IMAGINE
A BETTER FUTURE
FOR PATIENTS
Annual Report and Accounts 2021
I N D I V I O R A N N U A L R E P O R T A N D A C C O U N T S 2 0 2 1
Contents
Strategic Report
Governance
Financial Statements
118
128
171
Independent Auditors’
report
Financial statements
Information for
shareholders
58
60
62
63
91
Chair’s governance
statement
Board of Directors
Executive Committee
Corporate governance
Directors’ remuneration
report
112 Directors’ report
116 Statement of Directors’
responsibilities
1
2
4
6
8
10
16
18
22
24
30
38
39
43
47
57
Introduction
At a glance
Our purpose in action
Chair’s statement
Our purpose in action –
a patient story
Chief Executive
Officer’s review
Our purpose in action –
an employee
perspective
Chief Scientific
Officer’s review
Business model
Stakeholder
engagement
Responsibility
Non-financial
information statement
Financial review
Legal proceedings
Risk management
Viability statement
2021
Financial
Results
$791m +22%
$213m
$205m
Net revenue
(2020: $647m)
Operating profit
(2020: $156m operating loss)
Net income
(2020: $148m net loss)
$244m 88%
$187m 113%
$140m 137%
Net revenue from
SUBLOCADE®
(2020: $130m)
Adjusted operating profit*
(2020: $88m)
Adjusted net income*
(2020: $59m)
$853m 37%
$1,102m 28%
Year-end net cash balance**
(2020: $623m)
Year-end cash balance
(2020: $858m)
* Excluding exceptional items (further details on pages 137 to 139).
* * See Note 19 of the Notes to the Group financial statements for the definition of net cash.
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indivior.com
IMAGINE
...a better future for patients
WE DO.
Our vision is that the millions of people across the globe suffering
from substance use disorders and serious mental illness have
access to evidence-based treatment to change lives.
Our Company was founded to help tackle the opioid
crisis, one of the largest and most urgent public health
emergencies of our time. Our purpose is to bring science-
based, life-transforming treatments to patients. We strive
to help eliminate the stigma of addiction.
We discovered buprenorphine and developed it as
a leading evidence-based treatment for opioid dependence,
while concurrently advocating for a more effective recovery
care model. Buprenorphine is among the medications for
opioid use disorder that is included in the World Health
Organization (WHO) essential medication list.1
Medication-assisted treatment (MAT) for opioid use
disorder is a critical part of the solution to the global
opioid crisis.
MAT is the use of medications, in combination with
counseling and behavioral therapies, to provide a
“whole-patient” approach to the treatment of substance
use disorders.2 While therapy and rehab are powerful tools
in opioid use disorder and substance use disorder recovery,
science shows that patients who use medication in addition
to these treatments experience a higher recovery rate.3
Addiction and mental health are uniquely challenging
treatment spaces.
A common misunderstanding about medications
used to treat opioid use disorder is that some of the
medicines used simply substitute one drug for another.4
However, these medications may restore healthy
brain function, which leads to improvements in behaviors
associated with addiction. Longer-term use of these
medications is associated with improved outcomes.5
We take our role as a responsible steward of these
medications extremely seriously.
We cultivate a culture of integrity and commit ourselves
to the highest standards of governance. We believe
our long-term success is directly linked to operating
in a responsible way and in a way that minimizes
our impact on the environment. We support efforts
to educate around safety and proper use of our
medication-assisted treatments.
We are driving forward our understanding of addiction
and other serious mental health illnesses to create new
science that will help pave the way for an even deeper
understanding of patient needs and treatment innovation.
We engage at all levels across the addiction treatment
spectrum, interacting with governments, key opinion
leaders, physicians, payers, patients, and patient advocacy
groups to raise awareness and educate about addiction
as a chronic, relapsing disease.
Imagine a better future for patients.
We do.
1. WHO Model list of essential medications https://www.who.int/
selection_medicines/committees/expert/20/EML_2015_FINAL_
amended_JUN2015.pdf?ua=1 accessed Sept 19, 2021
2. https://www.samhsa.gov/medication-assisted-treatment
3. Substance Abuse and Mental Health Services Administration. (2016).
Decisions in Recovery: Medications for Opioid Use Disorder. Decisions
in Recovery Treatment for opioid use disorders (HHS Pub No.
SMA-16-4993), 2016. Retrieved from: www.samhsa.gov/brss-tacs/
recovery-support-tools/shared-decision-making
4. SAMSHA2018_TIP63MedicationsForOpioidUseDisorder/p1-3/col2/
para2/bullets1-3 (p.5) Retrieved from: TIP 63: Medications for
Opioid Use Disorder – Full Document | SAMHSA Publications
and Digital Products
5. Leshner, A. I., & Mancher, M. (2019). Summary. In Medications
for opioid use disorder save lives (p. 5). essay, The National
Academies Press.
Indivior | Annual Report and Accounts 2021
1
A T A G L A N C E
O U R R O L E I N T H E C R I S I S
IMAGINE
...a better future for patients
More than ever, the world is in need of
better outcomes for patients suffering
from substance use disorders (SUD)
and serious mental disease.
According to the United Nations, approximately
275 million people globally have used drugs in the
past year. Addiction is a disease reaching epidemic
proportions, with opioid dependence contributing
significantly to the disease burden.1
A growing crisis
275m past year drug users (2020)
200m
cannabis users
62m
20m
opioid users
cocaine users
27m
amphetamine
and prescription
stimulants users
18m
years of healthy
life lost due to
substance use
disorder (SUD)
in 2019
70%
of those were
opioid use
disorder (OUD)
Source: World Drug Report 2021 (United Nations publication, Sales No. E.21.XI.8)
1. World Drug Report 2021 (United Nations publication, Sales No. E.21.XI.8)
2. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
3. Volkow, N.D. The epidemic of fentanyl misuse and overdoses: challenges and strategies. World Psychiatry. 2021. 20: 195-196.
https://doi.org/10.1002/wps.20846.
2
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Opioid use disorder in the United States
In the US, there has been a marked increase in
drug overdoses. According to the Centers for Disease
Control & Prevention (CDC), more than 100,000 people
are predicted to have died from drug overdose in the
12-month period ended September 2021, with 78,388
of these deaths attributed to opioids.2
The majority of opioid-related overdose deaths in the
US are the result of synthetic opioids (mainly fentanyl
and illicit fentanyl analogs). Synthetic opioids are
more potent than heroin and can unexpectedly cause
respiratory depression by being ingested
as a substitute for heroin or with drugs such as
prescription opioids, cocaine, methamphetamine
or nonopioids with sedative or hypnotic properties
(e.g., benzodiazepines, gabapentin, and xylazine).3,4,5,6
Against the context of the concerning and dramatic
rise in deaths from opioid overdose3, Indivior is doing
more to understand the interaction between fentanyl
and buprenorphine. Data published in a peer-reviewed
journal indicates that sustained high-plasma
concentrations of buprenorphine reduced fentanyl-
induced respiratory depression in opioid-tolerant
participants during a recent study.
The unprecedented magnitude and dynamic nature
of the global SUD crisis worsened by the COVID-19
pandemic requires evidence that comprehensive
treatment strategies lead to better outcomes.
This is why, more than ever, we are focused on patients
suffering from SUD and serious mental disease.
Increased drug overdoses in the U.S.
Itʼs what drives us to do what we do
104,288 drug
overdose deaths
Predicted drug overdose deaths in the
12-month period ending September 2021
+99% increase since September 2015
Total drug
overdose deaths
+99%
increase since
September 2015
90,009
104,288
78,388
Opioid
overdose deaths
+138%
increase since
September 2015
60,058
40,085
16,419
52,278
32,819
8,821
71,575
69,277
69,720
67,733
68,110
48,393
47,769
48,876
54,122
31,496
34,666
27,842
Synthetic
opioid overdose
deaths such
as fentanyl
+672%
increase since
September 2015
Sep 15
Sep 16
Sep 17
Sep 18
Sep 19
Sep 20
Sep 21
Source: Centers for Disease Control and Prevention. Vital Statistics Rapid
Release: Provisional Drug Overdose Death Counts (updated 2/6/2022)
Purpose
Indiviorʼs purpose is to pioneer
life-transforming treatment
Vision
Indiviorʼs vision is that the millions
of people across the globe suffering
from substance use disorders and
serious mental illness have access
to evidence-based treatment to
change lives
Mission
Indiviorʼs mission is to be the
global leader who is a pioneer in
developing innovative prescription
treatments for people suffering
from substance use disorders
and mental disease
Commitment
Indivior commits to maintaining
a robust and responsible business
approach at all times
4. Dolinak, D, et al. Opioid Toxicity. Acad Forensic Pathol. 2017; (1): 19-35. doi: 10.23907/2017.003
5. Ochalek TA, Parker MA, Higgings ST, et al. Fentanyl exposure among patients seeking opioids treatments. J Subst Abuse Treat 2019; 96: 23-25.
doi: 10.1016/j.jsat.2018.10.007
6. O’Donnell J, Tanz LJ, Gladden RM, Davis NL, Bitting J. Trends in and Characteristics of Drug Overdose Deaths Involving Illicitly Manufactured
Fentanyls — United States, 2019–2020. MMWR Morb Mortal Wkly Rep 2021;70:1740-1746. DOI: DOI: http://dx.doi.org/10.15585/mmwr.mm7050e3
Indivior | Annual Report and Accounts 2021
3
STRATEGIC REPORT
O U R P U R P O S E I N A C T I O N
WE DO.
Indivior’s foundation is built on our
guiding principles, which puts our
purpose into action.
We foster a culture of integrity and commit
ourselves to high standards of governance.
We believe our long-term success is directly linked
to operating in a responsible way and in a way
that minimizes our impact on the environment.
We are proud of the work we have done and remain
resolutely focused on continuing to reduce barriers
to access and to develop new, innovative treatments
for patients. We have a clear multi-year strategy in
place to drive towards these goals, which we are
confident will create sustainable, long-term results
for all of our stakeholders.
We have a range of policies, processes, resources,
and relationships to ensure the responsible
management of our business. In practice, we address
these aspects of our business by focusing on not
only the environment and climate change, but also
patient safety and product quality, business conduct,
workforce, communities, and advocacy.
O U R P U R P O S E I N A C T I O N
A patient story
See page 8
An employee perspective
See page 16
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Indivior’s global presence
As a global pharmaceutical company working to help
change patients’ lives by pioneering life-transforming
treatments for addiction, including opioid use disorder
and other serious mental illnesses, Indivior strives
to increase access around the world to our evidence-
based portfolio of medical therapies.
SUBLOCADE® is the first long-acting buprenorphine-
based injectable approved by the US Food and Drug
Administration (FDA) for the treatment of moderate to
severe OUD.1 Our proprietary RECOVER™ Study
examines long-term recovery in individuals with
moderate to severe opioid use disorder (OUD) following
their transition from SUBLOCADE® into a real-world
setting.2,3
Administration of monthly subcutaneous (SC) injections
of SUBLOCADE only by a healthcare professional also
eliminates the risk of missing daily doses that might
result in subtherapeutic plasma levels, potentially
leading to relapse to opioid-seeking and opioid-taking
behaviors. Finally, because SUBLOCADE may only
be administered by a healthcare professional,
it is expected to negate any potential for
diversion or misuse.
SUBOXONE® (buprenorphine and naloxone) Sublingual
film (CIII) is also available in the US and some European
countries for the treatment of OUD.4 SUBOXONE Tablet is
available in some European as well as Asian and African
countries for the treatment of OUD, as is SUBUTEX®
(buprenorphine hydrochloride) Tablet.
PERSERIS® is the first once-monthly subcutaneous
extended-release injectable suspension of risperidone,
indicated for the treatment of schizophrenia in adults5,
available in the US.
1. SUBLOCADE® prescribing information. North Chesterfield, VA:
Indivior Inc; 2021. Retrieved from: https://www.sublocade.com.
2. Ling, W., Nadipelli, VR, Solem, CT, Chilcoat, H, Bickel, W.
Characterizing Patient Outcomes After Treatment: Results of the
RECOVER 24-month Observational Study. Presented at CPDD 2020
Virtual Meeting, June 22-24, 2020.
3. Struggling with recovery from opioid use disorder: Who is at risk
during COVID-19? Keith D.R., Tegge A.N., Stein J.S., Athamneh L.N.,
Craft W.H., Chilcoat H.D., Le Moigne A., DeVeaugh-Geiss A.,
Nadipelli V.R., Solem C., Albright V., and Bickel W.K.
4. SUBOXONE® prescribing information. North Chesterfield, VA:
Indivior Inc; 2021. Retrieved from: https://www.suboxone.com.
5. PERSERIS® prescribing information. North Chesterfield, VA:
Indivior Inc; 2021. Retrieved from: https://www.perserishcp.com
STRATEGIC REPORT
Further information
View our website,
www.indivior.com
Group A
Sweden
Canada
United States
Group C
Group B
Taiwan
Malaysia
Hong Kong
Israel
Indonesia
Australia
South Africa
New Zealand
SUBLOCADE Injection
PERSERIS Injection
SUBUTEX Tablet
SUBOXONE Tablet
SUBOXONE Film
Group A – Denmark, Finland, Germany, Italy,
Norway and United Kingdom.
Group B – Belgium, Croatia, Czech Republic,
France, Ireland, Luxembourg,
Malta, Portugal and Switzerland.
Group C – Austria, Bosnia & Herzegovina,
Cyprus, Estonia, Hungary, Iceland,
Latvia, Lithuania, Lebanon,
The Netherlands, Slovakia,
Spain and Turkey.
Global presence based on countries where
Indivior has a license and markets the
product (January 2022).
Our culture, driven by our Guiding Principles,
puts our purpose in action. But we have more
to do to achieve our vision.
Our Guiding Principles
Focus on
patient needs to
drive decisions
Believe that
people’s actions
are well intended
See it,
Own it,
Make it happen
Seek the wisdom
of the team
Care enough
to coach
Demonstrate
honesty and
integrity at all times
Indivior | Annual Report and Accounts 2021
5
C H A I R ’S S T A T E M E N T
Graham Hetherington
Chair
IN MY FIRST FULL YEAR
AS CHAIR OF INDIVIOR,
I AM PLEASED TO
REPORT SIGNIFICANT
PROGRESS ON OUR
COMMITMENT TO
CREATE VALUE FOR ALL
SHAREHOLDERS.
6
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In 2021, Indivior delivered across its four
Strategic Priorities. We also welcomed
four new non-executive directors which
broadened and strengthened
the Board’s skills and expertise.
We enter 2022 united behind Indivior’s
clear strategy towards the treatment
of addiction while generating sustained
value for shareholders.
Our focus is on actively driving Indivior towards
its potential. The opportunity for Indivior to make
a sustained difference has never been greater,
with overdose deaths in the US, mainly due to
opioids, at record levels and with concerning
escalation in misuse of other substances.
The Board remains committed to the relentless pursuit
of the top strategic priority which is the growth of
SUBLOCADE towards its peak net revenue goal of
$1 billion plus. With SUBLOCADE, Indivior has a unique
opportunity to make a major contribution to alleviating
the enormous societal problems caused by the opioid
epidemic and we are generating an increasing amount
of scientific evidence to support this.
Success with SUBLOCADE is also the biggest potential
driver of value creation and facilitator of other
strategic options, including diversification of sources
of revenue and building and advancing our pipeline for
future growth. These three strategic growth priorities,
combined with our fourth long-term strategic priority
of optimizing our operating model and financial
discipline, continue to be actively managed by the
Board in partnership with Mark Crossley and his team.
Mark, in his Chief Executive Officer’s review,
outlines the actions and results from 2021.
In 2021, the Board broadened its range of expertise
by adding experienced specialty pharmaceutical and
financial leaders as non-executives. We welcomed
Joanna Le Couilliard, previously at GSK, who brings
extensive experience of transforming commercial
models in the sector, and Mark Stejbach, previously at
Alkermes, with first-hand experience of growing novel
treatments targeting substance use disorders. Jo and
Mark complement the wide-ranging contribution from
Lorna Parker and the existing disease space expertise
from Tom McLellan and sector experience with Peter
Bains and Dan Phelan.
We also expanded the Board’s financial and capital
markets skills by adding Juliet Thompson, a FTSE 250
audit chair and former investment banker with sector
experience, and Jerome Lande, a partner at Scopia
Capital Management, our largest shareholder,
with extensive investment experience in the sector.
In 2021, the Board evaluated and partnered with
management to ensure balanced capital allocation
towards delivering shareholder value including
balancing reinvestment in growth and returning
excess capital to shareholders. In 2021, a strong
balance sheet and more positive cashflow, in part,
due to the resilience of the SUBOXONE Film business,
allowed us to announce and complete a $100 million
share repurchase program. Going forward, our capital
allocation priority will continue to be focused on
creating shareholder value, including reinvestment
for growth.
We continued to progress on our outstanding legal
matters, and were able to resolve some matters in
2021. We will continue to progress on our legal matters
and proceedings (as discussed on pages 43 to 46), with
appropriate disclosure continuing to be made through
normal channels in 2022, with these matters in the
background for the Group.
In 2022, we will remain unwavering in our focus
on our Strategic Priorities as well as ensuring good
corporate governance and compliance to create
value for stakeholders.
The Board remains committed to the
relentless pursuit of the top strategic
priority which is the growth of
SUBLOCADE® towards its peak net
revenue goal of $1 billion plus.
The Board has been considering Indivior’s optimal
listing structure, including a secondary listing in the
US. In February 2022, we announced our intention
to consult extensively before deciding whether to put
a formal resolution to shareholders. We believe this
could allow us to tap into a deeper pool of biopharma
investors in the US, to align investment interest in the
Group with its largest geographical area of opportunity,
and to greater visibility, and subsequently, greater
value appreciation over time. More information on
this initiative will be forthcoming as we undertake
our consultation with shareholders.
The Board recognizes the importance of
Environmental, Social & Governance (“ESG”)
matters to our stakeholders. We have invested in the
development of our ESG framework to measure our
progress against specific goals and to hold ourselves
to account. The Board will be actively engaged with
management to monitor progress in the year ahead.
The Board is fully committed to the highest standards
of corporate governance, compliance, and integrity.
We are acutely aware of the need to form a
representative Board reflecting the diversity of
society in all its forms and we are working towards
that goal at Board level. This is supported by the
wide-ranging diversity and inclusion initiative which
continues to be developed within the organization.
I am pleased that Indivior continues to meet the
standards required by the agreements
we signed with the US Government in 2020.
My Board colleagues join me in looking forward to
another year of progress in changing patients’ lives
with treatments for substance use disorders and
serious mental illness and, with it to create value for
all shareholders.
Graham Hetherington
Chair
Indivior | Annual Report and Accounts 2021
7
STRATEGIC REPORT
O U R P U R P O S E I N A C T I O N
IMAGINE
… a better world where access
to treatments and recovery
is a reality for all patients
WE DO.
Emilyʼs story
Emily remembers being a straight-A student and planning to go to college.
She imagined becoming a mother and having a happy life. Today, she is
the mother of two sons and considers herself happy. But she never
imagined that opioid use disorder would lead her through a challenging
20-year journey to achieve these goals.
Her plans changed when she became pregnant while in high school.
When her first son was born, she suffered from postpartum depression
and shortly afterward had her wisdom teeth removed. She began taking
medication to relieve the pain. It made her feel great, and soon she found
herself taking more and hiding her disease from family and friends.
When she was 21 years old, she overdosed for the first time.
Emily entered a rehabilitation program, but she relapsed a year later.
She recalls how awful she felt during withdrawal. Feeling very low,
she began using prescription opioids again and realized she had
a serious problem.
“I was taking anything I could find,” Emily remembers. “I ran out of money
too quickly. I was also running out of food.”
With the support of her mother, in 2008, Emily began a therapy regimen
that included medication assisted treatment. Emily learned about a new
buprenorphine long-acting injectable medication.
“SUBLOCADE had just come out,” Emily recalls. “I did extensive research
and realized it might be what I needed. I spoke to my doctor about it and
together we decided that I should start this new treatment. I was a little
scared at first, but it turned out fine, and I was relieved I had no cravings.”
Over time, Emily’s therapy regimen of a monthly subcutaneous injection
and regular sessions with a psychologist have helped her feel like she has
better control of her life. She says her eldest son is proud of her, and she
feels more engaged with her youngest son.
“It was one of the best moves I ever made,” she said about the decision
to begin her current therapy regimen. “I feel good. It’s nice to be thinking
of other things than taking a medicine every day.”
Now 39 years old, Emily’s priorities have changed. She has gone back to
school with the goal of becoming an addiction specialist to help others
who struggle with opioid use disorder.
“I tell people not to hesitate to get help,” Emily said. “The journey
is not going to be easy. You must be willing to give it a try. I wasn’t
ready when I was younger. Now I want to help others who struggle
with the cycle of addiction.”
8
indivior.com
Results may vary
SUBLOCADE (buprenorphine extended-release) injection
for subcutaneous use (CIII) 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.
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.
Taking other opioid medicines, benzodiazepines, alcohol,
or other central nervous system depressants (including
street drugs) while on SUBLOCADE can cause severe
drowsiness, decreased awareness, breathing problems,
coma, and death.
SUBLOCADE contains the opioid buprenorphine, a
controlled substance that can be abused in a manner
similar to other opioids. Naloxone, a medicine available
to patients for emergency treatment of an opioid overdose
may be prescribed when initiating or renewing SUBLOCADE
treatment, because patients being treated for opioid use
disorder have the potential for relapse, putting them
at risk for opioid overdose.
For further information
about SUBLOCADE, the full US Prescribing
Information, including BOXED WARNING,
and the Medication Guide, visit sublocade.com.
STRATEGIC REPORT
The journey is not going
to be easy. You must be
willing to give it a try.
I wasn’t ready when I was
younger. Now I want to help
others who struggle with
the cycle of addiction.
Emily
US patient
Indivior | Annual Report and Accounts 2021
9
C H I E F E X E C U T I V E O F F I C E R ’S R E V I E W
Mark Crossley
Chief Executive Officer
I AM DELIGHTED TO
REPORT THAT 2021
WAS A YEAR OF REAL
PROGRESS IN
POSITIONING INDIVIOR
FOR LONG-TERM
SUSTAINABLE GROWTH
AND SHAREHOLDER
VALUE CREATION.
Today, Indivior is a stronger company
with a brighter future. The fact that so
much was achieved against the backdrop
of the continuing COVID-19 pandemic
speaks to the commitment of our people:
their passion for and focus on delivering
for patients is truly humbling. Indeed,
never have our purpose – to deliver
pioneering life-transforming treatments
– and our patient-centered vision been
more critical and relevant as, tragically,
the need for our treatments has never
been more urgent.
10
indivior.com
2021 saw Indivior execute strongly
against our four Strategic Priorities:
1. Grow SUBLOCADE®
to >$1 billion of Net Revenue
2. Diversify Revenue
3. Build our Pipeline for Future Growth
4. Optimize our Operating Model
Delivering against these priorities helped Indivior
achieve renewed profitable growth and, importantly,
continued financial strength and resilience.
Compared to the previous year, net revenue grew
by 22% to $791 million and adjusted net income
increased 137% to $140 million. Cash flow from
operations was $395 million and the year-end
cash position was $1.1 billion.
Our strong financial performance and robust balance
sheet allowed us to accelerate important elements
of our strategy. We invested to build on our
leadership position in global addiction treatment
while also returning $100 million to shareholders
through a share repurchase program.
We saw significant accomplishments across each
of our Strategic Priorities and plan to build this
success moving forward to create a more valuable
and sustainable company.
The fact that so much was
achieved against the backdrop
of the continuing COVID-19
pandemic speaks to the
commitment of our people.
1
Grow
SUBLOCADE
to >$1 billion
of Net Revenue
This remains our most
important Strategic
Priority because
success here unlocks
opportunities to
reinvest and advance
the others. In 2021,
we delivered
SUBLOCADE net
revenue of $244
million, an increase
of 88% compared to 2020. This was a good result
considering the challenging market environment we
faced due to COVID-19 restrictions. Our team generated
consistent net revenue growth through 2021 and we
ended the year with approximately 49,000 patients.
With these strong results we are about a quarter
of the way to meeting our peak annual net revenue
and 180,000 patient goal. Looking ahead, we will
continue to focus on our successful strategy to expand
SUBLOCADE’s availability across Organized Health
Systems (OHS) in the U.S. These larger care systems
cover the majority of the approximately 3 million1
opioid use disorder (OUD) patients in the U.S. and
continue to gain influence due to consolidation in the
healthcare market. Our now established capability in
working with OHS clients is becoming a distinct
competitive advantage and we are continuing to
increase strategic investment to enhance our reach
and capabilities in this important channel.
We are targeting to activate over 500 priority OHS
customers, and at the end of 2021, we had agreements
in place with over 400. We are also exploring
opportunities within the criminal justice system, an
OHS sub-channel. This is an important patient setting
where daily treatment can be sub optimal given the
inherent restrictions. SUBLOCADE offers a treatment
avenue that meets the unique needs of the criminal
justice system, including once-monthly dosing and a
closed distribution system. As approximately 65%2 of
all currently incarcerated individuals meet the criteria
for substance use disorder, often for non-violent
offenses, it presents an important opportunity to
expand the treatment population for SUBLOCADE.
We are accelerating our progress in this channel
with a dedicated team of 21 people focused on
opening access to major correction customers.
The science behind SUBLOCADE is unique and
powerful, and we are investing further to differentiate
it from other existing treatments. 2021 saw continued
momentum in this area with 17 peer-reviewed articles
and an updated label including results from our study
on buprenorphine interaction with fentanyl.
Indivior | Annual Report and Accounts 2021
11
STRATEGIC REPORT
C H I E F E X E C U T I V E O F F I C E R ’S R E V I E W
C O N T I N U E D
New studies we are initiating in 2022 are designed
to build on the strong evidence base we have already
established to ensure SUBLOCADE remains relevant
to market trends we are observing. We want to remain
a leading voice and empirical data generator in the
fight against a disease epidemic that continues to
rage, killing over 76,0003 in the US alone in the last
year. This is a 24% increase over the previous year.
We look forward to another year of growth for
SUBLOCADE. In 2022, we expect net revenue to increase
to a range of $360 million to $400 million. At the
mid-point, this would represent an increase
of 56% compared to 2021 and approaching 40%
of our peak annual net revenue target of >$1 billion.
2
Diversify
Revenue
In 2021, we made
progress toward our
goal of establishing
a more diversified
revenue base. Twin
efforts are underway
to broaden both
our treatment
and geographic
opportunities within
our current portfolio.
PERSERIS (risperidone) is our long-acting risperidone
injectable treatment for schizophrenia in adults. 2021
net revenue for this product increased by 21% to $17
million. Our net revenue has been impacted by
COVID-19 as it both limited our ability both to access
the US healthcare system and expand beyond
our “pilot” sales force of 50 sales representatives at
launch. However, the differentiated product profile of
PERSERIS is increasingly being recognized by treating
physicians who have trialed the product. Among
healthcare providers in the US who prescribed
PERSERIS, the once-monthly risperidone long-acting
injectable was listed as the first- or second-line
preference 20%4 of the time. This has given us the
confidence to increase our investment in distributing
PERSERIS by doubling its sales force in 2022.
Our peak net revenue goal of $200 to $300 million is
predicated on operationalizing a national sales force.
In 2022, we expect the net revenue range for PERSERIS
to be $27 to $32 million. This performance range
reflects the uncertain timing between hiring, training,
and reaching full effectiveness of our expanded sales
force and the pace at which access to the healthcare
system reopens. We are planning for meaningful net
revenue acceleration to begin in 2023.
Our other diversification goal is to return our ex-US
markets to growth after the modest declines we have
seen over recent years, excluding any currency
benefits. We are pleased to have introduced to
targeted geographies two new treatments, SUBLOCADE
(SUBUTEX PR in some territories) and SUBOXONE
(buprenorphine and naloxone) Film, to power our
growth aspirations outside the US
In 2021, ex-US SUBLOCADE net revenue was $16 million
from Australia, Canada, and Israel. With approvals now
in place in 10 countries at the end of 2021, we plan to
build on this progress in 2022 as market
reimbursement is finalized. SUBOXONE Film is now
approved in Canada, the European Union, and the
United Kingdom. Adoption of SUBOXONE Film has been
adversely impacted by COVID-19 healthcare restrictions
during 2021, particularly in the European Union.
Our marketing efforts will continue to flex with the
evolving COVID-19 restrictions in these countries.
The science behind SUBLOCADE is
unique and powerful, and we are
investing further to differentiate
it from other existing treatments.
12
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3
Build and
advance our
Pipeline for
Future Growth
Our research and
development activities
are focused on
building on our
leadership position
in the treatment
of addiction.
Through three active
partnerships, we are
investing to advance
research into
molecules that address alcohol use disorder (AUD),
opioid use disorder (OUD) and cannabis-related
disorders (CrD).
The most advanced program is the strategic
collaboration we formed with France-based Aelis
Farma (“Aelis”) in June 2021. This gives the Group an
exclusive option for AEF0117, a first-in-class synthetic
CB1 specific signaling inhibitor designed to treat
cannabis-related disorders. The molecule is in
late-stage development – Phase 2B studies have
started – and would, if approved, address the growing
need for treatments targeting cannabis-related
dependency and psychosis. (CrD) instances are
increasing in the US, where regulation of marijuana
has relaxed (18 states5 now permit recreational
use), while THC levels within marijuana have
dramatically increased.
Over 48 million6 people used marijuana in the US
in 2019 and 4.8 million6 people had a CrD during the
same period. There are no FDA-approved medications
for cannabis-related disorders, which is concerning.
AEF0117 is the most advanced new chemical entity
under investigation and potentially represents
a unique opportunity to address a growing public
health need. Our confidence in Aelis is demonstrated
by a direct equity investment that we believe has
potential upside for shareholders as Aelis progresses
its pipeline.
We also have established partnerships for earlier-
stage assets that have continued to advance. INDV-
2000 (Selective Orexin-1 Receptor Antagonist), a
non-opioid treatment for moderate to severe opioid
use disorder, being developed in partnership with C4X
Discovery, is in Phase 1. A final Clinical Study Report for
a Single Ascending Dose (SAD) was completed and
demonstrated good safety and pharmacokinetics in
healthy volunteers. A Multiple Ascending Dose (MAD)
study is now being planned and scheduled for the
second half of 2022.
INDV-1000 (Selective GABAb Positive Allosteric
Modulator), for treatment of alcohol use disorder,
being developed in partnership with ADDEX
therapeutics, is pre clinical, with the lead identification
and optimization program continuing. We expect
to enter lead molecules and back-up molecules
into the optimization phase in 2022.
We continue to search actively for promising new
molecules that could enhance our addiction treatment
franchise. We expect to acquire and invest in
additional early- or late-stage assets at an appropriate
stage of value inflection and after thorough evaluation
by our science, strategy and regulatory teams.
4
Optimize our
Operating Model
and Financial
Discipline
Underpinning our
success is our
unwavering focus on
fiscal prudence and
operational rigor.
Our discipline ensures
we maintain a capital
position that can
support the growth
of the business and
deliver on our net
revenue goals for both SUBLOCADE and PERSERIS, as
well as outstanding obligations to the US Government.
In 2021, we solidified our capital structure with
a new $250 million replacement term loan, due June
2026. This new financing provides greater flexibility
by removing the leverage covenant and lower
mandatory principal payments.
With our capital structure set and the business
generating positive cash flow from operations,
we were able to fund a share repurchase of $100
million. As we move forward, we will continue to
evaluate capital allocation prudently, with
prioritization toward mechanisms to deliver
shareholder value including but not limited to
reinvestment across our Strategic Priorities.
In 2021, we progressed on our outstanding legal
matters by resolving some matters. Progress on
our legal matters and proceedings (as discussed
on page 43 to 46) remains an important component
of this strategic pillar.
We continue to search actively
for promising new molecules
that could enhance our
addiction treatment franchise.
Indivior | Annual Report and Accounts 2021
13
STRATEGIC REPORT
C H I E F E X E C U T I V E O F F I C E R ’S R E V I E W
C O N T I N U E D
Environmental, Social and Governance (ESG)
Compliance & Integrity
We are pleased to report good progress in developing
a measurable and accountable ESG program for the
Group (see the ‘Responsibility’ section on pages 30
to 37). To support our efforts, we have formed an ESG
Committee that will report directly to the Board and
the Remuneration Committee has committed to
including ESG metrics in the Group’s annual and/or
Long-Term Incentive Plans in 2023.
We have continued to build upon our diversity and
inclusion initiative, which we launched in 2020, and
will leverage the feedback from our global employee
base and work with third-party experts to ensure
we are focusing our resources in the most impactful
areas. We have a clear path forward and look forward
to reporting our continued progress in 2022 and
beyond.
Our Strategic Priorities are clear;
we are relentlessly focused on
improving execution and
demonstrating progress.
2021 was the first full year of operating within the
terms of three agreements as part of Indivior’s 2020
US Government Resolution. Through our discipline,
focus and ongoing commitment to being a compliant
Company, we believe we have successfully met all of
the commitments and external reporting requirements
agreed with the US Department of Justice, US Office of
Inspector General and US Federal Trade Commission.
Our commitment to excellence in meeting these
obligations is testament to our strong culture and
engagement at all levels to embed an effective Global
Integrity & Compliance Program at Indivior. We
measure our culture of integrity and compliance
annually via an independent and benchmarked survey
of our global workforce conducted by Ethisphere. With
continued above-benchmark results across all pillars
measured, and strong year-on-year progress, we will
look to build further on these achievements in 2022.
In conclusion, we enter 2022 with renewed confidence.
Our Strategic Priorities are clear; we are relentlessly
focused on improving execution and demonstrating
progress. Crucially, we have the people and the
financial resources to deliver on our commitments.
I would like to thank our employees for their tireless
work to move Indivior forward every day and our Board
for their ongoing wisdom, partnership and support.
Mark Crossley
Chief Executive Officer
1. Symphony Health Analytica and Indivior analytics
2. National Institute on Drug Abuse: Criminal Justice DrugFacts: https://nida.nih.gov/publications/drugfacts/criminal-justice
3. Source (updated 1/28/2021): Products – Vital Statistics Rapid Release – Provisional Predicted Drug Overdose Data (cdc.gov)
4. Q1 2021 HCP Attitudes, Trial, and Usage (ATU) study (quant), amongst HCPs aware of PERSERIS, n=100
5. Alaska, Arizona, California, Colorado, Connecticut, Illinois, Maine, Massachusetts, Michigan, Montana, Nevada, New Jersey,
New Mexico, New York, Oregon, Vermont, Virginia, and Washington. Includes states that have passed legislation to legalize
but the law has not yet gone into effect.
6. Substance Abuse and Mental Health Services Administration. (2020). Key substance use and mental health indicators in the
United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH
Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services
Administration. Retrieved from https://www.samhsa.gov/data/
14
indivior.com
OUR STRATEGIC PRIORITIES
Indivior’s Strategic Priorities provide a clear roadmap against which the Group and key stakeholders measure its overall strategic
progress. Collectively, they comprise the value creation foundation upon which the Group continues to build. In 2021, the Group
continued to make clear progress against each one of its Strategic Priorities.
1. GROW SUBLOCADE >$1 BILLION
2. DIVERSIFY REVENUE
PROGRESS
PROGRESS
› FY 2021 net revenue of $244 million increased
› FY 2021 PERSERIS net revenue of $17 million increased
88% versus FY 2020.
› The number of SUBLOCADE patients at the end of 2021
was approximately 49,0001, an increase of 69% versus
approximately 29,000 at the end FY 2020.
› The Group had agreements in place with over
400 Organized Health Systems at the end 2021,
progressing toward its target of 500+.
21% versus FY 2020; the Group is doubling the US
salesforce to approximately 100 professionals to
accelerate progress toward achieving its annual net
revenue goal of $200 to $300 million.
› Regulatory approval of SUBLOCADE (SUBUTEX Prolonged
Release) outside of the US has now been granted in
10 countries. 2021 approvals include Norway, Germany
and Italy. Prior approvals include Canada, Australia,
New Zealand, Israel, Sweden, Finland and Denmark.
The treatment has been launched in Canada, Australia
and Israel.
› Regulatory approval of SUBOXONE Film outside of the
US in 2021 was granted in New Zealand, Qatar, and
United Arab Emirates. Prior approvals include Australia,
Canada, Israel, all EU Member States and the UK, Iceland,
Norway, and Liechtenstein.
3. BUILD OUR PIPELINE
4. OPTIMIZE OUR OPERATING MODEL
PROGRESS
PROGRESS
› SUBLOCADE label updated to include relevant fentanyl
pharmacodynamic study (FDA approved); the label
update was based on the outcome of an open-label,
cross-over study showing that treatment-relevant
concentrations of buprenorphine significantly decreased
respiratory depression and resultant apnea (cessation
of breathing) induced by escalating doses of fentanyl.
› Acquired an exclusive option to Aelis Farma’s lead
compound (AEF 0117) for Cannabis Use Disorder and
Cannabis Induced Psychosis; Phase 2b study expected
to commence in Q1 2022.
› Early-stage assets:
• INDV – 1000 (w/ADDEX Therapeutics Ltd) lead
optimization of GABA-B positive allosteric modulator
for Alcohol Use Disorder led to advancement of the
ongoing characterization of two lead molecules.
• INDV – 2000 (w/ C4X Discovery) – completed Phase 1
of a Non-Opioid, Highly-Selective Orexin-1 Receptor
Antagonist single ascending dose (SAD) study and
pursued drug substance and drug product
development work.
› $1.1 billion of cash at the end of FY 2021
(net cash of $853 million).
› Completed term loan replacement providing the Group
greater flexibility by extending the maturity (June 2026)
and removing the leverage covenant.
› Completed $100 million share repurchase program;
33.8 million shares were repurchased at an average
weighted price of 219p.
› Completed sale of TEMGESIC/ BUPREX/ BUPREXX
(buprenorphine) analgesic business for approximately
$21 million of cash.
1. Rolling 12-month patients estimate using both Specialty Pharmacy and
Specialty Distributor proxy data.
Indivior | Annual Report and Accounts 2021
15
STRATEGIC REPORTWe work to help change lives
Like many people who grow up with a family member
who exhibits the symptoms of a serious mental illness,
Alicia did not know just what to make of her brother’s
behavior when she was younger. It took a while
for Alicia, her parents and three other siblings
to realize her brother’s symptoms of delusions
and hallucinations were common for someone
suffering from schizophrenia.
He was not accurately diagnosed with this mental
illness until he was 22 years old.
“Many people are stigmatized by this brain disorder,
and many people with schizophrenia are untreated
for their illness,” Alicia says. “My brother’s situation
really opened our family’s eyes to how challenging
it is to be properly diagnosed and treated for
schizophrenia. It was very hard on our family,
but even more difficult for my brother.”
Alicia said her brother has been in countless mental
health facilities and approximately eight different
group homes during the past 10 years. He has engaged
with many social workers and healthcare providers
specializing in mental illness.
When Alicia joined Indivior in 2019, she realized
it was an opportunity to not only help healthcare
providers learn more about Indivior’s treatment
option for schizophrenia in adults in the US, but
be in a stronger position to advocate for her brother.
Alicia is proud to work for Indivior where she can
support efforts to help remove the stigma associated
with serious mental illness and help provide access
to treatment options for those suffering from
schizophrenia. Schizophrenia is a chronic brain
disorder and Alicia hopes one day her brother,
with the right treatment plan, will experience
a fulfilling and purpose-driven life.
O U R P U R P O S E I N A C T I O N
IMAGINE
…removing the stigma of addiction
and serious mental illnesses
WE DO.
Our teams work tirelessly to support
the patient journey to treatment,
enable access to effective treatment,
and provide new scientific
understanding and knowledge
to the treatment community.
24 million people
diagnosed with schizophrenia globally
Source: World Health Organization:
Schizophrenia Fact Sheet. January 2022
16
indivior.com
My brother’s situation really
opened our family’s eyes to
how challenging it is to be
properly diagnosed and
treated for schizophrenia.
Alicia
Senior Clinical Specialist,
Commercial
Indivior | Annual Report and Accounts 2021
17
STRATEGIC REPORT
C H I E F S C I E N T I F I C O F F I C E R ’S R E V I E W
Christian Heidbreder
Chief Scientific Officer
OUR RESPONSE TO
THE OPIOID CRISIS:
NEW EVIDENCE
GENERATION
In 2021, our Research & Development
(R&D) organization supported
SUBLOCADE for the treatment of opioid
use disorder (OUD) through a broad
range of lifecycle management studies.
For example, a new US label update
was approved by the FDA based on the
outcome of an open-label, cross-over
study showing that treatment-relevant
plasma concentrations of buprenorphine
significantly decreased respiratory
depression and resultant apnea
(cessation of breathing) induced
by escalating doses of fentanyl.
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We further pursued our collaboration with Virginia
Polytechnic Institute and State University to extend
our Remission from Chronic Opioid Use-Studying
Environmental and Socio-Economic Factors on
Recovery (RECOVER® long-term study) to provide a
multidimensional (e.g., substance use, psychosocial
and physiological outcomes, temporal reward
preference) understanding of recovery from OUD
at an average of 4.2 years post-participation in
SUBLOCADE pivotal Phase 3 clinical trial. A pilot
proof-of-concept study supported by our Externally
Sponsored Studies (ESS) Program also showed that
SUBLOCADE treatment was acceptable to most
criminal justice-involved adult participants with OUD,
making it a feasible option in the setting of a large
jail opioid treatment program.1 Another pilot study
evaluating the effectiveness of SUBLOCADE in
Veterans Health Administration (VHA) facilities
for complex treatment-resistant patients with
high mortality risk showed that retention with
SUBLOCADE treatment was associated with a
reduction in emergency department (ED) visits,
days of hospitalization, non-prescribed opioid use,
and homelessness.2
Regulatory approval of SUBLOCADE outside of the
US has now been granted in 10 countries: Canada,
Australia, New Zealand, Israel, Sweden, Finland,
Denmark, Norway, Germany, and Italy.
In Canada, Alberta’s government announced that
it is the first province to fully cover the cost of
SUBLOCADE3. In Australia, an open-label real-world
community-based services study4 led by researchers
at the National Drug and Alcohol Research Centre
(NDARC) showed that SUBLOCADE treatment led to
declines in heroin use, non-prescribed opioid use,
and injecting drug use. Improvements in quality of
life, participation in employment, and treatment
satisfaction measures were also observed.
A pilot proof-of-concept study
supported by our Externally
Sponsored Studies (ESS) Program
also showed that SUBLOCADE
treatment was acceptable to most
criminal justice-involved adult
participants with OUD.
Expanding into the under-treated
cannabis-related disorders
The United Nations recently estimated that roughly 200 million
people had used cannabis in 2019, which represents 4% of the
global population.8 The number of cannabis users globally has
increased by nearly 18% over the past decade.9 In the US alone,
there were nearly 50 million past-year cannabis users among
people aged 12 or older in 2020.10 Numerous studies have
shown that there is a short- and long-term cerebral toxicity
of cannabis, marked mainly by cognitive, addictive and
psychotomimetic effects linked to the duration, frequency,
dose, and age at onset of cannabis use.11
We expanded pipeline toward Cannabis Use Disorder (CUD)
by entering into a strategic collaboration with Aelis Farma,
a public biotechnology company based in Bordeaux, France.
The collaboration includes an exclusive option and license
agreement for the global rights to AEF0117, Aelis’ first-in-class
synthetic Signaling Specific inhibitor (SSi) engineered to inhibit
the cannabinoid type 1 (CB1) receptor (CB1-SSi). In clinical
Phase 1 and Phase 2A studies, AEF0117 showed promising safety,
tolerability, and efficacy signals in subjects with CUD. A Phase
2B proof-of-concept study protocol that will be coordinated
by Prof. Frances Levin at Columbia University is planned
to start at the end of Q1-2022.
We geographically expanded our SUBOXONE film franchise
by securing regulatory approvals in Canada, Israel, all EU
Member States (+ UK, Iceland, Norway,
and Liechtenstein), New Zealand, Qatar and United
Arab Emirates. The review is ongoing in Kuwait,
and the Kingdom of Saudi Arabia.
With the support of an NIH grant entitled Clinical
Evaluation of C4X3256, a Non-Opioid, Highly Selective
Orexin-1 Receptor Antagonist for the Treatment of Opioid
Use Disorder we completed our Phase 1 INDV-2000-101
single ascending dose (SAD) study and pursued drug
substance and drug product development work. Finally,
our collaboration with Addex Therapeutics for the lead
optimization of INDV-1000 (GABA-B positive allosteric
modulator (PAM) for Alcohol Use Disorder (AUD) led to
major achievements with the ongoing characterization
of two lead molecules.
Indivior | Annual Report and Accounts 2021
19
STRATEGIC REPORT
C H I E F S C I E N T I F I C O F F I C E R ’S R E V I E W C O N T I N U E D
Imagining a better future for patients
According to the United Nations,6 approximately 275
million people globally have used drugs in the past year.
The burden of disease caused by drug use continues to
increase. In the United States in 2019, 18 million years of
healthy life were lost due to substance use disorder (SUD),
and opioid use disorder (OUD) accounted for 70%
of the total.6 Unfortunately, the COVID-19 pandemic has
intensified substance misuse: the decrease in health
services, limited access to medical care and increased
access to highly potent synthetic opioids such as fentanyl
and illicit fentanyl analogs have been complemented
by an increased supply of methamphetamine, resulting
in more than 100,000 drug overdose deaths in the
United States.7
The unprecedented magnitude and dynamic nature
of the global SUD crisis worsened by the COVID-19
pandemic requires evidence that comprehensive
treatment strategies lead to better outcomes that
ultimately offset medical costs associated with SUD,
and costs of incarceration, shelter, and welfare when
these burdensome conditions are untreated. In 2021,
our science was disseminated through 15 peer-reviewed
publications and 37 conference presentations around
the globe to further characterize the process of recovery,
identify factors that promote or hinder treatment success,
and develop new treatment strategies for SUD.
The burden of disease
caused by drug use
continues to increase.
1. Lee JD et al. (2021) Comparison of treatment retention of adults with opioid addiction managed with extended-release buprenorphine vs daily sublingual
buprenorphine-naloxone at time of release from jail. JAMA Netw Open, 4(9):e2123032. https://doi.org/10.1001/jamanetworkopen.2021.23032
2. Cotton AJ et al. (2021) Extended-release buprenorphine outcomes among treatment resistant veterans, Am J Drug Alcohol Abuse, 1-4,
https://doi.org/10.1080/00952990.2021.1992773
3. https://www.alberta.ca/release.cfm?xID=80578125DD79B-F2C1-83AF-C359561FDF962FFE
4. Farrell M et al. (2022) Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with
opioid dependence. Int J Drug Policy, 100: 103492. https://doi.org/10.1016/j.drugpo.2021.103492
5. Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States:
Results from the 2020 National Survey on Drug Use and Health (HHS Publication No. PEP21-07-01-003, NSDUH Series H-56).
Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.
6. World Drug Report 2021 (United Nations publication, Sales No. E.21.XI.8)
7. Centers for Disease Control and Prevention. Vital Statistics Rapid Release: Provisional Drug Overdose Data. Updated 2/6/2022
8. Global Overview: Drug Demand Drug Supply, World Drug Report, 2021, United Nations Office on Drugs and Crime.
Retrieved from: https://www.unodc.org/res/wdr2021/field/WDR21_Booklet_2.pd
9. https://news.un.org/en/story/2021/06/1094672
10. Substance Abuse and Mental Health Services Administration. (2021). Key substance use and mental health indicators in the United States:
Results from the 2020 National Survey on Drug Use and Health. Pg 2, column 1 (49.6, "nearly 50 million"); Pg 29, column 2 (14.2 million)
11. https://www.who.int/substance_abuse/publications/msbcannabis.pdf
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OUR PIPELINE AND MARKETED PRODUCTS
Compound Name
Preclinical
Phase 1
Phase 2
Phase 3
Regulatory Approval
or Review
Treatment for Substance Use Disorder
INDV-10001 – GABA-B Positive Allosteric Modulator
Treatment for Substance Use Disorder
INDV-20002 – Selective Orexin-1 Receptor Antagonist
Treatment for Cannabis Use Disorder
AEF01173 – Synthetic Signaling Specific inhibitor (SSi) of the
Cannabinoid Type 1 (CB1) Receptor
Treatment for Opioid Use Disorder
RBP-6000 – Buprenorphine XR Injection for Subcutaneous Use
Treatment for Schizophrenia
RBP-70004 – Risperidone XR Injection for Subcutaneous Use
Treatment for Opioid Use Disorder
Buprenorphine/Naloxone Sublingual Film
Treatment for Opioid Use Disorder
Buprenorphine/Naloxone Sublingual Tablet
Treatment for Opioid Use Disorder
Buprenorphine Sublingual Tablet
1 Partnership with Addex Therapeutics
1. Partnership with Addex Therapeutics
2 Partnership with C4X Discovery Holdings
2. Partnership with C4X Discovery Holdings
2 Partnership with Aelis Farma
3. Partnership with Aelis Farma
3 Partnership with HLS in Canada
4. Partnership with HLS Therapeutics in Canada
Indivior | Annual Report and Accounts 2021
21
STRATEGIC REPORTB U S I N E S S M O D E L
INSPIRING PATIENT
TRANSFORMATION
Our people, culture, expertise and insight, coupled with our innovative science
and stakeholder relationships, uniquely position us to help address patients’
unmet needs around the world.
How we generate value
The Group has been able to help address the global addiction crisis
through the development and commercialization of buprenorphine
medication-assisted treatments. By leveraging our capabilities,
we are also now serving adult patients with schizophrenia which
is a well-aligned adjacency for our business.
Advocacy
1
Stakeholder
engagement
Strong and enduring
relationships with key
stakeholders
Patient
needs
5
Sales and
marketing
Carefully managed
compliance and
adherence to
good practice
2
Research and
development
World-class
treatment
innovation
4
Maintaining and
developing value
treatments
Protecting IP and
developing IP value
3
Manufacturing
Producer of high-
quality medicines
Guiding Principles an d c o r e v
s
e
u
a l
Advocacy
Indivior advocates to increase global understanding and awareness,
destigmatize the disease and expand treatment access.
Meeting patient needs
Leveraging its deep understanding of patient needs, Indivior is committed
to addressing the global addiction crisis by expanding the availability of
its patient-focused treatments, including treatment access, while also
leveraging its scientific expertise to develop novel treatments.
Our assets
Highly skilled and
knowledgeable people
Indivior has an able workforce
and management team with a deep
understanding of patient needs
and a strong commitment to
improving patient lives.
Culture
Based on a clearly defined set
of Guiding Principles, Indivior’s
culture is a key competitive advantage
enabling Indivior to drive strategic
business growth and create social value.
Product portfolio
Indivior’s product portfolio is focused
on helping meet adult patient needs
in addiction and schizophrenia.
Intellectual property
Indivior has a unique portfolio
of licenses and patents which
provide a platform for the
creation of long-term value.
Financial capital
Indivior employs disciplined
asset allocation with a focus
on retaining a robust capital base
to ensure flexibility in addressing
legal matters, agility in managing
unknown market impacts, and
the ability to pursue identified
growth opportunities.
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indivior.com
Advocacy
1
4
Maintaining and
developing the value
of our treatments
Indivior has three main products. Two of these
are opioid addiction treatments: SUBLOCADE,
a buprenorphine extended-release injection
for subcutaneous use (CIII), and SUBOXONE,
a buprenorphine and naloxone sublingual film (CIII).
Indivior’s third treatment, PERSERIS (risperidone),
addresses schizophrenia and is for extended-release
injectable suspension. Indivior maintains the value of
these treatments by protecting its intellectual property
(IP) and developing IP value by obtaining further
international licenses outside North America.
Stakeholder engagement
For more than 20 years, we have worked and engaged
with policymakers, medical societies, patient advocacy
groups, healthcare providers, payers and other
stakeholders. These relationships provide Indivior
with critical insights to develop and enhance its
patient-focused business approach.
2
Research and development
Our aim is to advance treatment innovation
by developing new patient-focused treatments,
including enabling the Group to expand the scope
of treatment it provides to help address addiction
and the co-occurring disorders of addiction.
3
5
Manufacturing
Sales and marketing
Our aim is to improve the lives of patients through
an uninterrupted supply of high-quality products.
Our aim is to deliver high-quality products and accurate
information, and maintain strong and credible
relationships with customers and key stakeholders.
Indivior | Annual Report and Accounts 2021
23
STRATEGIC REPORT
S T A K E H O L D E R E N G A G E M E N T
HOW WE ENGAGE WITH
OUR STAKEHOLDERS
Regular engagement with our
stakeholders is fundamental
to developing and maintaining a
robust, sustainable, and successful
business model. Understanding the
views and focus areas of our
stakeholders helps inform our
decisions and drive progress
toward realizing Indivior’s
purpose, vision, and values.
Other relevant information can be found on
the Company’s website (www.indivior.com).
The following table summarizes Indivior’s
key stakeholders and their areas of interest.
It outlines how Indivior engages with each
group and includes illustrative highlights
of engagement activities during 2021.
Indivior regularly reviews its understanding
of each stakeholder group, their focus areas,
and the team’s efforts to identify further
opportunities to strengthen and learn
from these relationships.
Indivior employs experienced and qualified
individuals to conduct its stakeholder
engagement activities. These employees include
members of the governance, investor relations,
government, and communications teams,
supported by external advisors.
Further information
Other relevant information can
be found on the Group’s website
www.indivior.com
24
indivior.com
Treatment advocacy with
government, healthcare
professionals and
community stakeholders
Indivior advocates on public
policy issues that relate to opioid
use disorder (“OUD”) by engaging
responsibly with public officials,
policymakers and other
stakeholders at all levels of
government and with healthcare
professionals and community
stakeholders. In the US, Indivior’s
public policy priorities are focused
on expanding treatment access,
reducing barriers and promoting
equitable access to medication for
opioid use disorder (“MOUD”).
Addressing access
to treatment within the
New York State criminal
justice system
The US National Institute on
Drug Abuse (“NIDA”) estimates
that around 65% of the population
within the criminal justice system
have a substance use disorder
(“SUD”). However, only 5% of those
who need treatment actually receive
it. Until recently MOUD for persons
with OUD was generally unavailable
in criminal justice facilities.
Addressing the opioid crisis in the
United States means addressing
issues in criminal justice.
Indivior engaged its advocacy
team in New York, to join patient
and healthcare professional
organizational allies in support
of legislation mandating treatment
of OUD within the New York State
and local correctional institutions.
Following nearly a decade of
debate, in 2021 members of the
New York State legislature passed,
and the Governor signed legislation
mandating state prisons and
local jails to provide MOUD to all
incarcerated individuals suffering
from OUD. Treatment was required
to be consistent with the most
current professional and medical
standards, using individualized
This legislation
furthers an equitable
and comprehensive
public health approach
to ensuring individuals
have access to the care
they need, when they
need it, to aid in their
recovery journey while
incarcerated and upon
re-entry into the
community.
Mark Crossley
Chief Executive Officer
treatment plans and the
FDA-approved medication
the correctional healthcare
professional and patient
agree is best.
The legislation, the most extensive
of its kind in the country, also
required New York State to develop
and implement programs to
transition persons receiving
treatment for OUD in the
correctional system into the
community safely. Evidence shows
that in the first weeks and months
of release, individuals are 10 to 40
times more likely to die
of an opioid overdose than the
general population.
“This legislation furthers an
equitable and comprehensive
public health approach to ensuring
individuals have access to the care
they need, when they need it,
to aid in their recovery journey
while incarcerated and upon
re-entry into the community,”
Mark Crossley, Chief Executive Officer.
Family physicians
throughout the US
reported that there
was a “gap” in what
they need to know
to care for patients
with OUD.
AAFP resource
“Navigating Addiction and
Treatment: A Guide for Families”
is a resource for family members
who are navigating the complex
world of OUD. It was created by
the Addiction Policy Forum staff,
with support from Indivior, in
conjunction with an Expert Review
Panel composed of prominent
researchers and physicians
in the addiction field.
The publication is free of charge
to families throughout the US.
SECTION 172(1) STATEMENT
Section 172 of the Companies Act 2006 requires
each Director of the Company to act in the way
he or she considers, in good faith, would most
likely promote the success of the Company for
the benefit of its members as a whole. In this
way, Section 172 requires a Director to have
regard, among other matters, to the:
› likely consequences of any decisions
in the long term;
› interests of the Company’s employees;
› need to foster the Company’s business
relationships with suppliers, customers,
and others;
› impact of the Company’s operations on local
communities and the environment;
› desirability of the Company maintaining
a reputation for high standards of business
conduct; and the
› need to act fairly between members
of the Company.
In discharging its section 172 duties,
the Board has regularly considered the
factors set out above and the views of key
stakeholders. The Board acknowledges that
some decisions will not necessarily result
in a positive outcome for all our stakeholders.
However, by considering the Company’s
Purpose, Mission, Vision, and Values and
commitment to responsible business, together
with its Strategic Priorities and having a process
in place for decision-making, the Board aims
to ensure that its decisions are in the best
interests of the Company.
Further information regarding the principal
activities and decisions taken by the Board
during the year can be found in the section
entitled "Principal Board decisions" on
pages 68 to 70.
Provision of resources
to support the delivery
of OUD patient care
Information for medical
practitioners
The vision of the American
Academy of Family Physicians
(AAFP) is to transform health
care to achieve optimal health
for everyone. Their mission is
to improve the health of patients,
families, and communities
by serving their needs with
professionalism and creativity.
Family physicians throughout
the US reported that there
was a “gap” in what they need to
know to care for patients with OUD.
AAFP proposed a practice manual
tailored to the family physician
and Indivior was pleased to
support this initiative through
a grant. “Treating Opioid Use
Disorder as a Chronic Relapsing
Condition: A Practice Manual for
Family Physicians” was published
in February 2021.
Fourteen weeks after the manual
was issued on the AAFP website,
the Academy surveyed family
physicians who had accessed it.
When asked if they had used the
information in the manual
to screen for OUD, 50% responded
“Yes.” Of those who responded
“Yes,” 50% responded that they had
used the manual “Often”
for treating patients with OUD.
Information for patients,
caregivers and families
Indivior’s support for the
AAFP project was preceded
by the financial support the
company provided to the US
Addiction Policy Forum in 2020
to produce a guide about
addiction treatment for patients,
caregivers, and families.
