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Indivior PLC LSE:INDV

Company Conference
Presentation
Monday, September 13, 2021 2:30 PM GMT

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Contents

Table of Contents

Call Participants .................................................................................. 3

Presentation .................................................................................. 4

Question and Answer .................................................................................. 5

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INDIVIOR PLC COMPANY CONFERENCE PRESENTATION | SEP 13, 2021

Call Participants
EXECUTIVES

Mark Crossley
CEO & Executive Director

ANALYSTS

Thibault Boutherin
Morgan Stanley, Research Division

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INDIVIOR PLC COMPANY CONFERENCE PRESENTATION | SEP 13, 2021

Presentation
Thibault Boutherin
Morgan Stanley, Research Division
Good morning, and good afternoon, everyone. Thank you for joining this session at the Morgan Stanley
Global Healthcare Conference. My name is Thibault Boutherin. I'm part of pharmaceutical's equity research
team based in London. Before we start, I need to refer to important disclosures. [Audio Gap] as Morgan
Stanley research would you like to start with some informatory comments on the current situation and the
outlook for Indivior?
Mark Crossley
CEO & Executive Director
Thanks, Thibault and thanks for having us here today. And how poignant that this is a national recovery
month here in the U.S. for us to get together and talk about Indivior. I think Indivior is at a great spot
with regards to its development and its future, this is strategic sort of options we have in front of us.
We've come out of material overhangs on the business in a very good spot. And for us, the way forward
is extremely clear. We basically have a 4-pronged strategy as we move forward that we're relentlessly
focused on executing. The first one is growing SUBLOCADE to $1 billion plus in net revenue, and I'm
sure we'll talk about that a bit more. The second is on diversifying our revenue base. Initially, that is
on the organic side, bringing our film technology SUBLOCADE, too, our rest of world sort of countries
and launching those, and those have started with vigor in 2021. And also, we have another long-acting
injectable, PERSERIS, in schizophrenia that we're launching, very tight focus there on trying to expand our
revenue base.

The third is looking to rebuild our pipeline, and we're starting to bolster that out and taking it from opioid
use disorder product into true substance use disorder. We're the leaders in addiction in getting those
assets to bolster our pipeline have been key. You noticed that recently, we closed a deal with Aelis on a
cannabis use disorder, and we also have assets in the pipeline, a GABAB receptor with alcohol and an Ox1,
which is a nonopioid, opioid use.
I think the last pillar that we have is our continued operational excellence. One is delivering on what
we say we're going to do. That's key to us, key to our heritage. And then the second is maintaining our
flexibility. We had net cash at the half year of about $700 million. And we have a very disciplined capital
allocation strategy moving forward. So we're in an exciting place in the strategy, relentlessly focused in
the near term on delivering on SUBLOCADE and a bit of revenue diversification.

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Question and Answer


Thibault Boutherin
Morgan Stanley, Research Division
Thank you very much. Maybe I would like to start with a kind of big-picture question. Thank you for
outlining the strategy. So obviously, right now, the [indiscernible] franchise is eroding in the U.S. We are
progressing on the rollout of your injectable product, SUBLOCADE, that you're seeing good growth and
diversifying revenues ex-U.S. So how should we think about the shape of Indivior growth in the mid- and
long term? And what are your plans to, obviously, make this growth more sustainable beyond the next few
years? So just maybe another look of the kind of major opportunities and challenges that you see in the
years ahead for the business.
Mark Crossley
CEO & Executive Director
Yes. I think it's a great question, Thibault. And listen, I think, in the short term, it's all about getting
SUBLOCADE on to that trajectory to $1 billion. Obviously, that will be the biggest engine of growth in
the short term because we're sitting here with guidance for this year at $210 million to $230 million.
We've had 5 success -- 5 sequential quarters of double-digit quarter-over-quarter growth, which is just a
fabulous result despite the headwinds that COVID have put on the business.

