- Reports Fourth Quarter Revenues of $11.1 Billion; Full-Year
Revenues of $42.5 Billion
- Posts Fourth Quarter Loss Per Share of $4.45 and Non-GAAP
EPS of $1.46; Full-Year Loss Per Share of $3.99 and Non-GAAP EPS of
$6.44
- Completes Acquisition of MyoKardia, Expanding Leading
Cardiovascular Franchise
- Announces Debt Tender Offer for an Aggregate Purchase Price
of Up to $4.0 Billion
- Delivers Positive Results from POETYK-PSO-2 Evaluating
Deucravacritinib (TYK2 inhibitor) for Treatment of Moderate to
Severe Plaque Psoriasis
- Announces Licensing Agreement with The Rockefeller
University for SARS-CoV-2 Neutralizing Monoclonal Antibody
Combination for the Treatment of COVID-19
- Provides GAAP and Non-GAAP Financial Guidance for 2021;
Raises 2021 Non-GAAP EPS Guidance
- Affirms Long-term Financial Targets
Bristol Myers Squibb (NYSE:BMY) today reports results for the
fourth quarter and full year of 2020, which reflect robust sales,
strong operating performance and advancement of the company’s
product pipeline.
“In our first full year as a new company we delivered solid
operational and financial results, and laid a strong foundation for
the future,” said Giovanni Caforio, M.D., board chair and chief
executive officer, Bristol Myers Squibb. “I am grateful to our team
whose resilience and continued focus enabled us to grow our inline
business, launch promising new drugs and significantly advance our
pipeline while keeping our colleagues safe and maintaining the
supply of our medicines to patients. The growth opportunities from
our in-line and launch portfolios combined with a robust product
pipeline and disciplined business development strategy strongly
position the company to accelerate the renewal of our portfolio and
achieve long-term sustainable growth.”
Fourth
Quarter
$ amounts in millions, except per
share amounts
2020
2019
Change
Total Revenues
$11,068
$7,945
39%
Earnings (Loss) Per Share -
GAAP
(4.45)
(0.55)
**
Earnings (Loss) Per Share -
Non-GAAP
1.46
1.22
20%
Total Pro Forma Revenues*
11,068
10,103
10%
Full-Year
$ amounts in millions, except per
share amounts
2020
2019
Change
Total Revenues
$42,518
$26,145
63%
Earnings (Loss) Per Share -
GAAP
(3.99)
2.01
N/A
Earnings (Loss) Per Share -
Non-GAAP
6.44
4.69
37%
Total Pro Forma Revenues*
42,518
39,759
7%
*The pro forma revenues assume the company’s acquisition of
Celgene Corporation (Celgene Acquisition) and its divestiture of
Otezla® to Amgen Inc. (Otezla® Divestiture) occurred on January 1,
2019 and exclude foreign currency hedge gains and losses.
Management believes that measuring revenue rates on a comparable
pro forma basis is an appropriate way for investors to best
understand the underlying performance of the business. The pro
forma revenue is presented for informational purposes only and does
not purport to project the company’s revenue, results of operations
or financial position for any future period or as of any future
date. See “Worldwide Pro Forma Revenue” in Quarterly Package of
Financial Information for this quarter and full year of 2020, which
is available on
bms.com/investors/financial-reporting/quarterly-results, for
information on the revenue of the company and Celgene on a
stand-alone basis for the prior-year period. Otezla® is a trademark
of Amgen Inc.
**In excess of +100%
FOURTH QUARTER FINANCIAL
RESULTS
All comparisons are made versus the same period in 2019
unless otherwise stated.
- Bristol Myers Squibb posted fourth quarter revenues of $11.1
billion, an increase of 39% on a reported basis and 10% on a pro
forma basis. The increase was driven primarily by the impact of the
Celgene Acquisition, which was completed on November 20, 2019.
- U.S. revenues increased 43% to $6.8 billion in the quarter.
International revenues increased 34% to $4.3 billion in the
quarter. When adjusted for foreign exchange impact, international
revenues increased 30%.
- Gross margin increased from 68.6% to 73.7% in the quarter
primarily due to product mix, lower unwinding of inventory purchase
price accounting adjustments, partially offset by an impairment
charge related to Inrebic marketed product rights.
- Marketing, selling and administrative expenses increased 57% to
$2.7 billion in the quarter primarily due to $400 million of costs
associated with the broader portfolio resulting from the Celgene
Acquisition, as well as higher advertising and promotion expenses
and cash settlement of MyoKardia unvested stock awards.
- Research and development expenses increased 79% to $3.8 billion
in the quarter primarily due to $500 million of costs associated
with the broader portfolio resulting from the Celgene Acquisition,
as well as license and acquisition charges related to Dragonfly, an
in-process research and development (IPR&D) impairment charge
related to the discontinuation of the orva-cel program development
and cash settlement of MyoKardia unvested stock awards.
- Amortization of acquired intangible assets increased to $2.5
billion in the quarter reflecting the full quarter amortization
from the Celgene Acquisition.
- IPR&D charge of $11.4 billion was included in the quarter
due to the MyoKardia transaction being accounted for as an asset
acquisition.
- The effective tax benefit rate was 4.1% in the current quarter
and includes the impact of the non-deductible MyoKardia IPR&D
charge. Income taxes were $931 million despite pre-tax loss of $129
million in the same period a year ago primarily due to the Otezla®
divestiture, certain non-deductible expenses and purchase price
adjustments.
