- Reports Third Quarter Revenues of $11.6 Billion, an Increase
of 10% YoY
- Posts Third Quarter Earnings Per Share of $0.69 and Non-GAAP
EPS of $2.00
- Advances Product Pipeline with Significant Regulatory and
Clinical Milestones
- Achieves FDA Priority Review for Third Distinct Checkpoint
Inhibitor, Relatlimab and Nivolumab Fixed-Dose Combination, as
Treatment for Patients with Unresectable or Metastatic
Melanoma
- Adjusts GAAP and Raises Lower-End of Non-GAAP EPS Guidance
Range for 2021
Bristol Myers Squibb (NYSE:BMY) today reports results for the
third quarter of 2021, which reflect solid sales, strong commercial
execution and continued progress of the company’s pipeline.
“Our strong results reflect increased adoption of our new
product portfolio and continued demand growth across all four core
therapeutic areas,” said Giovanni Caforio, M.D., board chair and
chief executive officer, Bristol Myers Squibb. “Our teams advanced
the product portfolio and achieved significant regulatory and
clinical milestones, including for the fixed-dose combination of
relatlimab and nivolumab. Our deep and diverse product pipeline,
commercial execution and financial flexibility provide a strong
foundation that is enabling the company to bring new medicines that
benefit patients with serious unmet needs, drive in-line product
performance and deliver sustained growth.”
Third
Quarter
$ amounts in millions, except per
share amounts
2021
2020
Change
Total Revenues
$11,624
$10,540
10%
Earnings Per Share - GAAP
0.69
0.82
(16%)
Earnings Per Share - Non-GAAP
2.00
1.63
23%
THIRD QUARTER FINANCIAL
RESULTS
All comparisons are made versus the same period in 2020
unless otherwise stated.
- Bristol Myers Squibb posted third quarter revenues of $11.6
billion, an increase of 10%, driven by Revlimid, Eliquis, Opdivo
and our new product portfolio.
- U.S. revenues increased 12% to $7.3 billion in the quarter,
driven by higher demand for Revlimid, Eliquis and our new product
portfolio. International revenues increased 8% to $4.3 billion in
the quarter, driven by higher demand for Eliquis, Revlimid and
Opdivo. When adjusted for foreign exchange impact, international
revenues increased 6%.
- Gross margin increased from 76.3% to 80.3% in the quarter
primarily due to lower unwinding of inventory purchase price
accounting adjustments. On a non-GAAP basis, gross margin increased
from 80.6% to 81.1% in the quarter primarily driven by lower
royalties.
- Marketing, selling and administrative expenses increased 5% to
$1.8 billion in the quarter on a GAAP and non-GAAP basis primarily
due to investments to support new product launches.
- Research and development expenses increased 30% to $3.3 billion
in the quarter primarily due to an in-process research and
development (IPR&D) impairment charge. On a non-GAAP basis,
research and development expenses increased 7% to $2.4 billion in
the quarter primarily due to higher costs associated with the
broader portfolio and lower spending in the prior year due to
COVID-19.
- Amortization of acquired intangible assets increased $55
million to $2.5 billion in the quarter.
- The effective tax rate was 28.0% in the quarter, compared to
16.8% in the third quarter last year. The higher tax rate was
primarily due to a non-deductible IPR&D impairment charge in
the third quarter this year and non-taxable contingent value rights
fair value adjustments in the third quarter last year. On a
non-GAAP basis, the effective tax rate decreased 2.2% to 14.9% in
the quarter primarily as a result of changes in previously
estimated annual effective tax rates in 2020 due to jurisdictional
earnings mix.
- The company reported net earnings attributable to Bristol Myers
Squibb of $1.5 billion, or $0.69 per share, in the third quarter,
compared to net earnings of $1.9 billion, or $0.82 per share, for
the same period a year ago.
- The company reported non-GAAP net earnings attributable to
Bristol Myers Squibb of $4.5 billion, or $2.00 per share, in the
third quarter, compared to non-GAAP net earnings of $3.7 billion,
or $1.63 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.
