RNS Number : 7823L
15 January 2021
Indivior Provides Preliminary FY 2020 Financial Results Ahead of
This Release Contains Inside Information.
Slough, UK, and Richmond, VA, January 15, 2021 - The Group is
providing the below preliminary unaudited financial results based
on current financial information for the year ended December 31,
-- Total net revenue is now expected to be in the range of $645m
to $650m (guidance $595m to $620m) due to:
o Expected SUBLOCADE(R) net revenue between $128m to $130m
(guidance of $120m to $125m), which represents preliminary Q4 2020
SUBLOCADE(R) net revenue growth of 12% to 18% versus Q3 2020
reported SUBLOCADE(R) net revenue of $33m;
o The relative resilience of SUBOXONE(R) Film share through the
end of FY 2020 as well as benefits from modest stocking activity in
the U.S. in the fourth quarter; and,
o Expected PERSERIS(R) net revenue consistent with guidance of
$12m to $15m.
-- An operating expense base (SG&A and R&D combined)
that is expected to be slightly below guidance of $470m to
Based on these preliminary results, the Group now expects to
deliver adjusted pre-tax income ahead of its previous
Indivior expects to report FY 2020 results on February 18,
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 addiction.
Indivior is dedicated to transforming addiction from a global human
crisis to a recognized and treated chronic disease.
Building on its global portfolio of opioid dependence
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
addiction, including alcohol use disorder. Headquartered in the
United States in Richmond, VA, Indivior employs more than 700
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
This announcement contains certain statements that are
forward-looking. By their nature, forward-looking statements
involve risks and uncertainties as they relate to events or
circumstances that may or may not occur in the future. Actual
results may differ materially from those expressed or implied in
such statements because they relate to future events.
Forward-looking statements include, among other things, statements
regarding the Indivior Group's financial guidance for 2020, if any,
and its medium- and long-term growth outlook, its operational
goals, its product development pipeline and statements regarding
ongoing litigation and other statements containing the words
"subject to", "believe", "anticipate", "plan", "expect", "intend",
"estimate", "project", "may", "will", "should", "would", "could",
"can", the negatives thereof, variations thereon and similar
Various factors may cause differences between Indivior's
expectations and actual results, including, among others (including
those described in the risk factors described in the most recent
Indivior PLC Annual Report and in subsequent releases): factors
affecting sales of Indivior Group's products and financial
position; the outcome of research and development activities;
decisions by regulatory authorities regarding the Indivior Group's
drug applications or authorizations; the speed with which
regulatory authorizations, pricing approvals and product launches
may be achieved, if at all; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing and in the supply chain; disruptions in or failure of
information technology systems; the impact of existing and future
legislation and regulatory provisions on product exclusivity;
trends toward managed care and healthcare cost containment;
legislation or regulatory action affecting pharmaceutical product
pricing, reimbursement or access; challenges in the commercial
execution; claims and concerns that may arise regarding the safety
or efficacy of the Indivior Group's products and product
candidates; risks related to legal proceedings, including
compliance with the U.S. Department of Justice Resolution and
Settlement Agreements, noncompliance with which could result in
potential exclusion from participating in U.S. Federal health care
programs; the ongoing investigative and antitrust litigation
matters; the opioid national multi-district litigation and
securities class action litigation; the Indivior Group's ability to
protect its patents and other intellectual property; the outcome of
patent infringement litigation relating to Indivior Group's
products, including the ongoing ANDA lawsuits; changes in
governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; risks related to the evolving COVID-19 pandemic and the
potential impact of COVID-19 on the Indivior Group's operations and
financial condition, which cannot be predicted with confidence;
uncertainties related to general economic, political, business,
industry, regulatory and market conditions; and the impact of
acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
Consequently, forward-looking statements speak only as of the
date that they are made and should be regarded solely as our
current plans, estimates and beliefs. You should not place undue
reliance on forward-looking statements. We cannot guarantee future
results, events, levels of activity, performance or achievements.
Except as required by law, we do not undertake and specifically
decline any obligation to update, republish or revise
forward-looking statements to reflect future events or
circumstances or to reflect the occurrences of unanticipated
SUBOXONE(R) (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM
SUBOXONE(R) (buprenorphine and naloxone) Sublingual Film (CIII)
is a prescription medicine indicated for treatment of opioid
dependence and should be used as part of a complete treatment plan
to include counseling and psychosocial support.