- The company reported net loss attributable to Bristol Myers
Squibb of $10.0 billion, or $4.45 per share, in the fourth quarter,
compared to net loss of $1.1 billion, or $0.55 per share, for the
same period a year ago. The results in the current quarter include
costs and expenses resulting from the IPRD charge related to the
MyoKardia asset acquisition, purchase price accounting from the
Celgene Acquisition, contingent value rights fair value
adjustments, equity investment gains, intangible assets impairment
charges and other acquisition and integration expenses.
- The company reported non-GAAP net earnings attributable to
Bristol Myers Squibb of $3.3 billion, or $1.46 per share, in the
fourth quarter, compared to non-GAAP net earnings of $2.4 billion,
or $1.22 per share, for the same period a year ago. A discussion of
the non-GAAP financial measures is included under the “Use of
Non-GAAP Financial Information” section.
FOURTH QUARTER
PRODUCT REVENUE HIGHLIGHTS
$ amounts in millions
Product
Quarter Ended December 31,
2020 on Reported Basis
% Change from Quarter Ended
December 31, 2019 on Reported Basis
% Change from Quarter Ended
December 31, 2019 on Pro Forma Basis**
Revlimid
$3,280
*
18%
Eliquis
$2,269
12%
12%
Opdivo
$1,793
2%
2%
Orencia
$867
9%
9%
Pomalyst/Imnovid
$835
*
21%
Sprycel
$564
3%
3%
Yervoy
$471
22%
22%
Abraxane
$297
79%
(12)%
Empliciti
$91
(3)%
(3)%
Reblozyl
$115
N/A
N/A
Inrebic
$15
*
67%
Onureg
$14
N/A
N/A
Zeposia
$9
N/A
N/A
*In excess of +100%. Product rights were acquired as part of the
Celgene Acquisition.
**Pro forma product revenues assume the Celgene Acquisition and
the Otezla® Divestiture occurred on January 1, 2019 and exclude
foreign currency hedge gains and losses. Management believes that
measuring product revenue rates on a comparable pro forma basis is
an appropriate way for investors to best understand the underlying
performance of the business. The pro forma product revenue is
presented for informational purposes only and does not purport to
project product revenue for any future period or as of any future
date. See “Worldwide Pro Forma Revenues” in the Quarterly Package
of Financial Information for this quarter and full year of 2020,
which is available on
bms.com/investors/financial-reporting/quarterly-results, for
information on the product revenue of the company and Celgene for
the prior-year period. Otezla® is a trademark of Amgen Inc.
FULL-YEAR PRODUCT
REVENUE HIGHLIGHTS
$ amounts in millions
Product
Twelve Months Ended December
31, 2020 on Reported Basis
% Change from Twelve Months
Ended December 31, 2019 on Reported Basis
% Change from Twelve Months
Ended December 31, 2019 on Pro Forma Basis**
Revlimid
$12,106
*
12%
Eliquis
$9,168
16%
16%
Opdivo
$6,992
(3)%
(3)%
Orencia
$3,157
6%
6%
Pomalyst/Imnovid
$3,070
*
22%
Sprycel
$2,140
1%
1%
Yervoy
$1,682
13%
13%
Abraxane
$1,247
*
0%
Empliciti
$381
7%
7%
Reblozyl
$274
N/A
N/A
Inrebic
$55
*
*
Onureg
$17
N/A
N/A
Zeposia
$12
N/A
N/A
*In excess of +100%. Product rights were acquired as part of the
Celgene Acquisition.
**Pro forma product revenues assume the Celgene Acquisition and
the Otezla® Divestiture occurred on January 1, 2019 and exclude
foreign currency hedge gains and losses. Management believes that
measuring product revenue rates on a comparable pro forma basis is
an appropriate way for investors to best understand the underlying
performance of the business. The pro forma product revenue is
presented for informational purposes only and does not purport to
project product revenue for any future period or as of any future
date. See “Worldwide Pro Forma Revenues” in the Quarterly Package
of Financial Information for this quarter and full year of 2020,
which is available on
bms.com/investors/financial-reporting/quarterly-results, for
information on the product revenue of the company and Celgene for
the prior-year period. Otezla® is a trademark of Amgen Inc.