Indivior | Annual Report and Accounts 2021
25
STRATEGIC REPORT
S T A K E H O L D E R E N G A G E M E N T
C O N T I N U E D
OUR STAKEHOLDER
ENGAGEMENT
Patients and
Healthcare Providers (HCPs)
Workforce
Current & Potential
Shareholders
Debt Holders
Patient needs and the informational requirements of HCPs
are fundamental to the success of the business
Indivior has an experienced, passionate, and dedicated
workforce, who are committed to the Group’s vision and purpose
Current and potential shareholders have an interest in the
Access to capital is essential to maintaining a robust
performance and long-term prospects of the business
capital base and financial flexibility
What matters to them
› Access to treatment
› Product safety, quality, and efficacy
› Accurate and up-to-date information about the Group’s products
What matters to them
› A shared commitment to our vision and patients
› A diverse and inclusive workplace featuring flexibility, responsible
business practice, and clear communication channels
What matters to them
› Effective value-adding strategy and business model
› Financial and share price performance
What matters to them
› Financial stewardship and performance
› Compliance with debt agreement covenants
› Prudent cash management and effective risk management
› Risk management effectiveness
› Governance, quality of leadership, and transparency
› Governance and oversight
› Corporate responsibility performance
Why they matter to us
›
Indivior’s vision is that all patients around the world have
access to evidence-based treatment for the chronic conditions
and co-occurring disorders of addiction
Indivior is committed to pioneering innovative and accessible
treatments for addiction and its co-occurring disorders
›
Why they matter to us
›
Indivior wishes to ensure that its workforce shares the common
purpose of realizing Indivior’s vision and embraces its culture,
both of which are critical to its success
Indivior believes that a diverse and inclusive workplace enables
innovation and continuous improvement of quality
›
Why they matter to us
Why they matter to us
› The Board has fiduciary responsibilities to promote the long-term
› Continued access to capital is vital to the long-term performance
sustainable success of the Company
of the business, providing financial flexibility and liquidity
› Regular dialog and feedback between shareholders
› The investment community should fully understand Indivior’s
strategy, performance, earnings potential, and capital
allocation priorities
and the management team
› The investment community should fully understand
Indivior’s strategy, performance, earnings potential,
and capital allocation priorities
How we engage
› Responsible and compliant sales and marketing activities
› Supporting regulatory and legislative developments intended
to improve treatment access for patients and allow HCPs
to care for more patients when they decide to seek help
› Regular dialog with representative patient groups
› Regular advocacy activity
How we engage
› Annual Culture Surveys
› Regular "Town Hall" events hosted by senior management
› Dedicated Culture and Inclusion Champions Network
› Personal Development Reviews
› Regular training and development activity
› Engagement events with the Board
› Redesigned intranet
How we engage
How we engage
› Dedicated investor relations function
› Dedicated investor relations function
› Refreshed corporate website, including a distinct investor section
› Refreshed corporate website, including a distinct investor section
› Results presentations and regular engagement with
› Results presentations and regular engagement with debt holders
major shareholders
› Participation in healthcare sector investor conferences
› Development of ESG strategy
› Frequent analyst consultations
2021 highlights
› Publication of Indivior-sponsored studies to advance the
scientific understanding of addiction and the Group’s products
2021 highlights
› Regular "Town Hall" events hosted by senior management
› Redesigned Intranet, featuring internal and external news
and feature content
› Workforce engagement event between the designated
Non-Executive Director and Culture Inclusion Champions
› Diversity and inclusion training sessions for senior
management held to accelerate development
2021 highlights
› Regular dialog between senior management and Company’s
major shareholders and analysts
› Quarterly public financial reporting and results presentations
with the investment community
› Regular attendance at healthcare investor conferences
2021 highlights
› Quarterly financial reporting
› Maintenance of debt ratings
See pages 8 & 16
See pages 32 to 34
See pages 10 to 14
See pages 47 to 56
These pages feature patient and employee stories
This section provides further information about
Indivior’s workforce
The Chief Executive Officer’s review discusses the Group’s
The risk management section outlines Indivior’s approach
performance in 2021 and Indivior’s Strategic Priorities
to managing its principal risks
26
indivior.com
Patients and
Workforce
Healthcare Providers (HCPs)
Current & Potential
Shareholders
Debt Holders
Patient needs and the informational requirements of HCPs
Indivior has an experienced, passionate, and dedicated
are fundamental to the success of the business
workforce, who are committed to the Group’s vision and purpose
Current and potential shareholders have an interest in the
performance and long-term prospects of the business
Access to capital is essential to maintaining a robust
capital base and financial flexibility
What matters to them
› Access to treatment
› Product safety, quality, and efficacy
What matters to them
› A shared commitment to our vision and patients
› A diverse and inclusive workplace featuring flexibility, responsible
› Accurate and up-to-date information about the Group’s products
business practice, and clear communication channels
What matters to them
› Effective value-adding strategy and business model
› Financial and share price performance
› Prudent cash management and effective risk management
› Governance, quality of leadership, and transparency
› Corporate responsibility performance
What matters to them
› Financial stewardship and performance
› Compliance with debt agreement covenants
› Risk management effectiveness
› Governance and oversight
Why they matter to us
Why they matter to us
›
Indivior’s vision is that all patients around the world have
›
Indivior wishes to ensure that its workforce shares the common
access to evidence-based treatment for the chronic conditions
purpose of realizing Indivior’s vision and embraces its culture,
and co-occurring disorders of addiction
both of which are critical to its success
›
Indivior is committed to pioneering innovative and accessible
›
Indivior believes that a diverse and inclusive workplace enables
treatments for addiction and its co-occurring disorders
innovation and continuous improvement of quality
Why they matter to us
› The Board has fiduciary responsibilities to promote the long-term
Why they matter to us
› Continued access to capital is vital to the long-term performance
sustainable success of the Company
› Regular dialog and feedback between shareholders
and the management team
› The investment community should fully understand
Indivior’s strategy, performance, earnings potential,
and capital allocation priorities
of the business, providing financial flexibility and liquidity
› The investment community should fully understand Indivior’s
strategy, performance, earnings potential, and capital
allocation priorities
How we engage
How we engage
› Responsible and compliant sales and marketing activities
› Annual Culture Surveys
› Supporting regulatory and legislative developments intended
› Regular "Town Hall" events hosted by senior management
to improve treatment access for patients and allow HCPs
› Dedicated Culture and Inclusion Champions Network
to care for more patients when they decide to seek help
› Personal Development Reviews
› Regular dialog with representative patient groups
› Regular advocacy activity
› Regular training and development activity
› Engagement events with the Board
› Redesigned intranet
How we engage
› Dedicated investor relations function
› Refreshed corporate website, including a distinct investor section
› Results presentations and regular engagement with
How we engage
› Dedicated investor relations function
› Refreshed corporate website, including a distinct investor section
› Results presentations and regular engagement with debt holders
major shareholders
› Participation in healthcare sector investor conferences
› Development of ESG strategy
› Frequent analyst consultations
2021 highlights
2021 highlights
› Publication of Indivior-sponsored studies to advance the
› Regular "Town Hall" events hosted by senior management
scientific understanding of addiction and the Group’s products
› Redesigned Intranet, featuring internal and external news
and feature content
› Workforce engagement event between the designated
Non-Executive Director and Culture Inclusion Champions
› Diversity and inclusion training sessions for senior
management held to accelerate development
2021 highlights
› Regular dialog between senior management and Company’s
major shareholders and analysts
› Quarterly public financial reporting and results presentations
with the investment community
› Regular attendance at healthcare investor conferences
2021 highlights
› Quarterly financial reporting
› Maintenance of debt ratings
See pages 8 & 16
These pages feature patient and employee stories
This section provides further information about
See pages 32 to 34
Indivior’s workforce
See pages 10 to 14
See pages 47 to 56
The Chief Executive Officer’s review discusses the Group’s
performance in 2021 and Indivior’s Strategic Priorities
The risk management section outlines Indivior’s approach
to managing its principal risks
Indivior | Annual Report and Accounts 2021
27
STRATEGIC REPORTS T A K E H O L D E R E N G A G E M E N T
C O N T I N U E D
Suppliers
and Distributors
Communities
Governing Bodies, Regulators,
Media
and Professional Advisors
Indivior’s supply chain is critical to the effective and continuous
conduct of Indivior’s day-to-day business activities
By working with community groups, including charities
and patient advocacy groups, Indivior can amplify the need
to address the addiction crisis and bring together patient
support groups and networks
Indivior’s supply chain requirements and terms of business
What matters to them
›
› Contractual terms and payment timings
›
Indivior’s future development plans
› Tender process details
What matters to them
›
›
Indivior’s approach to the global addiction crisis
Indivior’s support for and work with patient advocacy groups,
medical societies, NGOs, and charities that address people
who are affected by addiction
Why they matter to us
› Maintenance of product quality is essential
› Ensuring that Indivior’s activities are supported
by a reliable and effective supply chain
Why they matter to us
›
Indivior supports groups and charities that offer assistance
to patients and families affected by addiction
Indivior activities should not cause nuisance, pollution,
or disruption
›
› A key business goal is to increase the scientific understanding
of the disease space and our Vision that evidence-based
treatments are available within wider stakeholder groups
Indivior supply chain requirements, terms of business and audits
How we engage
›
› Contractual terms and payment timings
›
Indivior’s future development goals
› Tender process details
› Communications and interactions with the relevant Indivior staff
How we engage
›
›
Indivior’s approach to the global addiction crisis
Indivior’s support for patient advocacy groups, medical societies,
NGOs, and charities that address the needs of people affected
by addiction
How we engage
regulatory matters
› Regular reporting and communications about governance and
› Accurate and timely news and information about
› Regular engagement with governments and regulators
› Dedicated points of contact for further information
› Supply of information about internal communications and training
and clarification
about compliance and regulatory matters
How we engage
Indivior’s activities
2021 highlights
› Key suppliers are regularly considered as part of the ongoing
assessment of business continuity risks
› Publication of the Supplier Code of Conduct
2021 highlights
› Ongoing cooperation with patient advocacy organizations
and medical bodies to provide education on OUD and
treatment options
› Continuation of the Indivior Volunteer Policy, which
enables employees to take paid time off to engage
in volunteering activities
2021 highlights
2021 highlights
› The Group believes that all requirements specified in the three
› Timely and regular news releases from the Group regarding
separate agreements have been met, including the filing of all
all material aspects of its activities during the year
scheduled and ad hoc reports and notifications.
› Publication of the Supplier Code of Conduct
› Redesign of the Indivior.com website
See www.indivior.com
See pages 24 and 31
See page 35
See Indivior’s website (www.indivior.com)
The Supplier Code of Conduct is available to view
on the Group’s website
Page 24 and page 31 set out further information regarding
Indivior’s approach to advocacy
Page 35 sets out further information regarding business
The redesigned website, launched in Q3 2021, includes
conduct and compliance with the 2020 Resolution Agreement
a dedicated media section
28
indivior.com
Indivior works with governing bodies, regulators, and
Stakeholders require up-to-date, timely, complete,
professional advisors to enable it to operate within the
and accurate information about Indivior
appropriate regulatory and legal requirements
What matters to them
to patients
What matters to them
Indivior’s activities
› Maintaining the required quality of treatments delivered
› Accurate and timely news and information about
› Conducting all marketing and distribution activities responsibly
› Points of contact for further information and clarification
and within applicable laws and regulations
› Ensuring that Indivior’s wider activities are conducted
within the law and applicable regulations
Why they matter to us
Why they matter to us
› Maintaining the Group’s license to operate
› Key stakeholder relationships are maintained through accurate
›
Indivior understands its obligations under laws and regulations
and up-to-date news and information in the media
Suppliers
and Distributors
Communities
Governing Bodies, Regulators,
and Professional Advisors
Media
Indivior’s supply chain is critical to the effective and continuous
By working with community groups, including charities
conduct of Indivior’s day-to-day business activities
and patient advocacy groups, Indivior can amplify the need
to address the addiction crisis and bring together patient
support groups and networks
What matters to them
What matters to them
›
Indivior’s supply chain requirements and terms of business
Indivior’s approach to the global addiction crisis
› Contractual terms and payment timings
›
Indivior’s future development plans
› Tender process details
Indivior’s support for and work with patient advocacy groups,
medical societies, NGOs, and charities that address people
who are affected by addiction
Why they matter to us
› Maintenance of product quality is essential
› Ensuring that Indivior’s activities are supported
by a reliable and effective supply chain
Why they matter to us
›
Indivior supports groups and charities that offer assistance
to patients and families affected by addiction
›
Indivior activities should not cause nuisance, pollution,
or disruption
› A key business goal is to increase the scientific understanding
of the disease space and our Vision that evidence-based
treatments are available within wider stakeholder groups
›
›
›
›
Indivior works with governing bodies, regulators, and
professional advisors to enable it to operate within the
appropriate regulatory and legal requirements
Stakeholders require up-to-date, timely, complete,
and accurate information about Indivior
What matters to them
› Maintaining the required quality of treatments delivered
What matters to them
› Accurate and timely news and information about
to patients
Indivior’s activities
› Conducting all marketing and distribution activities responsibly
› Points of contact for further information and clarification
and within applicable laws and regulations
› Ensuring that Indivior’s wider activities are conducted
within the law and applicable regulations
Why they matter to us
› Maintaining the Group’s license to operate
›
Indivior understands its obligations under laws and regulations
Why they matter to us
› Key stakeholder relationships are maintained through accurate
and up-to-date news and information in the media
How we engage
How we engage
›
Indivior supply chain requirements, terms of business and audits
Indivior’s approach to the global addiction crisis
› Contractual terms and payment timings
›
Indivior’s future development goals
› Tender process details
› Communications and interactions with the relevant Indivior staff
Indivior’s support for patient advocacy groups, medical societies,
NGOs, and charities that address the needs of people affected
by addiction
How we engage
› Regular reporting and communications about governance and
How we engage
› Accurate and timely news and information about
regulatory matters
› Regular engagement with governments and regulators
› Supply of information about internal communications and training
about compliance and regulatory matters
Indivior’s activities
› Dedicated points of contact for further information
and clarification
2021 highlights
2021 highlights
› Key suppliers are regularly considered as part of the ongoing
› Ongoing cooperation with patient advocacy organizations
assessment of business continuity risks
› Publication of the Supplier Code of Conduct
and medical bodies to provide education on OUD and
treatment options
› Continuation of the Indivior Volunteer Policy, which
enables employees to take paid time off to engage
in volunteering activities
2021 highlights
› The Group believes that all requirements specified in the three
separate agreements have been met, including the filing of all
scheduled and ad hoc reports and notifications.
› Publication of the Supplier Code of Conduct
2021 highlights
› Timely and regular news releases from the Group regarding
all material aspects of its activities during the year
› Redesign of the Indivior.com website
See www.indivior.com
See pages 24 and 31
See page 35
See Indivior’s website (www.indivior.com)
The Supplier Code of Conduct is available to view
Page 24 and page 31 set out further information regarding
on the Group’s website
Indivior’s approach to advocacy
Page 35 sets out further information regarding business
conduct and compliance with the 2020 Resolution Agreement
The redesigned website, launched in Q3 2021, includes
a dedicated media section
Indivior | Annual Report and Accounts 2021
29
STRATEGIC REPORTR E S P O N S I B I L I T Y
EMBRACING INDIVIOR’S
BUSINESS RESPONSIBILITIES
Steps to enhance Indivior’s ESG approach
Indivior’s management team recognizes the increasing
stakeholder interest in its responsible business
(or “ESG”) approach and performance. Several
steps have been taken and are planned in 2022 to
transparently evidence and formalize this aspect
of Indivior’s business. The Group has also commenced
or undertaken projects as part of its ongoing efforts
to address ESG matters. These include:
› The establishment of an ESG Committee. The first
meeting took place in January 2022. The Committee
comprises all of the members of the Executive
Committee and is Chaired by the Chief
Manufacturing and Supply Officer. The Committee
will meet quarterly and is responsible for:
› developing, implementing and monitoring
Indivior’s strategy on key Environmental,
Social and Governance (ESG) matters;
› setting appropriate targets related to the Group’s
ESG strategy and monitoring performance against
those targets; and
› reporting on the implementation and making
recommendations in respect of the Group’s ESG
strategy to the Board of Directors.
› The ESG Committee is supported by an ESG strategy
team made up of members of the workforce drawn
from different parts of the business, supported
by external advisors. The team is led by a full-time
ESG specialist who joined Indivior in the second
half of 2021.
› Indivior intends to publish its first climate change
statement and an environmental policy on its
corporate website in 2022.
› Indivior plans to introduce quarterly emissions
reporting internally in 2022 and, as part of this
process, is intending to expand the range of its
Scope 3 reporting.
› The launch of a redesigned corporate website
(www.indivior.com) in Q4 2021, which includes
a significantly expanded responsibility section
and enhanced opportunities for stakeholders
to understand Indivior’s activities.
› The Remuneration Committee has considered the
inclusion of ESG metrics in the Group’s annual and
long-term incentive plans and has committed to
including ESG metrics in the Group’s annual and/or
long-term incentive plans in 2023.
Indivior’s culture is shaped by its
Guiding Principles, which underpin our
decision-making processes and provide
a blueprint for all of Indivior’s activities.
This framework has also shaped Indivior’s
culture by driving its commitment to
remove the stigma of addiction and shift
its treatment into the delivery of
mainstream medicine.
See Indivior’s Business Model
on pages 22 to 23.
Indivior addresses this aspect of its business
by focusing on:
› Stakeholder engagement and advocacy
› Environment and climate change
› Patient safety and product quality
› Workforce matters
› Business conduct including its management
of integrity and compliance matters
Indivior’s recently redesigned corporate
website includes an expanded responsibility
section (www.indivior.com/responsibility)
30
indivior.com
Stakeholder engagement and advocacy
Environment and climate change
Investment community
Indivior recognizes the increasing interest in ESG
matters which is emanating from the investment
community and other key stakeholders. This has
included individual investors, specialist ESG research
agencies and investor research exercises that focus
on specific areas such as climate change.
Indivior’s Investor Relations and ESG teams continued
to respond to a variety of ESG information requests
during 2021 and the Group has continued to
participate in specific initiatives, such as CDP, which
addresses climate-change matters.
Indivior is also developing its reporting and disclosure
in line with the increasing requirements of the
regulators. This report includes a new section which
discloses information in line with the Task Force
on Climate-Related Financial Disclosures (“TCFD”).
Indivior has not, to date, produced a separate ESG
or non-financial report aligned to an appropriate
framework such as the Global Reporting Initiative.
The management team may consider introducing
this in the future should it be deemed appropriate.
The current intention is to utilize the corporate
website and the Annual Report and Accounts
for the expansion of Indivior’s ESG information.
Advocacy
Indivior advocates on public policy issues that relate
to addiction by engaging responsibly with public
officials, policymakers and other stakeholders at all
levels of government, with healthcare professionals
and with other stakeholders. These activities focus on:
› removing barriers to innovative treatments;
› addressing reimbursement barriers by supporting
the enforcement of the US Mental Health Parity
and Addiction Equity Act;
› increasing disease and treatment education;
› reducing the stigma associated with substance
use disorders; and
› advocating for access to treatment in
correctional settings.
Further details are available at the Indivior corporate
website (www.indivior.com/responsibility). A case
study of Indivior’s recent advocacy activities appears
on page 25 of this Annual Report and Accounts.
Information about Indivior’s climate change
strategy, governance, risks and metrics (except
for the performance information recorded below)
is recorded within the TCFD statement on
pages 36 to 37.
Indivior’s Fine Chemical Plant (“FCP”), which is located
in Hull (UK), is the location which represents Indivior’s
main area of environmental risk. Buprenorphine
is manufactured at this site using raw materials
and a seven-stage process involving the use of
hazardous chemicals.
The FCP has an environmental management
plan which focuses on performing a process of
continual improvement in line with the requirements
of the UK Environment Agency and good industry
practice. The site’s operations are governed
by the FCP’s Environmental Permit and its
ISO14001:2015 certification.
Indivior currently does not have emission reduction
targets. Indivior will consider introducing these
after it has introduced a regular internal emissions
reporting system during 2022.
More information about the FCP environmental
management plan and recent initiatives can be found
within the responsibility section of the corporate
website (www.indivior.com/responsiblity).
The rise in Scope 3 emissions is due to a methodology
change to include additional upstream emissions
associated with energy generation and fuel production
in line with good practice. The noted Scope 1 rise is the
result of greater activity levels at Indivior’s UK sites in
2021 (lower in 2020 because of the greater effect of the
global COVID-19 pandemic).
Indivior’s TCFD reporting disclosure can
be found on pages 36 to 37 of this report
Greenhouse gas emissions data for the
Indivior Group
Type
Scope 1
Scope 2 location-based
Scope 2 market-based
Scope 3
Total emissions location-based
Total emissions market-based
Per tonne of production
location-based
Per tonne of production
market-based
2021
tonnes
CO2e
516
1,800
2,055
684
3,000
3,255
1,308
2020
tonnes
CO2e
451
1,808
2,084
140
2,399
2,675
1,328
1,419
1,481
Indivior | Annual Report and Accounts 2021
31
STRATEGIC REPORTR E S P O N S I B I L I T Y
C O N T I N U E D
Greenhouse gas emissions split by territory
Patient safety and product quality
Type
Scope 1 UK
Scope 1 non-UK
Total Scope 1
Scope 2 location-based UK
Scope 2 location-based non-UK
Total Scope 2 location-based
Scope 2 market-based UK
Scope 2 market-based non-UK
Total Scope 2 market-based
Scope 3 UK
Scope 3 non-UK
Total Scope 3
Total UK emissions
location-based
Total non-UK emissions
location-based
Total emissions location-based
Total UK emissions
market-based
Total non-UK emissions
market-based
2021
tonnes
CO2e
2020
tonnes
CO2e
450
66
516
522
1,278
1,800
777
1,278
2,055
272
412
684
1,244
385
66
451
561
1,247
1,808
836
1,248
2,084
53
87
140
999
1,756
1,400
3,000
1,499
2,399
1,275
1,756
1,401
Total emissions market-based
3,255
2,675
Patient safety and product quality have always been
embedded in Indivior’s culture and are key elements
of its patient-focused business model.
The senior management team views this aspect
of the business as fundamental to the integrity of its
day-to-day activities. It promotes a culture of product
innovation and quality which it views as critical to the
maintenance of trust with regulators, healthcare
professionals and patients.
Indivior maintains and constantly evolves its
pharmacovigilance management system in partnership
with its manufacturing suppliers. These processes
monitor the safety of Indivior’s products in a
comprehensive and thorough manner. Indivior’s
management systems include the US FDA-required
Risk Evaluation and Mitigation Strategies (“REMS”)
program to mitigate the risk of accidental overdose,
misuse and abuse of sublingual film and to inform
healthcare professionals and patients of the risks
associated with the product. Indivior also has and
maintains an FDA-required REMS program for
SUBLOCADE in the US to mitigate the risk of
serious harm or death that could result
from intravenous self-administrations.
Globally, an ongoing program of enhancement of
Indivior’s product risk management plans is in place
to minimize these risks in other countries.
Energy consumption in MWh
Workforce
Type
Scope 1 UK
Scope 1 non-UK
Total Scope 1
Scope 2 location-based UK
Scope 2 location-based non-UK
Total Scope 2 location-based
Scope 2 market-based UK
Scope 2 market-based non-UK
Total Scope 2 market-based
2021
MWh
2020
MWh
2,398
719
3,117
2,460
2,766
5,226
2,460
2,766
5,226
2,090
717
2,807
2,408
2,569
4,977
2,408
2,569
4,977
Indivior’s qualified and experienced Human Resources
team maintain and develop a policy and practice
framework for the entire business. The team is
responsible for ensuring that Indivior is an employer
of choice. Indivior believes that its workforce is
fundamental to its long-term success and the
achievements of its aims and objectives.
Recorded within this section is key workforce data
and examples of recent workforce initiatives including
Indivior’s focus on diversity and inclusion (D&I).
Further information is recorded at the corporate
website (www.indivior.com/responsibility).
32
indivior.com
Workforce data
885
People employed by Indivior at December 31, 2021
(December 31, 2020: 788)
Breakdown of workforce data by territory
United States of America
2021
2020
508
Europe, Middle East, Africa and Canada
247
251
2021
2020
Australasia
2021
2020
26
29
China
0
2021
Breakdown of workforce data by
2020
key employment function
2
Function
Commercial
Compliance
Corporate Affairs and
Communications
Finance
Human Resources
Information Technology
Legal and Governance
Medical
Research and Development
Supply
Total
December 31
2021
December 31
2020
483
19
2
58
19
32
14
71
87
100
885
411
16
1
59
18
31
13
57
89
93
788
Diversity and inclusion
In 2020, Indivior entered into a partnership with
Heidrick and Struggles to accelerate its diversity
and inclusion (D&I) journey, addressing matters such
as gender, race, creed and sexual orientation with the
aim of creating an even more inclusive environment.
The ongoing project, which continued into 2021, has a
number of features, including:
› Over 400 digital conversations to obtain employee
feedback and views
612
› In-depth interviews with senior management
› The conduct of multiple employee focus groups
› A review of Human Resources data, practices
and outcomes
› The conduct of multiple Executive Committee
training and planning sessions
› Training company leaders on activating inclusion
› Surveying employees on D&I communications
preferences and tailoring subsequent
communications activities
In 2022, Indivior will:
› Roll out “activating inclusion” training for
the business leaders (c.250 employees) and
“accelerating inclusion” training for all individual
contributors (c.450 employees)
› Evolve the role of Indivior’s Culture Champions to
become Culture and Inclusion Champions through
the provision of advising training on “accelerating
inclusion” concepts that will reinforce D&I concepts
and initiatives across the business
› Train senior leaders and provide materials to enable
quarterly “leader-led roundtables” with employees
on relevant D&I topics
Additionally, Indivior will:
› Continue to look to expand sources for diverse
candidates in the talent acquisition process
› Continue to aspire to create diverse candidate
options for open and new positions
› Continue to review D&I data in relation to
succession planning processes and outcomes
Indivior | Annual Report and Accounts 2021
33
STRATEGIC REPORTR E S P O N S I B I L I T Y
C O N T I N U E D
Gender pay-gap assessment and diversity data
Addressing the COVID-19 pandemic
Indivior conducts regular gender pay reviews which
are voluntary and driven by the desire to do the right
thing and ensure pay equity. This exercise was first
conducted in 2018 when an independent review was
conducted by Mercer. It highlighted a small number of
potential matters which were immediately addressed.
Subsequent annual internal reviews are conducted
to ensure that an equitable approach is maintained
throughout the business.
Indivior’s gender diversity data, disclosed to meet the
requirements of S414c of the UK Companies Act 2006,
are recorded below.
Indivior’s diversity approach and performance is also
discussed on page 88 of this report.
Directors of Indivior PLC
All employees
11
885
Male: 73%
Female: 27%
Male: 50%
Female: 50%
As at December 31, 2021
Total Women
Directors of Indivior PLC
Senior Managers1
All employees
11
41
3
11
885
444
%
27
27
50
Men
8
30
441
%
73
73
50
1. Includes members of the Executive Committee who are not
Directors of Indivior PLC and all subsidiary company directors.
During 2021 Indivior continued to maintain the
measures it put in place in 2020 to maintain the
health, welfare and safety of its employees during
the pandemic. These were tailored to the specific
circumstances of each workforce group and site
(for example, workers at the FCP in Hull or salesforce
representatives working in communities across
the US).
The FCP put in place a comprehensive risk
management process within 2020 which it
is still continuing to operate and is tailoring
to current circumstances and prevailing UK
government regulations.
Indivior’s remaining sites put in place COVID-19
measures to protect the workforce. The majority
of workers at the Richmond headquarters and at
Slough (UK) worked from home for most of the year.
Sales and marketing professionals were supplied
with appropriate Personal Protective Equipment and
appropriate health and safety guidelines to ensure
their own safety,
Flexible working
Indivior’s management team is mindful
of its employees’ expectations following
the working environment changes and
experiences that resulted from the global
COVID-19 pandemic. Indivior continues
to promote flexible ways of working.
These include a new collaboration model
where eligible employees can work two
core days within the working week in
office, one flexible day in office and
the remaining two days remotely.
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indivior.com
Business conduct
Indivior has put in place a comprehensive compliance
approach to help ensure that all of its business
activities are conducted in a responsible and
compliant manner via the Global Indivior Integrity
and Compliance Program (ICP). It is administered
by a team of over 20 people by Indivior’s Chief Integrity
& Compliance Officer, who is a member
of the Executive Committee. Its operational methods
have evolved in a cross-functional manner through
integrated ownership and oversight at all levels
across Indivior’s departments.
In January 2019, Indivior established the Integrity &
Compliance Committee, which is chaired by the Chief
Integrity & Compliance Officer. It comprises all of the
members of the Executive Committee and meets
monthly. It is responsible for supporting the Chief
Executive Officer and Chief Integrity & Compliance
Officer with the administration of the ICP and
overseeing compliance with applicable laws, rules and
regulations related to Indivior’s business operations,
excluding compliance with securities regulation and
financial reporting requirements.
Another important ICP element is the Compliance
Champion Program. Its objective is to integrate and
expand the compliance footprint within Indivior by
training specific workforce members to act as support
within their business unit or function to address the
first line of compliance.
The ICP applies a “Learn, Adjust and Prevent”
approach and has a multi-year strategy to guide
continuous evolution.
Key ICP elements are:
› Optimization of written policies, procedures
and standards of conduct
› Administration of the ICP by the Chief Integrity
and Compliance Officer and the Integrity &
Compliance Committee
› Workforce training and education
› Open lines of communication
› Annual risk assessment process
› Internal monitoring and auditing related
to compliance
› Whistleblowing helpline for reporting
of concerns and related reviews and
internal investigation process
› Coaching and disciplinary processes
Meeting the requirements of the 2020
Resolution Agreement
In connection with the 2020 Resolution Agreement
between Indivior Inc. and Indivior PLC and the United
States Attorney’s Office for the Western District of
Virginia and the United States Department of Justice’s
Consumer Protection Branch, Indivior Inc.’s US
operations are subject to compliance measures
set forth in three separate agreements:
› A Corporate Integrity Agreement with the
Department of Health and Human Services Office
of Inspector General (OIG);
› Compliance Measures with the Department of Justice
(DOJ); and
› A Stipulated Order for Permanent Injunction with
the Federal Trade Commission (FTC).
These agreements contain various specific
requirements concerning, for example, governance,
policies, training, risk assessment, monitoring,
disclosure programs, incentive compensation,
data analytics, independent assessments,
certifications, and further require scheduled
and ad hoc reporting and notifications to the
respective government agencies.
At their core, the agreements are geared toward the
ongoing administration of an effective compliance
program. Indivior committed to building an effective
compliance program, and engaged in extensive
program building, staffing and preparedness efforts,
long before the 2020 Resolution Agreement.
The Group maintains this commitment today
as the established ICP continues to evolve and mature
based on internal learnings and relevant external
benchmarks, as noted above. Indivior has established
policies and procedures and government agreement
administration protocols that have assured and
continue to guide the successful implementation of
the requirements of all three agreements, which is
overseen by the Chief Integrity & Compliance Officer
and the Integrity & Compliance Committee (comprised
of all members of Indivior’s Executive Committee).
These policies, procedures, and protocols are
well-integrated into ongoing business operations.
To date, the Group believes that all requirements
specified in the three agreements have been met,
including the filing of all required scheduled and
ad hoc reports and notifications.
Supplier Code of Conduct
During 2021, Indivior published its first Supplier Code
of Conduct. This initiative followed on from the
publication of the updated Global Code of Conduct in
2020. Both documents are available for download from
the corporate website (www.indivior.com).
Indivior | Annual Report and Accounts 2021
35
STRATEGIC REPORTR E S P O N S I B I L I T Y
C O N T I N U E D
TASKFORCE ON CLIMATE-RELATED
FINANCIAL DISCLOSURES
Indivior recognizes that climate change
is an important issue for everyone around
the world. Climate change has resulted
in more frequent and greater weather
extremes including heatwaves, heavy
precipitation, droughts and tropical
cyclones across the globe. These climate
change-related extremes also present
business risks that may affect business
operating costs and potential disruption
to production and supply of medicines
to patients.
Indivior believes that in view of the scale, nature, and
size of this challenge, it is essential that governments
and relevant non-governmental organizations take the
lead in meeting this global challenge by putting clear,
stable and consistent carbon policies in place, which
include goals and measures that are well defined.
Indivior supports the activities of groups such as the
Intergovernmental Panel on Climate Change (IPCC)
and the UN Framework Convention on Climate
Change (UNFCCC) as well as the various regulatory
and best practice initiatives that aim to achieve
greater transparency and to enable stakeholders
to monitor related areas of climate change and
environmental performance.
The recommendations of the Taskforce on
Climate-related Financial Disclosures (TCFD)
provide a framework for consistent disclosure of
climate-related information. We support the TCFD
framework and we have made disclosures consistent
with the four TCFD recommendations and the
11 recommended disclosures.
We recognize that our approach to climate change
is at an initial stage with steps planned for 2022 and
beyond. We intend to enhance our reporting against
the recommendations as our strategy matures over
the next year.
Indivior has been responding to the CDP climate
change questionnaire since 2016, which is aligned to
the TCFD recommendations. Indivior will continue
responding to the CDP climate change questionnaire
each year and to requests for information about its
approach, management and performance relating to
climate change from its stakeholders.
Governance
Indivior’s Chief Executive Officer is responsible
for the executive management of the Group’s
business, including its approach to climate change and
for implementing strategy and delivering performance
against plans. To date the risks that climate change
present to Indivior have been considered by the audit
committee and the Board as part of its overall
consideration of risk.
Indivior formed an ESG committee in January 2022
which is chaired by Hillel West, Chief Manufacturing
and Supply Officer. The Committee comprises all
of the members of the Executive Committee. The ESG
Committee has responsibility for maintaining and
developing Indivior’s climate change strategy and
related policies, management systems (including risk)
and monitoring performance. Indivior has also formed
an ESG strategy team that is responsible for day-to-
day management of climate change matters that is
also headed by the Chief Manufacturing and Supply
Officer. Mark Crossley, Chief Executive Officer, has
overall responsibility for the Group’s ESG program.
Prior to these developments, Indivior’s day-to-day
climate change management was built around its
management of risk and costs including at local site
level. The principal area of focus was the Fine
Chemical Plant (“FCP”) in Hull (UK). Site management
at the FCP includes regular consideration of climate
change-related risks (particularly flooding) that are
also regularly discussed with the local regulator,
which is the UK Environment Agency. Day-to-day
management of the site is the responsibility of the
Chief Manufacturing and Supply Officer.
The Remuneration Committee has carefully considered
the inclusion of ESG metrics in the Group’s annual and
long-term incentive plans. The Committee is fully
aligned and supportive of developing metrics for
inclusion, but has determined that the Group’s ESG
strategy is not yet sufficiently mature to enable
specific and measurable targets to be included for
2022. The Committee is committed to including ESG
metrics in the Group’s annual and/or long-term
incentive plans in 2023.
Actions for 2022
The ESG Committee will lead the development
of Indivior’s ESG public strategy, policy and reporting
framework and supervise related stakeholder
engagement activities. The terms of reference and
matters arising statements for the Board Committees
and the Board will be updated, where relevant,
to address climate change.
36
indivior.com
Strategy
Risk management
Indivior understands that its stakeholders expect the
business to have in place a climate change plan and
strategy. To address this, Indivior is committed to
developing an action plan across all business
functions to minimize its environmental impact
and to reduce its carbon footprint.
This action plan will include:
› Carbon Reduction Initiatives – Collaborate
with property providers, business partners,
suppliers, regulators and employees to
implement energy conservation measures
where practicable at our operations
and offices.
› Renewable Energy Evaluation – Explore
renewable energy options such as wind, solar,
and hydro to enable operations and offices
to operate with a lower carbon footprint.
› Greenhouse Gas Portfolio Management –
Enhance environmental reporting processes to
improve GHG emission transparency and to
facilitate GHG reduction initiatives. Develop a
strategy to expand GHG reporting coverage to
Scope 3 by engaging key suppliers and other
stakeholders on climate issues to identify
effective sustainability opportunities.
› Target Setting – Establish GHG targets
in alignment with the IPCC and 2015 Paris
Climate Agreement.
› Leadership and Stakeholder Engagement –
Indivior’s ESG Committee will have oversight
of the climate change action plan and
implementation, with regular updates on GHG
performance as initiatives progress. Indivior
will continue to engage with and communicate
its climate change efforts to suppliers,
customers, consumers, shareholders and
other stakeholders interested in climate
change matters.
Actions for 2022
Indivior will monitor and further develop its climate
change strategy.
Climate risks are evaluated using the Group’s common
risk assessment approach, using criteria such as
financial metric values and likelihood of occurrence,
and are incorporated into our enterprise risk
assessments. From this objective baseline, the Group
then evaluates actual or potential impacts considering
subjective factors that may adjust the baseline to be
higher or lower.
Indivior’s Enterprise Risk Management (“ERM”) process
is designed to identify, assess, manage, report and
monitor risks and opportunities that may impact the
achievement of the Group’s strategy and objectives.
This includes adjusting the risk profile in line with the
Group’s risk tolerance to respond to new threats and
opportunities. These processes consider the short-,
medium- and long-term and address matters such as
expected changes in regulations and laws as well as
changes to the climate.
Indivior defines a material financial impact on the
business as one which could influence economic
decisions on the basis of the information provided.
With the Group’s strategic pillars focused on revenue
growth and diversification, the quantitative starting
point for materiality is 1 to 1.5% of net revenue. From
this objective baseline, the Group then evaluates
actual or potential impacts considering subjective
factors that may adjust the baseline higher or lower.
Indivior’s risk assessments have not detected that
climate change is a material risk or opportunity for the
business. Further details about these procedures can
be found within the risk section on pages 47 to 56.
Actions for 2022
Indivior will continue to monitor and assess its climate
change-related risks and address any material threats
that are identified.
Metrics and targets
Indivior’s measurement of its emissions to date has
been conducted annually. The emission data for 2021
are recorded on pages 31 to 32 of this Annual Report
and Accounts. In 2022, Indivior will develop a strategy
to expand Scope 3 emissions reporting coverage and
consider the use of intensity metrics (such as
emissions per employee or unit of turnover) to
monitor emissions performance and set targets.
This data will be applied to monitor Indivior’s
performance by the ESG Committee and also to set
reduction targets for various parts of the business.
Actions for 2022
Indivior will aim to set challenging emission reduction
targets for different parts of the business applying the
extended reporting and monitoring system.
Indivior | Annual Report and Accounts 2021
37
STRATEGIC REPORTN O N - F I N A N C I A L I N F O R M A T I O N S T A T E M E N T
NON-FINANCIAL INFORMATION STATEMENT
Indivior is committed to transparent reporting
and disclosure of its financial and non-financial
performance, risks and opportunities where this
information is relevant to shareholders and other
key stakeholders. Indivior is also required to comply
with the reporting requirements contained in sections
414CA and 414CB of the Companies Act 2006.
The table and other information below are provided
to assist readers of this report to understand Indivior’s
approach, policies and performance.
It also aims to highlight where further relevant
information, other than that disclosed within
this report, can be accessed.
Further information – pages 22 to 23
Business model
An explanation of Indivior’s business model.
Further information – pages 30 to 37
Responsibility
How Indivior addresses its responsible
business obligations.
Further information – pages 47 to 56
Risk management
A description of the principal risks and their
potential adverse impacts on the business
can be found on these pages of this report.
Non-financial performance
information
› Greenhouse gas
emissions
› Employee data
› Employee gender
diversity figures
› Political donations
Other reporting
requirements
Policies and statements of approach,
due diligence and outcomes
Risks, risk management and additional
information
Page
reference
Environmental
matters
› Environmental management
approach
› TCFD statement
› Business operations
› Supply
Employees
› Workforce management
› Business operations
approach
Human rights
› Diversity and inclusion policy
› UK Modern Slavery Statement
› Business operations
› Product Pipeline, regulatory
and safety
Social matters
›
Information Management
Policy
› Data Protection Policy
› Healthcare professionals
interaction policy
Anti-corruption
and bribery
› Anti-bribery policy
› Whistleblowing policy
› Product Pipeline, regulatory
and safety
› Commercialization
› Economic and financial
› Supply
› Legal and intellectual property
› Compliance
› About the Integrity &
Compliance Program
› Business operations
› Compliance
p31 and p32
(Emissions)
p49 and p54 (Business
operations and Supply
risks)
p33 (Employee data)
p49 (Business
operations risks)
p34 and p88 (Gender
diversity data)
p50 (Product Pipeline,
Regulatory and Safety
risks)
p115 (Political
donations)
p47-56 (Risks)
p35 (Business conduct
and 2020 Resolution
Agreement)
p49 (Business
operations risks)
p55-56 (Compliance
risks)
In particular, the Group provides the responsibility section of its website (www.indivior.com) for this purpose, participates in the
annual disclosure of environmental and climate change information to CDP (www.CDP.net) and regularly enters into dialog with
investors and investor research organizations (such as MSCI and FTSERussell) about this aspect of its activities.
38
indivior.com
F I N A N C I A L R E V I E W
FINANCIAL REVIEW
Year ended December 31 (as reported)
Net Revenue
2021
$m
791
213
205
28
2020
$m
647
(156)
(148)
(20)
2021
2020
2019
647
791
785
Net revenue
Operating profit/(loss)
Net income/(loss)
Basic EPS/(LPS) (cents per share)
NM: Not Meaningful
2021 operating and financial highlights
› Net revenue (NR) of $791m (+22% vs. 2020). 2021
SUBLOCADE NR grew to $244m (+88% vs. 2020)
due to strong growth from the Organized Health
Systems (OHS) channel and increased new
patient enrollments. 2021 US units dispensed
were approximately 183,0003 (+66% vs. 2020).
Total SUBLOCADE patients at the end of 2021
were approximately 49,000.
› 2021 PERSERIS NR of $17m (+21% vs. 2020). The Group
is investing to expand the PERSERIS sales force to
achieve US national coverage in 2022.
› 2021 SUBOXONE Film share averaged 20% (2020: 21%)
and exited 2021 at 22% (2020 exit share: 21%). Share
performance since the “at-risk” launch of generic
buprenorphine/naloxone film products in February
2019 has continued to diverge from historical
industry analogs.
› Reported operating profit of $213m (2020 operating
loss: $156m). On an adjusted basis1 2021 operating
profit was $187m (+113% vs. Adj. 2020).
› Reported net income of $205m (2020 net loss
of $148m). 2021 Adj. net income of $140m
(+137% vs. Adj. 2020).
› 2021 ending cash balance of $1,102m (2020: $858m);
net cash, as calculated per Note 19 of the Notes
to the Group financial statements, was $853m
(2020: $623m).
› Regulatory approval of SUBLOCADE (SUBUTEX
Prolonged Release) outside of the US has now been
granted in 10 countries. 2021 approvals include
Norway, Germany and Italy. Prior approvals include
Canada, Australia, New Zealand, Israel, Sweden,
Finland and Denmark. Launched in Canada,
Australia, and Israel.
› Regulatory approval of SUBOXONE Film outside of
the US in 2021 was granted in New Zealand, Qatar,
and United Arab Emirates. Prior approvals include
Australia, Canada, Israel, all EU Member States and
the UK, Iceland, Norway, and Liechtenstein.
US Dollars (m)
Adjusted Net Income1
2021
2020
2019
140
176
59
US Dollars (m)
Cash Balance
2021
2020
2019
858
1,102
1,060
US Dollars (m)
Net Cash2
2021
2020
2019
623
853
821
US Dollars (m)
1. Adjusted (Adj.) basis excludes the impact of exceptional items (see Note 5 of the Notes to the Groupʼs financial statements for details)
2. See Note 19 of the Notes to the Group financial statements for the definition of net cash
3. Excludes one-time-in-nature orders from criminal justice system customers
Indivior | Annual Report and Accounts 2021
39
STRATEGIC REPORTF I N A N C I A L R E V I E W C O N T I N U E D
Operating review
Share repurchase program
On December 23, 2021, the Group completed its $100m
irrevocable share repurchase program. Through the
program, the Group repurchased and canceled 34
million or 5% of the Group’s ordinary shares at a daily
weighted average purchase price of 219p. See Note 25
of the Notes to the Group’s financial statements for
further discussion.
US opioid use disorder (OUD) market update
In 2021, the U.S. buprenorphine medication-assisted
treatment (BMAT) market grew in mid-single digits.
Moderation in the growth rate versus 2020 reflects the
high base period for comparison, 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
OUD patient access to medication-assisted treatment
(MAT). Over the approximate two-year period just
ended (2020 and 2021), the BMAT market averaged
mid-to-high single-digits growth.
The Group continues to expect long-term US market
growth to be sustained in the mid-to-high single digit
percentage range due to increased severity and 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 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 among OHS and core HCPs to ensure
availability of this potentially important treatment
option to the estimated 1 million-plus patients per
month who are prescribed BMAT by HCPs.
Financial performance
Total net revenue in 2021 grew 22% to $791m at actual
exchange rates (2020: $647m; +21% at constant
exchange rates). The strong increase was primarily
driven by higher NR from SUBLOCADE (+88% vs. 2020),
continued growth in the BMAT market and by
relatively stable market share for SUBOXONE
(buprenorphine and naloxone) Film in the US.
2021 US net revenue increased 32% to $603m (2020:
$456m). Strong year-over-year SUBLOCADE net revenue
growth, SUBOXONE Film share resilience along with
underlying BMAT market growth were the principal
drivers of the net revenue increase.
2021 Rest of World and United Kingdom (collectively
“ROW”) net revenue decreased 2% at actual exchange
rates to $188m (2020: $191m; -7% at constant exchange
rates). The NR decline was mainly due to ongoing
competitive pressure in the legacy tablet business
in Western Europe, and the disposal of the legacy
TEMGESIC/ BUPREX / BUPREXX analgesic franchise
(2021 NR impact of -$5m), partially offset by NR from
new products (2021 ROW SUBLOCADE NR: $16m) and
favorable foreign currency translation benefits.
2021 reported and adjusted gross margin was 84%
(2020: 85%; Adj. 2020: 86%). 2020 adjusted gross margin
excludes $5m of net exceptional costs of sales related
to inventory provisions due to the adverse impact of
COVID-19. 2021 adjusted gross margin decline primarily
reflects the continued relative strength of SUBOXONE
Film in the United States, particularly in less profitable
government channels.
2021 SG&A expenses as reported were $431m (2020:
$666m). 2021 included $6m of net exceptional costs
which include the adjustments to provisions related
to DOJ-related matters (+$18m) and ANDA litigation
matters (-$24m). 2020 SG&A expenses included
exceptional costs of $239m, primarily related to
resolution of litigation matters. On an adjusted basis,
2021 SG&A expense decreased slightly from 2020 to
$425m (2020: $427m). The decline largely reflects
one-time costs related to the US direct-to-consumer
(DTC) advertising campaign for SUBLOCADE in the prior
period and lower legal fees and expenses related to
the DOJ matter. These were essentially offset by sales
and marketing investments to grow the Group’s
long-acting injectable technologies, SUBLOCADE
and PERSERIS, in the current period.
2021 R&D expenses were $52m (2020: $40m). The increase
reflects planned higher R&D activity, as certain projects
and post-market studies were suspended in 2020 due
to the pandemic, and strategic pipeline and production
capacity investments in 2021.
2021 other operating income was $32m (2020: $nil).
2021 included $32m of net exceptional other operating
income related to the net proceeds received from the
disposal of the legacy TEMGESIC/ BUPREX / BUPREXX
(buprenorphine) analgesic franchise outside of North
America (+$19m), net proceeds received from the
out-licensing of nasal naloxone opioid overdose
patents (+$1m) and Directors’ & Officers’ insurance
claim settlement (+$12m).
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2021 operating profit as reported was $213m (2020
operating loss: $156m). Net exceptional benefits of
$26m are included in 2021 and exceptional costs of
$244m are included in 2020. On an adjusted basis, 2021
operating profit was $187m (2020 adj. op. profit: $88m).
The improvement in 2021 adjusted operating profit was
primarily driven by strong net revenue growth.
2021 net finance expense as reported was $23m (2020:
$17m). The increase primarily reflects lower interest
income on the Group’s cash balance due to lower
short-term interest rates versus the year-ago period
and higher expense primarily related to interest on the
Group’s outstanding DOJ settlement amount.
2021 reported total tax benefit was $15m, an effective
tax rate of -8% (2020 tax benefit: $25m, 14% rate).
Excluding the $40m tax benefit on exceptional items in
2021, total tax expense was $25m, an effective tax rate
of 15% (2020: $12m, 17% rate).
2021 reported net income was $205m (2020 net loss:
$148m). Excluding the $65m after-tax benefit from
exceptional items, 2021 adjusted net income was
$140m (Adj. 2020: $59m). The significant increase
in 2021 adjusted net income was primarily driven by
higher operating profit, partially offset by higher tax
and net finance expenses.
2021 diluted earnings per share was 27 cents and 18
cents on an adjusted diluted basis (2020: 20 cents loss
per share on a diluted basis and 8 cents earnings per
share adjusted diluted basis). Higher 2021 adjusted
EPS is primarily due to higher net revenue and the
impact of the share repurchase program.
Balance sheet and cash flow
Cash and cash equivalents were $1,102m at year-end
2021, an increase of $244m versus the $858m position
at year-end 2020. The increase was due to higher
operating profit, timing of payments made on
government rebate payables, and proceeds from the
disposal of the legacy TEMGESIC/BUPREX/ BUPREXX
(buprenorphine) analgesic franchise outside of North
America, offset by cash used to purchase 34 million
ordinary shares as part of the Group’s share
repurchase program. Gross borrowings, before
issuance costs, were $249m at December 31, 2021 (2020:
$235m). As a result, net cash (as defined
in Note 19 of the Notes to the Group financial
statements) stood at $853m at December 31, 2021
(2020: $623m), a $230m increase over the fiscal year.
Net working capital (inventory plus trade receivables,
less trade and other payables) was negative $423m at
year-end 2021, versus negative $252m at the end of
2020. The change in the period was primarily a result
of timing of payments made on government rebate
and trade payables.
Cash generated by operating activities in 2021 was
$395m (2020 cash used: $148m), representing a change
of $543m primarily due to strong 2021 operating profit,
timing of government rebates payable and the surety
bond refunded. Net cash inflow from operating
activities was $353m in 2021 (2020 net cash outflow:
$193m) reflecting higher cash from operations and an
exceptional tax refund from the IRS, which were offset
by taxes paid, interest paid, and transaction costs paid
related to the Group’s debt refinancing.
2021 cash outflow from investing activities was $14m
(2020: $4m), which reflects a payment made to Aelis
Farma for an exclusive option and license agreement
to develop its leading compound (AEF0117) targeting
cannabis use disorders, which was partially offset by
the proceeds received from the sale of the legacy
TEMGESIC / BUPREX / BUPREXX (buprenorphine)
analgesic franchise outside of North America.
2021 cash outflow from financing activities was $94m
(2020: $10m), which reflects payments made for the
Group’s share repurchase program and principal lease
payments which were partially offset by the gross
proceeds received upon refinancing of the Group’s
term loan.
Alternative performance measures
(adjusted results)1
The Board and management use adjusted results 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. Further details of each adjustment
are available in Note 5 of the Notes to the Group’s
financial statements.
Reconciliation of gross profit to adjusted gross profit:
Gross profit
Exceptional cost of sales
Adjusted gross profit
1. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with IFRS.
2021
$m
664
–
664
2020
$m
550
5
555
Indivior | Annual Report and Accounts 2021
41
STRATEGIC REPORTF I N A N C I A L R E V I E W C O N T I N U E D
Reconciliation of operating profit/(loss) to adjusted operating profit:
Operating profit/(loss)
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Adjusted operating profit
Reconciliation of profit/(loss) before taxation to adjusted profit before taxation:
Profit/(loss) before taxation
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Exceptional finance expense
Adjusted profit before taxation
Reconciliation of net income/(loss) to adjusted net income:
Net income/(loss)
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Exceptional finance expense
Exceptional tax
Adjusted net income
Reconciliation of earnings/(loss) per share to adjusted earnings per share:
Earnings/(loss) per share
Exceptional selling, general and administrative expenses
Exceptional other operating income
Exceptional tax
Adjusted earnings per share
2021
$m
213
–
6
(32)
187
2021
$m
190
–
6
(32)
1
165
2021
$m
205
–
6
(32)
1
(40)
140
2021
cents
28
1
(4)
(6)
19
2020
$m
(156)
5
239
–
88
2020
$m
(173)
5
239
–
–
71
2020
$m
(148)
5
239
–
–
(37)
59
2020
cents
(20)
33
–
(5)
8
Weighted average number of shares (thousands)
728,299
732,863
Reconciliation of net cash:
Net cash at the beginning of the year
Net increase/(decrease) in cash and cash equivalents
New borrowings
Repayment of borrowings
Exchange differences
Net cash at end of year
42
indivior.com
2021
$m
623
245
(250)
236
(1)
853
2020
$m
821
(207)
–
4
5
623
L E G A L P R O C E E D I N G S
DOJ resolution
Reckitt Benckiser
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 US Federal Trade Commission (FTC), and US 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 US Attorney’s Office.
› As part of the resolution with the FTC and as
detailed in the text of the stipulated order, for a
10-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 is subject to reporting and monitoring
requirements, including annual reports and
compliance certifications from key management and
the Board’s Nominating & Governance Committee,
which is submitted to HHS-OIG. In addition, the
Group is subject to monitoring by an Independent
Review Organization, which submits audit findings to
HHS-OIG, and review by a Board Compliance Expert,
who prepared a compliance assessment report in
the first reporting period and will prepare a
compliance assessment report in the third reporting
period. To date, the Group reasonably believes
it has met all of the requirements specified in these
three agreements.
In November 2020, the Group made a payment of
$103m (including interest) when the resolution was
approved by the Court and made a subsequent
payment in January 2022 of $54m (including interest).
Subsequently, five annual installments of $50m will be
due every January 15 from 2023 through 2027. The final
instalment of $200m will be due in December 2027. The
Group carries a liability totaling of $492m (FY 2020:
$486m) pertaining to the DOJ resolution.
› On January 25, 2021, the Group reached a resolution
with Reckitt Benckiser as discussed in Note 21 of the
Notes to the Group’s financial statements.
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 sought reasonable
attorney’s fees and costs. Three other cases were
filed in the District Court of the District of New Jersey
that also 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 Group settled these matters in
2020 and 2021.
State and local matters
› 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. 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 settled with
the relators and the California Department of
Insurance in 2021.
› 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 settled with the relators and the
Illinois Insurance Department in 2021.
› 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 resolved the matter with the City
of Chicago in 2020.
Indivior | Annual Report and Accounts 2021
43
STRATEGIC REPORTL E G A L P R O C E E D I N G S
C O N T I N U E D
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 attorney’s 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. The Group filed a
Motion to Dismiss on June 24, 2021.
› In May 2018, Indivior Inc. received an informal
request from the Office of the United States Attorney
(“OUSA”) for the Southern District of New York,
seeking records relating to the SUBOXONE
manufacturing process and the Group is discussing
with the OUSA certain information and allegations
regarding the SUBOXONE manufacturing process
the government received.
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 US 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
was granted by the court in September 2021.
A settlement fairness hearing occurred in
January 2022 and the case was dismissed.
Intellectual Property-related-matters
ANDA litigation
› Indivior filed actions against Dr. Reddy’s Laboratories
S.A. and Dr. Reddy’s Laboratories, Inc. (together, “DRL”)
in the United States District Court for the District of
New Jersey (“NJ District Court”) alleging that DRL’s
generic buprenorphine/naloxone film product
infringes US Patent Nos. 9,687,454 and 9,931,305 (“the
’454 and ’305 Patents”) in 2017 and 2018, respectively.
The cases were consolidated in May 2018. 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 NJ District Court granted Indivior
a Preliminary Injunction (PI) pending the outcome of
a trial on the merits of the ’305 Patent, and required
44
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Indivior to post a surety bond for $72m in connection
with the PI. In November 2018, the Court of Appeals
for the Federal Circuit (CAFC) issued a decision
vacating the PI against DRL. On remand, the NJ District
Court construed the claims of the ’454 and ’305
Patents. Indivior and DRL stipulated to
noninfringement of the ’305 Patent under the court’s
claim construction, but Indivior retained its rights to
appeal the construction and pursue its infringement
claims pending appeal. Separately, DRL filed an
amended answer alleging various antitrust
counterclaims. Indivior’s infringement claims
concerning the ’454 patent and DRL’s antitrust
counterclaims remain pending in the NJ District Court.
Summary judgment motions have been fully briefed,
but the NJ District Court has not ruled on those
motions. No trial date has been set. In February 2022,
the NJ District Court ordered the parties to mediation.
› In November 2018, DRL filed two petitions for inter
partes review (“IPR”) of the ’454 Patent with the US
Patent and Trademark Office’s Patent Trial and
Appeal Board (“PTAB”). The PTAB denied institution
of one IPR petition but granted institution for the
other. The PTAB issued a decision in June 2020,
finding 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 CAFC. In December
2021, the CAFC affirmed the PTAB’s decision.
Indivior filed a petition with the CAFC for a panel
rehearing or rehearing en banc, which was denied
in March 2022.
› Indivior filed actions against Alvogen Pine Brook LLC
and Alvogen Inc. (together, “Alvogen”) in the NJ
District Court alleging that Alvogen’s generic
buprenorphine/naloxone film product infringes US
Patent Nos. 9,687,454 and 9,931,305 (“the ’454
and ’305 Patents”) in 2017 and 2018, respectively.
The cases were consolidated in May 2018. In January
2019, the NJ District Court granted Indivior a
temporary restraining order (“TRO”) to restrain the
launch of Alvogen’s generic buprenorphine/
naloxone film product pending a trial on the merits
of the ’305 Patent and Indivior was required to post
a surety bond of $36m. Indivior and Alvogen entered
into an agreement whereby Alvogen was enjoined
from selling in the US its generic buprenorphine/
naloxone film product unless and until the CAFC
issued a mandate vacating Indivior’s separate PI
against DRL. The CAFC’s mandate vacating Indivior’s
PI as to DRL issued in February 2019 and Alvogen
launched its generic product. Any sales in the US by
Alvogen are on an “at-risk” basis, subject to the
ongoing litigation against Alvogen in the NJ District
Court. In November 2019, Alvogen filed an amended
answer alleging various antitrust counterclaims.
In January 2020, Indivior and Alvogen stipulated to
noninfringement of the ’305 Patent under the court’s
claim construction, but Indivior retained its rights to
appeal the construction and pursue its infringement
claims pending appeal. Indivior’s infringement
claims concerning the ’454 patent and Alvogen’s
antitrust counterclaims remain pending in the NJ
District Court. Summary judgment motions have
been fully briefed, but the NJ District Court has not
ruled on those motions. No trial date has been set.
In February 2022, the NJ District Court ordered the
parties to mediation.
Opposition to SUBLOCADE European patent
› In October 2018, Teva Pharmaceutical Industries Ltd.
(“Teva”) filed a Notice of Opposition with the
European Patent Office (“EPO”) seeking to revoke
European Patent No. EP 2579874 (“EP 874”), which
relates to the formulation for SUBLOCADE. Oral
proceedings took place in September 2021 and the
patent was maintained as granted. Teva filed a
notice of appeal with their grounds for such appeal,
and the Group’s deadline to respond in writing to
such appeal is June 21, 2022.
› In March 2021, the law firm Elkington & Fife LLP filed
a Notice of Opposition with the EPO 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 responded
to the Opposition in August 2021. The oral hearing
has been set for October 10, 2022.
› 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.). 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 pled guilty to one count of making a
false statement relating to healthcare matters in one
state in 2012 (as discussed above under DOJ
Resolution). The Group continues to believe 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.
Antitrust litigation and consumer protection
Other antitrust and consumer protection claims
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 US 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
fully briefed and were argued in December 2021.
The deadline for the class exclusion or “opt out”
is May 15, 2022.
› 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 has cooperated 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 were pending in the
Eastern District of Pennsylvania. The complaints
were dismissed in July 2021. Plaintiffs filed Notices
of Appeal in August 2021 to the United States Court
of Appeals for the Third Circuit (“Third Circuit”).
The Third Circuit has indicated it may hear oral
arguments on this appeal in March 2022. Humana
also filed a Complaint in state court in Kentucky with
substantially the same claims as were raised in the
Indivior | Annual Report and Accounts 2021
45
STRATEGIC REPORTL E G A L P R O C E E D I N G S
C O N T I N U E D
Federal Court case. That case has been stayed
pending a decision in the Third Circuit appeal.
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), (5) Molina
Healthcare, Inc., and (6) Aetna Inc. are pending in the
Circuit Court for the County of Roanoke, Virginia (the
“Roanoke Plaintiffs”). 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. In June 2021, defendants’ motion to stay
was denied and certain claims were dismissed
without prejudice. The Roanoke Plaintiffs have
filed amended complaints, and the Group has
filed demurrers, seeking dismissal of some
of the asserted claims. Briefing is scheduled to be
completed on these demurrers in March of 2022.
The Group has begun its evaluation of the claims,
believes in its defenses, and intends to vigorously
defend itself. Engagement with the claimants has
been minimal. 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
approximately 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 US District
Court for the Northern District of Ohio. At the
present time, litigation against Indivior in the MDL
is stayed. 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.
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indivior.com
R I S K M A N A G E M E N T
PRINCIPAL RISKS AND
RISK MANAGEMENT
Effective management of existing and emerging
risks is critical to the success of our Group and the
achievement of our strategic objectives. Risk must be
accepted to a reasonable degree for our Group to
execute on our strategic objectives and pursue our
business opportunities in alignment with our mission.
Risk management is therefore an integral component
of our culture and governance.
Managing risks
Our Enterprise Risk Management (ERM) process is
designed to identify, assess, manage, report and
monitor risks and opportunities that may impact the
achievement of the Group’s strategy and objectives.
This includes adjusting the risk profile in line with the
Group’s risk appetite and tolerances to respond to
new threats and opportunities. An effective ERM
process is fundamental to our ability to meet and
align to our operational and strategic objectives.
The competitive market in which we operate has
industry-specific risks, particularly those relating to
new product development and commercialization,
intellectual property enforcement and legal
proceedings, and compliance with laws and
regulations. This requires that existing and emerging
business risks are effectively assessed, appropriately
measured, regularly monitored, and addressed
through mitigation plans. Our ERM process fosters
and embeds a Group-wide culture of risk management
that is responsive, forward-looking, consistent,
and accountable.
