TIDMINDV
RNS Number : 0556X
Indivior PLC
29 April 2021
Click on, or paste the following link into your web browser, to
view the associated PDF document.
http://www.rns-pdf.londonstockexchange.com/rns/0556X_1-2021-4-29.pdf
April 29, 2021
Q1 2021 Results Announced; FY 2021 Guidance Reiterated.
Quarter to March 31 2021 2020
$m $m
Net Revenue 180 153
----- ------
Operating Profit/(Loss) 57 (189)
----- ------
Net Income/(Loss) 80 (163)
----- ------
EPS/(LPS) (cents per
share) 11 (22)
----- ------
Adjusted Operating Profit* 51 3
----- ------
Adjusted Net Income/(Loss)* 38 (3)
----- ------
Adjusted EPS* (cents 5 -
per share)
----- ------
(*) Adjusted (Adj.) basis excludes the impact of exceptional
items as referenced in Notes 3 and 4.
Comment by Mark Crossley, CEO of Indivior PLC
"We have seen an encouraging start in FY 2021 with growth in net
revenue, operating profit and cash from execution against our
strategic priorities. Despite the ongoing impacts of COVID-19,
SUBLOCADE(R) (buprenorphine extended-release) injection achieved
solid net revenue growth both on a sequential and year-over-year
basis, and we expanded our Organized Health Systems (OHS) platform
to build the foundation for future growth. Looking ahead, we are
seeing healthcare restrictions in the US begin to ease from the
rapid pace of COVID-19 vaccinations, which supports our expectation
of increased in-person interactions with healthcare practitioners
in the second half of the year. As such, we are reiterating our FY
2021 base case guidance."
Q1 2021 Financial Highlights
-- Net revenue (NR) of $180m (+18% vs. Q1 2020) primarily
benefited from higher NR from SUBLOCADE, continued growth in the
buprenorphine medication-assisted (BMAT) market and relative market
share stability in the US for SUBOXONE (R) (buprenorphine and
naloxone) Film.
-- Reported operating profit of $57m (Q1 2020 op. loss: $189m).
Excluding exceptional benefits of $6m, adjusted operating profit
was $51m (adj. Q1 2020: $3m). The increase over the prior period
reflects higher NR and lower SG&A expense principally related
to the direct-to-consumer (DTC) advertising campaign for SUBLOCADE
in Q1 2020 and lower legal costs primarily due to resolving the
Department of Justice (DOJ) matter.
-- Reported net income was $80m which includes an exceptional
tax benefit of $36m recognized in relation to development credits
for SUBLOCADE. Adjusted net income of $38m (Q1 2020 adj. net loss:
$3m), primarily reflecting higher operating profit as described
above.
-- Cash of $945m at the end of Q1 2021 (+$87m vs. FY 2020). Net
cash of $711m (+$88m vs. FY 2020). The higher cash balance
primarily reflects the timing of government rebate payables related
to SUBOXONE Film and $26m of cash collateral returned by a surety
bond holder.
Q1 2021 Operating Highlights
-- SUBLOCADE NR of $43m (+48% vs. Q1 2020 and +10% vs. Q4 2020);
strong growth in the OHS channel, new US patient enrollments
increasing and favorable trade spend accrual updates. Q1 2021 US
dispenses approx. 35,700 units (+51% vs. Q1 2020 and +11% vs. Q4
2020).
-- PERSERIS(R) (risperidone) extended-release injection NR of
$3m (unchanged vs. Q1 2020 and -25% vs. Q4 2020).
-- SUBOXONE(R) Film share averaged 20% in Q1 2021 (Q1 2020: 22%)
and exited Q1 2021 at 20% (Q1 2020: 22%).
Reiterating FY 2021 Guidance
FY 2021 guidance issued by Indivior on February 18, 2021 is
unchanged.
U.S. Opioid Use Disorder (OUD) Market Update
In Q1 2021, growth of the U.S. buprenorphine medication-assisted
treatment (BMAT) market was 6%. The moderation in the growth rate
versus 2020 reflects the high base period for comparison in the
year-ago quarter, when the BMAT market grew in the low- to
mid-teens as a result of COVID-19-related demand and the
implementation of new federal and state government actions to
facilitate access to medication-assisted treatment (MAT) for OUD
patients.
The Group continues to expect long-term U.S. market growth to be
sustained in the high single-digit to low double-digit percentage
range due to increased overall public awareness of the opioid
epidemic and approved treatments, together with regulatory and
legislative actions that have expanded OUD treatment funding and
treatment capacity. The number of physicians, nurse practitioners
and physician assistants who have received a waiver to administer
MAT and those able to treat up to the permitted level of 275
patients continued to grow in Q1 2021. As a result, there is
increasing patient access to BMAT. Indivior supports efforts to
encourage more eligible healthcare practitioners (HCPs) to provide
BMAT, and the Group continues to resource its compliance
capabilities for the growing number of BMAT prescribers and
patients.
The Group's focus is to continue to expand access to SUBLOCADE
amongst OHS and core HCPs, in order to ensure availability of this
potentially important treatment option to the estimated 1 million+
patients per month who are prescribed BMAT by HCPs.
Financial Performance in Q1 2021
Total net revenue in Q1 2021 increased 18% to $180m (Q1 2020:
$153m) at actual exchange rates and by 14% at constant FX.
U.S. net revenue increased 25% to $131m (Q1 2020: $105m). Growth
in the overall U.S. BMAT market was in-line with Group expectations
discussed above ("U.S. Market Update"). Underlying market growth,
together with SUBLOCADE net revenue growth of 38% to $40m (Q1 2020:
$29m), relative stability in SUBOXONE Film share (avg. Q1 2021: 20%
vs. avg. Q1 2020: 22%) and favorable trade spend accrual updates
drove the net revenue increase. PERSERIS net revenue was flat
year-on-year at $3m (Q1 2020: $3m).
Rest of World net revenue increased 2% at actual exchange rates
to $49m (Q1 2020: $48m) and -8% at constant FX. ROW SUBLOCADE net
revenue contributed $3m in the Q1 2021 period. This benefit along
with favourable foreign currency translation was partially offset
by continued austerity measures and generic competition in Western
European markets.
Gross margin as reported was 82% (Q1 2020: 85%). On an adjusted
basis, excluding $7m of exceptional costs related to inventory
provisions due to the adverse impact of COVID-19, Q1 2020 gross
margin was 90%. The expected gross margin decline on a reported and
adjusted basis reflects unfavourable product mix due to the
continued market share resilience of SUBOXONE film, which is less
profitable due to the high proportion of revenue now coming from
government channels.
SG&A expenses as reported were $82m (Q1 2020: $309m). Q1
2021 SG&A expenses included an exceptional $5m release of DOJ
related matters provisions and a benefit of $1m related to the
out-licensing of nasal naloxone patents. Q1 2020 SG&A included
exceptional costs of $185m. The exceptional costs comprised $183m
related to the Department of Justice (DOJ) matter and $2m for
restructuring-related lease impairments.
On an adjusted basis, Q1 2021 SG&A expenses decreased 29% to
$88m (Q1 2020: $124m). The decrease reflects lower marketing
expenses, mainly resulting from the Q1 2020 U.S. DTC television
advertising campaign for SUBLOCADE, as well as a decline in legal
expenses following the resolution with the DOJ in 2020 . The
year-ago period benefitted from Executive Committee members
forgoing any bonus payment associated with the Group's Annual
Incentive Bonus Plan (AIP).
R&D expenses were $9m (Q1 2020: $10m). Both periods
primarily reflect R&D activities as part of the completed
strategic alignment to principally support SUBLOCADE Health
Economics and Outcomes Research (HEOR) and post-marketing study
commitments for SUBLOCADE and PERSERIS, as well as lower than
expected investments for supply-related projects.
Operating profit as reported was $57m (Q1 2020 op. loss: $189m).
Exceptional benefits of $6m are included in the current period.
Exceptional costs of $192m were included in the Q1 2020
results.
