October 24, 2024
|
|
|
|
|
|
|
Q3 and YTD 2024 Financial
Results
• Total Q3 2024 net revenue (NR)
of $307m, +13% vs. Q3 2023
• SUBLOCADE® Q3 2024 NR of $191m, +14% vs. Q3
2023; YTD 2024 SUBLOCADE NR of $562m, +24% vs. YTD 2023
• Expected settlement reached with
certain end payors to resolve remaining antitrust cases
|
Period to September 30th (Unaudited)
|
Q3
2024
$m
|
Q3
2023
$m
|
% Change
|
|
YTD
2024
$m
|
YTD
2023
$m
|
% Change
|
Net Revenue
|
307
|
271
|
13%
|
|
889
|
800
|
11%
|
Operating Profit/(Loss)
|
4
|
(183)
|
nm
|
|
(64)
|
(65)
|
-2%
|
Net Income/(Loss)
|
4
|
(135)
|
nm
|
|
(57)
|
(52)
|
10%
|
Diluted EPS ($)
|
$0.03
|
$(0.98)
|
nm
|
|
$(0.42)
|
$(0.38)
|
11%
|
Adjusted Basis
|
|
|
|
|
|
|
|
Adj. Operating
Profit1
|
97
|
60
|
62%
|
|
245
|
202
|
21%
|
Adj. Net
Income1
|
72
|
49
|
47%
|
|
182
|
162
|
12%
|
Adj. Diluted EPS1
($)
|
$0.54
|
$0.34
|
59%
|
|
$1.34
|
$1.14
|
18%
|
1 Adjusted Basis excludes the
impact of exceptional items and other adjustments as referenced and
reconciled in the "Adjusted Results" appendix on page 27. Adjusted
results are not a substitute for, or superior to, reported results
presented in accordance with International Financial Reporting
Standards ("IFRS").
The "Company" refers to Indivior PLC and the "Group" refers to
the Company and its consolidated subsidiaries.
Comment by Mark Crossley, CEO of Indivior
PLC
"Our third quarter results show
solid double-digit top- and bottom-line growth and are in line with
the business update we issued on October 10th. The general market
conditions we highlighted at that time continue and are reflected
in our maintained FY 2024 outlook.
Despite these near-term competitive
headwinds, we remain firm in our belief that SUBLOCADE has a
differentiated and optimal profile for opioid use disorder
patients, particularly with the ongoing proliferation of potent
synthetic opioids. Furthermore, as highlighted at our business
update, evidence among multiple co-prescribing cohorts since the
competitor's launch supports our belief that SUBLOCADE will retain
a leadership position in the long-acting injectable category, with
SUBLOCADE share currently in the mid-60s percent range across these
cohorts. Looking ahead, with continued strong execution
supplemented by important potential FDA label updates, we expect to
move beyond this near-term period of market disruption to
ultimately deliver SUBLOCADE peak net revenue of greater than $1.5
billion.
To further support our goal, we are
pursuing significant streamlining actions across both G&A and
R&D, including termination of pipeline activities outside of
OUD assets which are committed and underway. The savings from these
efforts will be used to fuel SUBLOCADE growth, fund year-over-year
incremental investment behind our two Phase 2 OUD assets and
underpin our focus on supporting Group margins. Taken together, we
expect to deliver a net reduction in overall operating expense in
FY 2025 of $10 million to $20 million when compared to the
mid-point of FY 2024 operating expense guidance.
Lastly, we continue to address
legacy litigation to create greater certainty for all stakeholders.
Our third quarter results include a $39 million provision for the
preliminary agreement related to the remaining parties in the
legacy antitrust litigation. While the parties must negotiate
material terms and conditions of the final settlement agreement,
when finalized this will close this legacy matter."
YTD/ Q3 2024 Financial
Highlights
• YTD
2024 total net revenue (NR) of $889m increased 11%
(YTD 2023: $800m); Q3
2024 total NR of $307m increased
13% (Q3 2023:
$271m).
• YTD 2024 reported operating loss was $64m (YTD 2023 operating loss:
$65m); Q3 2024
reported operating profit was $4m
(Q3 2023 operating loss: $183m). YTD 2024 adjusted
operating profit of $245m increased
21% (Adjusted YTD
2023: $202m). Q3
2024 adjusted operating profit of $97m increased 62% (Adjusted
Q3 2023: $60m).
