TIDMINDV
RNS Number : 2752G
Indivior PLC
14 November 2022
FOR IMMEDIATE RELEASE
Indivior To Acquire Opiant Pharmaceuticals
Acquisition Strengthens and Extends Indivior's Position as a
Leader in Addiction Treatment
Opiant Pipeline Anchored by OPNT003, an Opioid Overdose
Treatment with Clinically Demonstrated Characteristics Well-Suited
to Confront Illicit Synthetic Opioids Like Fentanyl
Potential Annual OPNT003 Net Revenue of $150 Million to $250
Million
Acquisition Expected to be Accretive to Earnings after the
Second Full Year of Launch of OPNT003
Indivior to Host Investor Call at 8:00 am U.S. Eastern Today
THIS RELEASE CONTAINS INSIDE INFORMATION
Richmond, VA, November 14, 2022 - Indivior PLC (LON: INDV)
("Indivior" or the "Company") and Opiant Pharmaceuticals, Inc.
(NASDAQ: OPNT) ("Opiant") today announced that the companies have
entered into a definitive agreement under which Indivior will
acquire Opiant for an upfront consideration of $20.00 per share, in
cash (approximately $145 million in aggregate), plus up to $8.00
per share in contingent value rights ("CVRs") that may become
payable in the event that certain net revenue milestones are
achieved during the relevant seven-year period by OPNT003 after its
approval and launch. The transaction has been unanimously approved
by the boards of directors of each company.
"Our work in combatting addiction has never been more critical,
with overdose deaths in the United States occurring at near record
numbers(1) ," said Mark Crossley, Chief Executive Officer of
Indivior. "Opiant's portfolio of product candidates is an excellent
strategic fit that diversifies and strengthens our offerings, while
Indivior's strong commercial capabilities are expected to propel a
combined product pipeline with the potential to help patients along
a continuum from substance use disorder and rescue to recovery. The
combination with Opiant will provide Indivior with one of the most
comprehensive and relevant treatment platforms to address the
ongoing U.S. opioid and overdose epidemic and extends our
leadership position in addiction treatments. We look forward to
working with Opiant's talented team as we undertake our shared
mission of changing patients' lives through access to
life-transforming treatment for substance use disorders."
"We are pleased to have reached an agreement that reflects the
great potential Opiant has created with OPNT003 and our pipeline of
medicines," said Roger Crystal, M.D., Opiant's President and Chief
Executive Officer. "This transaction combines Opiant with an
organization that shares our patient-focused mindset, and we
believe creates immediate value for patients, our employees and our
stockholders. It will enable us to leverage Indivior's global
scale, commercial strength and scientific expertise to accelerate
our mission to create best-in-class medicines for the treatment of
substance use disorders and drug overdose."
Opiant is a biopharmaceutical company developing treatments for
addiction and drug overdose leveraging intranasal and injectable
delivery technologies. Opiant contributed to the development of the
formulation of NARCAN(R) Nasal Spray, a treatment to reverse opioid
overdose. In addition to OPNT003, nasal nalmefene, the pipeline
includes OPNT002, nasal naltrexone, which is currently in a Phase
II trial to assess its potential as a treatment for alcohol
drinking and cravings, and OPNT004, a CB-1 antagonist in
preclinical development as a potential injectable treatment for
acute cannabinoid overdose ("ACO").
OPNT003 is an investigational opioid overdose reversal agent
that Opiant has been developing alongside a worsening opioid
crisis, driven by the increased prevalence of synthetic opioids,
such as illicit fentanyl. These powerful drugs are responsible for
the surge of overdose deaths in the United States (103,000-plus
overdose deaths reported in the latest annual period, of which over
75% were driven by opioids, mainly fentanyl and synthetic
opioids(1) ). OPNT003 is designed to be used by non-healthcare
individuals and delivered intranasally. Observations from multiple
clinical studies reinforce its potential rapid onset and long
duration of action. Opiant received FDA Fast Track Designation for
OPNT003 in November 2021 and is expected to complete its New Drug
Application ("NDA") submission for OPNT003 with the FDA in the
fourth quarter of 2022. Subject to approval by the FDA, anticipated
approval for a fast-track application is third quarter 2023, with
launch in the United States expected in the ensuing months.
