- Reports Second Quarter Revenues of $11.9 Billion, an
Increase of 2% YoY; or 5% When Adjusted for Foreign
Exchange
- Posts Second Quarter Earnings Per Share of $0.66 and
Non-GAAP EPS of $1.93; Includes Net Impact of ($0.14) per share for
GAAP and Non-GAAP EPS Due to Acquired IPRD1 Charges and Licensing
Income
- Delivers Robust Revenue Growth of 11% from In-Line Products
and New Product Portfolio; or 16% When Adjusted for Foreign
Exchange
- Expands Oncology Franchise with New Indications for Opdivo
and Planned Acquisition of Precision Oncology Company, Turning
Point Therapeutics
- Strengthens Cell Therapy Franchise with Broadest Label for
Breyanzi in Relapsed or Refractory Large B-cell Lymphoma after One
Prior Therapy
- Adjusts 2022 GAAP EPS Guidance; Reaffirms Non-GAAP EPS
Guidance
Bristol Myers Squibb (NYSE:BMY) today reports results for the
second quarter of 2022, which reflect continued in-line product
growth, strong momentum across the new product portfolio and
continued pipeline progress.
“I am very pleased with the continued strong demand for our
in-line products and new product portfolio, resulting in solid top
and bottom-line growth,” said Giovanni Caforio, M.D., board chair
and chief executive officer, Bristol Myers Squibb. “The momentum
with our business and strength of our pipeline, gives us
significant opportunities to drive continued growth, starting with
the anticipated approval for deucravacitinib in moderate to severe
plaque psoriasis and the expected transition of milvexian, our next
generation anti-thrombotic, to phase 3 development. With our
financial strength and dedicated workforce, we are well positioned
to help more patients and drive long-term value for our
shareholders.”
1 Acquired IPRD refers to certain in-process research and
development (“Acquired IPRD”) charges resulting from upfront or
contingent milestone payments in connection with asset acquisitions
or licensing of third-party intellectual property rights.
Second Quarter
$ amounts in millions, except per
share amounts
2022
2021
Change
Total Revenues
$11,887
$11,703
2%
Earnings Per Share – GAAP*
0.66
0.47
40%
Earnings Per Share –
Non-GAAP*
1.93
1.63
18%
* GAAP and non-GAAP earnings per share include the net impact of
Acquired IPRD charges and licensing income of ($0.14) per share in
the second quarter of 2022 and ($0.30) per share in the second
quarter of 2021.
SECOND QUARTER FINANCIAL
RESULTS
All comparisons are made versus the same period in 2021
unless otherwise stated.
- Bristol Myers Squibb posted second quarter revenues of $11.9
billion, an increase of 2%, driven by in-line products (primarily
Eliquis and Opdivo) and new product portfolio (Abecma, Opdualag and
Reblozyl), partially offset by recent LOE products (primarily
Revlimid) and foreign exchange impacts. When adjusted for foreign
exchange impacts, second quarter revenues increased 5%.
- U.S. revenues increased 12% to $8.3 billion in the quarter.
International revenues decreased 16% to $3.6 billion in the
quarter. When adjusted for foreign exchange impacts, international
revenues decreased 8%, primarily due to lower demand of Revlimid as
a result of generic erosion, partially offset by in-line products
(primarily Opdivo and Eliquis) and our new product portfolio.
- Gross margin decreased from 79.0% to 77.1% in the quarter
primarily due to product mix and an impairment charge resulting
from the divestiture of a manufacturing site, partially offset by
foreign exchange impacts and related hedging settlements. On a
non-GAAP basis, gross margin decreased from 79.8% to 78.3% in the
quarter primarily driven by product mix, partially offset by
foreign exchange impacts and related hedging settlements.
- Marketing, selling and administrative expenses decreased 5% to
$1.8 billion in the quarter on a GAAP and non-GAAP basis primarily
due to foreign exchange impacts.
- Research and development expenses decreased 6% to $2.3 billion
in the quarter primarily due to an in-process research and
development (IPRD) impairment charge in 2021, partially offset by
increased investment in our broad and diversified portfolio. On a
non-GAAP basis, research and development expenses increased 2% to
$2.3 billion in the quarter primarily due to investment in our
broad and diversified pipeline.