•
YTD 2024
reported net loss was $57m
(YTD 2023 net loss: $52m); Q3 2024 reported net
income was $4m (Q3
2023 net loss: $135m). YTD 2024 adjusted net income of $182m increased 12% (Adjusted
YTD 2023: $162m).
Q3 2024 adjusted net income of $72m increased 47% (Adjusted
Q3 2023: $49m).
•
Cash and
investments totaled $344m at September 30, 2024 (including $26m investments restricted for self-insurance) (FY
2023: $451m). The decrease
was primarily due to the Group's litigation settlement
payments of $158m and share repurchases of
$122m, partly offset by cash flow from
operating activities.
YTD/ Q3 2024 Product
Highlights
• SUBLOCADE (buprenorphine extended release)
Injection: YTD 2024 NR of
$562m (+24% vs. YTD
2023); Q3 2024 NR of $191m
(+14% vs. Q3
2023 and (1)% vs. Q2 2024). Year-over-year growth primarily reflects
continued volume growth in Organized Health System and Criminal
Justice System channels in the U.S. Q3 2024
U.S. units dispensed were approx. 158,500
(+19% vs. Q3 2023 and +2%
vs. Q2 2024). Total U.S. patients on a 12-month rolling
basis at the end of Q3 2024 were
approximately 166,600 (+37% vs.
Q3 2023 and +4% vs. Q2
2024).
•
OPVEE® (nalmefene) nasal
spray: Q3 2024 NR
of $15m comprised of two 100,000 unit orders from
the U.S. Biomedical Advancement Research and Development Authority
(BARDA). Near-term launch focus is on supporting policy
changes to enable nalmefene opioid rescue treatment and increasing
product trial among targeted users.
• SUBOXONE®
(buprenorphine/naloxone) Film: U.S.
share in Q3 2024 averaged 15%
(Q3 2023: 18%).
• PERSERIS®
(risperidone) extended release injection: YTD 2024 NR of $31m and
Q3 2024 NR of $8m.
As previously announced, sales and marketing of PERSERIS have been
discontinued.
• INDV-1000 (Alcohol Use Disorder):
discontinuing development of preclinical GABA-b Positive Allosteric
Modulator.
FY 2024
Guidance
On October 10th, the Group updated
its financial guidance for FY 2024 as detailed below.
Guidance assumes no material change
in exchange rates for key currencies compared with FY 2023 average
rates, notably USD/GBP and USD/EUR.
|
FY 2024
|
Net Revenue (NR)
|
$1,125m
to $1,165m
(+5% at midpoint vs. FY
2023)
|
SUBLOCADE NR
|
$725m to
$745m
(+17% at midpoint vs. FY 2023)
|
OPVEE NR
|
Approximately $15m
|
PERSERIS NR1
|
$32m to
$37m
|
SUBOXONE Film Market Share
|
Assumes
historic rate of share decline in FY 2024 of
1 to 2
percentage points and the potential impact from a fourth
buprenorphine/naloxone sublingual film generic in the U.S.
market
|
Adjusted Gross Margin
|
Low to
mid-80s % range
|
Adjusted SG&A
|
($555m)
to ($560m)
|
R&D
|
($115m)
to ($120m)
|
Adjusted Operating Profit
|
$260m to
$280m
(midpoint flat vs. FY 2023)
|
1As previously announced, sales and marketing of PERSERIS have
been discontinued.
Share Repurchase
Program
On July 25, 2024, Indivior
announced a new non-discretionary $100m share repurchase program
that commenced on August 5, 2024. Through October 11,
the Group repurchased and canceled 4,862k Indivior
ordinary shares as part of this program, equivalent to
approximately 4% of diluted shares outstanding, at a daily weighted
average purchase price of 839p. The cost was approximately $53m,
which includes directly attributable transaction
cost. This program is targeted to be completed by January 31,
2025.
Expected settlement reached
with certain end payors to resolve remaining antitrust
cases
Indivior continues to address
legacy litigation to create greater certainty for all stakeholders.
Today, the Group announces an expected settlement of the last
remaining antitrust litigation with (i) Humana, Inc. and certain of
its affiliates (collectively, "Humana") and (ii) with Centene
Corporation, Wellcare Healthcare Plans, Inc., New York Quality
Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC
(collectively, "Centene"). The Group has recorded a provision of
$39m reflecting the net present value (NPV) at the risk-free rate
of the agreed amounts to be paid in 2024 and 2025. The parties to
the settlement still must negotiate material terms and conditions
of the final settlement agreement, which Indivior expects to
resolve shortly. Final settlement, if reached, would resolve all of
the Group's remaining legacy antitrust litigation, including all
claims in the Kentucky and Pennsylvania state court actions filed
by Humana, and all claims in the Virginia state court action filed
by Centene.