Governance and responsibilities
The Board of Directors of Indivior PLC (the “Board”) has
overall responsibility for the Group’s risk management.
The Audit Committee assists the Board in overseeing
the Group’s risk management activities, including
reviewing the Group’s principal risks and emerging
Indivior’s approach to risk
Our Board of Directors oversees
Indivior’s risk management,
determines the Group’s risk
appetite, carries out an assessment
of the Group’s principal and
emerging risks and provides
governance of Indivior’s
principal risks
Our Executive Committee
monitors the effectiveness of risk
management activities and reviews
Indivior’s principal risks
Our Risk Management Team
coordinates the Enterprise Risk
Management (ERM) process
Board of
Directors
Executive
Committee
Risk Management
Team
Integrity & Compliance
Department
Our Integrity & Compliance
Department develops and
implements an effective compliance
management program
Risk Mitigation
Business Unit
and Corporate
Functional Leadership
Our Business Unit and Corporate
Functional Leadership executes
day-to-day risk management
activities and manages risk
mitigation actions within their
respective functions
or areas
Internal Audit
Team
Our Internal Audit Team provides
independent assurance of the
effectiveness of governance, risk
management and controls
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risks with a focus on key risk areas. In addition, the
Board’s Committees regularly review risks relevant to
their area of focus; this includes, but is not limited to,
risks relating to legal, financial, commercial, regulatory,
and compliance matters.
The Executive Committee is required by the Board to
oversee and monitor the effectiveness of the Group’s
risk management activities. Quarterly, the Executive
Committee reviews enterprise risks as part of its
regular quarterly business reviews and assesses any
changes impacting the Group, including emerging risks
and impacts to Indivior’s principal risks, as well as the
underlying mitigating plans.
Business Unit and Functional leadership executes
day-to-day risk management activities, including risk
identification, and manages risk mitigation actions
within their respective areas in alignment with the
ERM framework.
The Risk Management team facilitates the ERM
program, including the implementation of processes
and tools to identify, assess, measure, monitor and
report risks.
Our principal risks
The Board has carried out a robust risk assessment
to ensure that the principal and emerging risks are
effectively managed and/or mitigated to help ensure
the Group remains viable. The Board considers the
principal risks to be the most significant risks faced
by the Group; these include those risks that could
threaten the Group’s business model, future
performance, solvency, or liquidity.
While the Group aims to identify and manage such
risks, no risk management strategy can provide
absolute assurance against loss.
The tables on pages 49 to 56 provide insight into the
Group’s principal risks, outlining why effective
management of these risks is important, how we
manage them, how the risks relate to the Group’s
Strategic Priorities, and changes to the status of
these risks since 2020. Additional risks, not listed here,
that the Group cannot presently predict or does not
believe to be equally significant, may also materially
and adversely affect the Group’s business, results
of operations and financial condition. The principal
risks and uncertainties are not listed in order
of significance.
Principal risks remain unchanged compared to prior
year, except for three principal risks. Business
operations and supply principal risks which have
increased due to continuing pandemic-related
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challenges impacting internal and third-party
operations and the broad supply chain, manufacturing
quality challenges, and industry-wide cyber and talent
recruiting/retention risks. The economic and financial
principal risk has decreased primarily due to better-
than-anticipated financial performance.
Any one or combination of the risks listed below could
impact the Group’s viability (refer to our Viability
Statement on page 57).
Update to the response to the COVID-19
pandemic
The COVID-19 pandemic is continuing longer than
expected with the emergence of new variants, resulting
in continuing uncertainty. Governments worldwide
have deployed vaccination programs and other health
measures to lower virus infection and mortality rates,
which should, in time, enable businesses to return to
normal or near-normal operations. While operations
continue to be disrupted, our focus has been on the
health, safety and wellbeing of our employees,
patients, and the workforce of our partners.
Because of COVID-19, certain of our principal risks have
been revisited in the light of the potential impact of
the pandemic on those risks: business operations
(refer to page 49); product pipeline, regulatory, and
safety (refer to page 50); commercialization (refer to
page 51); and supply (refer to page 53). Given the
dynamic nature of the current environment, the
continuing impact of COVID-19 (including its variants)
on the Group’s operations and our financial position,
there remains uncertainty, which results in
a potentially heightened effect on four of our
principal risks to the Group.
Emerging risks
There is a continuous focus on identifying and
assessing potential emerging risks. The ERM and
Financial Planning & Analysis teams monitor potential
disruptions that could dramatically impact our
industry and business from a risk and opportunity
perspective. The Board and Executive Committee
review emerging risks.
The Group is proactively monitoring and assessing
potential impact of climate change on our Strategic
Priorities and business. See pages 36 and 37 for
information on Indivior's TCFD disclosures.
1. Business operations
Change from 2020
The Group’s operations rely on complex processes and systems, strategic partnerships and
specially qualified and high-performing personnel to develop, manufacture and sell our products.
Failure to continuously maintain operational and compliance processes and systems, as well as to
retain and/or recruit qualified personnel, could adversely impact products’ availability and patient
health, and ultimately the Group’s performance and financials. Additionally, an ever-evolving
regulatory, political, and technological landscape requires that we have the right priorities,
capabilities, and structures in place to successfully execute on our business strategy and adapt
to this changing environment.
COVID-19 pandemic – The COVID-19 pandemic is continuing longer than expected with the
emergence of new variants, resulting in continuing uncertainty. In response to COVID-19, the Group
established an agile cross-functional response structure and implemented a number of mitigation
and contingency actions to help maintain the functioning of operations across the organization,
supply of all products to our patients, and the welfare of our employees. The Group continuously
monitors the potential impact on the health and wellbeing of our employees, as well as the
workforce of our key third parties, which ultimately may impact our operations, and ensures our
mitigation and contingency actions are as appropriate and effective as possible. In the fourth
quarter of 2021, we introduced a hybrid working model (i.e., in-office and remote working) in those
countries where work-from-home restrictions were no longer in place. Given the shift to a remote
working environment started in 2020, the Group continues to closely monitor cybersecurity threats
and the overall operating effectiveness of the monitoring and control activities.
The current industry-wide challenging labor environment may have a potential negative impact
on the Group’s attrition rate and its ability to recruit for certain key positions in some geographies.
The Group has established tools, development, performance management and reward programs
to develop, retain, and recruit key personnel.
The incidence of sophisticated phishing and malware attacks, including ransomware, across
industries is rising with an increase of companies suffering operational disruption and loss
of data. The Group continuously assess cyber risk and manage the maturity of our infrastructure
to effectively defend against any cyber attacks.
Examples of risks
Management actions
→ Combination of
continued internal and
external (i.e., third-
party partners)
operational challenges
due to the COVID-19
pandemic, industry-
wide challenges to
maintain and recruit
key personnel, and
heightened global risk
of cyber incidents such
as ransomware.
Further information:
Chief Executive
Officer’s review:
See pages 10 to 15
Financial Review
section:
See pages 39 to 42
Link to Strategic Priorities
1 Grow SUBLOCADE
to $1bn+ Net Revenue
› Failure, disruptions, or significant
performance issues experienced
with our key processes,
Information Technology (IT)
systems, and/or at our critical
third-party partners, including
due to the COVID-19 pandemic
› Loss of intellectual property,
confidential data, and personally
identifiable information or
significant impact on operations
from cybersecurity breaches
› Failure to motivate, retain and
recruit qualified workforce and
key talent
› Continuous agile cross-functional response
management is in place
› Hybrid work policy enabling flexible ways of working,
2 Diversify Revenue
3 Build our Pipeline
for Future Growth
4 Optimize our
Operating Model
and increased use of technology for meetings
› Business operating standards, monitoring processes,
and contingency plans are in place
› IT policies, processes, systems, and disaster recovery
plans supporting overall business continuity are in
place, including cyber incidence response readiness
› Strategy, processes, and tools to secure systems
and protect data are deployed, including, security
awareness e-learning and phishing exercises
› Talent management programs are in place, including
talent review and retention programs with focus on
identifying key roles and successors
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2. Product Pipeline, Regulatory and Safety
Change from 2020
The development and approval of the Group’s products is an inherently risky and lengthy process
requiring significant financial, research and development resources, as well as strategic
partnerships. The Group is developing its early-stage assets (i.e., preclinical to phase 2 assets) in
partnership with external organizations. Complex regulations with strict and high safety standards
govern the development, manufacturing, and distribution of our products. Patient safety depends
on our ability to perform robust safety assessment and interpretation to ensure that appropriate
decisions are made regarding the benefit/risk profiles of our products. Deviations from these
quality and safety practices could impact patient safety and market access, which can have a
material effect on the Group’s performance and prospects. In addition, strong competition exists
for strategic collaborations, licensing arrangements and acquisition targets. If we are unable
to execute strategic transactions or if such transactions do not yield the expected product
development, synergies or financial performance, our business prospects may suffer.
COVID-19 pandemic – The COVID-19 pandemic continues to negatively impact our R&D operations,
specifically trial patient enrollments and chemistry, manufacturing & controls (CMC) operations,
therefore causing certain delays in the execution of our internal and third-party clinical and/or
CMC studies.
→ No change
Examples of risks
› Failure to advance the
development and/or obtain
regulatory approval of pipeline
products
› Failure to identify M&A targets,
conduct effective due diligence, or
to execute on M&A and drive value
for the organization
› Potential liability and/or
additional expenses associated
with ongoing regulatory
obligations and oversight
› Unexpected changes to the
benefit/risk profiles of our
products
Management actions
Link to Strategic Priorities
› Product development, including a stage-gate process,
and business development strategies are in place
1 Grow SUBLOCADE
to $1bn+ net revenue
› A post-marketing study program is in place
2 Diversify revenue
› Market valuation and financial modeling are in place
› Comprehensive cross-functional due diligence process
3 Build our pipeline
for future growth
is in place
› Ongoing Quality, Safety and Regulatory monitoring
and auditing programs are in place
› Policies and standards governing scientific
interactions and communication are in place
› Strategies to defend against and pursue appropriate
resolution of potential product liability claims are in
place
› Rigorous pharmacovigilance processes for ongoing
evaluation of data collected from multiple sources
related to patient safety are in place, including Risk
Evaluation & Mitigation Strategy (“REMS”) programs
in the US and Risk Management Plans (“RMP”)
outside the US
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3. Commercialization
Change from 2020
→ No change
Link to Strategic Priorities
1 Grow SUBLOCADE to
$1bn+ net revenue
2 Diversify revenue
Successful commercialization of our products is a critical factor for the Group’s sustained growth
and robust financial position. New products involve substantial investment in marketing, market
access and sales activities, product stocks, and other investments. Certain factors, if different than
anticipated, can significantly impact the Group’s performance and position. These factors include:
final label claims; healthcare professionals (HCP)/patient adoption and adherence; generic and
brand competition; pricing pressures; private and government reimbursement schemes and
systems; negotiations with payors; erosion and/or infringement of intellectual property (“IP”)
rights; and political and socioeconomic factors.
COVID-19 pandemic – The pandemic continues to result in overall fewer patient visits to healthcare
provider offices for non-COVID-19 reasons or essential treatments, as patients become unable or
unwilling to make visits due to overburdened healthcare systems, safety concerns, quarantines
and other travel restrictions, or elect to have remote consultations with their providers.
Furthermore, even though the Group has developed remote (digital) meeting capability with
healthcare providers, the Group’s commercial organization continues to only be able to engage
with a limited number of HCPs and Organized Health Systems (OHS). Although we experienced an
overall increase in new US patient enrollments and number of interactions with HCPs and OHS in
2021 as compared to 2020, we have not yet returned to pre-pandemic levels. Potential significant
decline in patient enrollments, or adherence to the patient journey, or the inability to effectively
engage with HCPs and OHS due to the continuing COVID-19 pandemic could have a negative impact
on the Group’s financial results and position.
Governments across the world continue to consider and take actions to lower drug prices. In the
US, there is bi-partisan support for drug pricing reforms at both federal and state levels, which
include potential legislative and regulatory actions to encourage the import of drugs, to price
drugs according to a defined international pricing reference, to encourage more competition, and
to undertake other initiatives. These, together with federal and state government fiscal constraints
resulting from the COVID-19 pandemic which constrain public benefit health programs, pose direct
and indirect downward pressure risk on drug prices. The Group continues to monitor potential
legislative and regulatory changes and their impacts, advocating for the Group’s products based
on scientific studies and patient-centered outcomes. However, certain potential legislative and
regulatory drug pricing changes could have an adverse impact on the Group’s financial
performance and results in the future.
Examples of risks
Management actions
› Launch of competing branded
› Continued investments in OHS access (including
and/or generic products
› Lower HCP adoption and patient
enrollments and/or adherence
to SUBLOCADE, including the
decrease linked to limited/
restricted patient visits and HCP
interactions due to the COVID-19
pandemic
› Unexpected changes to
government and/or commercial
reimbursement levels and
government pricing pressures
› Competition and challenges in the
product/geographic expansion
outside the US
a dedicated team for the Criminal Justice System)
and in interactions with HCP (including remote (digital)
meeting capability and virtual promotional events),
expansion of the Behavioral Health sales force
› Emphasizing value of products and health economics
tailored to commercial and government payors
through market access activities
› Patient platforms supporting provider location,
reimbursement support and co-pay assistance
for eligible patients are in place
› Ongoing training and development for field-based
employees are in place
› Policies and standards governing commercial
activities, including pricing, are in place
› Monitoring of government and commercial pricing
and reimbursement-related trends/measures and
development of mitigation strategies are in place
› International growth, pipeline development, marketing,
and business development strategies are in place
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4. Economic and financial
Change from 2020
The pharmaceutical business includes inherent risks and uncertainties, requiring the Group
to make significant financial investments to develop and support the success of our product
portfolio. Generating cash flow from our approved products, together with external financing,
sustains our financial position, allows development of new products and funds business growth.
Realizing value on those investments is dependent upon regulatory approvals, market acceptance
(including pricing reimbursement levels), strategic partnerships, competition, and legal
developments. Unfavorable outcomes from resolutions of legal proceedings, impacts from the
continuing COVID-19 pandemic, and/or changes in government pricing regulations could negatively
impact our operating results and financial position. Together with potential pressure on our level
of net working capital, our ability to comply with our debt covenants could be negatively impacted.
As a global business, we are also subject to political, economic, capital markets, and tax
regulation changes.
Examples of risks
Management actions
→ Decreased given the
better-than-anticipated
performance of both
SUBLOCADE and
SUBOXONE Film and
renegotiation of debt,
and growth of cash
balance
Link to Strategic Priorities
1 Grow SUBLOCADE to
$1bn+ net revenue
› Inability to raise capital, or execute
on business development and
alliance opportunities
› Failure to meet financial
obligations and performance
› Optimization of cost and finance structures,
and active expense management are in place
› Ongoing monitoring of financial performance
2 Diversify revenue
and compliance with financial covenants
3 Build our pipeline for
› Strategies supporting expansion opportunities
future growth
› Changes to international tax
and diversification are in place
environment and regulations,
including potential tax increases
as governments seek to fund
public finances
› Regular appraisals of debt and capital market
conditions with advisors and counterparties
are in place
› Ongoing monitoring of potential changes in tax
legislations and development of mitigation strategies
4 Optimize our
operating model
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5. Supply
Change from 2020
The manufacturing and supply of our products are highly complex and rely on a combination
of internal manufacturing capabilities and third parties for the timely supply of our finished drug
and combination drug products. The Group uses third parties, including contract manufacturing
organizations (CMOs), to manufacture, package and distribute our products. The manufacturing
of oral solid dose products, film products and aseptically filled injectables is subject to stringent
global regulatory, quality and safety standards, including Good Manufacturing Practice (GMP).
Major delays or interruptions in our supply chain and/or product quality failures could
significantly disrupt patient access, adversely impact the Group’s financial performance,
and lead to product recalls and/or potential regulatory actions against the Group, along
with potential reputational damages.
COVID-19 pandemic – The continuing pandemic could adversely impact our broad supply chain
(i.e., “supply to patient” delivery process) if we experience either a significant absence of our
employees and/or employees at our CMOs, vendors and service providers due to infection
and/or government containment measures, and/or capacity issues at our airfreight and road
logistics providers. Through ongoing management and proactive risk mitigation, internally and
with our CMOs, the Group has not experienced any significant COVID-19-related disruptions
to its supply-to-patient delivery process to date.
The Group’s products are filled and packaged by CMOs in the US and Europe, and some are single
sourced. The Group’s supply monitoring and contingency planning processes include proactive
management of inventories throughout the supply-to-patient delivery process and initiatives to
identify and qualify alternative sites and/or suppliers. Despite these mitigating measures,
if major delays, interruptions, or quality events occur at those CMOs, the delivery of products
to our patients could be significantly disrupted.
Examples of risks
Management actions
› Reliance on critical CMOs and
supply chain partners
› Inability to supply compliant
finished products in a continuous
and timely manner, including
operational disruptions due to the
COVID-19 pandemic
› Business continuity, disaster recovery, emergency
response plans, and enhanced communication
protocols across the supply chain network are in place
› Periodic risk-based reviews for critical vendors
are in place
› Contingency plans (including qualification of
alternative suppliers/providers) and management
of safety stocks are in place
› Comprehensive product quality and control processes
and manufacturing performance monitoring across the
supply chain network are in place
› Ongoing monitoring of inventory levels and business
contingency planning
→ Continued challenges
throughout the “supply
to patient” process due
to the COVID-19
pandemic, including
potential related
operational disruptions
at our CMOs and
capacity issues at our
logistics providers, and
manufacturing quality
challenges at two
CMOs. During 2021, the
Group worked closely
with our CMOs to
increase manufacturing
capacity, add alternatives
sites and strengthen
quality robustness in
order to secure supply
against growing demand.
Link to Strategic Priorities
1 Grow SUBLOCADE to
$1bn+ net revenue
2 Diversify revenue
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6. Legal and intellectual property
Change from 2020
Our pharmaceutical operations, which include the use of controlled substances, are subject to a
wide range of laws and regulations. Perceived or actual non-compliance with these applicable laws
and regulations by a pharmaceutical company can result in investigations or proceedings leading
to civil or criminal sanctions, fines and/or damages, as well as reputational damages.
IP rights protecting our products may be challenged by external parties, including generic
pharmaceutical manufacturers. Although we have developed patent protection for our products,
including SUBLOCADE, we are exposed to the risk that courts may decide that our IP rights are
invalid and/or that third parties do not infringe our asserted IP rights.
In connection with the agreements entered in 2020 to resolve criminal charges and civil
complaints related to SUBOXONE Film, the Group has specific requirements that are in addition
to the Group’s pre-existing obligations to comply with applicable laws and regulations associated
with its US pharmaceutical operations. The Group is subject to penalties if it fails to fulfill the
requirements within the agreements.
The Group is also a party to several civil lawsuits, including ongoing litigation in the Federal FCA
qui tam suits, and civil antitrust and state claims filed by various plaintiffs. Some of the civil claims
in part relate to the same conduct at issue in the Superseding Indictment filed by the DOJ.
The Group is also a defendant in approximately 400 civil lawsuits brought by various plaintiffs
as part of the opioid class action litigation. These cases are at a preliminary stage and are
currently stayed.
Unfavorable outcomes from resolutions of these legal proceedings could have a material adverse
impact on the Group’s business, financial condition and/or operating results (refer to Legal
proceedings section on pages 43 to 46).
Examples of Risks
Management Actions
→ No change
Link to Strategic Priorities
1 Grow SUBLOCADE to
$1bn+ net revenue
› Quality, patient safety, monitoring and compliance are
embedded in the Group’s processes and culture
› Cooperation with the Government authorities in
2 Diversify revenue
3 Build our pipeline for
future growth
connection with ongoing litigations, utilizing internal
and external counsel is in place
› Insurance coverage and monitoring activities are in
place
› Ongoing active review, management and enforcement
of our product patents, marketing exclusivity and other
IP rights are in place
› Strategies to defend against and pursue appropriate
resolution of potential IP claims are in place
› Geographic expansion and product diversification
strategies are in place
› Legal proceedings related to
antitrust, state, shareholders,
product liability claims,
government enforcement and/or
private litigation associated with
the manufacturing, marketing, and
distribution of our products
› Inability to obtain, maintain, and
protect patents and other
proprietary rights
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7. Compliance
Change from 2020
→ No change
Our Group operates on a global basis and the pharmaceutical industry is both highly competitive
and regulated. Complying with all applicable laws and regulations, including engaging in activities
that are consistent with legal and industry standards, and our Group’s Code of Conduct are core to
the Group’s mission, culture, and practices. The Group has processes and procedures to identify,
analyze and investigate any potential or actual violations of policy or law and, if necessary, take
appropriate remedial or corrective actions. Effective procedures and controls are necessary to
provide reliable information, prevent and detect potential fraud. Failure to comply with applicable
laws and regulations may subject the Group to civil, criminal, and administrative liability, including
the imposition of substantial monetary penalties, fines, damages and restructuring of the Group’s
operations through the imposition of compliance or integrity obligations, and have a potential
adverse impact on the Group’s prospects, reputation, results of operations and financial condition.
In 2020, as part of the Group’s resolution of federal criminal and civil charges related to its
legacy products (see Legal proceedings section on pages 43 to 46), the Group has also entered into
a Corporate Integrity Agreement (CIA) with HHS-OIG. The five-year CIA requires, among other things,
that the Group implement measures designed to ensure compliance with the statutes, regulations,
and written directives of US Medicare, US Medicaid, and all other US federal healthcare programs,
as well as with the statutes, regulations, and written directives of the US Food and Drug
Administration. The Group is subject to additional periodic reporting and monitoring requirements
related to the Agreements. In addition, the CIA requires reviews by an independent review
organization, compliance-related certifications from the Group’s executives and certain Board
members, and the implementation of a risk assessment and mitigation process. The CIA sets forth
specified monetary penalties that may be imposed on a per day basis for failure to comply with
the obligations specified in the CIA. The CIA also includes specific procedures under which the
Group must notify HHS-OIG if it fails to meet the requirements under the CIA. In the event that
HHS-OIG determines the Group to be in material breach of certain requirements of the CIA
(including repeated violations or any flagrant obligations under the CIA, a failure by the Group
to report a reportable event and/or take corrective action, a failure to engage and use an
independent review organization, or a failure to respond to certain requests from HHS-OIG),
the Group may be subject to exclusion from participation in the US federal healthcare programs,
which would have a severe impact on the Group’s ability to comply with the financial covenants in
the Group’s debt facility, maintain sufficient liquidity to fund its operations, pay off its debt in 2026,
generate future revenue and would ultimately impact the Group’s viability.
The Resolution Agreement with the United States Attorney’s Office for the Western District of
Virginia and Consumer Protection Branch contains certain requirements, such as reporting
obligations and that the Group’s Chief Executive Officer (a) certifies on an annual basis that,
to the best of their knowledge, after a reasonable inquiry, the Group was in compliance with the
US Federal Food, Drug and Cosmetic Act and has not committed healthcare fraud, or (b) provides
a list of all non-compliant activities and steps taken to remedy the activity. The FTC Stipulated
Order contains specific notice and reporting requirements over a 10-year period related
to certain activities (e.g., product switching conduct, filing of a Citizen Petition). The Group is
subject to contempt prosecution if it fails to comply with any terms of the Resolution Agreement.
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Change from 2020
Link to Strategic Priorities
1 Grow SUBLOCADE to
$1bn+ net revenue
2 Diversify revenue
3 Build our pipeline for
future growth
7. Compliance continued
Examples of risks
Management actions
› Failure to meet the requirements
of the government agreements
(i.e., CIA, DOJ, and FTC)
› Non-compliance with our Code
of Conduct, anti-corruption,
healthcare, data privacy, or local
laws and regulations across all
geographies
› Inability to adequately respond to
changes in laws and regulations,
including data privacy
› Failure to comply with payment
and reporting obligations under
the U.S. and foreign government
programs
› Oversight, monitoring and reporting of compliance
requirements with government agreements have been
implemented, including a management certification,
and defined sub-certification process
› Indivior Global Integrity & Compliance program and
development of compliance capabilities, guided by
defined strategic plan and learnings from program
operations are in place
› Compliance policies and processes, including Code
of Conduct and an enhanced risk assessment,
and related mandatory employee training programs
are in place
› Confidential independent reporting process for
employees to report concerns is in place
› Oversight and monitoring of controls are in place
across all markets
› Data privacy governance and management framework
are in place
› Continuous review and assessment of developments
in the law, applicable industry standards, and business
practices are in place
› Ongoing monitoring of controls over government
pricing and reporting is in place
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V I A B I L I T Y S T A T E M E N T
VIABILITY STATEMENT
The Group’s viability depends upon successful execution
of our business strategy, with a focus on:
› continued growth of SUBLOCADE toward its potential
› reasonable underperformance in the expected market
acceptance of SUBLOCADE over the viability period
(considering a 15% decline on forecasts),
of >$1 billion in annual net revenue,
› accelerated reversion to generic analogs for SUBOXONE Film, and
› diversification of net revenue, including PERSERIS and
rest-of-world net revenues,
› building and progressing the new product pipeline, and
› optimization of the operating model, including management
of our remaining litigation risks.
The Board has evaluated the Group’s risk profile considering
the business performance in 2021. A return to a more normal
situation and continued stability of the US film business
facilitated acceleration of investments in the Group’s
Strategic Priorities.
The Group’s future business prospects are evaluated
throughout the year as part of the strategic planning process.
This process is led by the Chief Executive Officer through the
Executive Committee and involves all relevant functions such
as R&D, manufacturing & supply chain, commercial, legal,
integrity & compliance, human resources and finance.
Development of the strategic plan includes a thorough
examination of the principal risks and potential actions
to manage and mitigate those risks.
› reasonably unfavorable outcome of antitrust class and state
claims at the previously made settlement demands of $290
million (refer to Legal Proceedings section on pages 43 to 46.
Having considered these risk factors along with other principal risks
set out on pages 47 to 56, the Directors have assessed the Group’s
ability to comply with the liquidity covenant in the Group’s debt
facility, maintain sufficient liquidity to fund its operations and
pipeline investments, fulfill obligations under litigation settlements
and the DOJ Resolution Agreement, and address the reasonably
possible financial implications of legal proceedings.
Other risks identified in the principal risk table on pages 47 to 56
were also considered, but the above financial risks and operating
considerations were considered the most immediate and significant
that could prevent the Group from delivering on its Strategic
Priorities and remaining viable. A number of other aspects of the
principal risks, including possible changes to government
pharmaceutical pricing and reimbursement, could also threaten
the Group’s viability in its current form, because of their nature or
potential impact, if they were to occur, but were not modeled
because the range of reasonably possible impacts are unknown.
The output of the strategic plan is the Group’s Strategic
Priorities, an analysis of the relevant and material principal
risks that could prevent the priorities from being realized,
and a financial budget covering the following year. The Board
reviews and approves the budget for the upcoming year as
well as the strategic plan, which includes challenging key
assumptions and risk mitigation plans included therein.
The results of this stress testing showed the Group would be able
to withstand the impact of these scenarios over the period of the
viability assessment. In doing so, the Group may use its cash
reserves if certain risks materialize. Although further cuts to the
Group’s operating costs and planned strategic investments are
not required in our scenario planning, the ultimate actions
required will vary to ensure ongoing viability of the Group.
In accordance with the UK Corporate Governance Code,
the Directors have assessed the viability of the Group. In
determining a time period to assess the viability of the Group,
the Directors considered the Group’s strategic plan, business
cycle, impact of generic and potential branded competition,
ongoing legal proceedings and liquidity. Considering the
recent investments in commercialization of our long-acting
injectable products and the status of antitrust and opioid
multi-district litigation, the Directors believe a four-year
period to the end of 2025 to be appropriate. This assessment
period provides a reasonable horizon for the financial
impact of these developments to be reasonably considered.
Uncertainty in financial forecasts increases over the time
period covered by our viability assessment.
The strategic plan reflects the Directors’ best estimate of the
Group’s future business prospects. Additionally, they have
“stress tested” the plan under various sensitivities. The resulting
scenario begins with a gradual reversion to observed generic
analogs for SUBOXONE Film in the US after 2023 and limited
uptake of PERSERIS. The stress testing then explores resilience
of the Group to the potential impact of principal risks set out
on pages 47 to 56. This sensitivity reflects “severe but plausible”
concurrent circumstances the Group could experience, specific
to commercialization and legal risks, as follows:
Other scenarios may occur that could impact the Group’s viability
during the assessment period beyond those modeled in stress
testing. In the early portion of the viability period, the Director’s
control over certain matters, such as the strategy to respond to
legal proceedings, helps mitigate risk to the Group’s viability.
However, over the full viability period, the Directors’ ability to
influence the outcome of such matters is more limited. The impacts
of government pharmaceutical pricing and reimbursement changes,
competition, and development of our pipeline may present further
risks after the viability assessment period.
Based on their assessment of the Group’s business prospects
and viability above, the Directors confirm their reasonable
expectation that the Group will continue in operation and
meet its liabilities as they come due over the four-year period
ending December 31, 2025.
The Strategic Report on pages 1 to 57 was approved
by the Board on March 17, 2022.
By Order of the Board
Kathryn Hudson
Company Secretary
Indivior | Annual Report and Accounts 2021
57
STRATEGIC REPORTI N T R O D U C T I O N T O G O V E R N A N C E
CHAIR’S
GOVERNANCE
STATEMENT
Graham Hetherington
Chair of the Board
Dear Shareholder,
Governance and purpose
On behalf of the Board, I am pleased
to present our Corporate Governance
Report for the year ended December 31,
2021. This report sets out our approach
to governance, important areas of focus
during the year, and how the Board
and its Committees operate.
Our purpose is underpinned by high
standards of governance and
compliance, and our commitment
to acting responsibly to build the
long-term success of the Group.
58
indivior.com
Indivior has a clear purpose: to pioneer life-
transforming treatments for patients suffering
from addiction and other serious mental illnesses.
Our purpose is underpinned by high standards of
governance and compliance, and our commitment
to acting responsibly to build the long-term success
of the Group and ultimately create value for
all shareholders.
Having led the Board throughout 2021, I am confident
that all Board members have contributed effectively
to the strategic goals of the Group and met challenges
as they arose. A strong governance framework and
regulatory control environment has supported the
decisions the Board has taken throughout the year.
Succession planning
During the year, we announced a number of new
appointments to the Board and shared details of
a comprehensive succession plan. These important
governance changes were designed to align with
and support the Group’s Strategic Priorities, while
continuing to represent the best interests
of all shareholders.
Indivior entered into a Relationship Agreement with
its largest shareholder, Scopia Capital Management LP
(“Scopia”). As part of this agreement, Jerome Lande
was appointed as representative director of Scopia
in March 2021.
Also in March 2021, Joanna Le Couilliard, Mark Stejbach
and Juliet Thompson were appointed as Non-Executive
Directors and we announced details of a phased and
comprehensive succession plan.
The Board also agreed to implement a phased
transition plan for those directors who joined the
Board at its inception in 2014. As part of that transition
plan, Lorna Parker stood down as the Chair of the
Nomination & Governance Committee following the
2021 AGM and I assumed that role; Lorna will remain
as a Non-Executive Director to provide a smooth
transition while a search process for a Non-Executive
Director, to be selected from a shortlist generated
with Scopia’s input and approved by the Board, is
completed. In line with the agreed transition plan,
Dan Phelan will step down from the Board by the
end of 2022 and Tom McLellan will step down from
the Board by the end of 2023.
Following the conclusion of the 2021 AGM, Daniel
Tassé stepped down as Senior Independent Director.
Daniel had served on the Board since its inception
in 2014 and acted as Interim Chair from June 2020
until my appointment in November 2020. I would
like to thank Daniel for his many strong contributions
during his tenure.
Diversity
As part of the Board’s succession plan, we remain
committed to improving diversity in its broadest terms.
During the year, female representation increased
from 13% (as at December 31, 2020) to 27% (as at
December 31, 2021).
Although we have not yet achieved the targets set by
the Hampton-Alexander Review, we have made good
progress in 2021 and will continue to focus on this as
we implement our succession plan. We remain fully
supportive of the aims of the Hampton-Alexander
and Parker Reviews.
Meetings and new ways of working
The COVID-19 pandemic continued to have a significant
impact on the business in 2021, and this included the
way in which the Board and its Committees worked
together. We continued to meet virtually, with the
timings of meetings shifted to accommodate multiple
time zones. Through continued investment in our IT
systems and infrastructure, the Board has been able
to work efficiently and securely throughout the year to
continue our formal program of business. I would like
to extend my thanks to the Board and the entire
management team, who have demonstrated their
patience, commitment, and flexibility by attending
Board and Committee meetings often held outside
of normal business hours.
We were delighted to finally bring all the Board
together to meet in November 2021 and I very
much hope that we are able to continue to meet
in person in 2022.
Engagement with shareholders
Due to COVID-19 restrictions, only a limited number of
shareholders were permitted to attend the Company’s
2021 AGM in person to ensure that it was quorate, and
a facility was put in place for shareholders to join the
meeting virtually.
We hope to welcome
shareholders to the 2022
AGM in person in the
absence of any relevant
UK Government
restrictions. Given the
unpredictable nature of
the COVID-19 pandemic,
we will provide a facility
for shareholders to join
the AGM virtually. We
encourage shareholders
to vote in advance of the
meeting, even if you
intend to join the
meeting in person or virtually.
During the year, we
announced a number of
new appointments to the
Board and shared details of
a comprehensive
succession plan.
The Board will monitor any changes to government
guidance to assess whether any modifications to the
format of the meeting are necessary or desirable.
Moving forward
As part of the Board’s commitment to creating
shareholder value, the Board approved a $100 million
share repurchase program, which commenced in July
2021 and was completed in December 2021. In July 2021,
the Company also announced it had successfully
negotiated an amendment to provide replacement
term loan facilities in an aggregate principal amount
of $250 million that will assist in achieving the
strategic objectives of the Company.
During the year, the Board assessed the optimal
listing structure for Indivior’s shares and reached the
preliminary view that an additional US listing is likely
to be beneficial to the Group’s profile and ability to
attract a broader group of shareholders. The Board
recognizes that this is an important topic for
shareholders and intends to consult extensively
before deciding whether to put a formal resolution to
shareholders regarding an additional listing in the US.
These activities and events show the willingness
of the Board to make pivotal decisions to enhance
shareholder value and fund future business growth.
Graham Hetherington
Chair of the Board
March 17, 2022
Indivior | Annual Report and Accounts 2021
59
GOVERNANCEB O A R D O F D I R E C T O R S
1
4
2
5
3
6
1. Graham Hetherington
Chair
Appointed to the Board
November 2019
Skills and experience
› Graham was appointed Non-Executive Director in
R N
November 2019 and Chair of the Board in November
2020. He brings substantial financial and industry
experience having served as Chief Financial Officer
of two FTSE 100 companies. Graham has a wide
knowledge of international finance management
and planning, including M&A and audit and risk
management coupled with an in-depth
understanding of the US market. This broad mix
of skills and experience allows him to make an
effective and valuable contribution to the Board.
› Fellow of the Chartered Institute of Management
Accountants (CIMA)
› BTG plc: Non-Executive Director & Senior
Independent Director (2016-2019)
› Shire plc: Chief Financial Officer (2008-2014)
› Bacardi: Chief Financial Officer (2007-2008)
› Allied Domecq plc: Chief Financial Officer
(1999-2005)
Other current appointments
None
C E
2. Mark Crossley
Chief Executive Officer
Appointed to the Board
February 2017
Skills and experience
› Mark was appointed Chief Executive Officer in June
2020. He was appointed to the Board in February
2017 and served as Chief Financial Officer between
2017 and 2019 and as Chief Financial & Operations
Officer between 2019 and 2020. Mark has a wealth
of financial and pharmaceutical industry experience
and knowledge. His extensive career experience
across multiple disciplines covering strategy,
finance, information technology and systems,
treasury, supply and procurement allows him to
bring a valuable perspective to the Board. This,
complemented with an understanding of the risks
and opportunities within the pharmaceutical
industry, is highly valued by the Board.
› Indivior Chief Strategy Officer
› Reckitt Benckiser Pharmaceuticals Inc.:
Global Finance Director
› Procter and Gamble: Associate Director
Corporate Portfolio Finance
› Procter and Gamble: Associate Director Female
Beauty Strategy and Business Planning
Other current appointments
None
60
indivior.com
3. Ryan Preblick
Chief Financial Officer
Appointed to the Board
November 2020
Skills and experience
› Ryan was appointed Chief Financial Officer and
D C E
Executive Director in November 2020, having served
as Interim Chief Financial Officer from June to
November 2020. He has a wealth of financial and
pharmaceutical industry knowledge and experience
across multiple disciplines covering strategy,
finance, information technology, commercial and
supply, which allows him to bring a valuable
perspective to the Board.
› Indivior SVP, Global Finance & Commercial
Operations
› Indivior VP, US Finance
› Altria Corporation (formerly Philip Morris)
Senior Manager Financial Planning & Analysis
› Honeywell International Corporate Finance
Other current appointments
None
N R
4. Daniel J. Phelan
Senior Independent Director
Designated Non-Executive Director
for Workforce Engagement
Appointed to the Board
November 2014
Skills and experience
› Dan possesses over 30 years of pharmaceutical and
executive management experience, including
extensive experience dealing with executive
remuneration matters. Having overseen and
led operational teams, Dan brings valuable
perspectives regarding people, leadership
and development coupled with a wide-ranging
knowledge of inclusion and diversity, thereby
bringing a cultural focus to the Board. He is
conscious of the value of shareholder engagement.
Dan is an active and knowledgeable Chair of the
Remuneration Committee.
› Rutgers University Board of Trustees:
Member (2013-2017)
› Computer Sciences Corporation:
Advisory Board member (2013-2015)
› RiseSmart: Advisory Board member (2012-2016)
› GlaxoSmithKline: Advisor to three CEOs and various
executive positions (1981-2012)
› TE Connectivity Ltd: Board Director (2006-2022)
Other current appointments
› GLG Institute: Advisor
A N
5. Jerome Lande
Non-Executive Director
Appointed to the Board
March 2021
Skills and experience
› Jerome has over 20 years of experience as a
professional investor, including substantial
investing in medical device, pharmaceutical and
healthcare companies. He currently serves as
Deputy Chief Investment Officer for Scopia Capital
Management. Jerome co-founded Coppersmith
Capital Management, where he was managing
partner and portfolio manager until it combined
with Scopia in 2016.
› MCM Capital Management, LLC: Partner (1998-2011)
› Forest City Realty Trust, Inc.: Board Director
› BA from Cornell University
Other current appointments
› CONMED Corporation: Board Director
› Itron Inc.: Board Director
A R
6. Joanna Le Couilliard
Independent Non-Executive Director
Appointed to the Board
March 2021
Skills and experience
› Jo is a healthcare industry veteran with 25 years’
healthcare management experience gained in
Europe, the US and Asia. Much of her career has
been in pharmaceuticals at GlaxoSmithKline where,
amongst other roles, she headed the US vaccines
business and Asia Pacific Pharmaceuticals business
and led a program to modernize the commercial
model.
› BMI Healthcare: Chief Operating Officer
› Frimley Park NHS Foundation Trust:
Non-Executive Director
› Cello Health PLC: Non-Executive Director
› Duke NUS Medical School in Singapore:
Non-Executive Director
Other current appointments
› Circassia Group plc: Non-Executive Director
› Alliance Pharma plc: Non-Executive Director
› Recordati S.p.A.: Non-Executive Director
7
10
8
11
9
12
7. Peter Bains
Independent Non-Executive Director
Appointed to the Board
August 2019
Skills and experience
› Peter has over 30 years of experience in the
A S
pharmaceutical and biotechnology industries
including a 23-year career at GlaxoSmithKline where
he held numerous senior operational
and strategic roles. His background provides
international experience and a deep commercial
understanding of sustained delivery coupled with
investment appraisal and contracting.
The Board values his experience in understanding
the risks and opportunities present in these
industries.
› Sosei Group Corporation: Chief Executive Officer
(2010-2018)
› Syngene International: Chief Executive Officer
(2010-2016)
Other current appointments
› ILC Therapeutics Limited: Chairman
› Apterna Limited: Non-Executive Director
› MiNA Therapeutics Limited: Chief Business Officer
(part-time role)
8. A. Thomas McLellan, Ph.D.
Independent Non-Executive Director
Appointed to the Board
November 2014
Skills and experience
› Tom has extensive experience in the field of
N S
addiction, which spans 40 years as
a career researcher in the treatment of, and
policy-making around, substance use and abuse.
This enables him to contribute valuable insight and
perspective to his work on Indivior’s Science &
Policy Committee which can have a material impact
on the operating context within a regulatory and
political environment.
› Published over 600 articles and chapters on
addiction research
› Tom has received a range of Life Achievement
Awards, including from the American, Swedish,
Italian, Egyptian and British Societies of Addiction
Medicine, and the American Public Health Association
9. Lorna Parker
Independent Non-Executive Director
Appointed to the Board
November 2014
Skills and experience
› Lorna has over 26 years of executive search
N R
experience, management assessment and board
consulting experience, and UK listed company
experience. Lorna provides strong leadership on
governance matters including succession planning.
Her experience and insight in collating and
understanding wide-ranging views contribute
to making her an invaluable source of knowledge
for the Board. At Manchester Square Partners, and
as an independent consultant, Lorna conducts
board effectiveness reviews for FTSE 100 companies.
› CVC Capital Partners: Senior Advisor (2016-2021)
› Future Academies: Director (2014-2017)
› BC Partners: Senior Advisor (2008-2016)
› Spencer Stuart: Partner (1989-2008); led the private
equity practice across Europe and the legal search
practice globally
Other current appointments
› PAI Partners SAS: Supervisory Board Member
› Royal Horticultural Society: Trustee
› National Opera Studio: Trustee
› Manchester Square Partners: Advisory Partner
A N
10. Juliet Thompson
Independent Non-Executive Director
Appointed to the Board
March 2021
Skills and experience
› Juliet has over 30 years of finance, banking and
board experience with significant focus in the
healthcare sector. Juliet is a proven FTSE 250 audit
chair and a former investment banker who has
spent her career advising pharmaceutical and
biotech companies.
› Juliet played a leading role in setting up Code
Securities, an investment banking firm focusing on
the healthcare sector, which was later acquired by
Nomura (becoming Nomura Code). At Nomura Code,
Juliet was a member of the Board and head of
corporate finance. As Managing Director, she worked
on over 50 transactions.
› Treatment Research Institute (TRI): Co-founder,
› Stifel: headed up the life sciences where she
CEO and Chairman until September 2016
› White House Office of National Drug Control Policy:
Deputy Director (2009-2011)
Other current appointments
› Recover Together, Inc.: Director
› Serves on several editorial boards
of scientific journals
advised CEOs and CFOs in the healthcare sector
› Vectura plc: Non-Executive Director
› GI Dynamics: Non-Executive Director
› Chartered Accountant holding an ACA from ICAEW
› BSc in Economics from the University of Bristol
Other current appointments
› Novacyt: Non-Executive Director
› OrganOx: Non-Executive Director
A S
11. Mark Stejbach
Independent Non-Executive Director
Appointed to the Board
March 2021
Skills and experience
› Mark has over 30 years of experience in biotech and
pharmaceuticals, including senior roles in a range
of commercial functions including marketing, sales,
economic affairs, managed care and finance. Mark
most recently served as Senior Vice President and
Chief Commercial Officer at Alkermes plc, where he
was responsible for building sales of Vivitrol from
$40m to $300m.
› Flexion Therapeutics: Non-Executive Director
(2016-2021)
› Tengion, Inc.: Chief Commercial Officer (2008-2012)
› EIP Pharma Inc.: Senior Commercial Advisor
Other current appointments
None
D C E
12. Kathryn Hudson
Company Secretary
Appointed Company Secretary
June 2015
Skills and experience
› Over 20 years of experience as a Company Secretary
and Chartered Governance Professional
› Fellow of the Chartered Governance Institute
› Kingfisher plc: Company Secretary (2012-2015)
› Senior Company Secretarial positions at Burberry
Group plc and ICAP plc
Other current appointments
None
Committee Membership Key
A Audit Committee
R Remuneration Committee
N Nomination & Governance Committee
S Science & Policy Committee
D Disclosure Committee
C Integrity & Compliance Committee
E ESG Committee
Indivior | Annual Report and Accounts 2021
61
GOVERNANCEE X E C U T I V E C O M M I T T E E
1
4
7
2
5
8
3
6
9
1. Mark Crossley
Chief Executive Officer
See biography on page 60.
2. Ryan Preblick
Chief Financial Officer
See biography on page 60.
C E
D C E
3. Jeff Burris
Chief Legal Officer
Skills and experience
› 25 years
› Over 13 years as head of the legal function at
D C E
various life sciences companies
Key previous roles
› Arbor Pharmaceuticals: Vice President, General
Counsel, Chief Compliance Officer and Secretary
› Alimera Sciences: Vice President, General Counsel,
Chief Compliance Officer and Secretary
› CryoLife: Vice President, General Counsel
and Chief Compliance Officer
› University of Chicago Law School: JD
4. Cindy Cetani
Chief Integrity and Compliance Officer
Skills and experience
› 30+ years
› Certification: Licensed Professional of Ethics
C E
and Compliance
Key previous roles
› Novartis Pharmaceuticals Corp: Chief Compliance
Officer and U.S. Country Compliance Head
› Novartis International AG: Head of Compliance
Operations, Group Integrity & Compliance
› Pharmacia Corp: Director of Operations,
Managed Markets
› Prudential Healthcare: Manager,
Advertising Compliance
› US Life: Assistant Vice President,
Commissions and Compensation
C E
5. Jon Fogle
Chief Human Resources Officer
Skills and experience
› 25+ years
› Senior certified professional in human resources
Key previous roles
› Reckitt Benckiser Pharmaceuticals Inc.:
Global Human Resources Director
› Reckitt Benckiser Pharmaceuticals Inc.:
Human Resources Director for the US
› Capmark Finance (formerly GMAC Commercial
Mortgage): Senior Vice President of Human
Resources, North America
D C E
6. Christian Heidbreder
Chief Scientific Officer
Skills and experience
› 30 years’ leadership in neurosciences
› 450+ publications
› Affiliate Professor, Dept. of Pharmacology &
Toxicology of the VCU School of Medicine
› Member of the National Advisory Council
on Drug Abuse
› Member of the Helping to End Addiction Long-term
(HEAL) Multi-Disciplinary Working Group
Key previous roles
› Reckitt Benckiser Pharmaceuticals Inc.:
Global R&D Director
› Altria: Health Sciences
› GlaxoSmithKline: R&D Centre of Excellence for
Drug Discovery in Psychiatry
› SmithKline Beecham: R&D Neuroscience
› Swiss Federal Institute of Technology (ETH): Biology
› National Institute on Drug Abuse:
Intramural Research Program
› University of Louvain: Psychopharmacology
7. Kathryn Hudson
Company Secretary
See biography on page 61
D C E
8. Richard Simkin
Chief Commercial and Strategy Officer
Skills and experience
› 20+ years
Key previous roles
› Reckitt Benckiser Pharmaceuticals Inc.:
D C E
President, North America
› Reckitt Benckiser: General Manager Portugal
› Reckitt Benckiser: Marketing Director UK Healthcare
› Reckitt Benckiser: Two Global Category roles and
a number of General Management positions
C E
9. Hillel West
Chief Manufacturing and Supply Officer
Skills and experience
› 25+ years
Key previous roles
› Teva Pharmaceuticals: VP, Integration
& Separation Management
› Teva Pharmaceuticals: Exec. Director,
Head of Specialty Medicines Supply Chain
› Teva Pharmaceuticals: Exec. Director,
Global Supply Chain and Operations Strategy
› PwC Consulting Europe: Head of Supply Chain
Strategy, Emerging Markets
› PwC Consulting US: Senior Director,
Supply Chain Transformation
Committee Membership Key
D Disclosure Committee
C Integrity & Compliance
Committee
E ESG Committee
62
indivior.com
C O R P O R A T E G O V E R N A N C E
CORPORATE GOVERNANCE
Roles and responsibilities of the Board
› major capital projects, acquisitions or divestments;
The role of the Board is to promote the long-term sustainable
success of the Company for the benefit of all stakeholders,
generating value for shareholders and contributing to the
wider society. The Board is responsible for setting the
long-term business strategy and establishing the Company’s
purpose, vision and values, which together underpin the
culture of the business.
The Board has a schedule of matters specifically reserved for
its decision-making and approval. The key areas reserved to
the Board include:
› the Group’s strategic aims and objectives and review of
performance against those aims and objectives;
› the Group’s annual budget and corporate plans;
› the Group’s annual, half-yearly and quarterly financial
reports and the reports included therein;
› dividend policy;
› succession planning for the Board and senior management,
all Board appointments and removals, remuneration
arrangements and termination payments;
› any increase in, or significant variation in, the terms of the
borrowing facilities of the Group;
› capital expenditure projects outside the scope of the
approved annual budgets and plans;
› routinely reviewing the Group’s confidential reporting
hotline facility (EthicsLine) and ensuring that arrangements
are in place for investigations and follow-up action;
› establishing an effective method for gathering the views of
the Group’s workforce and keeping this mechanism under
review; and
› considering the interests of the Group’s shareholders and
other key stakeholders in its discussions and decision-
making.
The matters reserved for approval by the Board are regularly
reviewed by the Board.
The Board has delegated responsibility for the day-to-day
management of the business to the Chief Executive Officer.
Board and Committee attendance
Directors are expected to attend all Board meetings, except for in exceptional circumstances. To maximize attendance,
scheduled meetings are arranged well in advance to help Directors avoid clashes with other commitments. If a Director is unable
to attend a meeting, they are provided with the briefing materials before the meeting and can discuss any agenda item with the
Chair of the Board, Chief Executive Officer or relevant Committee Chair. All Board and Committee meetings were held virtually
with the exception of the meetings in November 2021, when the Directors were able to meet in person for the first time since
the start of the COVID-19 pandemic.
Graham Hetherington1,2
Peter Bains3
Mark Crossley
Jerome Lande4
Joanna Le Couilliard5
A. Thomas McLellan
Lorna Parker
Daniel J. Phelan
Ryan Preblick
Juliet Thompson5
Mark Stejbach5
Daniel Tassé6
Independent
Date appointed to
the Board
n/a
Yes
No
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
November 2019
August 2019
February 2017
March 2021
March 2021
November 2014
November 2014
November 2014
November 2020
March 2021
March 2021
November 2014
Board
10/10
9/10
10/10
7/7
7/7
10/10
10/10
10/10
10/10
7/7
7/7
5/5
Audit
1/1
7/7
-
6/6
6/6
-
-
-
-
6/6
6/6
3/3
Nomination &
Governance
Remuneration
Science &
Policy
5/5
-
-
4/4
-
-
5/5
5/5
-
4/4
-
-
5/5
-
-
-
4/4
-
5/5
5/5
-
-
-
2/2
-
5/5
-
-
-
5/5
-
-
-
-
4/4
-
1. Graham Hetherington was appointed as an Independent Non-Executive Director on November 1, 2019, and was appointed Chair of the Board on
November 18, 2020.
2. Graham Hetherington remained a member of the Audit Committee following his appointment as Chair of the Board to ensure that the Committee
remained compliant with the Code requirement for one of the members to have recent and relevant financial experience. He stepped down as a member
of the Audit Committee on March 24, 2021, following the appointments of Jerome Lande, Joanna Le Couilliard, Mark Stejbach and Juliet Thompson.
3. Peter Bains was unable to attend one Board meeting during the year due to scheduling conflicts. He received papers in advance of the meeting
and held a follow-up call with Company Secretary following the meeting.
4. Jerome Lande was appointed as a Non-Executive Director on March 24, 2021. Mr Lande is a representative director of Scopia Capital Management LP,
the Company’s largest shareholder.
5. Joanna Le Couilliard, Juliet Thompson and Mark Stejbach were appointed as Independent Non-Executive Directors on March 24, 2021.
6. Daniel Tassé resigned as Senior Independent Director and Non-Executive Director on May 6, 2021.
Indivior | Annual Report and Accounts 2021
63
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Compliance with the 2018 UK Corporate
Governance Code
The 2018 UK Corporate Governance Code published
by the Financial Reporting Council (the “Code”) sets out
standards of good practice in relation to: board leadership
and company purpose; division of responsibilities;
composition, succession and evaluation; audit, risk
and internal control; and remuneration.
The Board is supportive of the standards set by the Code.
This section describes how the Board has applied the
Principles of the Code. Throughout the financial year and up
to the date of this report, the Company has complied with the
Provisions of the Code, with the exception of the following:
Provision 20 – Appointment of Non-Executive Director
An external search process was not used in connection
with the appointment of Jerome Lande. Mr Lande is a
representative director of Scopia Management LP (“Scopia”),
a significant shareholder of the Company. The Company was
therefore not compliant with Provision 20 of the Code in
respect of Mr Lande’s appointment. An external search
process was used for the appointments of Joanna Le
Couilliard, Mark Stejbach and Juliet Thompson. Further details
can be found in the Nomination and Governance Committee
Report on pages 86 to 87.
Provision 21 – Annual performance evaluation
There were a number of new appointments to the Board
in 2021, with new Board members attending their first Board
meeting in April 2021 (virtually) and their first in-person
meeting in November 2021. As a result of these changes to the
Board, it was agreed to defer the annual evaluation process
to allow the new Directors to complete their induction process
and develop their understanding of the business. Dr Tracy
Long of Boardroom Review Limited has been appointed to
undertake a full external evaluation; the external evaluation
process is underway and will be completed in the first
half of 2022.
The Company was therefore not compliant with Provision 21
of the Code as it did not complete the annual review of its
performance during the year.
Provision 24 – Audit Committee composition
In November 2020, Graham Hetherington was appointed
Chair of the Board. Mr Hetherington, who was the designated
member of the Audit Committee with recent and relevant
financial experience and competence in auditing and
accounting, remained a member of the Audit Committee until
March 2021, when Joanna Le Couilliard and Juliet Thompson
were appointed as members. Both Ms Le Couilliard and Ms
Thompson are considered to have recent and relevant
financial experience and competence in auditing and
accounting.
Jerome Lande was appointed as a member of the Audit
Committee in March 2021. Mr Lande is a partner of Scopia
Capital Management LP (“Scopia”), a significant shareholder of
the Company; he is therefore not considered independent
under Provision 10 of the Code. Notwithstanding this, given
Mr Lande’s considerable financial and investment experience
in the pharma sector, it was agreed that he would bring
significant skills and expertise to the Audit Committee and
would therefore be appointed a member of the Committee.
A Relationship Agreement between the Company and Scopia
was in place throughout the year to manage any conflicts of
interest that may arise from Mr Lande’s connection with
Scopia. Please refer to the Directors’ Report on page 114 for
further information on the Relationship Agreement.
The Company was therefore not compliant with Provision 24
of the Code during the year as the Chair of the Board was a
member of the Committee between January and March 2021
and Mr Lande, who is not considered independent, was a
member of the Committee from March 2021 onwards.
Board Leadership and Company Purpose
Purpose and culture
The Board’s primary focus is to support and further the
Group’s purpose of pioneering life-transforming treatment.
It is critical to the strategy and long-term success of the
Group that there is a culture and set of values that are widely
understood and that guide the organization in everything
it does.
The Board is responsible for establishing the Group’s purpose,
values and strategy, reviewing financial and operational
performance, risk management and appetite, the Group’s
capital structure and plans proposed by management to
implement the agreed strategy. The Board ensures that
sufficient resources are available to meet the objectives set.
The Board is collectively responsible for the long-term
success of the Company and for delivering value to
shareholders. The Board provides strategic leadership and
effective oversight of the Group’s operations, either directly or
through the work of its principal Committees. It has ultimate
responsibility for the oversight and monitoring of the Group’s
governance, principal risks and control framework. Further
information regarding the Group’s internal financial control
and risk management systems, including managing and
resolving litigation risks, can be found on page 82.
The Group’s culture is considered a key strength. The Board
has responsibility for assessing and monitoring the culture
of the Group and ensuring that its policies and practices are
aligned with this. Central to Indivior’s culture is the belief
that the workforce is fundamental to the Group’s ability to
succeed. On induction, all employees take part in an
interactive culture orientation session.
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The Group engaged an external consultancy, M Marino &
Associates, to support in a review of Indivior’s operating
culture and assess the impact of the current business
environment and internal changes on operating behaviors.
The review covered the period from 2016 to 2021 and was
based on the results of annual culture surveys and a sampling
of focus groups in 2019 and 2020.
The feedback from this review was positive and indicated
high levels of trust and transparency were being built across
the organization. The review also highlighted that there had
been a significant focus on diversity and inclusion in 2021.
The review had highlighted key opportunities which included
the continued focus on patients, building confidence in the
future of the business and investing in team building and
recognition events as COVID-19 restrictions abated.
During the year, Daniel J. Phelan (the designated
Non-Executive Director for workforce engagement)
hosted a discussion with members of the Culture
Champion network, which was attended in person and
virtually. Further information regarding the Board’s
engagement with the workforce is set out on page 73.
Stakeholder engagement
As part of its decision-making processes, the Board considers
the interests of shareholders, key stakeholders and wider
society. Further information regarding the Board’s stakeholder
engagement activities can be found in the stakeholder
engagement statement set out on pages 24 to 29 of the
Strategic Report, the “Responsibility” section on pages 30 to 37
and in the “Engagement with shareholders” section on
page 72. Further information regarding the Board’s activities
during the year, including examples of how it considered
the interests of stakeholders, is provided in the “Principal
Board decisions” section on pages 68 to 70.
Workforce policies and practices
The Board keeps workforce policies and practices under
review to ensure they are consistent with the Group’s values
and support the long-term sustainable success of the Group.
The Group’s Code of Conduct (“Doing the Right Things Right”)
sets out standards expected of the workforce and how
these standards align with the Group’s culture and
Guiding Principles.
During the year, the Group introduced a series of measures
for the welfare, health and safety of its employees. Further
information regarding the impact of the COVID-19 pandemic
on the workforce can be found on page 34.
During the year, the Chief Integrity & Compliance Officer
updated the Board on the continued focus on the Group’s
Integrity & Compliance Program including key program
enhancements and compliance with the Corporate Integrity
Agreement with the Office of the Inspector General of the U.S.
Department of Health and Human Services (the “CIA”), DOJ
Compliance Measures and FTC Stipulated Order, which
present ongoing reporting and annual requirements.
The Chief Integrity & Compliance Officer provided an overview
of reports received via the confidential reporting hotline
facility (EthicsLine), which provides a facility for members
of the workforce to raise concerns in confidence and (where
local regulations permit) anonymously. The Nomination &
Governance Committee routinely reviews reports received
via the EthicsLine and monitors the case management and
investigation process at each meeting. The Board has ultimate
responsibility for the Group’s confidential reporting facility
and there is a process in place for promptly escalating
significant reports. During the year, the Board reviewed
the reports received through the confidential reporting
facility and the arrangements in place for investigation
and follow-up action.
An independent Ethics & Compliance Program Perceptions
Survey was conducted by Ethisphere. The survey covers
employee perceptions of an ethical culture across eight
pillars, which include perceptions of the conduct, values and
communications of senior leadership and management and
awareness of the Integrity & Compliance Program. The survey
was completed by 69% of the workforce and the results had
improved across the majority of pillars, with all pillars
exceeding Ethisphere benchmarks.
Further information regarding the Group’s Integrity &
Compliance Program, including 2021 program highlights, can
be found in the “Responsibility” section on page 35.
The Remuneration Committee is responsible for reviewing
workforce remuneration and related policies and the
alignment of incentives with culture. Further information
regarding the Remuneration Committee’s review in 2021
can be found on page 106.
Indivior | Annual Report and Accounts 2021
65
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Compliance with the 2018 UK Corporate
Governance Code continued
Division of responsibilities
The roles of Chair and Chief Executive Officer are separate.
There is a clear division of responsibilities between the two
and they may not be exercised by the same individual.
Chair of the Board
The Chair leads the Board and is responsible for ensuring its
overall effectiveness. The Chair was considered independent
on appointment, demonstrates objective judgment and
promotes a culture of openness and constructive debate.