- Acquired IPRD decreased from $793 million in the same period a
year ago to $400 million in the current quarter. Acquired IPRD in
the current quarter primarily related to the buyout of a future
royalty obligation related to mavacamten ($295 million) and the
BridgeBio licensing transaction ($90 million). Acquired IPRD in the
same period a year ago was primarily related to a collaboration
agreement with Eisai ($650 million).
- Amortization of acquired intangible assets decreased 5% to $2.4
billion in the quarter primarily due to a longer than previously
expected market exclusivity period for Pomalyst.
- The GAAP effective tax rate changed from 31.7% to 27.0% in the
quarter and non-GAAP effective tax rate changed from 17.6% to 17.0%
in the quarter due to jurisdictional earnings mix including income
taxes attributed to Acquired IPRD charges.
- The company reported net earnings attributable to Bristol Myers
Squibb of $1.4 billion, or $0.66 per share, in the second quarter,
compared to $1.1 billion, or $0.47 per share, for the same period a
year ago. In addition to the items discussed above, the results
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 $4.2 billion, or $1.93 per share, in the
second quarter, compared to non-GAAP net earnings of $3.7 billion,
or $1.63 per share, for the same period a year ago.
- In addition to the items discussed above, the earnings per
share results in the current period 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 ($0.14) per share in the second quarter of 2022 and
($0.30) per share in the second quarter of 2021. For purposes of
comparability, the non-GAAP financial results for the second
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.
SECOND QUARTER PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Product
Quarter Ended June 30,
2022
Quarter Ended June 30,
2021
% Change from Quarter Ended
June 30, 2021
% Change from Quarter Ended
June 30, 2021 (Excl. F/X Impact)
In-Line Products
Eliquis
$3,235
$2,792
16%
20%
Opdivo
$2,063
$1,910
8%
12%
Pomalyst/Imnovid
$908
$854
6%
9%
Orencia
$876
$814
8%
11%
Sprycel
$544
$541
1%
5%
Yervoy
$525
$510
3%
7%
Empliciti
$77
$86
(10)%
(5)%
Mature and Other Products**
$435
$473
(8)%
(4)%
Total In-Line Products Revenue
$8,663
$7,980
9%
13%
New Product Portfolio
Reblozyl
$172
$128
34%
36%
Abecma
$89
$24
*
*
Zeposia
$66
$28
*
*
Breyanzi
$39
$17
*
*
Inrebic
$23
$16
44%
44%
Onureg
$32
$12
*
*
Opdualag
$58
N/A
N/A
N/A
Camzyos
$3
N/A
N/A
N/A
Total New Product Portfolio
Revenue
$482
$225
*
*
Total In-Line Products and New Product
Portfolio Revenue
$9,145
$8,205
11%
16%
Recent LOE Products
Revlimid
$2,501
$3,202
(22)%
(21)%
Abraxane
$241
$296
(19)%
(17)%
Total Recent LOE Products
Revenue
$2,742
$3,498
(22)%
(20)%
Total Revenue
$11,887
$11,703
2%
5%
* In excess of +100% ** Includes over-the-counter (OTC)
products, royalty revenue and other mature products.
FIRST HALF PRODUCT REVENUE
HIGHLIGHTS
$ amounts in millions
Product
Six-Months Ended June
30, 2022
Six-Months Ended June
30, 2021
% Change from Six-Months Ended
June 30, 2021
% Change from Six-Months Ended
June 30, 2021 (Excl. F/X Impact)
In-Line Products
Eliquis
$6,446
$5,678
14%
17%
Opdivo
$3,986
$3,630
10%
14%
Pomalyst/Imnovid
$1,734
$1,627
7%
9%
Orencia
$1,668
$1,572
6%
8%
Sprycel
$1,027
$1,011
2%
5%
Yervoy
$1,040
$966
8%
11%
Empliciti
$152
$171
(11)%
(7)%
Mature and Other Products**
$897
$979
(8)%
(6)%
Total In-Line Products Revenue
$16,950
$15,634
8%
12%
New Product Portfolio
Reblozyl
$328
$240
37%
38%
Abecma
$156
$24
*
*
Zeposia
$102
$46
*
*
Breyanzi
$83
$17
*
*
Inrebic
$41
$32
28%
28%
Onureg
$55
$27
*
*
Opdualag
$64
N/A
N/A
N/A
Camzyos
$3
N/A
N/A
N/A
Total New Product Portfolio
Revenue
$832
$386
*
*
Total In-Line Products and New Product
Portfolio Revenue
$17,782
$16,020
11%
14%
Recent LOE Products
Revlimid
$5,298
$6,146
(14)%
(12)%
Abraxane
$455
$610
(25)%
(24)%
Total Recent LOE Products
Revenue
$5,753
$6,756
(15)%
(14)%
Total Revenue
$23,535
$22,776
3%
6%
* In excess of +100% ** Includes over-the-counter (OTC)
products, royalty revenue and other mature products.
REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products in the second quarter were $8.7
billion compared to $8.0 billion in the prior year period,
representing an increase of 9%. In-line products revenue was
largely driven by:
- Eliquis revenues grew 16% compared to the prior year period.
U.S. revenues were $2.2 billion compared to $1.7 billion in the
prior year period, representing an increase of 27% driven primarily
by demand growth and favorable gross to net adjustments.
International revenues were $1.0 billion compared to $1.1 billion
in the prior year period, representing a decrease of 3% driven by
foreign exchange impacts, partially offset by higher demand.
- Opdivo revenues increased 8% compared to the prior year period.
U.S. revenues were $1.2 billion compared to $1.1 billion in the
prior year period, representing an increase of 12% driven by higher
demand across multiple indications including Opdivo plus
Yervoy-based combinations for non-small cell lung cancer, Opdivo
plus Cabometyx® combination for kidney cancer, and Opdivo-based
therapies for various gastric, bladder and esophageal cancers,
partially offset by declining second-line eligibility across tumors
and increased competition. International revenues were $858 million
compared to $834 million in the prior year period, 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 of 10%.
New Product Portfolio
- New product portfolio revenues grew to $482 million compared to
$225 million in the prior year period, driven by higher demand for
Abecma, Opdualag and Reblozyl.
Recent LOE Products
- Revlimid revenues declined by 22% compared to the prior year
period. U.S. revenues decreased 2% to $2.1 billion as compared to
the prior year period primarily driven by lower demand as a result
of generic erosion. International revenues were $371 million
compared to $1.0 billion in the prior year period, representing a
decrease of 64% driven by lower demand as a result of generic
erosion and to a lesser extent, foreign exchange impacts of
3%.
- Abraxane revenues declined 19% compared to the prior year
period. U.S. revenues were $176 million compared to $234 million in
the prior year period, representing a 25% decline driven by the
entry of authorized generics.
PRODUCT AND PIPELINE
UPDATE
Oncology
Category
Asset
Milestone
Regulatory
OpdualagTM
(nivolumab and relatlimab-rmbw)
The Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has
recommended approval of Opdualag for the first-line treatment of
advanced (unresectable or metastatic) melanoma in adults and
adolescents 12 years of age and older with tumour cell PD-L1
expression <1%. The positive opinion is based on results from
the Phase 2/3 RELATIVITY -047 trial.
Regulatory
Opdivo® (nivolumab)
The U.S. Food and Drug Administration
(FDA) approved Opdivo (injection for intravenous use) in
combination with fluoropyrimidine- and platinum-containing
chemotherapy as well as Opdivo plus Yervoy as first-line treatments
for adult patients with unresectable advanced or metastatic
esophageal squamous cell carcinoma regardless of PD-L1 status. The
approvals are based on results from the Phase 3 CheckMate -648
trial.
Clinical & Research
Five-year follow up results from Part 1 of
the Phase 3 CheckMate -227 trial demonstrated long-term, durable
survival outcomes with Opdivo plus Yervoy compared to chemotherapy
in first-line treatment of patients with metastatic non-small cell
lung cancer (NSCLC), regardless of PD-L1 expression levels. In the
primary endpoint population, the combination nearly doubled overall
survival rate compared to chemotherapy.
Three-year follow up results from the
Phase 3 CheckMate -9LA trial demonstrated long-term, durable
survival benefits with Opdivo plus Yervoy with two cycles of
chemotherapy compared to four cycles of chemotherapy in patients
with previously untreated metastatic NSCLC, regardless of PD-L1
expression and histology.