On an adjusted basis, Q1 2021 operating profit was $51m versus
$3m in Q1 2020. The increase primarily reflects higher net revenue
along with the decrease in operating expenses (principally
SG&A) related to the promotional initiatives for SUBLOCADE
(primarily the DTC campaign) in the prior-year period and lower
legal expenses following the DOJ resolution in 2020.
Net finance expense in the quarter was $4m (Q1 2020 net finance
expense: $2m). The net expense primarily reflects lower interest
income on the Group's cash balance due to lower short-term interest
rates versus the year-ago period and additional interest expense
associated with legal provisions/liabilities.
Tax benefit in the quarter was $27m at a rate of -51% (Q1 2020
tax benefit: $28m, 15%). On an adjusted basis, excluding a $36m tax
exceptional benefit for the approval of prior year orphan drug
credits, Q1 2021 tax expense was $9m at a rate of 19% (Q1 2020 a
non-meaningful rate excluding $32m of tax benefits on exceptional
costs).
Net income was $80m (Q1 2020 net loss: $163m), and $38m on an
adjusted basis excluding the $42m after-tax impact from exceptional
items (Q1 2020 adj. net loss: $3m). Q1 2020 adjusted net loss
excludes $160m after-tax impact from exceptional items.
Basic earnings per share was 11 cents and 5 cents on an adjusted
basic basis (Q1 2020 basic loss per share of 22 cents and nil on an
adjusted basis).
Balance Sheet & Cash Flow
Cash and cash equivalents at the end of Q1 2021 were $945m (FY
2020: $858m). Borrowings, net of issuance costs, were $234m at the
end of Q1 2021 (FY 2020: $235m). As a result, net cash stood at
$711m at the end of Q1 2021 (FY 2020: $623m).
Net working capital (inventory plus trade receivables and other
assets, less trade and other payables) was negative $250m at the
end of Q1 2021 versus negative $202m at the end of FY 2020. The
$48m change in the period was primarily driven by $26m of cash
collateral returned by a surety bond holder. Trade and other
payables remained relatively unchanged primarily due sustained
government rebate payables related to SUBOXONE Film.
Cash generated from operations in Q1 2021 was $95m (Q1 2020 cash
used in operations: $141m), a change of $236m primarily due
positive Q1 2021 operating profit, timing of government rebate
payables related to SUBOXONE Film and $26m of cash collateral
returned by a surety bond holder. Net cash inflow from operating
activities was $89m in the quarter (Q1 2020 net cash outflow:
$146m) reflecting the higher cash from operating activities and tax
and interest payments in the quarter.
Q1 2021 cash inflow from investing activities was $1m (Q1 2020:
nil) reflecting proceeds received from out-licensing of nasal
naloxone patents.
Q1 2021 cash outflow from financing activities was $3m (Q1 2020:
$2m), reflecting the principal portion of lease payments and the
quarterly amortisation on the term loan facility. In Q1 2020 cash
used in financing activities was partially offset by proceeds from
issuance of shares to satisfy the vesting of options under an
employee stock purchase plan.
R&D / Pipeline Update
Indivior's quarterly R&D and pipeline update may be found
at: http://www.indivior.com/research-and-development/ .
Principal Risk Factors
The Group utilizes a formal process to identify, evaluate and
manage significant risks. The Directors have reviewed the principal
risks and uncertainties for the remainder of the 2021 financial
year and do not consider there to be any changes from those
reported within the 2020 Indivior PLC Annual Report. The principal
risks and uncertainties affecting the Group's business activities
are detailed on pages 38 to 45 of the 2020 Indivior PLC Annual
Report. These include the following: business operations; product
pipeline, regulatory and safety; commercialization; economic and
financial; supply; legal and intellectual property; and compliance.
Please click here to access the report or go to
www.indivior.com/annual-reports/.
Exchange Rates
The average and period end exchange rates used for the
translation of currencies into U.S. dollars that have most
significant impact on the Group's results were:
Q1 2021 Q1 2020
GB GBP period end 1.3778 1.2460
-------- --------
GB GBP average rate 1.3785 1.2820
-------- --------
EUR Euro period end 1.1774 1.1143
-------- --------
EUR Euro average 1.2069 1.1026
-------- --------
Webcast Details
There will be a webcast today (April 29, 2021) at 1:00 PM BST
(8:00 am EDT) hosted by Mark Crossley, CEO. The details are below.
All required materials are available on the Group's website at
www.indivior.com .
Webcast link: https://edge.media-server.com/mmc/p/k5suipmj
Confirmation Code: 7968136
Participants, Local - London, United Kingdom: +44 (0) 2071 928338
Participants, Local - New York, United
States of America: +1 646 741 3167
For Further Information
Investor Enquiries Jason Thompson VP Investor Relations, +1 804 402 7123
Indivior PLC jason.thompson@indivior.com
Media Enquiries Jonathan Sibun Tulchan Communications +44 207 353 4200
US Media Inquiries +1 804 594 0836
Indiviormediacontacts@indivior.com
Corporate Website www.indivior.com
This announcement does not constitute an offer to sell, or the
solicitation of an offer to subscribe for or otherwise acquire or
dispose of shares in the Group to any person in any jurisdiction to
whom it is unlawful to make such offer or solicitation.
Forward-Looking Statements
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
events.
SUBOXONE(R) (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM
(CIII)
Indication
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
dependent.
Your healthcare provider may monitor liver function before and
during treatment.
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
accordingly.
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(R) (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 INFORMATION
INDICATION
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
STRATEGY
-- 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
REMS requirements.
Prescription use of this product is limited under the Drug
Addiction Treatment Act.
CONTRAINDICATIONS
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
addictive behaviors.
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.
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
occurs.
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
prescribed.
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
opioid.
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
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
www.sublocade.com .
PERSERIS(R) (risperidone) for extended-release injectable
suspension
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
PERSERIS (risperidone) is indicated for the treatment of
schizophrenia in adults.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS
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.
CONTRAINDICATIONS
PERSERIS should not be administered to patients with known
hypersensitivity to risperidone, paliperidone, or other components
of PERSERIS.
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
appropriate.
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and
weight gain.
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
causative factors.
Potential for Cognitive and Motor Impairment: Use caution when
operating machinery.
Seizures: Use caution in patients with a history of seizures or
with conditions that lower the seizure threshold.
ADVERSE REACTIONS
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
www.perseris.com .
Condensed consolidated interim income statement
Unaudited Unaudited
2021 2020
For the three months ended
March 31 Notes $m $m
Net Revenues 2 180 153
Cost of sales (32) (23)
Gross Profit 148 130
Gross profit before exceptional
items 4 148 137
Exceptional items 3 - (7)
------------------------------------- ------ --- ---------- ----------
Selling, general and administrative
expenses 3 (82) (309)
Research and development expenses 3 (9) (10)
------------------------------------- ------ --- ---------- ----------
Operating Profit/(Loss) 57 (189)
------------------------------------- ------ --- ---------- ----------
Operating profit before exceptional
items 4 51 3
Exceptional items 3 6 (192)
------------------------------------- ------ --- ---------- ----------
Finance income 2 4
Finance expense (6) (6)
------------------------------------- ------ --- ---------- ----------
Net finance expense (4) (2)
Profit/(Loss) Before Taxation 53 (191)
------------------------------------- ------ --- ---------- ----------
Income tax benefit 27 28
------------------------------------- ------ --- ---------- ----------
Taxation before exceptional
items 5 (9) (4)
Exceptional items within taxation 3,5 36 32
------------------------------------- ------ --- ---------- ----------
Net Income/(loss) 80 (163)
------------------------------------- ------ --- ---------- ----------
Earnings/(loss) per ordinary
share (cents)
Basic earnings/(loss) per share 6 11 (22)
Diluted earnings/(loss) per
share 6 10 (22)
Condensed consolidated interim statement of comprehensive
income/(loss)
Unaudited Unaudited
2021 2020
For the three months ended
March 31 $m $m
----------------------------------- ---- ---- ---------- ----------
Net income/(loss) 80 (163)
Other comprehensive income/(loss)
Items that may be reclassified
to profit or loss in subsequent
years:
Net exchange adjustments
on foreign currency translation 1 (10)
Other comprehensive income/(loss) 1 (10)
Total comprehensive income/(loss) 81 (173)
----------------------------------------------- ---------- ----------
The notes are an integral part of these condensed consolidated
interim financial statements.