U.S. OUD Market
Update
In Q3 2024, U.S. buprenorphine
medication-assisted treatments (BMAT) grew in mid-single digits in
volume terms. The Group continues to expect long-term U.S. growth
to be sustained in the mid- to high-single digit percentage range
due to increased overall public awareness of the opioid epidemic
and approved treatments, together with regulatory and legislative
actions.
Financial Performance in
YTD/Q3 2024
Total NR in YTD 2024 increased
11% to $889m (YTD 2023: $800m) at actual exchange rates (+11% at
constant exchange rates1). In Q3 2024, total NR
increased 13% to $307m (Q3
2023: $271m) at actual exchange rates (+13% at constant exchange
rates1).
U.S. NR increased 14% in YTD
2024 to $755m (YTD 2023: $662m) and by 15% in Q3 2024 to $261m (Q3
2023: $227m). Double-digit year-over-year SUBLOCADE volume growth
and the fulfillment of OPVEE orders from BARDA primarily drove the
increases in NR in both periods. Q3 2024 NR also benefited from
updates to channel mix and trade spend estimations for both
SUBLOCADE and SUBOXONE Film. These benefits were partially offset
by SUBLOCADE trade destocking versus stocking in the year-ago
quarter. Pricing was not material to NR growth.
Rest of World (ROW) NR decreased 3% at actual exchange rates in YTD 2024 to $134m
(YTD 2023: $138m) (-3% at constant exchange rates1).
Positive contributions from new products (SUBLOCADE /
SUBUTEX® Prolonged Release
and SUBOXONE Film) were more than offset by the ongoing generic
erosion of the legacy tablet business and the timing of shipments.
In Q3 2024, ROW NR increased 5% at actual exchange rates to $46m
(Q3 2023: $44m) (2% at constant exchange rates1) mainly
reflecting positive contributions from new products that were
partially offset by generic erosion of legacy tablet business. YTD
2024 SUBLOCADE / SUBUTEX Prolonged Release NR increased 27% to $38m
(YTD 2023: $30m) and in Q3 2024 increased 30% to $13m (Q3
2023: $10m), all at actual exchange
rates.
Gross margin as reported in YTD
2024 was 77% (YTD 2023: 83%) and 78% in Q3
2024 (Q3 2023: 83%). YTD 2024 and Q3 2024 included $51m and $10m, respectively, of costs related to the
discontinuation of sales and marketing for PERSERIS. In addition,
adjustments for amortization of acquired
intangible assets within cost of sales of $9m in YTD 2024 and $3m
in Q3 2024 were also included in the reported gross margin.
Excluding these costs and adjustments, adjusted
gross margin was 83% and 82% in YTD 2024 and Q3 2024, respectively
(both YTD 2023 and Q3 2023: 84%). The decrease in adjusted gross
margin in both YTD period and quarter primarily reflects cost
inflation and favorable pricing on specified batches produced in Q3
2023 that did not repeat in Q3 2024 partially offset by a
transitory benefit relating to the BARDA agreement that will
reverse in future periods and an improved product mix from the
continued growth of SUBLOCADE.
[1] Net
revenue at constant exchange rates is an alternative performance
measure used by management to evaluate underlying performance of
the business and is calculated by applying the prior year exchange
rate to current year net revenue in the currencies of the foreign
entities.
SG&A expenses as reported
in YTD 2024 were $665m (YTD 2023: $654m)
and $208m in
Q3 2024 (Q3 2023: $390m). YTD 2024 and Q3
2024 included $244m and $75m of exceptional
items, respectively (YTD 2023 and
Q3 2023: $262m and
$240m, respectively). See "Appendix" for
adjusted results for details of exceptional SG&A expenses for
YTD and Q3 2024 and
2023.
Excluding exceptional items, YTD
2024 adjusted SG&A expense increased 7% to $421m (Adjusted YTD 2023: $392m), reflecting
increased sales and marketing related to SUBLOCADE and the
launch of OPVEE, as well as cost inflation;
Q3 2024 adjusted SG&A expense decreased
11% to $133m (Adjusted Q3 2023: $150m), primarily
reflecting lower expenses from the discontinuation of PERSERIS, as
well as lower legal and other administrative expenses.
