THOUSAND OAKS, Calif.,
Aug. 26, 2019 /PRNewswire/
-- Amgen (NASDAQ: AMGN) announced today that it has entered
into an agreement with Celgene Corporation (NASDAQ: CELG) in
connection with its previously announced merger with Bristol-Myers
Squibb Company (NYSE: BMY) to acquire worldwide rights to
Otezla® (apremilast), the only oral, non-biologic
treatment for psoriasis and psoriatic arthritis, and certain
related assets and liabilities, for $13.4
billion in cash, or approximately $11.2 billion, net of the present value of
$2.2 billion in anticipated future
cash tax benefits. Amgen believes that the acquisition of Otezla
offers many benefits including:
- A strong strategic fit with Amgen's long-standing expertise
in psoriasis and inflammation
- A differentiated, oral therapy complementary to Amgen's
existing inflammation franchise of innovative biologics and
biosimilar products
- At least low double-digit Otezla sales growth, on average,
over the next five years
- Acceleration of Amgen's near- and long-term revenue
growth
- Immediate non-GAAP EPS accretion
- Intellectual Property exclusivity through at least 2028 in
the U.S.
- Worldwide rights which fit well with Amgen's international
presence and global expansion objectives
- Support of increased R&D investment in 2020 to advance
Amgen's innovative pipeline of first-in-class molecules
- No interruption in deployment of Amgen's capital allocation
priorities
"The acquisition of Otezla offers a unique opportunity for Amgen
to provide patients an innovative oral therapy for psoriasis and
psoriatic arthritis that fits squarely within our portfolio and
complements our Enbrel® and AMGEVITA®
brands," said Robert A. Bradway,
chairman and chief executive officer at Amgen. "We will take
advantage of our 20 years of experience in inflammatory disease to
realize the full global potential of Otezla as an affordable option
for patients with these serious, chronic inflammatory
conditions."
Otezla is the leading treatment in the post-topical,
pre-biologic segment in its approved indications. Otezla is
currently approved for three indications in the U.S.—the treatment
of patients with moderate-to-severe plaque psoriasis who are
candidates for phototherapy or systemic therapy; adult patients
with active psoriatic arthritis; and adult patients with oral
ulcers associated with Behçet's Disease. Otezla is approved in more
than 50 markets outside the U.S., including the European Union and
Japan, and has patent exclusivity
through at least 2028 in the U.S.
Sales of Otezla in 2018 were $1.6
billion driven by strong volume growth. Amgen has stated
previously that it will focus on medicines that can deliver
sustained, long-term volume driven growth and the
Company believes there is a significant opportunity to grow
Otezla through global expansion and new indications, with
expectations for Otezla to realize at least low double-digit sales
growth, on average, over the next five years.
Strategic Benefits of the Transaction
This transaction
will advance Amgen's strategy in several
ways:
- Bringing Innovative Medicines to Patients -- The number
of patients suffering from chronic inflammatory diseases is growing
worldwide. Amgen is already a leader in this very large therapeutic
category with Enbrel® (etanercept), a
biologic medicine marketed by Amgen in the U.S. and Canada to treat several chronic inflammatory
diseases, including moderate-to-severe rheumatoid arthritis,
moderate-to-severe plaque psoriasis, and psoriatic arthritis (PsA).
ENBREL and Otezla are complementary. ENBREL is most frequently
prescribed to treat moderate-to-severe rheumatoid arthritis, while
Otezla is positioned as a therapy of first-choice in patients with
moderate-to-severe psoriasis who are not satisfied with topical
therapies given its differentiated mechanism of action and
established efficacy and safety profile. In PsA, Otezla is
positioned for use in patients early in their disease and/or with
moderate joint involvement. Additionally, studies are currently
underway exploring potential new indications for Otezla, including
mild-to-moderate psoriasis.
- Expanding Geographic Reach -- Otezla is approved in 54
countries, including major markets such as France, Germany and Japan. Amgen is well positioned to continue
driving Otezla international sales growth.
- Investing for Long-Term Growth with Uninterrupted Capital
Allocation Plans -- The transaction is expected to contribute
to Amgen's near- and long-term revenue growth rate and will be
immediately accretive from close to non-GAAP earnings per share
growth, with acceleration thereafter. Amgen will finance the
transaction with current balance sheet cash and expects to retain
its investment grade credit rating. Additionally, Amgen's capital
allocation priorities will remain unchanged as we invest to grow
our business through internal investment and business development,
maintain an optimal capital structure to minimize our Weighted
Average Cost of Capital and continue to provide capital returns to
shareholders through a growing dividend and continued share
repurchases.