Transaction Details
Under the terms of the merger agreement, Indivior will acquire
all outstanding shares of Opiant for upfront consideration of
$20.00 per share in cash, plus up to $8.00 per share in contingent
value rights ("CVRs") that may become payable in the event that
certain net revenue milestones are achieved by Opiant's lead asset
(OPNT003) during the relevant seven-year period. Indivior expects
to fund the aggregate upfront consideration of approximately $145
million with existing cash.
Pursuant to the CVRs, Indivior would pay $2.00 per CVR if
OPNT003 achieves the following net revenue thresholds during any
period of four consecutive quarters prior to the seventh
anniversary of the U.S. commercial launch: (i) $225 million, (ii)
$300 million, and (iii) $325 million. The remaining (iv) $2.00 per
CVR would be paid if OPNT003 achieves net revenue of $250 million
during any period of four consecutive quarters prior to the third
anniversary of the U.S. commercial launch. The maximum amount
payable by Indivior should OPNT003 achieve all four CVRs would be
an additional approximately $68 million.
The transaction is subject to customary closing conditions,
including US antitrust clearance, clearance by the Committee on
Foreign Investment in the United States (CFIUS) and receipt of
approval of Opiant's stockholders. The members of the Board of
Directors of Opiant, who hold approximately 4.5% of the outstanding
Opiant shares, have entered into a voting agreement with Indivior
and agreed to vote their shares in favor of the transaction.
Pending approvals, the parties anticipate completing the
transaction in the first quarter of 2023.
Compelling Strategic and Financial Rationale
The transaction brings together two companies with the
leadership, resources, pipeline and history of success to introduce
new potentially life-changing addiction treatments, while also
delivering the potential to increase net revenue and drive
shareholder value. With an enhanced portfolio, Indivior will
benefit from:
-- Strengthened and Extended Leadership in Addiction Treatment
and Science: OPNT003 is highly complementary to SUBLOCADE(R)
(buprenorphine extended-release) Injection for subcutaneous release
(CIII) to include both evidence-based treatment and overdose rescue
options. The addition of OPNT003 provides Indivior with one of the
most comprehensive and relevant treatment platforms to address the
ongoing US opioid and overdose epidemic and enhances its portfolio
of addiction treatments. Specifically, Opiant brings new
formulation and nasal drug development capabilities as well as a
pipeline of earlier-stage assets to potentially treat other
substance use disorders, including Alcohol Use Disorder, Acute
Cannabinoid Overdose and Opioid Use Disorder (OUD).
-- A New and Attractive Growth Avenue : OPNT003 diversifies
Indivior's portfolio with a potential highly relevant treatment for
opioid overdose rescue. OPNT003 is uniquely suited as a potential
treatment for opioid overdose, including synthetic opioids, such as
fentanyl, which accounted for over 75% of reported U.S. overdose
deaths in the twelve-month period ending April 2022(1) . NARCAN(R)
Nasal Spray, the current standard of care for opioid overdose
rescue, had peak net revenue of over $400 million in FY 2021(2)
prior to generic entry in December that year. Indivior believes the
unique clinical profile of OPNT003 supports the potential for this
treatment to deliver annual net revenue of $150 million to $250
million.
-- Robust Commercial and Scientific Capabilities: Bringing
together the commercial and scientific capabilities and expertise
of both companies creates an opportunity to accelerate uptake of
OPNT003 upon commercialization. Indivior intends to leverage
capabilities in payor access as well as its commercial footprint in
Organized Health Systems (OHS) to further optimize the launch.
These efforts will be supported by deep advocacy partnerships and a
R&D organization that has been focused on innovating and
advancing paradigm-changing OUD treatment options for more than 20
years. Opiant's other clinical and pre-clinical pipeline assets are
expected to benefit further from Indivior's longstanding leadership
and relationships in addiction science. Indivior will benefit from
Opiant's commercial leadership with recent experience in the
overdose rescue market as well as significant expertise in nasal
delivery technology.
-- Attractive Financial Profile : Successful commercialization
of OPNT003 is expected to be accretive to Indivior's earnings after
the second full year of launch.
