- Reports Fourth Quarter Revenues of $11.4 Billion; Full-Year
Revenues of $46.2 Billion
- Fourth Quarter Revenues from In-Line Products and New
Product Portfolio were $9.0 Billion, an Increase of 7%, or 12% When
Adjusted for Foreign Exchange
- Full-Year Revenues from In-Line Products and New Product
Portfolio were $35.4 Billion, an Increase of 9%, or 13% When
Adjusted for Foreign Exchange
- Posts Fourth Quarter GAAP EPS of $0.95 and Non-GAAP EPS of
$1.82; Includes Net Impact of ($0.01) Per Share for GAAP and
Non-GAAP EPS Due to Acquired IPRD Charges and Licensing
Income
- Reports Full-Year GAAP EPS of $2.95 and Non-GAAP EPS of
$7.70; Includes Net Impact of ($0.24) Per Share for GAAP and
Non-GAAP EPS Due to Acquired IPRD Charges and Licensing
Income
- Provides GAAP and Non-GAAP Financial Guidance for 2023
Reflecting Continued Revenue and Earnings Growth
Bristol Myers Squibb (NYSE:BMY) today reports results for the
fourth quarter and full year of 2022, which reflect robust growth
of the in-line and new product portfolios, driven by strong
commercial execution and continued progress of the company's
pipeline.
“2022 was a successful year for our company, one of significant
clinical and regulatory achievements that broadened our product
portfolio and advanced our pipeline,” said Giovanni Caforio, M.D.,
board chair and chief executive officer, Bristol Myers Squibb. “We
are especially proud to have launched three first-in-class
medicines that address serious unmet medical needs for patients.
Our financial strength, talented workforce and proven ability to
execute will enable us to continue to progress our pipeline and
invest in future sources of innovation. With a younger and more
diversified portfolio, promising mid-to-late stage registrational
assets and a deep early-stage pipeline, I am confident that the
company is well positioned for multiple waves of innovation that
will support long-term growth.”
Fourth Quarter
$ amounts in millions, except per
share amounts
2022
2021
Change
Change
Excl.
F/X**
Total Revenues
$11,406
$11,985
(5)%
(1)%
Earnings Per Share - GAAP*
0.95
1.07
(11)%
N/A
Earnings Per Share -
Non-GAAP*
1.82
1.84
(1)%
N/A
* GAAP and non-GAAP earnings per share include the net impact of
Acquired IPRD charges and licensing income of ($0.01) per share in
the fourth quarter of 2022 and 2021. ** See "Use of Non-GAAP
Financial Information."
Full Year
$ amounts in millions, except per
share amounts
2022
2021
Change
Change
Excl.
F/X**
Total Revenues
$46,159
$46,385
—
3 %
Earnings Per Share - GAAP*
2.95
3.12
(5)%
N/A
Earnings Per Share -
Non-GAAP*
7.70
7.16
8 %
N/A
* GAAP and non-GAAP earnings per share include the net impact of
Acquired IPRD charges and licensing income of ($0.24) per share in
2022 compared to ($0.40) per share in 2021. ** See "Use of Non-GAAP
Financial Information."
FOURTH QUARTER FINANCIAL
RESULTS
All comparisons are made versus the same period in 2021
unless otherwise stated.
- Bristol Myers Squibb posted revenues of $11.4 billion, a
decrease of 5%, driven by recent LOE products (primarily Revlimid)
and foreign exchange impacts, partially offset by in-line products
(primarily Opdivo) and our new product portfolio (primarily
Opdualag and Abecma). When adjusted for foreign exchange, revenues
decreased 1%. Our in-line products and new product portfolio
increased 7% to $9.0 billion, or 12% when adjusted for foreign
exchange.
- U.S. revenues increased 5% to $7.9 billion. International
revenues decreased 22% to $3.5 billion. When adjusted for foreign
exchange, international revenues decreased 13%, primarily due to
lower demand for Revlimid as a result of generic erosion, partially
offset by in-line products (primarily Opdivo) and our new product
portfolio.
- Gross margin decreased from 80.3% to 77.3% and decreased from
80.3% to 77.9% on a non-GAAP basis primarily due to product mix and
higher manufacturing costs.
- On a GAAP and non-GAAP basis, marketing, selling and
administrative expenses decreased 4% to $2.3 billion primarily due
to foreign exchange.
- On a GAAP and non-GAAP basis, research and development expenses
remained constant at $2.5 billion.