Phase 3 CheckMate -901 trial comparing
Opdivo plus Yervoy to standard-of-care chemotherapy as a first-line
treatment for patients with untreated unresectable or metastatic
urothelial carcinoma who are ineligible for cisplatin-based
chemotherapy, did not meet the primary endpoint of overall survival
in patients whose tumor cells express PD-L1 ≥1% at final
analysis.
Hematology
Category
Asset
Milestone
Regulatory
Breyanzi®
(lisocabtagene maraleucel)
The FDA approved Breyanzi for the
treatment of adult patients with relapsed or refractory large
B-cell lymphoma (LBCL) after one prior therapy, including diffuse
LBCL not otherwise specified, high-grade B-cell lymphoma, primary
mediastinal LBCL and follicular lymphoma grade 3B, who relapse
within 12 months of first-line chemoimmunotherapy or who are not
eligible for transplant. The approval was based on the pivotal
Phase 3 TRANSFORM trial as well as the Phase 2 PILOT study.
The EMA validated the type II variation
application for extension of the indication of Breyanzi for the
treatment of adults with LBCL who are refractory or have relapsed
within 12 months of initial therapy and are candidates for
hematopoietic stem cell transplant. The EMA validation is based on
results from the Phase 3 TRANSFORM trial.
Reblozyl®
(luspatercept-aamt)
The company withdrew a supplemental
biologics license application for Reblozyl for the treatment of
anemia in adults with non-transfusion-dependent beta
thalassemia.
Clinical & Research
Breyanzi
Data from the primary analysis of the
Phase 2 PILOT trial showed substantial durable responses in
second-line LBCL among patients who were not deemed candidates for
high-dose chemotherapy and hematopoietic stem cell transplant.
Immunology
Category
Asset
Milestone
Clinical & Research
Orencia® (abatacept)
Top-line results from the Phase 3
Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV-1) Immune Modulators clinical trial, sponsored by the
National Institutes of Health, showed that treatment with Orencia
versus placebo displayed a strong, but not statistically
significant improvement in the primary endpoint of time to recovery
as measured by day of hospital discharge. Analyses of the secondary
endpoints, which included mortality and clinical status,
demonstrated Orencia reduced participants’ risk of death and
improved their clinical status at 28 days after entering the study
when compared with placebo.
deucravacitinib
Results from the Phase 2 PAISLEY trial
showed statistically significant efficacy at the primary endpoint
of Systemic Lupus Erythematosus (SLE) Responder Index-4 responses
at Week 32 among patients with moderate to severe SLE who were
treated with deucravacitinib versus placebo. Secondary endpoints
demonstrated clinically meaningful improvements at Week 48. The
safety profile was consistent with
previous trials in psoriasis and psoriatic
arthritis. Data demonstrated favorable risk-benefit profile
supportive of progressing into Phase 3.
Two-year results from the Phase 3 POETYK
PSO long-term extension (LTE) trial demonstrated durable efficacy
and a consistent safety profile in adult patients with moderate to
severe plaque psoriasis.
Zeposia®
(ozanimod)
Post-hoc analyses from the Phase 3
DAYBREAK open-label extension and Phase 3 SUNBEAM trials showed
that the majority of patients receiving Zeposia for multiple
sclerosis reported improved or preserved cognitive function, with
the greatest improvement seen when used early in the disease when
thalamic volume remains high.
Results from an analysis from the ongoing
Phase 3 DAYBREAK open-label extension trial showed that individuals
receiving Zeposia for multiple sclerosis demonstrated an immune
response to COVID-19 vaccination.
Business Development
- In June, the company and Turning Point Therapeutics, Inc.
(“Turning Point”) (NASDAQ:TPTX) announced a definitive merger
agreement under which Bristol Myers Squibb will acquire Turning
Point pursuant to a tender offer for $76.00 per share, in an all
cash transaction totaling approximately $4.1 billion. The planned
acquisition is expected to expand the company’s precision oncology
and solid tumor portfolio with the addition of repotrectinib and
other pipeline assets. Repotrectinib is a potential best-in-class
tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic
drivers of non-small cell lung cancer and other advanced solid
tumors. The consummation of the transaction is subject to the
satisfaction of customary closing conditions, including the tender
of a majority of the outstanding shares of Turning Point’s common
stock and the receipt of applicable regulatory approvals. In July,
the Company announced that the tender offer period was extended to
August 15. The acquisition is expected to close during the third
quarter of 2022.