R&D expenses in YTD 2024
and Q3 2024 were $76m and $22m, respectively (YTD 2023:
$77m; Q3 2023: $18m), and represented a decrease of 1% and
an increase of 22%, respectively. The modest decrease in the YTD
period was primarily due to lower activity related to
post-marketing studies for SUBLOCADE offset by pipeline advancement
activities principally related to Phase 2 studies for INDV-2000 and
INDV-6001. The increase in Q3 2024 primarily reflects the
aforementioned pipeline advancement activities for INDV-2000 and
INDV-6001.
Operating loss as reported
was $64m in YTD 2024 (YTD 2023 operating loss: $65m). The
change on a reported basis reflects higher NR and gross profit
offset by increased operating expenses. (See
"Appendix" for adjusted results details of
exceptional expenses included in operating profit).
After excluding exceptional
items and other adjustments of $309m and $267m
in YTD 2024 and YTD 2023,
respectively, YTD 2024 adjusted operating profit
increased 21% to $245m (YTD 2023:
$202m). The increase primarily reflects higher total NR partially
offset by increased SG&A expenses, primarily due to increased
sales and marketing related to SUBLOCADE and the launch of
OPVEE.
Q3 2024 operating
profit as reported was $4m (Q3
2023 operating loss: $183m). On an adjusted basis, Q3 2024
operating profit increased 62% to $97m (adjusted Q3
2023: $60m),
excluding exceptional costs and other adjustments
of $93m (Q3 2023: $243m). The increase on
an adjusted basis primarily reflects higher total NR and lower
SG&A expenses.
Net finance expense was $10m in
YTD 2024 (YTD 2023: $4m income) reflecting
a decrease in interest income on lower cash and
investment balances. Q3 2024 net finance expense was $5m (Q3 2023:
$2m income).
Reported tax benefit was $17m
in YTD 2024 and the effective tax rate was 23% (YTD 2023 tax
expense/rate: $9m, 15%). YTD 2024 adjusted tax expense was $53m,
and the adjusted effective tax rate was 23% (YTD 2023 adjusted tax
expense/rate: $44m, 21%). The adjusted results exclude tax benefits
on exceptional items and other adjustments. The movement in the
effective tax rate on adjusted profits was impacted by an increase
in the U.K. corporation tax rate from 23.5% to 25%. The Q3 2024
reported tax benefit was $5m, and the effective tax rate was not
meaningful (Q3 2023: $46m, 25%). The tax expense on Q3 2024
adjusted profits was $20m, and the adjusted effective tax rate was
22%. The tax expense on Q3 2023 adjusted profits amounted to $13m,
for a comparable adjusted effective tax rate of 21%.
Reported net loss in YTD 2024
was $57m and adjusted net income was $182m (YTD 2023 reported net
loss: $52m, adjusted net income: $162m). The 12% increase in net
income on an adjusted basis primarily reflected higher NR partly
offset by an increase in operating expense. Q3 2024 net income on a
reported basis was $4m (Q3 2023: net loss $135m), and net income of
$72m on an adjusted basis excluding the net after-tax impact from
exceptional items and other adjustments (Adjusted Q3 2023: $49m).
Higher Q3 2024 net income on an adjusted basis was primarily due to
an increase in NR.
Diluted (losses) earnings per share were $(0.42) on a reported basis and $1.34 on an adjusted
basis in YTD 2024 (YTD 2023: $(0.38) diluted earnings per share and
$1.14 adjusted diluted earnings per share). In Q3 2024, diluted
losses per share and adjusted diluted earnings per share were $0.03
and $0.54, respectively (Q3 2023: $(0.98) earnings per share on a
diluted basis and $0.34 earnings per share adjusted diluted
basis).
Balance Sheet & Cash
Flow
Cash and investments totaled
$344m at the end of Q3 2024, a decrease of $107m versus the $451m
position at the end of 2023. The decrease was primarily due to the
Group's litigation settlement payments of
$158m and share repurchases of
$122m, partly offset by cash inflow from
operating and investing activities.
Net working capital, defined by
management as inventory plus trade receivables, less trade and
other payables, was negative $386m on September 30, 2024,
versus negative $347m at the end of FY 2023, reflecting increases in the balance of accruals rebates,
discounts and returns due to the timing of rebated
invoicing.