- Acquired IPRD expenses decreased from $89 million in 2021 to
$52 million in 2022.
- Amortization of acquired intangible assets decreased 3% to $2.3
billion, due to expiration of Abraxane market exclusivity.
- 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 decreased from 15.1% to
10.9% primarily due to the release of income tax reserves,
partially offset by jurisdictional earnings mix.
- The company reported net earnings attributable to Bristol Myers
Squibb of $2.0 billion, or $0.95 per share, compared to $2.4
billion, or $1.07 per share. In addition to the items discussed
above, the net earnings include the impact of fair value
adjustments on equity investments in both periods.
- The company reported non-GAAP net earnings attributable to
Bristol Myers Squibb of $3.9 billion, or $1.82 per share, compared
to non-GAAP net earnings of $4.1 billion, or $1.84 per share.
- In addition to the items discussed above, the earnings per
share results in 2022 include the impact of lower weighted-average
common shares outstanding
FOURTH QUARTER PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Quarter Ended December 31,
2022
Quarter Ended December 31,
2021
% Change from Quarter Ended
December 31, 2021
% Change from Quarter Ended
December 31,
2021 (Excl. F/X
Impact)**
In-Line Products
Eliquis
$2,688
$2,671
1%
6%
Opdivo
$2,216
$1,988
11%
16%
Pomalyst/Imnovid
$877
$854
3%
6%
Orencia
$913
$864
6%
9%
Sprycel
$578
$555
4%
8%
Yervoy
$568
$545
4%
9%
Empliciti
$71
$81
(12)%
(7)%
Mature and Other Products*
$411
$441
(7)%
(2)%
Total In-Line Products Revenue
$8,322
$7,999
4%
9%
New Product Portfolio
Reblozyl
$199
$151
32%
34%
Abecma
$125
$69
81%
87%
Opdualag
$104
—
N/A
N/A
Zeposia
$79
$48
65%
69%
Breyanzi
$55
$40
38%
48%
Onureg
$37
$25
48%
52%
Inrebic
$23
$20
15%
15%
Camzyos
$16
—
N/A
N/A
Sotyktu
$7
—
N/A
N/A
Total New Product Portfolio
$645
$353
83%
87%
Total In-Line Products and New Product
Portfolio Revenue
$8,967
$8,352
7%
12%
Recent LOE Products
Revlimid
$2,260
$3,328
(32)%
(31)%
Abraxane
$179
$305
(41)%
(39)%
Total Recent LOE Products
$2,439
$3,633
(33)%
(32)%
Total Revenue
$11,406
$11,985
(5)%
(1)%
* Includes over-the-counter (OTC) products, royalty revenue and
other mature products. ** See "Use of Non-GAAP Financial
Information."
FOURTH QUARTER REVENUE
HIGHLIGHTS
In-Line Products
Revenues for in-line products were $8.3 billion compared to $8.0
billion, representing an increase of 4%, or 9% when adjusted for
foreign exchange. In-line products revenue was largely driven
by:
- Eliquis revenues grew 1%, or 6% when adjusted for foreign
exchange. U.S. revenues were $1.7 billion compared to $1.5 billion,
representing an increase of 15% driven primarily by demand growth
and favorable gross to net adjustments. International revenues were
$970 million compared to $1.2 billion, representing a decrease of
17% driven by foreign exchange impacts and lower average net
selling prices. When adjusted for foreign exchange impacts,
Eliquis' international revenues declined 6%.
- Opdivo revenues increased 11%, or 16% when adjusted for foreign
exchange. U.S. revenues were $1.3 billion compared to $1.1 billion,
representing an increase of 13% driven by higher demand for our
newer metastatic and adjuvant indications, partially offset by
declining second-line eligibility across tumors and increased
competition. International revenues were $951 million compared to
$868 million, representing an increase of 10% driven by higher
demand as a result of launches for additional indications and core
indications and timing of shipments, partially offset by foreign
exchange impacts. When adjusted for foreign exchange impacts,
Opdivo's international revenues increased 20%.
New Product Portfolio
- New product portfolio revenues grew to $645 million compared to
$353 million, representing growth of 83% driven by the launch of
Opdualag and higher demand for Abecma and Reblozyl. Excluding
foreign exchange, new product portfolio revenues grew 87%.
Recent LOE Products
- Revlimid revenues declined by 32% primarily due to lower demand
as a result of generic erosion.