- In June, the company and Immatics N.V. (NASDAQ: IMTX) announced
that they have expanded their strategic alliance to pursue the
development of multiple allogeneic off-the-shelf TCR-T and/or CAR-T
programs. (link)
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.
- The company announced that its Board of Directors elected
Deepak L. Bhatt, MD, MPH to the Board, effective June 14, 2022 and
that he will serve as a member of the Science & Technology
Committee of the Board of Directors. The size of the Board was
increased to eleven in connection with the election of Dr. Bhatt.
(link)
- In July, the company, in collaboration with Disability
Solutions, announced the launch of the Disability Diversity in
Clinical Trials (DDiCT) initiative that aims to improve clinical
trial participation of people with disabilities to ensure all
patient groups are reflective of the real-world population and
aligned with the epidemiology of the disease studies. (link)
Financial Guidance
Bristol Myers Squibb is adjusting its 2022 GAAP and non-GAAP
line-item guidance as follows:
Total Sales and In-Line Products & New Product Portfolio
sales are being adjusted to account for foreign exchange
impacts.
Non-GAAP gross margin is being increased to approximately 79%
primarily due to foreign exchange impacts.
Adjusting GAAP EPS guidance primarily due to changes in fair
market value of equity investments and reaffirming non-GAAP EPS
guidance.
Key 2022 GAAP and non-GAAP line-item guidance assumptions
are:
U.S. GAAP
Non-GAAP
April (Prior)
July (Revised)
April (Prior)
July (Revised)
Total Net Sales
In-line with 2021
$46.0 billion
In-line with 2021
$46.0 billion
Recent LOE Products1
~$10.0 billion or
double-digit decline
No change
~$10.0 billion or
double-digit decline
No change
Revlimid
$9.0-$9.5 billion
No change
$9.0-$9.5 billion
No change
In-line Products & New Product
Portfolio
~$36.5 billion or
Low double-digit increase
~$36.0 billion or
Low double-digit increase
~$36.5 billion or
Low double-digit increase
~$36.0 billion or
Low double-digit increase
Gross Margin %
~78%
No change
~78%
~79%
Operating Expenses2
Mid single-digit decline
No change
Low single-digit decline
No change
Tax Rate
~22%
~23%
~16.5%
No change
Diluted EPS3
$2.92-$3.22
$2.71-$3.01
$7.44 - $.7.74
No change
1 Key LOE Products = Revlimid and Abraxane 2 Operating Expenses
= MS&A and R&D, excluding acquired IPRD and Amortization of
acquired intangibles 3 April guidance includes net impact of
($0.21) from acquired IPRD and licensing income, which comprises
($0.10) in Q1 and an additional ($0.11) in April due to buyout of
future royalty obligation; July guidance includes YTD net impact of
($0.24) from acquired IPRD and licensing income
The 2022 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 and charges that may result from the
acquisition of Turning Point. Both GAAP and non-GAAP guidance
assume current exchange rates. The 2022 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 8 a.m.
EDT during which company executives will review the quarterly
financial results and address inquiries from investors and
analysts.
Investors and the general public are invited to listen to a live
webcast of the call at http://investor.bms.com. To be directly
connected to the conference call, enter your information here; the
link will be active 15 minutes prior to the scheduled start time of
the call, and does not require a dial-in number or operator
assistance to be connected. Investors and the public can also
access the live webcast by dialing in the U.S. toll free
888-300-0211 or international +1 786-460-7199, confirmation code:
6873379. 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. EDT on July 27 through 11:30 a.m.
EDT on August 10, 2022, by dialing in the U.S. toll free
888-203-1112 or international +1 719-457-0820, confirmation code:
6873379.
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
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. 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 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 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) 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 are making 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 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.
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 specified items 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, statements
relating to goals, plans and projections regarding the company’s
current and projected financial position, results of operations,
market position, product development, share repurchase program,
business strategy and the acquisition of Turning Point by the
company. 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. 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 and capital allocation strategy, planned
product launches and updates, expectations relating to its pipeline
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, contractual milestones will
be achieved or that the acquisition of Turning Point will be
completed on the current anticipated timeline or at all.
