ended December
31, 2023
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
In-Line Products
Eliquis
1%
4%
(3)%
(10)%
—%
(10)%
Opdivo
3%
(1)%
4%
8%
(3)%
11%
Orencia
8%
(3)%
11%
3%
(3)%
6%
Pomalyst/Imnovid
2%
2%
—%
2%
(1)%
3%
Yervoy
—%
(1)%
1%
3%
(2)%
5%
Sprycel
(32)%
(1)%
(31)%
(28)%
(3)%
(25)%
Mature and other products(a)
(6)%
(1)%
(5)%
(13)%
(2)%
(11)%
Total In-Line Products
(1)%
—%
(1)%
(3)%
(1)%
(2)%
New Product Portfolio
Reblozyl
10%
5%
5%
56%
2%
54%
Opdualag
N/A
N/A
N/A
N/A
N/A
N/A
Abecma
42%
3%
39%
25%
1%
24%
Zeposia
52%
9%
43%
51%
4%
47%
Breyanzi
23%
—%
23%
97%
(6)%
*
Camzyos
N/A
N/A
N/A
N/A
N/A
N/A
Sotyktu
N/A
N/A
N/A
N/A
N/A
N/A
Onureg
60%
10%
50%
76%
4%
72%
Inrebic
67%
—%
67%
*
*
*
Augtyro
N/A
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
45%
6%
39%
63%
2%
61%
Total In-Line Products and New Product
Portfolio
1%
—%
1%
(1)%
(1)%
—%
Recent LOE Products(b)
Revlimid
(21)%
(1)%
(20)%
(49)%
(2)%
(47)%
Abraxane
11%
(11)%
22%
28%
(11)%
39%
Total Recent LOE Products
(15)%
(4)%
(11)%
(39)%
(3)%
(36)%
Total
—%
—%
—%
(6)%
(1)%
(5)%
*
In excess of +/-100%.
**
See "Use of Non—GAAP Financial
Information".
(a)
Includes over-the-counter (OTC) products,
royalty revenue and other mature products.
(b)
Recent LOE products include products with
significant expected decline in revenue from a prior reporting
period as a result of a loss of exclusivity.
BRISTOL-MYERS SQUIBB COMPANY
WORLDWIDE REVENUES (C)
FOREIGN EXCHANGE IMPACT
(%)
FOR THE THREE AND TWELVE
MONTHS ENDED DECEMBER 31, 2023
(Unaudited)
Three Months Ended December
31, 2023
Twelve Months Ended December
31, 2023
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
In-Line Products
Eliquis
7%
1%
6%
4%
1%
3%
Opdivo
8%
—%
8%
9%
(1)%
10%
Orencia
8%
(1)%
9%
4%
(1)%
5%
Pomalyst/Imnovid
1%
—%
1%
(2)%
(1)%
(1)%
Yervoy
—%
—%
—%
5%
(1)%
6%
Sprycel
(9)%
—%
(9)%
(11)%
(1)%
(10)%
Mature and other products(a)
—%
(1)%
1%
(7)%
(1)%
(6)%
Total In-Line Products
5%
—%
5%
3%
(1)%
4%
New Product Portfolio
Reblozyl
61%
1%
60%
41%
1%
40%
Opdualag
83%
—%
83%
*
*
*
Abecma
(20)%
1%
(21)%
22%
1%
21%
Zeposia
68%
2%
66%
74%
2%
72%
Breyanzi
84%
—%
84%
100%
(1)%
*
Camzyos
*
*
*
*
*
*
Sotyktu
*
*
*
*
*
*
Onureg
27%
3%
24%
35%
—%
35%
Inrebic
26%
—%
26%
29%
—%
29%
Augtyro
N/A
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
66%
1%
65%
77%
1%
76%
Total In-Line Products and New Product
Portfolio
9%
—%
9%
7%
(1)%
8%
Recent LOE Products(b)
Revlimid
(36)%
—%
(36)%
(39)%
—%
(39)%
Abraxane
38%
(4)%
42%
24%
(3)%
27%
Total Recent LOE Products
(30)%
—%
(30)%
(34)%
—%
(34)%
Total
1%
—%
1%
(2)%
—%
(2)%
*
In excess of +/-100%.
**
See "Use of Non—GAAP Financial
Information".
(a)
Includes over-the-counter (OTC) products,
royalty revenue and other mature products.
(b)
Recent LOE products include products with
significant expected decline in revenue from a prior reporting
period as a result of a loss of exclusivity.
(c)
Worldwide (WW) includes U.S. and
International (Int'l).