In addition, we are continuing to launch those new products in rest of world, which will take the --
from a kind of a mid-single-digit contraction due to heavy competition. And we expect to ease that and
get into growth in the out years. So we look -- as we have those -- as we have PERSERIS in the U.S.
providing growth with a bit of contraction as we revert to analog and the film, we see this as a net growth
opportunity in the medium to long term to deliver really strong value to shareholders. And it's an exciting
thesis organically there.
Thibault Boutherin
Morgan Stanley, Research Division
Thank you, Mark. Maybe before we start to kind of dig a little bit more in the business. I just wanted to
have your kind of view and overview on the opioid crisis in the U.S. because, obviously, our business is
quite interfering with what's happening in terms of the opioid epidemic. So if you could give us a kind of
high-level overview on the situation and how it is evolving, that we are exiting the pandemic.
Mark Crossley
CEO & Executive Director
Yes. Thank you, Thibault. Listen, I don't think any of us have ever lived through a time period like we've
all gone through in the last 18 months. And we aren't suffering from a chronic relapsing brain disease such
as opioid abuse. And what you've seen in that disease space, which really has to do with getting stabilized
and dealing with your triggers is the pressures associated with the isolation that we've all felt. Some of
the financial pressures that people have felt through COVID as job security has been lessened, is people
are tending to reach for their drug of choice to cope with this added stress, and it's caused both opioid use
disorder diagnosis to be up.

But if you look at really the catastrophic measures of this, which is opioid overdoses and where the trends
have been on there, since the pandemic started, substance use disorders are up 30% to over 90,000.
Opioid overdose deaths are up 30% also and up to over 70,000 deaths a year due to overdose. Now
much of this is coming through the introduction of fentanyl into the supply chain, which is 30 to 50x more
powerful than the typical oxycodones or heroin that are usually the subject of abuse. And it's that -- those
synthetics that are driving 75% of the overdoses in the U.S.

So the pandemic merging with the epidemic is like a match to gasoline in what we've seen. And really, I
think, what we have to do in a disease space where we only have about 20% penetration of treatment,

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we need to turn that on its side, and we need to normalize the disease space and get to 80% to 90%
treatment rates similar to other normalized disease spaces.
Thibault Boutherin
Morgan Stanley, Research Division
That's very clear. Thank you, Mark. And I just want to maybe touch on the COVID-19 impact and on
your business, in particular. Just kind of if you could tell us how it's impacted your business over the past
18 months and how the kind of exit of the pandemic is going to shape your business over the next few
quarters in terms of, obviously, we just talked about the opportunities, but also in terms of your ability
to market your drug portfolio and also potential reversal from saving -- from the OpEx savings you could
have made during the period.
Mark Crossley
CEO & Executive Director
Certainly, Thibault, thanks. And listen, I think, COVID-19, as I said earlier, it's probably one of the most
unique situations. And early on in the pandemic, we had our sales force out for an entire quarter, right?
Because we just from a safety standpoint, didn't feel it was right. And then as we understood the disease
more, they reentered the field. And we ended up in this mixed call pattern of some digital call patterns
and some in person, but really, really limited access, which as the world has learned to deal with it,
including getting vaccines, we started to see that open up, right, and started to get more access to
physicians, started to see more patients being able to have in-person visits with physicians, or having
some unique interventions from policymakers like the DEA and SAMHSA coming together and allowing for
telehealth for initial visits for people suffering from opioid use disorder, which previously wasn't allowed.

All of these things together have allowed us to get more access, more see-ability from zero almost in that
first quarter where we were working from home and going to digital, to today, we're getting about 65% of
our visits in person. So we're starting to see the easing. Delta is out there. So you don't know where that's
going. It, obviously, is -- seems to be a bit more of a contagious version of the COVID virus. So we don't
know where that will go. But what we have seen is the health care facilities are dealing with COVID right
now and really helping their patients in such a tough time.
Thibault Boutherin
Morgan Stanley, Research Division
Great. Thank you. Just maybe you want to start spending a bit more time on SUBLOCADE. So you're,
obviously, currently in the rollout for this product. So can you tell us where you stand in the life cycle? And
when are the key drivers and blocks in the rollout that you are facing right now?
Mark Crossley
CEO & Executive Director
Yes, Thibault. I mean I think this is where we have really been breaking new paradigms in the treatment
for opioid addiction. First of all, SUBLOCADE it is a new paradigm of treatment. It is instead of taking daily
sublinguals where the patients choose their dose because they tell the doctor how they feel. We have
gotten to one dose that helps people deal and disrupt with the 3 primary drivers of addiction, which are
cravings, withdrawals and on-top euphoria when they use. So SUBLOCADE uniquely disturbs those 3 and
gives the patient a nice chance to get into and stay on recovery.