THIRD QUARTER PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Product
Quarter Ended September 30,
2021
Quarter Ended September 30,
2020
% Change from Quarter Ended
September 30, 2020
Revlimid
$3,347
$3,027
11%
Eliquis
$2,413
$2,095
15%
Opdivo
$1,905
$1,780
7%
Orencia
$870
$826
5%
Pomalyst/Imnovid
$851
$777
10%
Sprycel
$551
$544
1%
Yervoy
$515
$446
15%
Abraxane
$266
$342
(22%)
Empliciti
$82
$96
(15%)
Reblozyl**
$160
$96
67%
Inrebic**
$22
$13
69%
Onureg**
$21
$3
*
Zeposia**
$40
$2
*
Breyanzi**
$30
N/A
N/A
Abecma**
$71
N/A
N/A
*In excess of +100%. ** Included as part of the new product
portfolio
NINE-MONTH PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Product
Nine Months Ended September
30, 2021
Nine Months Ended September
30, 2020
% Change from Nine Months
Ended September 30, 2020
Revlimid
$9,493
$8,826
8%
Eliquis
$8,091
$6,899
17%
Opdivo
$5,535
$5,199
6%
Orencia
$2,442
$2,290
7%
Pomalyst/Imnovid
$2,478
$2,235
11%
Sprycel
$1,562
$1,576
(1%)
Yervoy
$1,481
$1,211
22%
Abraxane
$876
$950
(8%)
Empliciti
$253
$290
(13%)
Reblozyl**
$400
$159
*
Inrebic**
$54
$40
35%
Onureg**
$48
$3
*
Zeposia**
$86
$3
*
Breyanzi**
$47
N/A
N/A
Abecma**
$95
N/A
N/A
*In excess of +100%. **Included as part of the new product
portfolio
THIRD QUARTER PRODUCT AND PIPELINE
UPDATE
Cardiovascular
Eliquis
Legal
- In September, the Bristol Myers Squibb-Pfizer Alliance
announced that the Court of Appeals for the Federal Circuit
affirmed the U.S. District Court’s August 2020 decision finding the
composition of matter patent (US 6,967,208) and formulation patent
(US 9,326,945) covering Eliquis® (apixaban) valid and infringed.
Given the decision, the earliest that generic manufacturers are
permitted to launch their apixaban products is April 1, 2028,
subject to additional appeals and challenges. (link)
mavacamten
Regulatory
- In October, the company announced that the European Medicines
Agency (EMA) has validated its Marketing Authorization Application
(MAA) for mavacamten for the treatment of patients with obstructive
hypertrophic cardiomyopathy (oHCM). The application is based on the
results of the pivotal Phase 3 EXPLORER-HCM trial. (link)
Medical Meeting
- In September, at the Heart Failure Society of America Annual
Scientific Meeting, the company presented findings from a global
real-world evidence study that showed the risk of mortality
increases with worse New York Heart Association functional class
(NYHA class) for patients with oHCM. The study represents one of
the largest, multi-centered studies that specifically focuses on
the oHCM patient population. (link)
Oncology
Opdivo
Regulatory
- In October, the company announced that the European Commission
(EC) has approved Opdivo® (nivolumab) in combination with
fluoropyrimidine- and platinum-based combination chemotherapy for
the first-line treatment of adult patients with HER2-negative
advanced or metastatic gastric, gastroesophageal junction (GEJ), or
esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a
combined positive score ≥ 5. The EC’s decision is based on results
from the Phase 3 CheckMate -649 trial. (link)
- In September, the company announced that the U.S. Food and Drug
Administration (FDA) has accepted the supplemental Biologics
License Applications (sBLA) for both Opdivo® in combination with
Yervoy® (ipilimumab) and Opdivo in combination with
fluoropyrimidine- and platinum-containing chemotherapy as
first-line treatments for adult patients with unresectable
advanced, recurrent or metastatic esophageal squamous cell
carcinoma (ESCC). The application is based on results from the
Phase 3 CheckMate -648 trial. The FDA assigned a Prescription Drug
User Fee Act (PDUFA) goal date of May 28, 2022. (link)
- In August, the company announced that Opdivo was approved by
the FDA for the adjuvant treatment of patients with urothelial
carcinoma who are at high risk of recurrence after undergoing
radical resection, regardless of prior neoadjuvant chemotherapy,
nodal involvement or PD-L1 status. The approval is based on the
Phase 3 CheckMate -274 trial. (link)
- In August, the company announced that the EMA has validated its
Type II Variation MAA for both Opdivo in combination with Yervoy
and Opdivo in combination with fluoropyrimidine- and
platinum-containing chemotherapy as first-line treatments for adult
patients with unresectable advanced, recurrent or metastatic ESCC.