Treatment should be initiated under the direction of healthcare
providers qualified under the Drug Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE(R) Film if you are allergic to
buprenorphine or naloxone as serious negative effects, including
anaphylactic shock, have been reported.
SUBOXONE(R) Film can be abused in a manner similar to other
opioids, legal or illicit.
SUBOXONE(R) Film contains buprenorphine, an opioid that can
cause physical dependence with chronic use. Physical dependence is
not the same as addiction. Your healthcare provider can tell you
more about the difference between physical dependence and drug
addiction. Do not stop taking SUBOXONE(R) Film suddenly without
talking to your healthcare provider. You could become sick with
uncomfortable withdrawal symptoms because your body has become used
to this medicine.
SUBOXONE(R) Film can cause serious life-threatening breathing
problems, overdose and death, particularly when taken by the
intravenous (IV) route in combination with benzodiazepines or other
medications that act on the nervous system (i.e., sedatives,
tranquilizers, or alcohol). It is extremely dangerous to take
nonprescribed benzodiazepines or other medications that act on the
nervous system while taking SUBOXONE(R) Film.
You should not drink alcohol while taking SUBOXONE(R) Film, as
this can lead to loss of consciousness or even death.
Death has been reported in those who are not opioid
Your healthcare provider may monitor liver function before and
SUBOXONE(R) Film is not recommended in patients with severe
hepatic impairment and may not be appropriate for patients with
moderate hepatic impairment. However, SUBOXONE(R) Film may be used
with caution for maintenance treatment in patients with moderate
hepatic impairment who have initiated treatment on a buprenorphine
product without naloxone.
Keep SUBOXONE(R) Film out of the sight and reach of children.
Accidental or deliberate ingestion of SUBOXONE(R) Film by a child
can cause severe breathing problems and death.
Do not take SUBOXONE(R) Film before the effects of other opioids
(e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have
subsided as you may experience withdrawal symptoms.
Injecting the SUBOXONE(R) Film product may cause serious
withdrawal symptoms such as pain, cramps, vomiting, diarrhea,
anxiety, sleep problems, and cravings.
Before taking SUBOXONE(R) Film, tell your healthcare provider if
you are pregnant or plan to become pregnant. If you are pregnant,
tell your healthcare provider as withdrawal signs and symptoms
should be monitored closely and the dose adjusted as necessary. If
you are pregnant or become pregnant while taking SUBOXONE(R) Film,
alert your healthcare provider immediately and you should report it
using the contact information provided below.
Opioid--dependent women on buprenorphine maintenance therapy may
require additional analgesia during labour.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and
treatable outcome of prolonged use of opioids during pregnancy,
whether that use is medically authorized or illicit. Unlike opioid
withdrawal syndrome in adults, NOWS may be life-threatening if not
recognized and treated in the neonate. Healthcare professionals
should observe newborns for signs of NOWS and manage
Before taking SUBOXONE(R) Film, talk to your healthcare provider
if you are breastfeeding or plan to breastfeed your baby. The
active ingredients of SUBOXONE(R) Film can pass into your breast
milk. You and your healthcare provider should consider the
development and health benefits of breastfeeding along with your
clinical need for SUBOXONE(R) Film and should also consider any
potential adverse effects on the breastfed child from the drug or
from the underlying maternal condition.
Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how SUBOXONE(R) Film affects
you. Buprenorphine in SUBOXONE(R) Film can cause drowsiness and
slow reaction times during dose-adjustment periods.
Common side effects of SUBOXONE(R) Film include nausea,
vomiting, drug withdrawal syndrome, headache, sweating, numb mouth,
constipation, painful tongue, redness of the mouth, intoxication
(feeling lightheaded or drunk), disturbance in attention, irregular
heartbeat, decrease in sleep, blurred vision, back pain, fainting,
dizziness, and sleepiness.
This is not a complete list of potential adverse events
associated with SUBOXONE(R) Film. Please see full Prescribing
Information www.suboxoneREMS.com .
for a complete list.
