Performance Reflects Execution and Actions to
Strengthen the Company's Long-Term Growth Profile
- First Quarter Revenues were $11.9 Billion, increasing 5%
(+6% Adjusting for Foreign Exchange)
- Growth Portfolio Revenues were $4.8 Billion, increasing 8%
(+11% Adjusting for Foreign Exchange)
- Strengthened Long-Term Growth Profile Through Completion of
Karuna Therapeutics, RayzeBio, Mirati Therapeutics, and SystImmune
Transactions
- Including the One-Time Net Impact of Acquired IPRD Charges
and Licensing Income of $(6.30) From Recently Closed Transactions,
GAAP Loss Per Share was $(5.89); Non-GAAP Loss Per Share was
$(4.40)
- Achieved U.S. Approval of Abecma in Earlier-Line Multiple
Myeloma and Breyanzi in Chronic Lymphocytic Leukemia and Small
Lymphocytic Lymphoma and Positive Proof of Concept for Opdualag in
Non-Small Cell Lung Cancer
- Executing a Strategic Productivity Initiative to Deliver
~$1.5 Billion in Cost Savings, the Majority of Which Will be
Reinvested to Fund Innovation and Drive Growth
- Updating 2024 Non-GAAP EPS and Line-Item Guidance to Reflect
Impact of Recently Completed Transactions
Bristol Myers Squibb (NYSE: BMY) today reports results for the
first quarter of 2024, which reflect meaningful progress in the
company's growth portfolio and pipeline.
“We had a good start to 2024, with revenue growth, important
advances in our pipeline and the closure of several strategically
important transactions,” said Christopher Boerner, Ph.D., board
chair and chief executive officer, Bristol Myers Squibb. “Our focus
remains on strengthening the company's long-term growth profile. As
a part of our continued evolution, we're executing a strategic
productivity initiative that will allow us to be more agile, drive
efficiency across the company, and prioritize investing in
opportunities where we see the greatest potential to get the most
promising medicines to patients as quickly as possible."
First Quarter
$ in millions, except per share
amounts
2024
2023
Change
Change Excl. F/X**
Total Revenues
$11,865
$11,337
5%
6%
(Loss)/Earnings Per Share — GAAP*
(5.89)
1.07
N/A
N/A
(Loss)/Earnings Per Share — Non-GAAP*
**
(4.40)
2.05
N/A
N/A
Acquired IPRD charge and Licensing Income
Net Impact on Earnings Per Share
(6.30)
(0.01)
N/A
N/A
* GAAP and Non-GAAP loss per share include
the net impact of Acquired IPRD charges and licensing income
primarily driven by the Karuna Therapeutics asset acquisition and
SystImmune collaboration. ** See "Use of Non-GAAP Financial
Information".
FIRST QUARTER RESULTS
All comparisons are made versus the same period in 2023
unless otherwise stated.
- Bristol Myers Squibb posted first quarter revenues of $11.9
billion, an increase of 5% or 6% when adjusted for foreign exchange
impacts, primarily driven by Eliquis, Reblozyl and Opdualag,
partially offset by Opdivo and Revlimid.
- U.S. revenues increased 7% to $8.5 billion primarily due to
Eliquis, Reblozyl and Opdualag, partially offset by Revlimid.
Opdivo revenues were $1.2 billion compared to $1.3 billion,
representing a decrease of 10% primarily due to inventory and the
timing of orders, partially offset by demand growth.
- International revenues remained relatively flat at $3.4 billion
primarily due to lower average net selling prices, offset in part
by higher demand for Opdivo, Yervoy and Reblozyl. The negative
impact from foreign exchange was 5%.
- On a GAAP basis, gross margin decreased from 77.4% to 75.3%,
and on a non-GAAP basis, gross margin decreased from 77.8% to
75.5%, primarily due to product mix.
- On a GAAP basis, marketing, selling and administrative expenses
increased 34% to $2.4 billion, and on a non-GAAP basis, increased
13% to $2.0 billion, primarily due to the timing of spend and the
impact of recent acquisitions.
- On a GAAP basis, research and development expenses increased
16% to $2.7 billion, and on a non-GAAP basis, increased 6% to $2.3
billion, primarily due to the impact of recent acquisitions and
higher costs to support the overall portfolio.
- On a GAAP and non-GAAP basis, Acquired IPRD increased to $12.9
billion from $75 million, primarily due to the Karuna asset
acquisition and SystImmune collaboration. On a GAAP and non-GAAP
basis, licensing income was $12 million compared to $43 million
during the same period a year ago.
- On a GAAP basis, amortization of acquired intangible assets
increased 4% to $2.4 billion, primarily due to the Mirati
Therapeutics and RayzeBio acquisitions and approval of Augtyro in
the fourth quarter of 2023.
- On a GAAP basis, income tax expense was $392 million on a
pre-tax loss of $11.5 billion, and on a non-GAAP basis, income tax
expense was $732 million on a pre-tax loss of $8.2 billion,
primarily due to the $12.1 billion one-time, non-tax-deductible
charge for the acquisition of Karuna.
- On a GAAP basis, the company reported net loss attributable to
Bristol Myers Squibb of $11.9 billion, or ($5.89) per share, during
the first quarter of 2024 compared to net earnings of $2.3 billion,
or $1.07 per share, for the same period a year ago. In addition to
the items above, the decrease was also due to lower litigation and
other settlement income. The company reported on a non-GAAP basis
net loss attributable to Bristol Myers Squibb of $8.9 billion, or
($4.40) per share, during the first quarter of 2024 compared to net
earnings of $4.3 billion, or $2.05 per share, for the same period a
year ago. In addition to the items above, the decrease was also due
to higher interest expense resulting from new debt issuance to fund
recent acquisitions.
FIRST QUARTER PRODUCT REVENUE
HIGHLIGHTS
($ amounts in millions)
Quarter Ended March 31,
2024
% Change from Quarter Ended
March 31, 2023
% Change from Quarter Ended
March 31, 2023 Ex-F/X**
U.S.