He works with the Chief Executive Officer and Company
Secretary to ensure that all Directors receive timely and
clear information. The Chair works closely with the Senior
Independent Director and Non-Executive Directors. A part
of each Board meeting is reserved for a meeting of the
Chair and the Non-Executive Directors, without executive
management present.
Chief Executive Officer
The Chief Executive Officer is responsible for the day-to-day
leadership of the business. He is supported in this role by the
Executive Committee. The Chair and the Chief Executive Officer
work together, supported by the Company Secretary, to set the
Board’s agenda.
Senior Independent Director
The Senior Independent Director acts as a sounding board
for the Chair and can act as an intermediary for the other
Directors and shareholders when required. He also leads the
other Non-Executive Directors in the performance evaluation
of the Chair. He provides an alternative point of contact for
shareholders on matters where the usual channels of
communication are deemed inappropriate.
Daniel Tassé was the Senior Independent Director until May
2021. Daniel J. Phelan was appointed Senior Independent
Director in May 2021.
Board balance and independence
There is a clear division of responsibilities between the
leadership of the Board and executive leadership of the
business. The roles of Chair, Chief Executive Officer and Senior
Independent Director are clearly separated and set out in
writing. Their division of responsibilities, plus the matters
reserved for the Board and the terms of reference for each
principal Committee, ensure that no single individual can
have unfettered powers of decision-making.
At December 31, 2021, the Board comprised the Chair,
two Executive Directors and eight Non-Executive Directors.
The Board considers the independence of its Non-Executive
Directors annually, based on the criteria in the Code
and following consideration by the Nomination
& Governance Committee.
The Board considered the independence of the Non-Executive
Directors at its meeting in February 2022 and concluded that
all the Non-Executive Directors, with the exception of Jerome
Lande, remained independent of management and free from
any relationship that could interfere with their judgment.
Jerome Lande is not considered to be independent as he
is a partner of Scopia Capital Management LP (ʻScopiaʼ).
Scopia is a significant shareholder of the Company. There is
a Relationship Agreement in place between the Company
and Scopia to manage any conflicts of interest that arise
from Mr Lande’s connection with Scopia. Please refer to the
Directors’ Report on page 114 for further information
on the Relationship Agreement.
Graham Hetherington, the Chair of the Board, was considered
to be independent upon his appointment as a Non-Executive
Director in November 2019 and remained independent upon
his appointment as Chair of the Board in November 2020.
The Non-Executive Directors bring an external perspective
to Board discussion. The Company has benefited from the
broad range of skills and experience that the Non-Executive
Directors provide from different businesses and fields,
including the pharmaceutical, financial and research sectors.
They offer specialist advice, constructive challenge and
strategic guidance to the Executive Directors as well as
holding them to account.
Throughout the year they have helped to shape the Group’s
strategy, scrutinized the performance of management, agreed
goals and objectives and monitored the Group’s risk profile
and reporting of performance.
Board processes and the role of the Company Secretary
The Company Secretary ensures that the Board receives
appropriate and timely information and provides advice and
support to the Chair, Board and senior management on
regulatory and governance matters. All Directors have access
to the Board portal, which is used to distribute Board and
Committee materials and governance resources.
Board meetings are scheduled well in advance. Where it is
necessary to call meetings at short notice, efforts are made to
find suitable times when all Directors can attend; where this is
not possible, Directors are provided with briefing materials
and can discuss any agenda item with the Chair, Chief
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Board performance evaluation
The annual performance evaluation of the Board and its
Committees considers the Board’s composition, diversity and
how effectively members work together to achieve objectives.
As a result of a number of changes to the composition of the
Board during the year, the annual performance evaluation
was deferred to allow the new Directors to complete their
induction process and develop their understanding
of the business.
Further information regarding the Board performance
evaluation process can be found on page 71.
Audit, risk and internal control
The Board has ultimate responsibility for internal control
and risk management systems and considers regular reviews
carried out by the Audit Committee, which has responsibility
for monitoring such systems.
Further information about the role and work of the Audit
Committee is set out in the Audit Committee Report on pages
75 to 84.
Further information regarding the Group’s approach to risk
management, including the management of principal and
emerging risks, can be found on pages 47 to 56.
Remuneration
Further information about our approach to remuneration and
the role and work of the Remuneration Committee is set out
in the Directors’ Remuneration Report on pages 91 to 111.
Executive Officer or relevant Committee Chair. In addition,
updates and analysts’ notes are uploaded to the Board portal
to ensure that Directors are kept apprised of developments.
All Directors have direct access to the advice and services
of the Company Secretary. Directors may also obtain
independent professional advice as required at the
Company’s expense.
Time commitment
The letters of appointment for the Chair and Non-Executive
Directors state the expected time commitment to fulfill their
roles. The Chair and Non-Executive Directors are expected to
set aside sufficient time to prepare for meetings. The Board is
satisfied that all Directors continue to devote sufficient time
to discharge their duties effectively.
Composition, succession and evaluation
Appointment and re-appointment of Directors
There is a formal, rigorous and transparent procedure
for the appointment of new Directors. The process for
new appointments is led by the Nomination & Governance
Committee, which makes its recommendations to the Board.
In accordance with Provision 18 of the Code, all Directors will
stand for re-appointment at the 2022 AGM. The 2022 Notice of
AGM will include a biography for each Director setting out the
skills they bring to the Board and why their contribution is,
and continues to be, important to the long-term success of
the Group.
Further information regarding the process for the
appointment of the Chair, Executive and Non-Executive
Directors can be found in the Nomination & Governance
Committee Report on pages 85 to 88.
Succession planning and diversity
The Nomination & Governance Committee is responsible
for developing and overseeing the succession plans for the
Board and senior management and, as part of this review,
takes consideration of the length of service of each Director.
The Committee also considers the skills and experience
of each of the Directors and maintains a skills matrix.
Appointments and succession plans are based on merit
and objective criteria and, within this context, are intended
to promote diversity.
Further information regarding the review of succession
planning, diversity and inclusion in 2021 can be found
in the Nomination & Governance Committee Report.
Indivior | Annual Report and Accounts 2021
67
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Principal Board decisions in 2021
The Directors consider that they met sufficiently frequently to enable them to discharge their duties effectively. Details of the
principal matters discussed and decisions made during the year are shown in the following table. Consideration of all of the
Group’s stakeholders is an integral part of the Board’s decision-making and is predicated on discussions held with stakeholders.
Further information on the Group’s engagement with stakeholders can be found in the Strategic Report on pages 24 to 29.
Strategy
› The growth of SUBLOCADE remains the Group’s most important strategic priority as it is considered the biggest potential
driver of value creation and facilitator of other strategic priorities. The Board received an update on the operational
performance of the business at each scheduled meeting, which included an update on the performance of SUBLOCADE
and the focus on the development of the Organized Health Systems (“OHS”) channel.
› As COVID-19 restrictions showed signs of abating and the US healthcare system started to reopen, the Board agreed to invest
in the expansion of the PERSERIS sales force to achieve US national coverage in 2022.
› The Group sought to strengthen its leadership position in substance use disorder treatment by securing an exclusive
agreement with Aelis Farma for their leading mid-stage asset (AEF 0117) targeting cannabis-related disorders.
› In June 2021, the Board agreed to the repricing and maturity extension of its $250m term loan facilities. This replaced the
Group’s previous borrowing facilities, providing greater flexibility by removing the previous leverage covenant and introducing
a minimum liquidity covenant (greater of 50% of any outstanding balances or $100m). The new term loan has a maturity date
of June 30, 2026.
› The Board approved the disposal of the legacy TEMGESIC/BUPREX/BUPREXX (buprenorphine) analgesic franchise outside
of North America.
› The Board reviewed the Group’s use of capital and approved the implementation of a $100 million share repurchase program.
› The Board assessed the optimal structure for Indivior’s shares and reached the preliminary view that an additional US listing
is likely to be beneficial to the Group’s profile and ability to attract a broader group of shareholders. In February 2022, the
Group announced its intention to consult extensively before deciding whether to put a formal resolution to shareholders.
Financial and operational performance
› The Board reviewed and approved the FY 2020 preliminary announcement, the 2021 Q1 results announcement,
the 2021 half-year results announcement and the Q3 2021 results announcement.
› Based upon the strong commercial execution behind SUBLOCADE and the resilience of the legacy US SUBOXONE Film
business, net revenue guidance was raised in June and October 2021 (from a base case of $625m at the beginning of the
financial year to a range of $750m to $770m in October 2021); actual net revenue of $791m for the 2021 financial year was
significantly ahead of 2021 plan.
› The Board received updates from the Chief Manufacturing & Supply Officer regarding the Group’s supply chain, the processes
in place to ensure continuous supply and plans to increase the supply of SUBLOCADE and PERSERIS in line with projected
increases in demand.
Shareholder engagement
› The Chair of the Remuneration Committee consulted with shareholders in advance of, and following, the 2021 AGM, where the
2020 Remuneration Report and the resolution to re-elect the Chair of the Remuneration Committee received a 38.3% and
21.5% vote against respectively. Following consultation, an Update Statement was published on the Company’s website.
Further information regarding this can be found on page 109.
› The Board considered and agreed the terms of the Relationship Agreement with Scopia Capital Management LP,
a significant shareholder of the Company. Further information regarding the Relationship Agreement with Scopia
can be found on page 114.
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ESG
› An external review on Indivior’s operating culture was undertaken and the results were presented to the Board. The review
covered the period from 2016 to 2021 and was based on results of annual culture surveys and a sampling of focus groups in 2019
and 2020. The feedback was positive and indicated that high levels of trust and transparency were being built across the
organization and highlighted that there had been a significant focus on diversity and inclusion in 2021, which included training for
the Executive Committee and senior leadership. Further information on diversity and inclusion can be found on pages 33 and 88.
› The Board reviewed the 2021 Culture Survey and noted that the results had significantly improved since the last Culture
Survey had been conducted in 2019.
› The Board was updated on the development of the Group’s Environmental, Social and Governance (“ESG”) Strategy, including
the key areas of focus, reporting structure and investment in resources to support the program.
› The Board, supported by the Nomination & Governance Committee, reviewed and approved the Group’s Modern Slavery Statement.
Litigation matters
› During the year, the Board considered the Group’s legal strategy and agreed that no changes would be made to that strategy.
› Updates were provided on litigation matters at Board meetings by the Interim Chief Legal Officer. Information regarding legal
proceedings can be found on pages 43 to 46.
COVID-19 pandemic
› The Board was regularly updated on the financial and operational impact of the COVID-19 pandemic on the business.
This included ensuring a continuous supply of product was available and monitoring the financial impact on the business.
› The Board was updated on the Group’s response to the COVID-19 pandemic and the steps taken to protect the welfare of the
Group’s workforce. For the majority of 2021, most of the Group’s offices remained closed. In the second half of 2021 a pilot
hybrid working model was introduced. The “Collaboration Model” provides flexible working arrangements for office-based
members of the workforce who may choose to work remotely up to two days per week and work in the office three days per
week; with two fixed collaboration days to promote engagement and connectivity.
Succession planning
› Supported by the Nomination & Governance Committee, the Board approved the appointments of Jerome Lande,
Joanna Le Couilliard, Mark Stejbach and Juliet Thompson to the Board in March 2021 and agreed a phased succession plan
for those Non-Executive Directors who were appointed on demerger. As part of this phased succession plan, Lorna Parker
stepped down as Chair of the Nomination & Governance Committee and was succeeded by Graham Hetherington.
› The Nomination & Governance Committee considered the role of Senior Independent Director following Daniel Tassé’s notification
that he would not stand for re-election at the 2021 AGM. Following review and recommendation from the Nomination & Governance
Committee, Daniel J. Phelan was appointed as Senior Independent Director following Mr Tassé’s departure.
› All matters discussed by the Nomination & Governance Committee were summarized to the Board for consideration or
approval. Further information regarding those items discussed, including changes to the Board in 2021 and succession
planning activities, can be found on pages 85 to 88.
Audit and Risk
› On the recommendation of the Audit Committee, the Board agreed to recommend the re-appointment of
PricewaterhouseCoopers LLP as the External Auditor.
› Further information regarding the Group’s approach to risk management, including the management of its principal
and emerging risks, can be found on pages 47 to 56.
› All matters discussed by the Audit Committee were summarized to the Board for consideration or approval.
Further information regarding the work of the Audit Committee, including any significant internal audit findings
in 2021 can be found on pages 75 to 84.
Indivior | Annual Report and Accounts 2021
69
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Governance and compliance
› Following recommendations from the Audit and Disclosure Committees, the Board reviewed the Annual Report and Accounts
and concluded that, when taken as a whole, it is fair, balanced and understandable and provides the information necessary
for shareholders to assess the Group’s position, performance, business model and strategy.
› The Board, supported by the Nomination and Governance Committee, reviewed the continued progress of the Group’s
Integrity & Compliance Program and approved the submission of the Annual Board of Directors’ Resolution as required by
the U.S. Department of Justice’s Resolution Agreement and the Year 1 Annual Report to the Office of the Inspector General
of Health and Human Services (OIG) under the Group’s Corporate Integrity Agreement.
› The Board received refresher training on the Group’s disclosure obligations under the Market Abuse Regulation.
› The Company Secretary provided an update on the impact of the COVID-19 pandemic on the arrangements for the 2021 AGM
as a result of the continuing social distancing measures in the UK. Attendance at the 2021 AGM was, once again, limited to
essential personnel as result of COVID-19 restrictions. The Board agreed to provide a virtual facility for shareholders to be
able to listen to the AGM proceedings and to ask questions via an online chat facility.
Investor relations
› The Chief Executive Officer and Chief Financial Officer provided an update on feedback from investors following each
quarterly results announcement.
› The Board was kept abreast of the views of shareholders during the year by management and presentations from the
Group’s brokers.
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Board Induction of Jerome Lande,
Joanna Le Couilliard, Mark Stejbach
and Juliet Thompson
In March 2021, Jerome Lande, Mark Stejbach, Juliet
Thompson and Joanna Le Couilliard were appointed
as Non-Executive Directors. Their induction program
contained a number of core elements, which included:
Induction pack
The new Directors were provided with a comprehensive
induction pack, containing key corporate documents,
governance documents and copies of recent press
releases and analysts’ notes.
Business induction
Meetings were scheduled with members of the Executive
Committee and key employees to get an understanding
of the Group’s financial and commercial operations.
Corporate governance
The new Directors attended a corporate governance
induction session, which was delivered by external
counsel and covered the role, duties and legal
responsibilities of a director, the UK Listing Regime
and other legislative and regulatory matters.
Integrity & compliance
The new Directors received training on the hallmarks
of an effective compliance program and the Board’s
obligations under the Group’s Corporate Integrity
Agreement. This session was delivered by the Chief
Integrity & Compliance Officer and the Compliance
Expert to the Board.
Legal induction
The Interim External Chief Legal Officer provided
an overview of the key litigation matters impacting
the Group.
Internal Audit Services
The VP, Chief Audit Executive provided an overview
of the internal audit function, the internal audit plan
and the function’s key priorities for 2021.
External Audit
Meetings were held with the External Audit Partner to
develop an understanding of the role of the External
Audit. This included discussions regarding the current
areas of focus and risks of the audit, significant
judgment areas and regulatory and technical updates.
Board performance evaluation
2020 Effectiveness Review
The 2020 Effectiveness Review, which was internally facilitated,
highlighted a number of areas for focus in 2021; these areas
and the actions taken during the year to address them are set
out below.
› Driving the growth of SUBLOCADE, with particular reference
to Organized Health Systems channel development (OHC);
– the Board received an update on the performance of
SUBLOCADE and development of the OHS channel at each
scheduled meeting. During the course of the year,
SUBLOCADE net revenue increased by 88%, with good
progress in the OHS channel.
› Effective implementation and oversight of the CIA and other
government agreements;
– the Nomination & Governance Committee received an
update on the Group’s Integrity & Compliance Program at
each meeting. To date, all requirements specified in the
three agreements have been met, including the filing of all
required scheduled and ad hoc reports and notifications.
› Maintaining the culture of the organization, particularly with
respect to the impact of COVID-19, and Board engagement
with employees;
– the Board reviewed the results of the 2021 culture survey;
further information can be on page 69. Daniel J. Phelan,
the designated Non-Executive Director for workforce
engagement met with members of Indivior’s Culture
Champion network during the year and the focus of that
discussion was the culture of the organization and the
challenges brought about by the COVID-19 pandemic;
further information can be found on page 34.
› The successful development of early-stage assets to create
a sustainable and diversified platform for growth;
– supported by the Science & Policy Committee, the Board
approved entering into a strategic partnership with Aelis
Farma for their leading mid-stage asset (AEF 0117) targeting
cannabis-related disorders;
› The importance of orderly succession planning for the
Non-Executive Directors and gender and ethnic diversity
was identified as an area for focus;
– in March 2021, the Group announced the appointment
of four new Non-Executive Directors, two of whom are
female. We also announced a phased and comprehensive
succession plan for those Directors who joined the Board at
its inception in November 2014; further information can be
found on pages 86 to 87.
2021/2022 Board Effectiveness Review
The Company became a member of the FTSE 350 in September
2020. The 2021/2022 external effectiveness review will be the
Board’s first externally facilitated review since it became a
member of the FTSE 350 index. Dr Tracy Long of Boardroom
Review Limited has been appointed to undertake a full
external evaluation; that review is underway and will be
completed in the first half of 2022.
Indivior | Annual Report and Accounts 2021
71
GOVERNANCEDuring the year, the Chief Executive Officer, Chief Financial
Officer and the Vice President, Investor Relations met
regularly with the Group’s major shareholders and financial
analysts to discuss matters relating to the Group’s business
strategy and current performance. Where appropriate, the
Chair, Chair of each of the Committees and Non-Executive
Directors may attend meetings with major shareholders.
The Board regularly received reports covering discussions
with major shareholders and was informed of any issues
or concerns raised during those discussions. In addition,
the Group’s corporate brokers provided reports to the
Board on the views of investors.
Analysts’ briefing notes are circulated to the Board.
This process enhances the Board’s understanding of the
views of shareholders and enables them to judge what
future action would further assist investors’ understanding
of the Group’s strategic objectives.
Annual General Meeting
The AGM provides an opportunity for shareholders to put
questions to the Board of Directors and to vote on the
resolutions set out in the Notice of Meeting. All resolutions
are voted on by way of poll, with one vote for each share held.
The results of the poll are announced to the London Stock
Exchange and published on Indivior’s website shortly after
the end of the AGM.
Prior to the AGM, the Board receives and considers corporate
governance and voting guidelines issued by the Company’s
major institutional shareholders, representative bodies and
proxy advisory organizations.
It is intended that the 2022 AGM will be a physical meeting
to be held in London with an online facility for shareholders
to listen to the meeting and submit questions virtually.
The Board will monitor the situation in relation to the AGM,
with particular regard to any changes to the UK Government
restrictions and guidance and any other factors relating to the
health and safety of shareholders and the Board, and will
change the arrangements for the AGM if deemed necessary.
C O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Board induction
New Directors receive a comprehensive, tailored induction
program, which takes into account their background,
skills and their position on the Board and Committees.
The Company Secretary facilitates the induction of Directors
and monitors ongoing training needs for the Board. Where an
existing Director takes on a new role, they receive induction
appropriate to their new role. Further information regarding
the induction of new Non-Executive Directors in 2021 is set
out on page 71.
Board accountability
The Board is responsible for the integrity of the Group’s
Annual Report and Accounts and recognizes its responsibility
to present a fair, balanced and understandable assessment of
the Group’s position and prospects.
The Board has assessed, together with the Audit and
Disclosure Committees, all information available in
considering the overall drafting of the Group’s Annual Report
and Accounts and the process by which it was compiled and
reviewed. In doing so, the Board ensured that adequate time
was dedicated to the drafting process so that linkages and
consistencies were worked through and tested. Drafts
were reviewed by knowledgeable executives and senior
management not directly involved in the year-end process.
The Board recognizes that this responsibility extends to
interim and other inside information, information required
to be presented in relation to statutory requests and reports
to regulators. In relation to these requirements, reference
is made to the Statement of Directors’ Responsibilities for
preparing the Annual Report and financial statements,
set out on pages 116 and 117.
Engagement with shareholders
The Board recognizes the importance of regular, effective
and constructive communications with its shareholders.
The principal opportunity for shareholders to engage with
the Board is at the AGM. As a result of the COVID-19 pandemic,
the Group was unable to hold its 2021 AGM in the normal
way. Attendance at the 2021 AGM was limited to essential
personnel only. Shareholders were able to submit questions
to the Board in advance of the AGM by email. In addition,
a facility was put in place for shareholders to join the meeting
virtually, allowing shareholders to listen to the proceedings
and ask questions via an online chat facility.
The Group announces its financial results on a quarterly basis,
and these were released to the London Stock Exchange via an
authorized Regulatory Information Service, and subsequently
published on the Group’s website. Results announcements
were accompanied by a presentation for analysts and
investors from the Chief Executive Officer, Chief Financial
Officer and other executives; these were webcast live and
archived on the Group’s website. These presentations
included dedicated question and answer sessions,
where attendees were invited to ask questions.
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Board Committees
The Board has established four principal Committees to
support it in fulfilling its oversight responsibilities; these
are the Audit, Nomination & Governance, Remuneration
and Science & Policy Committees.
Each of these Committees has certain delegated
responsibilities which are set out in their Terms of Reference,
which are available at www.indivior.com. The Chair of each
principal Committee reports on the activities of their
respective Committee at the following Board meeting.
Copies of all papers and the minutes of meetings of the
principal Committees are available to all Directors.
Executive Committees
In addition to the principal Committees, the Group has four
executive Committees:
Executive Committee
The Executive Committee is chaired by the Chief Executive
Officer. The Committee comprises key functional leaders from
the business and its purpose is to assist the Chief Executive
Officer in discharging his duties. The Executive Committee
meets monthly.
Biographical details of the members of the Executive
Committee are on page 62.
Integrity & Compliance Committee
The Integrity & Compliance Committee comprises all members
of the Executive Committee and is chaired by the Chief
Integrity & Compliance Officer. The Integrity & Compliance
Committee meets monthly and is responsible for overseeing
compliance with applicable laws, rules and regulations related
to Indivior’s business operations (excluding compliance with
securities regulations and financial reporting requirements).
These meetings are also attended by the independent
Compliance Expert to the Board.
Workforce engagement
Workforce voice in the Boardroom
During the year, Daniel J. Phelan, the designated
Non-Executive Director for workforce engagement,
met with members of Indivior’s Culture and Inclusion
Champion network, some of whom in attended in
person while some attended the session virtually.
The focus of the discussion was the culture of the
organization, and the biggest challenges faced by the
business. The session was facilitated by an external
facilitator, and the Culture and Inclusion Champions
provided thoughtful and candid feedback.
Overall, feedback was very positive and there continues
to be strong commitment to the Group’s vision and
Guiding Principles. The challenges brought about by the
COVID-19 pandemic had been discussed and the new
hybrid working model, which provides office-based
employees with the opportunity to work flexibly, had
been generally positively received. The Group’s
continued focus on diversity and inclusion had also
been positively highlighted.
The Board hopes to be able to increase its face-to-face
engagement activities in 2022.
Global Town Halls
Global Town Hall meetings were held quarterly.
The purpose of these events is to provide a business
update and an opportunity for employees to ask
questions and engage with senior management.
In addition, internal and external speakers are invited
to present at meetings to provide an insight into
different areas, including Strategic Priorities, business
development and the global disease state. In 2021,
external speakers included an author, patient advocate
and healthcare professional. As a result of COVID-19,
these events were held virtually.
In November 2021, Mark Crossley visited the UK Slough
office and provided an update to employees followed
by a Q&A session.
Indivior | Annual Report and Accounts 2021
73
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Governance framework
The Board is responsible for ensuring there is a robust and transparent governance framework in place. There is a clear division
of responsibilities between the Board and its Committees; each role is clearly defined and is distinct from the other.
Principal Board Committees
Oversight of financial reporting,
audit and risk
Oversight of Board composition,
succession planning,
governance and
corporate compliance
Oversight of the link of reward
to strategy
Oversight of pipeline research &
development and public policy
strategy
A
Audit Committee
N
Nomination &
Governance Committee
R
Remuneration
Committee
S
Science &
Policy Committee
Indivior Board
D
Disclosure
Committee
E
Executive
Committee
C
Integrity &
Compliance Committee
E
ESG Committee
Oversight of disclosure and
reporting requirements
and the identification of
inside information
Oversight of the implementation
of the Group’s strategic plan
and monitoring of operational
performance
Oversight of the Group’s
Integrity & Compliance Program
Development and monitoring of
the Group’s ESG strategy.
Executive Committees
Disclosure Committee
ESG Committee
The Disclosure Committee comprises the Chief Financial
Officer, the Chief Commercial & Strategy Officer, the Chief
Legal Officer, the Chief Scientific Officer and the Company
Secretary and is chaired by the Chief Financial Officer.
The Committee meets as necessary and oversees the
disclosure of information in accordance with the UK Market
Abuse Regulation and the FCA’s Disclosure Guidance and
Transparency Rules.
The Disclosure Committee receives input and advice from
relevant individuals and advisors as required. These include
the Group’s brokers and external legal counsel.
In addition to the above executive committees, given the
increasing focus on Environmental, Social and Governance
(“ESG”) matters, the Executive Committee determined to
establish a formal ESG Committee. The ESG Committee’s
Terms of Reference were formalized in January 2022 and
the Committee’s first meeting was held shortly thereafter.
The ESG Committee comprises all members of the Executive
Committee and is chaired by the Chief Manufacturing &
Supply Officer. The Chief Executive Officer has overall
responsibility for ESG matters.
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AUDIT COMMITTEE
REPORT
Juliet Thompson
Chair of the Audit
Committee
At December 31, 2021, the membership of the
Committee was as follows:
› Juliet Thompson (Chair)
› Peter Bains
› Joanna Le Couilliard
› Jerome Lande
› Mark Stejbach
Details of attendance at Committee meetings can be
found on page 63.
On behalf of the Board, I am pleased to present
the Audit Committee Report for the financial
year ended December 31, 2021.
This report provides an overview of how the Committee
operates, an insight into the Committee’s activities and
its role in ensuring the integrity of the Group’s published
financial information and the effectiveness of its risk
management, controls and related processes. This report
should be read in conjunction with the separate section
of compliance under the UK Corporate Governance Code
on page 64.
In 2022, the Committee will continue to work closely with
the management team and the rest of the Board to meet
the opportunities and challenges facing the Group and
to help enhance stakeholder value.
Juliet Thompson
Chair of the Audit Committee
Members and meetings
There have been a number of changes to the composition
of the Committee during the year.
On March 24, 2021, Juliet Thompson, Joanna Le Couilliard,
Mark Stejbach and Jerome Lande were appointed as
Non-Executive Directors and members of the Committee.
Graham Hetherington, who had remained a member
of the Committee as he was the designated member of the
Committee with recent and relevant financial experience
and competence in auditing and accounting, stepped down
as a member of the Committee upon those appointments.
Juliet Thompson and Joanna Le Couilliard are both considered
to have recent and relevant financial experience and
competence in auditing and accounting (see Directors’
biographies on pages 60 to 61).
Daniel Tassé, who had served as a member of the Committee
since November 2014, and who had served as Chair of the
Committee from November 2020, did not stand for re-election
at the Company’s 2021 AGM, and accordingly stepped down
on the conclusion of that meeting. Juliet Thompson was
appointed Chair of the Committee on May 6, 2021.
The Committee, throughout the year, invited the Chair
of the Board, Chief Executive Officer, Chief Financial Officer,
Group Controller, VP, Chief Audit Executive, the Company
Secretary, Vice President-Tax, External Audit Partner and
other representatives from management and the External
Auditor to attend Committee meetings. The Deputy Company
Secretary acts as the secretary to the Committee.
The Committee reserves the right to meet without
any of these individuals present.
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75
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
The Chair of the Committee reports to the Board, as a
separate agenda item, on the activity of the Committee and
matters of particular relevance. The Board has access to
the Committee’s papers and receives copies of the minutes
of the Committee’s meetings. For part of each meeting, the
Committee meets separately with each of the Chief Financial
Officer, VP, Chief Audit Executive and the External Auditor.
The Committee also meets privately at each scheduled
meeting without management present.
The Committee has unrestricted access to Group
documents, information, employees, and the External Auditor.
The Committee may also take independent professional
advice on any matters covered by its Terms of Reference
at the Group’s expense.
Role and responsibilities
The Committee’s principal responsibility is to oversee and give
assurance to the Board with regard to the integrity of financial
reporting, internal controls over financial reporting, risk
management, and audit arrangements. In discharging this
responsibility, the Committee, with the assistance of
management, internal audit and the External Auditor,
focused its attention in the following areas:
Financial reporting
› To monitor the integrity of the Group’s financial reporting,
including all formal announcements relating to financial
results and compliance with accounting standards.
› To inform the Board of the outcome of the Group’s internal
and external audits and explain how they contributed to the
integrity of financial reporting.
› To review the Group’s strategy for management of key
financial risks, and ensure the Group has followed
appropriate accounting policies, and made appropriate
estimates and judgments.
› To challenge, where necessary, the consistency of,
and any changes to, accounting and treasury policies,
the clarity and completeness of disclosures, any
adjustments resulting from the external audit, the going
concern assumption, the viability statement and compliance
with accounting standards.
› To review the content of the quarterly, half-yearly and
annual financial results and to advise the Board of the
integrity of each. Further information is set out on page 81.
The Committee is mindful of the processes and controls
that underpin the annual financial results, ensuring that all
contributors, the core reporting team and senior management
are fully aware of the requirements and their responsibilities.
This includes the use and disclosure of alternative
performance measures (“adjusted” or “non GAAP” measures),
and the duties of the Directors under section 172 of the
Companies Act 2006 to promote the success of the Group for
the benefit of its members as well as considering the interests
of other stakeholders which will have an impact on the
Group’s long-term success.
The Committee reviewed a draft of the Annual Report and
Accounts to facilitate input and comment. The Committee
also reviewed the financial results announcements,
supported by the work of the Group’s Disclosure Committee,
which reviews and assesses the Annual Report and Accounts
and investor communications. This work enabled the
Committee to provide positive assurance to the Board to
assist them in making the statement required by the
2018 UK Corporate Governance Code.
Matters relating to Climate-related Financial Disclosures
are detailed on pages 36 to 37.
The COVID-19 pandemic continued to have a range of
implications on risk management and corporate reporting
in the year. Key risk factors and trends have been considered
in the assessment of the Group’s principal and emerging risks
and uncertainties.
The year-end close process was impacted by the continuation
of the COVID-19 pandemic as social distancing and travel
restrictions remained in place for the majority of the year.
The Group’s employees involved in the preparation of ongoing
management information, financial reporting and supporting
the external audit worked remotely for much of the year.
The year-end close process under these restrictions benefited
from the increase in our capabilities and the efficiencies
we have developed over the year, working away from our
offices and the internal controls over financial reporting
we implemented last year to support remote working
remain in place.
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Narrative reporting
Internal Audit Services
› The Committee reviewed a draft copy of its Report for
inclusion in the Annual Report and Accounts. This was
undertaken at a Committee Meeting held in February.
Additionally, Committee Members receive a draft copy
of the Annual Report and Accounts for Board discussion
on whether, taken as a whole, it is fair, balanced and
understandable and provides the information necessary
for shareholders to assess the Group’s position
and performance, business model and strategy.
› Reviewing and approving statements to be included in the
Annual Report and Accounts concerning the going concern
and viability statements.
Risk management
› To assist the Board in relation to its robust assessment of
the principal and emerging risks facing the Group and the
prospects of the Group for the purposes of disclosures
required in the Annual Report and Accounts.
Internal financial controls
› To review the effectiveness of the Group’s internal
controls over financial reporting, including the policies
and overall processes for assessing financial control and
effectiveness of corrective action taken by management.
Further information is set out on page 82.
Fraud
› To monitor the Group’s policies, procedures and controls
for preventing bribery and money laundering.
› To monitor and review the effectiveness of the Group’s
Internal Audit Services function in the context of the
Group’s overall governance, risks and controls framework.
› To consider and review the remit of the Internal Audit
Services function, ensuring it has adequate resources and
access to all information necessary to enable the effective
performance of the function. Further information can be
found on page 8 1.
› To review progress against the Internal Audit Services
plan along with any significant findings and the tracking
of remedial actions.
External Auditor
› To oversee the relationship between the Group and the
External Auditor, advise the Board how the External Auditor
has contributed to the integrity of the Group’s financial
reporting process, and to report to the Board whether it
considers the audit contract should be put out to tender,
thereby conforming to the requirements for tendering or
rotation of the audit services contract. Further information
is set out on pages 82 to 84.
› To review and monitor the External Auditor’s objectivity and
independence, agree the scope of their work, negotiate and
agree fees paid for the audit, assess the effectiveness of the
audit process and agree the policy in relation to the
provision of non-audit services.
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77
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Activities during the year
› The Committee reviewed a preliminary draft of the 2022
The Committee has an annual work plan linked to events
in the Group’s financial calendar including standing
items that the Committee considers, in addition to any
specific matters requiring the Committee’s attention.
The Committee met a total of seven times during the year
and considers that it met with sufficient frequency to enable
it to discharge its duties effectively. Details of the principal
matters discussed during the year are set out below.
Financial reporting
Budget/Plan.
› The Committee received a presentation on US Gross to Net
analysis, from the US Vice President Finance, outlining the
Group’s approach, processes, estimates used and
judgments taken with respect to rebates and similar
arrangements when determining the ultimate amount
of revenue to be recorded.
› The Committee met with the Chief Financial Officer
following each scheduled meeting.
› The Chief Financial Officer provided an update on the
Internal Audit Services and risk
financial performance of the business at each scheduled
meeting including market guidance where appropriate.
› The Committee reviewed and recommended to the Board
the quarterly, half-yearly and annual financial results,
including any recommended updates to market guidance.
› Matters relating to going concern, with supporting
analysis, were reviewed throughout the year.
› The viability statement was reviewed by the Committee.
The viability statement can be found on page 57.
› The Committee reviewed key accounting matters to
ensure the Group followed appropriate accounting
policies and made appropriate estimates and judgments.
› The Committee reviewed letters of representation
issued to the External Auditor prior to them being
agreed by the Board.
› At each scheduled Committee meeting, the Group
Controller presented a treasury operations update
including amendments to the treasury investment policy
and the implementation of a share repurchase program,
thereby assisting the Committee’s oversight of the
Group’s capital base.
› The Committee received presentations from the
Vice President-Tax regarding key tax judgments
and amendments to the annual tax strategy,
which is available on the Group’s website.
› The Committee reviewed the Group’s strategy for the
management of key financial risks.
› The Committee agreed the Internal Audit Services plan for
2021 and reviewed and approved the 2022 Internal Audit
Services plan. Both plans factored key risks to the Group,
including the impact of the COVID-19 pandemic.
› The Committee received presentations from the VP,
Chief Audit Executive on progress and delivery against
the Internal Audit Services plan and results of Internal
Audit Services activities, including key audit and
significant findings.
› The Committee reviewed the Group’s principal risks for
inclusion in the Annual Report and Accounts and financial
results announcements. Further information regarding the
Group’s principal risks can be found on pages 47 to 56.
› The Group’s Enterprise Risk Management (ERM) program
and process was reviewed by the Committee.
› The Group’s approach to cybersecurity and the threats
posed to the Group were reviewed by the Committee, and
discussed with the Chief Information & Innovation Officer
and Senior Information Security Head.
› The Committee reviewed the effectiveness of the Internal
Audit Services function, including the annual quality
assessment of the Internal Audit Services function.
› The Committee received a presentation on the risk
landscape and the impact the COVID-19 pandemic could
have across the Group and the need to re-prioritize
resources as and when required.
› The Committee met privately with the VP, Chief Audit
Executive following each scheduled meeting.
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Governance
› The Committee received an update from the Chief
Integrity and Compliance Officer on the work of the
Group’s Integrity & Compliance function.
› The Committee reviewed the Group’s policies relating
to related party transactions, non-audit services and
non-GAAP adjusted measures and approved
amendments where appropriate.
› The Committee received notification from the Financial
Reporting Council (FRC) advising that the Company’s 2020
Annual Report and Accounts had been included in the FRC’s
Thematic Review of Companies Disclosures relating to IAS
37 provisions, contingent liabilities and contingent assets.
The FRC confirmed they had no questions or queries to
raise with the Company. The Committee noted the FRC’s
general comments regarding improving existing and future
disclosures in the Company’s Annual Reports and Accounts.
› The Committee reviewed the Group’s insurance program
and made various recommendations regarding the
2021/22 renewal planning process.
› The Committee recommended to the Board the
re-appointment of PricewaterhouseCoopers LLP
as the External Auditor.
External Auditor
› The Committee agreed the External Auditor engagement and
audit fee for 2021 as well as the external audit plan for 2021.
› The Committee considered the accounting and audit
matters from the External Auditor’s reports issued
throughout the year.
› The Committee reviewed the independence of the
External Auditor.
› The Committee received technical and regulatory
update presentations from the External Audit partner.
› The annual quality assessment of the External Auditor
was undertaken and reviewed by the Committee.
› The Committee met privately with the External Auditor
following each scheduled meeting.
Significant judgments
In preparation for each meeting, management produced
briefing papers on significant matters for review and
discussion by the Committee. Management are invited
to attend Committee meetings in order to respond
to Committee inquiries. The following areas of focus in
relation to the Group’s Annual Report and Accounts and other
judgmental accounting areas were considered and discussed
with both management and the External Auditor:
Going Concern
› In light of the impact of the COVID-19 pandemic, ongoing
compliance requirements with respect to the Corporate
Integrity Agreement, provisions relating to litigation and
IP-related claims and other legal settlements, including the
settlement reached with Reckitt Benckiser Group plc in
January 2021, and the DoJ, the Committee reviewed key
assumptions. These assumptions underpinned
management’s longer-term forecasting,
and the sufficiency and adequacy of future funding
requirements, detailing sufficiency of the Group’s liquidity
over possible near-term trading and litigation outcomes.
› Cash outflows both before and after the going concern
period under different forecasting scenarios were assessed
by the Committee. To assist, management provided detailed
financial planning analyses, detailing sufficiency of the
Group’s liquidity over possible near-term trading and
litigation outcomes. Against this background, the Committee
considered the term loan refinancing, completed in June
2021, and the flexibility to deploy cash back into the
business and return to shareholders.
› The Committee assessed the current trends and net
revenue forecasts for SUBLOCADE, PERSERIS, US SUBOXONE
Film and rest of world products, including reasonably
possible downside scenarios for SUBLOCADE.
› The Committee continued to challenge management
regarding accounting processes to support the continuation
of management's litigation strategy for unresolved legal
matters, and to ensure internal accounting is consistent
with maintaining the strategy.
› The Committee approved the disclosures in relation
to both the going concern and viability assessment, and
recommended to the Board the preparation of the financial
statements under the going concern basis. The Committee
also recommended the $100m share repurchase program;
the program was implemented in July 2021 and completed
in December 2021.
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79
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Viability statement
› The Committee has challenged management on key
judgments and sources of estimation covering a number
of areas underlying the Group’s financial statements
and results. The Committee discussed the uncertainty
and potential outcome of ongoing litigation matters the
Group faced in order to support judgments taken regarding
maintaining provisions and/or contingent liabilities, which
represent the best estimate of potential outcome. Accruals
for returns, discounts, incentives and rebates were also
discussed with the Committee. Management’s growth
forecasts for both SUBLOCADE and PERSERIS were also
considered by the Committee in conjunction with the cash
flows utilized for going concern, viability and inventory and
other asset impairment and recoverability judgments.
› Given that certain matters disclosed in the Annual Report
and Accounts are highly judgmental, the Committee has
reviewed management’s assumptions and inputs into their
analysis and development of the judgments, estimates and
disclosures, and discussed the critical nature of each with
both management and the External Auditor.
› The Committee has satisfied itself that the Group’s
accounting policies and their application by management
are appropriate. The Committee is also satisfied with both
the appropriateness of analysis performed by management,
including the judgments made and estimates used, and the
related disclosures.
COVID-19 pandemic
› The COVID-19 pandemic continues to be a worldwide crisis
which remains uncertain. Authorities continue to impose
restrictions on both a regional and local basis. Since March
2020, the Committee has considered the implications of the
COVID-19 pandemic on the Group. The Committee has
considered future performance and potential impact on the
going concern assessment and its viability statement over
the next four years.
› The Committee has also considered the financial and
accounting implications on the Group, and the Committee
has reviewed and challenged scenarios considered by
management including cash flow forecasts. The Committee
has satisfied itself that management has adequately
identified and considered all potentially significant
accounting and disclosure matters.
› Following on from the going concern assessment, including
the effect of the COVID-19 pandemic, the Committee
assessed the prospects and challenges facing the Group.
The Committee considered scenarios that could impact
future financial projections and the ability of the Group
to remain viable.
› The Committee discussed with management the
dependencies on which the viability statement was reliant,
which included, amongst other items, the future growth
of SUBLOCADE and PERSERIS, payment of existing liabilities
and debts as they come due, the Group’s overall legal
strategy associated with remaining litigation matters and
expectations for the Group’s base business.
› The Committee reviewed management’s business plan
including net revenue and cash flow forecasts considering
the impact of the COVID-19 pandemic, and the possible use
of cash reserves during the viability period. The Committee
probed management’s judgment regarding litigation risks,
and management’s sensitivity analysis to assess SUBLOCADE
growth potential.
› The Committee discussed the appropriate timeframe
applicable for the Group over which to make the viability
statement. The Committee agreed that a four-year period is
an appropriate timeframe over which to make the viability
statement. Whilst the Committee have no reason to believe
that the Group will not be viable over a longer period, a
four-year period allows the Directors to make a viability
statement with reasonable confidence whilst providing
shareholders with an appropriate longer term outlook.
› Based on the Committee’s assessment of the Group’s
prospects, management’s approach to the challenges facing
the business, including appropriate and detailed financial
disclosures in the Annual Report and Accounts referencing
possible scenarios that could impact the Group’s viability
during the assessment period, the Committee agreed there
was a reasonable expectation the Group will be able to
continue to operate and meet its liabilities as they fall due
over the next four years. Further information on the Group’s
principal risks including the viability statement are detailed
on pages 47 to 57.
Critical accounting judgments and disclosures, and key
sources of estimation
› When applying the Group’s accounting policies,
management must make a number of key judgments on the
application of applicable accounting standards, estimates
and assumptions. These judgments and estimates are
based on relevant factors.
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Monitoring the integrity of reported financial
information
Ensuring the integrity of the financial statements and
associated announcements is a fundamental responsibility of
the Committee. During the year, the Committee reviewed the
Group’s FY 2020 preliminary results announcement, the 2021
half-yearly and quarterly financial results. In doing so, these
reviews considered:
› the accounting principles, policies and practices adopted in
the Group’s financial statements, any proposed changes to
them and the adequacy of their disclosure;
› the description of performance to ensure it was fair,
balanced and understandable;
› accounting matters or areas of complexity, the actions,
estimates and judgments of management in relation to
financial reporting, and the assumptions underlying the
going concern and viability statements;
› any significant adjustments to financial reporting identified
by the External Auditor;
› cybersecurity threats posed to the overall operating
effectiveness of controls;
› tax contingencies, compliance with statutory tax obligations
and the Group’s tax strategy;
› litigation and contingent liabilities affecting the Group;
› treasury policies;
› long-term funding options; and
› COVID-19 pandemic challenges necessitating continued
financial discipline.
Internal Audit Services
Internal Audit Services plays an important role by providing
assurance and advice relating to the Group’s governance, risks
and controls. The Internal Audit Services function reports into
the Committee and has authority to review any relevant part
of the Group or its business and has a planned schedule of
reviews that coincide with the Group’s risks. The Committee is
required to assist the Board in fulfilling its responsibilities
regarding the adequacy of resourcing and the effectiveness of
Internal Audit Services to ensure it is appropriate for the
Group’s needs. Internal Audit Services also has an important
role to play in reviewing the effectiveness of internal controls
over financial reporting as detailed on page 82.
The Committee approved the 2021 Internal Audit Services
plan which is structured to align with the Group’s Strategic
Priorities and key risks. An integrated planning process is
undertaken to ensure that internal audit work is appropriately
aligned to, and coordinated with, the activities of other
functions across the Group. The Internal Audit Services plan is
dynamic to provide flexibility to respond to any change in
priorities and risks, such as the COVID-19 pandemic. At each
scheduled Committee meeting, progress against the Internal
Audit Services plan is reviewed along with significant findings
and the tracking of remedial actions. The Committee also
tracks overdue remedial actions.
To fulfill its duties in keeping under review the effectiveness
of the Internal Audit Services function, the Committee
monitored the following areas linked to Internal Audit
Services:
› reporting lines and its access to the Committee and all
Board members;
› staffing and resources;
› plans and achievements of planned activity;
› results of audits and other significant findings, the
adequacy of management’s response and the timeliness
of their resolution; and
› changes since the last annual assessment of the significant
risks and the Group’s ability to respond to changes in its
business and the external environment.
Control issues across the Group remain low and those
which occurred did not result in any material impact
on the performance of the Group. Operational and procedural
controls were tested by Internal Audit Services and were
generally effective. Nevertheless, various issues were
identified and local management acted swiftly to put
in place remediation plans, including new Standard Operating
Procedures, all of which have been or are in the process
of being implemented.
During the year, the annual quality assessment review of the
Internal Audit Services function was carried out by Lintstock,
an independent evaluation consultancy. The assessment
included input from Internal Audit Services stakeholders
across the Group including the External Auditor. The
Committee noted the review contained strong, positive
feedback which demonstrates the quality and status of the
Internal Audit Services function within the Group. One area of
feedback identified is the desire for greater communication
from the Internal Audit Services team throughout the audit
process, and this will be addressed during 2022. Additionally,
the Committee recognized that the Internal Audit Services
function currently had the necessary blend of skills and
experience and quality of leadership to deepen business
understanding and awareness of the Group. The Committee
concluded that it remained satisfied that the resourcing,
quality and expertise of the Internal Audit Services function is
effective and appropriate for the requirements of the Group.
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81
GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Internal control over financial reporting and risk
management
The Committee acknowledges its duty to assist the Board
to fulfill its responsibilities for the Group’s risk management
and internal control systems, including the adequacy and
effectiveness of the control environment, internal control
over financial reporting and the Group’s compliance with
the 2018 Code.
During the year, all business areas prepared annual operating
plans and budgets. These are regularly reviewed and updated
as necessary. Performance against budget is monitored
centrally and is discussed at Committee and Board meetings.
The cash position of the Group is monitored daily by the
treasury function.
Clear guidelines are in place for capital expenditure and
investment decisions. These include budget preparation,
appraisal and review procedures, and delegated
authority levels.
Effective controls ensure the Group’s exposure to avoidable
risk is minimized, and the Committee is cognizant of the
material controls within the Group, including, amongst other
things, that proper accounting records are maintained,
financial information used within all business areas is reliable
and up-to-date, and the financial reporting processes comply
with relevant regulatory reporting requirements.
Internal control systems are in place in relation to the Group’s
financial reporting processes for preparation of consolidated
accounts. These systems include policies and procedures that
relate to the maintenance of records which accurately and
fairly reflect transactions, provide reasonable assurance
that transactions are recorded as necessary to permit the
preparation of financial statements, require representatives
of the Group to certify that their reported information gives
a true and fair view of the state of affairs of the business and
its results for the period, and review and reconcile reported
data. The Group Controller regularly updates the Committee
on the Group’s internal control over financial reporting,
particularly as for most of the year those employees who
are engaged in providing ongoing financial reporting have
been working remotely.
Control processes are designed to manage, rather than
eliminate, the risk of assets being unprotected and guard
against their unauthorized use, culminating in the failure
to achieve business objectives. Internal controls provide
reasonable and not total assurance against material
misstatement or loss.
The Group’s Enterprise Risk Management (ERM) process is
designed to identify, assess, manage, report and monitor risks
and opportunities that may impact the achievement of the
Group’s strategy and objectives. This includes adjusting the
risk profile in line with the Group’s risk tolerances to respond
to new threats and opportunities.
To fulfill its duties, the Committee reviewed:
› medium- and longer-term strategic plans, reports
on key operational issues, tax, treasury, risk management,
and Internal Audit Services reports;
› presentations from the Chief Information & Innovation
Officer outlining the Group’s approach to IT and
cybersecurity;
› reports from Internal Audit Services at each scheduled
Committee meeting covering key audit areas and any
deficiencies in the control environment covering internal
financial control, operational, IT and risk management; and
› External Auditor’s reports to the Committee.
Accordingly, the Committee confirms its oversight of the
process for identifying, evaluating and managing risks faced
by the Group and the operational effectiveness of the
appropriate controls, all of which have been in place
throughout the year and up to the date of approval of the
2021 Annual Report and Accounts. The Committee considered
whether any matter required disclosure as a significant failing
or weakness in internal control during the year. No such
matters were identified.
Misstatements
Management and the External Auditor reported to the
Committee misstatements they had found during their work
and, after due consideration, the Committee agreed that these
misstatements were not material and that no adjustments
were required.
External Auditor
PricewaterhouseCoopers LLP (PwC) were appointed as the
Group’s External Auditor on demerger in December 2014,
and were last re-appointed by shareholders at the AGM
in May 2021. The External Audit team is led by Sarah Quinn
(External Audit Partner), who was appointed following the
conclusion of the 2016 year-end audit.
The Committee oversees the work undertaken by the
External Auditor, and is responsible for the development,
implementation and monitoring of policies and procedures
on the use of the External Auditor for non-audit services in
accordance with professional and regulatory requirements.
These policies are reviewed to ensure the Group benefits,
in a cost-effective manner, from the cumulative knowledge
and experience of the External Auditor while ensuring
the External Auditor maintains the necessary degree
of independence and objectivity. During the year,
the Committee continued to meet with the External
Auditor following Committee meetings, without members
of management being present, and reviewed key issues
within their scope of interest and responsibility. Such
meetings provided a forum for open dialog and feedback.
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Auditor effectiveness
On behalf of the Board, the Committee is responsible for
assessing the effectiveness of the audit process. This process
was in place throughout the year and post year-end up
to and including the date of approval of the Annual Report
and Accounts.
In fulfilling its responsibilities in assessing the effectiveness
of the External Auditor the Committee reviewed:
› the fulfilment by the External Auditor of the agreed audit
plan and variations from it;
› reports highlighting the significant risks and key judgments
that arose during the course of the audit and their
resolution;
› a report from the External Audit Partner at each Committee
meeting; and
› fees charged for execution of the external audit.
As in previous years, the Committee received feedback from
key internal stakeholders in assessing the effectiveness of the
External Auditor. This assessment was undertaken by Lintstock
on the quality of the External Auditor’s communication,
delivery and interaction with the various finance teams across
the Group. The results were discussed with the Committee and
the External Auditor at the Committee meeting held in
November 2021, and it was concluded that the working
relationship between the External Auditor and the various
finance teams was effective and that the audit had been
undertaken in an independent, constructive and professional
manner with appropriate challenge.
The current External Audit Partner will rotate off the Group
audit on conclusion of the 2021 year-end audit, in accordance
with professional and regulatory requirements. Both the
Committee and management discussed with the External
Auditor the need to preserve continuity of External Auditor
team members and the need to undertake a thorough
induction program for the new External Audit Partner
to ensure knowledge of the Group audit is not diminished
and audit quality maintained.
To fulfill its responsibilities for oversight of the external audit
process the Committee reviewed:
› the terms, areas of responsibility, associated duties
and scope of the audit as set out in the engagement
letter with the External Auditor;
› the overall audit plan and fee proposal;
› key accounting and audit judgments and how the External
Auditor applied constructive challenge and professional
skepticism when dealing with management;
› recommendations made by the External Auditor to the
Committee and the adequacy of management’s response;
› recent and historical performance of the External Auditor
in relation to the Group’s audits including the quality
and probity of communication with the Committee;
› the depth of understanding of the Group’s business,
operations and systems, and accounting policies and
practices; and
› the demonstration of professional integrity and objectivity
to rotate and select other key engagement partners at least
every five years or as otherwise required by applicable law
or regulation.
During the year, the External Auditor has challenged
management’s judgments and assertions regarding:
› contingent liabilities associated with outstanding litigation,
including provisioning for ongoing IP matters;
› US sales rebate adjustments and accruals; and
› focus on management’s forecasts used to support going
concern, asset recognition and recoverability of assets.
The Committee continues to review annually the
appointment of the External Auditor, taking into account
the External Auditor’s effectiveness, independence
and Audit Partner rotation, and makes a recommendation
to the Board accordingly.
Any decision to open the external audit to tender would be
taken on the recommendation of the Committee. To date,
no tender has been conducted, and there are no contractual
obligations that restrict the Group’s current choice of External
Auditor. PwC has completed their eighth year as External
Auditor to the Company and a tender process will be required
prior to the year-end 2024.
Further details of the responsibilities of the Committee
regarding the engagement of the External Auditor and the
supply of non-audit services can be found in the Committee’s
Terms of Reference.
External Auditor independence
Indivior has a formal policy in place to safeguard the
independence of the External Auditor. The Committee and the
Chief Financial Officer keep the independence and objectivity
of the External Auditor under review, and during the year the
Committee formally reviewed the independence of the
External Auditor, and believes they remained independent
throughout the year. Separately, the External Auditor has
reported to the Committee confirming its independence
throughout the year within the meaning of the regulations on
this matter and in accordance with its professional standards.
To fulfill its responsibilities to ensure the independence of
the External Auditor, the Committee reviewed:
› a report from the External Auditor describing arrangements
to identify, report and manage any conflict of interest,
and policies and procedures for maintaining independence
and monitoring compliance with relevant requirements; and
› the extent of non-audit services provided by the
External Auditor.
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GOVERNANCEExternal Auditor re-appointment
The Committee has recommended to the Board that
PricewaterhouseCoopers LLP be proposed for re-appointment
by shareholders as the External Auditor at the AGM
in May 2022.
The external audit contract will be put out to tender at least
every 10 years and the Committee has discussed the most
appropriate time to carry out the external audit tender
process, taking into account the independence, objectivity and
quality of PwC’s external audit and has concluded that, based
on current performance, it is anticipated that a competitive
tender process will commence by no later than 2023 for the
2024 year end. The Committee has concluded that a
competitive tender is in the best interests of the Company’s
shareholders as it will allow the Company to appoint the audit
firm that will provide the highest quality, most effective and
efficient audit.
The Company continues to comply with the Statutory
Audit Services for Large Companies Market Investigation
(Mandatory Use of Competitive Tender Processes and Audit
Committee responsibilities) Order 2014 for the financial
year under review.
Juliet Thompson
Chair of the Audit Committee
March 17, 2022
C O R P O R A T E G O V E R N A N C E
C O N T I N U E D
The Committee has reviewed the nature and level
of non-audit services undertaken by the External Auditor
during the year to satisfy itself that there is no effect
on their independence.
Non-audit services
The Committee and the Board place great emphasis on the
objectivity of the Group’s External Auditor in reporting to
shareholders. The Group’s policy relating to the Provision
of Non-Audit Services recognizes the criticality of the
independence and objectivity of the External Auditor and the
need to ensure independence is not impaired by the provision
of non-audit services.
The Committee, in keeping under review the nature and level
of non-audit services undertaken by the External Auditor,
recognizes it may be more beneficial for the External Auditor
to provide certain services because of its existing knowledge
of the business or because the information required is a
by-product of the audit process. In these circumstances, the
External Auditor is permitted to provide certain non-audit
services where these are not, and are not perceived to be,
in conflict with its independence.
The Committee considers non-audit services when it is in the
best interests of the Group to do so, provided they can be
undertaken without jeopardizing the independence of the
External Auditor.
The Group’s policy on non-audit fees states that, on an annual
basis, non-audit fees by external auditors must not exceed
70% of the average of the Group’s external audit fees billed
over the last three-year period. Any permitted service with
a fee of $0.05m or less is considered trivial and must be
pre-approved by the Chief Financial Officer. Any services
with a fee of more than $0.05m must first be approved
by the Committee.
Amounts paid to the External Auditor were $3.6m (2020: $3.1m)
during the year, comprising $2.7m (2020: $2.6m) for audit
services and $0.9m (2020: $0.5m) for audit-related assurance
services as set out in Note 6 to the consolidated financial
statements. In conclusion, taking into account the application
of the Provision of Non-Audit Services Policy,
the Committee is satisfied that the External Auditor was
independent at all times during the year under review.
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NOMINATION & GOVERNANCE
COMMITTEE
Graham Hetherington
Chair of the
Nomination
& Governance
Committee
At December 31, 2021, the membership of the
Committee was as follows:
› Graham Hetherington (Chair)
› Jerome Lande
› A. Thomas McLellan
› Lorna Parker
› Daniel J. Phelan
› Juliet Thompson
Details of attendance at Committee meetings can be
found on page 63.
On behalf of the Board, I am pleased
to present the Nomination & Governance
Committee Report for the financial year
ended December 31, 2021.
During the year, the Committee supported the Board in the
development of a comprehensive and phased succession plan
and in making recommendations regarding the appointment
of new Non-Executive Directors. The new appointments
broadened the Board’s range of expertise by adding
additional specialty pharmaceutical, financial and investment
experience. The Committee will continue to implement the
phased succession plan over the course of 2022, taking into
consideration the skills, experience and diversity required
to support the long-term success of the Group.
The Committee has responsibility for reviewing the Group’s
corporate governance arrangements and oversees its
Integrity & Compliance Program. As part of the settlement
with the US Attorney’s Office for the Western District of
Virginia, the Group entered into a Corporate Integrity
Agreement with the Office of Inspector General of the U.S.
Department of Health and Human Services (the “CIA”), DOJ
Compliance Measures and FTC Stipulated Order, which
present ongoing reporting and annual requirements. To
support it in its oversight of the Integrity & Compliance
Program, the Board appointed an independent consultancy,
Epsilon Life Sciences, as Compliance Expert to the Board.
The Board and the Committee will continue to oversee the
continuous development of our Integrity & Compliance
Program in 2022.
Graham Hetherington
Chair of the Nomination & Governance Committee
Members and meetings
At the invitation of the Committee, the Chief Executive Officer,
the Chief Legal Officer and the Company Secretary attended
meetings of the Committee.The Company Secretary is
secretary to the Committee. The Chief Integrity &
Compliance Officer and Compliance Expert to the Board
attend the relevant section of each Committee meeting which
relates to integrity and compliance matters. For part of each
meeting, the Committee meets privately with the Chief
Integrity & Compliance Officer and the Compliance Expert
to the Board and then also separately meets with the
Compliance Expert to the Board only.
The Chair of the Committee reports on the activities of the
Committee at the following Board meeting, and copies of the
minutes of Committee meetings are circulated to all Directors.
In May 2021, Lorna Parker stepped down as Chair of the
Committee and Graham Hetherington assumed that role.
The Committee has authority to appoint search consultants
and other advisors at its discretion.
The Committee has delegated authority from the Board,
which is set out in its Terms of Reference.
Indivior | Annual Report and Accounts 2021
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GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Roles and responsibilities
The roles and responsibilities of the Committee fall into two
key areas:
Board composition and succession planning:
› reviewing the size, composition, diversity and balance
of skills of the Board and its Committees;
› overseeing the appointment process for Directors and
making recommendations to the Board regarding
appointments to the Board and its Committees; and
› overseeing succession plans for the Board, its Committees
and for senior management positions, and ensuring
that these support the development of a diverse pipeline
for succession.
Corporate governance and compliance:
› keeping the Group’s corporate governance arrangements
under review and monitoring external corporate
governance developments;
› reviewing and evaluating additional external appointments
for the Directors of Indivior PLC and members of the
Executive Committee and conflicts of interest notified by
Directors, and making recommendations to the Board; and
› overseeing the Integrity & Compliance Program.
Director independence and conflicts of interest
Processes exist for actual or potential conflicts of interest to
be reviewed and disclosed and to make sure Directors do not
participate in any decisions where they may have a conflict
or potential conflict.
External directorships
In accordance with Provision 15 of the 2018 Code, the External
Appointments Policy requires that the Directors of Indivior
PLC receive approval from the Board prior to accepting
an external appointment. In reviewing an additional
appointment, consideration will be given to the Director’s
existing commitments, the likely time commitment of the
new role (having regard to “overboarding” guidelines) and if
the appointment is likely to give rise to a conflict of interest.
