Indivior PLC, Q3 2021 Earnings Call, Oct 28, 2021

Indivior PLC LSE:INDV
FQ3 2021 Earnings Call Transcripts

Thursday, October 28, 2021 12:00 PM GMT
S&P Global Market Intelligence Estimates
-FY 2020- -FY 2021-
CONSENSUS CONSENSUS
EPS Normalized 0.08 0.14
Revenue (mm) 647.50 752.37

Currency: USD
Consensus as of Oct-28-2021 12:53 PM GMT
- EPS NORMALIZED -
CONSENSUS ACTUAL SURPRISE
FQ2 2020 - - -
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Contents
Table of Contents
Call Participants .................................................................................. 3

Presentation .................................................................................. 4
Question and Answer .................................................................................. 8
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INDIVIOR PLC FQ3 2021 EARNINGS CALL | OCT 28, 2021
Call Participants
EXECUTIVES
Christian Heidbreder
Chief Scientific Officer
Mark Crossley
CEO & Executive Director
Ryan Preblick
CFO & Executive Director
ANALYSTS
Max Stephen Herrmann

Stifel, Nicolaus & Company,
Incorporated, Research Division
Paul Cuddon
Numis Securities Limited, Research
Division
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Presentation
Operator
Good day, and thank you for standing by. Welcome to the Indivior Q3 Results 2021 Webcast. [Operator
Instructions] I must advise you that this conference is being recorded today, Thursday, the 28th of
October 2021. I would now like to hand the conference over to your speaker today, Mark Crossley, Chief
Executive Officer. Please go ahead.
Mark Crossley
Thank you very much. Good morning, and good afternoon, everyone. Thanks for joining us. With me today
to discuss our third quarter results are Ryan Preblick, our Chief Financial Officer; Dr. Christian Heidbreder,
our Chief Scientific Officer; and Jon Wasserman, our Interim General Counsel. For today's call, I'll provide
an overview of our strategic progress, after which Ryan will detail our financial performance and our
updated guidance. We'll then move on to Q&A.
Moving to Slide 3. I'll assume everyone's read the forward-looking statements, and I'll move on to
key messages for the third quarter. Let me start by saying how pleased I am with our Q3 performance
and progress. We continued to face a complex operating environment with the pandemic, but through
maintaining our dedication and focus on executing our strategy, we've delivered better than expected
financial results. And most importantly, we've made further good progress with SUBLOCADE, our key value
driver and top strategic priority.
Over the past year, you've heard us articulate our go-to-market strategy centered on organized health
systems. This strategic pivot in 2020 has really driven our momentum and the proof point is now 5
consecutive quarters of double-digit increases in SUBLOCADE underlying net revenue and patient
dispenses. On the back of this momentum, we're again raising our full year 2021 guidance for total net
revenue, largely on the strength of SUBLOCADE and continued SUBOXONE Film resilience. Ryan will take
you through the details shortly.
Looking more closely at our organized health systems strategy execution, as we learn more about
engaging and activating these large customers, we're increasingly confident that we've established the
right commercial strategy that we believe will drive us towards our $1 billion peak revenue goal for
SUBLOCADE. It's taken time, patience and investment, but we're starting to see the fruits of our labor
come through across a range of KPIs that point to continued momentum. To illustrate our progress, the
organized health systems category is already the main growth driver for SUBLOCADE, now generating
about 70% of our growth and accounting for 55% of our net revenue. This is faster than our stated target
for exiting 2021 at 50%.
We're also pleased with the increasing pace of activation of organized health system customers. At the
end of the quarter, we'd activated over 300 organizations, up from around 250 at the end of the second
quarter. As a reminder, our goal is to activate 500 priority organizations, so we're well over halfway
towards achieving our target. As I outlined in July, we continue to invest where we see the biggest
opportunities. This includes the criminal justice system, where we're building a dedicated commercial
team. Our efforts here are well-timed as legislation centering on medically assisted treatment for either
incarcerated or newly released patients or both gains momentum.
In addition to the Medicaid Reentry Act, which is being considered in Congress, New York state just passed
legislation establishing medically-assisted treatment in all state prisons and jails. The legislation goes
into effect February 2022 and is a major intervention on behalf of patients. In fact, 65% of incarcerated
patients suffer from SUD, while only 5% actually receive treatment. Meanwhile, despite the complications
posed by the delta variant in the quarter, our commercial organization continues to see improving levels of
healthcare professional engagement. In-person access was up to 70% in Q3, up from around 65% at the
half year. This improved access is helping SUBLOCADE patient enrollments to continue to reach new highs
and is also benefiting PERSERIS, as I will touch on shortly.
I want to close my opening remarks with our report card that demonstrates the progress we're making
against these strategic priorities. Starting with SUBLOCADE. We delivered Q3 net revenue of $65 million,