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; 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; changes under the 340B Drug Pricing Program; 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; 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; 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; 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; 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; the impact of adverse outcomes in lawsuits, claims,
proceedings and government investigations; 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. 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, which may prove to
be incorrect.
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.
Additional Information about the Tender Offer and Where to
Find It
This communication is for informational purposes only and is
neither an offer to purchase nor a solicitation of an offer to sell
securities, nor is it a substitute for the tender offer materials
that the company and Rhumba Merger Sub Inc. (“Offeror”) filed with
the SEC. At the time the tender offer was commenced, the company
caused Offeror to file a tender offer statement on Schedule TO and
Turning Point filed a recommendation statement on Schedule 14D-9.
INVESTORS AND TURNING POINT’S STOCKHOLDERS ARE STRONGLY ADVISED TO
READ THE TENDER OFFER STATEMENT AND THE RELATED SOLICITATION/
RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 FILED BY TURNING POINT
WITH THE SEC, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO
TIME, BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT SHOULD BE
CONSIDERED BY TURNING POINT’S INVESTORS BEFORE ANY DECISION IS MADE
WITH RESPECT TO THE TENDER OFFER. These documents are available at
no charge on the SEC’s website at www.sec.gov. In addition, a copy
of the offer to purchase, letter of transmittal and certain other
related tender offer documents may be obtained free of charge at
www.sec.gov or by directing a request to the company, Office of the
Corporate Secretary, 430 East 29th Street, 14th Floor, New York,
New York 10154-0037. A copy of the tender offer statement and the
solicitation/recommendation statement are made available to all
stockholders of Turning Point free of charge at
www.tptherapeutics.com.
In addition to the offer to purchase, the related letter of
transmittal and certain other offer documents, as well as the
solicitation/recommendation statement, the company and Turning
Point file annual, quarterly and special reports, proxy statements
and other information with the SEC. You may read any reports,
statements or other information filed by Bristol Myers Squibb or
Turning Point with the SEC at no charge on the SEC’s website at
www.sec.gov.
corporatefinancial-news
BRISTOL-MYERS SQUIBB
COMPANY PRODUCT REVENUES FOR THE THREE MONTHS ENDED
JUNE 30, 2022 AND 2021 (Unaudited, dollars in
millions)
Worldwide Revenues
U.S. Revenues(c)
2022
2021
% Change
2022
2021
% Change
In-Line Products
Eliquis
$
3,235
$
2,792
16%
$
2,192
$
1,722
27%
Opdivo
2,063
1,910
8%
1,205
1,076
12%
Pomalyst/Imnovid
908
854
6%
616
567
9%
Orencia
876
814
8%
654
593
10%
Sprycel
544
541
1%
372
325
14%
Yervoy
525
510
3%
326
328
(1) %
Empliciti
77
86
(10) %
47
51
(8) %
Mature and other products(a)
435
473
(8) %
147
130
13%
Total In-Line Products
8,663
7,980
9%
5,559
4,792
16%
New Product Portfolio
Reblozyl
172
128
34%
144
110
31%
Abecma
89
24
**
72
24
**
Zeposia
66
28
**
48
20
**
Breyanzi
39
17
**
33
17
94%
Inrebic
23
16
44%
20
15
33%
Onureg
32
12
**
25
12
**
Opdualag
58
—
N/A
58
—
N/A
Camzyos
3
—
N/A
3
—
N/A
Total New Product Portfolio
