UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): July 26, 2015
ALLERGAN PLC
(Exact
name of registrant as specified in its charter)
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Ireland |
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001-36867 |
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98-1114402 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS. Employer
Identification No.) |
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1 Grand Canal Square,
Docklands Dublin 2, Ireland |
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N/A |
(Address of principal executive offices) |
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(Zip Code) |
(862) 261-7000
(Registrants telephone number, including area code)
Not Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c) |
On July 26, 2015, Allergan plc and Naurex Inc. issued a joint press
release announcing entry into of an Agreement and Plan of Merger pursuant to which Allergan plc has agreed to acquire Naurex Inc. A copy of the joint press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit
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Description |
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99.1 |
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Joint Press Release, dated July 26, 2015. |
Allergan Cautionary Statement Regarding Forward-Looking Statements
Statements contained in this communication that refer to Allergans estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Allergans current perspective of existing trends and information as of the date of this communication. Forward
looking statements generally will be accompanied by words such as anticipate, believe, plan, could, should, estimate, expect, forecast,
outlook, guidance, intend, may, might, will, possible, potential, predict, project, or other similar words, phrases or
expressions. Such forward-looking statements include, but are not limited to, statements about the benefits of the Naurex acquisition, including future financial and operating results, Allergans or Naurexs plans, objectives, expectations
and intentions and the expected timing of completion of the transaction. It is important to note that Allergans goals and expectations are not predictions of actual performance. Actual results may differ materially from Allergans current
expectations depending upon a number of factors affecting Allergans business, Naurexs business and risks associated with acquisition transactions. These factors include, among others, the inherent uncertainty associated with financial
projections; successful closing of the Naurex acquisition; subsequent integration of the Naurex acquisition; the ability to obtain required regulatory approvals for the transaction (including the approval of antitrust authorities necessary to
complete the acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the transaction; the risk that
a condition to closing of the Naurex acquisition may not be satisfied on a timely basis or at all; the failure of the proposed transaction to close for any other reason; the impact of competitive products and pricing; the risks of fluctuations in
foreign currency exchange rates; the risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance on reasonable terms; periodic dependence on a small
number of products for a material source of net revenue or income; variability of trade buying patterns; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory
agency approvals or actions, if any; market acceptance of and continued demand for Allergans products; costs and efforts to defend or enforce intellectual property rights; difficulties or delays in manufacturing; the availability and pricing
of third party sourced products and materials; successful compliance with governmental regulations applicable to Allergans and Naurexs facilities, products and/or businesses; changes in the laws and regulations affecting, among other
things, pricing and reimbursement of pharmaceutical products; the loss of key senior management or scientific staff; and such other risks and uncertainties detailed in Allergans periodic public filings with the SEC, including but not limited
to Allergans Annual Report on Form 10-K for the year ended December 31, 2014, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015 (such periodic public filings having been filed under the Actavis
plc name), and from time to time in Allergans other investor communications. Except as expressly required by law, Allergan disclaims any intent or obligation to update or revise these forward-looking statements.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Date: July 27, 2015 |
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ALLERGAN PLC |
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By: |
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/s/ A. Robert D. Bailey |
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Name: |
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A. Robert D. Bailey |
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Title: |
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Chief Legal Officer and Corporate Secretary |
EXHIBIT INDEX
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Exhibit
No. |
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Description |
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99.1 |
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Joint Press Release, dated July 26, 2015. |
Exhibit 99.1
NEWS RELEASE
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CONTACTS: |
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ALLERGAN: |
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Investors: |
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Lisa DeFrancesco |
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(862) 261-7152 |
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Media: |
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Mark Marmur |
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(862) 261-7558 |
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NAUREX: |
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Canale Communications Pam Lord |
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pam@canalecomm.com |
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619-849-6003 |
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Naurex Inc. |
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Ashish Khanna |
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VP, Corporate Development |
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corporate@naurex.com |
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(847) 871-0377 |
Allergan to Acquire Naurex
Builds on Allergans World-Class Position and Leadership Strategy in Mental Health
Differentiated Therapies Utilizing Compelling New Mechanism Target Areas of Significant Unmet Medical Need in Major Depressive
Disorder
Two Lead Development Products Rapastinel (GLYX-13) and NRX-1074 Have Demonstrated Rapid and Robust Efficacy
in Phase 2 Clinical Studies
Naurex Preclinical Assets and Discovery Platform to Be Spun Out into New Company
DUBLIN and EVANSTON, III. July 26, 2015 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Naurex Inc., a
clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system, today announced that they have entered into a definitive agreement under which Allergan will acquire Naurex in an
all-cash transaction. Under the terms of the agreement,
Allergan will acquire Naurex for a $560 million upfront payment net of cash acquired, $460 million of which is payable upon the closing of the acquisition and $100 million of which is payable by
January of 2016 (or upon the closing if the closing has not occurred by such time), as well as potential R&D success-based and sales-threshold milestone payments. The Company remains committed to de-leveraging to below 3.5x debt-to-EBITDA by the
end of the first quarter of 2016.