Int'l (c)
WW(d)
U.S.
Int'l(c)
WW(d)
Int'l(c)
WW(d)
Growth Portfolio
Opdivo
$
1,155
$
923
$
2,078
(10)%
—%
(6)%
9%
(2)%
Orencia
572
226
798
4%
6%
4%
13%
6%
Yervoy
368
215
583
18%
10%
15%
17%
18%
Reblozyl
293
61
354
88%
22%
72%
22%
72%
Opdualag
198
8
206
71%
*
76%
*
76%
Abecma
52
30
82
(56)%
3%
(44)%
7%
(44)%
Zeposia
72
38
110
41%
41%
41%
41%
41%
Breyanzi
87
20
107
50%
54%
51%
54%
51%
Camzyos
77
7
84
*
N/A
*
N/A
*
Sotyktu
34
10
44
*
*
*
*
*
Augtyro
6
—
6
N/A
N/A
N/A
N/A
N/A
Krazati
21
—
21
N/A
N/A
N/A
N/A
N/A
Other Growth Products(a)
148
171
319
3%
26%
14%
30%
16%
Total Growth Portfolio
3,083
1,709
4,792
9%
8%
8%
15%
11%
Legacy Portfolio
Eliquis
2,821
899
3,720
12%
—%
9%
1%
9%
Revlimid
1,453
216
1,669
(5)%
(5)%
(5)%
(1)%
(4)%
Pomalyst/Imnovid
597
268
865
10%
(8)%
4%
(7)%
4%
Sprycel
282
92
374
(2)%
(34)%
(13)%
(30)%
(11)%
Abraxane
145
72
217
(10)%
(8)%
(9)%
10%
(3)%
Other Legacy Products (b)
95
133
228
19%
(20)%
(7)%
(17)%
(6)%
Total Legacy Portfolio
5,393
1,680
7,073
5%
(7)%
2%
(4)%
3%
Total Revenues
$
8,476
$
3,389
$
11,865
7%
—%
5%
5%
6%
*
In excess of +100%
**
See "Use of Non-GAAP Financial
Information".
(a)
Includes Nulojix, Onureg, Inrebic,
Empliciti and royalty revenue.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues
are included in International revenues. Prior period amounts have
been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and
International (Int'l).
FIRST QUARTER PRODUCT REVENUE
HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $4.8 billion
compared to $4.4 billion in the prior year period, representing
growth of 8%, or 11% when adjusted for foreign exchange impacts.
Growth Portfolio revenues were primarily driven by higher demand
for Reblozyl, Opdualag, Yervoy, Camzyos, and Sotyktu, partially
offset by Opdivo and Abecma.
Legacy Portfolio
Revenues for the Legacy Portfolio in the first quarter were $7.1
billion compared to $6.9 billion in the prior year period. Legacy
Portfolio revenues were largely driven by a 9% increase in Eliquis
worldwide revenues on a reported basis and when adjusted for
foreign exchange impacts, partially offset by a decline in Revlimid
worldwide revenues of 5%, or 4% when adjusted for foreign exchange
impacts.
PRODUCT AND PIPELINE
UPDATE
Cardiovascular
Category
Asset
Milestone
Clinical & Research
Camzyos® (mavacamten)
An analysis of results from the 10-month
post-launch evaluation of the Camzyos REMS Program in 1,524
patients demonstrated that approximately 1% of patients reported
clinical heart failure requiring hospitalization and 2.8% of
patients reported a decrease in left ventricular ejection fraction
to <50%.
Oncology
Category
Asset
Milestone
Regulatory
Opdivo® (nivolumab)
The U.S. Food and Drug Administration
(FDA) approved Opdivo, in combination with cisplatin and
gemcitabine, for the first-line treatment of adult patients with
unresectable or metastatic urothelial carcinoma (UC). The approval
is based on results from the Phase 3 CheckMate -901 trial
evaluating Opdivo in combination with cisplatin and gemcitabine
followed by Opdivo monotherapy, compared to cisplatin-gemcitabine
alone, for patients with previously untreated unresectable or
metastatic UC.
Krazati® (adagrasib)
The FDA accepted the supplemental New Drug
Application (sNDA) for Krazati in combination with cetuximab for
the treatment of patients with previously treated KRASG12C -mutated
locally advanced or metastatic colorectal cancer. The acceptance
was based on the results of the Phase 1/2 KRYSTAL-1 trial. The FDA
granted the application Priority Review and assigned a Prescription
Drug User Fee Act (PDUFA) goal date of June 21, 2024.
AugtyroTM (repotrectinib)
The FDA accepted the sNDA for Augtyro for
the treatment of adult and pediatric patients 12 years of age and
older with NTRK-positive locally advanced or metastatic solid
tumors. The acceptance is based on results from the registrational
Phase 1/2 TRIDENT-1 trial and the CARE study. The FDA granted the
application Priority Review and assigned a PDUFA goal date of June
15, 2024.
Opdivo
The FDA accepted the supplemental
Biologics Application (sBLA) for neoadjuvant Opdivo for the
perioperative treatment of resectable stage IIA to IIIB non-small
cell lung cancer (NSCLC). The FDA assigned a PDUFA goal date of
October 8, 2024. In addition, the European Medicines Agency (EMA)
validated the type II variation application for neoadjuvant Opdivo
with chemotherapy followed by surgery and adjuvant Opdivo for the
perioperative treatment of resectable stage IIA to IIIB NSCLC.
Application validation confirms the submission is complete and
begins the EMA’s centralized review procedure. The FDA’s sBLA
acceptance and the EMA’s application validation are based on
results from the Phase 3 CheckMate -77T trial.
Clinical & Research
Krazati
The pivotal Phase 3 KRYSTAL-12 study,
evaluating Krazati as a monotherapy in patients with pretreated
locally advanced or metastatic NSCLC harboring a KRASG12C mutation,
met the primary endpoint of progression-free survival (PFS) and the
key secondary endpoint of overall response rate as assessed by
Blinded Independent Central Review at final analysis for these
endpoints. The study remains ongoing to assess the additional key
secondary endpoint of overall survival.