The application is based on results from the Phase 3 CheckMate-648
trial. (link)
- In July, the company announced that the EC has approved Opdivo
for the adjuvant treatment of adult patients with esophageal or GEJ
cancer who have residual pathologic disease following prior
neoadjuvant chemoradiotherapy. The EC’s decision is based on
results from the Phase 3 CheckMate -577 trial. (link)
Medical Meetings
- In September, the company presented new data and analyses
across its cancer portfolio (link) at the European Society for
Medical Oncology (ESMO) 2021 Virtual Congress, including results
from the:
- Phase 3 CheckMate -214 trial, which showed that Opdivo plus
Yervoy continued to demonstrate durable, long-term survival
compared to sunitinib at five years in patients with previously
untreated advanced or metastatic renal cell carcinoma. (link)
- Phase 2 CheckMate -743 trial that demonstrated a durable
survival benefit at three years with first-line treatment of Opdivo
plus Yervoy compared to platinum-based standard-of-care
chemotherapy in patients with unresectable malignant pleural
mesothelioma, regardless of histology. (link)
relatlimab
Regulatory
- In September, the company announced that the FDA has accepted
for priority review the Biologics License Application for the
relatlimab and nivolumab fixed-dose combination for the treatment
of patients 12 years and older with unresectable or metastatic
melanoma. The application is based on the Phase 2/3 RELATIVITY-047
trial. The FDA assigned a PDUFA goal date of March 19, 2022.
(link)
Hematology
Abecma
Regulatory
- In August, the company announced that the EC has granted
Conditional Marketing Authorization for Abecma® (idecabtagene
vicleucel; ide-cel), a first-in-class B-cell maturation
antigen-directed chimeric antigen receptor (CAR) T cell
immunotherapy, for the treatment of adult patients with relapsed
and refractory multiple myeloma, who have received at least three
prior therapies, including an immunomodulatory agent, a proteasome
inhibitor and an anti-CD38 antibody and have demonstrated disease
progression on the last therapy. The approval of Abecma is based on
the pivotal Phase 2 KarMMa trial. (link)
Immunology
Zeposia
Regulatory
- In October, the company announced that the CHMP of the EMA has
recommended approval of Zeposia® (ozanimod) for the treatment of
adults with moderately to severely active ulcerative colitis (UC)
who have had an inadequate response, lost response, or were
intolerant to either conventional therapy or a biologic agent. The
recommendation is based on results from the pivotal Phase 3 True
North trial. (link)
Medical Meetings
- In October, the company presented new data from the Phase 3
DAYBREAK trial reinforcing the long-term efficacy and safety
profile of Zeposia in patients with relapsing forms of multiple
sclerosis. (link)
Orencia
Regulatory
- In August, the company announced that the FDA has accepted its
supplemental sBLA for Orencia® (abatacept) for the prevention of
moderate to severe acute graft versus host disease in patients six
years of age and older receiving unrelated donor hematopoietic stem
cell transplantation. The FDA granted the application Priority
Review and assigned a PDUFA goal date of December 23, 2021. The
submission is based on results from the Phase 2 GVHD-1 trial, also
known as ABA2, and a non-interventional (observational) study known
as GVHD-2. (link)
deucravacitinib
Clinical
- In October, the company announced the Phase 2 LATTICE-UC study
evaluating deucravacitinib compared to placebo in moderate to
severe UC did not meet the primary efficacy endpoint of clinical
remission at week 12, nor secondary efficacy endpoints. The safety
profile of deucravacitinib was consistent with previously reported
studies in psoriasis and psoriatic arthritis, and no new safety
signals were observed. The potential of deucravacitinib in UC
continues to be evaluated in IM011-127, a second Phase 2 trial that
also includes a higher dose. (link)
Medical Meetings
- In September, the company presented new data and analyses
highlighting the breadth and depth of our research on
deucravacitinib as well as the emerging dermatology pipeline at the
European Academy of Dermatology and Venereology (EADV) 30th
Anniversary Congress. (link)
Diversity, Equity and
Inclusion
- In August, the company announced a collaboration with five
Historically Black Colleges and Universities (HBCU) to launch
Tomorrow’s Innovators—a multimillion dollar strategic alliance to
attract top HBCU-affiliated talent to the bio-pharma industry.