BRISTOL-MYERS SQUIBB
COMPANY
RECONCILIATION OF GAAP AND
NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE
IMPACT
(Unaudited, dollars in
millions)
THREE MONTHS ENDED
2023
2022
Change $
Change %
Favorable / (Unfavorable) F/X
$ **
2023 Excl. F/X **
Favorable / (Unfavorable) F/X
% **
% Change Excl. F/X **
Revenues
$
11,477
$
11,406
$
71
1%
$
4
$
11,473
—%
1%
Gross profit
8,732
8,813
(81)
(1)%
N/A
N/A
N/A
N/A
Gross profit excluding specified
items(a)
8,770
8,886
(116)
(1)%
N/A
N/A
N/A
N/A
Gross margin(b)
76.1%
77.3%
Gross margin excluding specified items
76.4%
77.9%
Marketing, selling and administrative
2,073
2,266
(193)
(9)%
5
2,078
1%
(8)%
Marketing, selling and administrative
excluding specified items(a)
2,064
2,266
(202)
(9)%
5
2,069
—%
(9)%
Marketing, selling and administrative
excluding specified items as a % of revenues
18.0%
19.9%
Research and development
2,478
2,510
(32)
(1)%
(5)
2,473
—%
(1)%
Research and development excluding
specified items(a)
2,476
2,510
(34)
(1)%
(4)
2,472
(1)%
(2)%
Research and development excluding
specified items as a % of revenues
21.6%
22.0%
TWELVE MONTHS ENDED
2023
2022
Change $
Change %
Favorable / (Unfavorable) F/X
$ **
2023 Excl. F/X **
Favorable / (Unfavorable) F/X
% **
% Change Excl. F/X **
Revenues
$
45,006
$
46,159
$
(1,153)
(2)%
$
(232)
$
45,238
—%
(2)%
Gross profit
34,313
36,022
(1,709)
(5)%
N/A
N/A
N/A
N/A
Gross profit excluding specified
items(a)
34,488
36,378
(1,890)
(5)%
N/A
N/A
N/A
N/A
Gross margin(b)
76.2%
78.0%
Gross margin excluding specified items
76.6%
78.8%
Marketing, selling and administrative
7,772
7,814
(42)
(1)%
46
7,818
1%
—%
Marketing, selling and administrative
excluding specified items(a)
7,678
7,735
(57)
(1)%
46
7,724
1%
—%
Marketing, selling and administrative
excluding specified items as a % of revenues
17.1%
16.8%
Research and development
9,299
9,509
(210)
(2)%
12
9,311
—%
(2)%
Research and development excluding
specified items(a)
9,112
9,201
(89)
(1)%
12
9,124
—%
(1)%
Research and development excluding
specified items as a % of revenues
20.2%
19.9%
*
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
above for further details.
(b)
Represents gross profit as a percentage of
Revenues.
BRISTOL-MYERS SQUIBB
COMPANY
SPECIFIED ITEMS
(Unaudited, dollars in
millions)
Three Months Ended December
31,
Twelve Months Ended December
31,
2023
2022
2023
2022
Inventory purchase price accounting
adjustments
$
—
$
53
$
84
$
293
Intangible asset impairment
27
—
27
—
Site exit and other costs
11
20
64
63
Cost of products sold
38
73
175
356
Employee compensation charges
—
—
—
73
Site exit and other costs
9
—
94
6
Marketing, selling and
administrative
9
—
94
79
IPRD impairments
—
—
80
98
Priority review voucher
—
—
95
—
Inventory purchase price accounting
adjustments
—
—
—
130
Employee compensation charges
—
—
—
80
Site exit and other costs
2
—
12
—
Research and development
2
—
187
308
Amortization of acquired intangible
assets
2,278
2,343
9,047
9,595
Interest expense(a)
(13)
(17)
(52)
(83)
Equity investment (income)/losses
(54)
(163)
152
799
Integration expenses
62
97
242
440
Loss on debt redemption
—
—
—
266
Divestiture gains
—
—
—
(211)
Litigation and other settlements
—
144
(397)
140
Provision for restructuring
44
15
365
75
Other
32
1
55
71
Other (income)/expense, net
71
77
365
1,497
Increase to pretax income
2,398
2,493
9,868
11,835
Income taxes on items above
(695)
(345)
(1,639)
(1,332)
Income tax reserve release attributed to
Mead Johnson
—
(225)
—
(225)
Income taxes attributed to internal
transfer of certain assets
—
(72)
—
(72)
Income taxes attributed to a non-U.S. tax
ruling
—
—
(656)
—
Income taxes
(695)
(642)
(2,295)
(1,629)
Increase to net earnings
$
1,703
$
1,851
$
7,573
$
10,206
(a)
