- Increases First Quarter Revenues 14%
to $5.9 Billion
- Posts First Quarter GAAP EPS of
$1.04 and Non-GAAP EPS of $1.10
- Announces Shareholder Approval of
Celgene Acquisition
- Presents Important New Data at
American Association for Cancer Research and American College of
Cardiology Annual Meetings
- Reaffirms Non-GAAP EPS Guidance
Range of $4.10-$4.20 and Increases GAAP EPS Guidance Range to
$3.84-$3.94
Bristol-Myers Squibb Company (NYSE:BMY) today reported results
for the first quarter of 2019 which were highlighted by strong
demand for Opdivo (nivolumab) and Eliquis (apixaban) and a robust
operating performance across the portfolio.
“We had a very good first quarter during which the company
remained focused on delivering strong sales growth of our
prioritized brands and continuing to advance the science in our
disease areas of focus,” said Giovanni Caforio, M.D., chairman and
chief executive officer, Bristol-Myers Squibb. “We also achieved
approval from Bristol-Myers Squibb and Celgene shareholders to move
forward with the acquisition. Looking forward, we are focused on
our integration planning with Celgene and creating a leading
biopharma company, with potential first-in- and best-in-class
medicines, to address the unmet needs of our patients and create
long-term substantial growth.”
First
Quarter
$ amounts in millions, except per share amounts
2019
2018
Change
Total Revenues $5,920 $5,193 14% GAAP Diluted EPS 1.04 0.91 14%
Non-GAAP Diluted EPS 1.10 0.94 17%
FIRST QUARTER FINANCIAL
RESULTS
- Bristol-Myers Squibb posted first
quarter 2019 revenues of $5.9 billion, an increase of 14% compared
to the same period a year ago. Revenues increased 18% when adjusted
for foreign exchange impact.
- U.S. revenues increased 24% to $3.4
billion in the quarter compared to the same period a year ago.
International revenues increased 2%. When adjusted for foreign
exchange impact, international revenues increased 10%.
- Gross margin as a percentage of revenue
decreased from 69.5% to 68.9% in the quarter primarily due to
product mix and higher excise tax, partially offset by favorable
foreign exchange.
- Marketing, selling and administrative
expenses increased 3% to $1.0 billion in the quarter.
- Research and development expenses
increased 8% to $1.4 billion in the quarter.
- The effective tax rate was 13.3% in the
quarter, compared to 16.0% in the first quarter last year.
- The company reported net earnings
attributable to Bristol-Myers Squibb of $1.7 billion, or $1.04 per
share, in the first quarter, compared to net earnings of $1.5
billion, or $0.91 per share, for the same period in 2018. The
results for the first quarter of 2019 include $187 million of
Celgene-related acquisition and integration expenses.
- The company reported non-GAAP net
earnings attributable to Bristol-Myers Squibb of $1.8 billion, or
$1.10 per share, in the first quarter, compared to net earnings of
$1.5 billion, or $0.94 per share, for the same period in 2018. An
overview of specified items is discussed under the “Use of Non-GAAP
Financial Information” section.
- Cash, cash equivalents and marketable
securities were $10.0 billion, with a net cash position of $4.0
billion, as of March 31, 2019.
ACQUISITION OF CELGENE
CORPORATION
In April, the company announced its shareholders voted to
approve the company’s pending acquisition of Celgene Corporation.
The company continues to expect to close the acquisition in the
third quarter. (link)
FIRST QUARTER PRODUCT AND PIPELINE
UPDATE
Product Sales/Business Highlights
Global revenues for the first quarter of 2019, compared to the
first quarter of 2018, were driven by:
- Eliquis, which grew by $419 million or
28% increase
- Opdivo, which grew by $290 million or
19% increase
- Yervoy, which grew by $135 million or
54% increase
- Orencia, which grew by 8%
- Sprycel, which grew by 5%
Opdivo
Clinical
- The company today announced topline
results from the Phase 2 CheckMate -714 trial evaluating Opdivo
versus Opdivo plus Yervoy (ipilimumab) in patients with recurrent
or metastatic squamous cell carcinoma of the head and neck. The
study did not meet its primary endpoints.
- In April, at the American Association
for Cancer Research Annual Meeting 2019, the company announced
four-year survival results from pooled analyses of four studies
(CheckMate -017, -057, -063 and -003) in patients with
previously-treated advanced non-small cell lung cancer who were
treated with Opdivo. (link)
- In February, at the American Society of
Clinical Oncology 2019 Genitourinary Cancers Symposium, the company
announced new data and analysis from studies evaluating Opdivo plus
Yervoy:
- CheckMate -650: Results from the Phase
2 study evaluating Opdivo in combination with Yervoy in patients
with metastatic castration-resistant prostate cancer. (link)
- CheckMate -214: Results from the Phase
3 study evaluating Opdivo plus low-dose Yervoy in patients with
previously untreated advanced or metastatic renal cell carcinoma.