Condensed consolidated interim balance sheet
Unaudited Audited
Mar 31, Dec 31,
2021 2020
Notes $m $m
ASSETS
Non-current assets
Intangible assets 60 62
Property, plant and equipment 59 60
Right-of-use assets 41 43
Deferred tax assets 81 75
Other assets 7 103 104
344 344
Current assets
Inventories 91 93
Trade receivables 165 179
Other assets 7 23 50
Current tax receivable 5 43 7
Cash and cash equivalents 8 945 858
1,267 1,187
Total assets 1,611 1,531
-------------------------------------- ------ ---------- --------
LIABILITIES
Current liabilities
Borrowings 8 (4) (4)
Provisions and other liabilities 9 (89) (48)
Trade and other payables 12 (529) (524)
Lease liabilities (8) (8)
Current tax liabilities 5 (26) (15)
-------------------------------------- ------ ---------- --------
(656) (599)
-------------------------------------- ------ ---------- --------
Non-current liabilities
Borrowings 8 (229) (230)
Provisions and other liabilities 9 (521) (577)
Lease liabilities (41) (43)
(791) (850)
Total liabilities (1,447) (1,449)
-------------------------------------- ------ ---------- --------
Net assets 164 82
-------------------------------------- ------ ---------- --------
EQUITY
Capital and reserves
Share capital 13 73 73
Share premium 6 6
Other Reserves (1,295) (1,295)
Foreign currency translation reserve (12) (13)
Retained earnings 1,392 1,311
-------------------------------------- ------ ---------- --------
Total equity 164 82
-------------------------------------- ------ ---------- --------
The notes are an integral part of these condensed consolidated
interim financial statements.
Condensed consolidated interim statement of changes in
equity
Foreign
currency
Share Share Other translation Retained Total
capital premium reserve reserve earnings equity
Unaudited $m $m $m $m $m $m
---------------------------------- --------- --------- --------- ------------- ---------- --------
Balance at January 1, 2021 73 6 (1,295) (13) 1,311 82
----------------------------------- --------- --------- --------- ------------- ---------- --------
Comprehensive income
Net income - - - - 80 80
Other comprehensive income - - - 1 - 1
Total comprehensive income - - - 1 80 81
----------------------------------- --------- --------- --------- ------------- ---------- --------
Transactions recognised directly
in equity
Share-based plans - - - - 1 1
Balance at March 31, 2021 73 6 (1,295) (12) 1,392 164
----------------------------------- --------- --------- --------- ------------- ---------- --------
Balance at January 1, 2020 73 5 (1,295) (23) 1,449 209
----------------------------------- --------- --------- --------- ------------- ---------- --------
Comprehensive loss
Net loss - - - - (163) (163)
Other comprehensive loss - - - (10) - (10)
Total comprehensive loss - - - (10) (163) (173)
----------------------------------- --------- --------- --------- ------------- ---------- --------
Transactions recognised directly
in equity
Share-based plans - 1 - - 2 3
Balance at March 31, 2020 73 6 (1,295) (33) 1,288 39
----------------------------------- --------- --------- --------- ------------- ---------- --------
The notes are an integral part of these condensed consolidated
interim financial statements.
Condensed consolidated interim cash flow statement
Unaudited Unaudited
2021 2020
For the three months ended March 31 $m $m
-------------------------------------------------------- ---------- ----------
CASH FLOWS FROM OPERATING ACTIVITIES
Operating Profit/(Loss) 57 (189)
Depreciation, amortization, and impairment 3 6
Depreciation and impairment of right-of-use assets 2 3
Gain on disposal of ROU assets - (2)
Gain on disposal of intangible assets (1) -
Share-based payments - 2
Impact from foreign exchange movements - 5
Decrease in trade receivables 13 36
Decrease/(Increase) in other assets 28 (44)
Decrease/(increase) in inventories 3 (7)
Increase/(decrease) in trade and other payables 7 (133)
(Decrease)/increase in provisions* (17) 182
Cash generated from/(used in) operations 95 (141)
Interest paid (4) (5)
Interest received - 4
Taxes paid (2) (4)
Net cash inflow/(outflow) from operating activities 89 (146)
-------------------------------------------------------- ---------- ----------
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from disposal of intangible assets 1 -
Net cash inflow from investing activities 1 -
-------------------------------------------------------- ---------- ----------
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of borrowings (1) (1)
Payment of lease liabilities (2) (2)
Proceeds from the issuance of ordinary shares - 1
Net cash outflow from financing activities (3) (2)
-------------------------------------------------------- ---------- ----------
Net increase/(decrease) in cash and cash equivalents 87 (148)
Cash and cash equivalents at beginning of the period 858 1,060
Cash and cash equivalents at end of the period 945 912
-------------------------------------------------------- ---------- ----------
* - Changes in provisions and other liabilities line includes an
exceptional payment of $10m to RB in accordance with the settlement
agreement
The notes are an integral part of these condensed consolidated
interim financial statements.
Notes to the condensed consolidated interim financial
statements
1. BASIS OF PREPARATION AND ACCOUNTING POLICIES
Indivior PLC (the 'Company') is a public limited company
incorporated on September 26, 2014 and domiciled in the United
Kingdom. In these Condensed consolidated interim financial
statements ('Condensed Financial Statements'), reference to the
'Group' means the Company and all its subsidiaries.
These Condensed Financial Statements have been prepared in
conformity with International accounting standard 34, 'Interim
Financial Reporting', as contained in UK-adopted international
accounting standards ("IAS 34"). The financial information herein
has been prepared based on the accounting policies set out in the
annual accounts of the Group for the year ended December 31, 2020
and should be read in conjunction with those annual accounts. The
Group prepared its annual accounts in accordance with international
accounting standards in conformity with the requirements of the
Companies Act 2006, and in accordance with International Financial
Reporting Standards adopted pursuant to Regulation (EC) No
1606/2002 as it applies in the European Union (adopted IFRSs). In
preparing these Condensed Financial Statements, the significant
judgments made by management in applying the Group's accounting
policies and the key sources of estimation uncertainty were the
same as those that applied to the consolidated financial statements
for the year ended December 31, 2020, with the exception of changes
in estimates that are required in determining the provision for
income taxes. The Q1 2020 statement of cash flows has been expanded
to present trade receivables and other assets (current) in separate
line items to improve the transparency and consistency.
The Condensed Financial Statements do not include all the
information and disclosures required in the annual financial
statements and should be read in conjunction with the Group's
annual financial statements as at December 31, 2020. These
Condensed Financial Statements have been reviewed and not audited.
These Condensed Financial Statements were approved for issue on
April 28, 2021.
As disclosed in Notes 9, 10 and 11, the Group has liabilities
and provisions totaling $555m (FY 2020: $568m) for the Department
of Justice (DOJ) Resolution and related matters and the Reckitt
Benckiser (RB) settlement. The Directors have assessed the Group's
ability to comply with the financial covenants in the Group's debt
facility, maintain sufficient liquidity to fund its operations,
fulfill obligations under the DOJ and RB agreements, and address
the reasonably possible financial implications of the ongoing legal
proceedings. The Directors have modeled the risk that SUBLOCADE
will not meet revenue growth expectations due to the continued
impact from the COVID-19 pandemic (considering a 15% decline on
forecasts) as part of the Group's going concern assessment and
downside scenario. These risks were balanced against the Group's
current and forecast working capital position, impact of the cost
saving actions taken to date, and timing of the final balloon
payment on the term loan in Q4 2022 which is outside the going
concern assessment period. As a result of the factors set out
above, the Directors of the Group have a reasonable expectation
that the Group has adequate resources to continue in operational
existence for at least one year from the approval of these
Condensed Financial Statements and therefore consider it
appropriate to adopt the going concern basis for accounting and
preparing these Condensed Financial Statements.