Executive Directors may hold one non-executive appointment
and members of the Executive Committee may hold one
non-executive appointment subject to the approval of the
Executive Committee. The Executive Directors do not hold
any external directorships.
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Activities during the year
During the year, the Committee considered, amongst other
items, the following matters:
Corporate governance
During the year, the Committee was kept abreast of
developments in corporate governance by the Company
Secretary. In particular, the Committee:
› considered proposed changes to the UK Listing Rules
relating to Board and senior management diversity;
› reviewed the External Appointments Policy, which
requires that all Directors of Indivior PLC receive
approval from the Board prior to accepting an additional
external appointment;
› considered the independence of the Non-Executive
Directors and their other commitments and if these
were likely to give rise to a potential conflict of interest.
On the recommendation of the Committee, the Board
confirmed that each of the Non-Executive Directors, with
the exception of Jerome Lande (who is a representative
of the Group’s largest shareholder, Scopia Capital
Management LP) remained independent;
› received an update on the Group’s data privacy program,
which included the establishment of a Data Governance
Committee and appointment of a Senior Information
Risk Owner; and
› reviewed and approved the Group’s UK Modern Slavery
Statement, and recommended to the Board that it be
approved and published on the Group’s website
(www.indivior.com).
Succession planning
Non-Executive succession
During the year, the Board broadened its range of expertise
by adding four additional Non-Executive Directors, with
significant specialty pharmaceutical, investment and
financial experience. Joanna Le Couilliard, Jerome Lande,
Mark Stejbach and Juliet Thompson joined the Board in
March 2021.
Jerome Lande is a representative director of Scopia Capital
Management LP (“Scopia”), Scopia are a significant
shareholder of the Company. An external search process
was not used in connection with Mr Lande’s appointment.
Russell Reynolds Associates, who have no other connection
with the Company or individual Directors, were engaged to
support the Committee in the identification of potential
candidates with pharmaceutical industry and recent and
relevant financial experience. Russell Reynolds is accredited
under the Enhanced Code of Conduct for Executive Search
Firms and are a signatory to the Voluntary Code of Conduct
for Executive Search Firms.
Russell Reynolds developed candidate specifications for
the roles and developed a long and shortlist of candidates.
Eight potential candidates were interviewed and following
these interviews, Joanna Le Couilliard, Mark Stejbach and
Juliet Thompson were identified as possessing the
appropriate skills, experience and expertise. Following
review of any actual or potential conflicts and confirmation
of the time commitment required, the Committee
recommended the appointments of Ms Le Couilliard,
Ms Thompson and Mr Stejbach to the Board.
At the same time, the Group announced a phased and
comprehensive succession plan for those directors who
joined the Board at its inception in November 2014. As part
of that succession plan, Lorna Parker stood down as Chair
of the Nomination & Governance Committee at the 2021
AGM and Graham Hetherington assumed that role.
A search process is currently underway to appoint an
additional Non-Executive Director and Ms Parker will remain
a Director until that appointment is made to provide a
smooth transition and continuity. As announced in March
2021, the additional Non-Executive Director will be selected
from a shortlist generated with Scopia’s input and approved
by the Board.
In line with the agreed transition plan, Daniel J. Phelan
will step down from the Board by the end of 2022 and
Dr A. Thomas McLellan will step down from the Board
by the end of 2023.
Board effectiveness review
The Committee considered the approach regarding the
review of the effectiveness of the Board, its Committees
and the individual Directors.
There were a number of new appointments to the Board in
2021, with new Board members attending their first Board
meeting in April 2021 (virtually) and their first in-person
meeting in November 2021. As a result of these changes,
the Committee agreed to recommend to the Board that
the 2021 effectiveness review be delayed to allow the new
Directors to complete their induction process and develop
their understanding of the business. Dr Tracy Long of
Boardroom Review Limited has been appointed to undertake
a full external evaluation; that process is underway and
will be completed in the first half of 2022.
Integrity & Compliance
At each meeting, the Committee received an update
from the Chief Integrity & Compliance Officer on the
Group’s Integrity & Compliance Program. The Compliance
Expert to the Board also attends these parts of the
Committee’s meeting.
For part of each meeting, the Committee meets privately
with the Chief Integrity & Compliance Officer and the
Compliance Expert to the Board and then also separately
meets with the Compliance Expert to the Board only.
Ahead of each meeting, the Committee receives the Integrity
& Compliance dashboards, which show performance across
all program areas, including:
› progress against the Integrity & Compliance key strategic
priorities for the year;
› key program enhancements, including developments
to policies and process enhancements supported
by external advisors;
› risk assessments and mitigation plans;
› details of training and workforce education activities;
› field monitoring activities;
› transparency reporting;
› reports received via the Group’s confidential reporting
hotline (EthicsLine) and subsequent investigations; and
› staffing and resourcing of the Integrity & Compliance
Department.
Further information regarding the Group’s Integrity &
Compliance program can be found on page 35.
Indivior | Annual Report and Accounts 2021
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GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Appointments to the Board
There is a formal process in place for the recruitment of new
Directors. This process will normally include the appointment
of an external search consultancy to support the Committee
in the development of a candidate specification, development
of long and shortlists, conducting of screening interviews and
taking up of references. Candidate specifications are
developed by reference to the skills matrix, which is regularly
reviewed and updated by the Committee.
Prior to recommendation, a review is undertaken of any
actual or potential conflicts and there is an assessment of the
proposed Director’s existing commitments. Following these
steps, the Committee makes a recommendation to the Board
regarding the appointment of the preferred candidate to the
Board and relevant Committees.
Diversity & inclusion
At Indivior, we value our distinctive culture and believe
it is a key source of sustainable competitive advantage.
We believe diversity and inclusion in its broadest sense
supports innovation, continuous improvement of quality,
and increased speed and efficiency in meeting the various
needs of patients, customers and stakeholders.
Our Diversity and Inclusion Policy, which applies to the Board
and our workforce, reflects our beliefs and values. Supporting
and promoting the diversity of our people is an important
priority for the Group, and we have focused on developing
an inclusive culture that values all employees regardless
of their age, disability, gender, race, sexual orientation
or other protected characteristics. We achieve this through
targeted sourcing of people from diverse backgrounds and
cultures and an ongoing focus on creating an environment
that allows our talented people to prosper.
When making new appointments, the Nomination &
Governance Committee and the Board give careful
consideration to the skills, experience and knowledge
of the potential candidates and makes recommendations
and appointments based on merit, objective criteria
and, within this context, the promotion of diversity
of gender, social and ethnic backgrounds and cognitive
and personal strengths.
During the year, there were four new appointments to the
Board, two of which are female. Whilst we believe we have
made significant strides forward, we recognize that there is
more that we need to do, and the advancement of diversity
and inclusion remains a key priority for the Committee.
A search process is currently underway to identify an
additional Non-Executive Director, as announced in
March 2021. The Committee will carefully consider
the skills, experience and diversity of potential candidates
as part of that recruitment and recommendation process.
The Board is supportive of the targets set by the Hampton
Alexander Review and Parker Review and aspires to achieve
the targets set by Hampton Alexander Review by the 2023
AGM and the Parker Review by the target date of 2024.
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There are currently three female Directors on the Board,
representing 27% of the composition of the Board. Our senior
management (the Executive Committee) is comprised of 22%
women. At senior leadership levels in the organization
(direct reports to the Executive Committee), there is 33%
female representation.
The Group’s Diversity & Inclusion Policy is available
at www.indivior.com.
Graham Hetherington
Chair of the Nomination & Governance Committee
March 17, 2022
Directors of Indivior PLC
Male: 73%
Female: 27%
Executive Committee
Male: 78%
Female: 22%
Senior leadership
Male: 67%
Female: 33%
SCIENCE & POLICY
COMMITTEE
Peter Bains
Chair of the Science
& Policy Committee
At December 31, 2021, the membership of the
Committee was as follows:
› Peter Bains
› A.Thomas McLellan
› Mark Stejbach
Details of attendance at Committee meetings can be
found on page 63.
On behalf of the Board, I am pleased to present
the Science & Policy Committee Report for the
financial year ended December 31, 2021.
This has been a significant year for the Committee, during
which it has renewed its focus to support the Board in
delivering the Group’s R&D and Medical Affairs strategies, and
initiatives relating to the Group’s Government Affairs program,
through regular dialog with key policy and opinion leaders.
The Committee will continue to assist the Board in achieving
its strategic objectives and I look forward to working with
all stakeholders both current and future.
Peter Bains
Chair of the Science & Policy Committee
Members and meetings
The Committee typically meets before scheduled meetings
of the Board. At the invitation of the Chair of the Committee,
the Chief Scientific Officer and Chief Commercial and Strategy
Officer regularly attend meetings of the Committee.
Additionally, members of the Commercial and Government
Affairs teams have also attended meetings of the Committee
during the year on an ad hoc basis.
The Deputy Company Secretary is secretary to the Committee.
Role and responsibilities
The principal role and responsibilities of the
Committee include:
› to provide assurance to the Board regarding the quality,
competitiveness and integrity of the Group’s research and
development (R&D) activities;
› to evaluate emerging issues and trends in science and
policy matters including the potential impact of wider
government policy that may affect the Group’s overall
business strategy;
› to review the scientific technology and R&D capabilities
deployed within the business;
› to assess the decision-making processes for R&D projects
and programs, and to review benchmarking against industry
and scientific best practice, where appropriate; and
› to review relevant and important bioethical issues and
assist in the formulation of, and agreement on behalf of the
Board of, appropriate policies in relation to such issues.
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GOVERNANCEC O R P O R A T E G O V E R N A N C E
C O N T I N U E D
Activities during the year
During the year the Committee:
› monitored the strategic priorities of the R&D,
Medical Affairs and Government Affairs teams
to ensure continued alignment with the strategic
objectives of the Group;
› received detailed presentations, including but not
limited to, SUBLOCADE label updates, data collection
through the RECOVER long-term study, participation in
lifecycle management studies, expansion of the US Field
Medical team, the integrated use of data and data
analytics and focused investment in other sub-disease
areas of Substance Use Disorder;
› monitored and reviewed the planning and execution of
the final SUBLOCADE post-marketing requirement study;
› monitored and reviewed the progress and development
of the Groupʼs product pipeline growth strategy and
early stage asset development opportunities including
INDV-2000: Selective OX1 receptor antagonist, INDV-1000:
Selective GABAb positive allosteric modulator and asset
opportunities associated with the Group’s ATRIGEL drug
delivery platform;
› received comprehensive briefings on the Group’s public
policy strategies with emphasis on the federal and state
landscape in the US, including legislative developments
focusing on the provision of medication assisted
treatment and drug pricing reforms;
› reviewed the revised strategy and priorities for the
Group’s Global Medical Affairs team including strategic
alignment and collaboration between the US Medical
Affairs team and the Group’s R&D team;
› received briefings and endorsed the entering into a
strategic partnership with Aelis Farma to acquire an
exclusive option to Aelis Farma’s lead asset (AEF 0117) for
the treatment of Cannabis Use Disorder;
› reviewed strategy for controlled product involvement
in the US Criminal Justice System including greater
investment and embedded policy initiatives coupled with
greater participation and delivery to health ecosystems;
› monitored the Group’s initiative focused on advancing
patient interests through innovation, advancing policies
and messaging through the “New Leaf for Patients”
initiative;
› reviewed progress of regulatory filings outside the US
with particular emphasis on SUBOXONE Film; and
› throughout the year, the Chief Scientific Officer updated
the Committee on progress of Peer-Review publications
in which the Group was involved and approving the
Peer-Review Publication Plan for 2022.
The Committee has delegated authority from the Board,
which is set out in its Terms of Reference and available
to view on the Group’s website www.indivior.com.
The Committee has authority to appoint consultants
and other advisors at its discretion.
The Committee holds a private session at each
meeting without members of the management
team being present.
The Chair of the Committee reports on the activities of
the Committee to the Board, and copies of the minutes
of Committee meetings are circulated to all Directors.
Peter Bains
Chair of the Science & Policy Committee
March 17, 2022
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D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
ANNUAL REMUNERATION STATEMENT
Daniel J. Phelan
Chair of the
Remuneration
Committee
Dear Shareholders,
On behalf of the Board, I am pleased to present the Directors’
Remuneration Report for the financial year ended December
31, 2021. This report is split into three sections:
› the Annual Remuneration Statement, which summarizes the
remuneration outcomes in 2021 and how the Remuneration
Policy will be operated in the current financial year;
› the Annual Report on Remuneration, which describes
how the Remuneration Policy was implemented in 2021 and
how it will be operated in the current financial year; and
› a summary of the Directors’ Remuneration Policy, which was
approved by shareholders at the AGM on May 6, 2021.
My colleagues on the Remuneration Committee and I hope
that you find the report clear, transparent and informative,
and we look forward to your support on the resolution
relating on the Directors’ Remuneration Report at the 2022
AGM. The Committee believes the Remuneration Policy will
continue to support and drive our long-term growth ambitions
and deliver returns on behalf of shareholders.
All payments to Directors during the year were made in
accordance with the Remuneration Policy.
Remuneration policies and practices
We continue to implement the Remuneration Policy approved
at the 2021 AGM with the remuneration philosophy of aligning
the incentives of senior executives with the Group’s
Strategic Priorities.
Our Remuneration Policy is designed to support our Strategic
Priorities, the long-term sustainable success of the Group,
and our purpose of pioneering life-transforming treatments.
Our approach remains the careful balancing of our position
as a primarily US-based business that competes for talent
in a global market, but one which is UK listed and operates
within the UK governance framework. We recognize that our
remuneration structure is different in some respects from a
“typical” UK company; however, the Committee has carefully
designed the structure to balance these factors and to
support in attracting and retaining the talent needed to
deliver on our strategic ambitions.
A summary of the Remuneration Policy is on pages 110 and 111
of this Annual Report and Accounts.
2021 business performance
The COVID-19 pandemic continued to impact business
operations and market conditions in 2021. As COVID-19
restrictions began to abate, we saw signs of recovery and
growth in our business, particularly in the growth of
SUBLOCADE where the team generated consistent
quarter-on-quarter net revenue growth throughout
the year.
This positive operational performance enabled the Group to
grow net revenues to $791 million and adjusted net income to
$140 million. Our continued strong cash generation enabled
us to complete a $100 million share repurchase program
during the year and, over the course of 2021, the Group’s
share price increased by 136% (from 108.8p at December 31,
2020, to 257.0p at December 31, 2021).
2021 remuneration outcomes
The Group’s strong performance in 2021 resulted in a positive
outturn in respect of the 2019-2021 Long-Term Incentive Plan
and 2021 Annual Incentive Plan. This was the first time since
2018 (in respect of the 2015-2017 performance period) that
there has been any outturn under the Group’s Long-Term
Incentive Plan and the first year since 2020 (in respect of the
2019 AIP) where there has been any outturn under the Annual
Incentive Plan for the Executive Directors. The Committee
believes this year’s outturn reflects the positive performance
and significant progress the Group has made during the year.
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The Committee believes that the outcomes of the 2019-2021
Long-Term Incentive Plan and 2021 Annual Incentive Plan
accurately reflected the performance of the Group over the
relevant performance periods. Consequently, the Committee
concluded that it was not necessary to exercise its discretion
to override the formulaic outcomes under the 2019-2021
Long-Term Incentive Plan and 2021 Annual Incentive Plan.
Annual Incentive Plan
The 2021 Annual Incentive Plan measures were focused on
financial performance; global net revenue for SUBLOCADE and
US net revenue for PERSERIS; weighted 80%/20% respectively,
reflecting the key strategic focus on SUBLOCADE.
The Group continued to make significant progress in driving
the growth of SUBLOCADE, delivering consistent quarter-on-
quarter net revenue growth, achieving global net revenue of
$244 million in 2021 (2020: $130 million), which exceeded the
maximum target set. PERSERIS continued to make progress,
but growth was stymied by COVID-19 and the ability to access
the US healthcare system with a relatively small salesforce.
US net revenue of $17 million (2020: $14 million) was between
threshold and target. Overall, this resulted in an outturn of
88.5% of the maximum bonus payable.
In line with our Remuneration Policy, 75% of the bonus
earned was delivered in cash, and 25% has been deferred
into conditional shares for a period of two years under
the Deferred Bonus Plan.
Long-Term Incentive Plan
For Long-Term Incentive Plan awards granted in 2019,
and which vested in March 2022, the year ended December 31,
2021 was the final year of the three-year performance period.
These awards were subject to two separate measures (each
with 50% weighting): 1) relative Total Shareholder Return (TSR)
versus the constituents of the FTSE 250 Index excluding
investment trusts and 2) relative TSR versus the constituents
of the S&P 1500 Pharmaceutical and Biotech Index. Indivior
ranked between the 50th and 75th percentiles against each
of these TSR peer groups, resulting in the vesting of 67.8% of
the maximum award.
The award held by Mark Crossley, Chief Executive Officer,
will be released at the end of the two-year post-vesting
holding period.
Further information regarding the targets and remuneration
outcomes are set out in the Annual Report on Remuneration
on pages 96 to 110.
Implementation of Remuneration Policy for
Executive Directors in 2022
Base salary
The Executive Directors received a base salary increase of 4%
effective January 1, 2022. The Committee carefully considered
the increases in base salary and concluded that these were
appropriate given that they were aligned with the average
increase for the wider workforce.
Annual Incentive Plan
The structure of the Annual Incentive Plan remains unchanged
in 2022, with 75% of any bonus payment delivered in cash and
25% to be deferred into conditional shares for a period of two
years. The metrics will remain focused on the key strategic
growth drivers for the business: global net revenues for
SUBLOCADE and US net revenues for PERSERIS.
Long-Term Incentive Plan
Awards granted under the Long-Term Incentive Plan in 2022
will be subject to relative TSR versus the constituents of the
FTSE 250 (excluding investment trusts) and relative TSR versus
the constituents of the S&P 1500 Pharmaceutical and Biotech
Index, each with equal weighting. The Committee believes that
relative TSR remains a relevant metric as it is directly aligned
with the interests of shareholders. The use of two relative
TSR comparator groups is intended to balance the fact that
Indivior is a FTSE 250 listed company, but also recognizes
that Indivior operates within a specialized sector, where the
majority of its direct peers are listed in the US. The awards
granted to the Executive Directors in 2022 will be subject to
an additional two-year holding period following the end of the
three-year performance period. Further details can be found
on page 101.
ESG metrics
The Committee has carefully considered the inclusion of ESG
metrics in the Group’s annual and long-term incentive plans.
The Committee is fully aligned and supportive of developing
metrics for inclusion, but has determined that the Group’s ESG
strategy is not yet sufficiently mature to enable specific and
measurable targets to be included for 2022. The Committee
is committed to including ESG metrics in the Group’s annual
and/or long-term incentive plans in 2023.
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Engagement with shareholders has been ongoing since
the 2021 AGM and we have consulted with our largest
shareholders regarding the votes against these resolutions.
Following our consultation, we published an Update
Statement on our website in October 2021. The Committee
is grateful for the engagement and feedback received and
greatly values the views of our shareholders and their
representatives. Further information regarding the voting
outcome at the 2021 AGM, the Committee’s engagement
with shareholders during the year and their feedback
can be found on page 109.
2022 Annual General Meeting
We hope to receive your support for the Directors’
Remuneration Report at our AGM in May 2022.
Daniel J. Phelan
Chair of the Remuneration Committee
March 17, 2022
Shareholding requirements and post-cessation
holding requirements
Our executive shareholding requirements are significantly
higher than UK market practice. Executive Directors are
required to hold 1,500,000 shares or shares with a value
equivalent to 400% of salary (whichever is the lower),
aligned with the annual LTIP opportunity. They are expected
to achieve this holding within five years of the date of
appointment to their current role. Executive Directors are also
required to hold Indivior shares equal to their incumbent
shareholding requirement (or actual shareholding if lower)
for two years post departure.
At December 31, 2021, the Chief Executive Officer held shares
with a value equivalent to 211% of base salary and the Chief
Financial Officer held shares with a value of 73% of base
salary. They both have until 2025 to achieve their respective
shareholding requirements.
All-employee plans
The Group operates all-employee share plans in the US and
UK. The Executive Directors are not eligible to participate in
the US Employee Stock Purchase Plan, which is open to
US employees who do not participate in the Long-Term
Incentive Plan.
Shareholder engagement
The Committee is committed to aligning the interests of the
Executive Directors with shareholders and will continue to
take into account their feedback when making decisions in
respect of our remuneration practices.
The 2020 Directors’ Remuneration Report received
a 38.3% vote against and the resolution to approve my
re-appointment received a 21.5% vote against at the 2021
Annual General Meeting. We understand that there were
concerns about the approach taken in relation to the
termination arrangements for the former Chief Executive
Officer, Shaun Thaxter. While the Committee and the Board
are confident the right decision was made, we acknowledge
and understand that a significant number of shareholders
were concerned about the approach taken.
Indivior | Annual Report and Accounts 2021
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GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
REMUNERATION AT A GLANCE
Year ended 31 December 2021
Proposed implementation for 2022
Base
Salary
Base salaries effective 1 January 2021
Mark Crossley
Ryan Preblick
$775,000
$480,000
Pension
and
Benefits
Profit-sharing contributions of 4% of base salary
plus any Company match of 75% on elected
deferrals up to 4.5% of base salary provided
to Mark Crossley and Ryan Preblick, in line
with the wider workforce.
Other benefits provided in line with policy.
Base salaries were increased by 4% effective
January 1, 2022, in line with wider workforce
increases, as follows:
Mark Crossley
Ryan Preblick
$806,000
$499,200
The pension benefits of the Executive
Directors are aligned with those of the
wider US workforce.
Benefits include healthcare, car allowance
and life and disability insurance.
No changes will be made to benefits and
pension arrangements for 2022.
AIP
Performance against the AIP targets set at the
start of 2021 was as follows:
The maximum award for 2022 remains
unchanged:
Measure
Weighting
Outturn
(as a % of
maximum)
1. Mark Crossley – 200% of salary
2. Ryan Preblick – 120% of salary
Global net revenue –
SUBLOCADE
US net revenue –
PERSERIS
Outturn
80%
80.0%
20%
8.5%
88.5%
The performance measures are unchanged
from 2021 as follows:
Measure
Global net revenue – SUBLOCADE
US net revenue – PERSERIS
Weighting
80%
20%
25% of any bonus amount will be deferred
into conditional shares for two years under
the Deferred Bonus Plan.
The maximum number of shares to be
awarded is the lower of 400% of base salary
and 1,500,000 shares.
Performance measures remain unchanged
from the previous award:
Measure
TSR (FTSE 250)
TSR (S&P 1500 Pharma & Biotech)
A two-year holding period will apply
to vested awards.
Weighting
50%
50%
LTIP
For awards granted in 2019, performance
measures and outcomes were as follows:
Measure
TSR (FTSE 250)
TSR (S&P 1500 Pharma &
Biotech)
Outturn
Outturn
(as a % of
maximum)
Weighting
50%
43.8%
50%
24.0%
67.8%
Awards granted in 2021
The following awards were granted to Executive
Directors in 2021:
Measure
Mark Crossley
Ryan Preblick
Measure
TSR (FTSE 250)
% of base
salary
No. of shares
under award
348% 1,500,000
400% 1,068,329
Weighting
50%
50%
TSR (S&P 1500 Pharma & Biotech)
A two-year holding period applies to vested awards.
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UK Corporate Governance Code: Provision 40
When developing the 2021 Remuneration Policy and considering its proposed operation for 2022, the Committee was mindful of,
and feels it has appropriately addressed, the following factors set out in the UK Corporate Governance Code:
Clarity
Predictability
The Committee welcomes open and frequent dialog with
shareholders on our approach to remuneration. During the course
of the year, shareholders were consulted to gather feedback
and understand their views on our approach to remuneration,
including shareholder feedback in relation to the votes against
the Remuneration Report and re-appointment of Daniel Phelan
received at the 2021 AGM.
A focus group session, involving members of Indivior’s Culture &
Inclusion Champions Network, was held during the year to review
executive remuneration arrangements and their alignment with
wider pay policy. The feedback from that session was considered
by the Committee and will be used to guide future engagement
sessions.
Simplicity
We believe the remuneration arrangements for Executive Directors,
as well as those throughout the organization, are simple in nature
and well understood by both participants and shareholders.
The purpose, structure and strategic alignment has been clearly
laid out in the Remuneration Policy.
Risk
The Committee considers that the structure of incentive
arrangements does not encourage inappropriate risk-taking.
Performance targets for incentive arrangements are set to reward
delivery of the Group’s strategy, which is set in line with the Group’s
risk appetite.
AIP deferral, the LTIP holding period and our shareholding
requirement, including post-cessation holding, provide a clear link
to the ongoing performance of the business and the experience of
our shareholders. Malus and clawback provisions also apply to the
AIP and the LTIP.
Our Remuneration Policy contains details of threshold, target
and maximum opportunity levels under our AIP and LTIP, with
actual outcomes dependent on performance achieved against
predetermined measures and target ranges. This is illustrated
by the scenario charts, which can be found on page 89 of the
2020 Annual Report and Accounts.
Proportionality
Our performance measures and target ranges under the AIP and
LTIP are aligned with the Group’s strategy and with shareholders’
interests over the longer term.
Under the AIP and LTIP, discretion may be applied where formulaic
outturns are not considered reflective of underlying Group
or individual performance. The Committee has exercised this
discretion in recent years to reduce the outcomes under the
2018 AIP, the 2017-2019 LTIP and 2018-2020 LTIP to zero.
Alignment to culture
The Remuneration Policy has been designed to support the delivery
of the Group’s key Strategic Priorities and is aligned to Indivior’s
purpose, values and culture.
All employees are entitled to participate in the pension scheme.
The pension provided to the Executive Directors is aligned to the
wider US workforce rate.
Indivior | Annual Report and Accounts 2021
95
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C O N T I N U E D
ANNUAL REPORT
ON REMUNERATION
This Directors’ Remuneration Report has been prepared in accordance with the provisions of the Companies Act 2006 and
Schedule 8 of the Large and Medium-sized Companies and Groups (Accounts and Reports) Regulation 2008 (as amended),
the UK Corporate Governance Code (the “Code”) and the Financial Conduct Authority’s UK Listing Rules and Disclosure Guidance
and Transparency Rules.
The following report outlines our remuneration framework, how the Remuneration Policy was implemented in 2021, and how the
Committee intends to apply the Policy in 2022. This Annual Report on Remuneration, together with the Annual Remuneration
Statement from the Chair of the Committee, will be submitted to an advisory shareholder vote at the 2022 AGM. There were no
deviations from the procedure for the implementation of the Remuneration Policy during the year.
The Remuneration Committee
All members of the Committee are considered to be independent for the purposes of the Code, with the exception of the
Chair of the Board, who was independent on appointment. All members of the Committee exercise independent judgment
and discretion when authorizing remuneration outcomes, and they do not have a personal financial interest, other than as
shareholders, in the matters considered by the Committee. The Committee’s Terms of Reference require that the Chair of the
Committee should have served on a remuneration committee for at least 12 months prior to appointment.
Meetings
Only members of the Committee have the right to attend Committee meetings. The Company Secretary acts as secretary
to the Committee. At the invitation of the Committee, the Chief Executive Officer, Jon Fogle (Chief Human Resources Officer),
Diego Castro Albano (Global Compensation and Benefits Director), and Kathryn Hudson (Company Secretary) attended meetings
and provided advice to the Committee. The Committee meets with the advisors to the Committee at each meeting without
management present.
Members of the Committee and any person attending its meetings do not participate in and are not involved in deciding their
own remuneration outcomes.
The Chair of the Committee reports on the activities of the Committee at the following Board meeting, and copies of the minutes
of Committee meetings are circulated to all Directors.
Advice provided to the Remuneration Committee
Deloitte LLP were appointed as advisor to the Committee in December 2014, following a review undertaken in advance of the
Company’s listing on the London Stock Exchange. Deloitte LLP is a member of the Remuneration Consultants Group and, as such,
voluntarily operates under the code of conduct in relation to executive remuneration consulting in the UK. Fees for advice
provided to the Committee for the year, charged on a time spent basis, were £69.9k. Deloitte LLP also provided other employee
and tax-related services to the Group during the year. This included payroll support for the Non-Executive Directors and
tax-return support in respect of the Executive Directors’ US and UK taxable income.
Willis Towers Watson also provided the Committee with benchmarking information during the year and their fees in respect
of this were $59.9k. Willis Towers Watson also provided benefits consulting support in the US during the year.
The Committee reviews its relationships with its advisors periodically and is satisfied that the advice provided by Deloitte LLP
and Willis Towers Watson is objective and independent.
At December 31, 2021, the membership of the
Committee was as follows:
› Daniel J. Phelan
› Graham Hetherington
› Joanna Le Couilliard
› Lorna Parker
Details of attendance at Committee meetings can be
found on page 63.
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Role and responsibilities
Indivior’s remuneration policies and practices are designed to promote the Group’s purpose and its long-term sustainable
success. The Committee’s role is to assist the Board of Directors in fulfilling its oversight responsibility by ensuring that
Remuneration Policy and practices reward fairly and responsibly, are linked to corporate performance, and take account
of the generally accepted principles of good governance.
The Committee has delegated authority from the Board for determining the policy for Executive Director remuneration and
setting remuneration for the Chair, Executive Directors and senior management. This delegated authority is set out in the
Committee’s Terms of Reference.
On behalf of, and subject to approval by, the Board, the Committee primarily:
› sets and regularly reviews the Group’s overall remuneration strategy;
› determines the Remuneration Policy for senior management; and
› in respect of senior management sets, reviews and approves:
• remuneration policies, including the Annual and Long-Term Incentive Plans;
• individual remuneration and compensation arrangements;
• participation in the Group’s Annual and Long-Term Incentive Plans; and
• the targets for the Annual and Long-Term Incentive Plans.
Key activities during the year
During the year, the Committee:
› considered the voting outcomes in respect of the 2020 Annual Report on Remuneration and the re-appointment
of Daniel J. Phelan at the 2021 Annual General Meeting and engaged with shareholders to understand their views and
concerns. The Board subsequently approved the publication of an Update Statement on the Group’s website in October 2021;
› reviewed the Group’s executive remuneration arrangements in line with the 2021 Remuneration Policy;
› reviewed and agreed the outturn in respect of the AIP for the 2020 financial year and LTIP awards granted in 2018;
› reviewed and approved the targets and measures in respect of the 2022 AIP and the LTIP awards granted in March 2022;
the measures under the LTIP and AIP are unchanged from the prior year;
› reviewed the progress of the Executive Directors and members of the Executive Committee against their shareholding
requirements;
› considered the changes in the regulatory and corporate governance environment and emerging trends in executive
remuneration, with particular reference to the increasing focus on the inclusion of ESG metrics in executive remuneration plans;
› reviewed participation rates for the Group’s all-employee share plans;
› considered the approach in respect of engagement with the workforce on executive remuneration and its alignment with wider
pay policy. The Committee agreed that a focus group session be held and subsequently considered the feedback from that
session; and
› reviewed workforce remuneration arrangements and related policies and their alignment with Indivior’s culture and executive
remuneration arrangements.
Indivior | Annual Report and Accounts 2021
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Single total figure of remuneration for the Executive Directors (audited)
The table below sets out the remuneration of the Executive Directors for the financial year ended December 31, 2021, and
comparative figures for the financial year ended December 31, 2020 (where applicable).
Executive Directors
Fixed pay
Base salary
Taxable benefits3
Pension benefits
Total fixed pay
Variable pay
AIP5
LTIP
Total variable pay
Total pay
Mark Crossley
Ryan Preblick
2021
$'000
775.0
53.7
20.8
849.5
1,371.8
2,888.76
4,260.4
5,109.9
2020
$'000
674.91
61.4
24.2
760.5
–
–
–
2021
$'000
480.0
51.5
17.9
549.4
509.8
197.97
707.6
760.5
1,257.0
2020
$'000
55.42
6.3
–4
61.7
–
37.5
37.5
99.3
Note: Totals may not sum up due to rounding.
1. Mark Crossley was appointed Chief Executive Officer on June 29, 2020, and his base salary increased from $571,650 to $775,000; his base salary in 2020
represents his pro-rated salary during the year.
2. Ryan Preblick was appointed Chief Financial Officer and Executive Director on November 19, 2020, with a base salary of $480,000. His base salary shown is
for the period November 19 to December 31, 2020.
3. Taxable benefits included a car allowance ($19.5k) and medical cover ($16.6k for Mark Crossley and $25.6k for Ryan Preblick).
4. The Company had contributed the maximum amount permitted under Ryan Preblick’s pension arrangements prior to his appointment as Chief Financial
Officer and Executive Director, and consequently there were no further contributions made between the date of his appointment and December 31, 2020.
5. The AIP is paid 75% in cash, with the remaining 25% deferred into conditional shares for two years under the Deferred Bonus Plan.
6. The LTIP awards granted to Mark Crossley in March and August 2019 vested on March 5, 2022, will be released at the end of the two-year post-vesting
holding period.
The value of the award has been estimated based on the number of shares vesting (830,618) at the mid-market closing price of Indivior shares on
December 31, 2021 (257.0p), and converted to US$ using the GBP/US$ exchange rate on December 31, 2021 (GB£1:US$1.3532).
7. The LTIP award granted to Ryan Preblick in March 2019 vested on March 5, 2022. The value of the award has been estimated, based on the number of
shares vesting (56,895) at the mid-market closing price of Indivior shares on December 31, 2021 (257.0p), and converted to US$ using the GBP/US$
exchange rate on December 31, 2021 (GB£1:US$1.3532).
Base salary
The Executive Directors did not receive a base salary merit increase as part of the 2020/21 annual review cycle, in line with the
wider workforce. The Executive Directors received a base salary increase of 4% effective January 1, 2022. The Committee carefully
considered these increases in base salary and concluded that these were appropriate given that they were aligned with the
average increase for the wider workforce. The annual base salaries for the Executive Directors as at January 1, 2022 and January
1, 2021 are set out below.
Executive Directors
Mark Crossley
Ryan Preblick
Taxable benefits
Base salary at
January 1, 2022
$’000
Base salary at
January 1, 2021
$’000
% increase on
prior year
806.0
499.2
775.0
480.0
4%
4%
Taxable benefits consist primarily of healthcare, car allowance, life and disability insurance and professional support for the
completion of US and UK tax returns.
Pension benefits
Profit-sharing contributions were suspended from January 1, 2021 to September 30, 2021 for all US employees, including Mark
Crossley and Ryan Preblick, as part of certain cost initiatives implemented in response to the COVID-19 pandemic. In the period
between October 1, 2021 and December 31, 2021, Mark Crossley received pension contributions consisting of profit-sharing
contributions of $7,750 (4% of base salary) and Company match of $13,050 (75% on elected deferrals up to 4.5% of base salary).
Ryan Preblick received pension contributions consisting of profit-sharing contributions of $4,800 (4% of base salary ) and
Company match of $13,050 (75% on elected deferrals up to 4.5% of base salary).
No changes have been made to the pension arrangements for 2022. The pension benefits of the Executive Directors remain fully
aligned with those of the wider US workforce.
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Annual Incentive Plan (AIP) (audited)
AIP 2021
The maximum AIP opportunity for the Chief Executive Officer is 200% of base salary. The maximum AIP opportunity for the
Chief Financial Officer is 120% of base salary.
The Committee set stretching performance targets in the context of the business plan for 2021 and taking account of external
forecasts. These targets were set by reference to the key strategic drivers for the business: global net revenues for SUBLOCADE
and US net revenues for PERSERIS. For threshold performance, 12.5% of the maximum bonus would be paid, for target
performance, 50% of the maximum bonus would be paid, and 100% of the maximum bonus would be paid for the delivery of
exceptional performance significantly above both internal and external expectations. The outturn is calculated on a straight-line
basis between threshold and target, and between target and maximum.
The table below provides an overview of the performance against the targets set in respect of the two financial metrics set by
the Committee.
Measure
Global net revenue – SUBLOCADE
US net revenue – PERSERIS
Total
Performance targets
Weighting
Threshold
$m
80%
20%
100%
180
15
Target
$m
200
18
Maximum
$m
Achieved
$m
Outturn as a
% of maximum
220
21
244
17
80.0%
8.5%
88.5%
Overall performance resulted in a formulaic outturn of 88.5% of maximum. 25% of the 2021 AIP bonus payment has been
deferred into conditional shares for two years under the Deferred Bonus Plan (see 'Deferred Bonus Plan (DBP) Awards (audited)'
below.
AIP 2022
The Chief Executive Officer and Chief Financial Officer will have a maximum bonus opportunity under the AIP of 200% and 120%
of base salary respectively.
The Committee has considered the key strategic objectives for the business and has aligned the performance measures for the
2022 AIP with these. Consequently, the targets for 2022 will be focused on accelerating the global growth of SUBLOCADE and
advancing PERSERIS in the US, with the majority of the weighting on SUBLOCADE.
Bonuses for 2022 will be based on the following measures and weightings:
Measure
Global net revenue – SUBLOCADE
US net revenue – PERSERIS
Weighting
80%
20%
The performance targets for 2022 have not been disclosed as they are considered to be commercially sensitive.
However, we commit to disclosing the performance targets retrospectively in next year’s Annual Report on Remuneration.
In line with our Remuneration Policy, 75% of any bonus amount will be delivered in cash and 25% will be deferred into
conditional shares for two years under the Deferred Bonus Plan.
Deferred Bonus Plan (DBP) Awards (audited)
In line with the Remuneration Policy, 25% of the 2021 bonus was deferred into conditional shares under the DBP. The deferred
conditional share awards vest after two years subject to continued employment as well as malus provisions.
Executive Directors
Mark Crossley
Ryan Preblick
Date of grant
Mar 15, 2022
Mar 15, 2022
No of shares
under award1
Closing share
price at date
of grant
Face value
$’0002
Vesting date
96,077
35,703
269.8p
269.8p
356.2
132.4
Mar 15, 2024
Mar 15, 2024
1. The market value used to determine the number of shares under award was 274.0p, being the mid-market closing price of Indivior shares on the business
day immediately preceding the date of grant.
2. The face value of the awards have been calculated using the closing share price on the date of grant and converted to US$ exchange rate on December
31, 2021 (US$1.3532).
Indivior | Annual Report and Accounts 2021
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C O N T I N U E D
Long-Term Incentive Plan (LTIP) Awards (audited)
2019-2021 LTIP Awards
In 2019, the Committee determined that the quantum of awards to be granted under the LTIP would be reduced by 35%,
reflecting the decline in the Company’s share price between 2018 and 2019. In March 2019, Mark Crossley was granted an LTIP
award with a value equivalent to 325% of base salary (reduced by 35% from the maximum amount of 500% base salary under
the 2018 Remuneration Policy). In August 2019, Mr Crossley was granted an additional award to reflect his increased base salary
following the broadening of his responsibilities and promotion to Chief Financial & Operations Officer. This additional award
was calculated on his pro-rated base salary for the year, and calculated by reference to the share price used to determine the
March 2019 award.
Executive Director
Mark Crossley
Date of grant
No. of shares
under award
at maximum
Closing share
price at date
of grant
Face value
$’0001
Vesting date
Release date
Mar 5, 2019
1,180,880
Aug 8, 2019
44,222
108.4p
58.4p
1,697.8 Mar 5, 2022 Mar 5, 2024
34.3 Mar 5, 2022 Mar 5, 2024
1. The face value of the awards was calculated using the closing share price on the date of grant and converted to US$ using the GB£/US$ exchange rate on
December 31, 2019 (GB£1:US$1.3263).
The measures set and performance against those measures for the awards granted to Mark Crossley were as follows:
Measure
Relative TSR vs. the constituents of the FTSE 250 excluding investment trusts
Relative TSR vs. the constituents of the S&P 1500 Pharmaceutical and Biotech Index
Outcome
Weighting
(% of award)
50%
50%
Outturn
(as a % of
maximum)
43.8%
24.0%
67.8%
The awards remain subject to a two-year post vesting holding period and will be released in March 2024.
2021-2023 LTIP Awards
Under the 2018 Remuneration Policy, the Executive Directors would ordinarily have been granted annual LTIP awards with
a value of 500% of base salary. For the 2021-2023 awards, the Committee determined to grant awards in line with the 2021
Remuneration Policy in advance of its approval by shareholders at the 2021 AGM. On March 1, 2021, the Chief Executive Officer
was granted an award over 1,500,000 shares (348% of base salary), being the maximum cap under the 2021 Remuneration Policy.
The Chief Financial Officer was granted an award over 400% of base salary.
Executive Director
Date of grant
No. of shares
under award at
maximum1
Closing share
price at date
of grant
Face value
$’0002
Performance period
Vesting date
Release date3
Mark Crossley
Ryan Preblick
Mar 1, 2021
1,500,000
Mar 1, 2021
1,068,329
129.2p
129.2p
$2,622.5
Jan 2021–Dec 2023 Mar 1, 2024 Mar 1, 2026
$1,867.8
Jan 2021–Dec 2023 Mar 1, 2024 Mar 1, 2026
1. The market value used to determine the number of shares subject to awards was 128.2p, being the average mid-market closing price of Indivior shares on
the five business days immediately preceding the date of grant on March 1, 2021.
2. The face values of the awards have been calculated using the closing share price on the date of grant and converted to US$ using the GB£/US$ exchange
rate on December 31, 2021 (GB£1:US$1.3532).
3. Awards granted to the Executive Directors are subject to a post-vesting holding period of two years.
4. Conditional awards include the right to receive an amount equal in value to any dividends payable on the number of vested shares between the date of
grant and the release date.
The vesting of these awards is subject to the achievement of the following performance measures.
Measure
Weighting
Rationale for metric
Relative TSR vs. FTSE 250 excluding
investment trusts
Relative TSR vs. S&P 1500
Pharmaceutical and Biotech Index
50%
50%
Provides alignment with shareholders through the relative outperformance
of other UK listed companies.
Provides alignment with shareholders through the relative outperformance
of direct sector peers who are subject to similar market influences.
1. 12.5% of the maximum award will vest for Indivior being ranked median in comparison to the respective peer group, and 100% of the maximum award will
vest for being ranked upper quartile or above. The award will vest on a straight-line basis between median and upper quartile, with none of the awards
vesting if Indivior is ranked below median.
Relative TSR performance against each comparator group will be measured over three financial years (2021-2023). The 2021-2023
LTIP awards are subject to an additional two-year holding period following the end of the three-year performance period.
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2022-2024 LTIP Awards
On March 1, 2022, awards were granted to the Chief Executive Officer and Chief Financial Officer over shares with a value
equivalent to 400% of base salary.
Executive Director
Mark Crossley
Ryan Preblick
Date of grant
Mar 1, 2022
Mar 1, 2022
No. of shares
under award
at maximum1
Closing share
price at date
of grant
Face value
$’0002
Performance period
Vesting date
Release date
878,498
544,102
280.6p
280.6p
3,335.7
Jan 2022–Dec 2024 Mar 1, 2025
Mar 1, 2027
2,066.0
Jan 2022–Dec 2024 Mar 1, 2025
Mar 1, 2027
1. The market value used to determine the number of shares subject to awards was 274.12p, being the average mid-market closing price of Indivior shares
on the five business days immediately preceding the date of grant on March 1, 2022.
2. The face values of the awards have been calculated using the closing share price on the date of grant and converted to US$ using the GB£/US$ exchange
rate on December 31, 2021 (GB£1:US$1.3532).
The Committee considered the LTIP metrics in the current business context and determined that the performance measures
for 2022-2024 LTIP awards will remain focused on shareholder returns. One half will be based on relative ranked TSR versus
the FTSE 250 excluding investment trusts, and the other half will be based on relative ranked TSR versus the S&P 1500
Pharmaceutical & Biotech Index. The use of two relative TSR comparator groups is intended to balance the fact that Indivior
is a UK-listed company, but also recognizes that Indivior operates within a specialized sector, where the majority of its peers
are listed in the US.
Measure
Weighting
Rationale for metric
Relative TSR vs. FTSE 250 excluding
investment trusts
Relative TSR vs. S&P 1500
Pharmaceutical and Biotech Index
50%
50%
Provides alignment with shareholders through the relative outperformance of
other UK listed companies.
Provides alignment with shareholders through the relative outperformance of
direct sector peers who are subject to similar market influences.
1. 12.5% of the maximum award will vest for Indivior being ranked median in comparison to the respective peer group, and 100% of the maximum award will
vest for being ranked upper quartile or above. The award will vest on a straight-line basis between median and upper quartile, with none of the awards
vesting if Indivior is ranked below median.
Relative TSR performance against each comparator group will be measured over three financial years (2022-2024). The 2022-2024
LTIP awards are subject to an additional two-year holding period following the end of the three-year performance period.
Malus and Clawback
The Remuneration Committee has the discretion to scale back or cancel LTIP awards, extend the performance period or defer
the exercise period prior to the satisfaction of awards or after the end of any relevant holding period in the event that results
are materially misstated for part of the performance period applicable to an award, an individual’s conduct has amounted to
gross misconduct or, in respect of awards made after the adoption of the 2018 Remuneration Policy, in the event of serious
reputational damage to Indivior. Where LTIP awards have vested, the Committee has the discretion to “claw back” awards or
reduce amounts of other payments due to the individual up to the fifth anniversary of the grant of awards in the circumstances
described above.
Executive Financial Recoupment Program
As part of the Group’s Corporate Integrity Agreement with the Office of the Inspector General of the U.S. Department of Health
and Human Services, an Executive Financial Recoupment Program was implemented (the “Recoupment Program”). Under the
terms of the Recoupment Program, up to two years of performance pay may be put at risk of forfeiture and/or recoupment for
certain US-based executives (which includes both serving Executive Directors).
Forfeiture and/or recoupment may be applied in the event that it is determined that there has been a “Triggering Event”; a
Triggering Event includes significant misconduct (violation of law or regulation or a significant violation of an Indivior policy)
related to covered activities, or, significant misconduct related to covered activities by subordinate employees in the business
unit for which the relevant executive had responsibility that is not an isolated incident and which the relevant executive knew or
should have known was occurring.
Forfeiture and/or recoupment under the Recoupment Program may be applied to awards granted after November 20, 2020 and
will cease to apply to awards on July 24, 2025 or the date on which the Group’s obligations under the Corporate Integrity
Agreement expire (if later).
A copy of the Corporate Integrity Agreement can be found on the Group’s website (www.indivior.com).
Indivior | Annual Report and Accounts 2021
101
GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
Outstanding share awards under the LTIP and DBP (audited)
Details of conditional awards over shares awards held by the Executive Directors at December 31, 2021, are shown below.
No. of
shares
under
award at
January
1,2021
Granted
during the
year
Lapsed
during
the year
Released
during the
year2
No. of
shares
under
award at
December
31, 2021
Closing
share
price at
date of
grant
Face
value of
award
granted
in 2021
$’0003
Performance
period
Normal
vesting date
Normal
release date4
Executive
Directors
Plan1
Date of grant
Mark Crossley
-
-
-
-
-
-
-
-
-
-
-
-
LTIP
LTIP
LTIP
LTIP
LTIP
LTIP
DBP
Mar 1, 20215
-
1,500,000
Nov 6, 20206
157,981
Mar 9, 20206
2,057,610
Aug 8, 20197
44,222
Mar 5, 20197
1,180,880
Mar 9, 20188
452,209
Mar 13, 2020
188,523
-
-
-
-
-
-
-
-
-
-
-
452,209
-
Total
Ryan Preblick
4,081,425 1,500,000 452,209
1,500,000
129.2p
2,623
2021-2023 Mar 1, 2024 Mar 1, 2026
157,981
117.3p
2,057,610
44,222
45.0p
58.4p
1,180,880
108.4p
-
402.0p
188,523
43.7p
5,129,216
-
-
-
-
-
-
2020–2022 Mar 9, 2023 Mar 9, 2025
2020–2022 Mar 9, 2023 Mar 9, 2025
2019–2021 Mar 5, 2022 Mar 5, 2024
2019–2021 Mar 5, 2022 Mar 5, 2024
2018–2020 Mar 9, 2021 Mar 9, 2023
n/a Mar 13, 2022
n/a
1,068,329
129.2p
1,868
2021-2023 Mar 1, 2024 Mar 1, 2026
LTIP
LTIP
LTIP
LTIP
LTIP
LTIP
Mar 1, 20215
-
1,068,329
Mar 9, 2020
264,935
Mar 9, 2020
Mar 5, 2019
Nov 28, 2018
Mar 9, 2018
66,233
56,895
58,999
21,578
-
-
-
-
-
-
-
-
-
264,935
66,233
45.0p
45.0p
56,895
108.4p
26,609
7,638
32,390
13,940
-
-
58.4p
402.0p
-
-
-
-
-
2020–2022 Mar 9, 2023
n/a Mar 9, 2023
n/a Mar 5, 2022
n/a Nov 28, 2021
n/a Mar 9, 2021
n/a
n/a
n/a
n/a
n/a
Total
468,640
1,068,329
34,247
46,330
1,456,392
1. Awards granted under the LTIP and the DBP are made in the form of conditional awards over shares. Participants are entitled to receive an amount
equivalent in value to any dividends payable on the number of vested shares between the date of grant and the vesting (or release date for awards
subject to a post-vesting holding period).
2. These awards were settled on a net settled basis, resulting in a reduction in the number of shares delivered with a value equivalent to the taxes due on
vesting.
3. The face values of the awards granted in 2021 have been calculated using the closing share price on the date of grant and converted to US$ using the
GB£/US$ exchange rate on December 31, 2021 (GB£1:US$1.3532).
4. Awards granted to the Executive Directors under the LTIP are subject to a two-year post-vesting holding period and are then released to the Executive
Director. The LTIP awards held by Ryan Preblick, which were granted prior to his appointment as Chief Financial Officer, are not subject to a two-year
post-vesting holding period.
5. Mark Crossley was granted an LTIP award over 1,500,000 shares in March 2021, being the maximum award under the 2021 Remuneration Policy. Ryan
Preblick was granted an LTIP award with a value of 400% of base salary in March 2021.
6. Mark Crossley was granted an LTIP award with a value of 225% of base salary in March 2020. He was granted an additional award under the LTIP on
November 6, 2020, to reflect his increased base salary for 2020 following his appointment as Chief Executive Officer. The award was calculated on his
pro-rated base salary for the year and the market value used to calculate the number of shares subject to the award was 112.66p, being the average
mid-market closing price of Indivior shares for the five business days immediately preceding the date of grant on November 6, 2020.
7. Mark Crossley was granted LTIP award with a value of 325% of base salary in March 2019. He was granted an additional award under the LTIP on August 8,
2019, to reflect his increased base salary for 2020 following his appointment as Chief Financial & Operations Officer. The award was calculated on his
pro-rated base salary for the year and the market value used to calculate the number of shares subject to the award was 106.38p, being the same price
as that used to calculate his award in March 2019; the Committee determined that using the price used for the March award would avoid any inadvertent
gains as a result of the share price depreciation between March 2019 and August 2019.
8. Mark Crossley was granted an LTIP award with a value of 500% of base salary in March 2018.
9. Mark Crossley holds a vested but unexercised market-value option over 210,619 shares. This option was granted under the rules of the LTIP in December
2014 (on demerger) at an option price of 111.0p per share. The option vested on May 11, 2016 and is scheduled to lapse on December 28, 2024.
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indivior.com
Executive Directors’ shareholding and share interests (audited)
Indivior’s remuneration schemes have been designed to promote long-term shareholdings by Executive Directors. Awards
granted under the LTIP vest subject to the achievement of stretching performance targets measured over a performance period
of at least three years and are then subject to a two-year post vesting holding period. In addition, 25% of any annual bonus paid
under the AIP is deferred into conditional shares for two years under the Deferred Bonus Plan.
Aligned with the maximum opportunity under the LTIP, the Executive Directors are required to build a shareholding with a value
equivalent to 400% of base salary or 1,500,000 shares, whichever is the lower. For the purposes of this requirement the following
count towards the Executive Directors shareholding: shares held outright by the Executive (and where applicable shares held by
their spouse or partner); unvested awards granted under the DBP (adjusted to take account of the estimated tax liability arising
on vesting); awards granted under LTIP which have vested but are subject to a post-vesting holding period (adjusted to take
account of the estimated tax liability arising on release); and, vested but unexercised options (adjusted to take account of the
exercise price and estimated tax liability arising on exercise). Executive Directors have five years from the date of appointment
to their current role in which to achieve this shareholding requirement. Members of the Executive Committee are expected to
build a shareholding of 150% of base salary within the same time frames.
Once the requirement has been met, Executive Directors are not expected to buy shares in the open market to rebuild their
shareholding where the market value of their shareholding has subsequently reduced as a result of share price decline and/or
exchange rate fluctuations. In such circumstances, the Executive Directors would be expected to retain a proportion of shares
arising from future vestings or releases of shares to rebuild their holding.
The table below shows the shareholding of each of the Executive Directors (together with interests held by their connected
persons) and a summary of outstanding awards as at December 31, 2021. The changes in the interests of the Directors in the
shares of Indivior PLC between December 31, 2021 and the date of this report are noted in the table below.
Number of shares
owned outright
LTIP awards
Bonus awards Options held
Deferred
Executive Directors
At
March 17,
2022
At
December
31, 2021
Vested and
subject to
two-year
post-vesting
holding
period at
December
31, 2021
Unvested and
subject to
performance
conditions and
continued
employment
at December
31, 2021
Unvested and
subject to
continued
employment
at December
31, 2021
Unvested and
subject to
certain
conditions
at December
31, 2021
Vested
but not
exercised
Shareholding
requirement
(% of base
salary)
Shareholding
at December
31, 2021
(% of base
salary)
Date by which
shareholding
requirement to
be achieved
Mark Crossley
450,1624
346,663
Ryan Preblick
140,5315
109,296
-
-
4,940,693
-
188,523
210,6192
1,333,264
123,128
-
-
400%
400%
211%3
Jun 2025
73%
Nov 2025
1. In line with Indivior’s executive shareholding requirements, the Executive Directors’ shareholdings as a % of base salary have been calculated based on
shares owned outright valued using the three-month average share price to December 31, 2021 (237.1p), and the US/UK exchange rate over the same
period (GB£1:US$1.3492).
2. Mark Crossley holds a vested but unexercised market-value option over 210,619 shares. This option was granted under the rules of the LTIP in
December 2014 (on demerger) at an option price of 111.0p per share. The option vested on May 11, 2016 and is scheduled to lapse on December 28, 2024.
3. Includes shares owned outright, the unvested award held under the DBP (adjusted for the estimated tax liability arising on vesting) and the vested but
unexercised market value option (adjusted for the exercise price and estimated tax liability arising on vesting).
4. Mark Crossley was granted an award over 188,523 shares under the DBP on March 13, 2020. The vesting of this award was settled on a net settled basis,
resulting in the delivery of 103.499 shares to Mr Crossley on March 15, 2022.
5. Ryan Preblick was granted an award over 56,895 shares under the LTIP on March 5, 2019. The vesting of this award was settled on a net settled basis,
resulting in the delivery of 31,235 shares to Mr Preblick on March 7, 2022.
Payments to past Directors (audited)
Shaun Thaxter stepped down from the Board on June 27, 2020. His termination arrangements were detailed on page 103 of the
2020 Annual Report. In 2021, the Group paid $3,900 to Deloitte for the provision of UK and US tax return preparation services, in
line with Mr Thaxter’s termination arrangements. Save as previously disclosed, there were no other payments to past directors.
External appointments
Subject to the prior approval of the Board, Executive Directors are able to accept an external appointment to a corporate board
outside the Company. The Executive Directors do not hold any external appointments.
Indivior | Annual Report and Accounts 2021
103
GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
Review of past performance
Historical TSR performance
The graph below shows the TSR of the Company and the FTSE 250 Index over the period from admission on December 23, 2014,
to December 31, 2021. The FTSE 250 Index was selected on the basis that the Company was a member of the FTSE 250 Index in the
UK for the majority of the period.
350
300
250
200
150
100
50
0
)
d
e
s
a
b
e
r
(
)
£
(
e
u
l
a
V
Date of
admission
2014
2015
2016
2017
2018
2019
2020
2021
FTSE 250
Indivior
Chief Executive Officer remuneration
The historical total remuneration for the Chief Executive Officer for the period from January 1, 2014, to December 31, 2021, is set
out in the table below. The AIP payout and LTIP vesting level as a percentage of the maximum opportunity is also shown.
Shaun
Thaxter
2014
Shaun
Thaxter
2015
Shaun
Thaxter
2016
Shaun
Thaxter
2017
Shaun
Thaxter
2018
Shaun
Thaxter
2019
Shaun
Thaxter1
2020
Mark
Crossley1
2020
Mark
Crossley
2021
1,968.1
4,317.9
5,024.8
9,215.7
1,009.6
2,138.7
557.3
760.5
5,109.9
100%
94.5%
94.5%
78.5%
0.0%
65.5%
0.0%
0.0%
88.5%
n/a
93.3%
100%
73.5%
0.0%
0.0%
0.0%
0.0%
67.8%
Single figure of total
remuneration ($’000)
AIP (outturn as
a % of maximum)
LTIP (outturn as
a % of maximum)
1. Mark Crossley was appointed Chief Executive Officer on June 29, 2020. Shaun Thaxter was Chief Executive Officer from the date of listing in 2014 until
June 27, 2020.
2. Historical data is not provided prior to 2014 when the Group was a division of Reckitt Benckiser Group plc.
The Group has fewer than 250 employees in the UK and is therefore not required to publish Chief Executive Officer pay ratio
information as set out by The Companies (Miscellaneous Reporting) Regulations 2018.
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indivior.com
Percentage change in the remuneration of Directors and employees
The following table sets out the change in remuneration, excluding LTIP and pension contributions, paid to the Directors
who served on the Board in 2020 and 2021, compared with the average percentage change for the US employee population;
the majority of the Group’s employees are based in the US.
US Employee Population1
Executive Directors
Mark Crossley2
Ryan Preblick3
Non-Executive Directors
Graham Hetherington4
Peter Bains
Jerome Lande5
Joanna Le Couilliard5
A. Thomas McLellan
Lorna Parker
Daniel J. Phelan6
Mark Stejbach5
Juliet Thompson5
Year-on-year change in remuneration of Directors compared to US employee population
2021
2020
Base salary/
fees
Taxable
benefits
Annual bonus
Base salary/
fees
Taxable
benefits
Annual bonus
1.0%
(11.0)%
106%
4.8%
13.0%
(38.0)%
14.8%
766.7%
157.5%
0%
n/a8
n/a8
0%
(7.9)%
(15.0)%
n/a8
n/a8
(12.5)%
711.9%
n/a
n/a
n/a
n/a
(100)%9
n/a
(100)%9
n/a
n/a
n/a8
n/a8
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
27.7%
n/a
754.4%
172.0%
n/a
n/a
(10.7)%
0.0%
0.0%
n/a
n/a
32.7%
n/a
n/a
n/a
n/a
n/a
1.0%
n/a
(1.1)%
n/a
n/a
77.5%
1.3%
(100)%
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Former Non-Executive Director
Daniel Tassé7
(79.7)%
(100)%9
1. Indivior PLC is not an employing company and therefore the remuneration of the US employee population has been included as the comparator group as
this is where the majority of the Group’s employees are based.
2. Mark Crossley was appointed Chief Executive Officer on June 29, 2020, having previously served as Chief Financial & Operations Officer; his base salary for
2020 reflects his pro-rated base salary. Further details of his remuneration arrangements can be found on page 98.
3. Ryan Preblick was appointed Chief Financial Officer and Executive Director on November 19, 2020; his base salary and taxable benefits for 2020 reflects
his pro-rated base salary. Further details of his remuneration arrangements can be found on page 98.
4. Graham Hetherington was appointed as Independent Non-Executive Director on November 1, 2019 and appointed Chair of the Board on November 18,
2020. The large % change in his fee between 2019 and 2020 reflects that he was appointed during the latter part of 2019. The large % change in his fee
between 2020 and 2021 reflects that he was appointed Chair of the Board in November 2020.
5. Jerome Lande, Joanna Le Couilliard, Juliet Thompson and Mark Stejbach were appointed to the Board on March 24, 2021.
6. Daniel J. Phelan was appointed Senior Independent Director on May 7, 2021.
7. Daniel Tassé stepped down from the Board on May 6, 2021.
8. “n/a” refers to nil value in the previous year, which means that a year-on-year change cannot be calculated.
