SLOUGH, England and
RICHMOND, Va., July 11, 2019
/PRNewswire/ -- Indivior PLC (LON: INDV) today announced
revised expectations for FY 2019 net revenue and net income
following stronger than expected H1 2019 net revenue performance.
The primary driver has been the market share outperformance
of its branded SUBOXONE® (buprenorphine and naloxone) Film
when compared with historic analogues(1) of branded
pharmaceutical products facing generic competition. Indivior now
expects FY 2019 Group net revenue to be in the range of
$670m to $720m (previously $525m to $575m) and
net income in the range of $80m to
$130m (previously ($40m) to $10m),
excluding exceptional items and F/X. Cash at H1 2019 is expected to
be approximately $985m.
FY 2019 net revenue guidance assumes continued share erosion of
SUBOXONE® Film towards the rates of historic
analogues(1) over the remainder of 2019.
Previously-stated key FY 2019 guidance elements are being
- SUBLOCADE™ (buprenorphine extended-release) Injection net
revenue of $50m to $70m;
- Modest net revenue contribution from PERSERIS™ (risperidone)
for extended-release injection;
- Authorized generic buprenorphine/naloxone film contribution in
the tens of $-millions;
- Operating expense (SG&A and R&D combined) of
$440m to $460m (before exceptional costs); and,
- A tax rate in the high-single to low double-digit range.
Comment by Shaun Thaxter, CEO
of Indivior PLC
"We are raising our FY 2019 guidance after a
stronger than expected first half, in which the Group executed well
against its strategic priorities. Our financial performance and
strong cash position largely reflect the slower-than-expected pace
of erosion of SUBOXONE® Film and the sustained leadership position
of the authorized generic buprenorphine/naloxone film that is being
marketed by Sandoz Inc. We are seeing continued growth in
SUBLOCADE™ as we improve the prescription journey and increase
HCP trial and adoption, and we are continuing to see early interest
in PERSERIS™. We look forward to sharing more details on our
progress with our half-year results on 31st July."
H1 2019 Results Presentation Details
On 31 July 2019 Indivior will host a presentation of
its H1 2019 results at 11:30 am BST
(6:30 am EDT) at the London Stock
Exchange. This follows the scheduled release that day of the H1
2019 results at 7:00 am BST
(2:00 am EDT). Please contact
Jason Thompson, VP of Investor
Relations, to register for the results presentation (contact
information below). This presentation will also be webcast live.
The details are below. All H1 2019 materials will be available on
the Group's website at www.indivior.com.
Call Participants -
London, United Kingdom:
+44 (0) 207
Call Participants -
New York, United States of America:
+1 631 510
Indivior is a global specialty
pharmaceutical company with a 20-year legacy of leadership in
patient advocacy and health policy while providing education on
evidence-based treatment models that have revolutionized modern
addiction treatment. The name is the fusion of the words individual
and endeavour, and the tagline "Focus on you" makes the Company's
commitment clear. 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 strong pipeline of product candidates
designed to both expand on its heritage in this category and
address other chronic conditions and co-occurring disorders of
addiction, including alcohol use disorder and schizophrenia.
Headquartered in the United States
in Richmond, VA, Indivior employs
more than 800 individuals globally and its portfolio of products is
available in over 40 countries worldwide. Visit www.indivior.com to
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 2019 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; 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 the indictment by the U.S. Department of
Justice, potential exclusion from participating in U.S. Federal
Health Care Programs and the ongoing investigative and
antitrust litigation matters; 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; 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® (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
Treatment should be initiated under the direction of
healthcare providers qualified under the Drug Addiction Treatment
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 without naloxone.
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 maternal condition.
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® (buprenorphine) Sublingual Tablets (CIII),
please see the respective full Prescribing Information and
Medication Guide at www.suboxoneREMS.com.
SUBLOCADE™ (BUPRENORPHINE EXTENDED-RELEASE) INJECTION FOR
SUBCUTANEOUS USE (CIII)
INDICATION AND HIGHLIGHTED SAFETY
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® 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 addictive behaviours.
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 SUBLOCADE.
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 effect.
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™ (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
- Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of
- PERSERIS is not approved for use in patients with
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
(1) IMS Institute Report, January 2016; "Price Declines after Branded
Medicines Lose Exclusivity in the U.S."
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SOURCE Indivior PLC