The financial information contained in this document does not
constitute statutory accounts as defined in section 434 and 435 of
the Companies Act 2006. The Group's statutory financial statements
for the year ended December 31, 2020 were approved by the Board of
Directors on March 18, 2021 and will be delivered to the Registrar
of Companies.
2. SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the
internal reporting provided to the chief operating decision-maker
('CODM'). The CODM, who is responsible for allocating resources and
assessing performance of the operating segments, has been
identified as the Chief Executive Officer (CEO). The Group is
predominantly engaged in a single business activity, which is the
development, manufacture and sale of buprenorphine-based
prescription drugs for treatment of opioid dependence and related
disorders. The CEO reviews disaggregated net revenue on a
geographical and product basis. Financial results are reviewed on a
consolidated basis for evaluating financial performance and
allocating resources. Accordingly, the Group operates in a single
reportable segment.
Net revenues
Revenues are attributed to countries based on the country where
the sale originates. The following table represents net revenues
from continuing operations and non-current assets, net of
accumulated depreciation and amortization, by country. Non-current
assets for this purpose consist of intangible assets, property,
plant and equipment, right-of-use assets, and other assets. Net
revenues and non-current assets for the three months to March 31,
2021 and 2020 were as follows:
Net revenue:
2021 2020
For the three months ended March $m $m
31
---------------------------------- ---- ---- ----- -----
United States 131 105
Rest of World 49 48
Total net revenues 180 153
---------------------------------------------- ----- -----
On a disaggregated basis, the Group's net revenue by major
product line:
2021 2020
For the three months ended March 31 $m $m
------------------------------------- ----- -----
Sublingual/other 134 121
SUBLOCADE 43 29
PERSERIS 3 3
------------------------------------- ----- -----
Total 180 153
------------------------------------- ----- -----
Non-current assets:
Mar 31, Dec 31, 2020
2021
$m $m
--------------- -------- -------------
United States 138 141
Rest of World 125 128
--------------- -------- -------------
Total 263 269
--------------- -------- -------------
3. OPERATING EXPENSES
The table below sets out selected operating expenses
information:
2021 2020
For the three months ended March
31 $m $m
----------------------------------------------- ------ ---------------------------------------------------
Research and development expenses (9) (10)
----------------------------------------------- ------ ---------------------------------------------------
Selling and general expenses (37) (74)
Administrative expenses(1) (42) (229)
Depreciation, amortization and
impairment(2) (3) (6)
Total (82) (309)
----------------------------------------------- ------ ---------------------------------------------------
(1) Administrative expenses include exceptional items in the
current and prior period as outlined in the table below.
(2) Additional depreciation and amortization of $2m (2020: $3m)
for intangibles and ROU assets is included within cost of
sales.
Exceptional Items
Where significant expenses or income occur that do not reflect
the Group's ongoing operations, these items are disclosed as
exceptional items in the income statement. Examples of such items
could include restructuring and related expenses for the
reconfiguration of the Group's activities and/or capital structure,
impairment of current and non-current assets, certain costs arising
as a result of material and non-recurring regulatory and litigation
matters, and certain tax related matters.
The table below sets out exceptional items recorded in the
quarter:
2021 2020
For the three months ended March
31 $m $m
-------------------------------------------------- ------ ------
Cost of sales(1) - (7)
Restructuring costs(2) - (2)
Legal expenses/provision(3) 5 (183)
Other operating income(4) 1 -
Total exceptional items before taxes 6 (192)
-------------------------------------------------- ------ ------
Tax benefit on exceptional items(3) - 32
Exceptional tax item(5) 36 -
-------------------------------------------------- ------ ------
Total exceptional items 42 (160)
-------------------------------------------------- ------ ------
1. $7m of exceptional cost of sales in Q1 2020 relate to
inventory provisions due to the adverse impact of Covid-19 on the
business.
2. Restructuring costs in Q1 2020 consist primarily of lease
disposals. Restructuring costs are included in SG&A.
3. Negotiations with DOJ related plaintiffs in Q1 2021 led to a
change in the Group's provision for DOJ related matters which
resulted in a provision release of $5m. In Q1 2020, $183m of legal
costs and an exceptional tax benefit of $32m were recorded in
relation to the DOJ Resolution. Exceptional legal costs are
included within SG&A.
4. Exceptional income in Q1 2021 relates to the proceeds
received from the out-licensing of nasal naloxone opioid overdose
patents which are included within SG&A.
5. $36m exceptional tax benefit item relates to the approval of
tax credits by the Internal Revenue Service in relation to
development credits for SUBLOCADE claimed for years 2014 to
2017.
4. ADJUSTED RESULTS
The Board and management team use adjusted results and measures
to provide incremental insight to the financial results of the
Group and the way it is managed. The tables below show the list of
adjustments between the reported and adjusted results for both Q1
2021 and 2020. Refer to Note 3 for more information on exceptional
items.
Reconciliation of gross profit to adjusted gross profit
2021 2020
For the three months ended March 31 $m $m
------------------------------------- ---- ---- ----- -----
Gross profit 148 130
------------------------------------------------- ----- -----
Exceptional cost of sales - 7
------------------------------------------------- ----- -----
Adjusted gross profit 148 137
------------------------------------------------- ----- -----
Reconciliation of operating profit/(loss) to adjusted operating
profit
2021 2020
For the three months ended March 31 $m $m
------------------------------------------------- ---- ---- ----- ------
Operating profit/(loss) 57 (189)
------------------------------------------------------------- ----- ------
Exceptional cost of sales - 7
Exceptional selling, general and administrative
expenses (6) 185
------------------------------------------------------------- ----- ------
Adjusted operating profit 51 3
------------------------------------------------------------- ----- ------
Reconciliation of profit/(loss) before taxation to adjusted
profit before taxation
2021 2020
For the three months ended March 31 $m $m
------------------------------------------------- ---- ---- ----- ------
Profit/(loss) before taxation 53 (191)
------------------------------------------------------------- ----- ------
Exceptional cost of sales - 7
Exceptional selling, general and administrative
expenses (6) 185
Adjusted profit before taxation 47 1
------------------------------------------------------------- ----- ------
Reconciliation of net income/(loss) to adjusted net
income/(loss)
2021 2020
For the three months ended March 31 $m $m
------------------------------------------------- ---- ---- ----- ------
Net income/(loss) 80 (163)
------------------------------------------------------------- ----- ------
Exceptional cost of sales - 7
Exceptional selling, general and administrative
expenses (6) 185
Tax benefit on exceptional items - (32)
Tax exceptional (36) -
------------------------------------------------- ---- ---- ----- ------
Adjusted net income/(loss) 38 (3)
------------------------------------------------------------- ----- ------
5. TAXATION
The Group calculates tax expense for interim periods using the
expected full year rates, considering the pre-tax income and
statutory rates for each jurisdiction. The resulting expense is
allocated between current and deferred taxes based upon the
forecasted full year ratio.
In the three months ended March 31, 2021, the reported total tax
benefit was $27m, or a rate of -51% (Q1 2020 tax charge: $28m,
15%). On an adjusted basis tax expense of $9m (Q1 2020: $4m)
excluding tax exceptionals of $36m (Q1 2020: tax benefit on
exceptional costs $32m), on adjusted profit before tax of $47m (Q1
2020: $1m) represented a 19% quarterly effective tax rate (Q1 2020:
a non-meaningful rate). The current period exceptional tax benefit
of $36m relates to the tax credit receivable in relation to
development credits for SUBLOCADE claimed in prior years.
The Group's balance sheet at March 31, 2021 includes a current
tax receivable of $43m (FY 2020: $7m), a current tax payable of
$26m (FY 2020: $15m), and deferred tax asset of $81m (FY 2020:
$75m). The current tax receivable balance has increased due to
recording the receivable for SUBLOCADE development credits and
advance cash tax payments.