Krazati
Data from the cohorts of the Phase 1/2
KRYSTAL-1 study evaluating Krazati in combination with cetuximab
for the treatment of patients with previously treated
KRASG12C-mutated locally advanced or metastatic colorectal cancer
demonstrated clinically meaningful activity. With a median follow
up of 11.9 months in 94 patients, Krazati plus cetuximab
demonstrated an objective response rate of 34%, median PFS of 6.9
months, and median overall survival of 15.9 months in pre-treated
patients.
OpdualagTM (nivolumab and relatlimab)
Initial data from a randomized Phase 2
study evaluating Opdualag in NSCLC support the initiation of a
Phase 3 trial in 2024 evaluating Opdualag plus chemotherapy versus
PD-1/PD-L1 plus chemotherapy in an important segment of the
disease. Phase 2 data is expected to be disclosed later this
year.
Opdivo+Yervoy
The Phase 3 CheckMate -9DW trial
evaluating Opdivo plus Yervoy as a first-line treatment for
patients with advanced hepatocellular carcinoma who have not
received a prior systemic therapy met its primary endpoint of
improved overall survival compared to investigator's choice of
sorafenib or lenvatinib at a pre-specified interim analysis.
Hematology
Category
Asset
Milestone
Regulatory
Abecma® (idecabtagene vicleucel)
The European Commission (EC) approved
Abecma for the treatment of adult patients with relapsed and
refractory multiple myeloma who have received at least two prior
therapies, including an immunomodulatory agent, a proteasome
inhibitor, and an anti-CD38 antibody and have demonstrated disease
progression on the last therapy. The approval is based on results
from the Phase 3 KarMMa-3 trial. Abecma is the first CAR T cell
immunotherapy approved in the European Union for use in earlier
lines of therapy for relapsed and refractory multiple myeloma.
Abecma
The FDA approved Abecma for the treatment
of adult patients with relapsed or refractory multiple myeloma
after two or more prior lines of therapy, including an
immunomodulatory agent, a proteasome inhibitor, and an anti-CD38
monoclonal antibody. The approval is based on results from the
Phase 3 KarMMa-3 trial. Abecma is being jointly developed and
commercialized in the U.S. by Bristol Myers Squibb and 2seventy
bio, Inc.
Breyanzi® (lisocabtagene maraleucel)
The FDA granted accelerated approval of
Breyanzi for the treatment of adult patients with relapsed or
refractory chronic lymphocytic leukemia or small lymphocytic
lymphoma who have received at least two prior lines of therapy,
including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma
2 inhibitor. The accelerated approval is based on the Phase 1/2
open-label, single-arm TRANSCEND CLL 004 trial.
Reblozyl® (luspatercept-aamt)
The EC expanded approval of Reblozyl to
include the first-line treatment of adult patients with
transfusion-dependent anemia due to very low, low and
intermediate-risk myelodysplastic syndromes. The approval covers
all European Union member states and is based on the pivotal Phase
3 COMMANDS trial.
Immunology
Category
Asset
Milestone
Clinical & Research
Zeposia® (ozanimod)
First of two induction Phase 3 YELLOWSTONE
trials evaluating Zeposia in adult patients with moderate-to-severe
active Crohn's disease did not meet its primary endpoint of
clinical remission at Week 12. The safety profile of Zeposia in
this study was consistent with that observed in previously reported
trials.
Zeposia
Data from the Phase 3 DAYBREAK open-label
extension trial demonstrated the long-term efficacy and safety
profile of Zeposia in patients with relapsing forms of multiple
sclerosis. In the DAYBREAK long-term extension study, treatment
with Zeposia demonstrated a low annualized relapse rate of 0.098
and 67% of patients were relapse-free at six years. An analysis of
DAYBREAK data showed nearly 97% of followed patients were
relapse-free at 90 days post Zeposia discontinuation. Patients that
did relapse showed no evidence of rebound effect.
Neuroscience
Category
Asset
Milestone
Clinical & Research
KarXT (xanomeline-trospium)
Interim long-term efficacy data from the
Phase 3 EMERGENT-4 open-label extension trial demonstrated that
KarXT was associated with significant improvement in symptoms of
schizophrenia across all efficacy measures at 52 weeks. In
addition, pooled interim long-term safety, tolerability and
metabolic outcomes data from the Phase 3 EMERGENT-4 and EMERGENT-5
trials evaluating the safety, tolerability and efficacy of KarXT in
adults with schizophrenia showed that KarXT demonstrated a
favorable weight and long-term metabolic profile where most
patients experience stability or improvements on key metabolic
parameters over 52 weeks of treatment. KarXT was generally
well-tolerated, with a side effect profile consistent with prior
trials of KarXT in schizophrenia.
Business Development
The company recently completed multiple transactions,
strengthening its long-term growth profile and enhancing its
portfolio and pipeline.
- With the acquisition of Karuna Therapeutics, Inc., Bristol
Myers Squibb expanded its position in neuroscience and added
important assets, including KarXT, an antipsychotic with a novel
mechanism of action and differentiated efficacy and safety. KarXT
has a PDUFA goal date of September 26, 2024, for the treatment of
schizophrenia in adults.
- By acquiring RayzeBio, Inc., a clinical-stage
radiopharmaceutical therapeutics company with a differentiated
platform and state-of-the-art manufacturing capabilities, Bristol
Myers Squibb further diversified its oncology portfolio and gained
a rich pipeline of potentially first-in-class and best-in-class
drug development programs currently targeting solid tumors.
- Through the acquisition of Mirati Therapeutics, Inc., Bristol
Myers Squibb strengthened its pipeline and added commercialized
lung cancer medicine Krazati to its oncology portfolio, as well as
several promising clinical assets.