Opiant Products & Pipeline
Overdose Reversal (OPNT003)
OPNT003 is a patented intranasal nalmefene formulation that
utilizes an absorption-enhancing technology (Intravail(R) ) to
enhance its pharmacodynamic profile leading to the potential to act
more quickly and last longer when compared with certain
naloxone-based rescue agents such as NARCAN(R) Nasal Spray. Its
clinical profile has the potential to be beneficial given the
proliferation of illicit fentanyl and other powerful and illegally
made synthetic opioids. OPNT003 is covered by one issued patent for
the absorption technology (expiry 2025) and one patent application
covering formulation (expiry 2037), along with other patent
applications. Development of the OPNT003 program is being partially
funded by a grant from the National Institute on Drug Abuse (NIDA),
an institute of the National Institutes of Health, and a contract
from the Biological Advanced Research and Development Agency
(BARDA).
Alcohol Use Disorder (OPNT002)
OPNT002 is an investigational nasal naltrexone product targeting
Alcohol Use Disorder that is in Phase 2 for the reduction of
alcohol consumption or "craving." The target profile is a
self-administered "on-demand" medication.
Pre-Clinical
Opiant has one preclinical program, drinabant, a CB-1 receptor
antagonist for Acute Cannabinoid Overdose (OPNT004).
The person responsible for making this announcement is Kathryn
Hudson, Company Secretary.
Advisors
Centerview Partners is serving as financial advisor to Indivior,
and Covington & Burling LLP is serving as legal advisor to
Indivior. Lazard Frères & Co. LLC is serving as financial
advisor to Opiant and Latham & Watkins LLP is serving as legal
advisor to Opiant.
Conference Call and Webcast
In connection with this announcement, Indivior will host a
webcast and conference call today at 8:00 AM US Eastern Time /
13:00 GMT.
To access the presentation telephonically and the ability to ask
questions, please register through the following link:
https://register.vevent.com/register/BI69ac251d046c41f189178e8019409529
To access the webcast, please use the following link:
https://edge.media-server.com/mmc/p/a8yhnckc
About Indivior
Indivior is a global pharmaceutical company working to help
change patients' lives by developing medicines to treat addiction
and serious mental illnesses. Our vision is that all patients
around the world will have access to evidence-based treatment for
the chronic conditions and co-occurring disorders of substance use
disorder (SUD). Indivior is dedicated to transforming SUD from a
global human crisis to a recognized and treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a
pipeline of product candidates designed to both expand on its
heritage in this category and potentially address other chronic
conditions and co-occurring disorders of SUD, including alcohol use
disorder and cannabis use disorder. Headquartered in the United
States in Richmond, VA, Indivior employs more than 900 individuals
globally and its portfolio of products is available in over 40
countries worldwide. Visit www.indivior.com to learn more. Connect
with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior.
Important Information for Investors and Stockholders
This communication does not constitute a solicitation of any
vote or approval. Opiant intends to file with the SEC and mail to
its stockholders a definitive proxy statement in connection with
the proposed transactions. OPIANT'S STOCKHOLDERS ARE URGED TO READ
CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT AND ANY OTHER
RELEVANT DOCUMENTS THAT ARE FILED WITH THE SEC WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
OPIANT AND THE PROPOSED MERGER. Investors and stockholders may
obtain copies of the proxy statement and other documents filed with
the SEC by Opiant (when they became available) free of charge from
the SEC's website at www.sec.gov or by accessing Opiant's website
at www.opiant.com. Copies of the documents filed with the SEC by
Indivior (when they become available) may be obtained free of
charge from the SEC's website at www.sec.gov or by accessing
Indivior's website at www.indivior.com .
Participants in the Merger Solicitation
Indivior, Opiant, and certain of their directors, executive
officers and employees may be considered participants in the
solicitation of proxies from Opiant's stockholders with respect to
the proposed transactions. Information regarding the persons who
may, under SEC rules, be deemed participants in the solicitation of
Opiant's stockholders in connection with the proposed merger and a
description of their direct and indirect interests, by security
holdings or otherwise, will be set forth in the definitive proxy
statement that Opiant intends to file with the SEC when it becomes
available. Information about Indivior's directors and executive
officers is set forth in Indivior's Annual Report and Accounts 2021
available at www.individior.com. Information about Opiant's
directors and executive officers is set forth in Opiant's
definitive proxy statement for its 2022 Annual Meeting of
Stockholders, which was filed with the SEC on April 18, 2022. These
documents may be obtained as indicated above.