FOURTH QUARTER PRODUCT AND PIPELINE
UPDATE
Hematology
Category
Asset
Milestone
Regulatory
Reblozyl®* (luspatercept)
The Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has
recommended approval of Reblozyl as a treatment for adult patients
with anemia associated with non transfusion-dependent beta
thalassemia. Reblozyl is being developed and commercialized through
a global collaboration with Merck following Merck’s acquisition of
Acceleron Pharma, Inc. in November 2021.
Breyanzi® (lisocabtagene maraleucel)
Japan’s Ministry of Health, Labour and
Welfare approved Breyanzi for use in the second-line treatment of
patients with relapsed or refractory large B-cell lymphoma
regardless of whether autologous hematopoietic stem-cell
transplantation is intended. The approval is based on the results
of clinical trials in patients with relapsed or refractory
aggressive B-cell non-Hodgkin lymphoma after first-line therapy,
including global Phase III clinical trials (JCAR017-BCM-003) in
patients intended for autologous hematopoietic stem-cell
transplantation, Phase II clinical trials (017006) in the United
States in patients not intended for autologous hematopoietic
stem-cell transplantation, and cohort 2 of Phase II clinical trials
(JCAR017-
BCM-001) in Europe and Japan.
Clinical & Research
Breyanzi*
Positive topline results from the Phase 2
portion of the TRANSCEND CLL 004, a Phase 1/2, open-label,
single-arm, multicenter study evaluating Breyanzi in adults with
relapsed or refractory chronic lymphocytic leukemia or small
lymphocytic lymphoma, showed that the study met the primary
endpoint of complete response rate compared to historical control.
No new safety signals were reported for Breyanzi in this study.
Reblozyl
Phase 3 COMMANDS trial met its primary
endpoint, demonstrating a highly statistically significant and
clinically meaningful improvement in red blood cell transfusion
independence with concurrent hemoglobin increase in the first-line
treatment of adults with very low-, low-, or intermediate-risk
myelodysplastic syndromes who require red blood cell transfusions.
No new safety signals were reported.
Pipeline
Multiple Myeloma Portfolio
In December, the company presented new
data from across its multiple myeloma portfolio at the 64th
American Society of Hematology Annual Meeting and Exposition,
including:
Abecma(R) (idecabtagene vicleucel)
- Two first disclosures of Phase 2 KarMMa-2 trial evaluating
Abecma, demonstrating durable responses and predictable safety in
patients with multiple myeloma after early relapse from or
suboptimal response to stem cell transplant.
alnuctamab
- First multicenter results from the Phase 1 study of bispecific
TCE alnuctamab, administered subcutaneously every four weeks after
six months, showed a reduction in inflammatory toxicity relative to
intravenous administration, while maintaining anti-tumor activity
with deep responses.
GPRC5D CAR T (BMS-986393/ CC-95266)
- First disclosure of Phase 1 study for GPRC5D CAR T
(BMS-986393/CC-95266) demonstrating deep and durable responses with
a manageable safety profile across all dose levels, including
patients previously treated with a B-cell maturation
antigen-directed CAR T cell therapy.
mezigdomide
- First results from the dose expansion cohort of the Phase 1/2
study evaluating the novel oral CELMoD agent, mezigdomide with
dexamethasone (DEX), showing durable efficacy and a manageable
safety profile in patients who were highly refractory to multiple
prior therapies.
iberdomide
- New results from a cohort with patients previously exposed to a
BCMA-targeted therapy of iberdomide Phase 1/2 study, evaluating the
novel oral CELMoD agent with DEX, demonstrating clinically
meaningful efficacy and safety regardless of type of prior
anti-BCMA treatment.
Immunology
Category
Asset
Milestone
Regulatory
SotyktuTM* (deucrava- citinib)
The CHMP of the EMA has recommended the
approval of Sotyktu for the treatment of adults with
moderate-to-severe plaque psoriasis. The CHMP recommendation will
now be reviewed by the European Commission, which has the authority
to approve medicines for the European Union.
Clinical & Research
Zeposia®
(ozanimod)
New retrospective analyses from the
ongoing Phase 3 DAYBREAK open-label extension (OLE) study of
Zeposia in relapsing multiple sclerosis showed that more than 92%
of participants who received Zeposia mounted a serological response
following COVID-19 vaccination. Interim analyses of the ongoing
Phase 3 DAYBREAK OLE study showed that 68% of participants were
relapse-free at up to 74 months of treatment. Post hoc analyses of
the Phase 3 SUNBEAM, RADIANCE and DAYBREAK OLE studies demonstrated
that a greater proportion of patients treated with Zeposia versus
interferon beta-1a had a lower annualized rate of brain volume
loss.