FOURTH QUARTER PRODUCT AND PIPELINE
UPDATE
Oncology
Opdivo
Regulatory
- In January, the company announced that the U.S. Food & Drug
Administration (FDA) approved OPDIVO (nivolumab) in combination
with CABOMETYX® (cabozantinib), for the first-line treatment of
patients with advanced renal cell carcinoma. The approval is based
on the Phase 3 Checkmate -9ER trial. (link)
- In January, the company announced that the U.S. Food and Drug
Administration (FDA) has accepted its supplemental Biologics
License Application (sBLA) for Opdivo®, in combination with
fluoropyrimidine- and platinum-containing chemotherapy, for the
treatment of patients with advanced or metastatic gastric cancer,
gastroesophageal junction cancer (GEJC) or esophageal
adenocarcinoma (EAC), based on results from the CheckMate -649
trial. The U.S. FDA granted the application Priority Review and
assigned a Prescription Drug User Fee Act (PDUFA) goal date of May
25, 2021.(link)
- In January, the company announced that the U.S. FDA has
accepted its supplemental sBLA for Opdivo® for the treatment of
patients with resected esophageal or gastroesophageal junction
(GEJ) cancer in the adjuvant setting, after neoadjuvant
chemoradiation therapy (CRT), based on results from the Phase 3
CheckMate -577 trial. The U.S. FDA granted the application Priority
Review and assigned a PDUFA goal date of May 20, 2021.(link)
- In January, the company announced that the European Medicines
Agency (EMA) validated its Marketing Authorization Application
(MAA) for Opdivo, based on results from the Phase 3 CheckMate -577
trial, as an adjuvant treatment for esophageal or GEJ cancer in
adult patients with residual pathologic disease after neoadjuvant
chemoradiotherapy (CRT) and resection. (link)
- In January, the EMA validated the Type II Variation MAA for
Opdivo in combination with fluoropyrimidine- and platinum-based
combination chemotherapy for the first-line treatment of adult
patients with advanced or metastatic gastric cancer (GC), GEJ
cancer or esophageal adenocarcinoma (EAC). The filing was based on
the Phase 3 CheckMate -649 trial. (link)
- In November, the company announced that the European Commission
(EC) has approved Opdivo for the treatment of adults with
unresectable advanced, recurrent or metastatic esophageal squamous
cell carcinoma (ESCC) after prior fluoropyrimidine- and
platinum-based combination chemotherapy. (link)
- In November, the company announced that the EC, based on
results from the Phase 3 CheckMate -9LA trial, has approved Opdivo
plus Yervoy (ipilimumab) with two cycles of platinum-based
chemotherapy for the first-line treatment of adult patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors have no
sensitizing epidermal growth factor receptor (EGFR) mutation or
anaplastic lymphoma kinase (ALK) translocation. (link)
Clinical
- In December, the company announced that CheckMate -548, a Phase
3 trial evaluating the addition of Opdivo to the current standard
of care (temozolomide and radiation therapy) in patients with newly
diagnosed glioblastoma multiforme (GBM) with O6-methylguanine-DNA
methyltransferase (MGMT) promoter methylation following surgical
resection of the tumor, did not meet its primary endpoint of
overall survival (OS) in patients with no baseline corticosteroid
use or in the overall randomized population. (link)
Hematology
Revlimid
Patent Update
- In December, the company announced that its wholly owned
subsidiary, Celgene, and Cipla Limited (Cipla) have settled their
litigation related to patents for REVLIMID® (lenalidomide).
(link)
Inrebic®
Regulatory
- In December, the company announced the Committee for Medicinal
Products for Human Use (CHMP) of the EMA has recommended approval
of Inrebic (fedratinib) for the treatment of disease-related
splenomegaly (enlarged spleen) or symptoms in adult patients with
primary myelofibrosis, post-polycythaemia vera myelofibrosis or
post-essential thrombocythaemia myelofibrosis, who are Janus
Associated Kinase(JAK) inhibitor naïve or have been treated with
ruxolitinib. The CHMP recommendation will now be reviewed by the
EC, which has the authority to approve medicines for the EU.
(link)
Medical Conferences
In December, at the 2020 American Society of Hematology (ASH)
Annual Meeting, the company announced important new data and
analysis from its hematology portfolio:
- QUAZAR® AML-001: a study evaluating Onureg®(azacitidine
tablets; CC-486), an oral hypomethylating agent, as a treatment for
adult patients with acute myeloid leukemia (AML) who achieved first
complete remission (CR) or CR with incomplete blood count recovery
following intensive induction chemotherapy. (link)
- TRANSCEND CLL 004: longer-term follow-up from the Phase I study
evaluating liso-cel in relapsed or refractory chronic lymphocytic
leukemia or small lymphocytic lymphoma with liso-cel as monotherapy
and initial results from the combination cohort with ibrutinib.
(link)
- TRANSCEND NHL 001: safety and efficacy results in the cohort of
patients with relapsed or refractory (R/R) mantle cell lymphoma
(MCL) treated with liso-cel. (link)
- OUTREACH: initial results evaluating outcomes of treatment with
liso-cel for patients with relapsed or refractory large B-cell
lymphoma (LBCL) across inpatient and outpatient settings.
(link)
- First efficacy and safety results from a triplet combination
study including iberdomide, a cereblon E3 ligase modulator
(CELMoD)® agent, with daratumumab or bortezomib and dexamethasone
in patients with heavily pretreated R/R multiple myeloma.