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)
Three Months Ended December
31, 2023
Twelve Months Ended December
31, 2023
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross profit
$
8,732
$
38
$
8,770
$
34,313
$
175
$
34,488
Marketing, selling and administrative
2,073
(9)
2,064
7,772
(94)
7,678
Research and development
2,478
(2)
2,476
9,299
(187)
9,112
Amortization of acquired intangible
assets
2,278
(2,278)
—
9,047
(9,047)
—
Other (income)/expense, net
(371)
(71)
(442)
(1,158)
(365)
(1,523)
Earnings before income taxes
1,674
2,398
4,072
8,440
9,868
18,308
Provision for income taxes
(88)
695
607
400
2,295
2,695
Net earnings attributable to BMS used
for diluted EPS calculation
$
1,762
$
1,703
$
3,465
$
8,025
$
7,573
$
15,598
Weighted-average common shares
outstanding—diluted
2,033
2,033
2,033
2,078
2,078
2,078
Diluted earnings per share
$
0.87
$
0.83
$
1.70
$
3.86
$
3.65
$
7.51
Effective tax rate
(5.3)%
20.2%
14.9%
4.7%
10.0%
14.7%
Three Months Ended December
31, 2022
Twelve Months Ended December
31, 2022
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross profit
$
8,813
$
73
$
8,886
$
36,022
$
356
$
36,378
Marketing, selling and administrative
2,266
—
2,266
7,814
(79)
7,735
Research and development
2,510
—
2,510
9,509
(308)
9,201
Amortization of acquired intangible
assets
2,343
(2,343)
—
9,595
(9,595)
—
Other (income)/expense, net
(217)
(77)
(294)
576
(1,497)
(921)
Earnings before income taxes
1,859
2,493
4,352
7,713
11,835
19,548
Provision for income taxes
(166)
642
476
1,368
1,629
2,997
Net earnings attributable to BMS used
for diluted EPS calculation
$
2,022
$
1,851
$
3,873
$
6,327
$
10,206
$
16,533
Weighted-average common shares
outstanding—diluted
2,124
2,124
2,124
2,146
2,146
2,146
Diluted earnings per share
$
0.95
$
0.87
$
1.82
$
2.95
$
4.75
$
7.70
Effective tax rate
(8.9)%
19.8%
10.9%
17.7%
(2.4)%
15.3%
(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 DECEMBER 31, 2023 AND
DECEMBER 31, 2022
(Unaudited, dollars in
millions)
December 31,
2023
December 31,
2022
Cash and cash equivalents
$
11,464
$
9,123
Marketable debt securities - current
816
130
Marketable debt securities -
non-current
364
—
Cash, cash equivalents and marketable
debt securities
$
12,644
$
9,253
Short-term debt obligations
(3,119)
(4,264)
Long-term debt
(36,653)
(35,056)
Net debt position
$
(27,128)
$
(30,067)
BRISTOL-MYERS SQUIBB
COMPANY
2024 FULL YEAR FINANCIAL
GUIDANCE
The following table summarizes
the company's 2024 financial guidance:
Line item
Non-GAAP(a)
Total reported revenues
Low single-digit increase
Total revenues Ex-Fx(b)
Low single-digit increase
Gross margin %
~74%
Operating expenses(c)
Low single-digit increase
Other income/(expense)
~$250M
Effective tax rate
~17.5%
Diluted EPS(d)
$7.10 - $7.40
(a) 2024 Guidance reflects the recent
acquisition of Mirati closed in January 2024 and excludes planned
acquisitions of Karuna Therapeutics and RayzeBio, subject to
satisfaction of customary closing conditions.
(b) Ex-FX excludes the impact of foreign
exchange calculated by converting our current-period local currency
financial results using the prior period average currency rates and
comparing these adjusted amounts to our prior-period results.
(c) Operating expenses consist of
Marketing, Selling and Administrative expenses and Research and
Development expenses.
(d) Diluted EPS exclude the net impact of
future Acquired IPRD charges and licensing income.
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.”
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240202503029/en/
For more information, contact: Media: media@bms.com
Investor Relations: investor.relations@bms.com
Bristol Myers Squibb (NYSE:BMY)
過去 株価チャート
から 4 2024 まで 5 2024
Bristol Myers Squibb (NYSE:BMY)
過去 株価チャート
から 5 2023 まで 5 2024