Cash generated from operations in YTD 2024 was $94m (YTD 2023 cash used in
operations: $2m), reflecting ongoing
operating performance partially offset by litigation payments of
$158m. Net cash flow from
operating activities was $41m in YTD 2024 (YTD 2023 cash outflow:
$34m) primarily reflecting cash generated from operations less tax
payments.
Cash inflow from investing activities in
YTD 2024
was $59m (YTD 2023 cash outflow: $104m) reflecting investment
maturities, partially offset by capital expenditures. In the prior
year period, the outflow from investing activities primarily
reflected the Opiant acquisition, net of cash assumed.
Cash outflow from financing activities in
YTD 2024
was $129m (YTD 2023 cash outflow: $25m) primarily reflecting shares
repurchased and canceled. In the prior-year period, the outflow
from financing activities primarily reflected shares repurchased
and canceled and the extinguishment of debt assumed in the Opiant
acquisition.
Principal Risks
Update
The principal risks facing the
Group for the second half of 2024 are expected to be consistent
with those disclosed in the 2023 Annual Report and
Accounts.
Exchange
Rates
The average and period end exchange
rates used for the translation of currencies into U.S. dollars that
have the most significant impacts on the Group's results
were:
|
9 Months to September
30,
2024
|
9 Months to September
30,
2023
|
GB £ period end
|
1.3410
|
1.2125
|
GB £ average rate
|
1.2765
|
1.2444
|
|
|
|
€ Euro period end
|
1.1169
|
1.0503
|
€ Euro average
|
1.0869
|
1.0835
|
Webcast
Details
A live webcast presentation will be
held on October 24, 2024, at 13:00 GMT (8:00 am EDT) hosted by Mark
Crossley, CEO. The details are below. All materials will be
available on the Group's website prior to the event at
www.indivior.com. Please
copy and paste the below web links into your browser.
The webcast link: https://edge.media-server.com/mmc/p/ppm4ske8
Participants may access the
presentation telephonically by registering with the following link
(please cut and paste into your browser):
https://register.vevent.com/register/BId4d5b45a6f3e4291ba42150c1620fc64
(Registrants will have an option to be called
back directly immediately prior to the call or be provided a
call-in # with a unique pin code following their
registration)
For Further
Information
Investor Enquiries
|
Jason Thompson
|
VP, Investor Relations
Indivior PLC
|
+1 804 402 7123
jason.thompson@indivior.com
|
|
Tim Owens
|
Director, Investor Relations
Indivior PLC
|
+1 804 263 3978
timothy.owens@indivior.com
|
Media Enquiries
|
Jonathan Sibun
|
Teneo
U.S. Media Inquiries
|
+44 (0)20 7353 4200
+1 804 594 0836
Indiviormediacontacts@indivior.com
|
Corporate
Website
www.indivior.com
This announcement does not
constitute an offer to sell, or the solicitation of an offer to
subscribe for or otherwise acquire or dispose of shares in the
Group to any person in any jurisdiction to whom it is unlawful to
make such offer or solicitation.
The person responsible for making
this announcement is Kathryn Hudson, Company Secretary.
About
Indivior
Indivior is a global pharmaceutical
company working to help change patients' lives by developing
medicines to treat substance use disorders (SUD), overdose and
serious mental illnesses. Our vision is that all patients around
the world will have access to evidence-based treatment for the
chronic conditions and co-occurring disorders of SUD. Indivior is
dedicated to transforming SUD from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of OUD treatments, Indivior has a pipeline of product
candidates designed to both expand on its heritage in this category
and potentially address other chronic conditions and co-occurring
disorders of SUD. Headquartered in the United States in Richmond,
VA, Indivior employs over 1,000 individuals globally and its
portfolio of products is available in over 30 countries worldwide.
Visit www.indivior.com to learn more. Connect with Indivior on
LinkedIn by visiting www.linkedin.com/company/indivior.
Important Cautionary Note
Regarding Forward-Looking Statements
This announcement contains certain statements that are forward-looking.