The acquisition will strengthen Allergans long-term growth profile with the addition of Naurexs lead
development product rapastinel (GLYX-13), a once-weekly intravenous Phase 3-ready molecule that has demonstrated rapid, robust and sustained efficacy in multiple Phase 2 clinical studies in depression. The acquisition will also add
Naurexs development product NRX-1074, a next-generation drug candidate, the intravenous form of which has shown rapid and robust antidepressant efficacy in an initial
single-dose Phase 2 study. NRX-1074 is also an orally bioavailable drug candidate which is in Phase 1 studies. Rapastinel and NRX-1074 are both targeted modulators of
the N-methyl-D-aspartate (NMDA) receptor. Both therapies have been found to be well-tolerated in all studies to date, with no drug-related serious adverse events or any of the dissociative side effects
typically seen with NMDA antagonists.
The acquisition of Naurex is a great fit for Allergan and a compelling and exciting investment. We expect
Naurex will enhance Allergans mental health portfolio and build on our strategy to lead in this important therapeutic area, said Brent Saunders, CEO and President of Allergan. Naurexs unique pipeline comprises compounds that
utilize a new mechanism to target areas of significant unmet medical need in Major Depressive Disorder (MDD), including severe and/or treatment-resistant depression. These highly differentiated compounds will immediately bolster our exceptional
mental health pipeline.
Our team at Naurex has been successful in bringing these two highly innovative treatments for depression through
proof-of-concept clinical trials, said Norbert Riedel, Ph.D., President and CEO of Naurex. We recognized that Allergans deep commitment and experience in mental health position them particularly well to progress these programs
through further clinical development and into commercialization. This transaction also enables us to leverage our proven team and technology to continue innovating in this space through the spin-out of Naurexs platform and initiation of a
research collaboration with Allergan, a credible and committed partner in the field.
Naurexs Unique Drug Discovery Platform
Naurex has built a platform for discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules
discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor rather than shutting it down resulting in drugs that are both highly effective and well-tolerated. Naurexs discovery
platform has yielded a rich pipeline of NMDA receptor modulators, including subtype-selective molecules, with the potential to treat a broad set of psychiatric and neurologic disorders. Immediately prior to the closing of the acquisition, Naurex
will spin-out this discovery platform into a new company. Allergan and this new company will enter into a research collaboration focused on the discovery and early development of innovative small molecule NMDA receptor modulators for the treatment
of certain psychiatric and neurologic disorders. Allergan will receive first right to in-license a defined number of drug candidates resulting from the collaboration for certain indications. Further details on the new company will be shared at a
later date.