The closing of the acquisition is contingent on Bristol-Myers
Squibb entering into a consent decree with the Federal Trade
Commission in connection with the pending Celgene merger, the
closing of the pending merger with Celgene and the satisfaction of
other customary closing conditions. The transaction is expected to
close by the end of 2019.
"Otezla represents an exciting opportunity to strengthen Amgen's
presence in inflammation and continue Amgen's geographic
expansion," said Bradway. "We are excited about the opportunity
that Otezla represents for Amgen, for our shareholders, and for
patients worldwide, and we look forward to welcoming those staff
members who support Otezla to the Amgen family."
Dyal Co. LLC is acting as the lead financial advisor to Amgen.
Goldman Sachs & Co. is serving as a financial advisor and
Sullivan & Cromwell LLP is serving as legal advisor to
Amgen.
Amgen To Webcast Investor Call on Otezla
Acquisition
Amgen will host a webcast investor call on
Monday, Aug. 26 at 5 a.m. PT (8 a.m.
ET). Participating in the call from Amgen will be
Robert A. Bradway, chairman and
chief executive officer, and other members of Amgen's senior
management team.
Live audio of the investor meeting will be broadcast over the
internet simultaneously and will be available to members of the
news media, investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given at certain investor and
medical conferences, can be accessed on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the event.
Non-GAAP Financial Measures
In this press release we
reference non-GAAP EPS. We use non-GAAP EPS in connection
with our own budgeting and financial planning internally to
evaluate the performance of our business. Non-GAAP EPS is derived
by excluding certain amounts, expenses or income, from EPS
determined in accordance with GAAP. The determination of the
amounts that are excluded from non-GAAP EPS is a matter of
management judgment and depend upon, among other factors, the
nature of the underlying expense or income amounts recognized in a
given period. Historically, management has excluded the following
items from non-GAAP EPS, and such items may also be excluded in
future periods and could be significant: expenses related to
acquisition of businesses, including amortization and/or impairment
of acquired in intangible assets, including in-process research and
development, inventory step-ups, adjustments to contingent
consideration, integration costs, severance and retention costs and
transaction costs; charges associated with restructuring or cost
saving initiatives, including but not limited to asset impairments,
accelerated depreciation, severance costs and lease abandonment
charges; legal settlements or awards; non-routine settlements with
tax authorities; and the impact of the adoption of the U.S.
corporate tax reform. Non-GAAP financial measures are in addition
to, not a substitute for, or superior to, measures of financial
performance prepared in accordance with GAAP.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About
OTEZLA® (apremilast)
OTEZLA® (apremilast)
30 mg tablets is an oral small-molecule inhibitor of
phosphodiesterase 4 (PDE4) specific for cyclic adenosine
monophosphate (cAMP). PDE4 inhibition results in increased
intracellular cAMP levels, which is thought to indirectly modulate
the production of inflammatory mediators. The specific mechanism(s)
by which OTEZLA exerts its therapeutic action in patients is not
well defined.
U.S. PRESCRIBING INFORMATION
INDICATIONS
Otezla® (apremilast) is indicated for the
treatment of patients with moderate to severe plaque psoriasis who
are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
IMPORTANT SAFETY INFORMATION
Contraindications
Otezla® (apremilast) is contraindicated in
patients with a known hypersensitivity to apremilast or to any of
the excipients in the formulation.
Warnings and Precautions
Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea,
and vomiting were associated with the use of Otezla. Most events
occurred within the first few weeks of treatment. In some cases
patients were hospitalized. Patients 65 years of age or older and
patients taking medications that can lead to volume depletion or
hypotension may be at a higher risk of complications from severe
diarrhea, nausea, or vomiting. Monitor patients who are more
susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting.
Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts or other mood changes, and they
should contact their healthcare provider if such changes occur.
Psoriasis: Treatment with Otezla is associated with an increase
in depression. During clinical trials, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide.
Psoriatic Arthritis: Treatment with Otezla is associated with an
increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla.
Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the clinical trial, 1% (1/104)
reported depression or depressed mood compared to 1% (1/103)
treated with placebo. No instances of suicidal ideation or behavior
were reported in patients treated with Otezla or treated with
placebo.
Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla.
Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of
patients treated with Otezla and in 5% (19/382) of patients treated
with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of
patients treated with Otezla compared to 1% (3/382) of patients
treated with placebo.
Psoriatic Arthritis: Body weight loss of 5-10% was reported in
10% (49/497) of patients taking Otezla and in 3.3% (16/495) of
patients taking placebo.
Behçet's Disease: Body weight loss of >5% was reported
in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
patients taking placebo.
Drug Interactions: Apremilast exposure was decreased when Otezla
was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy
may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin,
phenobarbital, carbamazepine, phenytoin) is not recommended.
Adverse Reactions
Psoriasis: Adverse reactions reported in ≥5% of patients were
(Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper
respiratory tract infection (9, 6), tension headache (8, 4), and
headache (6, 4).
Psoriatic Arthritis: Adverse reactions reported in at least 2%
of patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 16
weeks (after the initial 5-day titration), were (Otezla%,
placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9,
2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2,
0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0,
0.2).
Behçet's Disease: Adverse reactions reported in at least ≥5% of
patients taking Otezla, that occurred at a frequency at least 1%
higher than that observed in patients taking placebo, for up to 12
weeks were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea
(19.2, 10.7); headache (14.4, 10.7); upper respiratory tract
infection (11.5, 4.9); upper abdominal pain (8.7, 1.9), vomiting
(8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract
infection (6.7, 4.9); arthralgia (5.8, 2.9).
Use in Specific Populations
Pregnancy: Otezla has not been studied in pregnant women. Advise
pregnant women of the potential risk of fetal loss. Consider
pregnancy planning and prevention for females of reproductive
potential. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to Otezla during pregnancy.
Information about the registry can be obtained by calling
1-877-311-8972 or
visiting https://mothertobaby.org/ongoing-study/otezla/.
Lactation: There are no data on the presence of apremilast or
its metabolites in human milk, the effects of apremilast on the
breastfed infant, or the effects of the drug on milk production.
The developmental and health benefits of breastfeeding should be
considered along with the mother's clinical need for Otezla and any
potential adverse effects on the breastfed child from Otezla or
from the underlying maternal condition.
Renal Impairment: Otezla dosage should be reduced in patients
with severe renal impairment (creatinine clearance less than 30
mL/min); for details, see Dosage and Administration, Section 2, in
the Full Prescribing Information.
Please click here for Full Prescribing
Information.
Otezla® is a registered trademark of
Celgene Corporation.
Please see Full Prescribing Information for ENBREL.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of the transaction described in
this press release, including anticipated Otezla sales growth and
the timing of non-GAAP EPS accretion, as well as estimates of
revenues, operating margins, capital expenditures, cash, other
financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and
prescriber patterns or practices, reimbursement activities and
outcomes and other such estimates and results. Forward-looking
statements involve significant risks and uncertainties, including
those discussed below and more fully described in the Securities
and Exchange Commission reports filed by Amgen, including our most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and current reports on Form 8-K. Unless
otherwise noted, Amgen is providing this information as of the date
of this news release and does not undertake any obligation to
update any forward-looking statements contained in this document as
a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products, including our
devices, after they are on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. Further,
while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may
be challenged, invalidated or circumvented by our competitors, or
we may fail to prevail in present and future intellectual property
litigation. We perform a substantial amount of our commercial
manufacturing activities at a few key facilities, including in
Puerto Rico, and also depend on
third parties for a portion of our manufacturing activities, and
limits on supply may constrain sales of certain of our current
products and product candidate development. In addition, we compete
with other companies with respect to many of our marketed products
as well as for the discovery and development of new products.
Further, some raw materials, medical devices and component parts
for our products are supplied by sole third-party suppliers.
Certain of our distributors, customers and payers have substantial
purchasing leverage in their dealings with us. The discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to acquire other
companies or products and to integrate the operations of companies
we have acquired may not be successful. A breakdown, cyberattack or
information security breach could compromise the confidentiality,
integrity and availability of our systems and our data. Our stock
price is volatile and may be affected by a number of events. Our
business performance could affect or limit the ability of our Board
of Directors to declare a dividend or our ability to pay a dividend
or repurchase our common stock. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Jessica Akopyan, 805-447-0974
(media)
Arvind Sood, 805-447-1060
(investors)
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