(link)
Financial Guidance
Bristol Myers Squibb is updating its 2021 GAAP EPS guidance
range of $2.77 - $2.97 to $2.68 - $2.83 and its non-GAAP EPS
guidance range of $7.35 - $7.55 to $7.40 - $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 is expected to be
approximately 79% for GAAP and approximately 80% for non-GAAP.
- Marketing, selling and administrative expenses to be in-line
with 2020 levels for GAAP and increasing in the low-single digits
for non-GAAP.
- Research and development expenses increasing in the low-single
digits for GAAP and increasing in the mid-single digits for
non-GAAP.
- An effective tax rate of approximately 26% for GAAP and
approximately 16.5% 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.
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 October 27, 2021 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 using this
link which becomes active 15 minutes prior to the scheduled start
time and entering your information to be connected. Investors and
the general public can also access the live webcast by dialing in
the U.S. toll free 800-263-0877 or international +1 313-209-7315,
confirmation code: 8911662. 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 on
http://investor.bms.com or by dialing in the U.S. toll free
888-203-1112 or international +1 719-457-0820, confirmation code:
8911662. The replay will be available beginning at 1:30 p.m. ET on
October 27 through 1:30 p.m. ET on November 10, 2021.
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. 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. 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. In addition, non-GAAP gross margin, which is gross profit
excluding certain specified items as a percentage of revenues,
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. 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.
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 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 up-front or contingent
milestone payments in connection with the acquisition or licensing
of third-party intellectual property rights, divestiture gains or
losses, stock compensation resulting from accelerated vesting of
Celgene awards, certain retention-related employee compensation
charges related to the Celgene transaction, 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 beginning in 2021) and amortization of fair value
adjustments of debt acquired from Celgene in our 2019 exchange
offer, among other items. Certain other significant tax items are
also excluded such as the impact resulting from internal transfer
of intangible assets and the Otezla* divestiture in the second
quarter 2020. 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.
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 also 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.
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; the impact of 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; 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; 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, 2020, 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 SEPTEMBER 30, 2021 AND
2020 (Unaudited, dollars in millions)
Worldwide Revenues
U.S. Revenues(b)
2021
2020
% Change
2021
2020
% Change
Prioritized Brands
Revlimid
$
3,347
$
3,027
11%
$
2,303
$
2,080
11%
Eliquis
2,413
2,095
15%
1,315
1,118
18%
Opdivo
1,905
1,780
7%
1,062
1,018
4%
Orencia
870
826
5%
644
588
10%
Pomalyst/Imnovid
851
777
10%
586
548
7%
Sprycel
551
544
1%
346
336
3%
Yervoy
515
446
15%
313
309
1%
Abraxane
266
342
(22)%
211
236
(11)%
Empliciti
82
96
(15)%
48
59
(19)%
Reblozyl
160
96
67%
147
92
60%
Inrebic
22
13
69%
20
13
54%
Onureg
21
3
**
21
3
**
Zeposia
40
2
**
32
2
**
Breyanzi
30
—
N/A
29
—
N/A
Abecma
71
—
N/A
67
—
N/A
Established Brands
Vidaza
36
106
(66)%
1
—
N/A
Baraclude
105
100
5%
2
3
(33)%
Other Brands(a)
339
287
18%
149
137
9%
Total
$
11,624
$
10,540
10%
$
7,296
$
6,542
12%
**
In excess of +/- 100%
(a)
Includes products that have lost
exclusivity in major markets, over-the-counter (OTC) brands and
royalty revenue.