9. Benefits comprised the grossed-up cost of providing professional support for the completion of UK tax returns for US tax residents. As a result of
COVID-19, the US-based Non-Executive Directors did not travel to the UK in the 2020/21 tax year and consequently did not incur a UK tax liability.
Indivior | Annual Report and Accounts 2021
105
GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
Workforce remuneration and engagement on executive remuneration
During the year, the Committee undertook a review of the remuneration arrangements and related policies for the wider
workforce. This comprised of a review of the Group’s core compensation programs, including the base salary merit increase
process, benefits, and short- and long-term incentive arrangements. Variable remuneration schemes are designed to drive
performance and behaviors consistent with the Group’s purpose, values and strategy. Performance measures under the AIP
are designed to align to the key strategic drivers for the year ahead, and are developed alongside the Group’s annual financial
plans. Performance measures for awards granted to senior leaders under the LTIP are subject to relative TSR measures and are
therefore directly aligned with the interests of shareholders.
In 2021, representatives from Indivior’s Culture & Inclusion Champions Network took part in a focus group session on
executive remuneration. The focus group consisted of seven employees, each representing different functions and levels of the
organization. The session, which took place in December 2021, included a presentation which explained the various principles,
policies and practices involved in setting executive remuneration and how these aligned with Indivior’s strategy, culture
and the wider workforce.
Following the session, a pulse survey was conducted to obtain feedback from the employee focus group. Overall feedback
was very positive, with all attendees agreeing that Indivior’s pay principles, policies and practices are aligned with strategy
and culture and that the principles, policies and practices for executives are aligned with the wider workforce. Areas for
enhancement were primarily focused on improving clarity and transparency. Feedback from the session will be used to guide
future employee engagement on executive remuneration, which will include executive remuneration as an element of discussion
at engagement sessions with the Designated Non-Executive Director for workforce engagement.
Feedback from the focus group session was reviewed and discussed at the Committee’s meeting in February 2022.
Further information on workforce engagement can be found on pages 73.
Relative importance of spend on pay
The following table shows total employee pay compared with shareholder distributions and research and development
expenses for 2021 and 2020. Research and development expenses have been selected as a comparator as this measure is
considered to be an indicator of investment in the future performance of the business.
Total employee pay1
Shareholder distributions2
Research and development expenses3
2021
$m
206
100
52
2020
$m
187
–
40
% change
10.2%
n/a
30.0%
1. See Note 7 to the Financial Statements on page 140 for further information regarding employee costs.
2. In line with the Dividend Policy approved by the Board in 2016, there were no dividends paid in respect of the 2020 and 2021 financial year. The Group
completed a $100m share repurchase program in 2021. See Note 25 to the Financial Statements on page 159 for further information regarding share capital.
3. See Note 4 to the Financial Statements on pages 136-137 for further information regarding research and development expenses.
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indivior.com
Dilution limits
Indivior’s share plans provide that awards can be satisfied by newly issued shares, the transfer of treasury shares, or existing
shares (purchased in the market and held in an employee benefit trust). Indivior’s share plans state that the aggregate number
of shares that may be issued to satisfy awards made under these plans must not exceed 10% of the Company’s issued share
capital in any ten-year period.
The Committee has reviewed the number of shares subject to award to ensure that these limits would not be breached by the
granting of awards in 2022.
Single total figure of remuneration for the Chair and Non-Executive Directors (audited)
The table below sets out the total remuneration received by the Chair and the Non-Executive Directors for the year ended
December 31, 2021.
Role as at December 31, 2021
2021 Fees1
’000
2020 Fees1
’000
2021
Benefits
’000
2020
Benefits2
’000
Graham Hetherington3
Chair
£275.0
£106.8
Peter Bains
Independent Non-
Executive Director
£85.0
£85.0
Jerome Lande4
Non-Executive Director
$83.7
Joanna Le Couilliard4
A. Thomas McLellan
Lorna Parker5
Daniel J. Phelan
Mark Stejbach4
Juliet Thompson4
Independent Non-
Executive Director
Independent Non-
Executive Director
Independent Non-
Executive Director
Senior Independent
Director
Independent Non-
Executive Director
Independent Non-
Executive Director
Former Non-Executive Director
Daniel Tassé6
Note: Totals may not sum up due to rounding.
-
-
£58.0
$108.3
$108.3
£78.3
£85.0
$141.1
$122.7
$83.7
£64.3
-
-
$52.9
$254.1
2021 Total 3
’000
2020 Total3
’000
£275.0
£106.8
£85.0
£85.0
$83.7
£58.0
-
-
-
-
-
-
$2.1
$108.3
$110.3
-
£78.3
£85.0
$2.1
$141.1
$124.8
-
-
$83.7
£64.3
-
-
$2.1
$52.9
$256.2
-
-
-
-
-
-
-
-
-
-
1. Fees paid to the Chair and the Non-Executive Directors are paid in their local currency. Since 2016, a fixed exchange rate (GB£1:US1.4434) has been
applied to translate UK amounts into US dollars, effectively setting fees at that time, on both a UK and US basis.
2. Benefits comprise the grossed-up cost of providing professional support for the completion of UK tax returns for US tax residents; these costs were
translated to US$ using the average exchange rate for 2020 (GB£1:US1.2833). As a result of COVID-19, the US-based Non-Executive Directors did not travel
to the UK in the 2020/21 tax year, and consequently did not incur a UK tax liability.
3. Graham Hetherington was appointed Chair of the Board on November 18, 2020.
4. Jerome Lande, Joanna Le Couilliard, Juliet Thompson and Mark Stejbach were appointed as Directors of the Company on March 24, 2021. The fee shown for
2021 is from the date of appointment to December 31, 2021.
5. Lorna Parker was the Chair of the Nomination & Governance Committee until May 6, 2021; she stepped down as Chair of that Committee and Graham
Hetherington assumed that role. Ms Parker remains a member of the Committee.
6. Daniel Tassé stepped down from the Board on May 6, 2021; the fee shown for 2021 is for the period from January 1, 2021 to May 6, 2021.
Indivior | Annual Report and Accounts 2021
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GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
Chair and Non-Executive Directors’ fees (audited)
The current fee levels for the Chair and Non-Executive Directors are set out in the table below.
Chair’s Fee2
Non-Executive Director Fee
Additional Senior Independent Director Fee
Additional Committee Chair Fee
Additional Committee Membership Fee
Fee in GB£1
Fee in US$1
£275,000
£55,000
n/a
£20,000
£10,000
n/a
$79,387
$28,868
$28,868
$14,434
1. Fees paid to the Chair and the Non-Executive Directors are paid in their local currency. Since 2016, a fixed exchange rate (GB£1:US1.4434) has been
applied to translate UK amounts into US dollars, effectively setting fees at that time, on both a UK and US basis.
2. The Chair of the Board does not receive additional fees for being a member of the Committees or for chairing any Committee.
The fees paid to the Chair and Non-Executive Directors were set at the time of listing in 2014 and have not been increased since
that time. The Chair and Non-Executive Directors’ Fee are reviewed on a biennial basis and are next scheduled to be reviewed
in November 2022. The Chair and the Non-Executive Directors are not eligible to participate in the Company’s annual bonus,
long-term incentive, or pension schemes.
Chair and Non-Executive Directors’ shareholding (audited)
The Chair and Non-Executive Directors are expected to acquire an interest in Indivior shares over the course of their
appointment. The following table shows the shareholdings of each of the Chair and Non-Executive Directors (together with the
interests of their connected persons) as at December 31, 2021 (or up to the date they stepped down from the Board) and as at
the date of this report. There have been no changes in the interests of the Chair and Non-Executive Directors in the shares of
Indivior PLC between December 31, 2021 and the date of this report.
Total number
of shares held at
March 17, 2022
Total number
of shares held at
December 31, 2021
Total number
of shares held at
December 31, 2020
54,000
79,220
319
-
7,546
25,890
60,318
41,424
-
54,000
79,220
319
-
7,546
25,890
60,318
41,424
-
54,000
50,000
n/a
n/a
7,546
25,890
60,318
n/a
n/a
Total number
of shares held at
date of stepping
down from Board
Total number
of shares held at
December 31, 2020
12,996
12,996
Peter Bains
Graham Hetherington
Jerome Lande
Joanna Le Couilliard
A. Thomas McLellan
Lorna Parker
Daniel J. Phelan
Mark Stejbach
Juliet Thompson
Former Directors
Daniel Tassé
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Executive Directors’ service agreements
The Executive Directors have service agreements that set out the contract between them and the Group.
Mark Crossley
Ryan Preblick
Date of appointment
June 2020
November 2020
Notice period
from Group
Notice period
from individual
Expiry of current term
12 months
12 months
12 months
Rolling contract
12 months
Rolling contract
Chair and Non-Executive Directors’ letters of appointment
The terms of service of the Chair and the Non-Executive Directors are contained in letters of appointment. In accordance
with the 2018 Code, the Chair and Non-Executive Directors are appointed subject to re-appointment by shareholders at the
Company’s next AGM following their appointment and re-appointment at each subsequent AGM. The Chair and Non-Executive
Directors are not entitled to receive compensation for loss of office.
The table below sets out the dates of appointment of the Chair and the Non-Executive Directors and the expiry of their current
terms.
Peter Bains
Graham Hetherington1
Jerome Lande2
Joanna Le Couilliard
A. Thomas McLellan
Lorna Parker
Daniel J. Phelan
Mark Stejbach
Juliet Thompson
Date of appointment
Expiry of current term
August 2019
July 2022
November 2019
November 2023
March 2021
December 2023
March 2021
March 2024
November 2014
November 2023
November 2014
November 2023
November 2014
November 2023
March 2021
March 2021
March 2024
March 2024
Length of service at
December 31, 2021
in years
Notice period
2
2
<1
<1
7
7
7
<1
<1
1 month
1 month
1 month
1 month
1 month
1 month
1 month
1 month
1 month
1. Graham Hetherington was appointed a Non-Executive Director in November 2019. He was appointed Chair of the Board in November 2020.
2. Jerome Lande was appointed a Non-Executive Director in March 2021; his appointment is subject to the terms of the Relationship Agreement between
the Company and Scopia Capital Management LP. Further information regarding the Relationship Agreement can be found on page 114.
Summary of voting outcomes for the 2021 Remuneration Policy and 2020 Remuneration Report
The 2020 Remuneration Report received a c.38.3% vote against at the 2021 Annual General Meeting and the resolution to re-elect
the Chair of the Remuneration Committee, Daniel J. Phelan, received a 21.5% vote against. We understand that a significant
number of shareholders were unsupportive of the termination arrangements for the former Chief Executive Officer, Shaun
Thaxter, and consequently voted against these resolutions.
Engagement with shareholders has been ongoing since the 2021 AGM and we have consulted with our largest shareholders
regarding the votes received against these resolutions. Given the absence of any findings of personal wrongdoing or
malfeasance by Mr Thaxter, the Board and the Remuneration Committee remain agreed that it could not pursue malus
and clawback claims and that Mr Thaxter retain his outstanding LTIP awards, pro-rated for time worked and subject to the
achievement of stretching performance conditions and a two-year post-vesting holding period. Mr Thaxter’s awards remain
subject to the Company’s malus and clawback policies. While the Committee is confident the right decision was made,
we also acknowledge that a significant number of shareholders were concerned about the approach taken.
Following our consultation, we published an Update Statement on our website in October 2021. The Committee is grateful for the
engagement and feedback received and greatly values the views of our shareholders and their representatives. The Committee
continues to take this constructive feedback into account when making decisions in respect of our remuneration framework.
The Remuneration Policy was last put to shareholders for a vote at the 2021 AGM and 95.2% of shareholders voted in favor of it.
The Remuneration Committee were very pleased with the level of support received for the 2021 Remuneration Policy, which we
believe recognizes the significant changes that have been made to Indivior’s remuneration structure to align to best practice
and corporate governance requirements.
Indivior | Annual Report and Accounts 2021
109
GOVERNANCED I R E C T O R S ’ R E M U N E R A T I O N R E P O R T
C O N T I N U E D
The votes cast by proxy and at the meeting in respect of the 2020 Directors’ Remuneration Report and 2021 Remuneration Policy
were as follows:
Resolution
Votes for
Votes for (%)
Votes against
Votes against (%)
Votes withheld
(abstentions)
Approve the 2020 Directors’
Remuneration Report (2021 AGM)
Approve the Remuneration Policy
(2021 AGM)
Summary Remuneration Policy
330,455,934
61.7%
204,877,688
38.3%
11,757,556
520,455,001
95.2%
26,236,873
4.8%
398,798
This section of the report sets out a summary of the Remuneration Policy that was approved by shareholders at the AGM on May
6, 2021, and became effective on that date. It is intended that the Policy will remain effective for a period of three years, i.e. until
2024. The full Policy can be found in the Directors’ Remuneration Report in the 2020 Annual Report on the Company’s website
www.indivior.com.
Summary Policy table – Executive Directors
Remuneration
element
Overview
Base salary
Base salaries are normally reviewed annually, with any increase normally being applied with effect from
January 1 each year. Base salary levels/increases take account of: the competitive practice in the Group’s
remuneration peer group; the scope and responsibility of the position; individual and overall business
performance; and salary increases awarded across the Group as a whole.
Pension benefits
Executive Directors may receive contributions into a defined contribution scheme, a cash allowance,
pension benefits in the form of profit-sharing contributions into the US qualified 401(K) plan, Group
matching on 401(K) elected deferrals, or a combination thereof.
Benefits
Maximum levels of contributions for Executive Directors will be in line with the rates available to the
wider workforce in the Executive Director’s local market.
Executive Directors may receive various market-competitive benefits, which may include: a company
car (or cash equivalent), travel allowance, private medical and dental insurance, travel accident policy,
disability and life assurance. Where appropriate, other benefits may be provided to take account of
individual circumstances, such as but not limited to expatriate allowances, relocation expenses, housing
allowance and education support. The Company provides Directors’ and Officers’ liability insurance, and
an indemnity to the extent permitted by law.
Annual Incentive
Plan (AIP)
Performance is assessed on an annual basis with measures and targets set by the Committee at the start
of the performance year. At the end of the performance year, the Committee determines the extent to
which these have been achieved.
Bonuses are paid after the end of the performance year. 75% of the annual bonus is delivered in cash
and 25% is deferred into shares for a period of two years. During the deferral period, deferred share
awards may be reduced or cancelled in certain circumstances. Dividend equivalents may be paid,
normally in the form of additional shares, on deferred share awards up to the end of the deferral period,
where relevant.
The Committee has discretion to adjust the formulaic bonus outcomes both upward and downward
(including to zero) to ensure alignment of pay with the underlying performance of the Group, e.g. in the
event performance is impacted by unforeseen circumstances outside management control.
The maximum annual bonus payable under the AIP is 200% of base salary.
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Remuneration
element
Overview
Long-Term Incentive
Plan (LTIP)
Awards under the LTIP may consist of grants of conditional share awards, nil cost options or
market-value share options which vest subject to the achievement of stretching performance targets
measured over a performance period of at least three years. Awards granted to Executive Directors are
subject to an additional holding period following the performance period. For awards with a three-year
performance period, this holding period will normally be two years.
The LTIP opportunity is reviewed annually with reference to market data and the associated cost to the
Group is calculated using an expected value methodology. The performance conditions are reviewed
before each award cycle to ensure they remain appropriate and targets are suitably stretching and may
be amended in accordance with the terms of the LTIP or if the Committee reasonably considers it
appropriate, provided that the amended performance conditions are not materially easier to satisfy.
Dividend equivalents may be paid, normally in the form of additional shares, on LTIP awards that vest
up to the end of the post-vesting holding period, where relevant.
The Committee has discretion to adjust the formulaic LTIP outcomes to improve the alignment of pay
with value creation for shareholders to ensure the outcome is a fair reflection of the underlying
performance of the Group.
The maximum annual award that may be made to any individual in respect of any financial year will be
the lower of 1,500,000 shares and 400% of base salary.
Executive Directors are expected to acquire a significant number of shares over a period of five years and
retain these until retirement from the Board of Directors. The shareholding requirement is the lower of
1,500,000 shares or the number of shares equivalent to 400% of base salary for the Executive Directors, in
line with the overall LTIP maximum. This is generally expected to be achieved within five years of the date
of appointment.
With effect from 2021, Executive Directors will also be subject to a post-cessation shareholding policy.
Executive Directors will normally be expected to maintain a holding of Indivior shares at a level equal to
the lower of the in-post shareholding guideline or the individual’s actual shareholding for a period of two
years from the date the individual ceases to be a Director. The specific application of this shareholding
policy will be at the Committee’s discretion. The Committee has the discretion to waive this requirement
in certain circumstances (e.g. compassionate circumstances).
Shareholding
guidelines
All-employee share
plans
Executive Directors may participate in all-employee share plans offered by the Group on the same basis
as is offered to the Group’s other eligible employees. Maximum opportunity for awards will be in line with
the savings limits set by local regulations.
Daniel J. Phelan
Chair of the Remuneration Committee
March 17, 2022
Indivior | Annual Report and Accounts 2021
111
GOVERNANCED I R E C T O R S ’ R E P O R T
DIRECTORS’ REPORT
The Directors present their Annual Report and Accounts which
includes the audited Group financial statements and audited
Parent Company financial statements for the year ended
December 31, 2021.
Corporate governance statement
The Directors’ Report on pages 112 to 115 which includes the
Corporate Governance Statement on pages 58 to 111, together
with the Strategic Report on pages 1 to 57, when taken
together constitute the management report as required
by DTR 4.1.8R.
The Statement of Directors’ Responsibilities on pages 116 to
117 is incorporated into the Directors’ Report by reference.
Directors and their interests
The Directors of the Company who served during the financial
year ended December 31, 2021 and up to the date of signing
the financial statements appear on pages 60 and 61. Details of
Directors’ interests in the Company’s ordinary shares,
including any interest in share awards and long-term
incentive plans, are set out in the Directors’ Remuneration
Report on pages 91 to 111.
No Director held a material interest at any time during the
year in any derivative or financial instrument relating to the
Company’s shares.
Powers of Directors
The following information fulfilling the further disclosure
requirements contained in the Companies Act 2006, Schedule
7 of the Large and Medium-Sized Companies and Groups
(Accounts and Reports) Regulations 2008 and the FCA’s Listing
Rules and Disclosure Guidance and Transparency Rules (DTRs)
has been included elsewhere within the Annual Report and
Accounts and is incorporated into the Directors’ Report by
reference:
The Directors are responsible for managing the business
of the Company and may exercise all the powers of the
Company, subject to the provisions of the Company’s Articles
of Association in respect of the liability incurred as a result of
their office. Powers relating to the issuing of shares are also
included in the Articles of Association, and such authorities
are renewed by shareholders at the AGM each year;
see page 113.
Disclosure
Location
Future business developments
and R&D activities
Strategic Report
(pages 18 to 21)
Principal Risks and
Risk Management
Going Concern
Strategic Report
(pages 47 to 56)
Statement of Directors’
Responsibilities (page 117)
Viability Statement
Strategic Report (page 57)
Greenhouse gas emissions
Stakeholder Engagement
Strategic Report
(pages 31 and 32)
Strategic Report
(pages 24 to 29)
Both the Directors’ Report and the Strategic Report have been
drawn up and presented in accordance with, and in reliance
upon, applicable company law in England and Wales.
The liabilities of the Directors in connection with those
reports shall be subject to the limitations and restrictions
provided by such law.
Appointment and replacement of Directors
The Company’s Articles of Association give the Directors
power to appoint and replace Directors. Under the Terms
of Reference of the Nomination & Governance Committee,
any appointment will be recommended by that Committee
for approval by the Board of Directors.
The Articles of Association require Directors to retire and
submit themselves for re-appointment at the first Annual
General Meeting (“AGM”) following appointment, and all
Directors who have held office at the date of the two
preceding AGMs.
Notwithstanding these provisions of the Articles of
Association, in compliance with the UK Corporate Governance
Code and in line with previous years, all Directors wishing to
continue in office will offer themselves for re-appointment by
the shareholders at the 2022 AGM. Details of unexpired terms
of Directors’ service contracts are set out in the Directors’
Remuneration Report on page 109.
Results and dividends
Director indemnities and insurance cover
The consolidated income statement is on page 128. The net
income for the financial year attributable to equity
shareholders amounted to $205m.
In line with the dividend policy approved by the Board in 2016,
the Directors do not recommend payment of a dividend
in respect of the financial year ended December 31, 2021.
The Directors have the benefit of an indemnity provision
contained in the Company’s Articles of Association in respect
of the liability incurred as a result of their office. Also,
throughout the financial year, the Company purchased and
maintained Directors’ and Officers, liability insurance for its
Directors and Officers, which remained in force at the date of
the approval of the Directors’ Report. Neither the indemnity
nor the insurance provides cover in the event that a Director
is found to have acted dishonestly or fraudulently.
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Articles of Association
Authority to purchase own shares
At the 2021 AGM, shareholders approved a resolution for the
Company to make purchases of its own shares up to a
maximum number of ordinary shares, being approximately
10% of the issued share capital. The authority is renewable
annually and shareholders will be asked to approve an
equivalent resolution at the 2022 AGM.
As announced on December 29, 2021, the Company completed
its share repurchase program to repurchase its ordinary
shares of $0.10 each. In aggregate, the Company purchased
33,763,488 shares for a total consideration of $99,997,939.89
between August 3, 2021 and December 29, 2021; all purchased
shares were subsequently cancelled.
The Directors consider it desirable for these general
authorizations to be available in order to maintain an efficient
capital structure but will only purchase the Company’s shares
in the market if they believe it is in the best interests of
shareholders generally.
Shares held in the Indivior PLC Employee Benefit Trust
The trustee of the Indivior PLC Employee Benefit Trust
(“EBT”) has agreed not to vote using any shares held
by the EBT at any general meeting. If any offer is made to
shareholders to acquire their shares the trustee will not be
obliged to accept or reject the offer in respect of any shares
which are at that time subject to subsisting awards, but will
have regard to the interests of the award holders and will
have power to consult them to obtain their views on the offer.
Subject to the above, the trustee may take action with respect
to the offer it thinks fair.
The Articles of Association may be amended by special
resolution of the shareholders.
Stakeholder engagement
How the Directors have had regard to the need to foster
business relationships with suppliers, customers and others
can be found on pages 26 to 29 of the Strategic Report.
Further information regarding the Board’s engagement
with the workforce can be found on page 26.
Shares
Share capital
Details of the Company’s share capital are set out in Note 25
on page 160.
The Company has one class of ordinary share which carries
no rights to fixed income. Each share carries the right to one
vote at general meetings of the Company. The ordinary shares
are listed on the Official List and traded on the London Stock
Exchange. As of December 31, 2021, the Company had
702,439,638 ordinary shares in issue. The Company does
not hold any shares in Treasury.
There are no restrictions on the voting rights attaching to the
Company’s ordinary shares or the transfer of securities in the
Company. No person holds securities in the Company which
carry special voting rights with regard to control of the
Company. The Company is not aware of any agreements
between holders of securities that may result in restrictions
on the transfer of securities or on voting rights.
The Company has a Sponsored Level 1 American Depositary
Receipt (“ADR”) program in the US. The ADR program is closed
to new issuances. For further information please go to
www.adr.com.
Authority to allot shares
At the 2022 AGM, the Directors will ask shareholders to renew
the authority last granted to them at the 2021 AGM to allot
shares up to a maximum of an amount equivalent to two-
thirds of the shares in issue (of which one-third must be
offered by way of rights issue). The renewed authority will
apply until the conclusion of the 2023 AGM. Two special
resolutions will be proposed at the 2022 AGM to authorize
the Directors to allot equity shares in the Company for cash,
without regard to the pre-emption provisions of the
Companies Act 2006.
These authorities are also renewable annually and are in line
with institutional shareholder guidance.
Indivior | Annual Report and Accounts 2021
113
GOVERNANCED I R E C T O R S ’ R E P O R T
C O N T I N U E D
Relationship Agreement with Scopia Capital
Management LP
In March 2021, the Company entered into a relationship
agreement with its largest shareholder, Scopia, which contains
certain standstill, voting and governance terms.
This includes commitments from Scopia:
› not to exercise voting rights in excess of 20 per cent of the
Companyʼs total voting rights; and
› to vote on ordinary course resolutions in accordance with
the Boardʼs recommendation.
The agreement also provides for Scopia to have one
representative director appointed to the Board (currently
Jerome Lande).
The agreement will remain in force until December 31, 2023,
unless extended or terminated earlier in accordance with
its terms.
Substantial shareholdings
As at December 31, 2021 and the date of this Report, the
Company had been notified under Rule 5 of the Disclosure
Guidance and Transparency Rules of the following major
interests in the voting rights in the capital of the Company:
At March
17, 2022
(% of total
voting rights)
At December
31, 2021
(% of total
voting rights)
Number of
Shares
99,868,842
13.52%
13.52%
37,559,040
5.13%
5.13%
Scopia Capital
Management LP
Standard Life
Aberdeen
Two Seas Capital
(formerly Kairos
Capital
Management)
Workforce
Our workforce includes employees, interns and contingent
workers. During the year under review, the Group employed
an average of 802 people worldwide (2020: 819). The Group’s
business priority remains to safeguard the well-being,
development and safety of its workforce. It also wants
its workforce to have opportunities to grow and progress
as part of an enjoyable career.
The Group is an inclusive and equal opportunity employer
that relies on Human Resources specialists throughout its
worldwide locations to ensure compliance with all applicable
laws governing employment practices and to advise on
all Human Resources policies and practices, including
for example recruitment and selection, training and
development, promotion and retirement.
Group policies seek to create a workplace that has an open
atmosphere of trust, honesty and respect. Harassment or
discrimination of any kind is not tolerated. This principle
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indivior.com
applies to all aspects of employment from recruitment
and promotion, through to termination and all other terms
and conditions of employment. It is Group policy not to
discriminate on the basis of any unlawful criteria, and its
practices include the prohibition on the use of child or forced
labor. Employment policies are fair and equitable and
consistent with the skills and abilities of the employee
and the needs of the business.
The Group is committed to offering equal opportunities in
recruitment, training, career development and promotion to
all people, including those with disabilities, having regard to
their individual aptitudes and abilities. As a matter of policy,
full and fair consideration is given to applicants with
disabilities and every effort is made to give employees who
become disabled while employed by the Group an opportunity
for retraining and for continuation in employment. It is Group
policy that the training, career development and promotion
of disabled persons should, as far as possible, be the same
as that of other employees.
The workforce are regularly updated on the financial and
economic factors affecting the performance of the Group.
Information relevant to the employees is provided to them
and, where appropriate, to employee trade union
representatives.
The Group also supports the wider fundamental human rights
of its employees.
Further information regarding our people can be found
on pages 32 to 34.
There are several agreements that take effect, alter or
terminate upon a change of control of the Company following
a takeover, such as commercial contracts, bank agreements,
property lease arrangements and employee share plans.
None of these are deemed to be significant in terms of their
potential impact on the business of the Group as a whole.
There are no significant agreements between the Company
and its Directors or employees providing for compensation for
loss of office or employment that occurs due to a takeover,
save that provisions of the Company’s share plans may cause
options and awards to vest on a takeover, and if the
employment of an Executive Director or other employee is
terminated by the Company following a takeover then there
may be an entitlement to appropriate notice and/or
compensation as provided in applicable contracts or terms of
employment.
There is no information that the Company would be required
to disclose about persons with whom it has contractual
or other arrangements which are essential to the business
of the Company.
66,672,048
9.07%
9.07%
Significant agreements – change of control
The Directors acknowledge that there are other significant
stakeholders, in addition to shareholders, who provide
valuable feedback and help shape the Group’s overall
approach to governance. For further information, please refer
to the Stakeholder Engagement section on pages 24 to 29
and specifically to the Section 172(1) Statement within this
on page 25.
Political donations
There were no political donations, as defined in the
Companies Act 2006, during 2021 (2020: nil). The Company’s
US subsidiaries do make “political donations” as defined
under UK law, but these donations are not subject to that law.
Donations by US subsidiaries did not exceed US$500,000.
Disclosures required under Listing Rule 9.8.4
There are no disclosures required to be made under UK
Listing Rule 9.8.4. Details of long-term incentive plans
can be found in the Directors’ Remuneration Report on
pages 100 to 102.
Annual General Meeting (“AGM”)
The AGM will be held at 11.00am (UK time) on Thursday, May 5,
2022, at the offices of Freshfields Bruckhaus Deringer LLP, 100
Bishopsgate, London EC2P 2SR. A full description of the
business to be conducted at the meeting is set out in the
Notice of AGM, available from the Company’s website
www.indivior.com.
Branches
Strategic Report
The Group has branches in Finland, Norway and Sweden.
The Strategic Report set out on pages 1 to 57 was approved by
the Board on March 17, 2022.
Disclosure of information to External Auditor
By Order of the Board
Kathryn Hudson
Company Secretary of Indivior PLC
234 Bath Road,
Slough, Berkshire, SL1 4EE
Company registration number: 09237894
March 17, 2022
Each of the persons who are Directors at the time when this
Directors’ Report is approved confirms that:
› so far as he/she is aware, there is no relevant audit
information of which the Company’s External Auditor is
unaware; and
› each Director has taken all reasonable steps that he/she
ought to have taken as a Director to make themselves
aware of any relevant audit information and to establish
that the Group and Parent Company’s External Auditor is
aware of that information.
For these purposes, relevant audit information means
information needed by the Company’s External Auditor
in connection with the preparation of their report on
pages 118 and 127.
External Auditor
PricewaterhouseCoopers LLP have agreed to be re-appointed
as the External Auditor of the Company. Resolutions for their
re-appointment, and to authorize the Audit Committee to
determine their remuneration, will be proposed at the
forthcoming AGM.
Financial risk management
Details of the Group’s use of financial instruments, together
with information on the Company’s risk objectives, policies
and exposure to price, credit, liquidity, cash flow and interest
rate risks, can be found in Note 17.
Indivior | Annual Report and Accounts 2021
115
GOVERNANCES T A T E M E N T O F D I R E C T O R S ’ R E S P O N S I B I L I T I E S
STATEMENT OF DIRECTORS’ RESPONSIBILITIES
IN RESPECT OF THE FINANCIAL STATEMENTS
The Directors are responsible for the maintenance and
integrity of the Parent Company’s website.
Legislation in the United Kingdom governing the preparation
and dissemination of financial statements may differ from
legislation in other jurisdictions.
Directors’ confirmations
The Directors consider that the Annual Report and Accounts,
taken as a whole, is fair, balanced and understandable and
provides the information necessary for shareholders to assess
the Group and Parent Company’s position and performance,
business model and strategy.
Each of the Directors, whose names and functions are listed
in the Annual Report and Accounts, confirm that, to the best
of their knowledge:
› the Group financial statements, which have been prepared
in accordance with UK-adopted international accounting
standards, give a true and fair view of the assets, liabilities,
financial position and profit of the Group;
› the Parent Company financial statements, which have been
prepared in accordance with United Kingdom Accounting
Standards, comprising FRS 101, give a true and fair view of
the assets, liabilities and financial position of the Parent
Company; and
› the Directors’ Report includes a fair review of the
development and performance of the business and the
position of the Group and Parent Company, together with
a description of the principal risks and uncertainties that
it faces.
Disclosure of information to auditors
A Directors’ statement in relation to disclosure of relevant
audit information can be found in the Directors’ Report on
page 115.
The Directors are responsible for preparing the Annual Report
and the financial statements in accordance with applicable
law and regulation.
Company law requires the Directors to prepare financial
statements for each financial year. Under that law the
Directors have prepared the Group financial statements
in accordance with UK-adopted international accounting
standards and the Parent company financial statements
in accordance with United Kingdom Generally Accepted
Accounting Practice (United Kingdom Accounting Standards,
comprising FRS 101 “Reduced Disclosure Framework”,
and applicable law).
Under company law, the Directors must not approve the
financial statements unless they are satisfied that they give
a true and fair view of the state of affairs of the Group and
Parent company and of the profit or loss of the group for that
period. In preparing the financial statements, the Directors
are required to:
› select suitable accounting policies and then apply them
consistently;
› state whether applicable UK-adopted international
accounting standards have been followed for the Group
financial statements and United Kingdom Accounting
Standards, comprising FRS 101 have been followed for the
parent company financial statements, subject to any
material departures disclosed and explained in the
financial statements;
› make judgments and accounting estimates that are
reasonable and prudent; and
› prepare the financial statements on the going concern basis
unless it is inappropriate to presume that the Group and
Parent Company will continue in business.
The Directors are responsible for safeguarding the assets of
the Group and Parent Company and hence for taking
reasonable steps for the prevention and detection of fraud
and other irregularities.
The Directors are also responsible for keeping adequate
accounting records that are sufficient to show and explain the
Group’s and Parent Company’s transactions and disclose with
reasonable accuracy at any time the financial position of the
Group and Parent Company and enable them to ensure that
the financial statements and the Directors’ Remuneration
Report comply with the Companies Act 2006.
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Going concern
The Group’s business model, strategy, and viability
assessment are set out in the Strategic Report on pages 1
to 57, along with the Group’s risk management strategy
and the principal risks that could threaten the Group’s
business model, future performance and solvency or liquidity.
The Group’s and Parent Company’s financial position, cash
flows, and liquidity position are discussed in the notes to the
Group and Parent Company financial statements, along with
the Group’s and Parent Company’s objectives, policies
and processes for managing its financial risks, and the
Group’s and Parent Company’s exposure to liquidity risk
and capital risk.
The Directors have considered the Group’s and Parent
Company’s financial plan, in particular with reference
to the period through June 2023.
As disclosed in Notes 5, 21, 22 and 23 to the Group Financial
Statements, the Group has liabilities and provisions totaling
$537m (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 minimum liquidity covenant in the
Group’s debt facility, maintain sufficient liquidity to fund its
operations, fulfill obligations under the DOJ resolution and RB
agreement, and address the possible financial implications
of the ongoing legal proceedings. The Directors have also
modeled the risk that SUBLOCADE will not meet revenue
growth expectations (considering a 15% decline on forecasts),
an accelerated reversion to generic analogs for SUBOXONE
Film, and the ongoing legal proceedings (as disclosed in
Note 23) may result in reasonably possible payments
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. As a result of the factors set
out above, the Directors of the Group and Parent Company
have a reasonable expectation that the Group and Parent
Company have adequate resources to continue in operational
existence for at least one year from the approval of these
financial statements.
The Directors have given the going concern assessment due
consideration and have concluded that it is appropriate to
adopt the going concern basis for accounting and preparing
these financial statements. The viability statement is on
page 57.
By Order of the Board
Kathryn Hudson
Company Secretary of Indivior PLC
234 Bath Road
Slough, Berkshire, SL1 4EE
Company Registration number: 9237894
March 17, 2022
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GOVERNANCEI N D E P E N D E N T A U D I T O R S ’ R E P O R T
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
INDEPENDENT AUDITORS’ REPORT TO THE
INDEPENDENT AUDITORSʼ REPORT TO THE
MEMBERS OF INDIVIOR PLC
MEMBERS OF INDIVIOR PLC
Report on the audit of the financial statements
Opinion
In our opinion:
› Indivior PLC’s Group financial statements and Parent Company financial statements (the 'financial statements') give a true and fair
view of the state of the Group’s and of the Parent Company’s affairs as at 31 December 2021 and of the Group’s profit and the
Group’s cash flows for the year then ended;
› the Group financial statements have been properly prepared in accordance with UK-adopted International Accounting Standards;
› the Parent Company financial statements have been properly prepared in accordance with United Kingdom Generally Accepted
Accounting Practice (United Kingdom Accounting Standards, comprising FRS 101 'Reduced Disclosure Framework', and applicable
law); and
› the financial statements have been prepared in accordance with the requirements of the Companies Act 2006.
We have audited the financial statements, included within the Annual Report and Accounts (‘Annual Report’), which comprise: the
Consolidated and Parent Company balance sheets as at 31 December 2021; the Consolidated income statement, the Consolidated
statement of comprehensive income/(loss), the Consolidated cash flow statement and the Consolidated and Parent Company
statements of changes in equity for the year then ended; and the notes to the financial statements, which include a description of the
significant accounting policies.
Our opinion is consistent with our reporting to the Audit Committee.
Basis for opinion
We conducted our audit in accordance with International Standards on Auditing (UK) ('ISAs (UK)') and applicable law. Our
responsibilities under ISAs (UK) are further described in the Auditors’ responsibilities for the audit of the financial statements section
of our report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Independence
We remained independent of the Group in accordance with the ethical requirements that are relevant to our audit of the financial
statements in the UK, which includes the FRC’s Ethical Standard, as applicable to listed public interest entities, and we have fulfilled
our other ethical responsibilities in accordance with these requirements.
To the best of our knowledge and belief, we declare that non-audit services prohibited by the FRC’s Ethical Standard were
not provided.
Other than those disclosed in Note 6, we have provided no non-audit services to the Parent Company or its controlled undertakings
in the period under audit.
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Our audit approach
Overview
Audit scope
› We conducted work in two key territories, being the US and UK. This included full scope audits at three components and specific
Financial Statement line item audit procedures for one further component.
› The components where we performed audit work, taken together with our central corporate functions, accounted for 93% of the
Group's net revenue and 82% of the Group's profit before tax adjusted for exceptional items (on an absolute basis).
› During the audit we focused on climate risk as part of our work. We enquired with management regarding its risk assessment and
governance process in place to address climate risk impacts including the impact of those risks on the underlying assumptions and
estimates that have been used in the financial statements.
Key audit matters
› Sales rebate adjustments recognised in the US business in relation to SUBOXONE and SUBLOCADE (Group)
› Ongoing litigation and investigative matters (Group)
› Carrying value of investments in subsidiaries (Parent Company)
Materiality
› Overall Group materiality: US$7.9m (2020: US$6.5m) based on 1% of total net revenue.
› Overall Parent Company materiality: US$14.7m (2020: US$14.6m) based on 1% of total assets.
› Performance materiality: US$5.9m (2020: US$4.8m) (Group) and US$11.0m (2020: US$11.0m) (Parent Company).
The scope of our audit
As part of designing our audit, we determined materiality and assessed the risks of material misstatement in the financial statements.
Key audit matters
Key audit matters are those matters that, in the auditors’ professional judgement, were of most significance in the audit of the
financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not
due to fraud) identified by the auditors, including those which had the greatest effect on: the overall audit strategy; the allocation of
resources in the audit; and directing the efforts of the engagement team. These matters, and any comments we make on the results
of our procedures thereon, were addressed in the context of our audit of the financial statements as a whole, and in forming our
opinion thereon, and we do not provide a separate opinion on these matters.
This is not a complete list of all risks identified by our audit.
Going concern considerations, recoverability of assets and the impact of COVID-19, which were key audit matters last year, are no
longer included. Going concern considerations has been removed following the resolution of the US Department of Justice matter
and the agreement reached with the US Department of Health and Human Services (HHS), therefore potential exclusion from
participating in US government health programmes has been eliminated as long as the company maintains compliance with the
Corporate Integrity Agreement (CIA). Recoverability of assets has been removed due to the improved performance of the Group and
given these are less sensitive to changes in forecast as compared to the prior year. The impact of COVID-19 has been removed as a
key audit matter as the impact on the Group has reduced and this is now incorporated within other key audit matters, where relevant.
Otherwise, the key audit matters below are consistent with last year.
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FINANCIAL STATEMENTS
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
C O N T I N U E D
C O N T I N U E D
Key audit matter
How our audit addressed the key audit matter
Ongoing litigation and investigative matters (Group)
We discussed actual or pending litigation and investigative
Refer to the Audit Committee report within the Corporate
Governance section and Note 2, 21, 22 and 23 to the Group
Financial Statements
The pharmaceutical industry is a highly regulated industry.
Compliance is required across the industry, however, with the US
representing 76% of the Group’s net revenue, the US regulatory
requirements, including those of the Federal Trade Commission
and US Food and Drug Administration is considered a significant
focus. The Group is engaged in a number of ongoing litigation
and investigative matters, which may have a material impact on
the Group Financial Statements.
As described in Note 21 to the Group Financial Statements, on 24
July 2020, the Group reached an agreement with the DOJ and
other litigants, which was approved by the court in November
2020. As at 31 December 2021, the Group has recorded other
liabilities amounting to $492m (2020: $486m) in relation to this
matter, with annual instalments payable until December 2027.
matters with the Group’s external and internal legal counsel to
gain an understanding of the status of each matter.
Where the Group has reached a settlement, we assessed
whether appropriate amounts have been recorded in the Group
Financial Statements and are classified appropriately as per the
agreed payment arrangements. We also assessed whether these
liabilities are appropriately discounted to net present value as at
31 December 2021.
Where contingent liabilities have been disclosed in the Group
Financial Statements we have evaluated management’s position
of the likely outcome by:
› reading documentation such as correspondence from external
legal counsel and Board and other committee minutes;
› reviewing management’s litigation paper;
› evaluating independent confirmations that we received from
the Group’s external legal counsel;
On 25 January 2021, the Group reached an agreement with
Reckitt Benckiser (RB) to pay a total of $50m and release RB
from any claims to seek damages relating to its settlement with
the DOJ and the FTC. As at 31 December 2021 the Group has
recorded other liabilities amounting to $40m (2020: $50m)
related to this settlement.
› utilising an auditor's subject matter expert to assess the
information provided by management and the Group's
external counsel in arriving at the judgements taken and
perform an independent review of public court documents
outlining the legal arguments presented in relation to
summary judgement hearings;
The Group is also involved in a number of other ongoing legal
matters as explained in Note 23 to the Group Financial
Statements. The Group believes that it has strong defences and
is actively litigating these matters.
We focused on this area because the outcome of claims is
uncertain and the positions taken by the Directors are based
on the application of material judgements and estimation.
Accordingly, should the outcomes of the legal proceedings differ
from those anticipated by the Directors, this could materially
impact the Group’s results and balance sheet position.
› enquiring (with support of an auditor’s subject matter expert)
of external and internal legal counsel; and
› agreeing the magnitude of the contingent liability disclosed
to previous settlement offers received from plaintiffs as
confirmed by external legal counsel.
In addition, we considered the completeness of litigation and
investigative matters through discussions with internal and
external legal counsel, by reading Board and Committee minutes
and reviewing legal expense accounts. We did not detect any
other litigation and investigative matters that had not already
been disclosed to us.
Given the Group entered into a Corporate Integrity Agreement
with the Office of Inspector General (OIG) of the United States
Department of Health and Human Services (HHS) in 2020, we
have reviewed the ongoing compliance activities that are
required under the terms of this agreement and based on
enquiries with management and a review of the reporting
submitted we have not identified any areas of non-compliance.
Finally, we reviewed the sufficiency and appropriateness
of the legal proceedings disclosures in the Group Financial
Statements based on our underlying work. We determined that
appropriate disclosures are included in Note 21, 22 and 23 to the
Group Financial Statements.
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Key audit matter
How our audit addressed the key audit matter
Sales rebate adjustments recognised in the US business
in relation to SUBOXONE and SUBLOCADE (Group)
Refer to the Audit Committee report within the Corporate
Governance section and Notes 2 and 24 to the Group
Financial Statements
At 31 December 2021, payables in respect of sales rebates,
discounts and returns totalled $436m; 96% of which originated
in the US in relation to Managed Care, Federal and Medicaid
(31 December 2020: $396m of which 96% originated in the US).
In the US, the Group sells products through both wholesalers
into pharmacies and through specialty pharma distributors.
The ultimate net amount received is determined based on the
contractual arrangements that the Group has with the patient’s
insurer or other payment programmes (Medicaid, Medicare or
equivalent schemes). The time between initial shipment to the
wholesaler (when the revenue is recognised) and the dispensing
of a product to a patient may be several weeks or months.
Accordingly, an estimate of the net amount to be received is
necessary at the date of shipment, when the revenue is
recognised. As a result, net revenue recognised on sales to
wholesale and retail distributors is subject to a final
determination of the ultimate sales price in the form of rebates,
discounts and sales returns. The estimate is more subjective for
the recently launched products where there is a shorter
track record.
We focused on this area as the process for calculating sales
rebates is complex and highly manual, requiring management to
use judgement and estimation and is therefore at risk of
management manipulation or bias.
We have focused on the rebate accruals for Medicaid and
Managed Care, as the key judgements and estimates are with
respect to these balances.
We have performed the following procedures on
management’s estimate:
› Understood and evaluated the end-to-end process around
rebate provisions, including authorisation and approval of
commitments and subsequent payments;
› Performed a retrospective review of the 2020 accruals by
comparing accruals recognised in previous periods to actual
rebates received in order to test the historical accuracy in
calculating these accruals;
› Detailed testing of rebate contracts with third parties on a
sample basis;
› Reviewed true up assessments of amounts paid compared to
amounts provided;
› Used Government Pricing Specialists to advise on the
reasonableness of the assumptions on average manufacturer
price, unit rebate amount and best price for product,
including advising on relevant changes in the US government
pricing regulations;
› Tested rebate calculations; and
› Tested the integrity of the model used to determine the level
of rebates.
To assess the accuracy and completeness of the rebates
balances, we have determined that the most appropriate
approach is to develop an independent point estimate or an
independent range to encompass reasonable outcomes using
independently verifiable inputs and assumptions, including
historical invoices received, adjusted for current volumes, rebate
rates and adjustments based on industry experience of
inventory pipeline. We have developed these separately by
product as this reflects the way in which they are managed
and the performance of each product is assessed separately.
The total accruals recognised in the Group Financial Statements
were not materially different from our internally generated
expectations.
We have evaluated management’s revenue recognition policy
and from the evidence obtained we found the assumptions,
methodology and policies used to be consistent with
UK-adopted International Accounting Standards, noting
no differences.
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FINANCIAL STATEMENTS
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
C O N T I N U E D
C O N T I N U E D
Key audit matter
How our audit addressed the key audit matter
We have considered the market capitalisation of the Group as at
31 December 2021 and note that given the increase in share price
over the course of 2021 the market capitalisation (adjusted for
net cash) of the Group exceeds the book value of the investment
in subsidiaries of $1,437m as at 31 December 2021.
In addition to market capitalisation, we have considered other
internal and external factors, including comparing the carrying
value of the investment in subsidiaries to the book value of net
assets and no impairment triggers have been identified, such
that we have concluded that it is appropriate that no
impairment assessment has been performed by management.
Carrying value of investments in subsidiaries (Parent)
Refer to Notes 1 and 2 to the Parent Company
Financial Statements
Investments in subsidiaries of $1,437m (2020: $1,437m) are
accounted for at cost less provision for impairment in the Parent
Company’s balance sheet at 31 December 2021.
Investments are assessed for impairment if impairment
indicators exist. If such indicators exist, the recoverable amounts
of the investments in subsidiaries are estimated in order to
determine the extent of the impairment loss, if any. Any such
impairment loss is recognised in the Income Statement.
At 31 December 2021, the market capitalisation of the Group was
higher than the book value of the investment held on the Parent
Company balance sheet and there are no other internal or
external indicators of impairment such that management has
concluded that no assessment for impairment is required.
How we tailored the audit scope
We tailored the scope of our audit to ensure that we performed enough work to be able to give an opinion on the financial
statements as a whole, taking into account the structure of the Group and the Parent Company, the accounting processes and
controls, and the industry in which they operate.
The Group operates a single business activity and therefore has one reportable segment. The Group Financial Statements are a
consolidation of 45 components comprising the Group’s operating businesses and centralised Group functions. The Group
consolidation, financial statements disclosures and corporate functions were audited by the Group engagement team. This included
our work over legal matters, intangible assets impairment, tax, borrowings, net finance expense, share-based payments and equity.
In addition to centralised Group audit procedures, we conducted our audit by concentrating our work on those parts of the Group
that make up the most significant proportions of the Group Financial Statements. We identified one component in the US and two in
the UK and Ireland that required a full scope audit due to their size. Audit procedures over specific financial statement line items
were performed at a further component in the US to give sufficient audit coverage. The Parent Company is not in Group audit scope
as it is a holding company and predominantly eliminated on consolidation which is tested centrally. With the largest components of
the Group being the US and UK and Ireland we focused our audit work there. For the audit of the US component, we utilised our
Richmond, Virginia based component audit team with knowledge and experience of the US pharmaceuticals industry and regulations.
For the audit of the UK and Ireland components, we utilised our Reading, UK based component audit team with knowledge and
experience of the UK and European pharmaceuticals industry and regulations. These component teams were supplemented by
procedures performed on certain Group related balances by PwC staff based in London, UK.
Although our Group engagement team could not carry out a physical site visit to the US component in the current year, there were no
changes made to the extent of our oversight of the components, nor to the extent of the work performed by the component teams.
We held numerous meetings with our component teams, including via video conference, and performed remote reviews of the key
working papers associated with the component teams audits in the US and UK. We were also in attendance at both the US and UK
component audit closing meetings. This helped to ensure that the Group audit team was sufficiently involved in the component
auditors’ planned response to the sales rebate key audit matter.
Taken together, the components and corporate functions where we conducted audit procedures accounted for 93% of the Group’s net
revenues and 82% of the Group’s profit before tax adjusted for exceptional items (on an absolute basis). This provided the evidence we
needed for our opinion on the Consolidated Financial Statements taken as a whole. This was before considering the disaggregated Group
level analytical review procedures, which covered certain of the Group’s smaller and lower risk components that were not directly included
in our Group audit scope.
Materiality
The scope of our audit was influenced by our application of materiality. We set certain quantitative thresholds for materiality. These,
together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit
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procedures on the individual financial statement line items and disclosures and in evaluating the effect of misstatements, both
individually and in aggregate on the financial statements as a whole.
Based on our professional judgement, we determined materiality for the financial statements as a whole as follows:
Overall
materiality
How we
determined it
Rationale for
benchmark
applied
Financial statements – Group Financial statements – Parent Company
US$7.9m (2020: US$6.5m).
US$14.7m (2020: US$14.6m).
1% of total net revenue.
1% of total assets.
As the market focus is on the Group’s
revenues rather than profitability, we
have considered net revenue to be the
most appropriate benchmark for
materiality.
As explained in the scoping section and based on our professional judgement,
the Parent Company is not in Group audit scope as it is a holding company which
is predominantly eliminated on consolidation. We believe total assets is the
primary measure used by the shareholders in assessing the performance of the
entity, and is a generally accepted auditing benchmark for holding companies.
For each component in the scope of our Group audit, we allocated a materiality that is less than our overall Group materiality. The range of
materiality allocated across components was between $3.0m and $7.1m.
We use performance materiality to reduce to an appropriately low level the probability that the aggregate of uncorrected and undetected
misstatements exceeds overall materiality. Specifically, we use performance materiality in determining the scope of our audit and the
nature and extent of our testing of account balances, classes of transactions and disclosures, for example in determining sample sizes.
Our performance materiality was 75% (2020: 75%) of overall materiality, amounting to US$5.9m (2020: US$4.8m) for the Group financial
statements and US$11.0m (2020: US$11.0m) for the Parent Company financial statements.
In determining the performance materiality, we considered a number of factors – the history of misstatements, risk assessment
and aggregation risk and the effectiveness of controls – and concluded that an amount at the upper end of our normal range
was appropriate.
We agreed with the Audit Committee that we would report to them misstatements identified during our audit above $0.5m (Group
audit) (2020: $0.6m) and $1.5m (Parent Company audit) (2020: $1.5m) as well as misstatements below those amounts that, in our view,
warranted reporting for qualitative reasons.
Conclusions relating to going concern
Our evaluation of the directors’ assessment of the Group's and the Parent Company’s ability to continue to adopt the going concern
basis of accounting included:
› agreeing the underlying cash flow projections to Board approved forecasts, assessing how these forecasts are compiled and
assessing the accuracy of these forecasts by reviewing third-party data for SUBLOCADE and PERSERIS revenue streams;
› evaluating the key assumptions within management’s forecasts and ensuring that such assumptions are consistent with those
modelled in relation to impairment assessments and deferred tax recoverability;
› evaluating the assumptions regarding the revenue forecast for SUBOXONE Film by reference to the actual results since the launch
of other generics for film;
› considering with the support of an auditor's expert, the potential timing to resolve the remaining outstanding legal matters
and noted that based on the Board's strategy to litigate, the resolution of these matters is not expected to occur in the going
concern period;
› assessing whether the downside model prepared by management appropriately considered the risks facing the business as
identified in the principal risk section of the Strategic Report;
› performing additional sensitivities on the downside model by incorporating a further decline in revenues and additional legal
payments relating to the other ongoing litigation and investigation matters; and
› checking the mathematical accuracy of the spreadsheet used to model future financial performance and determining whether the
minimum cash balance requirements will be met.
Based on the work we have performed, we have not identified any material uncertainties relating to events or conditions that,
individually or collectively, may cast significant doubt on the Group's and the Parent Company’s ability to continue as a going concern
for a period of at least twelve months from when the financial statements are authorised for issue.
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FINANCIAL STATEMENTS
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
C O N T I N U E D
C O N T I N U E D
In auditing the financial statements, we have concluded that the directors’ use of the going concern basis of accounting in the
preparation of the financial statements is appropriate.
However, because not all future events or conditions can be predicted, this conclusion is not a guarantee as to the Group's and the
Parent Company's ability to continue as a going concern.
In relation to the directors’ reporting on how they have applied the UK Corporate Governance Code, we have nothing material to add or
draw attention to in relation to the directors’ statement in the financial statements about whether the directors considered it appropriate
to adopt the going concern basis of accounting.
Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of
this report.
Reporting on other information
The other information comprises all of the information in the Annual Report other than the financial statements and our auditors’
report thereon. The directors are responsible for the other information, which includes reporting based on the Task Force on Climate-
related Financial Disclosures (TCFD) recommendations. Our opinion on the financial statements does not cover the other information
and, accordingly, we do not express an audit opinion or, except to the extent otherwise explicitly stated in this report, any form of
assurance thereon.
In connection with our audit of the financial statements, our responsibility is to read the other information and, in doing so, consider
whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit, or
otherwise appears to be materially misstated. If we identify an apparent material inconsistency or material misstatement, we are
required to perform procedures to conclude whether there is a material misstatement of the financial statements or a material
misstatement of the other information. If, based on the work we have performed, we conclude that there is a material misstatement
of this other information, we are required to report that fact. We have nothing to report based on these responsibilities.
With respect to the Strategic Report and Directors’ Report, we also considered whether the disclosures required by the UK Companies
Act 2006 have been included.
Based on our work undertaken in the course of the audit, the Companies Act 2006 requires us also to report certain opinions and
matters as described below.
Strategic Report and Directors’ Report
In our opinion, based on the work undertaken in the course of the audit, the information given in the Strategic Report and Directors’
Report for the year ended 31 December 2021 is consistent with the financial statements and has been prepared in accordance with
applicable legal requirements.
In light of the knowledge and understanding of the Group and Parent Company and their environment obtained in the course of the
audit, we did not identify any material misstatements in the Strategic Report and Directors’ Report.
Directors’ Remuneration
In our opinion, the part of the Directors’ Remuneration Report to be audited has been properly prepared in accordance with the
Companies Act 2006.
Corporate governance statement
The Listing Rules require us to review the directors’ statements in relation to going concern, longer-term viability and that part of the
corporate governance statement relating to the Parent Company’s compliance with the provisions of the UK Corporate Governance
Code specified for our review. Our additional responsibilities with respect to the corporate governance statement as other
information are described in the Reporting on other information section of this report.
Based on the work undertaken as part of our audit, we have concluded that each of the following elements of the corporate
governance statement is materially consistent with the financial statements and our knowledge obtained during the audit, and we have
nothing material to add or, with the exception of the matter noted below, nothing else we wish to draw attention to in relation to:
› The directors’ confirmation that they have carried out a robust assessment of the emerging and principal risks;
› The disclosures in the Annual Report that describe those principal risks, what procedures are in place to identify emerging risks
and an explanation of how these are being managed or mitigated;
› The directors’ statement in the financial statements about whether they considered it appropriate to adopt the going concern basis
of accounting in preparing them, and their identification of any material uncertainties to the Group’s and Parent Company’s ability
to continue to do so over a period of at least twelve months from the date of approval of the financial statements;
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› The directors’ explanation as to their assessment of the Group's and Parent Company’s prospects, the period this assessment
covers and why the period is appropriate; and
› The directors’ statement as to whether they have a reasonable expectation that the Parent Company will be able to continue in
operation and meet its liabilities as they fall due over the period of its assessment, including any related disclosures drawing attention
to any necessary qualifications or assumptions.
However, we draw attention to the disclosures made within the Viability Statement of the Annual Report regarding the possible
scenarios that may occur where the uptake of SUBLOCADE falls significantly below expectations, there is an accelerated reversion to
generic analogues for SUBOXONE film, and there is an unfavourable outcome of remaining legal proceedings at the amount disclosed
in Note 23 to the Group Financial Statements.
Our review of the directors’ statement regarding the longer-term viability of the Group was substantially less in scope than an audit and
only consisted of making inquiries and considering the directors’ process supporting their statement; checking that the statement is in
alignment with the relevant provisions of the UK Corporate Governance Code; and considering whether the statement is consistent with
the financial statements and our knowledge and understanding of the Group and Parent Company and their environment obtained in
the course of the audit.
In addition, based on the work undertaken as part of our audit, we have concluded that each of the following elements of the
corporate governance statement is materially consistent with the financial statements and our knowledge obtained during the audit:
› The directors’ statement that they consider the Annual Report, taken as a whole, is fair, balanced and understandable, and provides
the information necessary for the members to assess the Group’s and Parent Company's position, performance, business model
and strategy;
› The section of the Annual Report that describes the review of effectiveness of risk management and internal control systems; and
› The section of the Annual Report describing the work of the Audit Committee.
We have nothing to report in respect of our responsibility to report when the directors’ statement relating to the Parent Company’s
compliance with the Code does not properly disclose a departure from a relevant provision of the Code specified under the Listing
Rules for review by the auditors.
Responsibilities for the financial statements and the audit
Responsibilities of the directors for the financial statements
As explained more fully in the Statement of Directors' Responsibilities, the directors are responsible for the preparation of the
financial statements in accordance with the applicable framework and for being satisfied that they give a true and fair view. The
directors are also responsible for such internal control as they determine is necessary to enable the preparation of financial
statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, the directors are responsible for assessing the Group’s and the Parent Company’s ability to
continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of
accounting unless the directors either intend to liquidate the Group or the Parent Company or to cease operations, or have no
realistic alternative but to do so.
Auditors’ responsibilities for the audit of the financial statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material
misstatement, whether due to fraud or error, and to issue an auditors’ report that includes our opinion. Reasonable assurance
is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a
material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually
or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these
financial statements.
Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with
our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which
our procedures are capable of detecting irregularities, including fraud, is detailed below.
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FINANCIAL STATEMENTS
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
I N D E P E N D E N T A U D I T O R S ’ R E P O R T
C O N T I N U E D
C O N T I N U E D
Based on our understanding of the Group and industry, we identified that the principal risks of non-compliance with laws and
regulations related to pharmaceutical regulatory requirements (including, but not limited to, those of the Federal Trade Commission,
US Food and Drug Administration, the European Medicines Agency and the UK Medicines & Healthcare products Regulatory Agency) in
addition to the on-going compliance requirements with respect to the CIA and US, UK and European tax legislation (refer to the Risk
Management section of the Annual Report), and we considered the extent to which non-compliance might have a material effect on
the financial statements. We also considered those laws and regulations that have a direct impact on the financial statements such
as the Companies Act 2006. We evaluated management’s incentives and opportunities for fraudulent manipulation of the financial
statements (including the risk of override of controls), and determined that the principal risks were related to posting inappropriate
journal entries to manipulate revenue or expenditure, and management bias in accounting estimates. The Group engagement team
shared this risk assessment with the component auditors so that they could include appropriate audit procedures in response to
such risks in their work. Audit procedures performed by the Group engagement team and/or component auditors included:
› Discussions, including a PwC industry forensic specialist, with management, VP Internal Audit, Chief Integrity and Compliance Officer
and the Group’s Chief Legal Officer and legal advisors, including consideration of known or suspected instances of non-compliance
with laws and regulation and fraud;
› Reviewing key correspondence with regulatory authorities, including reviewing the reporting submitted under the terms of the CIA, and
discussion with external and internal legal counsel;
› Review of significant component’s auditors’ working papers;
› Reading of internal audit reports;
› Challenging assumptions and judgements made by management in its significant accounting estimates, in particular in relation to
litigation related other liabilities and contingent liabilities, provisions, sales rebate adjustments, impairment of intangible assets
and recoverability of other non-current assets, deferred tax assets and inventories;
› Obtaining an understanding of management’s controls designed to prevent and detect irregularities;
› Assessment of matters reported on the Group’s whistleblowing helpline and the results of management’s investigation of such
matters; and
› Identifying and testing journal entries, in particular any journal entries posted with unusual account combinations, or posted by
senior management.