Forward-looking statements include, among other things, express and
implied statements regarding: the Indivior Group's financial
guidance including operating and profit margins for 2024 and its
medium- and long-term growth outlook; expected future growth and
expectations for sales levels for particular products (including
without limitation SUBLOCADE); expectations regarding the future
impact of factors that have affected sales in the past; assumptions
regarding expected changes in share and expectations regarding the
extent and impact of competition; assumptions regarding future
exchange rates; strategic priorities, strategies for value
creation, and operational goals; our expectations regarding the
expected final terms, scope, and timing of an expected settlement
related to the provision we recorded regarding claims (i) in the
opioid litigation (including the MDL) brought by certain
municipalities and tribal nations and (ii) by Humana, Centene, and
their affiliates to settle legacy antitrust claims; expected growth
rates, growing normalization of medically assisted treatment for
opioid use disorder, and expanded access to
treatment; and other statements containing the words
"believe," "anticipate," "plan," "expect," "expectations,"
"intend," "estimate," "forecast," "strategy," "target," "guidance,"
"outlook," "potential," "project," "priority," "may," "will,"
"should," "would," "could," "can," "outlook," "guidance," the
negatives thereof, and variations thereon and similar expressions.
By their nature, forward-looking statements involve risks and
uncertainties as they relate to events or circumstances that may or
may not occur in the future.
Actual results may differ
materially from those expressed or implied in these forward-looking
statements due to a number of factors, including: lower than expected future sales of our products; greater than
expected impacts from competition; failure to achieve market
acceptance of OPVEE; unanticipated costs; whether we are able to
identify efficiencies and fund additional investments that we
expect to generate increased revenues, and the timing of such
actions; and litigants who choose to "opt out" of proposed
settlements or with whom we are otherwise unable or unwilling to
agree to final terms. For information about some of the
risks and important factors that could affect our future results
and financial condition, see "Risk Factors" in Indivior's Annual
Report on Form 20-F for the fiscal year 2023 and its other filings
with the U.S. Securities and Exchange Commission.
We have based the forward-looking
statements in this press release on our current expectations and
beliefs concerning future events. Forward-looking statements
contained in this press release apply only at the date of this
press release and, except as required by law, we undertake no
obligation to update or revise any forward-looking statement,
whether due to new information, future developments, or
otherwise.
Unaudited condensed
consolidated interim income statement
|
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
Notes
|
$m
|
$m
|
$m
|
$m
|
Net Revenue
|
2
|
307
|
271
|
889
|
800
|
Cost of sales
|
|
(69)
|
(46)
|
(208)
|
(135)
|
Gross Profit
|
|
238
|
225
|
681
|
665
|
Selling, general and administrative
expenses
|
3
|
(208)
|
(390)
|
(665)
|
(654)
|
Research and development
expenses
|
3
|
(22)
|
(18)
|
(76)
|
(77)
|
Net other operating
income
|
|
(4)
|
-
|
(4)
|
1
|
Operating Profit/(Loss)
|
|
4
|
(183)
|
(64)
|
(65)
|
Finance income
|
4
|
5
|
12
|
18
|
33
|
Finance expense
|
4
|
(10)
|
(10)
|
(28)
|
(29)
|
Net Finance (Expense)/Income
|
|
(5)
|
2
|
(10)
|
4
|
Loss Before Taxation
|
|
(1)
|
(181)
|
(74)
|
(61)
|
Income tax benefit
|
5
|
5
|
46
|
17
|
9
|
Net Income/(Loss)
|
|
4
|
(135)
|
(57)
|
(52)
|
|
|
|
|
|
|
Earnings per ordinary share (in dollars)
|
|
|
|
|
|
Basic earnings/(loss) per
share
|
6
|
$0.03
|
$(0.98)
|
$(0.42)
|
$(0.38)
|
Diluted earnings/(loss) per
share
|
6
|
$0.03
|
$(0.98)
|
$(0.42)
|
$(0.38)
|
Unaudited condensed
consolidated interim statement of comprehensive
income
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Net Income/(Loss)
|
4
|
(135)
|
(57)
|
(52)
|
Other comprehensive loss
|
|
|
|
|
Items that may be reclassified to profit or loss in subsequent
years:
|
|
|
|
|
Foreign currency translation
adjustment, net
|
6
|
(13)
|
4
|
(9)
|
Other comprehensive
income/(loss)
|
6
|
(13)
|
4
|
(9)
|
Total comprehensive income/(loss)
|
10
|
(148)
|
(53)
|
(61)
|
The
notes are an integral part of these unaudited condensed
consolidated interim financial statements.