482
225
**
403
198
**
Total In-Line and New Product
Portfolio
9,145
8,205
11%
5,962
4,990
19%
Recent LOE Products(b)
Revlimid
2,501
3,202
(22) %
2,130
2,164
(2) %
Abraxane
241
296
(19) %
176
234
(25) %
Total Recent LOE Products
2,742
3,498
(22) %
2,306
2,398
(4) %
Total
$
11,887
$
11,703
2%
$
8,268
$
7,388
12%
**
In excess of +/- 100%
(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 SIX MONTHS ENDED
JUNE 30, 2022 AND 2021 (Unaudited, dollars in
millions)
Worldwide Revenues
U.S. Revenues(c)
2022
2021
% Change
2022
2021
% Change
In-Line Products
Eliquis
$
6,446
$
5,678
14 %
$
4,339
$
3,645
19 %
Opdivo
3,986
3,630
10 %
2,304
2,020
14 %
Pomalyst/Imnovid
1,734
1,627
7 %
1,173
1,079
9 %
Orencia
1,668
1,572
6 %
1,246
1,129
10 %
Sprycel
1,027
1,011
2 %
677
600
13 %
Yervoy
1,040
966
8 %
637
622
2 %
Empliciti
152
171
(11) %
94
102
(8) %
Mature and other products(a)
897
979
(8) %
280
282
(1) %
Total In-Line Products
16,950
15,634
8 %
10,750
9,479
13 %
New Product Portfolio
Reblozyl
328
240
37 %
278
208
34 %
Abecma
156
24
**
128
24
**
Zeposia
102
46
**
69
33
**
Breyanzi
83
17
**
74
17
**
Inrebic
41
32
28 %
35
30
17 %
Onureg
55
27
**
44
26
69 %
Opdualag
64
—
N/A
64
—
N/A
Camzyos
3
—
N/A
3
—
N/A
Total New Product Portfolio
832
386
**
695
338
**
Total In-Line and New Product
Portfolio
17,782
16,020
11 %
11,445
9,817
17 %
Recent LOE Products(b)
Revlimid
5,298
6,146
(14) %
4,168
4,122
1 %
Abraxane
455
610
(25) %
349
459
(24) %
Total Recent LOE Products
5,753
6,756
(15) %
4,517
4,581
(1) %
Total
$
23,535
$
22,776
3 %
$
15,962
$
14,398
11 %
**
In excess of +/- 100%
(a)
Includes over-the-counter (OTC) brands and
royalty revenue.
(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 SIX MONTHS ENDED JUNE 30, 2022 AND 2021
(Unaudited, dollars and shares in millions except per share
data)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Net product sales
$
11,485
$
11,405
$
22,793
$
22,203
Alliance and other revenues
402
298
742
573
Total Revenues
11,887
11,703
23,535
22,776
Cost of products sold(a)
2,720
2,452
5,191
5,293
Marketing, selling and administrative
1,787
1,882
3,618
3,548
Research and development(b)
2,321
2,478
4,581
4,697
Acquired IPRD(b)
400
793
733
799
Amortization of acquired intangible
assets
2,417
2,547
4,834
5,060
Other (income)/expense, net
284
(2)
933
(704)
Total Expenses
9,929
10,150
19,890
18,693
Earnings Before Income Taxes
1,958
1,553
3,645
4,083
Provision for Income Taxes
529
492
933
993
Net Earnings
1,429
1,061
2,712
3,090
Noncontrolling Interest
8
6
13
14
Net Earnings Attributable to BMS
$
1,421
$
1,055
$
2,699
$
3,076
Weighted-Average Common Shares
Outstanding:
Basic
2,133
2,227
2,140
2,232
Diluted
2,149
2,252
2,157
2,258
Earnings per Common Share:
Basic
$
0.67
$
0.47
$
1.26
$
1.38
Diluted
0.66
0.47
1.25
1.36
Other (income)/expense, net
Interest expense(c)
$
313
$
330
$
639
$
683
Royalties and licensing income
(508)
(405)
(985)
(772)
Equity investment losses/(gains)
308
(148)
952
(749)
Integration expenses
124
152
229
293
Contingent consideration
—
—
1
(510)
(Gain)/Loss on debt redemption
(9)
—
266
281
Provision for restructuring
20
78
43
123
Litigation and other settlements
25
44
(12)
36
Investment income
(27)
(12)
(37)
(21)
Divestiture gains
—
(11)
(211)
(11)
Other
38
(30)
48
(57)
Other (income)/expense, net
$
284
$
(2)
$
933
$
(704)
(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 SIX MONTHS
ENDED JUNE 30, 2022 AND 2021 (Unaudited, dollars in
millions)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021(a)
2022
2021
Inventory purchase price accounting
adjustments
$
102
$
88
$
154