There are inherent limitations in the audit procedures described above. We are less likely to become aware of instances of
non-compliance with laws and regulations that are not closely related to events and transactions reflected in the financial
statements. Also, the risk of not detecting a material misstatement due to fraud is higher than the risk of not detecting one resulting
from error, as fraud may involve deliberate concealment by, for example, forgery or intentional misrepresentations, or through
collusion.
Our audit testing might include testing complete populations of certain transactions and balances, possibly using data auditing
techniques. However, it typically involves selecting a limited number of items for testing, rather than testing complete populations.
We will often seek to target particular items for testing based on their size or risk characteristics. In other cases, we will use audit
sampling to enable us to draw a conclusion about the population from which the sample is selected.
A further description of our responsibilities for the audit of the financial statements is located on the FRC’s website at:
www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditors’ report.
Use of this report
This report, including the opinions, has been prepared for and only for the Parent Company’s members as a body in accordance with
Chapter 3 of Part 16 of the Companies Act 2006 and for no other purpose. We do not, in giving these opinions, 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.
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Other required reporting
Companies Act 2006 exception reporting
Under the Companies Act 2006 we are required to report to you if, in our opinion:
› we have not obtained all the information and explanations we require for our audit; or
› adequate accounting records have not been kept by the Parent Company, or returns adequate for our audit have not been received
from branches not visited by us; or
› certain disclosures of directors’ remuneration specified by law are not made; or
› the Parent Company financial statements and the part of the Directors’ Remuneration Report to be audited are not in agreement
with the accounting records and returns.
We have no exceptions to report arising from this responsibility.
Appointment
Following the recommendation of the Audit Committee, we were appointed by the members on 23 December 2014 to audit the
financial statements for the year ended 31 December 2014 and subsequent financial periods. The period of total uninterrupted
engagement is eight years, covering the years ended 31 December 2014 to 31 December 2021.
Other matter
As required by the Financial Conduct Authority Disclosure Guidance and Transparency Rule 4.1.14R, these financial statements form
part of the ESEF-prepared annual financial report filed on the National Storage Mechanism of the Financial Conduct Authority in
accordance with the ESEF Regulatory Technical Standard (‘ESEF RTS’). This auditors’ report provides no assurance over whether the
annual financial report has been prepared using the single electronic format specified in the ESEF RTS.
Sarah Quinn (Senior Statutory Auditor)
for and on behalf of PricewaterhouseCoopers LLP
Chartered Accountants and Statutory Auditors
London
17 March 2022
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FINANCIAL STATEMENTS
C O N S O L I D A T E D I N C O M E S T A T E M E N T
C O N S O L I D A T E D I N C O M E S T A T E M E N T
For the year ended December 31
Net revenue
Cost of sales
Gross profit
Gross profit before exceptional items
Exceptional items
Selling, general and administrative expenses
Research and development expenses
Other operating income
Operating profit/(loss)
Operating profit before exceptional items
Exceptional items
Finance income
Finance expense
Net finance expense
Net finance expense before exceptional items
Exceptional items within finance expense
Profit/(loss) before taxation
Income tax benefit
Taxation before exceptional items
Exceptional items within taxation
Net income/(loss)
Earnings/(loss) per ordinary share (cents)
Basic earnings/(loss) per share
Diluted earnings/(loss) per share
C O N S O L I D A T E D S T A T E M E N T O F C O M P R E H E N S I V E I N C O M E / ( L O S S )
C O N S O L I D A T E D S T A T E M E N T O F C O M P R E H E N S I V E I N C O M E / ( L O S S )
For the year ended December 31
Net income/(loss)
Other comprehensive (loss)/income
Items that may be reclassified to profit or loss in subsequent years:
Net exchange adjustments on foreign currency translation
Other comprehensive (loss)/income
Total comprehensive income/(loss)
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Notes
3
5
4
4
4
5
8
5
9
5
10
10
2021
$m
791
(127)
664
664
–
(431)
(52)
32
213
187
26
4
(27)
(23)
(22)
(1)
190
15
(25)
40
205
28
27
2021
$m
205
(7)
(7)
198
2020
$m
647
(97)
550
555
(5)
(666)
(40)
–
(156)
88
(244)
9
(26)
(17)
(17)
–
(173)
25
(12)
37
(148)
(20)
(20)
2020
$m
(148)
10
10
(138)
C O N S O L I D A T E D B A L A N C E S H E E T
C O N S O L I D A T E D B A L A N C E S H E E T
As at December 31
Assets
Non-current assets
Intangible assets
Property, plant and equipment
Right-of-use assets
Deferred tax assets
Other assets
Current assets
Inventories
Trade receivables
Other assets
Current tax receivable
Cash and cash equivalents
Total assets
Liabilities
Current liabilities
Borrowings
Provisions
Other liabilities
Trade and other payables
Lease liabilities
Current tax liabilities
Non-current liabilities
Borrowings
Provisions
Other liabilities
Lease liabilities
Total liabilities
Net assets
Equity
Capital and reserves
Share capital
Share premium
Capital redemption reserve
Other reserves
Foreign currency translation reserve
Retained earnings
Total equity
Notes
2021
$m
2020
$m
11
12
13
14
16
15
16
16
18
19
21
21
24
13
19
21
21
13
25
26
26
26
82
58
37
105
106
388
95
202
32
13
1,102
1,444
1,832
(3)
(5)
(61)
(720)
(8)
(7)
(804)
(239)
(76)
(474)
(36)
(825)
62
60
43
75
104
344
93
179
50
7
858
1,187
1,531
(4)
(38)
(10)
(524)
(8)
(15)
(599)
(230)
(51)
(526)
(43)
(850)
(1,629)
203
(1,449)
82
70
7
3
(1,295)
(20)
1,438
203
73
6
–
(1,295)
(13)
1,311
82
The financial statements on pages 128 to 161 were approved by the Board of Directors on March 17, 2022 and signed on its behalf by:
Mark Crossley
Director
Ryan Preblick
Director
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
Share
premium
$m
Capital
redemption
reserve $m
Other
reserves
$m
Foreign
currency
translation
reserve
$m
Retained
earnings
$m
5
–
–
–
1
–
–
1
6
6
–
–
–
1
–
–
–
–
1
7
–
(1,295)
(23)
1,449
–
–
–
–
–
–
–
–
–
–
–
–
–
3
–
–
–
3
3
–
–
–
–
–
–
–
–
10
10
–
–
–
–
(1,295)
(13)
(148)
–
(148)
–
8
2
10
1,311
(1,295)
(13)
1,311
–
–
–
–
–
–
–
–
–
–
(7)
(7)
–
–
–
–
–
–
205
–
205
–
(101)
11
(1)
13
(78)
(1,295)
(20)
1,438
Total
equity
$m
209
(148)
10
(138)
1
8
2
11
82
82
205
(7)
198
1
(101)
11
(1)
13
(77)
203
C O N S O L I D A T E D S T A T E M E N T O F C H A N G E S I N E Q U I T Y
C O N S O L I D A T E D S T A T E M E N T O F C H A N G E S I N E Q U I T Y
Notes
Share
capital
$m
73
–
–
–
–
–
–
–
73
73
–
–
–
–
(3)
–
–
–
(3)
70
25
27
14
25
25
27
14
Balance at January 1, 2020
Comprehensive loss
Net loss
Other comprehensive income
Total comprehensive loss
Transactions recognized directly in equity
Shares issued
Share-based plans
Deferred taxation on share-based payments
Total transactions recognized directly
in equity
Balance at December 31, 2020
Balance at January 1, 2021
Comprehensive income
Net income
Other comprehensive loss
Total comprehensive income
Transactions recognized directly in equity
Shares issued
Shares repurchased and canceled
Share-based plans
Settlement of equity awards
Deferred taxation on share-based plans
Total transactions recognized directly in equity
Balance at December 31, 2021
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C O N S O L I D A T E D C A S H F L O W S T A T E M E N T
C O N S O L I D A T E D C A S H F L O W S T A T E M E N T
For the year ended December 31
Cash flows from operating activities
Operating profit/(loss)
Depreciation, amortization, and impairment
Gain on disposal of intangible assets
Gain on disposal of right-of-use assets
Depreciation and impairment of right-of-use assets
Share-based plans
Settlement of tax on employee awards
Impact from foreign exchange movements
(Increase)/Decrease in trade receivables
Decrease/(Increase) in current and non-current other assets
Increase in inventories
Increase/(Decrease) in trade and other payables
(Decrease)/Increase in provisions and other liabilities1
Cash generated from/(used in) operations
Interest paid
Interest received
Exceptional tax refund
Taxes paid
Transaction costs related to debt refinancing
Net cash inflow/(outflow) from operating activities
Cash flows from investing activities
Purchase of property, plant and equipment
Purchase of intangible asset
Exceptional net proceeds from disposal of intangible assets
Net cash outflow from investing activities
Cash flows from financing activities
Proceeds from borrowings
Repayment of borrowings
Payment of lease liabilities
Proceeds from the issuance of ordinary shares
Cash paid for the repurchase and cancellation of shares (including direct transaction costs)
Net cash outflow from financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of the year
Exchange difference
Cash and cash equivalents at end of the year
Notes
11, 12
13
13
27
19
12
11
11
19
19
25
18
2021
$m
213
15
(20)
–
7
11
(1)
(3)
(25)
16
(3)
201
(16)
395
(18)
1
31
(48)
(8)
353
(4)
(30)
20
(14)
250
(236)
(8)
1
(101)
(94)
245
858
(1)
1,102
2020
$m
(156)
18
–
(2)
8
8
–
(5)
15
(44)
(16)
(103)
129
(148)
(20)
9
–
(34)
–
(193)
(4)
–
–
(4)
–
(4)
(7)
1
–
(10)
(207)
1,060
5
858
1. Changes in provisions and other liabilities for 2021 include exceptional payments of $10m for the RB settlement and $9m for DOJ-related matters (2020 includes
a $103m initial payment under the DOJ resolution).
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
1. General information
Indivior PLC (the “Company”) and its subsidiaries (together,
“Indivior” or the “Group”) are predominantly engaged in the
development, manufacture and sale of buprenorphine-based
prescription drugs for the treatment of opioid dependence, and
co-occurring disorders (the “Indivior Business”).
The Indivior Business was previously the pharmaceuticals
business of the Reckitt Benckiser Group plc (RB), carried
out by RBP Global Holdings Limited and its subsidiaries.
The Company is a public limited company incorporated and
domiciled in England, United Kingdom on September 26, 2014,
and is the holding company for the Group. The address of the
registered office and company number are stated on page 171.
The principal accounting policies adopted in the preparation of
these financial statements are set out below. Unless otherwise
stated, these policies have been consistently applied to all
years presented.
2. Basis of preparation
On December 31, 2020, IFRS as adopted by the European Union
at that date was brought into UK law and became UK-adopted
International Accounting Standards, with future changes being
subject to endorsement by the UK Endorsement Board. The
Group transitioned to UK-adopted International Accounting
Standards in its Group financial statements on 1 January 2021.
This change constitutes a change in accounting framework.
However, there is no impact on recognition, measurement, or
disclosure in the period reported as a result of the change in
framework. The financial statements of the Group have been
prepared in accordance with UK-adopted International
Accounting Standards and with the requirements of the
Companies Act 2006 as applicable to companies reporting under
those standards.
The financial statements are presented in US dollars ($) and are
prepared on a historical cost basis except where otherwise
stated. The 2020 balance sheet has been expanded to present
provisions and other liabilities on separate lines to improve the
presentation and transparency.
The Directors have considered the Group’s and Parent
Company’s financial plan, in particular reference to the period
through to June 2023.
As disclosed in Notes 5, 21, 22 and 23 to the Group financial
statements, the Group has liabilities and provisions totaling
$537m (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 minimum liquidity covenant in the Group’s debt
facility, maintain sufficient liquidity to fund its operations, fulfill
obligations under the DOJ resolution and RB agreement, and
address the reasonably possible financial implications of the
ongoing legal proceedings. The Directors have also modeled the
risk that SUBLOCADE will not meet revenue growth expectations
(considering a 15% decline on forecasts), an accelerated
reversion to generic analogs for SUBOXONE Film, and the
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ongoing legal proceedings (as disclosed in Note 23) may result
in reasonably possible payments 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. As a result of the factors
set out above, the Directors of the Group and Parent Company
have a reasonable expectation that the Group and Parent
Company have adequate resources to continue in operational
existence for at least one year from the approval of these
financial statements.
The Directors have given the going concern assessment due
consideration and have concluded that it is appropriate to adopt
the going concern basis for accounting and preparing these
financial statements. The viability statement is on page 57.
Adoption of new and revised standards
The Group has applied the following amendments for the
first time for their annual reporting period commencing
1 January 2021:
Interest Rate Benchmark Reform
(Amendments to IFRS 9, IAS 29 and IFRS 7)
Interest Rate Benchmark Reform (Amendments to IFRS 9,
IAS 39 and IFRS 7) was issued in response to the ongoing reform
of interest rate benchmarks around the world. These standards
relate to the replacement of benchmark interest rates such as
LIBOR, a priority of global regulators. The International
Accounting Standards Board (IASB) identified two phases of the
reform: Phase 1 amendments primarily deal with pre-LIBOR
reform where uncertainty could arise in the lead-up to transition
and Phase 2 amendments relate to post-LIBOR reform, when
uncertainty is removed, and new rates adopted. Phase 1
amendments provide relief from applying specific hedge
accounting requirements. The Group’s adoption of these
amendments had no impact on the consolidated financial
statements as the amendments were not applicable to
the Group.
Phase 2 amendments primarily address potential financial
reporting issues that may arise when LIBOR is replaced.
For contractual changes or changes to cash flows directly
required by LIBOR reform, the effective interest rate (EIR) will be
updated without adjusting the carrying amount of the financial
asset/liability or the EIR will be used to recalculate the carrying
amount, with any modification gain or loss recognized in profit or
loss. Phase 2 amendments became effective in 2021. While the
Group’s term loan is USD LIBOR based, the term loan contains
fallback language to convert to a new reference rate when USD
LIBOR is discontinued or becomes non-representative, which is
expected to occur in early 2023. The Group does not expect the
adoption of this standard to have a significant impact on the
future consolidated financial statements.
2. Basis of preparation continued
COVID-19 related rent concessions (Amendments to IFRS 16)
The Group did not receive rent concessions due to COVID-19 or
other factors. As this amendment was not applicable it did not
have an impact on the amounts recognized in prior periods or
the current year and are not expected to significantly affect
future periods.
New accounting standards issued but not yet effective
Certain new accounting standards, amendments to accounting
standards and interpretations have been published that are not
mandatory for December 31, 2021 reporting periods and have not
been early adopted by the Group. These standards, amendments,
or interpretations are not expected to have a material impact on
the entity in the current or future reporting periods and on
foreseeable future transactions.
Basis of consolidation
The consolidated financial statements include the results of the
Company and its subsidiaries, which are entities controlled by
the Group. The Company has a 100% direct or indirect interest in
all of its consolidated subsidiaries. Inter-company transactions,
outstanding balances payable or receivable and unrealized
income and expense on transactions between Group companies
have been eliminated on consolidation. All subsidiaries have
year ends which are co-terminous with the Company’s. For IFRS
reporting, subsidiaries’ accounting policies are consistent with
the policies adopted by the Group.
Foreign currency translation
The financial statements of each Group entity is measured using
the currency of the primary economic environment in which the
entity operates (the functional currency), which is generally the
local currency with the exception of treasury and holding
companies where the functional currency is the US dollar. The
Group’s presentation currency is the US dollar.
Foreign currency transactions are translated into the functional
currency using exchange rates prevailing at the dates of the
transactions. Foreign exchange gains and losses resulting from
the settlement of foreign currency transactions and from the
remeasurement of monetary assets and liabilities denominated
in foreign currencies are recognized within SG&A in the
income statement.
The exchange rates used for the translation of currencies into US
dollars that have the most significant impact on the Group’s
results were:
GBP year-end exchange rate
GBP average exchange rate
EUR year-end exchange rate
EUR average exchange rate
2021
2020
1.3532
1.3763
1.1378
1.1840
1.3651
1.2833
1.2226
1.1403
The financial statements of subsidiaries with different functional
currencies are translated into US dollars on the following basis:
› Assets and liabilities at the year-end rate.
› Profit and loss account items at the weighted average
exchange rate for the year.
Exchange differences arising from translation of retained
earnings and the net investment in foreign entities are taken to
equity and recognized in the statement of comprehensive
income on consolidation.
Accounting estimates and judgments
The Directors make several estimates and assumptions regarding
the future and significant judgments in applying the Group’s
accounting policies.
Key estimates and assumptions
Estimates and assumptions may affect the reported amount of
assets and liabilities, disclosure of contingent assets and
liabilities, and the reported amounts of revenues and expenses.
These estimates are based on the Group’s knowledge of the
amount, events, or actions; however, actual results may
ultimately differ from those estimates. Estimates and underlying
assumptions are reviewed on an ongoing basis. The Group
reviewed the impact of COVID-19 on key business practices and
further evaluated estimates used in judgmental accounting
positions. This review focused on inventory obsolescence, impact
on cash flow (going concern), impairment of intangible assets,
impairment of fixed assets and expected credit loss provisions
for trade receivables. Revisions to estimates are recognized
prospectively. The key estimates and assumptions used in the
financial statements are set out below.
Provisions for returns, discounts, incentives and rebates
The Group offers various types of reductions from list
prices on its products. Products sold in the United States
are covered by various programs (such as Medicare and
Medicaid) under which products are sold at a discount. Rebates
are granted to healthcare authorities, and under contractual
arrangements with certain customers. Some wholesalers are
entitled to chargeback incentives under specific contractual
arrangements. Cash discounts may also be granted for prompt
payment.
The discounts, incentives and rebates described above are
estimated based on contractual arrangements with customers or
terms of the relevant regulations and/or agreements applicable
for transactions with healthcare authorities, and in some cases
on assumptions about the attainment of targeted volumes.
Several months may pass between the original estimate of
rebates due and confirmation of the amount, which may
increase the estimation risk. Please refer to Note 3 for
further details.
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
2. Basis of preparation continued
Ongoing litigation and IP-related claims
The Group also estimates the amount of product returns based
on contractual sales terms and reliable historical data, adjusted
for future expectations. The estimates are recognized in the
period in which the underlying sales are recognized, as a
reduction of sales revenue.
A 5% variation in our provision for rebates and product returns
would impact net revenue by $22m. For more details of accruals
for returns, discounts, incentives, and rebates, see Note 24 to the
Group financial statements.
Impairment of intangible assets
In carrying out impairment reviews, specifically in relation to
products in development, several significant assumptions have to
be made. These include the probability of success in obtaining
regulatory approvals, future rate of market growth, discount rates,
market demand for the products acquired, future profitability, and
levels of reimbursement for pharmaceutical products. If actual
results should differ, or changes in expectations arise, impairment
charges may be required which would have a material adverse
impact on reported results and financial position. Consistent with
other products in early stages of development, it is reasonably
possible that products in development could fail to obtain
regulatory approvals. The probability of success is factored into
the risk-adjusted calculation of the recoverable amount; however,
failure to reach commercialization would result in a full
impairment of the asset. See Note 11 to the Group financial
statements for further details.
Critical judgments
The Directors have made the following critical judgments in
applying the Group’s accounting policies that have the most
significant effect on the amounts recognized in the Group
financial statements:
The Group is involved in litigation, arbitration, and other
legal proceedings. These proceedings typically are related to
compliance and trade practices, commercial claims, product
liability claims, intellectual property rights, and employment and
wrongful discharge claims. For each claim or grouping of similar
claims, the Directors make judgments regarding the relative
merits and risks within the claims. These judgments inform the
Group’s defense strategies, whether a loss or settlement from
the claims is probable and whether sufficient information exists
to make a reliable estimate of the likely outcome of the claims.
Provisions are recognized when the Group has a present legal or
constructive obligation, an outflow of resource to settle the
obligation is more likely than not, and the amount can be
reliably estimated. The Directors have assessed as ‘contingent’
matters that cannot be reliably estimated or are not considered
probable at the current time. For more details of all the
outstanding legal proceedings including those that have
been deemed contingent, see Note 23 to the Group
financial statements.
Provisions, when made, are valued based on the Directors’ best
estimates considering all available information, external advice,
and historical experience. The assessment of provisions can
involve a series of complex judgments about future events and
can rely heavily on estimates and assumptions, including advice
from counsel on the merits of the claim, the settlement or
litigation strategy, amount and timing of potential payments, and
discounting. The Group currently maintains a provision related to
DOJ-related matters for $5m (2020: $32m) and IP-related claims
for $73m (2020: $47m). These provisions are valued based on the
Directors’ best estimates considering available historical
information and external advice. Provisions for DOJ-related
matters are expected to be settled within the next 12 months and
are not expected to materially change. IP-related claims are
expected to be settled in FY 2023/2024 and are not expected to
materially change over the next 12 months, or through
settlement proceedings, as the Group’s estimate considers the
value of the court-established surety bonds and an assessment
by subject matter experts. For more details of provisions for
litigation and IP-related claims, see Notes 21 and 23 to the Group
financial statements.
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› accruals for sales returns are calculated on the basis of
management’s best estimate of the amount of product that
will ultimately be returned in accordance with our return
policy. The Group’s returns policy allows the customer to
return products within a certain period either side of the
expiry date (usually three to six months before and six to
twelve months after the expiry date). The accrual is estimated
on the basis of past experience of sales returns and
expectations of future returns.
The Group also takes account of factors such as levels of
inventory in its various distribution channels, product expiry
dates, information about potential discontinuation of products
and the entry of competing products into the market. In each
case, the accruals are subject to continuous review and
adjustment as appropriate, based on the most recent
information available to management. The Group believes it has
the ability to measure each of the above accruals reliably, using
the following factors in developing its estimates:
› the nature and patient profile of the underlying product;
› the applicable regulations and/or the specific terms and
conditions of contracts with governmental authorities,
wholesalers and other customers;
› historical data relating to similar contracts, in the case of
qualitative and quantitative rebates and chargeback incentives;
› past experience and sales growth trends;
› actual inventory levels in distribution channels, monitored
by the Group using internal sales data and externally
provided data;
› the shelf life of the Group’s products; and
› market trends including competition, pricing and demand.
There may be adjustments to the accruals when the actual
rebates are invoiced based on utilization information submitted
to the Group (in the case of accruals for rebates related to sales
targets or contractual rebates) and claims/invoices received (in
the case of regulatory rebates and chargebacks). Management
believes the estimates made are reasonable; however, such
estimates involve judgments on distribution channel mix,
distributors’ sales performance and market competition.
3. 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 engaged in a single business activity, which is
predominantly 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.
Accounting policy
Revenues
Net revenues are generated from sales of pharmaceutical
products, net of provisions for returns, discounts, incentives
and rebates.
Net revenue is recognized when a contractual promise
to a customer (performance obligation) has been fulfilled
by transferring control over pharmaceutical products to
the customer, substantially all of which is upon receipt of
the products by the customer. The amount of net revenue
recognized is based on the consideration expected in exchange
for pharmaceutical products. The consideration Indivior receives
may be fixed or variable. Variable consideration is only
recognized when it is highly probable that a significant reversal
will not occur. The Group has no material contracts with more
than one performance obligation.
The Group is required to determine the net transaction price in
respect of each of its contracts with customers. In making such
judgment, the Group assesses the impact of any variable
consideration in the contract due to returns, discounts,
incentives and rebates. These are estimated and recognized in
the period in which the underlying sales are recognized as a
reduction of sales revenue.
These amounts are calculated as follows:
› accruals for rebates based on attainment of sales targets
are estimated and recorded as each of the underlying sales
transactions is recognized;
› accruals for price reductions under government and
state programs, largely in the US, are estimated on the
basis of the specific terms of the relevant regulations
and agreements, and recorded as the underlying sales
transactions are recognized;
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
3. Segment information continued
Revenues are attributed geographically based on the country where the sale originates. The following table represents net revenues
and non-current assets, net of accumulated depreciation, amortization and impairment, by country. Non-current assets for this
purpose consist of intangible assets, property, plant and equipment, right-of-use assets, and other assets.
Net revenue:
For the year ended December 31
United States
Rest of World
United Kingdom
Total
On a disaggregated basis, the Group’s net revenue by major product line:
For the year ended December 31
SUBLOCADE
PERSERIS
Sublingual/Other
Total
Significant customers
2021
$m
603
181
7
791
2021
$m
244
17
530
791
2020
$m
456
182
9
647
2020
$m
130
14
503
647
Net revenues include amounts derived from significant customers that amount to 10% or more of the Group’s revenues as net follows
(in percentages of total net revenue):
Customer
Customer A
Customer B
Customer C
Non-current assets:
At December 31
United States
United Kingdom
Rest of World
Total
2021
%
21%
18%
18%
2021
$m
133
145
5
283
2020
%
19%
17%
21%
2020
$m
141
122
6
269
4. Operating expenses and other operating income
Research and development
Research expenditure is charged to the consolidated income statement in the year in which it is incurred.
Development expenditure is expensed as incurred, unless the following criteria are met, in which case it is capitalized:
› it must be technically feasible to complete the development project (or intangible asset) so that the related product will be
available for use or sale;
› there is an intention to complete the intangible asset or development project and use or sell it;
› the Group has the ability to use the intangible asset or to sell it;
› the way in which the intangible asset will generate probable future economic benefits. The Group must be able to demonstrate the
existence of a market for the intangible asset's output or for the intangible asset itself or, if it is to be used internally, it must be
able to demonstrate the usefulness of the intangible asset;
› adequate technical, financial and other resources are available to complete the development and to use or sell the intangible asset; and
› expenditure attributable to the intangible asset during its development can be reliably measured.
Amounts capitalized are amortized over the useful life of the developed product, once commercialized.
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4. Operating expenses and other operating income continued
The Group has determined that filing for regulatory approval is generally the earliest point at which internal development costs can
be capitalized. However, judgment is exercised when assessing the point at which it is probable that the asset created will generate
future economic benefits, which may not be until final regulatory approval for certain assets. All internal development expenditure
incurred prior to filing for regulatory approval is therefore expensed as incurred. Internally generated intangibles recognized include
software and technology and development costs in relation to PERSERIS.
Selling, general and administrative expenses
Expenses are recognized in respect of goods and services received when supplied in accordance with contractual terms. Provision is
made when an obligation exists for a future liability in respect of a past event and where the amount of the obligation can be
reliably estimated.
Marketing and promotional expenses are charged to the income statement as incurred.
The table below sets out selected operating costs and expense information.
Research & development expenses
Selling and marketing expenses
Administrative and general expenses1
Selling, general and administrative expenses
Notes
2021
$m
(52)
(192)
(239)
(431)
2020
$m
(40)
(202)
(464)
(666)
Depreciation, amortization and impairment2
11, 12, 13
(13)
(17)
1. Administrative and general expenses include exceptional costs in the current and prior year as outlined in Note 5. Medical Affairs functional costs are included in
administrative expenses.
2. Depreciation and amortization expense is included in research and development and selling, general and administrative expenses. Depreciation and
amortization expense of $9m (2020: $9m) for intangibles and ROU assets is included within cost of sales.
Other operating income
Other operating income is credited to the income statement as incurred. Other operating income includes the net cash proceeds
received from the disposal of the TEMGESIC/BUPREX/BUPREXX (buprenorphine) analgesic franchise outside of North America to
Eumedica Pharmaceuticals AG for $19m, the out-licensing of nasal naloxone opioid overdose patents for $1m, and the Directors’ and
Officers’ insurance reimbursements for $12m. See further discussion under “Exceptional Items” in Note 5.
Other operating income
5. Exceptional items and adjusted results
2021
$m
32
2020
$m
–
Where significant expenses or income that do not reflect the Group’s ongoing operations are incurred during the year, these items
are disclosed as exceptional items in the income statement. Examples of such items could include income or restructuring and
related expenses for the reconfiguration of the Group’s activities and/or capital structure, impairment of current and non-current
assets, proceeds from the sale of intangible assets, certain costs arising as a result of material and non-recurring regulatory and
litigation matters, certain non-recurring benefits, and certain tax-related matters. Exceptional items are excluded from adjusted
results consistent with the internal reporting provided to Management and the Directors.
Adjusted results are not a substitute for, or superior to, reported results presented in accordance with IFRS. Exceptional items with an
impact of less than $1m are not considered for exceptional treatment.
The COVID-19 pandemic had an adverse impact on the Group in 2020, primarily driven by a decrease in patient enrollments during
the onset of the initial outbreak. In 2020, the Group announced cost-saving actions to protect the financial and operational flexibility
of the Group. Consistent with the Group’s existing policies, the restructuring charges due to COVID-19 were considered non-recurring
and therefore classified as exceptional. Additionally, the Group revised estimates used in inventory provision calculations for
SUBLOCADE and PERSERIS which led to an overall increase in inventory needing to be provided for. Provisions were based on
expiration dating and sales forecasts associated with SUBLOCADE and PERSERIS inventory in line with the Group policy. The change in
inventory provision due to COVID-19 was considered a one-off transaction in 2020 and therefore recorded as exceptional. No
exceptional items were recorded in 2021 specifically due to the impact of COVID-19.
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
5. Exceptional items and adjusted results continued
Exceptional items
Exceptional items within cost of sales
Cost of sales1
Total exceptional items within cost of sales
Exceptional items within SG&A
Restructuring costs2
Legal expenses/provision3
ANDA litigation4
Debt refinancing5
Total exceptional items within SG&A
Exceptional items within other operating income
Net proceeds from the sale of intangible assets6
Insurance reimbursement7
Total exceptional items within other operating income
Exceptional items within net finance expense
Debt refinancing5
Total exceptional items within net finance expense
Total exceptional items before taxes
Exceptional items within tax
Tax on exceptional items
Exceptional tax items8
Total exceptional items within taxation
Total exceptional items
2021
$m
–
–
1
18
(24)
(1)
(6)
20
12
32
(1)
(1)
25
(3)
43
40
65
2020
$m
(5)
(5)
(11)
(228)
–
–
(239)
–
–
–
–
–
(244)
37
–
37
(207)
1. 2020 exceptional cost of sales relate to changes in inventory provision estimates due to the adverse impact of COVID-19 on
the business.
3.
2. Restructuring costs incurred in 2020 relate to cost-saving actions taken by the Group in response to challenges posed by COVID-
19. In 2021 the restructuring program concluded, and the remaining provision was released which resulted in an exceptional
benefit of $1m.
In 2021, negotiation with DOJ-related plaintiffs led to a change in the Group’s provision for DOJ-related matters which resulted in a
provision release of $18m. Legal costs incurred in 2020 relate to net settlement expenses with the DOJ Resolution/DOJ-Related
Matters ($178m) and RB ($50m). Refer to Note 23, Legal proceedings for further discussion.
In 2021, upon conclusion of expert discovery, the Group increased the provision for intellectual property-related matters – ANDA
Litigation, to $73m, resulting in an exceptional charge for $24m. Refer to Note 23, Legal proceedings for further discussion.
4.
5. Debt refinancing costs in 2021 consist of advisory and legal fees incurred related to the Group’s debt refinancing. These costs are
included in SG&A. Additionally, in 2021 the Group wrote off $1m of unamortized deferred financing costs due to extinguishment
and settlement of the previous term loan. These costs are included within finance expense.
6. Exceptional other operating income in 2021 relates to the net proceeds received from the disposal of the TEMGESIC / BUPREX /
BUPREXX (buprenorphine) analgesic franchise outside of North America to Eumedica Pharmaceuticals AG for $19m. Remaining
exceptional income in 2021 relates to the proceeds received from the out-licensing of nasal naloxone opioid overdose patents for
$1m. Refer to Note 4 for further discussion.
In 2021, the Group recognized $12m exceptional other income related to a Directors’ & Officers’ insurance reimbursement claim.
7.
8. Exceptional tax benefit recorded in 2021 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, the tax impact of settlement costs incurred with Reckitt
Benckiser (RB) which were recorded in the prior year.
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5. Exceptional items and adjusted results continued
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 2021
and 2020.
Reconciliation of gross profit to adjusted gross profit:
Gross profit
Exceptional cost of sales
Adjusted gross profit
Reconciliation of operating profit/(loss) to adjusted operating profit:
Operating profit/(loss)
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Adjusted operating profit
Reconciliation of profit/(loss) before taxation to adjusted profit before taxation
Profit/(loss) before taxation
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Exceptional finance expense
Adjusted profit before taxation
Reconciliation of net income/(loss) to adjusted net income
Net income/(loss)
Exceptional cost of sales
Exceptional selling, general and administrative expenses
Exceptional other operating income
Exceptional finance expense
Tax on exceptional items
Exceptional tax items
Adjusted net income
Reconciliation of basic earnings/(loss) per share to adjusted basic earnings per share:
Basic earnings/(loss) per share
Exceptional selling, general and administrative expenses
Exceptional other operating income
Tax on exceptional items
Exceptional tax items
Adjusted basic earnings per share
Weighted average number of shares (thousands)
Notes
Notes
Notes
Notes
Notes
10
10
10
2021
$m
664
–
664
2021
$m
213
–
6
(32)
187
2021
$m
190
–
6
(32)
1
165
2021
$m
205
–
6
(32)
1
3
(43)
140
2021
cents
28
1
(4)
–
(6)
19
2020
$m
550
5
555
2020
$m
(156)
5
239
–
88
2020
$m
(173)
5
239
–
–
71
2020
$m
(148)
5
239
–
–
(37)
–
59
2020
cents
(20)
33
–
(5)
–
8
728,299
732,863
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
6. Auditors’ remuneration
Audit of Parent Company and consolidated financial statements:
Audit of the Group’s Annual Report and financial statements
Audit of the Group’s subsidiaries
Audit services
Audit-related assurance services
Total auditors’ remuneration
2021
$m
(2.3)
(0.4)
(2.7)
(0.9)
(3.6)
2020
$m
(2.3)
(0.3)
(2.6)
(0.5)
(3.1)
Audit-related assurance services pertained primarily to the performance of quarterly reviews and, for 2021, incremental audit
procedures under US auditing standards in anticipation of future listing in the US.
7. Employees
Employee benefits
Short-term obligations
Liabilities for salaries and wages, including non-monetary benefits, vacation and accumulating sick leave expected to be settled
within 12 months after the end of the period in which the employees render the related service, are recognized in respect of
employees’ services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities
are settled. The liability for vacation and accumulating sick leave is recognized in the provision for employee benefits. All other short-
term employee benefits are included within trade and other payables.
Pension commitments
Some companies within the Group operate defined contribution and (funded and unfunded) defined benefit pension schemes.
The cost of providing pensions to employees who are members of defined contribution schemes is charged to the income statement
as contributions are made. The Group has no further payment obligations in respect of such schemes once the contributions have
been paid. See also Note 21.
Post-retirement benefits other than pensions
Some companies within the Group provide post-retirement medical care to their retirees. The costs of providing these benefits are
accrued over the period of employment and the liability recognized in the balance sheet is calculated using the projected unit credit
method and is discounted to its present value and the fair value of any related asset is deducted. See also Note 21.
Details of employee costs
(a) Staff costs
The total employment costs, including Directors, were:
Wages and salaries
Social security costs
Pension costs1
Share-based payments
Exceptional termination reversal/(costs)
Total staff costs
Note
27
5
2021
$m
(165)
(25)
(6)
(11)
1
(206)
2020
$m
(139)
(22)
(9)
(8)
(9)
(187)
1. Pension costs predominately reflect contributions made towards the Group’s defined contribution plans.
Key Management is defined as the Executive Committee, a body of nine employees (2020: 9 employees) including the CEO and the
functional leads directly reporting the CEO. Compensation awarded to Key Management was:
Short-term employee benefits
Termination costs
Share-based payments
Total compensation awarded to Key Management
Remuneration for executive and non-executive Directors are disclosed on pages 91 through 111.
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2021
$m
(10)
(1)
(7)
(18)
2020
$m
(6)
(2)
(5)
(13)
7. Employees continued
(b) Staff numbers
The average monthly number of persons employed by the Group, including Directors, during the year was:
Operations
Management
Research and development
Average number of employees
8. Net finance expense
2021
573
164
65
802
2020
567
168
84
819
Finance costs of borrowings are recognized in the income statement over the term of those borrowings. Finance costs related to lease
arrangements are recognized in the income statement over the lease period. Finance costs on legal matters predominantly relate to
the Group’s settlement with the DOJ and are recognized in the income statement over the settlement payment period. See Note 21 for
further details. Finance income on cash and cash equivalents and investments are recognized in the income statement in the period
they are earned.
Finance income
Interest income on cash and cash equivalents/investments
Other finance income
Total finance income
Finance expense
Interest expense on borrowings
Interest expense on lease liabilities
Interest expense on legal matters
Other finance expense
Total finance expense
Net finance expense
9. Income tax
2021
$m
1
3
4
(16)
(2)
(8)
(1)
(27)
(23)
2020
$m
7
2
9
(14)
(3)
(7)
(2)
(26)
(17)
Income tax for the year comprises current and deferred tax. Current tax is the expected tax payable on taxable income for the
year, using tax rates enacted, or substantively enacted, at the balance sheet date, and any adjustment to tax payable in respect of
previous years.
Income tax is recognized in the income statement except to the extent that it relates to items recognized in other comprehensive
income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.
Current tax
Adjustments for prior year exceptional tax items
Other adjustments for prior year
Total current tax
Origination and reversal of temporary differences
Adjustments for changes in tax rates
Adjustments for prior year deferred tax
Total deferred tax
Total income tax benefit
2021
$m
(48)
43
2
(3)
18
(1)
1
18
15
2020
$m
(11)
–
3
(8)
37
–
(4)
33
25
The standard rate of corporation tax in the UK was 19% for the year ended December 31, 2021 (2020: 19%). The Group’s profits for the
year ended December 31, 2021, are taxed at an effective rate of -8% (2020: 14%).
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
9. Income tax benefit/(expense) continued
The total tax benefit for the year reconciles to the accounting profit as follows:
Profit/(loss) before taxation
Tax at the notional UK corporation tax rate of 19% (2020: 19%)
Effects of:
Tax at rates other than the UK corporation tax rate
Permanent differences
R&D tax credit
Adjustment for prior year exceptional tax items
Other adjustments for prior year
Adjustments to amounts carried in respect of unresolved tax matters
Impact of rate changes
Share awards
Income tax benefit
2021
$m
190
36
(1)
(4)
(1)
(43)
(2)
(1)
1
–
(15)
The reported effective tax rate of -8% (2020: 14%) was impacted by:
› Permanent difference tax benefit of $4m (2020: tax expense of $7m). Permanent differences arise due to differences between
financial statement income and taxable income determination that will never reverse. Current year differences resulted from
income not subject to tax, offset by business expenses not deductible.
› The adjustments for prior year exceptional tax items relate to exceptional tax items detailed in Note 5.
› The other adjustments in respect of prior years relate to tax accrual to return true ups of $2m benefit (2020: $5m expense).
› Excluding the impact of exceptional items, the effective tax rate for the year ended December 31, 2021, was 15% (2020: 17%).
Income tax benefit
Tax on exceptional items
Exceptional tax items
Income tax expense excluding exceptional items
2021
$m
(15)
(3)
43
25
2020
$m
(173)
(33)
5
7
(1)
–
5
(6)
–
(2)
(25)
2020
$m
(25)
37
–
12
Details of the exceptional items can be found at the bottom of Note 5.
The Group believes it has made adequate provision for the liabilities likely to arise from periods that are open and not yet agreed by
tax authorities. The ultimate liability for such matters may vary from the amounts provided and is dependent upon the outcome of
agreements with relevant tax authorities or litigation where appropriate. As a multinational Group, tax uncertainties remain in
relation to Group financing, intercompany pricing, the location of taxable operations and the tax treatment of exceptional items.
Management has concluded tax provisions made to be appropriate and does not believe a significant risk of material change to
uncertain tax positions exists in the next 12 months.
Factors affecting future tax charges
As a Group with worldwide operations, Indivior is subject to several factors that may affect future tax charges, principally the levels
and mix of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. The enacted
United Kingdom Statutory Corporation Tax rate is 19% for the year ended December 31, 2021. 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 increase to the corporation tax
rate was substantively enacted on May 24, 2021. The effect of the rate change is immaterial.
Other tax matters
In 2019, a European Commission review into State Aid concluded the UK’s Finance Company Partial Exemption rules are only partly
justified. The UK Government was required to initiate recovery of the alleged State Aid where they assess a benefit of the potential
State Aid has been received. HMRC has confirmed that there has been no such benefit to the Group and therefore the enquiry in
relation to this matter up to December 31, 2017, is closed. HMRC has opened enquiries in relation to years ended December 31, 2018,
and December 31, 2019, in relation to this matter. Based on the similar fact pattern applicable to the later years, the Group has
determined no provision is required.
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9. Income tax benefit/(expense) continued
As disclosed in Note 21, the Group reached a settlement with Reckitt Benckiser on January 25, 2021. Based on the strength of external
advice received, an $8m tax benefit from the settlement cost has been recognized in the year within exceptional tax items. Tax
authorities may potentially challenge the Group’s position.
The potential tax liability on unremitted earnings would be less than $1m. Given our permanent investment assertion and the
immateriality of this balance, no provision has been made at this time.
10. Earnings/(loss) per share
Basic earnings/(loss) per share
Diluted earnings/(loss) per share
Adjusted basic earnings per share
Adjusted diluted earnings per share
Basic
2021
cents
28
27
19
18
2020
cents
(20)
(20)
8
8
Basic earnings/(loss) per share is calculated by dividing net income/(loss) for the year attributable to owners of the Company by the
weighted average number of ordinary shares in issue during the year.
Diluted
Diluted earnings/(loss) per share is calculated similarly to the basic earnings/(loss) per share but adds to 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 share awards and options. The weighted average number of shares is adjusted for the
number of shares granted, assuming the vesting of all awards and exercise of all stock options as of the beginning of the period.
The weighted average number of ordinary shares outstanding for 2021 (on a basic basis) includes the favorable impact of the share
repurchase program. Refer to Note 25 for further details.
Weighted average number of shares
On a basic basis
Dilution for share awards and options
On a diluted basis
Adjusted earnings per share
2021
thousands
728,299
42,842
771,141
2020
thousands
732,863
37,132
769,995
The Directors believe that earnings/(loss) per share, adjusted for the impact of exceptional items after the appropriate tax amount,
provides meaningful information on underlying trends to shareholders in respect of earnings per share. Reconciliations of net
income/(loss) to adjusted net income and earnings/(loss) per share to adjusted earnings per share are included in Note 5.
11. Intangible assets
Intangible assets are carried at cost less accumulated amortization and impairment.
Payments made in respect of acquired distribution rights are capitalized when it is probable that the expected future economic
benefits attributable to the asset will flow to the Group. The useful life of the acquired distribution rights is determined based on
legal, regulatory, contractual, competitive, economic or other relevant factors. Acquired rights with finite lives are subsequently
amortized using the straight-line method over their defined useful economic lives. Amortization expense related to acquired
distribution rights is included in selling, general and administrative expenses.
Payments related to the acquisition of rights to products in development or marketed products are capitalized if it is probable that
future economic benefits from the asset will flow to the Group. Probability of future economic benefit is assumed for all payments
made for externally acquired products in development and therefore capitalized. Subsequent success-based milestone payments up
to and including approval are capitalized when achieved. Amortization of the asset starts when it becomes available for use, at which
point the asset is amortized over its useful economic life, which is generally estimated as the patent life within the product’s primary
market. Amortization of marketed products is recognized within cost of sales.
Gains and losses on the disposal of intangible assets are determined by comparing the asset’s carrying value with any sale proceeds
and are included in the income statement.
Indivior | Annual Report and Accounts 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
11. Intangible assets continued
Impairment of intangible assets
The carrying values of intangible assets are reviewed for impairment annually and/or when events or changes in circumstances
indicate the carrying value may be impaired depending on the intangible asset type. If any such indication exists, the recoverable
amount of the asset is estimated in order to determine the extent of impairment loss. Where it is not possible to estimate the
recoverable amount of an individual asset, the Group estimates the recoverable amount of the cash-generating unit to which
it belongs.
An asset’s recoverable amount is the higher of an asset’s or cash-generating unit’s fair value less costs of disposal or its value in use.
In assessing value in use, its estimated future cash flows are discounted to their net present value using a pre-tax discount rate that
reflects the current market assessments of the time value of money and the risks specific to the asset.
In carrying out impairment reviews of products in development, several significant assumptions have to be made. These include the
probability of success in obtaining regulatory approvals, future rate of market growth, discount rates, market demand for the
products acquired, future profitability, and levels of reimbursement for pharmaceutical products. If actual results should differ, or
changes in expectations arise, impairment charges may be required which would have a material adverse impact on reported results
and financial position. Products in development of $39m (2020: $10m) are subject to potential impairment in line with the
aforementioned assumptions.
Sensitivity analysis
For the INDV-2000 asset, which is a product in development valued at $10m (2020: $10m), the recoverable amount calculation is
particularly sensitive due to limited headroom when compared to the carrying amount as at December 31, 2021, which could give rise
to future impairment. The Group performed a sensitivity analysis by applying reasonable changes to key assumptions used in the
calculation. Consistent with other products in early stages of development, it is reasonably possible that the product could fail to
obtain regulatory approvals. The probability of success is factored into the risk-adjusted calculation of the recoverable amount;
however, failure to reach commercialization would result in a full impairment of the asset. The Group determined that an increase of
50bps to the discount rate and a three-month delay in the launch timeline would result in an impairment of $5m, assuming all other
factors are kept constant. Reasonable changes in any individual assumption will not result in a material impairment charge.
Cost
At January 1, 2021
Additions
Disposal
Exchange adjustments
At December 31, 2021
Accumulated amortization and impairment
At January 1, 2021
Amortization charge
Disposal
Exchange adjustments
At December 31, 2021
Net book amount at December 31, 2021
Acquired
distribution rights
$m
Products in
development
$m
Marketed
products
$m
Software
$m
235
–
(12)
(3)
220
235
–
(12)
(3)
220
–
37
30
–
(1)
66
27
–
–
–
27
39
57
–
–
–
57
15
6
–
–
21
36
39
–
–
–
39
29
3
–
–
32
7
Total
$m
368
30
(12)
(4)
382
306
9
(12)
(3)
300
82
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11. Intangible assets continued
Cost
At January 1, 2020
Exchange adjustments
At December 31, 2020
Accumulated amortization and impairment
At January 1, 2020
Amortization charge
Exchange adjustments
At December 31, 2020
Net book amount at December 31, 2020
Acquired distribution rights
Acquired
distribution rights
$m
Products in
development
$m
Marketed
products
$m
Software
$m
Total
$m
228
7
235
228
–
7
235
–
36
1
37
26
–
1
27
10
56
1
57
9
6
–
15
42
39
–
39
24
5
–
29
10
359
9
368
287
11
8
306
62
In 2021, $19m of net cash proceeds were received from the disposal of the TEMGESIC /BUPREX / BUPREXX (buprenorphine) analgesic
franchise outside of North America to Eumedica Pharmaceuticals AG which had a nil carrying value.
Products in development
Products in development are products in different stages of research and development which have not received regulatory approval.
These products are not amortized as they are not yet in use but are assessed for impairment at the end of each reporting period.
Once approved in their primary market, products in development are transferred to marketed products. There were no new primary
market product approvals in 2021.
In 2021 the Group entered a strategic collaboration with Aelis Farma that includes an exclusive option for the license of the global
rights to AEF0117, a leading compound to treat cannabis-related disorders. Under the agreement, the Group paid $30m to secure
the option.
In 2021, $1m of proceeds were received for the out-licensing of nasal naloxone opioid overdose patents to Adapt Pharmaceuticals
(Emergent BioSolutions) which had a nil carrying value.
Marketed products
Marketed products include approved product rights for SUBLOCADE of $17m (2020: $18m) and PERSERIS of $19m (2020: $24m) which
are amortized on a straight-line basis over the patent exclusivity period in the United States, the major market to which the approvals
relate. In 2021, a new SUBLOCADE patent was approved in the United States extending the patent exclusivity period and amortization
period from 2031 to 2035. All products are assessed for impairment indicators at the end of each reporting period and tested for
impairment annually. No impairments were recognized in the year. Amortization expense of $6m (2020: $6m) was recognized in cost
of sales.
Software
Acquired computer software licenses and related implementation costs are capitalized at cost. For cloud-based software licenses,
implementation costs are expensed as incurred and subscription costs are expensed ratably over the license period. These costs are
typically amortized on a straight-line basis, generally over a period of up to five years. Acquired computer software primarily relates
to SAP, the Group’s ERP system. In 2020, the Group extended the useful life estimate for its SAP instance through December 2024.
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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145
FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
12. Property, plant and equipment
Property, plant and equipment are stated at cost less accumulated depreciation and impairment, with the exception of freehold land,
which is shown at cost less impairment. Cost includes expenditure that is directly attributable to the acquisition of the asset.
The cost of subsequent improvements and enhancements are included in the asset’s carrying amount or recognized as a separate
asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the
cost of the item can be reliably measured.
Except for freehold land and assets under construction, the cost of property, plant and equipment is depreciated on a straight-line
basis over the expected useful life of the asset. For this purpose, expected lives are determined within the following limits:
› freehold buildings: not more than 20 years;
› plant and equipment: not more than 10 years;
› motor vehicles and computer equipment: not more than 4 years; and
› leasehold improvements: up to the expected lease term.
Assets’ residual values and useful lives are reviewed, and adjusted if necessary, at each balance sheet date. Property, plant and
equipment are reviewed for impairment if events or changes in circumstances indicate that the carrying amount may not be
appropriate. Freehold land is reviewed for impairment on an annual basis.
Gains and losses on the disposal of property, plant and equipment are determined by comparing the asset’s carrying value with any
sale proceeds and are included in the income statement.
Cost
At January 1, 2021
Additions
Exchange adjustment
At December 31, 2021
Accumulated depreciation and impairment
At January 1, 2021
Charge for the year
Exchange adjustment
At December 31, 2021
Net book amount at December 31, 2021
Cost
At January 1, 2020
Additions
Exchange adjustment
At December 31, 2020
Accumulated depreciation and impairment
At January 1, 2020
Charge for the year
Exchange adjustment
At December 31, 2020
Net book amount at December 31, 2020
Land and
buildings
$m
Plant and
equipment
$m
55
–
–
55
18
3
–
21
34
73
4
–
77
50
3
–
53
24
Land and
buildings
$m
Plant and
equipment
$m
54
–
1
55
14
4
–
18
37
66
6
1
73
46
3
1
50
23
Total
$m
128
4
–
132
68
6
–
74
58
Total
$m
120
6
2
128
60
7
1
68
60
Depreciation expense of $6m (2020: $7m) is included in SG&A. Additions in the year relate primarily to PERSERIS syringe-filler
equipment and other manufacturing equipment.
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13. Leases and right-of-use assets
Leases and right-of-use assets
As a lessee, the Group assesses whether a contract conveys the right to control use of an identified asset for a period in exchange for
consideration, in which case it is classified as a lease. The Group recognises a right-of-use asset (lease asset) and a corresponding
liability at the lease commencement date, measured on a present value basis.
Leases with a term of 12 months or less (short-term leases) and low-value leases are not recognized on the balance sheet. For these
short-term and low-value leases, the Group recognizes the lease payments as an operating expense on a straight-line basis over the
term of the lease.
The Group’s right-of-use assets are calculated based upon the following:
› the amount of the initial measurement of the lease liability;
› any lease payments made to the lessor at or before the commencement date, less any lease incentives (e.g. rent abatements,
tenant improvement allowances) received; and
› any initial direct costs incurred by the Group.
Right-of-use assets are amortized on a straight-line basis from the commencement date of the lease over the shorter of the lease
term or useful life of the right-of-use asset. Right-of-use assets are assessed for impairment whenever there is an indication the
carrying amount may not be recoverable, generally using cash flow projections for the cash-generating unit in which the right-of-use
asset belongs.
Lease liabilities are initially measured at the present value of the lease payments to be made over the lease term using the discount
rate for the lease at lease commencement. If the interest rate implicit in the lease can be determined, it will be used to measure the
liability. If an interest rate is not implicit in the lease, the incremental borrowing rate for the respective loan type at the date of
commencement will be used, which ranged from 3.9% to 6.8% depending upon type of lease and country of origin. Generally, the
Group uses its incremental borrowing rate as the discount rate.
The Group remeasures the lease liability (and makes a corresponding adjustment to the related right-of-use asset) whenever the
lease terms or expected payments under the lease change, or a modification occurs that is not accounted for as a separate lease.
Lease payments are allocated between principal and finance cost. The finance cost is charged to profit or loss over the lease period
to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The repayment of lease
liabilities and corresponding interest payments are recognized as cash flows from financing activities.
The Group leases various properties and equipment (including vehicles). Rental contracts are typically made for fixed periods of 3 to
10 years but may have termination or extension options. The Group assesses whether it is reasonably certain to exercise the options
at lease commencement and subsequently, if there is a change in circumstances within its control. Extension options (or periods after
termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated). Such
assessment involves management judgment and estimations based on information at the time the assessments are made. Potential
future cash outflows of $21m (2020: $21m) have not been included in the lease liability because it is not reasonably certain that the
leases will be extended (or not terminated).
The following tables summarize movements of the right-of-use assets in 2021 and 2020:
Net Book Value
At January 1, 2021
Additions
Depreciation
Exchange adjustments
At December 31, 2021
Land and
buildings
$m
Plant and
equipment
$m
14
–
(2)
–
12
29
2
(5)
(1)
25
Total
$m
43
2
(7)
(1)
37
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
13. Leases and right-of-use assets continued
Net Book Value
At January 1, 2020
Additions
Depreciation
Impairment
Exchange adjustments
At December 31, 2020
Land and
buildings
$m
Plant and
equipment
$m
17
2
(3)
(2)
–
14
30
3
(5)
–
1
29
Depreciation expense of $4m (2020: $5m) is included in SG&A and $3m (2020: $3m) in cost of sales within the income statement.
Additions in the year relate primarily to vehicle leases and office space.
Lease liabilities at December 31, 2021 and 2020 by maturity were as follows:
Within one year
Later than one and less than five years
More than five years
Gross lease liabilities
Less: future interest on lease liabilities
Net lease liabilities
Lease payments during the year were comprised of the following:
Interest paid on lease liabilities
Payments of lease liabilities
Total lease payments
14. Deferred tax
2021
$m
10
29
12
51
(7)
44
2021
$m
2
8
10
Total
$m
47
5
(8)
(2)
1
43
2020
$m
10
31
19
60
(9)
51
2020
$m
3
7
10
Deferred tax is recognized on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts
in the consolidated financial statements using the balance sheet approach. Deferred tax is not recorded if it arises from the initial
recognition of an asset or liability in a transaction (other than a business combination) that affects neither accounting nor taxable
profit or loss at that time. Deferred tax is determined using tax rates (and laws) that have been enacted or substantively enacted at
the balance sheet date and apply when the deferred tax asset or liability is expected to reverse. They are revalued for changes in tax
rates when new tax rates are substantively enacted.
The Group recognizes deferred tax assets to the extent that sufficient future taxable profits are probable against which these future
tax deductions can be utilized. At December 31, 2021, the Group’s net deferred tax assets of $105m includes $81m (2020: $51m) in USA
and $11m (2020: $7m) in UK. Deferred tax assets relate primarily to inventory costs capitalized for tax purposes, litigation liabilities
(including exceptional items that are not expected to recur), share-based compensation, and other short-term timing differences.
Recognition of deferred tax assets is driven by the Group’s ability to utilize the deferred tax asset which is reliant on forecast taxable
profits arising in the jurisdiction in which the deferred tax asset is recognized. The Group has assessed recoverability of deferred tax
assets using Group-level budgets and forecasts consistent with those used for the assessment of viability and asset impairments,
particularly in relation to levels of future sales. These forecasts are therefore subject to similar uncertainties to those assessments.
This exercise is reviewed each year and, to the extent required, an adjustment to the recognized deferred tax asset may be made.
With the exception of specific assets that are not currently considered accessible (see unrecognized deferred tax assets below),
management have concluded full recognition of deferred tax assets to be appropriate and do not consider there a significant risk
of a material change in their assessment in the next 12 months.
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14. Deferred tax continued
Deferred tax assets
At January 1, 2020
Credit to the income statement
Credit directly to equity
At December 31, 2020
(Charged)/credit to the income
statement
Credit directly to equity
Exchange adjustments
At December 31, 2021
Unrealized
profit in
inventory
$m
Short-term
temporary
differences
$m
Share-based
payments
$m
Long-term
temporary
differences
$m
Inventory costs
capitalized
$m
12
2
–
14
(6)
–
–
8
19
–
–
19
4
–
–
23
2
2
2
6
1
13
–
20
1
27
–
28
6
–
(1)
33
4
–
–
4
11
–
–
15
Other
$m
2
2
–
4
2
–
–
6
Total
$m
40
33
2
75
18
13
(1)
105
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 increase to the corporation tax rate was substantively enacted on May 24, 2021. The effect of the rate change is immaterial.
The Group has not recognized deferred tax assets in relation to certain losses and interest expense in the UK, as the likelihood of
future economic benefit is not sufficiently assured.
Unrecognized deferred tax assets consist of those in respect of losses of earlier periods of $14m (2020: $11m) and on interest expense
of $8m (2020: $6m). Both the losses and interest expense have an unlimited carry-forward period.
15. Inventories
Raw materials, stores and consumables, work in progress and finished goods are stated at the lower of cost or net realizable value.
Cost comprises materials, direct labor and an appropriate portion of overhead expenses (based on normal operating capacity)
required to get the inventory to its present location and condition. Inventory valuation is determined on a first in, first out basis.
Selling expenses, product amortization, and certain other overhead expenses are excluded from product cost. Net realizable value is
the estimated selling price less applicable selling expenses. Impairment of inventory is recognized in cost of sales.
Inventory, net is comprised of:
Raw materials, stores and consumables
Work in progress
Finished goods and goods held for resale
Total inventories, net
2021
$m
34
28
33
95
2020
$m
38
19
36
93
The cost of inventories recognized as an expense and included as cost of sales amounted to $127m (2020: $97m). The increase in cost
of sales is primarily due to higher volume. Cost of sales included inventory write-offs and losses of $12m (2020: $6m). The inventory
provision (reflected in the carrying amounts above) at December 31, 2021, was $13m (2020: $12m).
16. Trade receivables and other assets
Trade receivables are initially recognized at their invoiced amounts less estimated adjustments for deductions such as cash
discounts. Trade receivables consist of amounts due from customers, primarily wholesalers and distributors, for which there is no
significant history of default. The credit risk of customers is assessed, taking into account their financial positions, past experiences
and other relevant factors. Individual customer credit limits are imposed based on these factors. Provisions for expected credit losses
are established using an expected credit loss model (ECL). The provisions are based on a forward-looking ECL, which includes
possible default events on the trade receivables over the entire holding period. These provisions represent the difference between
the carrying amount in the consolidated balance sheet and the estimated collectible amount. Charges for ECL are recognized in the
consolidated income statement within SG&A expenses. The recognized amounts approximate fair value.
The Group is not aware of any deterioration in the credit quality of its customers and considers the net receivables to be
fully recoverable.
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
16. Trade receivables and other assets continued
Trade receivables
Trade receivables
Less: provision for ECL
Trade receivables, net
The ageing of past due trade receivables as of December 31 is as follows:
Up to three months past due
Three to six months past due
Over six months past due
Not due and not impaired
Provision for impairment of receivables
Trade receivables – net
2021
$m
205
(3)
202
2021
$m
6
1
6
13
192
(3)
202
2020
$m
181
(2)
179
2020
$m
9
3
2
14
167
(2)
179
As at December 31, 2021, a provision of $3m (2020: $2m) was recorded against the trade receivables balance based on the Group’s
assessment of ECL. The assessment factors are discussed earlier within this note. The maximum exposure to credit risk at the year
end is the carrying value of each class of receivable. The Group does not hold any collateral as security.