The change in the adjusted effective tax rate was primarily
driven by the relative contribution to pre-tax income by taxing
jurisdiction in the quarter.
Other tax matters
The European Commission issued a press release on April 2, 2019
announcing its conclusion that the United Kingdom ('UK') Finance
Company Partial Exemption Rules are partly justified. The UK
government has made an annulment application to the General Court
against this decision. The UK government is now required to
initiate recovery of the alleged State Aid irrespective of any
appeal against the decision. The Group continues to monitor its
position regarding the potential State Aid challenge and based upon
our fact pattern has determined that no provision is required at
this time. The Group has benefited from the UK controlled foreign
company financing exemption and the tax thereon is approximately
$25m including interest.
The enacted United Kingdom ("UK") Statutory Corporation Tax rate
was 19% for the year ended December 31, 2020. On March 3, 2021 the
UK Chancellor announced an increase in the corporation tax rate
from 19% to 25% with effect from April 1, 2023. The rate is not
substantively enacted or enacted at March 31, 2021. The impact of
the rate increase to the UK deferred tax assets held at March 31,
2021 would be less than $1m.
6. EARNINGS/(LOSS) PER SHARE
2021 2020
For the three months ended March 31 cents cents
------------------------------------- ------- -------
Basic earnings/(loss) per share 11 (22)
Diluted earnings/(loss) per share 10 (22)
Adjusted basic earnings per share 5 -
Adjusted diluted earnings per share 5 -
--------------------------------------- ------- -------
Basic
Basic earnings/(loss) per share ("EPS" or "LPS") is calculated
by dividing profit/(loss) for the period attributable to owners of
the Company by the weighted average number of ordinary shares in
issue during the period.
Diluted
Diluted earnings/(loss) per share is calculated by adjusting the
weighted average number of ordinary shares outstanding to assume
conversion of all dilutive potential ordinary shares. The Company
has dilutive potential ordinary shares in the form of stock options
and awards. The weighted average number of shares is adjusted for
the number of shares granted assuming the exercise of stock
options.
2021 2020
Weighted average number of shares Thousands thousands
---------------------------------------- ----------- -----------
On a basic basis 734,220 731,982
Dilution from share awards and options 47,124 45,106
On a diluted basis 781,344 777,088
----------------------------------------- ----------- -----------
Adjusted Earnings
The Directors believe that diluted earnings per share, adjusted
for the impact of exceptional items after the appropriate tax
amount, provides more meaningful information on underlying trends
to shareholders in respect of earnings per ordinary share. A
reconciliation of net income to adjusted net income is included in
Note 4.
7. CURRENT AND NON-CURRENT OTHER ASSETS
Mar 31 Dec
31
2021 2020
Current and non-current other assets $m $m
-------------------------------------- ---- ------- ------
Short-term prepaid expenses 17 17
Other current assets 6 33
-------------------------------------------- ------- ------
Total other current assets 23 50
-------------------------------------------- ------- ------
Long-term prepaid expenses 21 22
Other non-current assets 82 82
-------------------------------------------- ------- ------
Total other non-current assets 103 104
-------------------------------------------- ------- ------
Total 126 154
-------------------------------------------- ------- ------
Other current and non-current assets as of December 31, 2020
primarily represent the funding of surety bonds in relation to
intellectual property related matters (see Note 11 for further
discussion) . In Q1 2021, one of the surety bond holders returned
$26m causing a decrease in other current assets. Long-term prepaid
expenses relate primarily to payments for contract manufacturing
capacity.
8. FINANCIAL LIABILITIES - BORROWINGS
Dec
Mar 31 31
2021 2020
Bank loans $m $m
-------------------------- ---- ------- ------
Bank loans - current (4) (4)
Bank loans - non-current (229) (230)
-------------------------------- ------- ------
Total bank loans (233) (234)
-------------------------------- ------- ------
Dec
Mar 31 31
2021 2020
Analysis of net debt $m $m
--------------------------- ---- ------- ------
Cash and cash equivalents 945 858
Borrowings* (234) (235)
Total net cash 711 623
--------------------------------- ------- ------
*Borrowings reflect the principal amount drawn before debt
issuance costs of $1m (FY 2020: $1m). These do not include lease
liabilities of $49m (FY 2020: $51m).
Dec
Mar 31 31
2021 2020
Reconciliation of net debt $m $m
------------------------------------- ---- ------- ------
The movements in the period were as
follows:
Net cash at beginning of period 623 821
Net increase/(decrease) in cash and
cash equivalents 87 (202)
Net repayment of borrowings 1 4
Net cash at end of period 711 623
------------------------------------------- ------- ------
Net cash is presented as it is relevant to our term loan maximum
leverage ratio. Net cash is not reduced for lease liabilities of
$49m (FY 2020: $51m), in accordance with the term loan ratio
calculations.
At March 31, 2021, the term loan was trading at approximately
100% (FY 2020: 98%) of par value. Cash at bank, trade receivables,
and trade payables are assumed to approximate their fair values.
The terms of the loan in effect at March 31, 2021 are as
follows:
Nominal Required Maximum
interest annual leverage
Currency margin Maturity repayments ratio
-------------------- ---------- ------------- ---------- ------------ ----------
Libor* (1%)
Term loan facility USD + 4.5% 2022 $4m 3.0
--------------------- ---------- ------------- --------- ------------ ----------
*The Term Loan matures after publication of LIBOR is expected to
end. We have engaged with the administrative agent and expect to
work with other market participants in the transition to a
reasonable substitute base rate. No financial impact is
expected.
-- Nominal interest margin is calculated over three-month LIBOR
subject to the LIBOR floor of 1%.
-- The maximum leverage ratio (adjusted aggregated net debt
divided by Adjusted EBITDA) is a financial covenant to maintain net
secured leverage below 3.0x.
-- A $50m revolving credit facility is available to the Group
which remained undrawn at the balance sheet date.
9. PROVISIONS AND OTHER LIABILITIES
Mar Dec
31 31
2021 2020
Provisions & other liabilities $m $m
---------------------------------------- ---- ------ ------
Provisions
DOJ related matters (27) (32)
Intellectual property related matters (48) (47)
Restructuring costs (3) (6)
Other (4) (4)
---------------------------------------------- ------ ------
Total provisions (82) (89)
---------------------------------------------- ------ ------
Other liabilities
DOJ resolution (488) (486)
RB indemnity settlement (40) (50)
---------------------------------------------- ------ ------
Total other liabilities (528) (536)
---------------------------------------------- ------ ------
Total provisions and other liabilities (610) (625)
---------------------------------------------- ------ ------
The Group is involved in legal and intellectual property
disputes as described in Note 11, "Legal Proceedings."
Provisions
Provisions are recognized when the Group has a present legal or
constructive obligation as a result of past events, an outflow of
resources to settle that obligation is probable, and the amount can
be reliably estimated. Provisions are measured at the present value
of management's best estimate of the expenditure required to settle
the present obligation at the reporting date.
The Group carries a provision of $27m (FY 2020: $32m) pertaining
to DOJ related matters as discussed in Note 11. Negotiations with
DOJ related plaintiffs resulted in an exceptional provision release
of $5m in Q1 2021 (see Note 3). DOJ related matters of $27m which
are expected to be settled within the year.
The Group carries provisions totaling $48m (FY 2020: $47m) for
intellectual property related matters, all of which relate to
potential redress for ongoing intellectual property litigation with
DRL and Alvogen should the Group not be successful with those cases
outlined in Note 11, Intellectual property related matters: ANDA
litigation. The provision represents the Group's estimate of
potential damages for lost profits owed to DRL and Alvogen for the
period between FDA approval and lifting of the preliminary
injunction based on industry analogous for generic market share
capture. Finance costs are recognized in the income statement at an
interest rate of 5.25%. In Q1 2021, the Group recorded finance
expense totaling $1m (Q1 2020: $1m). The Group does not expect this
matter to be settled within a year and therefore the provision of
$48m has been classified as non-current.