Now where that journey is happening versus the sublingual side is where there's been a bit of a strategic
pivot throughout the launch. We could, at one point, only launch in our heritage call platform in doctors'
offices. But having a controlled substance that is an injectable that has to be managed in these small
doctors' offices is a burden on those. And what we've done is strategically pivot into organized health
systems. These are what I would call big hospital systems. Typically, there's a hub in the middle and
then they've got satellite sort of facilities, and they're able to see a lot of patients. Over 25,000 waivered
physicians are in these facilities and well over 1 million opioid use disorder sufferers.

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Now critically important, it's these facilities who, once you get through the initial SOPs, the initial
administrative burden of allowing the controlled injectable specialty pharmacy drug on site, they have
the services to be able to manage the journey to allow the physician to be free to make his choice on
medications based on what is efficacious. And what we see as we launch in these spaces, is physicians not
only add more patients per HCP but they do it faster than you would see in a normal platform.

So organized health systems are a key element there, a key element of our 5 quarter-over-quarter
growth. Another key element of the strategy is criminal justice system channel. And this is one where
we've been putting in a lot of work. But what you have is you have a channel where 60% to 65% of your
patients, because of the nature of this disease, they pass through the criminal justice system at one time
or another. Only when they're in jail, typically patient -- only about 5% of patients actually get medically
assisted treatment. Once they come out of jail, 75% of those patients end up reusing and reintroducing
opioids within the first 3 months they're out. So this is a critical area where you've got a significant
turnover of patients going through because of the nature of the disease, and we're just now starting to see
quite a bit of momentum in this area.

So it's quite exciting with regards to where we are there. And then I would say, lastly, with regards to the
strategy on SUBLOCADE, I think, if you pivot to evidence generation, this is a disease space where there
hasn't been a lot of new science that has come into the market since buprenorphine medically assisted
treatment came in 2003. What we're doing is create a bolus of information. We did our RECOVER study,
which showed that patients on SUBLOCADE, if they're on for a year or more, they have a 75% higher
chance of staying in recovery. I mean that's great science, it's breakthrough. It's a longitudinal study.

And then the other piece that's out there is the fentanyl study that the team has done, which has affected
a buprenorphine element into the label that talks about buprenorphine's role and interaction with fentanyl
and how it can suppress the impacts of fentanyl on individuals when they get it. And you'll recall, 75%
of the overdoses that we're talking about of those 70,000 people are because of fentanyl and synthetic
opioids. So it's an exciting time for us on SUBLOCADE as we're moving forward. And you can see why
we've enjoyed those 5 quarters in a row of double-digit growth.
Thibault Boutherin
Morgan Stanley, Research Division
Thank you very much. And I want to spend maybe a little bit more time on -- you just mentioned the
criminal justice system in the U.S. as the probably increasingly important channel. So just if you could
give us an indication of the size. As this channel is also related to government, this imply maybe a lower
margin than the rest of the SUBLOCADE business. And just as, if you could comment on the recurrence of
these revenues.
Mark Crossley
CEO & Executive Director
Yes. No, it's a good one, Thibault. And listen, again, for us, we're very excited about the progress here.
While there is a low treatment rate in prisons, we're seeing quite a bolus of movement here, a lot of
inbound traffic of some people looking to use SUBLOCADE, and we showed some of that strategic progress
in the second quarter, where we had a one-off $7 million order from one system -- one prison system,
which is going to -- they're going to treat their patients while they're incarcerated not just upon release.

