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
RICHMOND, Va., Nov. 14,
2022 /PRNewswire/ -- 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.
Acquisition Strengthens and Extends
Indivior's Position as a Leader in Addiction Treatment
"Our work in combatting addiction has never been more critical,
with overdose deaths in the United
States occurring at near record numbers1," 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® 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 opioids1). 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®
(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 20221. NARCAN® Nasal Spray, the
current standard of care for opioid overdose rescue, had peak net
revenue of over $400 million in FY
20212 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®)
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® 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.
Sources:
- Centers for Disease Control and Prevention (cdc.gov); Products
- Vital Statistics Rapid Release - Provisional Predicted Drug
Overdose Data (cdc.gov)
- 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
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SOURCE Indivior