*Announced in January 2023.
FULL YEAR FINANCIAL
RESULTS
All comparisons are made versus the same period in 2021
unless otherwise stated.
- Bristol Myers Squibb posted revenues of $46.2 billion,
consistent with the prior year, driven by in-line products
(primarily Eliquis and Opdivo) and our new product portfolio
(primarily Opdualag, Abecma and Reblozyl), offset by recent LOE
products (primarily Revlimid) and foreign exchange. When adjusted
for foreign exchange, revenues increased 3%. Our in-line products
and new product portfolio increased 9% to $35.4 billion, or 13%
when adjusted for foreign exchange.
- U.S. revenues increased 9% to $31.8 billion. International
revenues decreased 17% to $14.3 billion. When adjusted for foreign
exchange, international revenues decreased 8%, primarily due to
lower demand for Revlimid as a result of generic erosion, partially
offset by in-line products (primarily Opdivo) and our new product
portfolio.
- Gross margin decreased from 78.6% to 78.0% and decreased from
79.9% to 78.8% on a non- GAAP basis primarily due to product mix,
higher manufacturing costs, partially offset by foreign
exchange.
- On a GAAP basis, marketing, selling and administrative expenses
increased 2% to $7.8 billion. On a non-GAAP basis, marketing,
selling and administrative expenses increased 1% to $7.7
billion.
- On a GAAP basis, research and development expenses decreased 7%
to $9.5 billion primarily due to an IPRD impairment charge in 2021.
On a non-GAAP basis, research and development expenses decreased 2%
to $9.2 billion.
- Acquired IPRD expenses decreased from $1.2 billion to $815
million. Acquired IPRD in 2022 was primarily related to a buyout of
a future royalty obligation related to mavacamten and upfront and
milestone charges relating to Dragonfly licensing arrangement.
Acquired IPRD in 2021 was primarily related to a collaboration
agreement with Eisai and Agenus licensing transaction.
- Amortization of acquired intangible assets decreased 4% to $9.6
billion, due to a change in the expected expiration of the market
exclusivity period for Pomalyst to the first quarter of 2026 and
the expiration of Abraxane market exclusivity.
- The GAAP effective tax rate increased from 13.4% to 17.7%
primarily due to an income tax benefit of $1.0 billion in 2021
related to internal transfers of certain intangible assets,
partially offset by the release of income tax reserves and
jurisdictional earnings mix. The non-GAAP effective tax rate
decreased from 16.0% to 15.3% for the full year primarily due to
the release of income tax reserves, partially offset by
jurisdictional earnings mix.
- The company reported net earnings attributable to Bristol Myers
Squibb of $6.3 billion, or $2.95 per share, compared to $7.0
billion, or $3.12 per share. In addition to the items discussed
above, the net earnings include the impact of fair value
adjustments on equity investments in both periods and contingent
value rights in 2021.
- The company reported non-GAAP net earnings attributable to
Bristol Myers Squibb of $16.5 billion, or $7.70 per share, compared
to non-GAAP net earnings of $16.1 billion, or $7.16 per share. In
addition to the items discussed above, the earnings per share
results in 2022 include the impact of lower weighted-average common
shares outstanding.
Beginning with the first quarter of 2022, 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 are no longer
excluded from non-GAAP results. These R&D charges that were
previously specified are now presented in a new financial statement
line item labeled Acquired IPRD. GAAP and non-GAAP earnings per
share include the net impact of Acquired IPRD charges and licensing
income of ($0.01) per share in the fourth quarter for both periods.
GAAP and non-GAAP earnings per share include the net impact of
Acquired IPRD charges and licensing income of ($0.24) per share in
full-year 2022 and ($0.40) per share in full-year 2021. For
purposes of comparability, the non-GAAP financial results for the
fourth quarter of 2021 have been updated to reflect this change. A
discussion of the non- GAAP financial measures is included under
the “Use of Non-GAAP Financial Information” section.