(b)
Includes Puerto Rico.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2021 AND
2020 (Unaudited, dollars in millions)
Worldwide Revenues
U.S. Revenues(b)
2021
2020
% Change
2021
2020
% Change
Prioritized Brands
Revlimid
$
9,493
$
8,826
8%
$
6,425
$
6,094
5%
Eliquis
8,091
6,899
17%
4,960
4,258
16%
Opdivo
5,535
5,199
6%
3,082
2,982
3%
Orencia
2,442
2,290
7%
1,773
1,642
8%
Pomalyst/Imnovid
2,478
2,235
11%
1,665
1,559
7%
Sprycel
1,562
1,576
(1)%
946
944
—
Yervoy
1,481
1,211
22%
935
820
14%
Abraxane
876
950
(8)%
670
659
2%
Empliciti
253
290
(13)%
150
177
(15)%
Reblozyl
400
159
**
355
155
**
Inrebic
54
40
35%
50
40
25%
Onureg
48
3
**
47
3
**
Zeposia
86
3
**
65
3
**
Breyanzi
47
—
N/A
46
—
N/A
Abecma
95
—
N/A
91
—
N/A
Established Brands
Vidaza
135
390
(65)%
8
2
**
Baraclude
327
343
(5)%
8
9
(11)%
Other Brands(a)
997
1,036
(4)%
418
448
(7)%
Total
$
34,400
$
31,450
9%
$
21,694
$
19,795
10%
**
In excess of +/- 100%
(a)
Includes products that have lost
exclusivity in major markets, over-the-counter (OTC) brands and
royalty revenue.
(b)
Includes Puerto Rico.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS FOR THE THREE AND NINE MONTHS
ENDED SEPTEMBER 30, 2021 AND 2020 (Unaudited, dollars and shares in
millions except per share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Net product sales
$
11,243
$
10,197
$
33,446
$
30,555
Alliance and other revenues
381
343
954
895
Total Revenues
11,624
10,540
34,400
31,450
Cost of products sold(a)
2,291
2,502
7,584
8,863
Marketing, selling and administrative
1,788
1,706
5,336
4,940
Research and development
3,251
2,499
8,747
7,393
Amortization of acquired intangible
assets
2,546
2,491
7,606
7,162
Other (income)/expense, net
(409)
(915)
(1,113)
(488)
Total Expenses
9,467
8,283
28,160
27,870
Earnings Before Income Taxes
2,157
2,257
6,240
3,580
Provision for Income Taxes
605
379
1,598
2,548
Net Earnings
1,552
1,878
4,642
1,032
Noncontrolling Interest
6
6
20
20
Net Earnings Attributable to BMS
$
1,546
$
1,872
$
4,622
$
1,012
Weighted-Average Common Shares
Outstanding:
Basic
2,219
2,257
2,227
2,260
Diluted
2,243
2,290
2,253
2,295
Earnings per Common Share:
Basic
$
0.70
$
0.83
$
2.08
$
0.45
Diluted
0.69
0.82
2.05
0.44
Other (income)/expense, net
Interest expense(b)
$
328
$
346
$
1,011
$
1,065
Contingent consideration
—
(988)
(510)
(597)
Royalties and licensing income
(425)
(403)
(1,197)
(1,124)
Equity investment gains
(465)
(244)
(1,214)
(724)
Integration expenses
141
195
434
535
Provision for restructuring
27
176
150
451
Litigation and other settlements
13
10
49
41
Transition and other service fees
(6)
(18)
(43)
(129)
Investment income
(12)
(13)
(33)
(99)
Reversion excise tax
—
—
—
76
Divestiture losses/(gains)
2
1
(9)
(6)
Intangible asset impairment
—
—
—
21
Loss on debt redemption
—
—
281
—
Other
(12)
23
(32)
2
Other (income)/expense, net
$
(409)
$
(915)
$
(1,113)
$
(488)
(a)
Excludes amortization of acquired
intangible assets.