nearly double Q3 2020. When we look at this sequentially, this compares with $61 million in the second
quarter, but I remind you, that included a large $7 million order from a criminal justice system customer.
If we set that aside, sequential net revenue growth would have been around 20%. And with year-to-date
net revenue reaching $169 million, we're pleased to again raise our full year guidance for SUBLOCADE.
Among the KPIs we track, you can see from the slide that the growth in SUBLOCADE net revenue is being
driven by strong double-digit growth in U.S. patient dispenses and in the total number of patients under
treatment as well as by increasing net revenue contribution from ex-U.S. launches, which brings me on
to the next strategic priority, revenue diversification. On this measure, I'm pleased to report we've made
further progress with launches in new geographies for SUBLOCADE and SUBOXONE Film. Net revenue
for SUBLOCADE in international markets was $4 million in the quarter. We're also pleased with initial
SUBOXONE Film net revenue from new markets in the European Union, and we expect its contribution to
grow as we move forward.
The combination of these product launches is helping us offset the declines we continue to see in the
legacy tablet product. We also saw a welcome return to growth for PERSERIS, our monthly risperidone
injectable, targeting schizophrenia patients in the U.S. This reflected the progressive reopening of
healthcare systems in the U.S. that I referenced earlier. We're seeing renewed month-over-month growth
and are now increasing the investment behind this important asset to enable us to reach the $200 million
to $300 million net revenue potential that we believe this differentiated product can deliver. Toward this
end, we will be investing to double the PERSERIS sales force to achieve full national coverage in fiscal year
2022. The our net revenue goal has always been predicated on national coverage and with the U.S. health
care system continuing to open now is the right time to make this investment.
Regarding the pipeline as well as strengthening our evidence base for our long acting injectables, we
continue to progress our innovative early stage approaches to a range of addiction disorders. In particular,
we're looking forward to the early 2022 start of the Phase 2b study of AEF 0117, the promising asset for
cannabis use disorder, on which we have an exclusive license from Aelis. Finally, on our operating model,
we maintained our focus on prudent cash management and asset optimization so that we can balance
investment in the business with returning value to shareholders.
By the end of the quarter, we had bought back shares for a total of $31 million as a part of the $100
million share buyback program we announced in July. Even after this outflow, we ended the third quarter
with a strong cash position of over $1 billion and net cash over $750 million. This leaves us strongly
positioned to pursue our strategy, both organically and potentially inorganically as we see the right
opportunities. To quickly summarize, the team has delivered another strong quarter of execution and
delivery against our strategic priorities, which exceeded our expectations.
I'll now hand over to Ryan to take you through the financials in more detail.
Ryan Preblick
Good morning, and good afternoon. Looking at the Q3 results in more detail on Slide 8. We had another
solid financial performance. What stands out to me and what I will cover in more detail in just a moment
is, first, Q3 -- strong Q3 net revenue growth of 18%, which brings overall year-to-date net revenue to
$568 million, an increase of 23% compared to the year ago period. Our growth continues to be led by
SUBLOCADE's strong performance in the U.S. SUBLOCADE Q3 and year-to-date net revenue growth
was 97% and 86%, respectively, versus last year. And as you have heard, this performance, along with
SUBOXONE's continued resilience is allowing us to raise full year 2021 guidance.
Second, we are beginning to see the step-up in operating expenses from the sales and marketing
investments we are making behind SUBLOCADE to accelerate its leadership position in U.S. OUD
treatment. And as Mark discussed, we have also approved a significant investment behind PERSERIS to
drive this treatment towards our stated peak annual net revenue goal of $200 million to $300 million. Our
OpEx in the back half of 2021 will reflect these growth investments. And as such, we do expect to be at
the higher end of our $470 million to $480 million OpEx range for full year of 2021.
Third, we have maintained our strong financial position. Gross cash at the end of the third quarter stood
at over $1 billion. This has allowed us to deliver on our #1 capital allocation priority of investing in the
business while also returning value to shareholders in the form of our share repurchase program.
Now, looking at the P&L in more detail on Slide 9, starting with net revenue. We continue to be pleased
with the progression of our overall net revenue in the third quarter to $187 million. The principal drivers
of the strong year-over-year increase were the continued outstanding growth in U.S. SUBLOCADE net
revenue and SUBOXONE Film resilience in the U.S. Q3 SUBLOCADE net revenue of $65 million represents
growth of 20% sequentially when you exclude the large criminal justice system order of $7 million from
last quarter's net revenue of $61 million. On the same basis, dispenses in the quarter increased 13%. The
difference versus the net revenue growth rate being the initial stocking from some new CJS customers and
rebate accrual adjustments.
