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.
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the full release here:
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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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230831157622/en/
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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