- The company completed an exclusive license and collaboration
agreement with SystImmune to develop and commercialize a
potentially first-in-class EGFRxHER3 bispecific antibody-drug
conjugate with the potential to treat a variety of solid tumors,
including lung and breast cancer.
On April 22, Bristol Myers Squibb and Cellares announced a
worldwide capacity reservation and supply agreement for the
manufacture of CAR T cell therapies. As a part of the agreement,
Cellares will optimize, automate, and tech-transfer select Bristol
Myers Squibb CAR T cell therapies onto its automated and
high-throughput manufacturing platform, the Cell ShuttleTM. This
agreement enables Bristol Myers Squibb to expand its manufacturing
capacity, meeting the growing demand for its diverse range of cell
therapies through a platform that is scalable and has the potential
to improve turnaround time, bringing the promise of cell therapies
to more patients faster.
Strategically Enhancing Productivity
and Efficiency
Bristol Myers Squibb is executing a strategic productivity
initiative that will drive approximately $1.5 billion in cost
savings by the end of 2025, the majority of which will be
reinvested to fund innovation and drive growth.
As a part of this initiative, the company is:
- Focusing resources on R&D programs with the potential to
deliver the greatest return on investment;
- Prioritizing investing in key growth brands; and
- Optimizing operations across the organization.
Company executives will provide additional details on these
actions during the company's first quarter 2024 earnings conference
call.
Financial Guidance
As previously communicated, Bristol Myers Squibb is updating
portions of its 2024 line-item guidance, including Non-GAAP EPS, to
reflect the impact of recent transactions.
- Non-GAAP EPS was updated to account for the following:
2024 Non-GAAP EPS
Guidance
February Diluted EPS (Prior)
$7.10 - $7.40
Acquired IPRD Impact1
($6.30)
Dilution Impact (RayzeBio)
($0.13)
Dilution Impact (Karuna Therapeutics)
($0.30)
Total Deals Impact
($6.73)
Revised Diluted EPS
$0.40 - $0.70
1 Primarily represents the Acquired IPRD
impact from the Karuna Therapeutics asset acquisition and
SystImmune collaboration.
- Non-GAAP other income/(expense) was updated primarily due to
the financing of the recent acquisitions.
- Non-GAAP tax rate was updated to approximately 69% to reflect
the impact of a $12.1 billion one-time, non-tax-deductible IPRD
charge from the Karuna Therapeutics acquisition, which is expected
to contribute 51% to the full-year tax rate.
- 2024 line-item guidance updates are:
Non-GAAP2
February
(Prior)
April (Revised)
Total Revenues
Low single-digit increase
No Change
Total Revenues
(excl. F/X)
Low single-digit increase
No Change
Gross Margin %
~74%
No Change
Operating Expenses1
Low single-digit increase
No Change
Other income/(expense)
~$250M
~($250M)
Effective tax rate
~17.5%
~69%
Diluted EPS
$7.10 - $7.40
$0.40 - $0.70
1 Operating Expenses = MS&A and
R&D, excluding Acquired IPRD and Amortization of acquired
intangible assets. 2 See "Use of Non-GAAP Financial
Information."
The 2024 financial guidance excludes the impact of any potential
future strategic acquisitions, divestitures, specified items that
have not yet been identified and quantified, and the impact of
future Acquired IPRD charges. To the extent we have quantified the
impact of significant R&D charges or other income resulting
from upfront or contingent milestone payments in connection with
asset acquisitions or licensing of third-party intellectual
property rights, we may update this information from time to time
on our website www.bms.com, in the "Investors" section. Non-GAAP
guidance assumes current exchange rates. The financial guidance is
subject to risks and uncertainties applicable to all
forward-looking statements as described elsewhere in this press
release.
A reconciliation of forward-looking non-GAAP measures, including
non-GAAP EPS, to the most directly comparable GAAP measures is not
provided because comparable GAAP measures for such measures are not
reasonably accessible or reliable due to the inherent difficulty in
forecasting and quantifying measures that would be necessary for
such reconciliation. Namely, we are not without unreasonable
effort, able to reliably predict the impact of accelerated
depreciation and impairment charges, legal and other settlements,
gains and losses from equity investments and other adjustments. In
addition, the company believes such a reconciliation would imply a
degree of precision and certainty that could be confusing to
investors. These items are uncertain, depend on various factors and
may have a material impact on our future GAAP results. See
"Cautionary Statement Regarding Forward-Looking Statements" and
"Use of Non-GAAP Financial Information."
Environmental, Social & Governance
(ESG)
As a leading biopharmaceutical company, Bristol Myers Squibb's
passion for making an impact extends beyond the discovery,
development and delivery of innovative medicines that help patients
prevail over serious diseases.
- On April 2, 2024, the company published its latest ESG report,
which details the company's meaningful progress, its evolved ESG
strategy, and its long-term aspirational ESG goals. The company's
evolved approach further integrates its ESG strategy and its
business strategy. The ESG strategy focuses on three core pillars:
advancing patient health around the world, expanding the boundaries
of science, and fostering a high-performing and inclusive global
workforce. Highlights from the report include:
- Advancing tailored access programs in low-and middle-income
countries;
- Making clinical trials more accessible to underrepresented
groups and ensuring research efforts better reflect patient
populations;
- Sustained workforce representation and increased community
engagement by the company's employees;
- Advancing climate action goals and increasing the company's
renewable energy footprint; and
- Incorporating new ESG metrics into the executive compensation
program and advancing data privacy and cybersecurity efforts.
Conference Call
Information
Bristol Myers Squibb will host a conference call today,
Thursday, April 25, 2024, at 8:00 a.m. ET during which company
executives will review quarterly financial results and address
inquiries from investors and analysts. Investors and the general
public are invited to listen to a live webcast of the call at
http://investor.bms.com.
Investors and the public can register for the live conference
call here. Those unable to register can access the live conference
call by dialing in the U.S. toll-free 1-833-816-1116 or
international +1 412-317-0705. Materials related to the call will
be available at http://investor.bms.com prior to the start of the
conference call.