Other liabilities
Other liabilities represent contractual obligations to third
parties where the amount and timing of payments is fixed. Where
other liabilities are not interest-bearing and the impact of
discounting is significant, other liabilities are recorded at their
present value, generally using rate approximating the risk-free
rate at the time the Group entered into the obligation.
On July 24, 2020, the Group reached a resolution with the DOJ
and other litigants described in Note 11 under "DOJ Resolution",
which was finalized i n November 2020 and the first payment of
$103m (including interest) was made. Subsequently, six annual
instalments of $50m will be due every January 15 from 2022 to 2027
with the final instalment of $200m due in December 2027. Interest
accrues on certain portions of the resolution which will be paid
together with the annual instalment payments. For
non-interest-bearing portions, the liability has been recorded at
the net present value based on timing of the estimated payments.
The discount rate and interest rate are 1.25%. In Q1 2021 the Group
recorded interest expense totaling $2m (Q1 2020: nil). As of March
31, 2021, $51m has been classified as current on the Group's
balance sheet.
On January 25, 2021, the Group reached a resolution with Reckitt
Benckiser (RB) to resolve claims which RB issued in the Commercial
Court in London on November 13, 2020, seeking indemnity under the
2014 Demerger Agreement. Pursuant to the settlement, RB withdrew
the US $1.4b claim to release Indivior from any claim for indemnity
under the Demerger Agreement relating to the DOJ and FTC
settlements which RB entered into in July 2019, as well as other
claims for indemnity arising from those matters. The Group has
agreed to pay RB a total of $50m and has agreed to release RB from
any claims to seek damages relating to its settlement with the DOJ
and the FTC. The Group made a $10m payment in February 2021,
following the resolution. Subsequently, annual instalment payments
of $8m will be due every January from 2022 to 2026. The Group
carries a liability totaling $40m (FY 2020: $50m) related to this
settlement. The effect of discounting was not material.
10. CONTINGENT LIABILITIES
The Group has assessed certain legal and other matters to be not
probable based upon current facts and circumstances, including any
potential impact the DOJ resolution could have on these matters.
These represent contingent liabilities. Except for those matters
discussed in Note 11 under "DOJ Related Matters" and "Intellectual
Property Related Matters", for which provisions have been
recognized, Note 11 sets out the contingent liabilities for legal
and other disputes for which the Group has assessed as contingent
liabilities. The Group has also assessed the State Aid matter
discussed in Note 5 to be a contingent liability.
11. LEGAL PROCEEDINGS
DOJ Resolution
Agreement to Resolve Criminal Charges and Civil Complaints
Related to SUBOXONE Film
-- The Group settled with the United States Department of
Justice (Justice Department or DOJ), the U.S. Federal Trade
Commission (FTC), and U.S. state attorneys general the criminal and
civil liability in connection with a multi-count indictment brought
in April 2019 by a grand jury in the Western District of Virginia,
a civil lawsuit joined by the Justice Department in 2018, and an
FTC investigation. Under the terms of the resolution agreement with
the Justice Department, the Group has agreed to compliance terms
regarding its sales and marketing practices. Compliance with these
terms is subject to annual Board and CEO certifications submitted
to the U.S. Attorney's Office.
-- As part of the resolution with the FTC and as detailed in the
text of the stipulated order, for a ten-year period Indivior Inc.
is required to make specified disclosures to the FTC and is
prohibited from certain conduct.
-- Under the terms of the five-year Corporate Integrity
Agreement with the HHS Office of the Inspector General (HHS-OIG),
the Group will continue its commitment to promote compliance with
laws and regulations and its ongoing evolution of an effective
compliance program, including written standards, training,
reporting, and monitoring procedures. The Group will be subject to
reporting and monitoring requirements, including annual reports and
compliance certifications from key management and the Board
Nominating & Governance Committee submitted to HHS-OIG. In
addition, the Group will be subject to monitoring by an Independent
Review Organization, who will submit audit findings to HHS-OIG, and
review by a Board Compliance Expert, who will prepare two
compliance assessment reports in the first and third reporting
periods of the Corporate Integrity Agreement.
In November 2020, the Group made a payment of $103 million
(including interest) when the resolution was approved by a judge.
Subsequently, six annual instalments of $50 million will be due
every January 15 from 2022 through 2027. The final instalment of
$200 million will be due in December 2027. The Group carries a
liability totaling of $488 million (FY 2020: $486m) pertaining to
the DOJ resolution.
DOJ Related Matters
Federal FCA Qui Tam Suits
-- In August 2018, the United States unsealed three qui tam
suits pending in the Western District of Virginia that made a
variety of allegations under state and federal False Claims Act
statutes regarding marketing and promotion practices related to
SUBOXONE, and in some instances claiming unlawful retaliation. The
suits also seek reasonable attorney's fees and costs. Many of the
civil claims concern the same conduct at issue in the Superseding
Indictment filed by the Justice Department. Indivior is aware of
additional claims pending in the District of New Jersey regarding
similar allegations about marketing and promotion practices which
were resolved along with the three Western District of Virginia qui
tam suits in the federal civil settlement agreement with the
Justice Department; and resolved with the state Attorney Generals
in civil settlement agreements with the fifty states, D.C., and
Puerto Rico. The Group is in discussions with certain relators
aimed toward resolving the retaliation claims and claims for
attorney's fees and costs.
State and Local Matters
-- In October 2016, Indivior was served with a subpoena for
records from the State of Connecticut Office of the Attorney
General under its Connecticut civil false claims act authority. The
subpoena requests documents related to the Group's marketing and
promotion of SUBOXONE products and its interactions with a
non-profit third-party organization. The Group has reached an
agreement to resolve this matter and has finalized the settlement
agreement.
-- In November 2016, Indivior was served with a subpoena for
records from the State of California Department of Insurance under
its civil California insurance code authority. The subpoena
requests documents related to SUBOXONE(R) Film, SUBOXONE(R) Tablet,
and SUBUTEX(R) Tablet. The State of California served additional
deposition subpoenas on Indivior in 2017 and served a subpoena in
2018 requesting documents relating to the bioavailability /
bioequivalency of SUBOXONE Film, manufacturing records for the
product and its components, and the potential to develop dependency
on SUBOXONE Film. The Group has fully cooperated in this civil
investigation and is in discussions aimed toward resolving the
matter. Certain of the qui tam suits filed in the Western District
of Virginia and the District of New Jersey assert claims under the
civil California insurance code. The Group is in discussions toward
resolving these claims and claims for associated attorney's fees
and costs.
-- In June 2019, the Group learned that the State of Illinois
Insurance Department is investigating potential violations of its
civil Insurance Claims Fraud Prevention Act with respect to its
sales and marketing activity. Certain of the qui tam suits filed in
the Western District of Virginia and the District of New Jersey
assert claims under this statute, including claims for associated
attorney's fees and costs. The Group is in discussions aimed toward
resolving this matter.
-- In addition to the federal and state health program claims,
claims have been asserted under the city false claims acts of
Chicago and New York City regarding the promotion of Suboxone film.
The Group has resolved the matter with the City of Chicago.
False Claims Act Allegations
-- In August 2018, the United States District Court for the
Western District of Virginia unsealed a declined qui tam complaint
alleging causes of action under the Federal and state False Claims
Acts against certain entities within the Group predicated on best
price issues and claims of retaliation (United States ex rel.
Miller v. Reckitt Benckiser Group PLC et al., Case No.
1:15-cv-00017 (W.D. Va.)). The suit also seeks reasonable
attorneys' fees and costs. We understand that all government
plaintiffs have declined to intervene. The Group was served with
the complaint in January 2021. We are in discussions regarding this
matter with the plaintiff-relator.
-- In May 2018, Indivior Inc. received an informal request from
the Office of the United States Attorney for the Southern District
of New York, seeking records relating to the Suboxone manufacturing
process. We are in discussions with the government regarding the
matter.
Securities Class Action Litigation
-- In April 2019, Michael Van Dorp filed a putative class action
lawsuit in the United States District Court for the District of New
Jersey on behalf of holders of publicly traded Indivior securities
alleging violations of U.S. federal securities laws under the
Securities Exchange Act of 1934. The complaint names Indivior PLC,
Shaun Thaxter, Mark Crossley and Cary J. Claiborne as defendants.