(b)
Includes amortization of purchase price
adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30,
2021 AND 2020 (Unaudited, dollars in millions)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Inventory purchase price accounting
adjustments
$
97
$
456
$
264
$
2,590
Intangible asset impairment
—
—
315
—
Employee compensation charges
—
—
—
3
Site exit and other costs
—
3
24
32
Cost of products sold
97
459
603
2,625
Employee compensation charges
—
7
1
34
Site exit and other costs
1
(1)
—
4
Marketing, selling and
administrative
1
6
1
38
License and asset acquisition charges
200
203
980
528
IPRD impairments
610
—
840
—
Inventory purchase price accounting
adjustments
1
8
1
25
Employee compensation charges
—
8
1
41
Site exit and other costs
1
4
1
99
Research and development
812
223
1,823
693
Amortization of acquired intangible
assets
2,546
2,491
7,606
7,162
Interest expense(a)
(29)
(40)
(91)
(122)
Contingent consideration
—
(988)
(510)
(597)
Royalties and licensing income
—
(53)
(29)
(154)
Equity investment gains
(465)
(214)
(1,227)
(693)
Integration expenses
141
195
434
535
Provision for restructuring
27
176
150
451
Reversion excise tax
—
—
—
76
Divestiture losses/(gains)
2
1
(9)
(6)
Loss on debt redemption
—
—
281
—
Other (income)/expense, net
(324)
(923)
(1,001)
(510)
Increase to pretax income
3,132
2,256
9,032
10,008
Income taxes on items above
(183)
(405)
(871)
(699)
Income taxes attributed to Otezla®
divestiture
—
11
—
266
Income taxes attributed to internal
transfer of intangible assets
—
—
—
853
Income taxes
(183)
(394)
(871)
420
Increase to net earnings
$
2,949
$
1,862
$
8,161
$
10,428
(a)
Includes amortization of purchase price
adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE
ITEMS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021 AND
2020 (Unaudited, dollars and shares in millions except per share
data)
Three Months Ended September 30,
2021
Nine Months Ended September 30,
2021
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross Profit
$
9,333
$
97
$
9,430
$
26,816
$
603
$
27,419
Marketing, selling and administrative
1,788
(1)
1,787
5,336
(1)
5,335
Research and development
3,251
(812)
2,439
8,747
(1,823)
6,924
Amortization of acquired intangible
assets
2,546
(2,546)
—
7,606
(7,606)
—
Other (income)/expense, net
(409)
324
(85)
(1,113)
1,001
(112)
Earnings Before Income Taxes
2,157
3,132
5,289
6,240
9,032
15,272
Provision for Income Taxes
605
183
788
1,598
871
2,469
Noncontrolling interest
6
—
6
20
—
20
Net Earnings Attributable to BMS used for
Diluted EPS Calculation
$
1,546
$
2,949
$
4,495
$
4,622
$
8,161
$
12,783
Weighted-Average Common Shares Outstanding
- Diluted
2,243
2,243
2,243
2,253
2,253
2,253
Diluted Earnings Per Share
$
0.69
$
1.31
$
2.00
$
2.05
$
3.62
$
5.67
Effective Tax Rate
28.0
%
(13.1)
%
14.9
%
25.6
%
(9.4)
%
16.2
%
Three Months Ended September 30,
2020
Nine Months Ended September 30,
2020
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross Profit
$
8,038
$
459
$
8,497
$
22,587
$
2,625
$
25,212
Marketing, selling and administrative
1,706
(6)
1,700
4,940
(38)
4,902
Research and development
2,499
(223)
2,276
7,393
(693)
6,700
Amortization of acquired intangible
assets
2,491
(2,491)
—
7,162
(7,162)
—
Other (income)/expense, net
(915)
923
8
(488)
510
22
Earnings Before Income Taxes
2,257
2,256
4,513
3,580
10,008
13,588
Provision for Income Taxes
379
394
773
2,548
(420)
2,128
Noncontrolling interest
6
—
6
20
—
20
Net Earnings Attributable to BMS used for
Diluted EPS Calculation
$
1,872
$
1,862
$
3,734
$
1,012
$
10,428
$
11,440
Weighted-Average Common Shares Outstanding
- Diluted
2,290
2,290
2,290
2,295
2,295
2,295
Diluted Earnings Per Share
$
0.82
$
0.81
$
1.63
$
0.44
$
4.54
$
4.98
Effective Tax Rate
16.8
%
0.3
%
17.1
%
71.2
%
(55.5)
%
15.7
%
(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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211027005310/en/
Media: media@bms.com Investor Relations: Tim Power,
609-252-7509, timothy.power@bms.com; Nina Goworek, 908-673-9711,
nina.goworek@bms.com.
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