A replay of the webcast will be available at
http://investor.bms.com approximately three hours after the
conference call concludes. A replay of the conference call will be
available beginning at 11:30 a.m. ET on April 25, 2024, through
11:30 a.m. ET on May 9, 2024, by dialing in the U.S. toll free
1-877-344-7529 or international +1 412-317-0088, confirmation code:
5034750.
About Bristol Myers
Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook, and
Instagram.
corporatefinancial-news
Use of Non-GAAP Financial
Information
In discussing financial results and guidance, the company refers
to financial measures that are not in accordance with U.S.
Generally Accepted Accounting Principles (GAAP). The non-GAAP
financial measures are provided as supplemental information to the
financial measures presented in this press release that are
calculated and presented in accordance with GAAP and are presented
because management has evaluated the company’s financial results
both including and excluding the adjusted items or the effects of
foreign currency translation, as applicable, and believes that the
non-GAAP financial measures presented portray the results of the
company's baseline performance, supplement or enhance management's,
analysts' and investors' overall understanding of the company’s
underlying financial performance and trends and facilitate
comparisons among current, past and future periods. In addition,
non-GAAP gross margin, which is gross profit excluding certain
specified items, as a percentage of revenues, non-GAAP operating
margin, which is gross profit less marketing, selling and
administrative expenses and research and development expenses
excluding certain specified items as a percentage of revenues,
non-GAAP operating expenses, which is marketing, selling and
administrative and research and development expenses excluding
certain specified items, non-GAAP marketing, selling and
administrative expenses, which is marketing, selling and
administrative expenses excluding certain specified items, and
non-GAAP research and development expenses, which is research and
development expenses excluding certain specified items, are
relevant and useful for investors because they allow investors to
view performance in a manner similar to the method used by our
management and make it easier for investors, analysts and peers to
compare our operating performance to other companies in our
industry and to compare our year-over-year results.
This earnings release and the accompanying tables also provide
certain revenues and expenses as well as non-GAAP measures
excluding the impact of foreign exchange ("Ex-Fx"). We calculate
foreign exchange impacts by converting our current-period local
currency financial results using the prior period average currency
rates and comparing these adjusted amounts to our current-period
results. Ex-Fx financial measures are not accounted for according
to GAAP because they remove the effects of currency movements from
GAAP results.
Non-GAAP financial measures such as non-GAAP earnings and
related EPS information are adjusted to exclude certain costs,
expenses, gains and losses and other specified items that are
evaluated on an individual basis after considering their
quantitative and qualitative aspects and typically have one or more
of the following characteristics, such as being highly variable,
difficult to project, unusual in nature, significant to the results
of a particular period or not indicative of past or future
operating results. These items are excluded from non-GAAP earnings
and related EPS information because the company believes they
neither relate to the ordinary course of the company’s business nor
reflect the company’s underlying business performance. Similar
charges or gains were recognized in prior periods and will likely
reoccur in future periods, including amortization of acquired
intangible assets, including product rights that generate a
significant portion of our ongoing revenue and will recur until the
intangible assets are fully amortized, unwind of inventory purchase
price adjustments, acquisition and integration expenses,
restructuring costs, accelerated depreciation and impairment of
property, plant and equipment and intangible assets, costs of
acquiring a priority review voucher, stock compensation resulting
from acquisition-related equity awards, pension, legal and other
contractual settlement charges, equity investment and contingent
value rights fair value adjustments (including fair value
adjustments attributed to limited partnership equity method
investments), income resulting from the change in control of the
Nimbus Therapeutics TYK2 Program and amortization of fair value
adjustments of debt acquired from Celgene in our 2019 exchange
offer, among other items. Deferred and current income taxes
attributed to these items are also adjusted for considering their
individual impact to the overall tax expense, deductibility and
jurisdictional tax rates.
Because the non-GAAP financial measures are not calculated in
accordance with GAAP, they should not be considered superior to and
are not intended to be considered in isolation or as a substitute
for the related financial measures presented in the press release
that are prepared in accordance with GAAP and may not be the same
as or comparable to similarly titled measures presented by other
companies due to possible differences in method and in the items
being adjusted. We encourage investors to review our financial
statements and publicly-filed reports in their entirety and not to
rely on any single financial measure.
Reconciliations of the non-GAAP financial measures to the most
comparable GAAP measures are provided in the accompanying financial
tables and will also be available on the company’s website at
www.bms.com. Within the accompanying financial tables presented,
certain columns and rows may not add due to the use of rounded
numbers. Percentages and earnings per share amounts presented are
calculated from the underlying amounts.
A reconciliation of forward-looking non-GAAP measures, including
non-GAAP EPS, to the most directly comparable GAAP measures is not
provided because comparable GAAP measures for such measures are not
reasonably accessible or reliable due to the inherent difficulty in
forecasting and quantifying measures that would be necessary for
such reconciliation. Namely, we are not, without unreasonable
effort, able to reliably predict the impact of accelerated
depreciation and impairment charges, legal and other settlements,
gains and losses from equity investments and other adjustments. In
addition, the company believes such a reconciliation would imply a
degree of precision and certainty that could be confusing to
investors. These items are uncertain, depend on various factors and
may have a material impact on our future GAAP results.
Website Information
We routinely post important information for investors on our
website, BMS.com, in the “Investors” section. We may use this
website as a means of disclosing material, non-public information
and for complying with our disclosure obligations under Regulation
FD. Accordingly, investors should monitor the Investors section of
our website, in addition to following our press releases,
Securities and Exchange Commission ("SEC") filings, public
conference calls, presentations and webcasts. We may also use
social media channels to communicate with our investors and the
public about our company, our products and other matters, and those
communications could be deemed to be material information. The
information contained on, or that may be accessed through, our
website or social media channels are not incorporated by reference
into, and are not a part of, this document.
