THOUSAND
OAKS, Calif. and DUBLIN, Sept. 1,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon
Therapeutics plc (NASDAQ:HZNP) today announced the entry into a
consent order agreement with the Federal Trade Commission (FTC)
that resolves the pending FTC administrative lawsuit. This clears
the path to take the final steps to close Amgen's acquisition of
Horizon.
As a result of the consent order agreement, Amgen and Horizon
expect that the parties will jointly file stipulated proposed
orders to dismiss the preliminary injunction motion and dissolve
the temporary restraining order (TRO) in the U.S. District Court
for the Northern District of Illinois, and that Amgen and Horizon will
quickly seek the final approvals required under Irish law to close
the acquisition.
Amgen has consistently stated to the FTC, the courts and the
public that it has no reason, ability or intention to bundle
Horizon's TEPEZZA® (teprotumumab-trbw) or
KRYSTEXXA® (pegloticase injection) with any of its
products. This narrow assurance, formalized in the consent order
with the FTC, will have no impact on Amgen's business.
The companies anticipate being able to close the acquisition in
early fourth-quarter 2023 and look forward to the opportunity to
serve patients around the world suffering from rare diseases.
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.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index. In
2023, Amgen was named one of "America's Greatest Workplaces" by
Newsweek and one of "America's Climate Leaders" by USA Today.
For more information, visit Amgen.com and follow us on
Twitter, LinkedIn, Instagram, TikTok, YouTube and
Threads.
About Horizon
Horizon is a global biotechnology
company focused on the discovery, development and commercialization
of medicines that address critical needs for people affected by
rare, autoimmune and severe inflammatory diseases. Our pipeline is
purposeful: We apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
visit HorizonTherapeutics.com and follow us on
Twitter, LinkedIn, Instagram and Facebook.
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
collaborations, or potential collaborations, with any other company
(including BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance
of Otezla® (apremilast) (including anticipated Otezla
sales growth and the timing of non-GAAP EPS accretion), the
Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or
the proposed acquisition of Horizon Therapeutics plc (including the
potential outcome of any litigation with the Federal Trade
Commission, prospective performance and outlook of Horizon's
business, performance and opportunities and any potential strategic
benefits, synergies or opportunities expected as a result of such
acquisition), 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, effects of pandemics or
other widespread health problems on our business, outcomes,
progress, 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. An outbreak
of disease or similar public health threat, such as COVID-19, and
the public and governmental effort to mitigate against the spread
of such disease, could have a significant adverse effect on the
supply of materials for our manufacturing activities, the
distribution of our products, the commercialization of our product
candidates, and our clinical trial operations, and any such events
may have a material adverse effect on our product development,
product sales, business and results of operations. 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, products or
technology, and to integrate the operations of companies or to
support the products or technology we have acquired, may not be
successful. There can be no guarantee that we will be able to
realize any of the strategic benefits, synergies or opportunities
arising from the Horizon acquisition, and such benefits, synergies
or opportunities may take longer to realize than expected. We may
not obtain regulatory clearance to acquire Horizon or be able to
successfully integrate Horizon, and such acquisition or integration
may take longer, be more difficult or cost more than expected. A
breakdown, cyberattack or information security breach of our
information technology systems 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 and operations may be negatively affected
by the failure, or perceived failure, of achieving our
environmental, social and governance objectives. The effects of
global climate change and related natural disasters could
negatively affect our business and operations. Global economic
conditions may magnify certain risks that affect our business. 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.
Horizon Forward-Looking Statements
This news release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are often identified by words such as
"anticipate," "believe," "intend," "estimate," "expect," "see,"
"continue," "could," "can," "may," "will," "likely," "depend,"
"should," "would," "plan," "predict," "target," and similar
expressions, and may include references to assumptions and relate
to Horizon's future prospects, developments and business
strategies, and the acquisition of Horizon by Amgen. Such
forward-looking statements include, but are not limited to,
statements relating to the acquisition, the FTC litigation and
Horizon's and Amgen's expectations with respect to the timing of
future events, including estimated timing of closing the
acquisition. Horizon's expectations and beliefs regarding these
matters may not materialize. Actual outcomes and results may differ
materially from those contemplated by these forward-looking
statements as a result of uncertainties, risks, and changes in
circumstances, including but not limited to risks and uncertainties
related to: whether and when the district court enters an order
dissolving the TRO; whether and when a new sanction hearing is
scheduled by the Irish High Court; the ability of the parties to
consummate the acquisition in a timely manner or at all; the
satisfaction (or waiver) of conditions to the consummation of the
acquisition; the occurrence of any event, change or other
circumstance or condition that could give rise to the termination
of the transaction agreement governing the acquisition; and the
outcome of any additional legal proceedings that have or may be
instituted against the parties or any of their respective directors
or officers related to the acquisition. Additional risks and
uncertainties that could cause actual outcomes and results to
differ materially from those contemplated by the forward-looking
statements are included under the caption "Risk Factors" and
elsewhere in Horizon's most recent filings with the SEC, including
its Annual Report on Form 10-K for the year ended December 31, 2022, and any subsequent reports on
Form 10-Q or Form 8-K filed with the SEC from time to time and
available at www.sec.gov. These documents can be accessed on
Horizon's website at
https://ir.horizontherapeutics.com/financial-information/sec-filings.