FULL YEAR PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Full Year Ended December 31,
2022
Full Year Ended December
31, 2021
% Change from Full Year Ended
December 31, 2021
% Change from Full Year Ended
December 31, 2021 (Excl. F/X Impact)***
In-Line Products
Eliquis
$11,789
$10,762
10%
14%
Opdivo
$8,249
$7,523
10%
14%
Pomalyst/Imnovid
$3,497
$3,332
5%
8%
Orencia
$3,464
$3,306
5%
8%
Sprycel
$2,165
$2,117
2%
6%
Yervoy
$2,131
$2,026
5%
10%
Empliciti
$296
$334
(11)%
(7)%
Mature and Other Products*
$1,749
$1,900
(8)%
(5)%
Total In-Line Products Revenues
$33,340
$31,300
7%
11%
New Product Portfolio
Reblozyl
$717
$551
30%
32%
Abecma
$388
$164
**
**
Opdualag
$252
—
N/A
N/A
Zeposia
$250
$134
87%
93%
Breyanzi
$182
$87
**
**
Onureg
$124
$73
70%
74%
Inrebic
$85
$74
15%
16%
Camzyos
$24
—
N/A
N/A
Sotyktu
$8
—
N/A
N/A
Total New Product Portfolio
$2,030
$1,083
87%
92%
Total In-Line Products and New Product
Portfolio Revenues
$35,370
$32,383
9%
13%
Recent LOE Products
Revlimid
$9,978
$12,821
(22)%
(21)%
Abraxane
$811
$1,181
(31)%
(30)%
Total Recent LOE Products
$10,789
$14,002
(23)%
(22)%
Total Revenue
$46,159
$46,385
—
3%
* Includes OTC products, royalty revenue and other mature
products. ** In excess of +100%. *** See "Use of Non-GAAP Financial
Information."
FULL YEAR REVENUE
HIGHLIGHTS
In-Line Products
Revenues for in-line products were $33.3 billion compared to
$31.3 billion, representing an increase of 7% or 11% when adjusted
for foreign exchange. In-line products revenue was largely driven
by:
- Eliquis revenues grew 10%, or 14% when adjusted for foreign
exchange. U.S. revenues were $7.8 billion compared to $6.5 billion,
representing an increase of 21% driven primarily by favorable gross
to net adjustments and demand growth. International revenues were
$4.0 billion compared to $4.3 billion, representing a decrease of
7% driven primarily by foreign exchange impacts and lower average
net selling prices. When adjusted for foreign exchange impacts,
Eliquis' international revenues increased 4%.
- Opdivo revenues increased 10%, or 14% when adjusted for foreign
exchange. U.S. revenues were $4.8 billion compared to $4.2 billion,
representing an increase of 15% driven by higher demand for our
newer metastatic and adjuvant indications, partially offset by
declining second-line eligibility across tumors and increased
competition. International revenues were $3.4 billion compared to
$3.3 billion, representing an increase of 3% driven by higher
demand as a result of launches for additional indications and core
indications, partially offset by foreign exchange impacts. When
adjusted for foreign exchange impacts, Opdivo's international
revenues increased 14%.
New Product Portfolio
- New product portfolio revenues grew to $2.0 billion compared to
$1.1 billion, representing growth of 87% driven by the launch of
Opdualag and higher demand for Abecma and Reblozyl. Excluding
foreign exchange, new product portfolio revenues grew 92%.
Recent LOE Products
- Revlimid revenues declined by 22% primarily due to lower demand
as a result of generic erosion.
Environmental, Social & Governance
(ESG)
As a leading biopharma company, we understand our responsibility
extends well beyond the discovery, development, and delivery of
innovative medicines. Our evolving Environmental, Social, and
Governance (ESG) strategy builds on a legacy of comprehensive and
global sustainability efforts. To learn more about our priorities
and goals, please visit our latest ESG report.
Financial Guidance
Bristol Myers Squibb provides its 2023 GAAP EPS guidance range
of $4.03 - $4.33 and its non-GAAP EPS guidance range of $7.95 -
$8.25. Key 2023 GAAP and non-GAAP line-item guidance assumptions
are:
- Total revenues are expected to increase by approximately 2% at
reported rates and approximately 2% excluding foreign exchange.
- Revenues from Revlimid are expected to be approximately $6.5
billion.
- Gross margin is expected to be approximately 77% for GAAP and
for non-GAAP.
- Operating expenses1 are expected to decrease by mid-single
digits for GAAP and decrease by low single digits for
non-GAAP.
- An effective tax rate of approximately 22% for GAAP and
approximately 17% for non-GAAP.