Cautionary Statement Regarding
Forward-Looking Statements
This earnings release and the related attachments (as well as
the oral statements made with respect to information contained in
this release and the attachments) contain certain “forward-looking”
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, regarding, among other things, the company’s
2024 financial guidance, plans and strategy, including its business
development and capital allocation strategy, anticipated
developments in the company’s pipeline, expectations with respect
to the company’s future market position and the projected benefits
of the company’s alliances and other business development
activities. These statements may be identified by the fact that
they use words such as “should,” “could,” “expect,” “anticipate,”
“estimate,” “target,” “may,” “project,” “guidance,” “intend,”
“plan,” “believe,” “will” and other words and terms of similar
meaning and expression in connection with any discussion of future
operating or financial performance, although not all
forward-looking statements contain such terms. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. No forward-looking statement can be
guaranteed and there is no assurance that the company will achieve
its financial guidance and long-term targets, that the company’s
future clinical studies will support the data described in this
release, that the company’s product candidates will receive
necessary clinical and manufacturing regulatory approvals, that the
company’s pipeline products will prove to be commercially
successful, that clinical and manufacturing regulatory approvals
will be sought or obtained within currently expected timeframes, or
that contractual milestones will be achieved.
Forward-looking statements are based on current expectations and
projections about the company’s future financial results, goals,
plans and objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond the company’s control and
could cause the company’s future financial results, goals, plans
and objectives to differ materially from those expressed in, or
implied by, the statements. Such risks, uncertainties and other
matters include, but are not limited to: increasing pricing
pressures from market access, pharmaceutical pricing controls and
discounting; market actions taken by private and government payers
to manage drug utilization and contain costs; the company’s ability
to retain patent exclusivity of certain products; regulatory
changes that result in lower prices, lower reimbursement rates and
smaller populations for whom payers will reimburse; changes under
the 340B Drug Pricing Program; the company’s ability to obtain and
maintain regulatory approval for its product candidates; the
company’s ability to obtain and protect market exclusivity rights
and enforce patents and other intellectual property rights; the
possibility of difficulties and delays in product introduction and
commercialization; increasing industry competition; potential
difficulties, delays and disruptions in manufacturing, distribution
or sale of products; the company’s ability to identify potential
strategic acquisitions, licensing opportunities or other beneficial
transactions; failure to complete, or delays in completing,
collaborations, acquisitions, divestitures, alliances and other
portfolio actions and the failure to achieve anticipated benefits
from such transactions and actions; the risk of an adverse patent
litigation decision or settlement and exposure to other litigation
and/or regulatory actions or investigations; the impact of any
healthcare reform and legislation or regulatory action in the
United States and international markets; increasing market
penetration of lower-priced generic products; the failure of the
company’s suppliers, vendors, outsourcing partners, alliance
partners and other third parties to meet their contractual,
regulatory and other obligations; the impact of counterfeit or
unregistered versions of the company’s products and from stolen
products; product label changes or other measures that could reduce
the product's market acceptance for the company's products and
result in declining sales; safety or efficacy concerns regarding
the company’s products or any product in the same class as the
company’s products; the risk of cyber-attacks on the company’s
information systems or products and unauthorized disclosure of
trade secrets or other confidential data; the company’s ability to
execute its financial, strategic and operational plans; the
company’s dependency on several key products; any decline in the
company’s future royalty streams; the company’s ability to attract
and retain key personnel; the impact of the company’s significant
indebtedness; political and financial instability of international
economies and sovereign risk; interest rate and currency exchange
rate fluctuations, credit and foreign exchange risk management;
risks relating to the use of social media platforms; the impact of
our exclusive forum provision in our by-laws for certain lawsuits
on our stockholders’ ability to obtain a judicial forum that they
find favorable for such lawsuits; issuance of new or revised
accounting standards; and risks relating to public health
outbreaks, epidemics and pandemics.
Forward-looking statements in this earnings release should be
evaluated together with the many risks and uncertainties that
affect the company’s business and market, particularly those
identified in the cautionary statement and risk factors discussion
in the company’s Annual Report on Form 10-K for the year ended
December 31, 2023, as updated by the company’s subsequent Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and other filings
with the SEC. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, the company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
changed circumstances or otherwise.
BRISTOL-MYERS SQUIBB
COMPANY CONSOLIDATED STATEMENTS OF EARNINGS FOR THE
THREE MONTHS ENDED MARCH 31, 2024 AND 2023 (Unaudited,
dollars and shares in millions except per share data)
Three Months Ended March
31,
2024
2023
Net product sales
$
11,559
$
11,048
Alliance and other revenues
306
289
Total Revenues
11,865
11,337
Cost of products sold(a)
2,932
2,566
Marketing, selling and administrative
2,367
1,762
Research and development
2,695
2,321
Acquired IPRD
12,949
75
Amortization of acquired intangible
assets
2,357
2,256
Other (income)/expense, net
81
(413
)
Total Expenses
23,381
8,567
(Loss)/Earnings Before Income Taxes
(11,516
)
2,770
Provision for Income Taxes
392
503
Net (Loss)/Earnings
(11,908
)
2,267
Noncontrolling Interest
3
5
Net (Loss)/Earnings Attributable to
BMS
$
(11,911
)
$
2,262
Weighted-Average Common Shares
Outstanding:
Basic
2,023
2,099
Diluted
2,023
2,113
(Loss)/Earnings per Common
Share:
Basic
$
(5.89
)
$
1.08
Diluted
(5.89
)
1.07
Other (income)/expense, net
Interest expense(b)
$
425
$
288
Royalty and licensing income
(161
)
(363
)
Royalty income - divestitures
(271
)
(188
)
Equity investment (gains)/losses
(102
)
155
Integration expenses
71
67
Litigation and other settlements
2
(325
)
Investment income
(183
)
(102
)
Provision for restructuring
220
67
Acquisition expense
49
—
Other
31
(12
)
Other (income)/expense, net
$
81
$
(413
)
(a) Excludes amortization of acquired
intangible assets. (b) Includes amortization of purchase price
adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB
COMPANY PRODUCT REVENUES FOR THE THREE MONTHS ENDED
MARCH 31, 2024 AND 2023 (Unaudited, dollars in
millions)
Change vs. 2023
2024
2023
GAAP
Excl. F/X**
U.S.