(link)
The following data were also presented at the 2020 ASH Annual
Meeting by the company and bluebird bio, Inc. (Nasdaq: BLUE):
- Phase 1 CRB-401: longer-term data from the original Phase 1
CRB-401 study evaluating the companies’ investigational B-cell
maturation antigen (BCMA) directed chimeric antigen receptor (CAR)
T cell therapy, idecabtagene vicleucel (ide-cel) in relapsed and
refractory multiple myeloma (RRMM). (link)
- Phase 2 KarMMA: analyses from the Phase 2 KarMMA study of
patients with triple-class exposed relapsed and refractory multiple
myeloma (RMM). (link)
Immunology
Deucravacitinib (BMS-986165; TYK2 inhibitor)
Clinical
- In February, the company announced results from POETYK PSO-2,
the second Phase 3 trial evaluating deucravacitinib, a novel, oral,
selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of
patients with moderate to severe plaque psoriasis. POETYK PSO-2 met
both co-primary endpoints evaluating deucravacitinib versus
placebo, with significantly more patients achieving Psoriasis Area
and Severity Index (PASI 75) and Physician's Global Assessment
(sPGA) scales and met multiple key secondary endpoints versus
Otezla® (apremilast). (link)
Zeposia
Clinical
- In February, the company announced that U.S. FDA has accepted
its supplemental New Drug Application (sNDA) for Zeposia for the
treatment of adults with moderately to severely active ulcerative
colitis (UC). The FDA granted Priority Review to the application
and assigned a PDUFA goal date, or target action date, of May 30,
2021. (link)
- In December, the company announced that the EMA has validated
its MAA for Zeposia (ozanimod) for the treatment of adults with
moderately to severely active ulcerative colitis (UC). (link)
Medical Conferences
In November, at the American College of Rheumatology (ACR)
Convergence 2020, the company announced important new data and
analysis across its Immunology portfolio:
- deucravacitinib (BMS-986165): results from an ongoing Phase 2
study evaluating the safety and efficacy of deucravacitinib
(BMS-986165) compared with placebo in adults with active psoriatic
arthritis met the primary endpoint. (link)
- Iberdomide: results from a Phase 2b trial in patients with
active systemic lupus erythematosus (SLE) assessing iberdomide met
its primary endpoint in patients with high Type 1 interferon or
Aiolos gene expressions. (link)
Business Development
- In November, the company announced that it has successfully
completed its acquisition of MyoKardia (MyoKardia Acquisition) in
an all cash transaction for approximately $13.1 billion.
(link)
Capital Allocation
The company continues to maintain a consistent, balanced
approach to capital allocation focused on prioritizing investment
for growth through business development along with reducing debt,
commitment to dividend growth and share repurchase.
- Today, the company announced a debt tender offer for an
aggregate purchase price of up to $4.0 billion. (link)
- In January 2021, the company announced that its Board of
Directors has authorized incremental share repurchases of up to an
additional $2 billion of the company’s outstanding shares of common
stock. With this increase, the remaining share repurchase capacity
under the company’s share repurchase program was approximately $6.4
billion. During 2021, the company plans to repurchase $3.0-$4.0
billion of its shares. (link)
Commitment to Sustainability, Diversity
and Inclusion
- In December, the company announced it is strengthening its
commitment to environmental sustainability on a global basis by
setting new 2030 and 2040 goals. By 2030, the company will purchase
100% of the electricity it uses from renewable sources, and by
2040, it will be carbon neutral in its Scope 1 (direct) and Scope 2
(indirect) emissions and reach the targets of equitable water use,
zero waste to landfill and 100% electric vehicles in its fleet.
(link)
- In November, the Bristol Myers Squibb Foundation and National
Medical Fellowships announced that they will leverage $100 million
of the previously announced commitment from Bristol Myers Squibb
and the Bristol Myers Squibb Foundation to diversity and inclusion
to develop a program to extend the reach of clinical trials into
underserved patient populations in urban and rural U.S.
communities. (link)
COVID-19 Pandemic
Response
During the current world health crisis, the company continues to
take all necessary actions to promote public health by carrying out
its mission of providing life-saving medicines to the patients who
depend on the company and supporting relief efforts across the
globe. (link)
- In February, the company and The Rockefeller University
announced that they have entered into a definitive agreement under
which Bristol Myers Squibb has been granted a global exclusive
license to develop, manufacture, and commercialize Rockefeller’s
novel monoclonal antibody (“mAb”) duo treatment that neutralizes
the SARS-CoV-2 virus for therapy or prevention of COVID-19.
(link)
Financial Guidance
Bristol Myers Squibb is providing 2021 GAAP EPS guidance in the
range of $3.12-$3.32 and is increasing its non-GAAP EPS guidance
range from $7.15 - $7.45 to $7.35 - $7.55. Both GAAP and non-GAAP
guidance assume current exchange rates. Key 2021 GAAP and non-GAAP
line item guidance assumptions are:
- Worldwide revenues increasing in the high-single digits.
- Gross margin as a percentage of revenue to be approximately
80.5%.
- Marketing, selling and administrative expenses to be in-line
with 2020 levels for GAAP and increasing in the low-single digit
range for non-GAAP.
- Research and development expenses decreasing in the high-single
digits for GAAP and increasing in the mid-single digits for
non-GAAP.
- An effective tax rate of approximately 22% for GAAP and
approximately 16% for non-GAAP.
The 2021 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. The 2021
non-GAAP EPS guidance is explained and further excludes other
specified items as discussed 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.
Long-term Financial
Targets
Bristol Myers Squibb is also affirming 2020-2025 long-term
financial targets communicated in January 2021 (link):
- Expects low to mid-single digit revenue CAGR and low
double-digit revenue CAGR excluding Revlimid® & Pomalyst® at
constant exchange rates
- Expects to maintain low to mid-40s percent non-GAAP operating
margin
- Expects significant cash flow generation of $45-$50 billion
dollars from 2021 -2023.
This financial guidance excludes the impact of any potential
future strategic acquisitions and divestitures as well as any
specified items as discussed under “Use of Non-GAAP Financial
Information.” There is no reliable or reasonably estimable
comparable GAAP measures for this non-GAAP financial guidance. The
financial guidance is subject to risks and uncertainties applicable
to all forward-looking statements as described elsewhere in this
press release.
Company and Conference Call
Information
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.