Unaudited condensed
consolidated interim balance sheet
|
|
Sep 30,
2024
|
Dec 31,
2023 (Retrospectively
adjusted1)
|
|
Notes
|
$m
|
$m
|
ASSETS
|
|
|
|
Non-current assets
|
|
|
|
Intangible assets
|
7
|
190
|
234
|
Property, plant and
equipment
|
|
79
|
82
|
Right-of-use assets
|
|
37
|
33
|
Deferred tax assets
|
5
|
304
|
267
|
Investments
|
8
|
26
|
41
|
Other assets
|
9
|
29
|
28
|
|
|
665
|
685
|
Current assets
|
|
|
|
Inventories
|
|
178
|
142
|
Trade receivables
|
|
251
|
254
|
Other assets
|
9
|
32
|
457
|
Current tax receivable
|
5
|
20
|
-
|
Investments
|
8
|
30
|
94
|
Cash and cash
equivalents
|
|
288
|
316
|
|
|
799
|
1,263
|
Total assets
|
|
1,464
|
1,948
|
|
|
|
|
LIABILITIES
|
|
|
|
Current liabilities
|
|
|
|
Borrowings
|
10
|
(3)
|
(3)
|
Provisions
|
11
|
(48)
|
(408)
|
Other liabilities
|
11
|
(76)
|
(125)
|
Trade and other payables
|
14
|
(815)
|
(743)
|
Lease liabilities
|
|
(11)
|
(9)
|
Current tax liabilities
|
5
|
(9)
|
(18)
|
|
|
(962)
|
(1,306)
|
Non-current liabilities
|
|
|
|
Borrowings
|
10
|
(235)
|
(236)
|
Provisions
|
11
|
(84)
|
(5)
|
Other liabilities
|
11
|
(315)
|
(367)
|
Lease liabilities
|
|
(35)
|
(34)
|
|
|
(669)
|
(642)
|
Total liabilities
|
|
(1,631)
|
(1,948)
|
Net liabilities
|
|
(167)
|
-
|
|
|
|
|
EQUITY
|
|
|
|
Capital and reserves
|
|
|
|
Share capital
|
15
|
65
|
68
|
Share premium
|
|
13
|
11
|
Capital redemption
reserve
|
|
11
|
7
|
Other reserve
|
|
(1,295)
|
(1,295)
|
Foreign currency translation
reserve
|
|
(31)
|
(35)
|
Retained earnings
|
|
1,070
|
1,244
|
Total equity
|
|
(167)
|
-
|
1The unaudited condensed consolidated interim balance sheet as
of December 31, 2023 was retrospectively adjusted during Q1 2024 to
reflect measurement period adjustments related to the November 2023
acquisition of an aseptic manufacturing facility. Refer to Note 1
and Note 17.
The
notes are an integral part of these unaudited condensed
consolidated interim financial statements.
Unaudited condensed
consolidated interim statement of changes in
equity
|
Notes
|
Share
capital
|
Share
premium
|
Capital
redemption reserve
|
Other
reserve
|
Foreign
currency translation reserve
|
Retained
earnings
|
Total
equity
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Balance at January 1, 2023
|
|
68
|
8
|
6
|
(1,295)
|
(39)
|
1,303
|
51
|
Comprehensive income
|
|
|
|
|
|
|
|
|
Net loss
|
|
-
|
-
|
-
|
-
|
-
|
(52)
|
(52)
|
Other comprehensive loss
|
|
-
|
-
|
-
|
-
|
(9)
|
-
|
(9)
|
Total comprehensive loss
|
|
-
|
-
|
-
|
-
|
(9)
|
(52)
|
(61)
|
Transactions recognized directly in equity
|
|
|
|
|
|
|
|
|
Shares issued
|
|
1
|
3
|
-
|
-
|
-
|
-
|
4
|
Share-based plans
|
|
-
|
-
|
-
|
-
|
-
|
16
|
16
|
Settlement of tax on equity
awards
|
|
-
|
-
|
-
|
-
|
-
|
(22)
|
(22)
|
Shares repurchased and
canceled
|
|
-
|
-
|
-
|
-
|
-
|
(11)
|
(11)
|
Transfer to share repurchase
liability
|
|
-
|
-
|
-
|
-
|
-
|
9
|
9
|
Taxation on share-based
plans
|
|
-
|
-
|
-
|
-
|
-
|
(10)
|
(10)
|
Balance at September 30, 2023
|
|
69
|
11
|
6
|
(1,295)
|
(48)
|
1,233
|
(24)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2024
|
|
68
|
11
|
7
|
(1,295)
|
(35)
|
1,244
|
-
|
Comprehensive income
|
|
|
|
|
|
|
|
|
Net loss
|
|
-
|
-
|
-
|
-
|
-
|
(57)
|
(57)
|
Other comprehensive