1 Consists of MS&A and R&D, excluding Acquired IPRD and
Amortization of acquired intangible assets.
The 2023 financial guidance excludes the impact of any potential
future strategic acquisitions and divestitures, and any specified
items that have not yet been identified and quantified and impact
of future Acquired IPRD charges. To the extent in the future we
quantify 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 2023 non-GAAP EPS guidance is further explained under “Use of
Non-GAAP Financial Information.” The financial guidance is subject
to risks and uncertainties applicable to all forward-looking
statements as described elsewhere in this press release.
Conference Call
Information
Bristol Myers Squibb will host a conference call today at 9:00
a.m. ET during which company executives will review 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 also access the live conference
call by dialing in the U.S. toll free 888-300-3045 or international
+1 646-568-1027, conference code: 3734085. 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 on
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 through 11:30
a.m. ET on February 16, 2023, by dialing in the U.S. toll free
800-770-2030 or international +1 647-362-9199, conference code:
3734085.
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.
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 expense 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 expense 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, 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) 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.
Beginning with the first quarter of 2022, 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 are no longer
excluded from our non-GAAP financial measures. We made these
changes to our presentation of non-GAAP financial measures
following comments from and discussions with the U.S. Securities
and Exchange Commission. For purposes of comparability, the
non-GAAP financial measures for the prior periods have been updated
to reflect this change.
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 attached 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.
Also note that a reconciliation of forward-looking non-GAAP
gross margin, non-GAAP operating expenses and non-GAAP tax rate 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 able to
reliably predict the impact of the unwind of inventory purchase
price adjustments, accelerated depreciation and impairment of
property, plant and equipment and intangible assets, and stock
compensation resulting from acquisition-related equity awards, or
currency exchange rates beyond the next twelve months. In addition,
the company believes such a reconciliation would imply a degree of
precision and certainty that could be confusing to investors. The
variability of the specified items may have a significant and
unpredictable 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 2023 financial guidance, plans and strategy,
including its business development and capital allocation strategy,
anticipated developments in the company’s pipeline and expectations
with respect to the company’s future market position. 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.
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 it
finds favorable for such lawsuits; issuance of new or revised
accounting standards; and risks relating to public health
outbreaks, epidemics and pandemics, including the impact of the
COVID-19 pandemic on the company’s operations.
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, 2021, 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.
corporatefinancial-news
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE THREE MONTHS ENDED
DECEMBER 31, 2022 AND 2021
(Unaudited, dollars in
millions)
Worldwide Revenues
U.S. Revenues(c)
2022
2021
% Change
2022
2021
% Change
In-Line Products
Eliquis
$
2,688
$
2,671
1
%
$
1,718
$
1,496
15
%
Opdivo
2,216
1,988
11
%
1,265
1,120
13
%
Pomalyst/Imnovid
877
854
3
%
625
584
7
%
Orencia
913
864
6
%
710
637
11
%
Sprycel
578
555
4
%
418
351
19
%
Yervoy
568
545
4
%
345
330
5
%
