THOUSAND OAKS, Calif.,
Oct. 31, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) announced today that it has entered into a strategic
collaboration with BeiGene that will significantly accelerate
Amgen's plans to expand its oncology presence in China, the world's second-largest
pharmaceutical market. BeiGene is a research-based,
oncology-focused biotechnology company with an established and
highly experienced team in China,
including a 700-person commercial organization and a 600-person
clinical development organization.
"This strategic collaboration with BeiGene will enable Amgen to
serve significantly more patients by expanding our presence in the
world's most populous country," said Robert
A. Bradway, Amgen's chairman and chief executive officer.
"Cancer is a leading cause of death in China and will only become a more pressing
public health issue as the Chinese population ages. With its
extensive commercial and clinical capabilities within China and a commitment to global quality
standards, BeiGene is the ideal strategic collaborator as we seek
to make a meaningful difference in the lives of millions of cancer
patients in China and around the
world."
As part of the collaboration:
- Amgen will acquire a 20.5% stake in BeiGene for approximately
$2.7 billion in cash. This represents
a purchase price of $174.85 per
BeiGene American Depositary Share on NASDAQ, a 36% premium to
BeiGene's 30-day volume-weighted average share price as of
Oct. 30, 2019. Amgen will nominate
one person to serve on BeiGene's Board of Directors.
- Under the agreement, BeiGene will commercialize
XGEVA® (denosumab), KYPROLIS® (carfilzomib)
and BLINCYTO® (blinatumomab) in China during which time the parties will
equally share profits and losses. Two of these products will revert
to Amgen, one after five years and one after seven years. Following
the commercialization period, BeiGene will have the right to retain
one product and will be entitled to receive royalties on sales in
China for an additional five years
on the products not retained. XGEVA was launched in China in September of this year; KYPROLIS and
BLINCYTO are both in Phase 3 trials in China.
- Amgen and BeiGene will collaborate to advance 20 medicines from
Amgen's innovative oncology pipeline in China and globally. BeiGene will share global
research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen
will pay royalties to BeiGene on the sales of these products
outside of China, with the
exception of AMG 510, Amgen's first-in-class KRASG12C
inhibitor that is being studied as a potential treatment for solid
tumors. Amgen anticipates utilizing data from clinical trials
conducted in China to advance the
development of its oncology portfolio globally.
- Of the 20 oncology medicines in development, BeiGene will
assume commercial rights in China
for seven years after launch for those that receive approval in
China, including AMG 510. After
this time, BeiGene will retain rights to up to six of these
products in China, excluding AMG
510, while rights on remaining products revert to Amgen. Amgen and
BeiGene will share profits in China equally on these products until the
rights revert to Amgen, after which Amgen will pay royalties to
BeiGene on sales in China for a
period of five years after reversion.
- Amgen will continue to commercialize its non-oncology product
portfolio in China. Earlier this
year, Amgen launched its first-ever product in China, Repatha® (evolocumab), an
LDL cholesterol-lowering treatment proven to reduce the risk of
heart attacks and stroke. Amgen expects to launch a number of other
non-oncology medicines in China
over the next several years, including Prolia®
(denosumab), which reduces the risk of fracture in postmenopausal
women with osteoporosis.
- XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in
Amgen's oncology pipeline, will be manufactured at Amgen's existing
facilities.
Since 2011, Amgen has expanded its geographic presence from
approximately 50 to 100 countries, enabling the company to play a
growing role in serving the rapidly increasing demand for better
healthcare around the world. The pharmaceutical market in
China is expected to grow briskly
as access to new medicines continues to improve. With approximately
four million people diagnosed with cancer annually and 2.3 million
deaths from the disease each year, the need for new oncology
treatments in China is
particularly acute and the oncology market is one of the
fastest-growing segments of the overall pharmaceutical market
there.
Amgen will purchase its equity stake in BeiGene with available
cash and expects to retain its investment grade credit rating.
"Amgen's capital allocation priorities remain unchanged," said
David W. Meline, executive vice
president and chief financial officer at Amgen. "We will continue
to grow our business through internal investment and business
development, while providing attractive returns to our shareholders
through a growing dividend and continued share repurchases."
The transaction is expected to close in early 2020 subject to
BeiGene shareholder approval, the expiration or termination of
waiting periods under all applicable antitrust laws, and
satisfaction of other customary closing conditions.
Goldman Sachs & Co. LLC is acting as exclusive financial
advisor, and Latham & Watkins LLP is serving as legal advisor
to Amgen.
Webcast Details
Amgen will host a webcast call
today at 2 p.m. PT. where members of Amgen's
executive management team will discuss the Company's strategic
collaboration with BeiGene.
Live audio webcast of the investor call 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.
For more information about Amgen's products, including important
safety information, please visit www.xgeva.com, www.kyprolis.com,
www.blincyto.com, www.repatha.com, and www.prolia.com.
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 biologics manufacturing 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 the world's
largest independent biotechnology company, 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.
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 BeiGene strategic collaboration, including the impact on
non-GAAP EPS, 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. 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. We or others could
identify safety, side effects or manufacturing problems with our
products, including our devices, after they are on the market. 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. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
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. We rely on
collaborations with third parties for the development of some of
our product candidates and for the commercialization and sales of
some of our commercial products. 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. 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, 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 collaborate with or acquire other companies or products and to
integrate the operations of companies or in support of products 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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SOURCE Amgen