So I think that's a key initiative of where we get. You're getting a patient when they're open to treatment
because they want to transform their lives, they don't want to keep cycling in and out of prisons. And you
can help get them on that road to recovery and then bridge them in their return to society via a continuity
of care in a handoff.

I think another key element that you see where there's quite a bit of positive momentum here is the
administration, the Congress are trying to put forward sort of efforts to help in this area. There's been a
bit of funding that's been coming out from the President's budgets, from CARE, Cures and some of the
new initiatives. And then, there is also a piece of legislation that is in Congress today called the Medicaid
Reentry Act. That, if and when it's passed, will allow for patients to get treatment for addiction and mental

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health upon release from jail. So that continuity of care where they're most vulnerable that we're going to
be able to help them with that as they reenter society.

Now when it comes to revenue, I think, the key here is people that enter prison, the normal people that
enter prison because of substance use disorder in a related crime, they're in there for a relatively short
duration. Call it, 3, call it, 6 months, somewhere in that range. So it's quite a turnover sort of population.
So I think the key here is starting them on their journey and allowing them to reenter society.

So the revenue itself during that 3 to 6 months that people are actually in the criminal justice system is
probably the least strategic for helping this disease space. It's really the reentry and what that means for
keeping them on the journey. So it's a very crucial, very strategic channel. We're getting lots of inbound
traffic, and we're excited about the early steps. But it will be in chunks as we go. As we talked about the
$7 million, that will be a few quarters' worth of revenue for that prison system. And we'll continue to work
with partners to have SUBLOCADE be a choice.

It is such a perfect vehicle in a prison where if the previous barriers are when it's a daily dosing of a
sublingual, you have to logistically get the patient or in this case, the prisoner to the dispensary. There's
resource constraints, there are safety constraints, liability constraints. If you can do that just once every
28 days, with a paradigm shifting medication, it is the perfect vehicle for this channel to get these patients
off to a fair start. So we're excited about the opportunities, Thibault.
Thibault Boutherin
Morgan Stanley, Research Division
Okay. Thank you. And maybe if you could spend some time on the ex-U.S. situation. So if you could tell
us kind of explain to us the size of the opportunity for SUBLOCADE outside of the U.S., the stages of the
rollout and where you see the most opportunities for growth. And maybe some color on kind of access and
reimbursement topic in key geographies outside of the U.S.
Mark Crossley
CEO & Executive Director
Certainly. And listen, I think, we spend a lot of time in the U.S. because of the prodigious sort of statistics
with the death, but this is a global problem, and it's nondiscriminatory, hits across all social classes, all
ethnic sort of folks. So when we think about the rest of world, what we've had historically is we have had
a heritage business of tablets, SUBLOCADE and Subutex. And what we have now for the first time is we're
able to bring 2 new technologies to a highly competitive market. It's both genericized and there are other
branded competitors in the market.

So what you've seen over the last 3 to 4 years is a mid-single-digit decline on the business. But wow,
that's pretty good given the competition, given it's genericized. I mean the business has held up well and
that's a testament to that rest of world team.

Moving forward, new technologies can change paradigms. And I think the film technology, which we've
seen in the U.S., is preferred by patients because it dissolves faster, it tastes better. And SUBLOCADE,
which changes the paradigm, we think can stem that decline and get us headed back towards growth.

With regards to the film, the film went through a central approval process. So it's in the midst of launch all
across Europe, but it's early days with regards to that, right? So that takes time, and that will move and
where we'll see the majority of that momentum is as it starts to take in 2022. SUBLOCADE is a country-
by-country filing. We're in Australia. We're in Canada. We're in Israel, and we're in the Nordics. But we're
still working through both approval, which we're getting in more, but then also reimbursement and pricing.
And that's the piece that has to come before we can start with Zeal getting into those markets. But we're
excited at the opportunity. We think we've got a game-changing paradigm, one we don't see in other long-
actings that are available.
Thibault Boutherin
Morgan Stanley, Research Division

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INDIVIOR PLC COMPANY CONFERENCE PRESENTATION | SEP 13, 2021

Thank you, Mark. And maybe I want to move on to, maybe [indiscernible] service, which is obviously, your
extended release injectable drug for the treatment of schizophrenia. Just if you could comment on the
current [indiscernible] service product and your initiatives, the initiatives you've taken to fuel growth. And
if you could just guide us through the next steps in the life cycle for this product.
Mark Crossley
CEO & Executive Director
Yes. And it's one we do get a lot of questions on because it has been disproportionately impacted by
COVID. And it's one where we have a product. The product has differentiation. The simplicity of the dosing
regimen here where you dose once. And then the next dose doesn't come for 28 days is not replicated
with any other commercialized product out there.