The forward-looking statements set out in this news release are
made only as of the date hereof. Horizon assumes no obligation and
does not intend to update these forward-looking statements, except
as required by law.
Statements Required by the Irish Takeover Rules
The directors of Amgen accept responsibility for the information
contained in this news release relating to Amgen and the Amgen
Horizon Statements (as defined below), except for the
statements made by Horizon in respect of Amgen (the
"Horizon Amgen Statements"). To the best of
the knowledge and belief of the directors of Amgen (who have taken
all reasonable care to ensure such is the case), the information
contained in this news release for which they accept responsibility
is in accordance with the facts and does not omit anything likely
to affect the import of such information.
The directors of Horizon accept responsibility for the
information contained in this news release relating to
Horizon and for the Horizon Amgen Statements, except for the
statements made by Amgen in respect of Horizon (the "Amgen
Horizon Statements"). To the best of the
knowledge and belief of the directors of Horizon (who have taken
all reasonable care to ensure that such is the case), the
information contained in this news release for which they accept
responsibility is in accordance with the facts and does not omit
anything likely to affect the import of such information.
Dealing Disclosure Requirements
Under the
provisions of Rule 8.3(b) of the Irish Takeover Panel Act, 1997,
Takeover Rules, 2022 (the "Irish Takeover
Rules"), if any person is, or becomes, 'interested' in 1% or
more of any class of 'relevant securities' of Horizon, that person
must publicly disclose all 'dealings' in any 'relevant securities'
of Horizon during the 'offer period', by not later than
3:30 p.m. (E.T.) on the 'business
day' following the date of the relevant transaction.
If two or more persons co-operate on the basis of any agreement
either express or tacit, either oral or written, to acquire an
'interest' in 'relevant securities' of Horizon or any securities
exchange offeror, they will be deemed to be a single person for the
purpose of Rule 8.3 of the Irish Takeover Rules.
A disclosure table, giving details of the companies in whose
'relevant securities' 'opening position' and 'dealings' should be
disclosed can be found on the Irish Takeover Panel's website at
www.irishtakeoverpanel.ie.
'Interests' in securities arise, in summary, when a person has
long economic exposure, whether conditional or absolute, to changes
in the price of securities. In particular, a person will be treated
as having an 'interest' by virtue of the ownership or control of
securities, or by virtue of any option in respect of, or derivative
referenced to, securities.
Terms in quotation marks are defined in the Irish Takeover
Rules, which can be found on the Irish Takeover Panel's website. If
you are in any doubt as to whether or not you are required to
disclose a 'dealing' under Rule 8 of the Irish Takeover Rules,
please consult the Irish Takeover Panel's website at
www.irishtakeoverpanel.ie or contact the Irish Takeover Panel
on telephone number +353 1 678 9020.
General
A copy of this news release will be available,
free of charge (subject to certain restrictions relating to persons
resident in certain restricted jurisdictions) on Amgen's website at
https://wwwext.amgen.com/horizon-offer and on Horizon's
website at https://ir.horizontherapeutics.com/information by
no later than 12:00 noon (E.T.) on the business day following this
news release and throughout the course of the pending transaction.
Neither the contents of Amgen's nor Horizon's websites nor the
contents of any other website accessible from hyperlinks are
incorporated into, or form part of, this statement.
AMGEN CONTACTS:
Jessica Akopyan, 805-440-5721
(media)
Justin Claeys, 805-313-9775
(investors)
HORIZON CONTACTS:
Tina Ventura,
Investor-relations@horizontherapeutics.com (investors)
Geoff Curtis,
media@horizontherapeutics.com (U.S. media contact)
Eimear Rigby,
media@horizontherapeutics.com (Ireland media contact)
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SOURCE Amgen