There will be a conference call on February 4 at 10 a.m. ET
during which company executives will review financial information
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 or by dialing in the U.S. toll free
800-458-4121 or international +1 313-209-6672, confirmation code:
4441406, or using this link which becomes active 15 minutes prior
to the scheduled start time and entering your information to be
connected. Materials related to the call will be available at the
same website prior to the conference call.
A replay of the call will be available beginning at 1:30 p.m. ET
on February 4 through 1:30 p.m. ET on February 18, 2021. The replay
will also be available through http://investor.bms.com or by
dialing in the U.S. toll free 888-203-1112 or international
719-457-0820, confirmation code: 4441406.
###
.
Use of Non-GAAP Financial
Information
This earnings release contains non-GAAP financial measures,
including non-GAAP earnings and related EPS information that are
adjusted to exclude certain costs, expenses, gains and losses and
other specified items that are evaluated on an individual basis.
Reconciliations of these non-GAAP financial measures to the most
comparable GAAP measures are provided in the accompanying financial
tables and also available on the company’s website at
www.bms.com.
These non-GAAP items are adjusted 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 future operating
results. Similar charges or gains were recognized in prior periods
and will likely reoccur in future periods, including amortization
of acquired intangible assets beginning in the fourth quarter of
2019, including product rights that generate a significant portion
of our ongoing revenue, unwind of inventory fair value adjustments,
acquisition and integration expenses, restructuring costs,
accelerated depreciation and impairment of property, plant and
equipment and intangible assets, R&D charges or other income
resulting from upfront or contingent milestone payments in
connection with the acquisition or licensing of third-party
intellectual property rights, costs of acquiring a priority review
voucher, IPRD charge resulting from the MyoKardia acquisition,
divestiture gains or losses, stock compensation resulting from
accelerated vesting of Celgene awards, certain retention-related
employee compensation charges related to the Celgene Acquisition,
pension, legal and other contractual settlement charges, interest
expense on the notes issued in May 2019 incurred prior to the
Celgene Acquisition and interest income earned on the net proceeds
of those notes, equity investment and contingent value rights fair
value adjustments 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 internal transfer of intangible assets and
the Otezla® Divestiture. This earnings release also provides
international revenues excluding the impact of foreign
exchange.
Non-GAAP information is intended to 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 facilitate comparisons among
current, past and future periods. For example, non-GAAP earnings
and EPS information are indications of the company’s baseline
performance before items that are considered by us to not be
reflective of the company’s ongoing results. In addition, this
information is among the primary indicators that we use as a basis
for evaluating performance, allocating resources, setting incentive
compensation targets and planning and forecasting for future
periods. This information is not intended to be considered in
isolation or as a substitute for net earnings or diluted EPS
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.
In connection with presenting our outlook, we are also providing
revenue (ex-FX) and non-GAAP operating margin guidance for
2020-2025. There are no reliable or reasonably estimable comparable
GAAP measures for this because we are not able to reliably predict
the impact of specified items or currency exchange rates beyond the
next twelve months. As a result, the reconciliation of these
non-GAAP measures to the most directly comparable GAAP measures is
not available without unreasonable effort. 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, statements
relating to goals, plans and projections regarding the company’s
financial position, results of operations, market position, product
development and business strategy. 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. One can also
identify forward-looking statements by the fact that they do not
relate strictly to historical or current facts. These statements
are likely to relate to, among other things, the company’s ability
to execute successfully its strategic plans, including its business
development strategy generally and in relation to its ability to
realize the projected benefits of the Celgene Acquisition and the
MyoKardia Acquisition, the full extent of the impact of the
COVID-19 pandemic on the company’s operations and the development
and commercialization of its products, potential laws and
regulations to lower drug costs, market actions taken by private
and government payers to manage drug utilization and contain costs,
the expiration of patents or data protection on certain products,
including assumptions about the company’s ability to retain patent
exclusivity of certain products and the impact and the result of
governmental investigations. No forward-looking statement can be
guaranteed, including that the company’s future clinical studies
will support the data described in this release, product candidates
will receive necessary clinical and manufacturing regulatory
approvals, pipeline products will prove to be commercially
successful, clinical and manufacturing regulatory approvals will be
sought or obtained within currently expected timeframes or
contractual milestones will be achieved.
