RNS Number : 5648D
30 June 2021
Indivior Raises FY 2021 Guidance
This release contains inside information.
Slough, UK and Richmond, VA, June 30, 2021 - Indivior PLC (LON:
INDV) today announced that it is raising FY 2021 guidance to
reflect increasing business momentum:
-- Higher net revenue (NR) expectations for SUBLOCADE(R)
(buprenorphine extended-release) injection;
-- Continued relative share resilience of SUBOXONE(R)
(buprenorphine and naloxone) Film in the U.S.; and,
-- Updated foreign exchange (FX) assumptions.
These factors are supporting better-than-expected business
performance through the first half of 2021. As a result, FY 2021 NR
and adjusted pre-tax income are now expected to be significantly
above the Group's original guidance. Indivior will report Q2 and H1
2021 results on July 29th.
Key elements of Indivior's raised FY 2021 guidance are as
-- Total FY 2021 NR range of $705m to $740m (previously: up to
$625m), reflecting stronger SUBLOCADE performance, a continued more
modest rate of SUBOXONE Film market share erosion for the remainder
of 2021 and benefits from more favorable FX translation of
approximately $10m ($USD vs. GBP and EURO at the end of Q2 2021).
Product specific guidance is as follows:
-- SUBLOCADE FY 2021 NR range of $210m to $230m (previously:
$185m to $210m), based on stronger demand and a large order from a
new criminal justice system customer (NR contribution of
approximately $7m in Q2 2021)
-- PERSERIS(R) (risperidone) extended-release injection FY 2021
NR range of $17m to $20m (unchanged)
-- Adjusted gross margin in the low-80%s range, modestly above
previous expectations due to expected relative stability in the
commercial channel for SUBOXONE Film.
-- Adjusted operating expense (SG&A+R&D) range of $470m
to $480m (previously: $420m to $440m), reflecting incremental
performance-based expenses and updated FX translational impacts, as
well as incremental discretionary long-acting injectable (LAI)
growth investments of up to $25m.
-- A significantly higher level of positive adjusted pre-tax income than previously expected.
The person responsible for making this announcement is Kathryn
Hudson, Company Secretary of Indivior PLC.
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 cooccurring 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 www.linkedin.com/company/indivior
For Further Information
Investor Enquiries Jason Thompson VP Investor Relations, +1 804 402 7123
Indivior PLC email@example.com
Media Enquiries Jonathan Sibun Tulchan Communications +44 207 353 4200
US Media Inquiries +1 804 594 0836
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 2021 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 expressions.
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 Group's agreements with the U.S. Department of
Justice and with the Office of Inspector General of the Department
of Health and Human Services, noncompliance with which could result
in potential exclusion from U.S. Federal health care programs; the
ongoing investigative and antitrust litigation matters; the opioid
multi-district 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 items.
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
About SUBLOCADE(R) (7)
SUBLOCADE (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 counseling and psychosocial support.
HIGHLIGHTED SAFETY INFORMATION
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
local tissue damage, and thrombo-embolic events, including life
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 REMS
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
Opioids can cause sleep-related breathing disorders e.g.,
central sleep apnea (CSA), sleep-related hypoxemia. Opioid use
increases the risk of CSA in a dose-dependent fashion. Consider
decreasing the opioid using best practices for opioid taper if CSA
Strongly consider prescribing naloxone at SUBLOCADE initiation
or renewal because patients being treated for opioid use disorder
have the potential for relapse, putting them at risk for opioid
overdose. Educate patients and caregivers on how to recognize
respiratory depression and how to treat with naloxone if
Risk of Serious Injection Site Reactions: The most common
injection site reactions are pain, erythema and pruritis with some
involving abscess, ulceration, and necrosis. The likelihood of
serious injection site reactions may increase with inadvertent
intramuscular or intradermal administration.
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 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
About SUBOXONE(R) (8)
SUBOXONE(R) (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM
SUBOXONE (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 Film if you are allergic to buprenorphine
or naloxone as serious negative effects, including anaphylactic
shock, have been reported.
SUBOXONE Film can be abused in a manner similar to other
opioids, legal or illicit.
SUBOXONE 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 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 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 Film.
You should not drink alcohol while taking SUBOXONE 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 Film is not recommended in patients with severe hepatic
impairment and may not be appropriate for patients with moderate
hepatic impairment. However, SUBOXONE Film may be used with caution
for maintenance treatment in patients with moderate hepatic
impairment who have initiated treatment on a buprenorphine product
Keep SUBOXONE Film out of the sight and reach of children.
Accidental or deliberate ingestion of SUBOXONE Film by a child can
cause severe breathing problems and death.
Do not take SUBOXONE 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 Film product may cause serious withdrawal
symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep
problems, and cravings.
Before taking SUBOXONE 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 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 Film, talk to your healthcare provider if
you are breastfeeding or plan to breastfeed your baby. The active
ingredients of SUBOXONE 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 Film and should also consider any potential adverse
effects on the breastfed child from the drug or from the underlying
Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how SUBOXONE Film affects you.
Buprenorphine in SUBOXONE Film can cause drowsiness and slow
reaction times during dose-adjustment periods.
Common side effects of SUBOXONE 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 Film. Please see full
Prescribing Information www.suboxoneREMS.com for a complete list.
*To report pregnancy or side effects associated with taking
SUBOXONE 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 Film, SUBOXONE
(buprenorphine and naloxone) Sublingual Tablets (CIII), or
SUBUTEX(R) (buprenorphine) Sublingual Tablets (CIII), please see
the respective full Prescribing Information and Medication Guide at
PERSERIS(R) (risperidone) for extended-release injectable
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
PERSERIS (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
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