The Group’s trade receivables are denominated in the following currencies:
Sterling
Euro
US dollar
Other currencies
Total trade receivables
Current and non-current other assets
Short-term prepaid expenses
Other current assets
Total other current assets
Long-term prepaid expenses
Other non-current assets
Total other non-current assets
Total other assets
2021
$m
2
16
172
15
205
2021
$m
18
14
32
22
84
106
138
2020
$m
4
18
146
13
181
2020
$m
17
33
50
22
82
104
154
Other current and non-current assets relate primarily to surety bond funding (see Note 23). At December 31, 2021, collateral provided
to surety bond holders, inclusive of accrued interest, was $82m (2020: $108m). In 2021, one of the surety bond holders returned $26m
causing a decrease in other current assets, which is partially offset by a $6m increase related to a Directors’ & Officers’ insurance
claim settlement receivable.
Long-term prepaid expenses relate primarily to payments for contract manufacturing capacity.
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17. Financial instruments and risk management
The Group’s financial assets and liabilities include trade receivables, other assets, cash and cash equivalents, borrowings, trade and
other payables as set out in Notes 16, 18, 19 and 24, respectively. The Group measures financial assets and liabilities at amortized cost.
Financial assets and liabilities are offset, and the net amount reported in the consolidated balance sheet when there is a legally
enforceable right to offset and net settlement is intended. The carrying value (less impairment provision, where applicable) of current
borrowings, cash, trade receivables, other assets, trade accruals and trade payables is assumed to approximate fair value due to their
short-term nature. The non-current borrowing, which is presented at amortized cost, was trading at approximately 99% (2020: 98%) of
par value.
Financial risk management of the Group is mainly exercised and monitored at Group level. The Group’s financing and financial
risk management activities are centralized to achieve benefits of scale and control with the goal of maximizing liquidity and
mitigating operational and financial risks. Financial exposures of the Group are managed in a manner consistent with underlying
business risks. Only those risks and flows generated by the underlying commercial operations are managed; speculative transactions
are not undertaken.
Foreign exchange risk management
The Group operates internationally and is exposed to foreign exchange risk arising from various currency exposures. Foreign
exchange risk arises from future commercial transactions, recognized assets and liabilities, and net investments in foreign operations.
The Group’s policy is to align the foreign currency assets and liabilities within its major subsidiaries in order to provide some
protection against the remeasurement exposure on profits.
Interest rate risk management
The Group has interest-bearing assets and liabilities. The Group monitors interest income and expense rate exposure on a regular
basis with an objective of minimizing net interest cost. The main interest rate risk arises from the Group’s borrowings, which are
discussed in Note 19, due to the floating interest rate. This exposure is partially offset by the interest income generated on the
Group’s cash and cash equivalents which are based on variable market interest rates.
Liquidity risk management
Liquidity risk is the risk that the Group is not able to settle or meet its obligations on time or at a reasonable price. The Group’s policy
is to ensure sufficient funding and facilities are in place to meet foreseeable liquidity requirements. The Group manages and
monitors liquidity risk through regular reporting of current cash and borrowing balances and periodic review of short-, medium- and
long-term cash forecasts, while considering the maturity of its borrowing facility. At December 31, 2021, Indivior had $3m (2020: $4m)
of borrowings repayable within one year and $1,102m (2020: $858m) of cash and cash equivalents.
Credit risk management
The Group’s exposure to credit risk arises from cash and cash equivalents, deposits with banks and financial institutions, trade
receivables and other assets. Financial institution counterparties are subject to approval under the Group’s counterparty risk policy
and such approval is limited to financial institutions with a BBB rating or above. Concentration of credit risk with respect to trade
receivables in the US is limited as the balances consist of amounts due from customers, primarily major wholesalers and distributors,
for whom there is no significant history of default. Outside the US, no single customer accounts for a significant share of Group’s
trade receivables balance. In the US, in line with other pharmaceutical companies, the Group sells its products through a small
number of wholesalers in addition to hospitals, pharmacies, physicians and other groups. Sales to the three largest wholesalers
amounted to approximately 57% of the Group sales in 2021 and 2020. At December 31, 2021, the Group had trade receivables due from
these three wholesalers totaling $142m (2020: $142m). The Group is exposed to a concentration of credit risk in respect of these
wholesalers such that, if one or more of them encounters financial difficulty, it could materially and adversely affect the Group’s
financial results. The Group’s credit risk monitoring activities relating to these wholesalers include a review of their financial
information and Standard & Poor’s credit ratings, and establishment and periodic review of credit limits. However, the Group believes
there is no further credit risk provision required in relation to these customers (see Note 16).
Indivior | Annual Report and Accounts 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
17. Financial instruments and risk management continued
Capital risk management
The Group considers capital to be net cash plus total reported equity. Net cash is calculated as cash and cash equivalents less
total borrowings. Total borrowings do not include lease liabilities of $44m (2020: $51m). Refer to Note 19 for further discussion
on borrowings.
Total equity includes share capital, reserves and retained earnings as shown in the consolidated balance sheet.
Net cash
Total equity
Note
19
2021
$m
853
203
1,056
2020
$m
623
82
705
The objectives for managing capital are to safeguard the Group’s ability to continue as a going concern, in order to provide returns for
shareholders and benefits for other stakeholders and to maintain an efficient capital structure to optimize the cost of capital.
The Group monitors net cash, which at year end amounted to net cash of $853m (2020: $623m) to maintain an appropriate level of
financial flexibility.
18. Cash and cash equivalents
Cash and cash equivalents comprise cash in hand, current balances with banks and similar institutions, and highly liquid investments
with original maturities of less than three months.
Cash and cash equivalents
There were no bank overdrafts at December 31, 2021 or 2020.
19. Financial liabilities – borrowings
2021
$m
1,102
2020
$m
858
Interest-bearing borrowings are recognized initially at fair value less attributable transaction costs. Subsequent to initial recognition,
interest-bearing borrowings are stated at amortized cost, with any difference between cost and redemption value being recognized
within finance expense in the income statement over the year of the borrowings on an effective interest basis.
Borrowings are classified as a current liability unless the Group has an unconditional right to defer settlement of the liability for at
least 12 months after the reporting date.
In 2021, the Group completed a refinancing of its term loan, repaying in full the existing $235m term loan and replacing it with a new
term loan with a principal amount of $250m. As a result of the debt refinancing, the Group incurred a collective charge of $2m related
to writing off unamortized deferred financing costs due to the extinguishment and settlement of previous term loan ($1m) and
advisory fees incurred in conjunction with the refinancing ($1m). These costs were classified as exceptional. See Note 5 for
further details.
The Group capitalized $8m of deferred financing and original issue discount costs related to the new term loan, which were netted
against the total amount borrowed and are amortized over the maturity period.
Term loan
Term loan – current
Term loan – non-current
Total term loan
Analysis of net cash
Cash and cash equivalents
Borrowings1
Total net cash
2021
$m
(3)
(239)
(242)
2021
$m
1,102
(249)
853
2020
$m
(4)
(230)
(234)
2020
$m
858
(235)
623
1. Borrowings reflect the outstanding principal amount drawn before debt issuance cost of $7m (2020: $1m). These do not include lease liabilities of $44m (2020: $51m).
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19. Financial liabilities – borrowings continued
Reconciliation of net cash
Net cash at beginning of year
Net increase/(decrease) in cash and cash equivalents
New borrowings
Repayment of borrowings
Exchange adjustments
Net cash at end of year
2021
$m
623
245
(250)
236
(1)
853
2020
$m
821
(207)
–
4
5
623
Net cash is presented consistently with prior periods and represents a measure of liquidity considered by the Directors. The term
loan traded at approximately 99% of par value at December 31, 2021 (2020: 98%).
The terms of the loan in effect at December 31, 2021 are as follows:
Term loan facility
Currency
USD
Nominal interest
margin
LIBOR (0.75%)
+5.25%
Maturity
2026
Required annual
payments
1%
Minimum liquidity
Larger of $100m or 50% of
Loan Balance
While the new term loan is USD Libor based, the new term loan contains fallback language to convert to a new reference rate
when USD LIBOR is discontinued or becomes non-representative, which is expected to occur in early 2023. The term loan amounting
to $249m (2020: $235m), is secured against the assets of certain subsidiaries of the Group in the form of guarantees issued by
respective subsidiaries.
Also included within the terms of the loan were:
› Nominal interest margin is calculated over three-month USD LIBOR, subject to a floor of 0.75%; and
› There are no revolving credit commitments.
Maturity of gross borrowings (including expected interest using the rate at the balance
sheet date)
Within one year or on demand
Bank loans payable due:
Later than one and less than five years
More than five years
Gross borrowings (including interest)
Analysis of changes in liabilities from financing activities
2021
$m
18
298
–
316
2020
$m
17
243
–
260
At January 1,
2021
$m
(4)
(230)
(51)
(2)
(287)
Cash flows
$m
Profit and loss
$m
Additions
$m
Reclassifications
$m
Exchange adj.
$m
3
–
8
16
27
–
–
–
(14)
(14)
–
(11)
(2)
–
(13)
(2)
2
–
–
–
–
–
1
–
1
At December 31,
2021
$m
(3)
(239)
(44)
–
(286)
Current borrowings
Non-current borrowings
Lease liabilities
Interest payable
Total financial liabilities
20. Commitments
The Group has various purchase commitments for services and materials in the ordinary course of business. These commitments are
generally entered into at current market prices and reflect normal business operations.
As of December 31, 2021, the Group had no material PP&E or intangible asset commitments for future periods.
Indivior | Annual Report and Accounts 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
21. Provisions and other liabilities
The Group is involved in legal and intellectual property disputes as described in Note 23, 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 more likely than not, 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.
Provisions are reviewed regularly, and amounts updated where necessary to reflect the latest assumptions. The assessment of
provisions can involve complex judgments about future events and can rely heavily on judgments and estimates. Given the inherent
uncertainties related to these judgments and estimates, the actual outflows resulting from the realization of those risks could differ
adversely and materially from the Group’s assessments.
Provisions
At January 1, 2020
Charged to the income statement
Transfer to other liabilities
Interest and discounting
Utilized during the year/payments
At December 31, 2020
Released/(Charged) to income statement
Interest and discounting
Utilized during the year/payments
At December 31, 2021
Provisions
Current
Non-current
At December 31, 2021
Current
Non-current
At December 31, 2020
DOJ-related matters
DOJ-related
matters
$m
IP-related
matters
$m
Restructuring
costs
$m
Other
provisions
$m
Total
provisions
$m
(438)
(178)
586
(2)
–
(32)
18
–
9
(5)
(5)
–
(5)
(32)
–
(32)
(45)
–
–
(2)
–
(47)
(24)
(2)
–
(73)
–
(73)
(73)
–
(47)
(47)
(2)
(9)
–
–
5
(6)
1
–
5
–
–
–
–
(6)
–
(6)
(3)
(1)
–
–
–
(4)
1
–
–
(3)
–
(3)
(3)
–
(4)
(4)
(488)
(188)
586
(4)
5
(89)
(4)
(2)
14
(81)
(5)
(76)
(81)
(38)
(51)
(89)
The Group carries a provision of $5m (2020: $32m) pertaining to all of the DOJ-related matters as discussed in Note 23. Negotiations
with the DOJ-related plaintiffs resulted in an exceptional provision release of $18m (2020: nil). The remaining movement of $9m in the
provision relates to amounts settled and paid during the year. DOJ-related matters of $5m are based upon settlement discussions in
progress or analogs of comparable settlements and are expected to be settled within the year.
IP-related matters: ANDA litigation
The Group carries provisions totaling $73m (2020: $47m) for intellectual property-related matters, all of which relate to potential
redress for intellectual property litigation with DRL and Alvogen should the Group not be successful with those cases outlined in
Note 23, Intellectual property-related matters: ANDA litigation. In 2021, upon conclusion of expert discovery, the Group increased the
provision for intellectual property-related matters to $73m, resulting in an exceptional charge of $24m (2020: nil). The provision
represents the Group’s best estimate of potential damages owed to DRL and Alvogen for the period between FDA approval and lifting
of the preliminary injunction. This estimate considers the value of the court-established surety bonds. The provision has been
recorded at the net present value, using a risk-free rate, considering the estimated timing of the settlement in FY 2023/2024, timing of
which is dependent upon progression of the trial. During the year, the Group recorded finance expense totaling $2m (2020: $2m) for
time value of money on the provision. The Group does not expect the matter to be settled within a year and therefore the entire
provision is classified as non-current. Refer to Note 23 for further details.
Restructuring costs
The restructuring provision related to cost-saving initiatives announced and implemented in 2020 which consisted of redundancy and
related costs has been fully utilized as of December 31, 2021.
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21. Provisions and other liabilities continued
Other provisions
Other provisions totaling $3m (2020: $4m) primarily represent retirement benefit costs which are not expected to be settled within
one year.
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 a discount rate appropriate to the liability or approximating the risk-free rate at the time the Group entered into
the obligation.
Other liabilities
At January 1, 2020
Charged to the income statement
Transfer from provisions
Interest and discounting
Utilized during the year/payments
At December 31, 2020
Contract liabilities
Interest and discounting
Utilized during the year/payments
At December 31, 2021
Other liabilities
Current
Non-current
At December 31, 2021
Current
Non-current
At December 31, 2020
DOJ resolution
DOJ Resolution
$m
RB indemnity
settlement
$m
Other
$m
Total
other liabilities
$m
–
–
(586)
(3)
103
(486)
–
(6)
–
(492)
(53)
(439)
(492)
–
(486)
(486)
–
(50)
–
–
–
(50)
–
–
10
(40)
(8)
(32)
(40)
(10)
(40)
(50)
–
–
–
–
–
–
(3)
–
–
(3)
–
(3)
(3)
–
–
–
–
(50)
(586)
(3)
103
(536)
(3)
(6)
10
(535)
(61)
(474)
(535)
(10)
(526)
(536)
In July 2020, the Group reached an agreement with the DOJ and other litigants described in Note 23 under “DOJ and related matters”
to resolve the investigation of alleged charges of healthcare fraud, wire fraud, mail fraud, and conspiracy, in connection with the
marketing and promotion practices, pediatric safety claims, and overprescribing of SUBOXONE Film and/or SUBOXONE Tablet by
certain physicians. In November 2020, the Group made a payment of $103m (including interest) when resolution was approved by a
judge. Subsequently, six annual installments of $50m will be due every January from 2022 to 2027. A final installment of $200m will be
due in December 2027. Interest accrues on certain portions of the resolution which will be paid together with the annual installments.
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 2021, the Group recorded finance expense totaling $6m (2020: $3m). As of
December 31, 2021, the Group carries other liabilities of $492m (2020: $486m) related to the settlement agreement with the DOJ.
RB resolution
In January 2021, the Group announced it had reached an agreement with Reckitt Benckiser (RB) to resolve claims which RB issued
in the Commercial Court in London in November 2020, seeking indemnity under the 2014 Demerger Agreement. Pursuant to the
settlement, RB agreed to withdraw the $1.4b claim and 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. Indivior 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 settlement. Subsequently,
annual installment payments of $8m will be due every January from 2022 to 2026. The effect of discounting was not material.
The Group carries a liability totaling $40m (2020: $50m) related to this settlement.
Other
Other represents deferred revenue related to a supply agreement which is non-current as of December 31, 2021.
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
22. 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 23 under “DOJ Resolution”, “Reckitt Benckiser”, “DOJ-Related Matters” and “Intellectual Property-Related Matters”,
for which provisions have been recognized, Note 23 sets out the contingent liabilities for legal and other disputes for which the Group
has assessed as contingent liabilities. Refer to Note 9 for discussion on State Aid and other tax-related contingent liabilities.
23. 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 US Federal Trade Commission (FTC),
and US 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 US
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 is subject to reporting and
monitoring requirements, including annual reports and compliance certifications from key management and the Board’s Nominating
& Governance Committee, which is submitted to HHS-OIG. In addition, the Group is subject to monitoring by an Independent Review
Organization, which submits audit findings to HHS-OIG, and review by a Board Compliance Expert, who prepared a compliance
assessment report in the first reporting period and will prepare a compliance assessment report in the third reporting period. To
date, the Group reasonably believes it has met all of requirements specified in these three agreements.
In November 2020, the Group made a payment of $103m (including interest) when the resolution was approved by the Court and
made a subsequent payment in January 2022 of $54m (including interest). Subsequently, five annual installments of $50m will be due
every January 15 from 2023 through 2027. The final installment of $200m will be due in December 2027. The Group carries a liability
totaling of $492m (2020: $486m) pertaining to the DOJ resolution.
Reckitt Benckiser
On January 25, 2021, the Group reached a resolution with Reckitt Benckiser as discussed in Note 21.
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 sought reasonable attorney’s fees and costs. Three other cases were
filed in the District Court of the District of New Jersey that also 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
Group settled these matters in 2020 and 2021.
State and local matters
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. 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 settled with the relators and the California Department of
Insurance in 2021.
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 settled with the relators and the Illinois Insurance Department in 2021.
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 resolved the matter with the City of Chicago in 2020.
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23. Legal proceedings continued
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. The Group
filed a Motion to Dismiss on June 24, 2021.
In May 2018, Indivior Inc. received an informal request from the Office of the United States Attorney (“OUSA”) for the Southern District
of New York, seeking records relating to the SUBOXONE manufacturing process and the Group is discussing with the OUSA certain
information and allegations regarding the SUBOXONE manufacturing process the government received.
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 US 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 was granted by the court in
September 2021. A settlement fairness occurred in January 2022 and the case was dismissed.
Intellectual property-related matters
ANDA litigation
Indivior filed actions against Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (together, “DRL”) in the United States
District Court for the District of New Jersey (“NJ District Court”) alleging that DRL’s generic buprenorphine/naloxone film product
infringes US Patent Nos. 9,687,454 and 9,931,305 (“the ‘454 and ’305 Patents”) in 2017 and 2018, respectively. The cases were
consolidated in May 2018. 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 NJ District Court
granted Indivior a Preliminary Injunction (PI) pending the outcome of a trial on the merits of the ’305 Patent, and required Indivior to
post a surety bond for $72m in connection with the PI. In November 2018, the Court of Appeals for the Federal Circuit (CAFC) issued a
decision vacating the PI against DRL. On remand, the NJ District Court construed the claims of the ’454 and ’305 Patents. Indivior and
DRL stipulated to noninfringement of the ’305 Patent under the court’s claim construction, but Indivior retained its rights to appeal
the construction and pursue its infringement claims pending appeal. Separately, DRL filed an amended answer alleging various
antitrust counterclaims. Indivior’s infringement claims concerning the ’454 patent and DRL’s antitrust counterclaims remain pending
in the NJ District Court. Summary judgment motions have been fully briefed, but the NJ District Court has not ruled on those motions.
No trial date has been set. In February 2022, the NJ District Court ordered the parties to mediation.
In November 2018, DRL filed two petitions for inter partes review (“IPR”) of the ’454 Patent with the US Patent and Trademark Office’s
Patent Trial and Appeal Board (“PTAB”). The PTAB denied institution of one IPR petition but granted institution for the other. The PTAB
issued a decision in June 2020, finding 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 CAFC.
In December 2021, the CAFC affirmed the PTAB’s decision. Indivior filed a petition with the CAFC for a panel rehearing or rehearing
en banc, which was denied in March 2022.
Indivior filed actions against Alvogen Pine Brook LLC and Alvogen Inc. (together, “Alvogen”) in the NJ District Court alleging that Alvogen’s
generic buprenorphine/naloxone film product infringes US Patent Nos. 9,687,454 and 9,931,305 (“the ‘454 and ’305 Patents”) in 2017 and
2018, respectively. The cases were consolidated in May 2018. In January 2019, the NJ District Court granted Indivior a temporary restraining
order (“TRO”) to restrain the launch of Alvogen’s generic buprenorphine/naloxone film product pending a trial on the merits of the ’305
Patent and Indivior was required to post a surety bond of $36m. Indivior and Alvogen entered into an agreement whereby Alvogen was
enjoined from selling in the US its generic buprenorphine/naloxone film product unless and until the CAFC issued a mandate vacating
Indivior’s separate PI against DRL. The CAFC’s mandate vacating Indivior’s PI as to DRL issued in February 2019 and Alvogen launched its
generic product. Any sales in the US by Alvogen are on an “at-risk” basis, subject to the ongoing litigation against Alvogen in the NJ District
Court. In November 2019, Alvogen filed an amended answer alleging various antitrust counterclaims. In January 2020, Indivior and Alvogen
stipulated to noninfringement of the ’305 Patent under the court’s claim construction, but Indivior retained its rights to appeal the
construction and pursue its infringement claims pending appeal. Indivior’s infringement claims concerning the ’454 patent and Alvogen’s
antitrust counterclaims remain pending in the NJ District Court. Summary judgment motions have been fully briefed, but the NJ District
Court has not ruled on those motions. No trial date has been set. In February 2022, the NJ District Court ordered the parties to mediation.
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
23. Legal proceedings continued
Opposition to SUBLOCADE European patent
In October 2018, Teva Pharmaceutical Industries Ltd. (“Teva“) filed a Notice of Opposition with the European Patent Office (“EPO”)
seeking to revoke European Patent No. EP 2579874 (“EP 874“), which relates to the formulation for SUBLOCADE. Oral proceedings took
place in September 2021 and the patent was maintained as granted. Teva filed a notice of appeal with their grounds for such appeal,
and the Group’s deadline to respond in writing to such appeal is June 21, 2022.
In March 2021, the law firm Elkington & Fife LLP filed a Notice of Opposition with the EPO 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 responded to the Opposition in August 2021. The
oral hearing has been set for October 10, 2022.
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 US 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 fully briefed and were argued in December
2021. The deadline for the class exclusion or “opt out” is May 15, 2022.
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.). 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 pled guilty to
one count of making a false statement relating to healthcare matters in one state in 2012 (as discussed above under DOJ Resolution). The
Group continues to believe 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 has cooperated 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 were pending in the Eastern
District of Pennsylvania. The complaints were dismissed in July 2021. Plaintiffs filed Notices of Appeal in August 2021 to the United States
Court of Appeals for the Third Circuit (“Third Circuit”). The Third Circuit has indicated it may hear oral arguments on this appeal in March
2022. Humana also filed a Complaint in state court in Kentucky with substantially the same claims as were raised in the Federal Court
case. That case has been stayed pending a decision in the Third Circuit appeal. 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), (5) Molina Healthcare, Inc., and (6) Aetna Inc. are pending in the Circuit Court for the County of Roanoke, Virginia (the “Roanoke
Plaintiffs”). 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. In June 2021, defendants’ motion to stay was denied and certain claims were dismissed
without prejudice. The Roanoke Plaintiffs have filed amended complaints, and the Group has filed demurrers, seeking dismissal of some
of the asserted claims. Briefing is scheduled to be completed on these demurrers in March of 2022.
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23. Legal proceedings continued
The Group has begun its evaluation of the claims, believes in its defenses, and intends to vigorously defend itself. Engagement with
the claimants has been minimal. 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 approximately 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 US District Court for the Northern District of Ohio. At the present time, litigation against Indivior in the MDL
is stayed. 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.
24. Trade and other payables
Sales returns and rebates
Accounts payable
Accruals and other payables
Other tax and social security payable
Interest payable
Trade and other payables
2021
$m
(436)
(137)
(136)
(11)
–
(720)
2020
$m
(396)
(20)
(97)
(9)
(2)
(524)
Sales return and rebate accruals, primarily in the US, are provided for by the Group at the point of sale in respect of the estimated
rebates, discounts or allowances payable to direct and indirect customers. Trade and other payables are recognized initially at fair
value and, where applicable, subsequently measured at amortized cost using the effective interest method. Accruals are made at the
time of sale, while the amounts eventually 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 channel (e.g. Medicaid, Medicare, Managed Care) and product mix. The level of accrual is reviewed and adjusted in light of
historical experience of actual rebates, discounts or allowances given and returns made, and any expected changes in arrangements
or rules. Future events could cause the assumptions on which the accruals are based to change, which could affect the future results
of the Group.
The increase in trade payables is primarily driven by timing of payments made on government rebate payables in the US.
The carrying amounts of total trade and other payables are denominated in the following currencies:
Sterling
Euros
US dollar
Other currencies
25. Share capital
Issued and fully paid
At January 1, 2021
Ordinary shares issued
Shares repurchased and canceled
At December 31, 2021
2021
$m
(36)
(10)
(658)
(16)
(720)
2020
$m
(25)
(14)
(473)
(12)
(524)
Equity
ordinary
shares
Nominal value
paid per share
$
Nominal
value
$m
733,635,511
2,311,560
(33,507,433)
702,439,638
0.10
0.10
0.10
73
–
(3)
70
In addition, 256,055 ordinary shares purchased as part of the share repurchase program were canceled in January 2022. These shares
are included in the total number of share capital outstanding as at December 31, 2021.
Indivior | Annual Report and Accounts 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E G R O U P F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
25. Share capital continued
Issued and fully paid
At January 1, 2020
Ordinary shares issued
At December 31, 2020
Ordinary shares issued
Equity
ordinary
shares
Nominal value
paid per share
$
Nominal
value
$m
730,787,719
2,847,792
733,635,511
0.10
0.10
73
–
73
During the year, 2,311,560 ordinary shares (2020: 2,847,792) were allotted to satisfy vesting/exercises under the Group’s Long-Term
Incentive Plan and the US Employee Stock Purchase Plan.
Shares repurchased and canceled
On July 30, 2021, the Group commenced an irrevocable share repurchase program for an aggregate purchase price up to no more than
$100m or 73,462,098 of ordinary shares. On December 23, 2021, the program concluded with the Group repurchasing 33,763,488 of the
Group’s ordinary shares over the duration of the program for an aggregate nominal value of $3m ($0.10 per share). All ordinary shares
repurchased during the program were canceled (except for those canceled in January 2022) which resulted in a transfer of the
aggregate nominal value to a capital redemption reserve. The total cost of the share repurchase program was $101m, consisting of
$100m paid for the repurchase of shares and $1m of directly attributable transaction costs paid, which include advisory fees and
stamp duties.
26. Other equity
Foreign currency translation
The foreign currency translation reserve contains the accumulated foreign exchange differences from the translation of the financial
statements of the Group’s foreign operations arising when the Group’s entities are consolidated.
Other reserves
The other reserves balance relates to the Group formation in 2014. It represents the difference between the nominal value
of the shares issued by the Company and the net investment in the Group by the former owner.
Capital redemption reserve
The capital redemption reserve was created for capital maintenance purposes as a result of the repurchase and cancellation of
ordinary shares under the share repurchase program executed in 2021.
27. Share-based plans
The Group operates three equity-settled executive and employee share plans. For all grants of share options and awards, the fair
value at the grant date is calculated using appropriate pricing models. The grant date fair value is recognized over the vesting period
as an expense, with a corresponding increase in retained earnings.
Employee plans
Indivior Long-Term Incentive Plan (LTIP)
In 2015, a share-based incentive plan was introduced for employees (including Executive Directors) of the Group. An award under the
LTIP can take the form of a nil-cost option, a market value option, or a conditional award.
The Remuneration Committee may determine the vesting of awards is conditional upon the satisfaction of one or more performance
conditions. Awards with performance conditions granted under the LTIP will normally have a performance period of at least three
years. Awards granted to Executive Directors are subject to a further two-year post-vesting period.
The fair values of awards granted under the Long-Term Incentive Plans are calculated using a Monte Carlo simulation model. The key
assumptions in the simulation model are share price of the Company, expected volatilities of the Company, risk-free rate, and
dividend yield.
Other employee plans
The Group operates an HMRC-approved SAYE plan for UK employees and US Employee Stock Purchase Plan (“ESPP”) for US
employees. The amounts recognized for these plans are not material for disclosure.
For all plans, the inputs to the option pricing models are reassessed for each grant. The following assumptions were used in
calculating the fair value of options granted.
160
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27. Share-based plans continued
Award
Grant date
2019 March 5, 2019
2019 March 5, 2019
2019
August 8, 2019
2020 March 9, 2020
2020 March 9, 2020
2020 November 6, 2020
2021 March 1, 2021
2021 March 1, 2021
Performance
period
Share price on
grant date
£
Volatility
%
Dividend yield
%
Expected life in
years
Risk-free interest
rate1
%
Weighted average
fair value
£
2019–21
2019–21
2019–21
2020–22
2020–22
2020–23
2021-23
2021-23
1.08
1.08
0.58
0.45
0.45
1.17
1.29
1.29
73
73
73
110
110
110
115
115
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3
3
3
3
3
3
3
3
0.82
0.82
0.82
0.10
0.10
0.10
0.10
0.10
0.77
0.50
0.50
0.41
0.42
1.10
1.16
1.17
1. The risk-free interest rate reflects the continuous risk-free yield based on the UK Government interest rates as of the valuation date, based upon a maturity
commensurate with the performance period.
At the end of the year, the maximum number of shares that could vest under the Group’s LTIP was:
Outstanding at January 1, 2020
Awarded
Vested/Exercised
Forfeited
Outstanding at December 31, 2020
Awarded
Vested/Exercised
Forfeited
Outstanding at December 31, 2021
Charged to income statement
The expense charged to the income statement for share-based payments is as follows:
Granted in current year
Granted in prior years
Unvested awards due to unmet performance conditions
Total share-based expense for the year
Total LTIP
millions
25
22
(1)
(12)
34
14
(1)
(7)
40
2020
$m
(3)
(10)
5
(8)
2021
$m
(6)
(7)
2
(11)
The Group does not expect income statement benefits for unvested awards due to unmet performance conditions in the coming
years, as performance conditions for outstanding awards are market-based.
28. Related parties
In March 2021, the Group entered into a relationship agreement with its largest shareholder, Scopia Capital Management LP ("Scopia").
The relationship agreement provides for Scopia to have one representative director appointed to the Board and contains certain
standstill, voting and governance terms. This includes commitments from Scopia not to exercise voting rights in excess of 20%
of the Group’s total voting rights and to vote on ordinary course resolutions in accordance with the Board's recommendation.
The relationship agreement will remain in force until December 31, 2023, unless extended or terminated earlier in accordance with
its terms.
Key management compensation is disclosed in Note 7.
The subsidiaries included in the consolidated financial statements at December 31, 2021 are disclosed in Note 2 to the Parent
Company financial statements.
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FINANCIAL STATEMENTS
H I S T O R I C A L F I N A N C I A L I N F O R M A T I O N
H I S T O R I C A L F I N A N C I A L I N F O R M A T I O N
Income statement
Revenue from continuing operations
Operating profit/(loss)
Net finance (expense)/income
Profit/(loss) on ordinary activities before tax
Tax benefit/(expense) on profit on ordinary activities
Net income/(loss)
Balance sheet
Net assets/(liabilities)
Net working capital2
Statistics
Reported basis
Operating margin
Tax rate
Diluted earnings/(loss) per share (cents)
2021
$m
791
213
(23)
190
15
205
203
(423)
2020
$m
647
(156)
(17)
(173)
25
(148)
82
(252)
2019
$m
785
178
2
180
(46)
134
209
(323)
26.9%
-7.9%
27
-24.1%
14.4%
(20)
22.7%
25.6%
18
20181
$m
1,005
292
(14)
278
(3)
275
66
(356)
29.1%
1.1%
37
20171
$m
1,093
193
(56)
137
(79)
58
(203)
(335)
17.7%
57.7%
8
1. 2018 and 2017 balances have not been restated to reflect the adoption of IFRS 16.
2. Net working capital includes inventory plus trade receivables less trade and other payables for 2021 and 2020. Net working capital for 2017-2019 includes the
aforementioned accounts plus current other assets.
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P A R E N T C O M P A N Y B A L A N C E S H E E T
P A R E N T C O M P A N Y B A L A N C E S H E E T
As at December 31
Fixed assets
Investments in subsidiaries
Deferred tax
Current assets
Debtors due within one year
Cash and cash equivalents
Creditors due within one year
Net current assets
Creditors due after one year
Net assets
Equity
Share capital
Share premium
Capital redemption reserve
Retained earnings
Total equity
Note
2021
$m
2020
$m
2
3
4
6
6
7
1,437
1,437
–
9
21
(11)
19
(32)
1,424
70
7
3
1,344
1,424
5
6
19
(11)
14
(40)
1,416
73
6
–
1,337
1,416
The net income of the Parent Company for the financial year was $105m (2020: $60m net loss). The financial statements on pages 163
to 170 were approved by the Board of Directors on March 17, 2022 and signed on its behalf by:
Mark Crossley
Director
Ryan Preblick
Director
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Indivior Annual Report 2021
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163
FINANCIAL STATEMENTS
P A R E N T C O M P A N Y S T A T E M E N T O F C H A N G E S I N E Q U I T Y
P A R E N T C O M P A N Y S T A T E M E N T O F C H A N G E S I N E Q U I T Y
Balance at January 1, 2020
Comprehensive loss
Net loss for the financial year
Other comprehensive income
Total comprehensive loss
Transactions with owners
Shares issued
Share-based plans
Deferred taxation on share-based payments
Total transactions recognized directly in equity
Balance at December 31, 2020
Balance at January 1, 2021
Comprehensive income
Net income for the financial year
Other comprehensive income
Total comprehensive income
Transactions with owners
Shares issued
Shares repurchased and canceled
Share-based plans
Settlement of equity awards
Deferred taxation on share-based payments
Total transactions recognized directly in equity
Balance at December 31, 2021
Notes
Share
capital
$m
73
8
8
–
–
–
–
–
–
–
73
73
–
–
–
–
(3)
–
–
–
(3)
70
Share
premium
$m
Capital
redemption
reserve
$m
5
–
–
–
1
–
–
1
6
6
–
–
–
1
–
–
–
–
1
7
–
–
–
–
–
–
–
–
–
–
–
–
–
–
3
–
–
–
3
3
Retained
earnings
$m
1,387
(60)
–
(60)
–
8
2
10
1,337
Total
equity
$m
1,465
(60)
–
(60)
1
8
2
11
1,416
1,337
1,416
105
–
105
–
(101)
11
(1)
(7)
(98)
1,344
105
–
105
1
(101)
11
(1)
(7)
(97)
1,424
164
164
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N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
The Parent Company financial statements of Indivior PLC
(the “Company”) for the year ended December 31, 2021, were
authorized for issue by the Board of Directors on March 17, 2022,
and the balance sheet was signed on the Board’s
behalf by Mark Crossley and Ryan Preblick. Indivior PLC
is an investment holding company and is a public limited
company incorporated and domiciled in England, United
Kingdom. The address of the registered office and company
number are given on page 171.
These financial statements were prepared in accordance with
Financial Reporting Standard 101. ‘Reduced Disclosure
Framework’ (FRS 101). The financial statements are prepared
under the historical cost convention, and in accordance with the
Companies Act 2006 as applicable to companies using FRS 101.
As permitted by s408 (4) of the Companies Act 2006, no profit
and loss account is presented for Indivior PLC. The results of the
Company are included in the consolidated financial statements
of Indivior PLC.
The accounting policies which follow apply to preparation of the
financial statements for the year ended December 31, 2021. They
have all been applied consistently throughout the year and the
preceding year. The financial statements are prepared in US
dollars and are rounded to the nearest million.
The exchange rates used for the translation of currencies into US
dollars that have the most significant impact on the Company
results were:
GBP year-end exchange rate
GBP average exchange rate
2021
1.3532
1.3763
2020
1.3651
1.2833
1. Accounting policies
Basis of preparation
Indivior PLC (the “Company”) is the Parent Company of the
Indivior Group. Indivior PLC is a public limited company
incorporated and domiciled in England, United Kingdom.
The Company and its subsidiaries (together, “the Group”) are
predominantly engaged in the development, manufacture and
sale of buprenorphine-based prescription drugs for the
treatment of opioid dependence, and co-occurring disorders.
The Parent Company financial statements have been prepared
in accordance with Financial Reporting Standard 101, ‘Reduced
Disclosure Framework’ (FRS 101) and the Companies Act 2006
(the “Act”) for all periods presented.
The Company is included in the Group financial statements of
Indivior PLC, which are publicly available on the Company’s
website.
The Directors have considered the Group’s and Parent
Company’s financial plan, in particular reference to the period
through to June 2023.
As disclosed in Notes 5, 21, 22 and 23 of the Notes to the Group
Financial Statements, the Group has liabilities and provisions
totaling $537m (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 minimum liquidity covenant in the Group’s debt
facility, maintain sufficient liquidity to fund its operations, fulfill
obligations under the DOJ resolution and RB agreement, and
address the reasonably possible financial implications of the
ongoing legal proceedings. The Directors have also modeled the
risk that SUBLOCADE will not meet revenue growth expectations
(considering a 15% decline on forecasts), an accelerated
reversion to generic analogs for SUBOXONE Film, and the
ongoing legal proceedings (as disclosed in Note 23) may result in
reasonably possible payments 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. As a result of the factors set
out above, the Directors of the Group and Parent Company have
a reasonable expectation that the Group and Parent Company
have adequate resources to continue in operational existence
for at least one year from the approval of these financial
statements.
The Directors have given the going concern assessment due
consideration and have concluded that it is appropriate to adopt
the going concern basis for accounting and preparing these
financial statements. The viability statement is on page 57.
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Indivior Annual Report 2021
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FINANCIAL STATEMENTS
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
1. Accounting policies continued
Foreign currency translation
The Company has taken advantage of the following disclosure
exemptions under FRS 101:
a. The requirements of paragraphs 45(b) and 46 to 52 of IFRS 2
Share-Based Payments for an ultimate parent: the share-
based payment arrangement must concern its own equity
instruments and its separate financial statements must be
consolidated financial statements of the Group; and in both
cases, this exemption requires that equivalent disclosures are
included in the consolidated financial statements of the Group
in which the entity is consolidated.
b. The requirements of paragraphs 17 and 18 of IAS 24
Related-Party Disclosures to disclose information about key
management personnel compensation and related party
transactions entered into between two or more members of
a group, provided that any subsidiary which is a party to the
transaction is wholly owned by such a member.
c. The requirements of paragraphs 30 and 31 of IAS 8 Accounting
Policies, Changes in Accounting Estimates and Errors to
provide information about the impact of IFRSs that have been
issued but are not yet effective.
d. The requirements of IAS 7 Statement of Cash Flow to prepare
a cash flow statement for any qualifying entity.
e. The requirements of paragraphs 10(d), 10(f), 16, 38, 38A-D,
40A-D, 111, 134-6 of IAS 1 Presentation of Financial Statements
to present:
› a cash flow statement;
› a statement of financial position and related notes
at the beginning of the earliest comparative period
whenever an entity applies an accounting policy
retrospectively, makes a retrospective restatement, or when
it reclassifies items in its financial statements;
› an explicit statement of compliance with IFRS. Indeed,
FRS 101 prohibits such a statement of compliance and an
FRS 101 statement of compliance is required instead; and
› information about capital and how it is managed.
New standards and amendments
Interest Rate Benchmark Reform (Amendments to IFRS 9,
IAS 29 and IFRS 7) Phase II and COVID-19 Related Rent
Concessions (Amendments to IFRS 16) are new accounting
standards that are effective from January 1, 2021 and have had
no impact on the Parent Company.
Transactions denominated in foreign currencies are translated
using exchange rates prevailing at the dates of the transactions.
Foreign exchange gains and losses resulting from the settlement
of foreign currency transactions and from the translation at year-
end exchange rates of monetary assets and liabilities
denominated in foreign currencies are recognized in the
income statement.
Taxation
The tax charge/credit is based on the result for the year
and takes into account taxation deferred due to timing
differences between the treatment of certain items for taxation
and accounting purposes. Deferred tax liabilities are provided for
in full and deferred tax assets are recognized to the extent that
they are considered recoverable.
A deferred tax asset is considered recoverable if it can
be regarded as more likely than not that there will be suitable
taxable profits against which to recover carried-forward tax
losses and from which the future reversal of underlying timing
differences can be deducted.
Deferred tax is measured at the tax rates that are expected
to apply in the periods in which the timing differences are
expected to reverse, based on tax rates and laws that have been
enacted or substantively enacted by the balance sheet date.
Deferred tax is measured on an undiscounted basis.
Cash and cash equivalents
Cash and cash equivalents comprise cash in hand, current
balances with banks and similar institutions, and highly liquid
investment with original maturities of less than three months.
Financial instruments
The Company only enters into basic financial instrument
transactions that result in the recognition of basic financial
assets and liabilities, including receivables and payables and
loans to and from related parties. These transactions are initially
recorded at transaction price and subsequently recognized at
amortized cost. See Note 17 of the Notes to the Group financial
statements for more information on the Group’s policies on
financial instruments.
Accounting estimates and judgments
In the application of the Company’s accounting policies, the
Directors are required to make some estimates and assumptions
about the carrying amounts of assets and liabilities that are not
readily apparent from other sources. The estimates and
associated assumptions are based on historical experience and
other factors that are considered to be relevant. Actual results
may differ from these estimates. See Note 2 of the Parent
Company financial statements for key judgments and
assumptions used in assessing the carrying value of the
Company's investments.
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2. Investments in subsidiaries
Investments in subsidiaries are stated at the lower of cost and their recoverable amount, which is determined as the higher
of fair value less cost to sell and value in use.
At January 1
At December 31
Impairment of investments in subsidiaries
2021
$m
1,437
1,437
2020
$m
1,437
1,437
A review of the potential impairment of an investment is carried out by the Directors if events or changes in circumstances indicate
that the carrying value of the investment may not be recoverable. Such impairment reviews are performed in accordance with IAS 36
Impairment of Assets. At the end of the year the Directors evaluated internal and external factors and other triggering events that
may give rise to a potential impairment.
The Directors also consider the relationship between market capitalization of the Company and the carrying value of the Company's
investments, among other factors, when reviewing for indicators of impairment. As at December 31, 2021, Indivior PLC's market
capitalization (adjusted for net cash) was above the Company's investments in subsidiaries value of $1,437m (2020: $1,437m) indicating
no impairment triggers. The Directors concluded its evaluation noting that no impairment indicators were identified.
The Directors believe that the carrying value of the investments is supported by the underlying net assets of the subsidiary. The cost
of investments has been determined with reference to the nominal value of shares issued as permitted by s615 of the Act. The
Directors have concluded that the investment in subsidiary balance was fully recoverable, and no impairment was required as of
December 31, 2021.
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FINANCIAL STATEMENTS
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
2. Investments in subsidiaries continued
Subsidiaries
The subsidiaries as at December 31, 2021, all of which are included in the consolidated financial statements, are shown below, in
accordance with s410 of the Act.
Name
Bio-Found Limited
Indivior Austria GmbH
Indivior Belgium SRL
Indivior Canada Ltd
Indivior Česko s.r.o
Indivior Deutschland GmbH
Indivior España S.L.U.
Indivior EU Limited
Country of
incorporation
or registration
and operation
Registered office
Principal activity
Effective %
of share capital
held by the Group
England and Wales 234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
Austria
Belgium
Canada
Czech Republic
Germany
Spain
England and Wales The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY,
Kärntner Ring 12, 3. Stock, 1010 Wien, Austria
De Kleetlaan 12A, 1831 Machelen, Belgium
333 Bay Street, Suite 2400, Toronto, Ontario, M5H 2T6, Canada
Na Prikope 988/31, Prague 1, Czech Republic
Hermsheimer Straße 3, 68163 Mannheim, Germany
Pasceo de la Castellana, 135-planta 7a, 28406 Madrid, Spain
Dormant company
Ordinary shares 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Operating company Common shares 100
In liquidation
Ordinary shares 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Indivior Europe Limited
Indivior Finance LLC
Indivior Finance (2014) LLC
Ireland
US*
US
United Kingdom
27 Windsor Place, Dublin 2, Ireland
251 Little Falls Drive, Wilmington, Delaware 19808, United States
251 Little Falls Drive, Wilmington, Delaware 19808, United States
Indivior Finance S.àr.l
Indivior France SAS
Indivior Global Holdings Limited England and Wales 234 Bath Road, Slough, Berkshire.SL1 4EE, United Kingdom
21 Fort Elizabeth, L-1463 Luxembourg
7 Avenue de la Cristallerie, 92310 Sèvres, France
Luxembourg
France
Indivior Hrvatska d.o.o.
Indivior Inc.
Indivior Israel Ltd
Indivior Italia S.r.l
Indivior Jersey Limited
Indivior Jersey Finance LLC
Indivior Jersey Finance (2021)
Limited
Indivior Nederland B.V.
Indivior Nordics ApS
Croatia
US
Israel
Italy
Jersey
US**
Jersey
Netherlands
Denmark
Indivior Pty Ltd
Australia
Indivior Schweiz AG
Indivior SMTM LLC
Indivior Solutions Inc.
Indivior South Africa (Pty) Ltd
Switzerland
US
US
South Africa
Indivior Treatment Services, Inc. US
Indivior UK Limited
Ozaljska 136, 10 000 Zagreb, Croatia
251 Little Falls Drive, Wilmington, Delaware 19808, United States
6th Habanai St., Modiin, 7178365, Israel
Corso di Porta Romana 68, 20122 Milano, Italy
28 Esplanade, St Helier, Jersey, JE2 3QA, Jersey
251 Little Falls Drive, Wilmington, Delaware 19808, United States
28 Esplanade, St Helier, Jersey, JE2 3QA, Jersey
Basisweg 10, 1043AP Amsterdam, Netherlands
c/o Lundgrens Advokatpartnerselskab, Tuborg Boulevard 12, 4.,
2900 Hellerup, Denmark
Pod B.02, Level 3, 78 Waterloo Road, Macquarie Park, NSW 2113,
Australia
Neuhofstrasse 5A, 6340, Baar, Switzerland
251 Little Falls Drive, Wilmington, Delaware 19808, United States
251 Little Falls Drive, Wilmington, Delaware 19808, United States
Building 21 C, Woodlands Office Park, 20 Woodlands Drive,
Woodmead, 2191, South Africa
251 Little Falls Drive, Wilmington, Delaware 19808, United States
England and Wales The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY,
Indivior UK Finance Limited
Indivior UK Finance Lending Limited
Indivior UK Finance No1 Limited
Indivior UK Finance No2 Limited
Indivior UK Finance No3 Limited
England and Wales
England and Wales
England and Wales
England and Wales
England and Wales
United Kingdom
156 Great Charles Street, Queensway, Birmingham B3 3HN
156 Great Charles Street, Queensway, Birmingham B3 3HN
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
Operating company Ordinary shares 100
Common stock 100
Finance company
Holding and finance
US $1 shares 100
company
Finance company
US $100 shares 100
Operating company Ordinary shares 100
Holding and
Ordinary shares 100
operating company
Operating company Ordinary shares 100
Operating company Common stock 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Ordinary shares 100
In liquidation
Membership interests
Finance company
Ordinary shares 100
Finance company
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Operating company Ordinary shares 100
Finance company
Operating company Common stock 100
Operating company Common stock 100
Membership interests
Operating company Common stock 100
Holding and
Ordinary shares 100
operating company
In liquidation
In liquidation
Finance company
Finance company
Finance company
Ordinary shares 100
Ordinary shares 100
Ordinary shares 100
Ordinary shares 100
Company limited by
guarantee
Class A and Class B
common stock 100
Ordinary shares 100
Indivior US Holdings Inc.
US
251 Little Falls Drive, Wilmington, Delaware 19808, United States
Holding company
RBP Global Holdings Limited
England and Wales 234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
Holding and Finance
company
* Indivior Finance LLC is registered in the US state of Delaware but also has a UK establishment.
** Indivior Jersey Finance LLC is registered in the US state of Delaware, but also has a principal place of business in Jersey.
With the exception of Indivior Global Holdings Limited, none of the above subsidiaries is held directly by Indivior PLC.
The following subsidiaries were dissolved or deregistered in 2021: Indivior (Beijing) Pharmaceuticals Information Consulting Co. Ltd,
Indivior Finance (2015) S.àr.l, Indivior Ireland (Investments) Limited, Indivior Middle East FZ-LLC, and Indivior Portugal Unipessoal LDA.
The following subsidiaries have been placed in liquidation effective in 2021: Indivior Česko s.r.o., Indivior Jersey Limited, Indivior UK
Finance Limited, and Indivior UK Finance Lending Limited. The following subsidiaries were newly formed in 2021: Indivior Jersey
Finance (2021) Limited and Indivior SMTM LLC.
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2. Investments in subsidiaries continued
Exemption from statutory audit by parent guarantee
Certain wholly owned entities within the Group are covered by a guarantee provided by Indivior PLC. Under this guarantee, the
Company guarantees all outstanding liabilities of these entities as at December 31, 2021. No liability is expected to arise under this
guarantee. These entities will utilize an exemption under Section 479A of the Act from the requirement for statutory audit of the
individual entity accounts. The entities covered by this guarantee are listed below.
Name
Country of
incorporation
or registration
and operation
Registered office
Indivior Global Holdings Limited England and Wales 234 Bath Road, Slough, Berkshire.SL1 4EE, United Kingdom
Indivior UK Finance No1 Limited
Indivior UK Finance No2 Limited
Indivior UK Finance No3 Limited
England and Wales
England and Wales
England and Wales
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
234 Bath Road, Slough, Berkshire, SL1 4EE, United Kingdom
Principal activity
Holding and
operating company
Finance company
Finance company
Finance company
Effective %
of share capital
held by the Group
Ordinary shares 100
Ordinary shares 100
Ordinary shares 100
Company limited by
guarantee
3. Deferred tax
Deferred tax assets
2021
$m
–
Deferred tax assets relate primarily to share awards of $nil (2020: $5m).
4. Debtors due within one year
Debtor balances due within one year have been assessed for recoverability in accordance with IFRS 9 and no impairment was
identified and thus no provision was recorded. In 2021 and 2020 there have been no credit losses.
Amounts owed by subsidiaries
Corporate tax receivable
Prepayments and other receivables
Debtors due within one year
Amounts owed by Group undertakings are unsecured and repayable on demand.
5. Financial instruments
Financial assets:
Financial assets that are debt instruments measured at amortized cost
Financial liabilities:
Financial liabilities that are measured at amortized cost
2021
$m
–
–
9
9
2021
$m
–
(43)
2020
$m
5
2020
$m
3
1
2
6
2020
$m
3
(51)
Indivior | Annual Report and Accounts 2021
Indivior Annual Report 2021
169
169
FINANCIAL STATEMENTS
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
N O T E S T O T H E P A R E N T C O M P A N Y F I N A N C I A L S T A T E M E N T S
C O N T I N U E D
C O N T I N U E D
6. Creditors
Amounts falling due after one year:
Amounts owed to third parties
Amounts falling due within one year:
Amounts owed to subsidiaries
Amounts owed to third parties
Creditors
2021
$m
(32)
(2)
(9)
(43)
2020
$m
(40)
(1)
(10)
(51)
Amounts owed to Group undertakings are payable within one year with a maturity date of December 2022. Amounts owed
to third parties primarily relate to the settlement agreement between the Group and Reckitt Benckiser. Further information on the
settlement can be found in Note 21 of the Notes to the Group financial statements.
7. Share capital and share premium
Further information on the share capital of the Company including the repurchase and cancellation of ordinary shares can be found
in Note 25 of the Notes to the Group financial statements. Share premium represents additional paid in capital or paid in surplus (not
distributable). All ordinary shares repurchased under the share repurchase program were canceled resulting in a transfer of the
aggregate nominal value to a capital redemption reserve.
8. Share-based plans
The disclosure relating to the Company is detailed in Note 27 of the Notes to the Group financial statements.
9. Directors and employees
There were no employees of the Company during this or the previous financial year.
Details of the remuneration for the Group’s key management personnel and Directors, are given in Note 7 of the Notes to the Group
financial statements.
10. Auditors’ remuneration
The fee charged for the statutory audit of the Company was $0.04m (2020: $0.04m). Details for the Group audit fees and non-audit
fees are given in Note 6 of the Notes to the Group financial statements.
11. Related party transactions
The Company has taken advantage of the exemption within IAS 24 Related Party Disclosures not to disclose related party transactions
with wholly owned subsidiaries of the Group. There were no other related party transactions.
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I N F O R M A T I O N F O R S H A R E H O L D E R S
INFORMATION
FOR SHAREHOLDERS
Registered address
Indivior PLC
234 Bath Road, Slough, Berks, SL1 4EE, UK
Registered in England and Wales
(company number: 09237894)
Website: www.indivior.com
Company Secretary
Kathryn Hudson
Email: cosec@indivior.com
Registrar
Computershare Investor Services PLC
The Pavilions, Bridgwater Road, Bristol, BS99 6ZZ, UK
Website: www.investorcentre.co.uk
Telephone: +44 (0) 370 707 1820
Key dates
First quarter financial results
announcement
Annual General Meeting
Half year financial results
announcement
Third quarter financial results
announcement
April 28, 2022
May 5, 2022
July 28, 2022
October 27, 2022
Note: dates may be subject to change
Annual General Meeting (“AGM”)
The AGM will be held at 11.00am on May 5, 2022 at the offices
of Freshfields Bruckhaus Deringer LLP, 100 Bishopsgate,
London EC2P 2SR. The Notice of Meeting, together with
information regarding the business to be conducted at the
meeting and results of voting, will be available on the
Company’s website www.indivior.com.
To the extent that the prevailing circumstances as at the date
of the AGM continue to permit in person attendance,
shareholders who plan to attend the meeting in person are
asked not to attend if they are displaying any symptoms of
COVID-19. An online facility will be made available to enable
shareholders to listen to the AGM and submit questions.
Shareholders are encouraged to submit their votes ahead of
the meeting either by submitting a form of proxy or by voting
electronically (please see the Notice of Meeting for further
details regarding voting at the AGM).
Managing your shareholding
Investor centre
Investor Centre is Computershare’s easy to use self-service
website (www.investorcentre.co.uk) through which
shareholders can do the following:
› amend personal details;
› view payment and tax information;
› register for eComms; and
› view share balances.
eComms
Our Registrar, Computershare Investor Services PLC,
is responsible for sending shareholder communications
and documents to you as well as handling any queries
you may have.
We encourage you to join the growing number of our
shareholders who receive shareholder communications
and documents electronically, in place of receiving paper
copies by mail. By registering for eComms you will receive
information by email quickly and efficiently and help us to
reduce both our environmental impact and our costs.
Visit www.investorcentre.co.uk/eComms to register for the
eComms service, or alternatively contact Computershare by
using one of the methods outlined on the “Contact Us” page.
By registering you will receive an email to let you know when
and how to access shareholder documents online.
Shareholders who receive eComms are entitled to request
hard copy shareholder documents at any time free of charge
and can also revoke their consent to receive eComms at
any time.
Dividends
The Board have determined that it does not anticipate the
payment of dividends for the foreseeable future. The Directors
are of the view that the dividend policy remains appropriate
for the Group considering its current financial position
and strategy.
Indivior | Annual Report and Accounts 2021
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FINANCIAL STATEMENTS
I N F O R M A T I O N F O R S H A R E H O L D E R S
C O N T I N U E D
Dealing in Indivior securities
Boiler room scams
Ordinary shares
The Company has ordinary shares admitted to the Official
List of the Financial Conduct Authority and traded on the
London Stock Exchange, a regulated market. Live trading
data for the Company’s ordinary shares can be accessed
through www.indivior.com/en/investors/share-price-and-
tools, or via the London Stock Exchange’s website
www.londonstockexchange.com.
Shareholders wishing to sell or purchase shares in the
Company may do so through a bank or a stockbroker.
Alternatively, please go to www.computershare.com/dealing/
uk for a range of dealing services made available by
Computershare.
Shareholders are advised to be wary of any offers of
unsolicited investment advice or offers of free company or
research reports. These are typically from overseas brokers,
who target UK shareholders offering to sell them what
often turn out to be worthless or high-risk shares in US or
UK securities.
If you receive any unsolicited investment advice you should
firstly obtain the name of the person and organization
and check that they are properly authorized by the Financial
Conduct Authority before getting involved, by visiting
www.fca.org.uk/register.
Using an unauthorized firm to buy or sell shares or other
securities will prohibit access to the Financial Ombudsman
Service or Financial Services Compensation Scheme.
Shareholder analysis
Analysis of shareholder bands at December 31, 2021
Range
1 - 1,000
1,001 - 5,000
5,001 - 10,000
10,001 - 100,000
100,001 - 999,999,999
Total
Analysis of shareholder categories as at December 31, 2021
Individuals
Bank or nominees
Investment trust
Insurance company
Other company
Pension trust
Other corporate body
Total
No. of
Shareholders
8,548
1,862
194
259
245
%
No. of Shares(i)
76.95
16.76
1.75
2.33
2.21
2,685,625
3,747,016
1,379,522
8,620,238
686,007,237
11,108
100% 702,439,638
Holdings
10,018
967
13
2
80
2
26
%
No. of Shares(i)
90.19
9,227,566
8.71
0.12
0.02
0.72
0.02
0.22
526,675,523
25,840
12,492
23,290,628
6,501
143,201,088
11,108
100% 702,439,638
%
0.38
0.53
0.20
1.23
97.66
100%
%
1.31
74.98
0.00
0.00
3.32
0.00
20.39
100%
(i) 256,055 ordinary shares purchased as part of the share repurchase program were cancelled in January 2022. These shares are
included in the total number of shares detailed above.
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American Depositary Receipts
ShareGift
In addition to having its securities listed on the London Stock
Exchange, Indivior sponsors a Level 1 American Depositary
Receipt (ADR) program in the US. The ADRs are publicly traded
on a US over-the-counter market, under symbol INVVY; the
value of one Indivior ADR corresponds to the value of five
ordinary shares of the Company. Please note that with effect
from Monday December 2, 2019 the ADR Program was closed
to new issuances.
For questions related to Indivior’s ADR Program, please
contact Equiniti Shareowner Services (see details) or
visit the J.P. Morgan Depositary Receipts Services website
at www.adr.com.
We support ShareGift, a charity share donation scheme
(registered charity number: 1052686).
Through ShareGift, shareholders with only a very small
number of shares, which might be considered uneconomic to
sell, are able to donate them to charity.
Donated shares are aggregated and sold by ShareGift, the
proceeds being passed on to a wide range of UK registered
charities.
Please contact ShareGift with any queries or for further
information using the details below or visit the ShareGift
website at www.sharegift.org.
JPMorgan Chase Bank, N.A.
383 Madison Avenue, Floor 11
New York, NY 10179, US
ADR Holders can contact:
Equiniti Shareowner Services
P.O. Box 64874, St. Paul, MN 55164-0874, US
Delivery of ADR Certificates and overnight mail:
Equinti Shareowner Services 1110
Centre Point Curve, Suite 101
Mendota Heights, MN 55120, US
General enquiries:
In the US: +1 (800) 990 1135
Hearing impaired: +1 (866) 700 1652
Outside the US: +1 (651) 453 2128
www.shareowneronline.com/informational/contact-us
Email: help@sharegift.org
Telephone: +44 (0)20 7930 3737
Address: PO Box 72253, London, SW1P 9LQ.
Disclaimer
The purpose of this Annual Report and Accounts is to provide
information to members of the Company. The Annual Report
and Accounts have been prepared for, and only for, the members
of the Company, as a body, and no other persons. The Company,
its Directors and employees, agents or advisors do not accept
or assume responsibility to any other person to whom this
document is shown or into whose hands it may come and any
such responsibility or liability is expressly disclaimed.
The Annual Report and Accounts contains certain forward-
looking statements with respect to the operations,
performance and financial condition of the Group. By their
nature, these statements involve uncertainty, since future
events and circumstances can cause results and
developments to differ materially from those anticipated.
The forward-looking statements reflect knowledge and
information available at the date of preparation of this
Annual Report and Accounts and the Company undertakes
no obligation to update these forward-looking statements.
Nothing in this Annual Report and Accounts should be
construed as a profit forecast.
This report is printed on paper certified in accordance with the FSC® (Forest Stewardship Council®) and is recyclable and acid-free.
Pureprint Ltd is FSC certified and ISO 14001 certified showing that it is committed to all round excellence and improving
environmental performance is an important part of this strategy.
Pureprint Ltd aims to reduce at source the effect its operations have on the environment and is committed to continual
improvement, prevention of pollution and compliance with any legislation or industry standards.
Pureprint Ltd is a Carbon / Neutral® Printing Company.
Designed and produced by Black Sun Plc www.blacksunplc.com
Indivior | Annual Report and Accounts 2021
173
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Our name is iconic
Our name is iconic of the individual
patient’s journey to reclaim life from the
disease of addiction and our endeavor
to address patients’ unmet needs.
Our logo radiates our patient-focused,
holistic approach to expanding access to
evidence-based treatment for addiction
worldwide.