To report pregnancy or side effects associated with taking
SUBOXONE(R) Film, please call 1-877-782-6966. You are encouraged to
report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about SUBOXONE(R) Film, SUBOXONE(R)
(buprenorphine and naloxone) Sublingual Tablets (CIII), or
SUBUTEX(R) (buprenorphine) Sublingual Tablets (CIII), please see
the respective full Prescribing Information and Medication Guide at
SUBLOCADE(TM) (BUPRENORPHINE EXTENDED-RELEASE) INJECTION FOR
SUBCUTANEOUS USE (CIII)
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
SUBLOCADE is indicated for the treatment of moderate to severe
opioid use disorder in patients who have initiated treatment with a
transmucosal buprenorphine-containing product, followed by dose
adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan
that includes counselling and psychosocial support.
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS
ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION
-- Serious harm or death could result if administered
intravenously. SUBLOCADE forms a solid mass upon contact with body
fluids and may cause occlusion, local tissue damage, and
thrombo-embolic events, including life threatening pulmonary
emboli, if administered intravenously.
-- Because of the risk of serious harm or death that could
result from intravenous self-administration, SUBLOCADE is only
available through a restricted program called the SUBLOCADE REMS
Program. Healthcare settings and pharmacies that order and dispense
SUBLOCADE must be certified in this program and comply with the
HIGHLIGHTED SAFETY INFORMATION
Prescription use of this product is limited under the Drug
Addiction Treatment Act.
SUBLOCADE should not be administered to patients who have been
shown to be hypersensitive to buprenorphine or any component of the
ATRIGEL(R) delivery system.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine,
a Schedule III controlled substance that can be abused in a manner
similar to other opioids. Monitor patients for conditions
indicative of diversion or progression of opioid dependence and
Respiratory Depression: Life threatening respiratory depression
and death have occurred in association with buprenorphine. Warn
patients of the potential danger of self-administration of
benzodiazepines or other CNS depressants while under treatment with
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal
syndrome is an expected and treatable outcome of prolonged use of
opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic
replacement of corticosteroids, and wean patient off of the
Risk of Opioid Withdrawal with Abrupt Discontinuation: If
treatment with SUBLOCADE is discontinued, monitor patients for
several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests
prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist
Opioids: Verify that patient is clinically stable on transmucosal
buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid
analgesic whenever possible. If opioid therapy is required, monitor
patients closely because higher doses may be required for analgesic
Adverse reactions commonly associated with SUBLOCADE (in >=5%
of subjects) were constipation, headache, nausea, injection site
pruritus, vomiting, increased hepatic enzymes, fatigue, and
injection site pain.
For more information about SUBLOCADE, the full Prescribing
Information including BOXED WARNING, and Medication Guide visit
PERSERIS(TM) (risperidone) for extended-release injectable
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
PERSERIS(TM) (risperidone) is indicated for the treatment of
schizophrenia in adults.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
See full prescribing information for complete boxed warning.
-- Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death.
-- PERSERIS is not approved for use in patients with dementia-related psychosis.
PERSERIS should not be administered to patients with known
hypersensitivity to risperidone, paliperidone, or other components
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke in Elderly
Patients with Dementia-Related Psychosis: Increased risk of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack), including fatalities. PERSERIS is not approved for use in
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): Manage with immediate
discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue treatment if clinically
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and
Hyperprolactinemia: Prolactin elevations occur and persist
during chronic administration. Long-standing hyperprolactinemia,
when associated with hypogonadism, may lead to decreased bone
density in females and males.
Orthostatic Hypotension: Monitor heart rate and blood pressure
and warn patients with known cardiovascular disease or
cerebrovascular disease, and risk of dehydration or syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete
blood counts (CBC) in patients with a history of a clinically
significant low white blood cell count (WBC) or history of
leukopenia or neutropenia. Consider discontinuing PERSERIS if a
clinically significant decline in WBC occurs in absence of other
Potential for Cognitive and Motor Impairment: Use caution when
Seizures: Use caution in patients with a history of seizures or
with conditions that lower the seizure threshold.
The most common adverse reactions in clinical trials (>= 5%
and greater than twice placebo) were increased weight,
sedation/somnolence and musculoskeletal pain. The most common
injection site reactions (>= 5%) were injection site pain and
erythema (reddening of the skin).
For more information about PERSERIS, the full Prescribing
Information including BOXED WARNING, and Medication Guide visit
Investor Contact :
Jason Thompson, Indivior
Vice President, Investor Relations
Media Contacts :
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