(link)
Eliquis
Clinical
- In March, at the American College of
Cardiology’s 68th Annual Scientific Session 2019, the company and
its alliance partner Pfizer announced results from the Phase 4
AUGUSTUS trial evaluating Eliquis versus vitamin K antagonists in
patients with non-valvular atrial fibrillation and recent acute
coronary syndrome and/or undergoing percutaneous coronary
intervention. The data was simultaneously published in the New
England Journal of Medicine. (link)
Sprycel
Regulatory
- In February, the company announced the
European Commission approved Sprycel (dasatinib) in combination
with chemotherapy for the treatment of pediatric patients with
newly diagnosed Philadelphia chromosome-positive acute
lymphoblastic leukemia.
2019 FINANCIAL GUIDANCE
Bristol-Myers Squibb is increasing its 2019 GAAP EPS guidance
range to $3.84 - $3.94 and confirming its non-GAAP EPS guidance
range of $4.10 - $4.20. Both GAAP and non-GAAP guidance assume
current exchange rates. Key 2019 GAAP and non-GAAP line-item
guidance assumptions are:
- Worldwide revenues increasing in the
mid-single digits.
- Gross margin as a percentage of revenue
to be approximately 70% for both GAAP and non-GAAP.
- Marketing, selling and administrative
expenses decreasing in the mid-single digit range for both GAAP and
non-GAAP.
- Research and development expenses
decreasing in the high-single digits for GAAP and increasing in the
high-single digits for non-GAAP.
- An effective tax rate of approximately
14% for GAAP and approximately 16% for non-GAAP.
The financial guidance for 2019 excludes the impact of any
potential future strategic acquisitions and divestitures, including
any impact of the Celgene acquisition other than expenses incurred
in the first quarter of 2019, and any specified items that have not
yet been identified and quantified. The non-GAAP 2019 guidance also
excludes other specified items as discussed under “Use of Non-GAAP
Financial Information.” Details reconciling adjusted non-GAAP
amounts with the amounts reflecting specified items are provided in
supplemental materials available on the company’s website.
Guidance inclusive of the Celgene acquisition will be provided
after the close of the transaction. The company’s previously
announced sale of the UPSA consumer health business to Taisho
Pharmaceutical Holdings Co., Ltd. for $1.6 billion is anticipated
to be completed in July 2019.
Use of Non-GAAP Financial
Information
This earnings release contains non-GAAP financial measures,
including non-GAAP earnings and related EPS information, that are
adjusted to exclude certain costs, expenses, gains and losses and
other specified items that are evaluated on an individual basis.
These items are adjusted after considering their quantitative and
qualitative aspects and typically have one or more of the following
characteristics, such as being highly variable, difficult to
project, unusual in nature, significant to the results of a
particular period or not indicative of future operating results.
Similar charges or gains were recognized in prior periods and will
likely reoccur in future periods, including acquisition and
integration expenses, restructuring costs, accelerated depreciation
and impairment of property, plant and equipment and intangible
assets, R&D charges or other income resulting from up-front or
contingent milestone payments in connection with the acquisition or
licensing of third-party intellectual property rights, divestiture
gains or losses, pension, legal and other contractual settlement
charges and debt redemption gains or losses, 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.
Non-GAAP information is intended to portray the results of the
company’s baseline performance, supplement or enhance management,
analysts and investors overall understanding of the company’s
underlying financial performance and facilitate comparisons among
current, past and future periods. For example, non-GAAP earnings
and EPS information is an indication of the company’s baseline
performance before items that are considered by us to not be
reflective of the company’s ongoing results. In addition, this
information is among the primary indicators that we use as a basis
for evaluating performance, allocating resources, setting incentive
compensation targets and planning and forecasting for future
periods. This information is not intended to be considered in
isolation or as a substitute for net earnings or diluted EPS
prepared in accordance with GAAP and may not be the same as or
comparable to similarly titled measures presented by other
companies due to possible differences in method and in the items
being adjusted.
Company and Conference Call
Information
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook. For more
information about Bristol-Myers Squibb's proposed acquisition of
Celgene, please visit https://bestofbiopharma.com.
There will be a conference call on April 25, 2019 at 10:30 a.m.
ET during which company executives will review financial
information and address inquiries from investors and analysts.
Investors and the general public are invited to listen to a live
webcast of the call at http://investor.bms.com or by calling the
U.S. toll free 888-254-3590 or international 720-543-0302,
confirmation code: 7211894. Materials related to the call will be
available at the same website prior to the conference call. A
replay of the call will be available beginning at 1:45 p.m. ET on
April 25, 2019 through 1:45 p.m. ET on May 9, 2019. The replay will
also be available through http://investor.bms.com or by calling the
U.S. toll free 888-254-3590 or international 720-543-0302,
confirmation code: 7211894.