Cautionary Statement Regarding Forward-Looking Statements
Statements included in this press release that are not a
description of historical facts are forward-looking statements.
Words or phrases such as "believe," "may," "could," "will,"
"estimate," "continue," "anticipate," "intend," "seek," "plan,"
"expect," "should," "would" or similar expressions are intended to
identify forward-looking statements and are based on our current
beliefs and expectations. These forward-looking statements include,
without limitation, statements regarding the proposed acquisition
of Opiant, the expected timetable for completing the transaction,
future financial and operating results, benefits and synergies of
the transaction, future opportunities for the combined businesses
and any other statements regarding events or developments that we
believe or anticipate will or may occur in the future. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. There are a
number of important factors that could cause actual events to
differ materially from those suggested or indicated by such
forward-looking statements. These factors include risks and
uncertainties related to, among other things: uncertainties as to
the timing of the proposed merger; the possibility that competing
acquisition proposals will be made; the inability to complete the
proposed merger due to the failure to obtain Opiant's stockholder
adoption of the merger agreement or the failure to satisfy other
conditions to completion of the proposed merger, including required
regulatory clearances or approvals ; the potential that the
expected benefit and opportunities of the transaction, if
completed, may not be realized or may take longer to realize than
expected; the risk that OPNT003 does not receive FDA approval in
the expected timeline, or at all; challenges inherent in product
research and development, including uncertainty of clinical
successes and obtaining regulatory approval and challenges to
patents; the failure of the transaction to close for any other
reason; the effects of disruption caused by the transaction making
it more difficult to maintain relationships with employees,
collaborators, customers, vendors and other business partners; the
risk that stockholder litigation in connection with the proposed
merger may result in significant delay or costs of defense,
indemnification and liability; diversion of management's attention
from ongoing business concerns and other risks and uncertainties
that may affect future results of the combined company, including
the risks described in Indivior's Annual Report and Accounts 2021
and press releases and filings since that time and Opiant's Annual
Report on Form 10-K for the year ended December 31, 2021, Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2022, and
June 30, 2022 and in subsequently filed Current Reports on Form
8-K. All forward-looking statements are qualified in their entirety
by this cautionary statement and neither Indivior or Opiant
undertake any obligation to revise or update this report to reflect
events or circumstances after the date hereof, except as required
by law.
For Indivior
Media Contacts:
UK Media :
Tulchan Communications
+44 207-353-4200
US Media :
Jennifer Ginther
Director, Communications
Indivior PLC
Mobile: 804-467-1593
Investors and Analysts :
Jason Thompson
Vice President, Investor Relations
Indivior PLC
Mobile: 804-402-7123
Tim Owens
Director, Investor Relations
Indivior PLC
Mobile: 804-263-3978
Sources :
1. Centers for Disease Control and Prevention (cdc.gov);
Products - Vital Statistics Rapid Release - Provisional Predicted
Drug Overdose Data (cdc.gov)
2. Emergent Biosolutions Inc. Quarterly 2021 News Releases
Class 2 Transaction Disclosures
The Group notes that this is a Class 2 transaction and below
provides the following additional information.
( a) details of the transaction, including the name of the other
party to the transaction: see above
(b) a description of the business carried on by, or using, the
net assets the subject of the transaction: see above
(c) the consideration, and how it is being satisfied (including
the terms of any arrangements for deferred consideration): see
above
(d) the value of the gross assets the subject of the
transaction: $48.4 mil. (at June 30, 2022)
(e) the profits attributable to the assets the subject of the
transaction: $2.9 mil. (at December 31, 2021)
(f) the effect of the transaction on the listed company
including any benefits which are expected to accrue to
the company as a result of the transaction: see above
(g) details of any service contracts of proposed directors of
the listed company : not applicable
-ends-
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
ACQQZLBFLFLBFBE
(END) Dow Jones Newswires
November 14, 2022 02:00 ET (07:00 GMT)
Indivior (LSE:INDV)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Indivior (LSE:INDV)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024