So in a space where adherence is the #1 unmet need, we have a differentiated product. And our active
happens to be the most prescribed on a volume basis of the orals with risperidone and we're the only once
monthly risperidone. So this -- what we see is that this product profile that we have, really once doctors
understand it, they build it into their practice.

Now COVID because of see-ability and access to doctors' offices, when COVID hits, you rely on the trusted
partners you have. And there are other players who have been established in the market well before us.
And we were just starting our fourth quarter of our launch when COVID hit. So we were starting to see
really nice growth and looking to expand from a pilot sort of sales force of about 50 people to a more
normalized launch when COVID hit.

You won't normally hear from me as a CEO is actually, I take great pride in the fact that we kept our net
revenue flat during COVID, and we're starting to see a little bit of an uptick now that we're starting to get
see-ability again. And the reason is, is because what we've seen is, despite not getting into the doctor's
office as much, we've been able to maintain revenue because the physicians who did adopt it, we saw
them taking patient shares up to low double digits, kind of 12%, 13%, 14%. And which, for us, what it's
doing is proving the thesis. Physicians like this medication, it's working as we'd expect and patients like it
also.

So we're excited as we come out of the effects -- or the easing of the effects of COVID to really drive
PERSERIS and differentiate revenues moving forward. Now we've given guidance of $200 million to $300
million. So this isn't as big of a value driver as SUBLOCADE. But we see it as a meaningful diversification
moving forward.
Thibault Boutherin
Morgan Stanley, Research Division
Maybe just a follow-up question on [indiscernible]. So you are fully committed on keeping the asset in-
house and you are not open to potential partnerships or potentially out-licensing the new system.
Mark Crossley
CEO & Executive Director
Yes. Listen, we have a sales force and believe in the product, and we'll continue to move forward in that
way. We think it can really help differentiate for patients suffering from schizophrenia.
Thibault Boutherin
Morgan Stanley, Research Division
And I just maybe want to spend some time on your pipeline as well. So just if you could give us some
insights on the existing projects. You have -- obviously, was selective of one receptor antagonist for
cannabis use disorders in Phase I. So just if you could tell us what is the next step for this asset and the
potential differentiation with the existing opioid use disorder treatments.
Mark Crossley
CEO & Executive Director

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Yes. So I think that [ Selective Ericson One ], I think, we're excited about this because it is, I would say,
probably, one, it will be the first of drugs that can actually deal with cravings, withdrawals, but it isn't an
opioid right? So this one acts very similar to buprenorphine is the hypothesis. So we're excited to progress
this through.

I think the key here is we've done in a single ascending dose that we're finalizing on, and we look to do
the multiple ascending dose in the first quarter, kicked that off in the first quarter of next year.

Now I'd love to be able to take this medication and put it into a long-acting injectable. There's some
volume differences versus buprenorphine that don't allow that. But even with an oral dose on this,
which we're targeting once daily, we see this could be a real breakthrough as people start to shift to
management of these sort of diseases with nonopioid choices.
Thibault Boutherin
Morgan Stanley, Research Division
Thank you. And you also said that the pipeline, as you mentioned earlier, the partnership with Aelis Farma
for the development of synthetic CB1 specific signaling EBITDA. So what are the timelines for this project?
And what are the synergies with your existing portfolio?
Mark Crossley
CEO & Executive Director
Yes, I think this one is a great one. It gets us back to our heritage of understanding a need and helping
develop a disease space as we did with opioid use disorder where we brought and launched buprenorphine
medical-assisted treatment in the U.S. where it didn't exist. I think this is a similar area.