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) contains certain
“forward-looking” statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, regarding, among other
things, statements relating to goals, plans and projections
regarding the company’s financial position, results of operations,
market position, product development and business strategy. These
statements may be identified by the fact they use words such as
“should,” “could,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will”
and other words and terms of similar meaning and expression in
connection with any discussion of future operating or financial
performance, although not all forward-looking statements contain
such terms. One can also identify forward-looking statements by the
fact that they do not relate strictly to historical or current
facts. These statements are likely to relate to, among other
things, the company’s ability to execute successfully its strategic
plans, including its business development strategy generally and in
relation to its ability to complete the financing transactions in
connection with and to realize the projected benefits of the
company’s pending acquisition of Celgene, 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 result of governmental investigations.
No forward-looking statement can be guaranteed, including that the
company’s future clinical studies will support the data described
in this release, product candidates will receive necessary clinical
and manufacturing regulatory approvals, pipeline products will
prove to be commercially successful, clinical and manufacturing
regulatory approvals will be sought or obtained within currently
expected timeframes or contractual milestones will be achieved.
Such forward-looking statements are based on historical
performance and current expectations and projections about the
company’s future financial results, goals, plans and objectives and
involve inherent risks, assumptions and uncertainties, including
internal or external factors that could delay, divert or change any
of them in the next several years, 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, challenges inherent in new product development,
including obtaining and maintaining regulatory approval;
competitive developments affecting current products; difficulties
and delays in product introduction and commercialization; industry
competition from other manufacturers; the company’s ability to
obtain and protect market exclusivity rights and enforce patents
and other intellectual property rights; the risk of an adverse
patent litigation decision or settlement and exposure to other
litigation and/or regulatory actions; pricing controls and
pressures (including changes in rules and practices of managed care
organizations and institutional and governmental purchasers); the
impact of any U.S. healthcare reform and legislation or regulatory
action in the U.S. and markets outside the U.S. affecting
pharmaceutical product pricing, reimbursement or access; changes in
tax law and regulations, including the impact of the Tax Cuts and
Jobs Act of 2017 and related guidance; any significant issues that
may arise related to the company’s joint ventures and other
third-party business arrangements; the company’s ability to execute
its financial, strategic and operational plans or initiatives; the
ability to attract and retain key personnel; the company’s ability
to identify potential strategic acquisitions or transactions and
successfully realize the expected benefits of such transactions,
including with respect to the proposed acquisition of Celgene; the
conditions to closing the Celgene transaction will be satisfied
and, if the transaction closes, the company’s ability to
successfully integrate Celgene, manage the impact of the company’s
increased indebtedness, achieve anticipated synergies and
effectively address any risks that Celgene currently faces,
including the loss of patent protection for any of its
commercialized products and the failure to obtain approvals for its
pipeline products; difficulties or delays 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; 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; political and financial
instability of international economies and sovereign risk; and
issuance of new or revised accounting standards.
Forward-looking statements in this earnings release should be
evaluated together with the many uncertainties that affect the
company’s business, particularly those identified in the cautionary
factors discussion in the company’s Annual Report on Form 10-K for
the year ended December 31, 2018, 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 federal securities law, the company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
changed circumstances or otherwise.
BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUE FOR THE THREE
MONTHS ENDED MARCH 31, 2019 AND 2018 (Unaudited, dollars in
millions) Worldwide Revenues U.S.
Revenues 2019 2018
%Change
2019 2018
%Change
Three Months Ended
March 31,
Prioritized Brands Opdivo $ 1,801 $ 1,511 19% $ 1,124 $ 938
20% Eliquis 1,925 1,506 28% 1,206 885 36% Orencia 640 593 8% 449
385 17% Sprycel 459 438 5% 240 214 12% Yervoy 384 249 54% 275 162
70% Empliciti 83 55 51% 58 37 57%
Established Brands
Baraclude 141 225 (37)% 7 10 (30)% Other Brands(a) 487 616 (21)% 90
147 (39)%
Total $ 5,920 $ 5,193 14% $ 3,449 $ 2,778
24% (a) Includes Sustiva, Reyataz, Daklinza and all
other products that have lost exclusivity in major markets,
over-the-counter brands and royalty revenue.