Such forward-looking statements are based on historical
performance and 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, risks relating to various risks related to public
health outbreaks, epidemics and pandemics, including the impact of
the COVID-19 pandemic on the company’s operations and that the
company cannot reasonably assess or predict at this time the full
extent of the adverse effect that the COVID-19 pandemic will have
on its business, financial condition, results of operations and
cash flows; increasing pricing pressures from market access,
pharmaceutical pricing controls and discounting, changes to tax and
importation laws and other restrictions in the United States, the
European Union and other regions around the world that result in
lower prices, lower reimbursement rates and smaller populations for
whom payers will reimburse; challenges inherent in new product
development, including obtaining and maintaining regulatory
approval; 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; the risk of certain
novel approaches to disease treatment (such as CAR T therapy);
industry competition from other manufacturers; potential
difficulties, delays and disruptions in manufacturing, distribution
or sale of products, including without limitation, interruptions
caused by damage to the company’s and the company’s suppliers’
manufacturing sites; integrating the company’s and Celgene’s
business and operations, including with respect to human capital
management, portfolio rationalization, finance and accounting
systems, sales operations and product distribution, pricing systems
and methodologies, data security systems, compliance programs and
internal controls processes, on the company’s ability to realize
the anticipated benefits from the Celgene Acquisition; the risk of
an adverse patent litigation decision or settlement and exposure to
other litigation and/or regulatory actions; the impact of any
healthcare reform and legislation or regulatory action in the
United States and international markets; changes in tax law and
regulations; the failure of the company’s suppliers, vendors,
outsourcing partners, alliance partners and other third parties to
meet their contractual, regulatory and other obligations;
regulatory decisions impacting labeling, manufacturing processes
and/or other matters; the impact on the company’s competitive
position from counterfeit or unregistered versions of its products
or stolen products; the adverse impact of cyber-attacks on the
company’s information systems or products, including unauthorized
disclosure of trade secrets or other confidential data stored in
the company’s information systems and networks; the company’s
ability to execute its financial, strategic and operational plans;
the company’s ability to identify potential strategic acquisitions,
licensing opportunities or other beneficial transactions; the
company’s dependency on several key products; any decline in the
company’s future royalty streams; the company’s ability to
effectively manage acquisitions, divestitures, alliances and other
portfolio actions and to successfully realize the expected benefits
of such actions; the company’s ability to attract and retain key
personnel; the impact of the company’s significant additional
indebtedness that it incurred in connection with the Celgene
Acquisition and the MyoKardia Acquisition and its issuance of
additional shares in connection with the Celgene Acquisition on its
ability to operate the combined company; political and financial
instability of international economies and sovereign risk; interest
rate and currency exchange rate fluctuations, credit and foreign
exchange risk management; our exclusive forum provision in our
by-laws for certain lawsuits could limit our stockholders’ ability
to obtain a judicial forum that it finds favorable for such
lawsuits; and issuance of new or revised accounting standards. In
addition, the financial guidance provided in this release relies on
assumptions about the duration and severity of the COVID-19
pandemic, timing of the return to a more stable business
environment, patient and physician behaviors, buying patterns and
clinical trial activities (together, the “Recovery Process”), among
other things. If the actual Recovery Process differs materially
from our assumptions, the impact of COVID-19 on our business could
be worse than expected and our results may be negatively
impacted.
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, 2019, 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
PRODUCT REVENUES
FOR THE THREE MONTHS ENDED
DECEMBER 31, 2020 AND 2019
(Unaudited, dollars in
millions)
Worldwide Revenues
U.S. Revenues(d)
2020(b)
2019(c)
% Change
2020(b)
2019(c)
% Change
Prioritized Brands
Revlimid
$
3,280
$
1,299
**
$
2,197
$
899
**
Eliquis
2,269
2,034
12
%
1,227
1,156
6
%
Opdivo
1,793
1,763
2
%
963
1,020
(6)
%
Orencia
867
792
9
%
626
577
8
%
Pomalyst/Imnovid
835
322
**
577
226
**
Sprycel
564
549
3
%
351
319
10
%
Yervoy
471
385
22
%
304
254
20
%
Abraxane
297
166
79
%
214
122
75
%
Empliciti
91
94
(3)
%
53
63
(16)
%
Reblozyl
115
—
N/A
104
—
N/A
Inrebic
15
5
**
15
5
**
Onureg
14
—
N/A
14
—
N/A
Zeposia
9
—
N/A
7
—
N/A
Established Brands
Vidaza
65
58
12
%
—
1
(100)
%
Baraclude
104
122
(15)
%
3
4
(25)
%
Other Brands(a)
279
356
(22)
%
127
108
18
%
Total
$
11,068
$
7,945
39
%
$
6,782
$
4,754
43
%
**
In excess of +/- 100%.
(a)
Includes Sustiva, Reyataz,
Daklinza and all other BMS and Celgene products acquired as part of
the Celgene acquisition that have lost exclusivity in major
markets, over-the-counter brands and royalty revenue. Other Brands
includes $46 million worldwide and $58 million U.S. revenues
relating to Celgene products for the three months ended December
31, 2020.
(b)
Includes Celgene product revenues
for the entire period.
(c)
Includes Celgene product revenues
from November 20, 2019 through December 31, 2019.
(d)
Includes Puerto Rico.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE TWELVE MONTHS ENDED
DECEMBER 31, 2020 AND 2019
(Unaudited, dollars in
millions)
Worldwide Revenues
U.S. Revenues(d)
2020(b)
2019(c)
% Change
2020(b)
2019(c)
% Change
Prioritized Brands
Revlimid
$
12,106
$
1,299
**
$
8,291
$
899
**
Eliquis
9,168
7,929
16
%
5,485
4,755
15
%
Opdivo
6,992
7,204
(3
)%
3,945
4,344
(9
)%
Orencia
3,157
2,977
6
%
2,268
2,146
6
%
Pomalyst/Imnovid
3,070
322
**
2,136
226
**
Sprycel
2,140
2,110
1
%
1,295
1,191
9
%
Yervoy
1,682
1,489
13
%
1,124
1,004
12
%
Abraxane
1,247
166
**
873
122
**
Empliciti
381
357
7
%
230
246
(7
)%
Reblozyl
274
—
N/A
259
—
N/A
Inrebic
55
5
**
55
5
**
Onureg
17
—
N/A
17
—
N/A
Zeposia
12
—
N/A
10
—
N/A
Established Brands
Vidaza
455
58
**
2
1
100
%
Baraclude
447
555
(19
)%
12
20
(40
)%
Other Brands(a)
1,315
1,674
(21
)%
575
383
50
%
Total
$
42,518
$
26,145
63
%
$
26,577
$
15,342
73
%
**
In excess of +/- 100%.