Int'l (c)
WW (d)
U.S.
Int'l (c)
WW (d)
U.S.
Int'l (c)
WW (d)
U.S.
Int'l (c)
WW (d)
Growth Portfolio
Opdivo
$
1,155
$
923
$
2,078
$
1,281
$
921
$
2,202
(10
)%
—%
(6)%
(10)%
9%
(2)%
Orencia
572
226
798
551
213
764
4
%
6%
4%
4%
13%
6%
Yervoy
368
215
583
312
196
508
18
%
10%
15%
18%
17%
18%
Reblozyl
293
61
354
156
50
206
88
%
22%
72%
88%
22%
72%
Opdualag
198
8
206
116
1
117
71
%
*
76%
71%
*
76%
Abecma
52
30
82
118
29
147
(56
)%
3%
(44)%
(56)%
7%
(44)%
Zeposia
72
38
110
51
27
78
41
%
41%
41%
41%
41%
41%
Breyanzi
87
20
107
58
13
71
50
%
54%
51%
50%
54%
51%
Camzyos
77
7
84
29
—
29
*
N/A
*
*
N/A
*
Sotyktu
34
10
44
15
1
16
*
*
*
*
*
*
Augtyro
6
—
6
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Krazati
21
—
21
—
—
—
N/A
N/A
N/A
N/A
N/A
N/A
Other Growth Products(a)
148
171
319
144
136
280
3
%
26%
14%
3%
30%
16%
Total Growth Portfolio
3,083
1,709
4,792
2,831
1,587
4,418
9
%
8%
8%
9%
15%
11%
Legacy Portfolio
Eliquis
2,821
899
3,720
2,527
896
3,423
12
%
—%
9%
12%
1%
9%
Revlimid
1,453
216
1,669
1,523
227
1,750
(5
)%
(5)%
(5)%
(5)%
(1)%
(4)%
Pomalyst/Imnovid
597
268
865
541
291
832
10
%
(8)%
4%
10%
(7)%
4%
Sprycel
282
92
374
289
140
429
(2
)%
(34)%
(13)%
(2)%
(30)%
(11)%
Abraxane
145
72
217
161
78
239
(10
)%
(8)%
(9)%
(10)%
10%
(3)%
Other Legacy Products(b)
95
133
228
80
166
246
19
%
(20)%
(7)%
19%
(17)%
(6)%
Total Legacy Portfolio
5,393
1,680
7,073
5,121
1,798
6,919
5
%
(7)%
2%
5%
(4)%
3%
Total Revenues
$
8,476
$
3,389
$
11,865
$
7,952
$
3,385
$
11,337
7
%
—%
5%
7%
5%
6%
*
In excess of +100%
**
See "Use of Non-GAAP Financial
Information".
(a)
Includes Onureg, Nulojix, Empliciti and
royalty revenues.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues
are included in International revenues. Prior period amounts have
been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and
International (Int'l).
BRISTOL-MYERS SQUIBB
COMPANY INTERNATIONAL REVENUES(a) FOREIGN EXCHANGE
IMPACT (%) FOR THE THREE MONTHS ENDED MARCH 31, 2024
(Unaudited)
Three Months Ended March 31,
2024
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
Growth Portfolio
Opdivo
—%
(9)%
9%
Orencia
6%
(7)%
13%
Yervoy
10%
(7)%
17%
Reblozyl
22%
—%
22%
Opdualag
*
*
*
Abecma
3%
(4)%
7%
Zeposia
41%
—%
41%
Breyanzi
54%
—%
54%
Camzyos
N/A
N/A
N/A
Sotyktu
*
*
*
Augtyro
N/A
N/A
N/A
Krazati
N/A
N/A
N/A
Other Growth Products(b)
26%
(4)%
30%
Total Growth Portfolio
8%
(7)%
15%
Legacy Portfolio
Eliquis
—%
(1)%
1%
Revlimid
(5)%
(4)%
(1)%
Pomalyst/Imnovid
(8)%
(1)%
(7)%
Sprycel
(34)%
(4)%
(30)%
Abraxane
(8)%
(18)%
10%
Other Legacy Products(c)
(20)%
(3)%
(17)%
Total Legacy Portfolio
(7)%
(3)%
(4)%
Total Revenues
—%
(5)%
5%
*
In excess of +100%
**
See "Use of Non-GAAP Financial
Information".
(a)
Beginning in 2024, Puerto Rico revenues
are included in International revenues. Prior period amounts have
been reclassified to conform to the current presentation.
(b)
Includes Onureg, Nulojix, Empliciti and
royalty revenues.
(c)
Includes other mature brands.
BRISTOL-MYERS SQUIBB
COMPANY WORLDWIDE REVENUES(a) FOREIGN EXCHANGE IMPACT
(%) FOR THE THREE MONTHS ENDED MARCH 31, 2024
(Unaudited)
Three Months Ended March 31,
2024
Revenue Change %
F/X % Favorable/ (Unfavorable)
**
Revenue Change % Ex- F/X
**
Growth Portfolio
Opdivo
(6)%
(4)%
(2)%
Orencia
4%
(2)%
6%
Yervoy
15%
(3)%
18%
Reblozyl
72%
—%
72%
Opdualag
76%
—%
76%
Abecma
(44)%
—%
(44)%
Zeposia
41%
—%
41%
Breyanzi
51%
—%
51%
Camzyos
*
*
*
Sotyktu
*
*
*
Augtyro
N/A
N/A
N/A
Krazati
N/A
N/A
N/A
Other Growth Products(b)
14%
(2)%
16%
Total Growth Portfolio
8%
(3)%
11%
Legacy Portfolio
Eliquis
9%
—%
9%
Revlimid
(5)%
(1)%
(4)%
Pomalyst/Imnovid
4%
—%
4%
Sprycel
(13)%
(2)%
(11)%
Abraxane
(9)%
(6)%
(3)%
Other Legacy Products(c)
(7)%
(1)%
(6)%
Total Legacy Portfolio
2%
(1)%
3%
Total Revenues
5%
(1)%
6%
*
In excess of +100%
**
See "Use of Non-GAAP Financial
Information".