$
167
Intangible asset impairment
—
—
—
315
Site exit and other costs
43
1
43
24
Cost of products sold
145
89
197
506
Employee compensation charges
—
1
—
1
Site exit and other costs
4
—
6
(1)
Marketing, selling and
administrative
4
1
6
—
IPRD impairments
—
230
40
230
Inventory purchase price accounting
adjustments
21
—
108
—
Employee compensation charges
—
—
—
1
Research and development
21
230
148
231
Amortization of acquired intangible
assets
2,417
2,547
4,834
5,060
Interest expense(b)
(21)
(28)
(48)
(62)
Equity investment losses/(gains)
307
(154)
950
(762)
Integration expenses
124
152
229
293
Contingent consideration
—
—
—
(510)
(Gain)/Loss on debt redemption
(9)
—
266
281
Provision for restructuring
20
78
43
123
Litigation and other settlements
—
—
(40)
—
Divestiture gains
—
(11)
(211)
(11)
Other
42
—
42
—
Other (income)/expense, net
463
37
1,231
(648)
Increase to pretax income
3,050
2,904
6,416
5,149
Income taxes on items above
(321)
(292)
(719)
(595)
Increase to net earnings
$
2,729
$
2,612
$
5,697
$
4,554
(a)
Revised to exclude significant R&D
charges or other income resulting from up-front 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 SIX MONTHS ENDED JUNE
30, 2022 AND 2021 (Unaudited, dollars and shares in millions
except per share data)
Three Months Ended June 30,
2022
Six Months Ended June 30,
2022
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross Profit
$
9,167
$
145
$
9,312
$
18,344
$
197
$
18,541
Marketing, selling and administrative
1,787
(4
)
1,783
3,618
(6
)
3,612
Research and development
2,321
(21
)
2,300
4,581
(148
)
4,433
Amortization of acquired intangible
assets
2,417
(2,417
)
—
4,834
(4,834
)
—
Other (income)/expense, net
284
(463
)
(179
)
933
(1,231
)
(298
)
Earnings Before Income Taxes
1,958
3,050
5,008
3,645
6,416
10,061
Provision for Income Taxes
529
321
850
933
719
1,652
Net Earnings Attributable to BMS used for
Diluted EPS Calculation
$
1,421
$
2,729
$
4,150
$
2,699
$
5,697
$
8,396
Weighted-Average Common Shares Outstanding
- Diluted
2,149
2,149
2,149
2,157
2,157
2,157
Diluted Earnings Per Share
$
0.66
$
1.27
$
1.93
$
1.25
$
2.64
$
3.89
Effective Tax Rate
27.0
%
(10.0
) %
17.0
%
25.6
%
(9.2
) %
16.4
%
Three Months Ended June 30,
2021
Six Months Ended June 30,
2021
GAAP
Specified Items(a)
Non-GAAP
GAAP
Specified Items(a)
Non-GAAP
Gross Profit
$
9,251
$
89
$
9,340
$
17,483
$
506
$
17,989
Marketing, selling and administrative
1,882
(1
)
1,881
3,548
—
3,548
Research and development
2,478
(230
)
2,248
4,697
(231
)
4,466
Amortization of acquired intangible
assets
2,547
(2,547
)
—
5,060
(5,060
)
—
Other (income)/expense, net
(2
)
(37
)
(39
)
(704
)
648
(56
)
Earnings Before Income Taxes
1,553
2,904
4,457
4,083
5,149
9,232
Provision for Income Taxes
492
292
784
993
595
1,588
Net Earnings Attributable to BMS used for
Diluted EPS Calculation
$
1,055
$
2,612
$
3,667
$
3,076
$
4,554
$
7,630
Weighted-Average Common Shares Outstanding
- Diluted
2,252
2,252
2,252
2,258
2,258
2,258
Diluted Earnings Per Share
$
0.47
$
1.16
$
1.63
$
1.36
$
2.02
$
3.38
Effective Tax Rate
31.7
%
(14.1
) %
17.6
%
24.3
%
(7.1
) %
17.2
%
(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 JUNE 30, 2022 AND
DECEMBER 31, 2021 (Unaudited, dollars in millions)
June 30, 2022
December 31,
2021
Cash and cash equivalents
$
10,750
$
13,979
Marketable debt securities – current
2,478
2,987
Cash, cash equivalents and marketable
debt securities
13,228
16,966
Short-term debt obligations
(4,953)
(4,948)
Long-term debt
(37,107)
(39,605)
Net debt position
$
(28,832)
$
(27,587)
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