Empliciti
71
81
(12
)%
44
50
(12
)%
Mature and other products(a)
411
441
(7
)%
141
146
(3
)%
Total In-Line Products
8,322
7,999
4
%
5,266
4,714
12
%
New Product Portfolio
Reblozyl
199
151
32
%
157
130
21
%
Abecma
125
69
81
%
94
67
40
%
Opdualag
104
—
N/A
104
—
N/A
Zeposia
79
48
65
%
58
34
71
%
Breyanzi
55
40
38
%
42
38
11
%
Onureg
37
25
48
%
27
22
23
%
Inrebic
23
20
15
%
17
17
—
Camzyos
16
—
N/A
16
—
N/A
Sotyktu
7
—
N/A
7
—
N/A
Total New Product Portfolio
645
353
83
%
522
308
69
%
Total In-Line and New Product
Portfolio
8,967
8,352
7
%
5,788
5,022
15
%
Recent LOE Products(b)
Revlimid
2,260
3,328
(32
)%
2,021
2,270
(11
)%
Abraxane
179
305
(41
)%
116
228
(49
)%
Total Recent LOE Products
2,439
3,633
(33
)%
2,137
2,498
(14
)%
Total Revenues
$
11,406
$
11,985
(5
)%
$
7,925
$
7,520
5
%
(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
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2022 AND
2021 (Unaudited, dollars in millions)
Worldwide Revenues
U.S. Revenues(c)
2022
2021
% Change
2022
2021
% Change
In-Line Products
Eliquis
$
11,789
$
10,762
10
%
$
7,786
$
6,456
21
%
Opdivo
8,249
7,523
10
%
4,812
4,202
15
%
Pomalyst/Imnovid
3,497
3,332
5
%
2,438
2,249
8
%
Orencia
3,464
3,306
5
%
2,638
2,410
9
%
Sprycel
2,165
2,117
2
%
1,497
1,297
15
%
Yervoy
2,131
2,026
5
%
1,304
1,265
3
%
Empliciti
296
334
(11
)%
185
200
(8
)%
Mature and other products(a)
1,749
1,900
(8
)%
565
580
(3
)%
Total In-Line Products
33,340
31,300
7
%
21,225
18,659
14
%
New Product Portfolio
Reblozyl
717
551
30
%
591
485
22
%
Abecma
388
164
**
297
158
88
%
Opdualag
252
—
N/A
252
—
N/A
Zeposia
250
134
87
%
177
99
79
%
Breyanzi
182
87
**
151
84
80
%
Onureg
124
73
70
%
95
69
38
%
Inrebic
85
74
15
%
69
67
3
%
Camzyos
24
—
N/A
24
—
N/A
Sotyktu
8
—
N/A
8
—
N/A
Total New Product Portfolio
2,030
1,083
87
%
1,664
962
73
%
Total In-Line and New Product
Portfolio
35,370
32,383
9
%
22,889
19,621
17
%
Recent LOE Products(b)
Revlimid
9,978
12,821
(22
)%
8,359
8,695
(4
)%
Abraxane
811
1,181
(31
)%
580
898
(35
)%
Total Recent LOE Products
10,789
14,002
(23
)%
8,939
9,593
(7
)%
Total Revenues
$
46,159
$
46,385
—
$
31,828
$
29,214
9
%
** In excess of +/- 100% (a) Includes 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.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS FOR THE THREE AND TWELVE MONTHS
ENDED DECEMBER 31, 2022 AND 2021 (Unaudited, dollars and shares in
millions except per share data)
Three Months Ended December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
Net product sales
$
11,065
$
11,609
$
44,671
$
45,055
Alliance and other revenues
341
376
1,488
1,330
Total Revenues
11,406
11,985
46,159
46,385
Cost of products sold(a)
2,593
2,356
10,137
9,940
Marketing, selling and administrative
2,266
2,354
7,814
7,690
Research and development(b)
2,510
2,518
9,509
10,195
Acquired IPRD(b)
52
89
815
1,159
Amortization of acquired intangible
assets
2,343
2,417
9,595
10,023
Other (income)/expense, net
(217
)
393
576
(720
)
Total Expenses
9,547
10,127
38,446
38,287
Earnings Before Income Taxes
1,859
1,858
7,713
8,098
(Benefit)/Provision for Income Taxes
(166
)
(514
)
1,368
1,084
Net Earnings
2,025
2,372
6,345
7,014
Noncontrolling Interest
3
—
18
20
Net Earnings Attributable to BMS
$
2,022
$
2,372
$
6,327
$
6,994
Weighted-Average Common Shares
Outstanding:
Basic
2,108
2,202
2,130
2,221
Diluted
2,124
2,219
2,146
2,245
Earnings per Common Share:
Basic
$
0.96
$
1.08
$
2.97
$
3.15
Diluted
0.95
1.07
2.95
3.12
Other (income)/expense, net
Interest expense(c)
$
294
$
323
$
1,232
$
1,334
Royalties and licensing income
(316
)
(317
)
(1,283
)
(1,067
)
Royalty Income - divestitures
(235
)
(219
)
(832
)
(666
)
Equity investment (income)/losses
(165
)
469
801
(745
)
Integration expenses
97
130
440
564
Loss on debt redemption
—
—
266
281
Divestiture gains
—
—
(211
)
(9
)
Litigation and other settlements
146
33
178
82
Investment income
(82
)
(6
)
(171
)
(39
)
Provision for restructuring
15
19
75
169
Contingent consideration
(10
)
(32
)
(9
)
(542
)
Other
39
(7
)
90
(82
)
Other (income)/expense, net
$
(217
)
$
393
$
576
$
(720
)
(a) Excludes amortization of acquired intangible assets. (b)