(a)
Includes Sustiva, Reyataz,
Daklinza and all other BMS and Celgene products acquired as part of
the Celgene acquisition that have lost exclusivity in major
markets, over-the-counter brands and royalty revenue. Other Brands
includes $308 million worldwide and $295 million U.S. revenues
relating to Celgene products for the twelve months ended December
31, 2020.
(b)
Includes Celgene product revenues
for the entire period.
(c)
Includes Celgene product revenues
from November 20, 2019 through December 31, 2019.
(d)
Includes Puerto Rico.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF
EARNINGS
FOR THE THREE AND TWELVE MONTHS
ENDED DECEMBER 31, 2020 AND 2019
(Unaudited, dollars and shares in
millions except per share data)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020(c)
2019(d)
2020(c)
2019(d)
Net product sales
$
10,766
$
7,662
$
41,321
$
25,174
Alliance and other revenues
302
283
1,197
971
Total Revenues
11,068
7,945
42,518
26,145
Cost of products sold(a)
2,910
2,492
11,773
8,078
Marketing, selling and administrative
2,721
1,734
7,661
4,871
Research and development
3,750
2,097
11,143
6,148
IPRD charge - MyoKardia acquisition
11,438
—
11,438
—
Amortization of acquired intangible
assets
2,526
1,062
9,688
1,135
Other (income)/expense, net
(1,826
)
689
(2,314
)
938
Total Expenses
21,519
8,074
49,389
21,170
(Loss)/Earnings Before Income Taxes
(10,451
)
(129
)
(6,871
)
4,975
(Benefit)/Provision for Income Taxes
(424
)
931
2,124
1,515
Net (Loss)/Earnings
(10,027
)
(1,060
)
(8,995
)
3,460
Noncontrolling Interest
—
(4
)
20
21
Net (Loss)/Earnings Attributable to
BMS
$
(10,027
)
$
(1,056
)
$
(9,015
)
$
3,439
Weighted-Average Common Shares
Outstanding:
Basic
2,252
1,918
2,258
1,705
Diluted
2,252
1,918
2,258
1,712
(Loss)/Earnings per Common Share:
Basic
$
(4.45
)
$
(0.55
)
$
(3.99
)
$
2.02
Diluted
(4.45
)
(0.55
)
(3.99
)
2.01
Other (income)/expense, net
Interest expense(b)
$
355
$
279
$
1,420
$
656
Contingent consideration
(1,160
)
523
(1,757
)
523
Royalties and licensing income
(403
)
(393
)
(1,527
)
(1,360
)
Equity investment gains
(504
)
(290
)
(1,228
)
(275
)
Integration expenses
182
191
717
415
Provision for restructuring
79
269
530
301
Litigation and other settlements
(235
)
77
(194
)
77
Transition and other service fees
(20
)
(26
)
(149
)
(37
)
Investment income
(22
)
(116
)
(121
)
(464
)
Reversion excise tax
—
—
76
—
Divestiture (gains)/losses
(49
)
3
(55
)
(1,168
)
Intangible asset impairment
—
—
21
15
Pension and postretirement
(7
)
(8
)
(13
)
1,599
Acquisition expenses
—
182
—
657
Other
(42
)
(2
)
(34
)
(1
)
Other (income)/expense, net
$
(1,826
)
$
689
$
(2,314
)
$
938
(a)
Excludes amortization of acquired
intangible assets.
(b)
Includes amortization of purchase
price adjustments to Celgene debt.
(c)
Includes Celgene results of
operations for the entire period.
(d)
Includes Celgene results of
operations from November 20, 2019 through December 31, 2019.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND TWELVE MONTHS
ENDED DECEMBER 31, 2020 AND 2019
(Unaudited, dollars in
millions)
Three Months Ended December
31,
Twelve Months Ended December
31,
2020(b)
2019(c)
2020(b)
2019(c)
Inventory purchase price accounting
adjustments
$
98
$
660
$
2,688
$
660
Intangible asset impairment
575
—
575
—
Employee compensation charges
1
1
4
1
Site exit and other costs
1
24
33
197
Cost of products sold
675
685
3,300
858
Employee compensation charges
241
27
275
27
Site exit and other costs
—
8
4
9
Marketing, selling and
administrative
241
35
279
36
License and asset acquisition charges
475
—
1,003
25
IPRD impairments
470
—
470
32
Inventory purchase price accounting
adjustments
11
—
36
—
Employee compensation charges
241
33
282
33
Site exit and other costs
16
109
115
167
Research and development
1,213
142
1,906
257
IPRD charge - MyoKardia
acquisition
11,438
—
11,438
—
Amortization of acquired intangible
assets
2,526
1,062
9,688
1,062
Interest expense(a)
(37
)
73
(159
)
322
Contingent consideration
(1,160
)
523
(1,757
)
523
Royalties and licensing income
(14
)
(15
)
(168
)
(24
)
Equity investment gains
(463
)
(294
)
(1,156
)
(279
)
Integration expenses
182
191
717
415
Provision for restructuring
79
269
530
301
Litigation and other settlements
(239
)
75
(239
)
75
Investment income
—
(44
)
—
(197
)
Reversion excise tax
—
—
76
—
Divestiture (gains)/losses
(49
)
3
(55
)
(1,168
)
Pension and postretirement
—
(3
)
—
1,635
Acquisition expenses
—
182
—
657
Other
—
2
—
2
Other (income)/expense, net
(1,701
)
962
(2,211
)
2,262
Increase to pretax income
14,392
2,886
24,400
4,475
Income taxes on items above
(1,034
)
(264
)
(1,733
)
(687
)
Income taxes attributed to Otezla®
divestiture
—
808
266
808
Income taxes attributed to internal
transfer of intangible assets
—
—
853
—
Income taxes
(1,034
)
544
(614
)
121
Increase to net earnings
$
13,358
$
3,430
$
23,786
$
4,596
(a)
Includes amortization of purchase
price adjustments to Celgene debt.