BRISTOL-MYERS SQUIBB COMPANY CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE MONTHS ENDED MARCH 31, 2019 AND 2018 (Unaudited,
dollars and shares in millions except per share data)
Three Months EndedMarch 31,
2019 2018 Net product sales $ 5,713 $ 4,972 Alliance and
other revenues 207 221 Total Revenues 5,920
5,193 Cost of products sold 1,844 1,584 Marketing,
selling and administrative 1,006 980 Research and development 1,351
1,250 Other income (net) (260 ) (400 ) Total Expenses 3,941
3,414 Earnings Before Income Taxes 1,979 1,779
Provision for Income Taxes 264 284 Net
Earnings 1,715 1,495 Net Earnings Attributable to Noncontrolling
Interest 5 9 Net Earnings Attributable to BMS $ 1,710
$ 1,486 Average Common Shares Outstanding:
Basic 1,634 1,633 Diluted 1,637 1,640 Earnings per Common
Share Basic $ 1.05 $ 0.91 Diluted 1.04 0.91 Other income
(net) Interest expense $ 45 $ 46 Investment income (56 ) (36 )
Equity investment gains (175 ) (15 ) Provision for restructuring 12
20 Acquisition and integration expenses 187 — Litigation and other
settlements 1 — Equity in net income of affiliates — (24 )
Divestiture gains — (45 ) Royalties and licensing income (308 )
(367 ) Transition and other service fees (2 ) (4 ) Pension and
postretirement 44 (11 ) Intangible asset impairment — 64 Other (8 )
(28 ) Other income (net) $ (260 ) $ (400 )
BRISTOL-MYERS SQUIBB COMPANY SPECIFIED ITEMS FOR THE THREE MONTHS
ENDED MARCH 31, 2019 AND 2018 (Unaudited, dollars in millions)
Three Months EndedMarch 31,
2019 2018 Impairment charges $ — $ 10 Accelerated
depreciation and other shutdown costs 12 3
Cost of
products sold 12 13
Marketing, selling and
administrative 1 1 License and asset acquisition charges
— 60 IPRD impairments 32 — Site exit costs and other 19 20
Research and development 51 80 Equity
investment gains (175 ) (15 ) Provision for restructuring 12 20
Acquisition and integration expenses 187 — Divestiture gains — (43
) Royalties and licensing income — (50 ) Pension and postretirement
49 31 Intangible asset impairment — 64
Other
income (net) 73 7
Increase to pretax income 137
101 Income taxes on specified items (43 ) (8 ) Income taxes
attributed to U.S. tax reform — (32 )
Income taxes
(43 ) (40 )
Increase to net earnings $ 94 $ 61
BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF
CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS FOR THE
THREE MONTHS ENDED MARCH 31, 2019 AND 2018 (Unaudited, dollars in
millions) Three Months Ended March 31, 2019 GAAP
SpecifiedItems(a)
Non-GAAP
Gross Profit $ 4,076 $ 12 $ 4,088 Marketing, selling and
administrative 1,006 (1 ) 1,005 Research and development 1,351 (51
) 1,300 Other income (net) (260 ) (73 ) (333 ) Earnings Before
Income Taxes 1,979 137 2,116 Provision for Income Taxes 264 (43 )
307 Noncontrolling interest 5 — 5 Net Earnings Attributable
to BMS used for Diluted EPS Calculation $ 1,710 $ 94 $ 1,804
Average Common Shares Outstanding - Diluted 1,637 1,637 1,637
Diluted Earnings Per Share $ 1.04 $ 0.06 $ 1.10 Effective
Tax Rate 13.3 % 1.2 % 14.5 % Three Months Ended March 31,
2018 GAAP
SpecifiedItems(a)
Non-GAAP
Gross Profit $ 3,609 $ 13 $ 3,622 Marketing, selling and
administrative 980 (1 ) 979 Research and development 1,250 (80 )
1,170 Other income (net) (400 ) (7 ) (407 ) Earnings Before Income
Taxes 1,779 101 1,880 Provision for Income Taxes 284 (40 ) 324
Noncontrolling interest 9 — 9 Net Earnings Attributable to
BMS used for Diluted EPS Calculation $ 1,486 $ 61 $ 1,547
Average Common Shares Outstanding - Diluted 1,640 1,640 1,640
Diluted Earnings Per Share $ 0.91 $ 0.03 $ 0.94 Effective
Tax Rate 16.0 % 1.2 % 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 CASH/(DEBT) CALCULATION AS OF MARCH 31, 2019 AND
DECEMBER 31, 2018 (Unaudited, dollars in millions)
March 31, 2019 December 31, 2018 Cash and cash equivalents $
7,335 $ 6,911 Marketable securities - current 1,429 1,973
Marketable securities - non-current 1,233 1,775
Cash, cash equivalents and marketable securities 9,997
10,659 Short-term debt obligations (381 ) (1,703 ) Long-term debt
(5,635 ) (5,646 )
Net cash position $ 3,981 $ 3,310
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190425005173/en/
Media:Priyanka Shah, 609-252-7956, priyanka.shah1@bms.com
Investor Relations:John Elicker, 609-252-4611,
john.elicker@bms.com or Tim Power, 609-252-7509,
timothy.power@bms.com
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