Touching on PERSERIS, net revenue was $5 million, up slightly compared to $4 million in the previous
quarter. As Mark said, we are seeing renewed sequential month-to-month growth with the reopening of
the U.S. healthcare system. Quickly turning to U.S. films performance, net revenue remained resilient at
$77 million, which was essentially unchanged versus the year ago quarter. This was primarily due to mix
as volume from a small number of non-contracted payers remained steady in the quarter. U.S. share was
relatively unchanged compared to the previous quarter at 20%. Looking ahead, while the resilience of film
remains a welcome positive both for our net revenue and cash position, we continue to caution that there
are no strategic actions we are taking to maintain current share that we expect share erosion towards
industry analogs over time.
Closing up the net revenue discussion with rest of the world, third quarter net revenue of $44 million
on an actual basis decreased 8% compared to the year ago quarter. The sale of the TEMGESIC/BUPREX
business impacted net revenue by about $2 million in the quarter, while continued competition in the
legacy tablet market was the other major factor. These items were partially offset by net revenue from
SUBLOCADE of $4 million and modest sales of SUBOXONE Film. As our new products become more widely
available and health systems normalize across the EU, we expect to reverse the net revenue declines we
have historically seen in the rest of the world business and to return to growth.
Looking at gross margin, Q3's 86% level was ahead of our low-80s expectations. This was due to better
productivity and some onetime supplier credits we received in Q4. Also in Q4, we expect gross margin to
be in the low-80s. And as such, our gross margin outlook for full year 2021 overall remains in the low-80s
range. Proceeding to operating profit, we saw a year-over-year improvement in Q3 on an adjusted basis
of 27% to $38 million. This result includes incremental growth investments behind our LAI technologies.
Q3 OpEx, which redefined as SG&A and R&D, was $123 million. This compares to adjusted OpEx of $101
million in Q3 last year.
As we previously indicated, the growth investments we are making in full year 2021 are primarily focused
on SUBLOCADE, including search engine marketing and the deployment of a dedicated team focused on
criminal justice system customers. We've also begun this year to invest behind increasing the U.S. sales
force of PERSERIS. Our goal is to achieve U.S. national coverage in full year 2022 in line with the expected
broader reopening of the U.S. healthcare system. As Mark indicated, we will essentially plan to double the
sales force.
Continuing down the P&L, net revenue was $27 million, reflecting a tax rate of 13%. While substantially
ahead of the prior year, net income was down versus the prior quarter, mainly due to the increased
investment levels we expect to see for the remainder of 2021 and a modest step-up in net interest
expense. Finally, in the quarter, you may have noted some exceptionals, the result of which is a wash
between the items. First, we had a technical adjustment to our ANDA litigation provision amounting to $24
million, which is non-cash and includes modest interest. This adjustment is based on our most up-to-date
expert judgment of the potential value we would owe.
I would, however, like to call out 2 important points here. First, we continue to believe strongly in the
validity of our 454 patent; and second, that we had already posted cash collateral totaling $82 million
that exceeds the revised total provision amount of $73 million. As such, we feel well covered should our
litigation efforts prove unsuccessful. Fully offsetting this $24 million item are proceeds from the sale of
the legacy TEMGESIC/BUPREX business outside the U.S. for net 19 and $5 million of DOJ related accrual
reversals.
Turning to the balance sheet on Slide 10. We exited the quarter with just over $1 billion in cash. The main
cash movements during the quarter were the sale proceeds of approximately $19 million net related to
the disposal of the TEMGESIC business and an outflow of approximately $31 million relating to share
repurchases. With regards to the share repurchase program, at the end of Q3, we had repurchased and
canceled approximately 11.7 million shares at an average price of approximately 190 pence.
Finally, to wrap up on guidance on Slide 11. We are pleased to raise our total net revenue expectations
to $750 million to $770 million. This is based on our expectations for continued sequential net revenue
growth of SUBLOCADE and an essentially unchanged U.S. share position for SUBOXONE Film for the
remainder of the year of around 20%. The midpoint of our revised total net revenue guidance, $760
million, would represent an approximately 18% increase versus full year 2020 net revenue of $647 million.
Within the total, we have raised and narrowed our expectations for full year 2021 SUBLOCADE net
revenue to between 235 and $245 million from $210 million to $230 million. This reflects better than
expected business momentum we have seen so far this year, including with CJS customers. The midpoint
of our new SUBLOCADE net revenue guidance would represent a year-over-year increase of 85%. The
other elements of our guidance, including gross margin, OpEx range are unchanged. However, given
our increased net revenue guidance, we are now also expecting our pretax income to be higher than we
previously forecasted.
With that, we are happy and available to take your questions.
Question and Answer