(b)
Includes Celgene results of
operations for the entire period.
(c)
Includes Celgene results of
operations from November 20, 2019 through December 31, 2019.
(d)
Includes Celgene results of
operations from November 20, 2019 through December 31, 2019.
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, 2020 AND 2019
(Unaudited, dollars and shares in
millions except per share data)
Three Months Ended December 31,
2020
Twelve Months Ended December 31,
2020
GAAP(a)
Specified Items(a)(b)
Non GAAP(a)
GAAP(a)
Specified Items(a)(b)
Non- GAAP(a)
Gross Profit
$
8,158
$
675
$
8,833
$
30,745
$
3,300
$
34,045
Marketing, selling and administrative
2,721
(241
)
2,480
7,661
(279
)
7,382
Research and development
3,750
(1,213
)
2,537
11,143
(1,906
)
9,237
IPRD charge - MyoKardia acquisition
11,438
(11,438
)
—
11,438
(11,438
)
—
Amortization of acquired intangible
assets
2,526
(2,526
)
—
9,688
(9,688
)
—
Other (income)/expense, net
(1,826
)
1,701
(125
)
(2,314
)
2,211
(103
)
(Loss)/Earnings Before Income Taxes
(10,451
)
14,392
3,941
(6,871
)
24,400
17,529
(Benefit)/Provision for Income Taxes
(424
)
1,034
610
2,124
614
2,738
Noncontrolling interest
—
—
—
20
—
20
Net (Loss)/Earnings Attributable to BMS
used for Diluted EPS Calculation
$
(10,027
)
$
13,358
$
3,331
$
(9,015
)
$
23,786
$
14,771
Weighted-Average Common Shares Outstanding
- Diluted
2,252
2,286
2,286
2,258
2,293
2,293
Diluted (Loss)/Earnings Per Share
$
(4.45
)
$
5.91
$
1.46
$
(3.99
)
$
10.43
$
6.44
Effective Tax Rate
4.1
%
11.4
%
15.5
%
(30.9
)%
46.5
%
15.6
%
Three Months Ended December 31,
2019
Twelve Months Ended December 31,
2019
GAAP(c)
Specified Items(b)(c)
Non-GAAP(c)
GAAP(c)
Specified Items(b)(c)
Non-GAAP(c)
Gross Profit
$
5,453
$
685
$
6,138
$
18,067
$
858
$
18,925
Marketing, selling and administrative
1,734
(35
)
1,699
4,871
(36
)
4,835
Research and development
2,097
(142
)
1,955
6,148
(257
)
5,891
Amortization of acquired intangible
assets
1,062
(1,062
)
—
1,135
(1,062
)
73
Other (income)/expense, net
689
(962
)
(273
)
938
(2,262
)
(1,324
)
(Loss)/Earnings Before Income Taxes
(129
)
2,886
2,757
4,975
4,475
9,450
Provision for Income Taxes
931
(544
)
387
1,515
(121
)
1,394
Noncontrolling interest
(4
)
—
(4
)
21
—
21
Net (Loss)/Earnings Attributable to BMS
used for Diluted EPS Calculation
$
(1,056
)
$
3,430
$
2,374
$
3,439
$
4,596
$
8,035
Weighted-Average Common Shares Outstanding
- Diluted
1,918
1,941
1,941
1,712
1,712
1,712
Diluted (Loss)/Earnings Per Share
$
(0.55
)
$
1.77
$
1.22
$
2.01
$
2.68
$
4.69
Effective Tax Rate
(721.7
)%
735.7
%
14.0
%
30.5
%
(15.7
)%
14.8
%
(a)
Includes Celgene results of
operations for the entire period.
(b)
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.
(c)
Includes Celgene results of
operations from November 20, 2019 through December 31, 2019.
BRISTOL-MYERS SQUIBB COMPANY
NET DEBT CALCULATION
AS OF DECEMBER 31, 2020 AND
DECEMBER 31, 2019
(Unaudited, dollars in
millions)
December 31, 2020
December 31, 2019(a)
Cash and cash equivalents
$
14,546
$
12,346
Marketable debt securities - current
1,285
3,047
Marketable debt securities -
non-current
433
767
Cash, cash equivalents and marketable
debt securities
16,264
16,160
Short-term debt obligations
(2,340
)
(3,346
)
Long-term debt
(48,336
)
(43,387
)
Net debt position
$
(34,412
)
$
(30,573
)
(a)
Includes Celgene balances as of
December 31, 2019.
Corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210204005588/en/
For more information, contact:
Media: 609-252-3345, media@bms.com
Investor Relations: Tim Power, 609-252-7509,
timothy.power@bms.com; Nina Goworek, 908-673-9711,
nina.goworek@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2024 to May 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From May 2023 to May 2024