In February 2021, the parties reached a settlement agreement. A
Motion for Entry of Order Preliminarily Approving Settlement is
pending with the court.
I ntellectual Property Related Matters
ANDA Litigation
-- Litigation against DRL is currently pending in the District
of New Jersey regarding U.S. Patent No. 9,687,454 and 9,931,305
("the '454 and '305 Patents"). DRL received final FDA approval for
all four strengths of its generic buprenorphine/naloxone film
product in June 2018, and immediately launched its generic
buprenorphine/naloxone film product "at-risk." In July 2018, the
District Court issued a ruling granting Indivior a Preliminary
Injunction (PI) pending the outcome of a trial on the merits of the
'305 Patent. Indivior was required to post a surety bond for $72
million in connection with the PI. In November 2018, the CAFC
issued a decision vacating the PI against DRL. DRL launched its
product at-risk in February 2019. In June 2019, DRL filed a motion
for leave to file their first amended Answer, Affirmative Defenses,
and Counterclaims to add various antitrust counterclaims resulting
from the injunction that was issued against DRL. The motion was
granted in November 2019. In January 2020, Indivior and DRL entered
into a joint stipulation that DRL did not infringe the '305 Patent
based on the District Court's claim construction ruling, but that
Indivior retained its right to appeal the issue of infringement of
the '305 Patent. Indivior maintains its infringement claims on the
'454 patent, and DRL maintains its counterclaims. No trial date has
been set for either the patent claims or the antitrust
counterclaims.
-- In November 2018, DRL filed two separate petitions for inter
partes review ("IPR") of the '454 Patent with the USPTO. The USPTO
denied institution of one of the IPR petitions but granted
institution for the second IPR petition. The Patent Trial and
Appeal Board (USPTO) issued a decision in June 2020, holding that
claims 1-5, 7, and 9-14 were unpatentable, but that DRL had not
shown that claim 8 is unpatentable. Claim 6 was not challenged and
therefore was not addressed in the PTAB decision. Indivior appealed
to the Court of Appeals for the Federal Circuit in July 2020. No
court date has been set yet.
-- Litigation against Alvogen is pending in the United States
District Court for the District of New Jersey regarding the '454
and '305 Patents. In January 2019, Indivior filed a motion for a
temporary restraining order ("TRO") and preliminary injunction in
the District of New Jersey, requesting that the Court restrain the
launch of Alvogen's generic buprenorphine/naloxone film product
until a trial on the merits of the '305 Patent. Alvogen received
approval for its generic product in January 2019. The same day, the
District of New Jersey granted a TRO until February 7, 2019. In
January 2019, Indivior and Alvogen entered in to an agreement
whereby Alvogen was enjoined from the use, offer to sell, or sale
within the United States, or importation into the United States, of
its generic buprenorphine and naloxone sublingual film product
unless and until the CAFC issued a mandate vacating the PI against
DRL. The mandate vacating the DRL PI issued in February 2019, and
Alvogen launched its generic product. Any sales in the US are on an
"at-risk" basis, subject to the ongoing litigation against Alvogen
in the District of New Jersey. In August 2019, Alvogen filed a
motion for leave to file an amended Answer to Complaint and
Separate Defenses and Counterclaims to add various antitrust
counterclaims. The motion was granted in November 2019. In January
2020, Indivior and Alvogen entered into a joint stipulation that
Alvogen did not infringe the '305 Patent based on the District
Court's claim construction ruling, but that Indivior retained its
right to appeal the issue of infringement of the '305 Patent.
Indivior maintains its infringement claims on the '454 patent, and
Alvogen maintains its counterclaims. No trial date has been set for
either the patent claims or the antitrust counterclaims.
Opposition to SUBLOCADE European Patent
-- In October 2018, Teva Pharmaceutical Industries Ltd. ("Teva")
filed a Notice of Opposition with the European Patent Office
seeking to revoke European Patent No. EP 2579874 ("EP 874"), which
relates to the formulation for SUBLOCADE. Oral proceedings are
scheduled to take place in September 2021.
-- In March 2021, the law firm Elkington & Fife LLP filed a
Notice of Opposition with the European Patent Office seeking to
revoke European Patent No. EP 3215223 ("EP 223"), which relates to
the dosing regimen for SUBLOCADE. The Opposition alleges that the
claims of EP 223 lack inventive step and extend beyond the content
of the application as originally filed. The Group will respond to
the Opposition on or before the deadline in August 2021.
Antitrust Litigation and Consumer Protection
Antitrust Class and State Claims
-- Civil antitrust claims have been filed by (a) a class of
direct purchasers, (b) a class of end payor plaintiffs, and (c) a
group of states, now numbering 41, and the District of Columbia.
Each set of plaintiffs filed generally similar claims alleging,
among other things, that Indivior violated U.S. federal and/or
state antitrust and consumer protection laws in attempting to delay
generic entry of alternatives to SUBOXONE Tablets. Plaintiffs
further allege that Indivior unlawfully acted to lower the market
share of these products. These antitrust cases are pending in
federal court in the Eastern District of Pennsylvania. The court
has not set a trial date. Summary judgment motions related to the
Direct Purchaser, End Payor, and States actions were filed in March
2021. Opposition briefs were filed in April 2021 and reply briefs
are due in May 2021.
-- In 2013, Reckitt Benckiser Pharmaceuticals, Inc. (now known
as Indivior Inc.) received notice that it and other companies were
defendants in a lawsuit initiated by writ in the Philadelphia
County (Pennsylvania) Court of Common Pleas. See Carefirst of
Maryland, Inc. et al. v. Reckitt Benckiser Inc., et al., Case. No.
2875, December Term 2013. The plaintiffs include approximately 79
entities, most of which appear to be insurance companies or other
providers of health benefits plans. The Carefirst Plaintiffs have
not served a complaint, but they have indicated that their claims
are related to those asserted by the plaintiffs in re Suboxone, MDL
No. 2445 (E.D. Pa.). In February 2021, the Court sent a Notice of
Proposed Termination. The Carefirst case remains pending.
The Group has evaluated the antitrust class and state claims in
light of the DOJ settlement under which a Group subsidiary plead
guilty to one count of making a false statement relating to health
care matters in one state in 2012. The Group continues to believe
in its defenses and continues to vigorously defend itself. Select
plaintiffs in these matters have previously made settlement demands
(which were not accepted and most of which are not current offers),
totaling approximately $290m, which was used for contingency
planning only to model possible downside financial effects. The
final aggregate cost of these matters, whether resolved by
litigation or by settlement, may be materially different. If the
Group were to entertain further settlement discussions, we make no
representations as to what amounts, if any, it may agree to pay,
nor regarding what amounts the plaintiffs will demand.
Other Antitrust and Consumer Protection Claims
-- In July 2019, the Indiana Attorney General issued a Civil
Investigative Demand investigating potential violations of
Indiana's Civil Deceptive Consumer Sales Act with respect to sales
and marketing activity by the Company. The Group is cooperating
fully in this civil investigation.
-- In 2020, the Group was served with lawsuits from a number of
insurance companies, some of whom are proceeding both on their own
claims and through the assignment of claims from affiliated
companies. Cases filed by (1) Humana Inc. and (2) Centene
Corporation, Wellcare Healthcare Plans, Inc., New York Quality
Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC are
pending in the Eastern District of Pennsylvania. Cases filed by (1)
Blue Cross and Blue Shield of Massachusetts, Inc., Blue Cross and
Blue Shield of Massachusetts HMO Blue, Inc., (2) Health Care
Service Corp., (3) Blue Cross and Blue Shield of Florida, Inc.,
Health Options, Inc., (4) BCBSM, Inc. (d/b/a Blue Cross and Blue
Shield of Minnesota) and HMO Minnesota (d/b/a Blue Plus), and (5)
Molina Healthcare, Inc. are pending in the Circuit Court for the
County of Roanoke, Virginia. The allegations in these cases include
many allegations made in other litigations, including prior
antitrust complaints, indictments, and qui tam complaints. These
plaintiffs have asserted claims under federal and state RICO
statutes, state antitrust statutes, state statutes prohibiting
unfair and deceptive practices, state statutes prohibiting
insurance fraud, and common law fraud, negligent misrepresentation,
and unjust enrichment. Defendants' motions to dismiss are fully
briefed and pending.