Operator
Thank you, Ryan. [Operator Instructions] And our first question today comes from the line of Max Herman
of Stifel.
Stifel, Nicolaus & Company, Incorporated, Research Division
Congratulations on a strong quarter. 3 questions, if I may. Firstly, just wanted to understand a little
bit about the SUBLOCADE performance. Obviously, benefiting a little bit. I think, you mentioned from
additional criminal justice systems revenues in the third quarter, I wondered if you could kind of give us
a bit of a clearer idea of how significant those were and what the trends are with this new sales force
and also the SUBLOCADE rollout in ex-U.S. seems flat quarter-on-quarter. So, -- but obviously, at just $4
million, it's hard to see exactly what the movement was. That's the first question. Secondly, just longer
term, what do you think the business can do in terms of the margin? And how will that evolve over time,
particularly given where you historically were? Obviously, those have dipped over the last few years with
generic competition, but then as SUBLOCADE gains traction. And then finally, just a little bit more detail
on the patent litigation increase in provision, if you may.
Mark Crossley
Thanks, Max. Appreciate the questions. Maybe I'll take the first 2, and then I'll hand over to Ryan to
talk a little bit about the provision. I think when it comes to the SUBLOCADE performance, we're really
excited about the continued progress there, 5 quarters in a row of double-digit growth. And it is uniform
across the organized health systems. If you think about the dynamics versus the second quarter to third
quarter, with the $7 million that was in Q2, actually, criminal justice was probably less than that in the
quarter. Now, we don't carve that out. But what we have seen is just continued strategic progress across
all of our organized health system KPIs and continued momentum moving forward. So, I think an exciting
testament to the strategy that we pivoted our organization behind last year. On the ex-U.S., listen, we're
in Israel, Australia and Canada and continue to make good progress in those markets with regards to
increased HCP engagement, increased patient usage. Unfortunately, we have seen in Australia, where
they're continuing to deal with COVID at a higher level maybe than the rest of world, they've gone back
down into a countrywide lockdown, but that obviously impacts some of the mantra there, but continued
great progress on SUBLOCADE in the rest of world business, too. When I think about margin over time,
listen, we've made a number of, what I would call, working investments in increasing the strategic
elements of the sales force with the criminal justice with getting PERSERIS up to a full national sales force
we've added in medical science liaisons to help with the new science that Christian and his team have
created behind SUBLOCADE and the disease space in general. And as we look to move forward, some of
those will obviously annualized next year and I think you'll see T&E kind of come back to normal levels
in 2022. And then from a business standpoint, we're relatively scaled absent pipeline sort of investments
as they move forward. So, we'll guide on that when we get to February, but I think those are a few of the
moving pieces with regards to that. So, Ryan, could you help Max with the -- regards to the provision?
Ryan Preblick
Yeah, the change to the provision is simply a change to our management's best estimate that's required
by accounting standard, IAS #37. And all it really is, is during the normal case proceedings over the last
couple of weeks, the damages experts from both sides had the chance to testify. And coming out of that,
we were able to use this new Intel to form the basis for this update. It doesn't change our position on our
patent defense, and we will continue to fight this in court as we previously communicated. It is a non-cash
event because if you recall, we have posted the cash collateral sometime last year up to $82 million.
Stifel, Nicolaus & Company, Incorporated, Research Division