(a)
Worldwide (WW) includes U.S. and
International (Int'l).
(b)
Includes Onureg, Nulojix, Empliciti and
royalty revenues.
(c)
Includes other mature brands.
BRISTOL-MYERS SQUIBB
COMPANY RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS
AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT * FOR THE
PERIOD ENDED MARCH 31, 2024 (Unaudited, dollars in
millions)
2024
2023
Change $
Change %
Favorable / (Unfavorable) F/X
$ **
2024 Excl. F/X **
Favorable / (Unfavorable) F/X
% **
% Change Excl. F/X **
Revenues
$
11,865
$
11,337
$
528
5%
$
(153
)
$
12,018
(1)%
6%
Gross profit
8,933
8,771
162
2%
N/A
N/A
N/A
N/A
Gross profit excluding specified
items(a)
8,955
8,825
130
1%
N/A
N/A
N/A
N/A
Gross margin(b)
75.3
%
77.4
%
Gross margin excluding specified items
75.5
%
77.8
%
Marketing, selling and administrative
2,367
1,762
605
34%
21
2,388
2%
36%
Marketing, selling and administrative
excluding specified items(a)
1,989
1,762
227
13%
21
2,010
1%
14%
Research and development
2,695
2,321
374
16%
9
2,704
1%
17%
Research and development excluding
specified items(a)
2,346
2,206
140
6%
9
2,355
1%
7%
*
Foreign exchange impacts were derived by
converting our current-period local currency financial results
using the prior period average currency rates and comparing these
adjusted amounts to our current-period results.
**
See "Use of Non-GAAP Financial
Information".
(a)
Refer to the Specified Items schedule
below for further details.
(b)
Represents gross profit as a percentage of
Revenues.
BRISTOL-MYERS SQUIBB
COMPANY SPECIFIED ITEMS (Unaudited, dollars in
millions)
Three Months Ended March
31,
2024
2023
Inventory purchase price accounting
adjustments
$
8
$
53
Site exit and other costs
14
1
Cost of products sold
22
54
Acquisition related charges(a)
372
—
Site exit and other costs
6
—
Marketing, selling and
administrative
378
—
IPRD impairments
—
20
Priority review voucher
—
95
Acquisition related charges(a)
348
—
Site exit and other costs
1
—
Research and development
349
115
Amortization of acquired intangible
assets
2,357
2,256
Interest expense(b)
(13
)
(14
)
Equity investment (gain)/losses
(102
)
150
Acquisition expenses
49
—
Integration expenses
71
67
Litigation and other settlements
—
(335
)
Provision for restructuring
220
67
Other
10
(5
)
Other (income)/expense, net
235
(70
)
Increase to pretax income
3,341
2,355
Income taxes on items above
(340
)
(293
)
Increase to net earnings
$
3,001
$
2,062
(a) Includes cash settlement of unvested
stock awards, and other related costs incurred in connection with
the recent acquisitions. (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 (Unaudited, dollars and shares in
millions except per share data)
Three Months Ended March 31,
2024
GAAP
Specified Items(a)
Non-GAAP
Gross profit
$
8,933
$
22
$
8,955
Marketing, selling and administrative
2,367
(378
)
1,989
Research and development
2,695
(349
)
2,346
Amortization of acquired intangible
assets
2,357
(2,357
)
—
Other (income)/expense, net
81
(235
)
(154
)
(Loss)/Earnings before income
taxes
(11,516
)
3,341
(8,175
)
Provision for income taxes
392
340
732
Net (loss)/earnings attributable to BMS
used for diluted EPS calculation
$
(11,911
)
$
3,001
$
(8,910
)
Weighted-average common shares
outstanding—diluted
2,023
2,023
2,023
Diluted (loss)/earnings per share
$
(5.89
)
$
1.49
$
(4.40
)
Effective tax rate
(3.4
)%
(5.6
)%
(9.0
)%
Three Months Ended March 31,
2023
GAAP
Specified Items(a)
Non-GAAP
Gross profit
$
8,771
$
54
$
8,825
Marketing, selling and administrative
1,762
—
1,762
Research and development
2,321
(115
)
2,206
Amortization of acquired intangible
assets
2,256
(2,256
)
—
Other (income)/expense, net
(413
)
70
(343
)
Earnings before income taxes
2,770
2,355
5,125
Provision for income taxes
503
(293
)
796
Net earnings attributable to BMS used
for diluted EPS calculation
$
2,262
$
2,062
$
4,324
Weighted-average common shares
outstanding—diluted
2,113
2,113
2,113
Diluted earnings per share
$
1.07
$
0.98
$
2.05
Effective tax rate
18.2
%
(2.7
)%
15.5
%
(a) Refer to the Specified Items schedule
above for further details. Effective tax rate on the Specified
Items represents the difference between the GAAP and Non-GAAP
effective tax rate.
BRISTOL-MYERS SQUIBB
COMPANY NET DEBT CALCULATION AS OF MARCH 31, 2024 AND
DECEMBER 31, 2023 (Unaudited, dollars in millions)
March 31, 2024
December 31,
2023
Cash and cash equivalents
$
9,330
$
11,464
Marketable debt securities - current
340
816
Marketable debt securities -
non-current
367
364
Cash, cash equivalents and marketable
debt securities
$
10,037
$
12,644
Short-term debt obligations
(6,190
)
(3,119
)
Long-term debt
(49,487
)
(36,653
)
Net debt position
$
(45,640
)
$
(27,128
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240425548503/en/
Media: media@bms.com Investor Relations:
investor.relations@bms.com
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