Rapastinel and NRX-1074 offer the potential for faster onset of action, equal or greater efficacy and a more favorable safety and
tolerability profile than traditional anti-depressants, said David Nicholson, EVP and President of Global Brands Research and Development for Allergan. If approved, they will provide a significant and complementary addition to our
world-class CNS and mental health portfolio. Our ongoing research collaboration will also position us to continue to leverage Naurexs innovative drug discovery platform to drive further long-term value and provide patients with needed
treatment options in this important therapeutic area.
The transaction is subject to customary closing conditions, including the expiration or
termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction by the end of 2015.
Additional information about Naurex, rapastinel and NRX-1074, as well as the unmet medical need in the treatment of MDD is available as a slide presentation
on the Allergan web site at http://ir.allergan.com.
About Rapastinel (GLYX-13)
Rapastinel (GLYX-13) is a novel NMDA receptor modulator being developed as an adjunctive treatment for difficult-to-treat major depressive disorder. Unlike
most currently approved antidepressants, which act on serotonin and related neurotransmitter pathways in the brain, rapastinel works through an entirely different mechanism, mobilizing glutamate pathways to enhance synaptic plasticity and improve
the communication between neuronal cells.
In Phase 2b clinical trial results presented at the Annual Meeting of the American College of
Neuropsychopharmacology last year, it was demonstrated that repeat-dose adjunctive treatment with rapastinel resulted in robust and sustained antidepressant effects in subjects with inadequate responses to their current antidepressants. Rapastinel
was well-tolerated with no drug-related serious adverse events reported, including no sign of the psychotomimetic, or psychosis-like, effects associated with NMDA receptor antagonists such as ketamine. These data confirmed the efficacy and safety
results from an earlier Phase 2 single-dose study of rapastinel, which also documented the drugs rapid onset of antidepressant activity in as little as two hours. Naurex has completed an end-of-Phase 2 meeting with the U.S. Food and Drug
Administration and the Phase 3 program is expected to begin in 2016.
About Major Depressive Disorder (MDD)
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7% of the
adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a persons ability to function. Depression
costs the U.S. an estimated $83 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.
About Allergan
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals,
high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class
products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, womens health, urology, cardiovascular and anti-infective therapeutic categories, and operates the worlds
third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of
the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver
innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergans website
at www.allergan.com.
About Naurex
Naurex is a
clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system. The company has built a platform for
discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates
the NMDA receptor rather than shutting it down resulting in drugs that are both highly effective and well-tolerated. Naurexs lead molecule, rapastinel (GLYX-13), is Phase 3-ready, having demonstrated rapid, robust and sustained
efficacy in multiple Phase 2 clinical studies in depression, an area of high unmet need that has seen little innovation in decades. NRX-1074, a next-generation, intravenous drug candidate, has also shown rapid and robust antidepressant efficacy in
Phase 2 studies. NRX-1074 is also an orally bioavailable drug candidate in Phase 1 studies. Naurexs platform has yielded a rich pipeline of NMDA receptor modulators, including subtype-selective molecules, with the potential to treat a broad
set of psychiatric and neurologic disorders.
Major investors in Naurex include Adams Street Partners, LVP Life Science Ventures, Baxter Ventures and
Baxalta Ventures, Savitr Capital, Genesys Capital, H. Lundbeck A/S, PathoCapital Group, Takeda Ventures, Druid BioVentures, Shire LLC, Longboat Ventures, Goudy Park Capital, EcoR1 Capital, Sabby Capital, Northwestern University, Cowen Investments
and Portola Capital Partners.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect
Allergans current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may
differ materially from Allergans current expectations depending upon a number of factors affecting Allergans business. These factors include, among others, whether clinical trials of rapastinel or NRX-1074 will be successful, the
difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergans products; risks associated with acquisitions, mergers
and joint ventures; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergans periodic public filings with the Securities and Exchange Commission, including but not limited to Allergans Quarterly
Report on Form 10-Q for the quarter ended March 31, 2015 (such periodic public filings having been filed under the Actavis plc name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
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