Sorry, just to follow-up. I thought the surety bond had been returned or something, just to clarify on what
the collateral is.
Ryan Preblick
So, I think it was about a year ago or year and a half years ago, we were required to fund the full cap
amount of $108 million I think it was. During the proceedings, one of the bondholders did return close to
$20 million, $25 million back to us, but that still leaves us outstanding cash of $82 million.
Operator
[Operator Instructions] Your next question today comes from the line of Paul Cuddon of Numis Securities.
Paul Cuddon
Numis Securities Limited, Research Division
I've just got, I think, 3. The first one was just on the environment for SUBOXONE, just the pricing
environment, the Q2 to Q3 revenue number for U.S. SUBOXONE seems to have declined slightly. So, I'm
just wondering if that's a gross to net type situation. And I suppose it also kind of feeds into the market
environment where we sort of hear of increased funding and from an adjusted system kind of focus on
medical assisted treatment and yet global market growth is a bit slower. And then just also on the Aelis
Pharma collaboration and funding for the Phase 2b study, means how well are they supported to run that
study?
Mark Crossley
I'll start maybe with the market growth things and I'll hand it over to Ryan on some of the film dynamics,
and then we'll ask Christian to comment on Aelis Pharma. From a market growth standpoint, I think we
have seen a bit of slowing of that market growth in 2021 to kind of mid to low single-digits. But I think we
have to think a little bit bigger picture with regards to the market dynamics. We're still in a tremendously
underserved disease space, only about 20% penetration of treatment with overdoses that have grown
over 30% year-over-year and are in excess of 70,000 per year, which is just an amazing stat in developed
countries such as the United States. Behind that sort of environment where, for whatever reason, stigma
knowledge is such a low penetration of treatment we're seeing unprecedented sort of funding, legislation
sort of activity to bring this to the forefront. HHS just put out an overdose strategy yesterday, and we
talked a little bit earlier with regards to what's happening in New York state and the criminal justice.
So, while this year was a little bit low in market growth, the base year or the year before was mid-teens
or maybe a little higher. And we think that that kind of average of those, as we move forward, thinking
to mid to high single-digit sort of market growth still is where we see the market going. So, with that,
maybe, Ryan, talk about the film dynamics.
Ryan Preblick
I'll break your question down into 2 parts, if you don't mind. So, A, you had a question about Q3 versus
Q2 of this year. So, fundamentally, the share did remain flat at about 20 share points. The decline versus
Q2 was just a result of having some trade spend releases in Q2. Q2 is one of those quarters where we
really began looking at our balance sheet accruals from the previous year to see how we did versus our
assumption. So, there were some trade spend releases in Q2 that did not recur in Q3. But there was no
external factors that would change that. And then part B of your question was the total film dynamic.
So, we are certainly pleased to have the share remaining at the 20%, and we believe that it will remain
there for the balance of the year. And because there has nothing changed in the marketplace since Q2,
there's still 3 generic players. We haven't promoted the product since 2018 and still believe that COVID
has had an impact on the share, as we discussed over the last couple of quarters due to patient continuity
concerns and the benefit of telehealth. And one data point in the state of New York in Q4, they decided
to put the film back on their formulary as a preferred agent. That was their decision. So, you may see
a small uptick in the film in Q4. But net-net the current film situation may or may not roll over in 2022.
That will come as a result of the state's formulated decisions as they begin to ramp up. But as usual, we
continue to caution that we believe there's no structural reason in the market that the share with the 3
generic players should not revert to analogs over time, and we will certainly give guidance in February at
that point.
Mark Crossley
Christian, could you just talk about the partnership with Aelis and where we're headed on that asset?
Christian Heidbreder
Chief Scientific Officer
We have a very good partnership with Aelis Farma. As you probably know, we established a joint
committee on a monthly basis to really discuss the overall strategy with the main focus right now on the
clinical Phase 2b protocol, which has been finalized, and this is a key collaboration with the New York State
Psychiatric Institute with Dr. Frances Levin as the principal investigator. We also nailed down the non-
clinical strategy that is all the toxicology studies that need to be performed prior to the start of the Phase
2b as well as before the completion of the Phase 3. So, altogether, very nice progress there, protocol
finalized, ready to go in first quarter 2022.
Paul Cuddon
Numis Securities Limited, Research Division
And if I could just make one quick follow-up on the -- on SUBLOCADE. To what extent the Sentinel claim
has opened up an opportunity for you within sort of ER sort of discharges and whether you can put some
investment in there?
Mark Crossley
I think Sentinel claim, obviously, is quite pertinent given what is happening with overdoses. With
overdoses over 70,000 a year and about 75-ish percent of those the data says are synthetic opioids,
fentanyl and other types. So, it is quite pertinent. It is a buprenorphine-based claim, not a SUBLOCADE
claim, but we think it is quite pertinent. And listen, we think it's created some discussions within the
medical community with regards to broadened use of buprenorphine and SUBLOCADE, which is a
buprenorphine product to address this.
Operator
There are no further questions at this time. Back to you, Mark.
Mark Crossley
Okay. Thank you very much. Well, listen, that concludes our Q3 results. I'd like to thank everyone on
the call -- both on the call and on the web for their continued support of Indivior, and we look forward to
seeing you at the various conferences and one to one. Thank you very much.
Operator
That does conclude our webcast for today. Thank you all for participating.
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FQ3 2021 Earnings Call Transcripts

EPS Normalized 0.08 0.14

Revenue (mm) 647.50 752.37

CONSENSUS ACTUAL SURPRISE

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

Max Stephen Herrmann

Question and Answer

Stifel, Nicolaus & Company, Incorporated, Research Division

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