Research and development charges resulting from upfront or
contingent milestone payments in connection with asset acquisitions
or licensing of third-party intellectual property rights have been
reclassified to the Acquired IPRD line item beginning with the
first quarter of 2022. Prior period results have been revised for
comparability. (c) Includes amortization of purchase price
adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31,
2022 AND 2021 (Unaudited, dollars in millions)
Three Months Ended December
31,
Twelve Months Ended December
31,
2022
2021(a)
2022
2021(a)
Inventory purchase price accounting
adjustments
$
53
$
—
$
293
$
264
Intangible asset impairment
—
—
—
315
Site exit and other costs
20
—
63
24
Cost of products sold
73
—
356
603
Employee compensation charges
—
—
73
1
Site exit and other costs
—
2
6
2
Marketing, selling and administrative
—
2
79
3
IPRD impairments
—
—
98
840
Inventory purchase price accounting
adjustments
—
—
130
1
Employee compensation charges
—
—
80
1
Site exit and other costs
—
—
—
1
Research and development
—
—
308
843
Amortization of acquired intangible
assets
2,343
2,417
9,595
10,023
Interest expense(b)
(17
)
(29
)
(83
)
(120
)
Equity investment losses/(income)
(163
)
469
799
(758
)
Integration expenses
97
130
440
564
Loss on debt redemption
—
—
266
281
Divestiture gains
—
—
(211
)
(9
)
Litigation and other settlements
144
—
140
—
Provision for restructuring
15
19
75
169
Contingent consideration
—
(32
)
—
(542
)
Other
1
—
71
—
Other (income)/expense, net
77
557
1,497
(415
)
Increase to pretax income
2,493
2,976
11,835
11,057
Income taxes on items above
(345
)
(261
)
(1,332
)
(993
)
Income tax reserve release attributed to
Mead Johnson
(225
)
—
(225
)
—
Income taxes attributed to internal
transfers of intangible assets
(72
)
(983
)
(72
)
(983
)
Income taxes
(642
)
(1,244
)
(1,629
)
(1,976
)
Increase to net earnings
$
1,851
$
1,732
$
10,206
$
9,081
(a) Revised to exclude significant R&D charges or other
income resulting from upfront and contingent milestone payments in
connection with asset acquisitions or licensing of third-party
intellectual property rights (including related income tax
impacts). (b) Includes amortization of purchase price adjustments
to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE
ITEMS FOR THE THREE AND TWELVE MONTHS ENDED DECEMBER 31, 2022 AND
2021 (Unaudited, dollars and shares in millions except per share
data)
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
(Benefit)/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
%
Three Months Ended December 31,
2021
Twelve Months Ended December 31,
2021
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross Profit
$
9,629
$
—
$
9,629
$
36,445
$
603
$
37,048
Marketing, selling and administrative
2,354
(2
)
2,352
7,690
(3
)
7,687
Research and development
2,518
—
2,518
10,195
(843
)
9,352
Amortization of acquired intangible
assets
2,417
(2,417
)
—
10,023
(10,023
)
—
Other (income)/expense, net
393
(557
)
(164
)
(720
)
415
(305
)
Earnings Before Income Taxes
1,858
2,976
4,834
8,098
11,057
19,155
(Benefit)/Provision for Income Taxes
(514
)
1,244
730
1,084
1,976
3,060
Net Earnings Attributable to BMS used for
Diluted EPS Calculation
$
2,372
$
1,732
$
4,104
$
6,994
$
9,081
$
16,075
Weighted-Average Common Shares Outstanding
- Diluted
2,219
2,219
2,219
2,245
2,245
2,245
Diluted Earnings Per Share
$
1.07
$
0.77
$
1.84
$
3.12
$
4.04
$
7.16
Effective Tax Rate
(27.7
) %
42.8
%
15.1
%
13.4
%
2.6
%
16.0
%
(a) Refer to the Specified Items schedule 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, 2022 AND DECEMBER 31, 2021
(Unaudited, dollars in millions)
December 31, 2022
December 31, 2021
Cash and cash equivalents
$
9,123
$
13,979
Marketable debt securities
130
2,987
Cash, cash equivalents and marketable
debt securities
9,253
16,966
Short-term debt obligations
(4,264
)
(4,948
)
Long-term debt
(35,056
)
(39,605
)
Net debt position
$
(30,067
)
$
(27,587
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230202005178/en/
Media: media@bms.com Investor Relations:
investor.relations@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2023 to Apr 2024