Cannabis use disorder -- cannabis use, excuse me, is growing unbelievably fast. And I think it's doubling
in size -- to double in size over the next 5 years, the actual cannabis market. The products that are out
there have much higher concentrations of THC. If you go back 20 years ago, you're talking 3% to 4%.
Now the average is somewhere around 20%, and there are even higher concentration doses out there into
the 30s and beyond.

This higher THC with prolonged exposure and so that can lead to what they call cannabis use disorder and
related disorders. And one of those is cannabis-induced psychosis, which what we're seeing is with these
high doses uses and frequent use, we're seeing an increase in admittances into the emergency or more
the A&E, as you'd say, over and over in London. And we foresee that with this growth, this higher potency,
this normalization of the space, a disease space and a need that's going to be there in the coming years.

So with our connect and developed model that we've had, we worked with Aelis and have brought that in-
house. They will continue to develop the drug through [ 2b ], which is being finalized protocol to start next
year. And then we'll take over and have an option at the end of that as it becomes Phase III ready. So it's
an exciting opportunity for us to get back to our heritage in creating or helping solve a future need.
Thibault Boutherin
Morgan Stanley, Research Division
Awesome. Maybe a last question would be precisely on your connect and developed R&D and business
development strategies. Just if you can comment on your priorities in terms of deal size, in terms of asset
maturity. And are you looking exclusively into the substance and new space? Or could you expand to
adjacent neurology disorders or even potentially assets outside of neurology?
Mark Crossley
CEO & Executive Director
Yes. No, it's a great question. Listen, I think, this connect and develop model, for me, it is a key way to be
able to partner with folks and to be able to bring assets into the pipeline in addiction. Addiction just has a
relatively lack of efficacious treatments outside of opioid use disorder, where you have a few options.

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If you look at methamphetamine use disorder, the stimulant to cocaine, cannabis doesn't really have
anything on the market. And even alcohol use disorder, most of them most of them are not efficacious.
They tend to be more negative repercussions if you were to take alcohol. So there's nothing out there. So
for us, we continue to canvass the market. There's a lot of bio companies that are exploring the science
here, realizing there's a major need. But those assets are typically -- Aelis is a [ 2b ]. That's typically
[ 2b ] or earlier. So they tend to be earlier assets that we partner and we bring them in at the right point,
and then we do kind of license deals where we make payments out as they derisk and shareholders realize
value moving from one stage to another and the probability of success moves down.

So those are smaller deals similar to the ones we've done. I think in the medium term -- and listen, we're
focusing on those tuck-ins and we're focusing on SUBLOCADE. In the medium term is when we start to
look to as we're growing, as margins are expanding, what does it look like for something that's a bit more
transformative than M&A, but I think that's 12 months or more. So we're going to stick to our knitting in
the short term with regards to expanding the pipeline and our organic growth theory -- or thesis.
Thibault Boutherin
Morgan Stanley, Research Division
That's great, Mark. Maybe a last one, if I can, on your capital allocation, if you could come back on your
priorities. You recently announced a share buyback plan. Do you expect share buyback to become a
regular part of your capital allocation policy? Or is this more of a one-off?
Mark Crossley
CEO & Executive Director
Yes, it's a great question. And listen, we got to a spot where we are quite comfortable with our capital
structure in doing, in exploring a way to deliver value to shareholders through a share buyback program.
I think you could tally up everything that we've disclosed, we're about 20% of the way through that. So
we've got a long ways to go before that's complete. So committing to an ongoing program at this time,
I think, what we'll do is as we get closer to completion, we'll have that on the front burner of the Board
as capital allocation is at every meeting, and decide on that versus the other competing priorities on the
business. But we thought it was a unique way to be able to get some value to shareholders in the short
term.
Thibault Boutherin
Morgan Stanley, Research Division
That's very clear. Thank you. Thank you very much, Mark, for taking the time to be with us today. And
thank you to all the investors who are listening on the webcast. Thank you very much.
Mark Crossley
CEO & Executive Director
Thank you, Thibault. Thank you for the time.

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