The Group has begun its preliminary evaluation of the claims,
believes in its defenses, and intends to vigorously defend itself.
Currently, engagement with the claimants has been minimal and the
Group's evaluation of the various claims is in preliminary stages.
Accordingly, no estimate of the range of potential loss can be made
at this time.
Civil Opioid Litigation
-- Indivior has been named as a defendant in fewer than 400
civil lawsuits brought by state and local governments, public
health agencies, and individuals against manufacturers,
distributors and retailers of opioids alleging that they engaged in
a longstanding practice to market opioids as safe and effective for
the treatment of long term chronic pain in order to increase the
market for opioids and their own market share. The vast majority of
these cases have been consolidated and are pending in a federal
multi-district litigation (MDL) in U.S. District Court for the
Northern District of Ohio. At the present time, litigation against
Indivior in the MDL is stayed. There remain three (3) cases against
Indivior pending in state courts located in Arizona, Pennsylvania
and Virginia, which are similarly stayed at the current time. Given
the status and preliminary stage of litigation in both the MDL and
state courts, no estimate of possible loss in the opioid litigation
can be made at this time.
12. TRADE AND OTHER PAYABLES
Mar Dec
31 31
2021 2020
$m $m
---------------------------------------- ---- ------ ------
Sales returns and rebates (408) (396)
Trade payables (25) (20)
Accruals (85) (99)
Other tax and social security payables (11) (9)
Total (529) (524)
---------------------------------------------- ------ ------
Sales return and rebate accruals, primarily in the U.S., are
provided in respect of the estimated rebates, discounts or
allowances payable to direct and indirect customers. Accruals are
made at the time of sale while the actual amounts to be paid are
based on claims made some time after the initial recognition of the
sale. As the amounts are estimated, they may not fully reflect the
final outcome and are subject to change dependent upon, amongst
other things, the payor channel (e.g. Medicaid, Medicare, Managed
Care, etc.) and product mix. The level of accrual is reviewed and
adjusted in the light of historical experience of actual rebates,
discounts or allowances given and returns made, and any changes in
arrangements or rules. Future events may cause the assumptions on
which the accruals are based to change, which could affect the
future results of the Group.
13. SHARE CAPITAL
Nominal Aggregate
value nominal
Equity paid value
ordinary per $m
shares share
----------------------- ------------ -------- ----------
Issued and fully paid
At January 1, 2021 733,635,511 $0.10 73
Allotments 985,478 $0.10 -
At March 31, 2021 734,620,989 73
------------------------ ------------ -------- ----------
Nominal Aggregate
value nominal
Equity paid value
ordinary per $m
shares share
----------------------- ------------ -------- ----------
Issued and fully paid
At January 1, 2020 730,787,719 $0.10 73
Allotments 1,620,613 $0.10 -
At March 31, 2020 732,408,332 73
------------------------ ------------ -------- ----------
Allotment of ordinary shares
During the period, 985,478 ordinary shares (2020: 1,620,613)
were allotted to satisfy vestings/exercises under the Group's
Long-Term Incentive Plan and U.S. Employee Stock Purchase Plan.
14. POST BALANCE SHEET EVENTS
On April 12, 2021 the Internal Revenue Service approved a tax
credit in relation to development credits for SUBLOCADE claimed in
prior years and issued a refund for approximately $36m. The Group
accounted for this event as an adjusting post balance sheet event.
See Notes 3 and 5 for further discussion.
DIRECTORS' RESPONSIBILITY STATEMENT
The Directors declare that, to the best of their knowledge:
-- This set of Condensed Consolidated Interim Financial
Statements, which have been prepared in accordance with
International account standard 34, 'Interim Financial Reporting',
as contained in UK-adopted international accounting standards ("IAS
34"), gives a true and fair view of the assets, liabilities,
financial position, and profit or loss of Indivior; and
-- The interim management report gives a fair review of the
information in line with regulations 4.2.7 and 4.2.8 of the
Disclosure Guidance and Transparency Rules.
The Directors are responsible for the maintenance and integrity
of the Group's website. Legislation in the United Kingdom governing
the preparation and dissemination of financial statements may
differ from legislation in other jurisdictions.
Indivior PLC's Directors are listed in the Annual Report and
Accounts for 2020. Jerome Lande, Jo Le Couilliard, Mark Stejbach
and Juliet Thompson were appointed as Non-Executive Directors on
March 23, 2021.
Details of all current Directors are available on our website at
www.indivior.com
By order of the Board
Mark Crossley Ryan Preblick
Chief Executive Officer Chief Financial Officer
April 28, 2021
Independent review report to Indivior PLC
Report on the Condensed consolidated interim financial
statements
Our conclusion
We have reviewed Indivior PLC's Condensed consolidated interim
financial statements (the "interim financial statements") in the Q1
2021 Results of Indivior PLC for the three month period ended 31
March 2021 (the "period").
Based on our review, nothing has come to our attention that
causes us to believe that the interim financial statements are not
prepared, in all material respects, in accordance with
International Accounting Standard 34, 'Interim Financial
Reporting', as contained in UK-adopted international accounting
standards ("IAS 34").
What we have reviewed
The interim financial statements comprise:
-- the Condensed consolidated interim balance sheet as at 31 March 2021;
-- the Condensed consolidated interim income statement and
Condensed consolidated interim statement of comprehensive
income/(loss) for the period then ended;
-- the Condensed consolidated interim statement of changes in
equity for the period then ended;
-- the Condensed consolidated interim cash flow statement for the period then ended; and
-- the explanatory notes to the interim financial statements.
The interim financial statements included in the Q1 2021 Results
of Indivior PLC have been prepared in accordance with IAS 34.
As disclosed in note 1 to the interim financial statements, the
financial reporting framework that will be applied in the
preparation of the next full annual financial statements of the
group is applicable law and UK-adopted international accounting
standards.
Responsibilities for the interim financial statements and the
review
Our responsibilities and those of the directors
The Q1 2021 Results, including the interim financial statements,
is the responsibility of, and has been approved by the directors.
The directors are responsible for preparing the Q1 2021 Results in
accordance with IAS 34.
Our responsibility is to express a conclusion on the interim
financial statements in the Q1 2021 Results based on our review. We
do not, in giving this conclusion, accept or assume responsibility
for any other purpose or to any other person to whom this report is
shown or into whose hands it may come save where expressly agreed
by our prior consent in writing.
What a review of interim financial statements involves
We conducted our review in accordance with International
Standard on Review Engagements (UK and Ireland) 2410, 'Review of
Interim Financial Information Performed by the Independent Auditor
of the Entity' issued by the Auditing Practices Board for use in
the United Kingdom. A review of interim financial information
consists of making enquiries, primarily of persons responsible for
financial and accounting matters, and applying analytical and other
review procedures.
A review is substantially less in scope than an audit conducted
in accordance with International Standards on Auditing (UK) and,
consequently, does not enable us to obtain assurance that we would
become aware of all significant matters that might be identified in
an audit. Accordingly, we do not express an audit opinion.
We have read the other information contained in the Q1 2021
Results and considered whether it contains any apparent
misstatements or material inconsistencies with the information in
the interim financial statements.
PricewaterhouseCoopers LLP
Chartered Accountants
London
28 April 2021
, 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
QRFUKUWRAVUSURR
(END) Dow Jones Newswires
April 29, 2021 07:00 ET (11:00 GMT)
Indivior (LSE:INDV)
Historical Stock Chart
From Feb 2024 to Mar 2024
Indivior (LSE:INDV)
Historical Stock Chart
From Mar 2023 to Mar 2024