income
|
|
-
|
-
|
-
|
-
|
4
|
-
|
4
|
Total comprehensive income/(loss)
|
|
-
|
-
|
-
|
-
|
4
|
(57)
|
(53)
|
Transactions recognized directly in equity
|
|
|
|
|
|
|
|
|
Shares issued
|
|
1
|
2
|
-
|
-
|
-
|
(1)
|
2
|
Share-based plans
|
|
-
|
-
|
-
|
-
|
-
|
18
|
18
|
Settlement of tax on equity
awards
|
|
-
|
-
|
-
|
-
|
-
|
(20)
|
(20)
|
Shares repurchased and
canceled
|
|
(4)
|
-
|
4
|
-
|
-
|
(122)
|
(122)
|
Transfer to share repurchase
liability
|
|
-
|
-
|
-
|
-
|
-
|
(16)
|
(16)
|
Transfer from share repurchase
liability
|
|
-
|
-
|
-
|
-
|
-
|
22
|
22
|
Taxation on share-based
plans
|
|
-
|
-
|
-
|
-
|
-
|
2
|
2
|
Balance at September 30, 2024
|
|
65
|
13
|
11
|
(1,295)
|
(31)
|
1,070
|
(167)
|
The
notes are an integral part of these unaudited condensed
consolidated interim financial statements.
Unaudited condensed
consolidated interim cash flow statement
|
2024
|
2023
|
For the nine months ended September 30
|
$m
|
$m
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
Operating loss
|
(64)
|
(65)
|
Depreciation and amortization of
property, plant and equipment and intangible assets
|
18
|
13
|
Impairment of property, plant and
equipment and intangible assets
|
45
|
-
|
Depreciation of right-of-use
assets
|
6
|
6
|
Share-based payments
|
18
|
16
|
Settlement of tax on employee
awards
|
(20)
|
(22)
|
Impact from foreign exchange
movements
|
2
|
(11)
|
Unrealized loss on equity
investment
|
6
|
-
|
Decrease/(increase) in trade
receivables
|
3
|
(26)
|
Decrease/(increase) in current and
non-current other assets2
|
422
|
(50)
|
Increase in
inventories1
|
(36)
|
(26)
|
Increase in trade and other
payables
|
72
|
91
|
(Decrease)/increase in provisions
and other liabilities2 3
|
(378)
|
72
|
Cash generated from/(used in) operations
|
94
|
(2)
|
Interest paid
|
(25)
|
(24)
|
Interest received
|
18
|
32
|
Taxes paid
|
(46)
|
(40)
|
Net cash inflow/(outflow) from operating
activities
|
41
|
(34)
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
Acquisition of assets, net of cash
acquired
|
-
|
(124)
|
Purchase of property, plant and
equipment
|
(13)
|
(4)
|
Purchase of investments
|
(14)
|
(40)
|
Maturity of investments
|
88
|
95
|
Purchase of intangible
assets
|
(2)
|
(31)
|
Net cash inflow/(outflow) from investing
activities
|
59
|
(104)
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
Repayment of borrowings
|
(2)
|
(12)
|
Principal elements of lease
payments
|
(7)
|
(6)
|
Shares repurchased and
canceled
|
(122)
|
(11)
|
Proceeds from the issuance of
ordinary shares
|
2
|
4
|
Net cash outflow from financing activities
|
(129)
|
(25)
|
|
|
|
Exchange difference on cash and
cash equivalents
|
1
|
(1)
|
|
|
|
Net decrease in cash and cash equivalents
|
(28)
|
(164)
|
Cash and cash equivalents at
beginning of the period
|
316
|
774
|
Cash and cash equivalents at end of the
period
|
288
|
610
|
1 Discontinuation of PERSERIS sales and marketing (refer to Note
18) resulted in impairment of inventory.
2Changes in the line items current and non-current other assets
and provisions and other liabilities for YTD 2024 include the
settlement of the Antitrust MDL liabilities (refer to Note 13) and
release of related escrow funding following final court
approval.
3Changes in the line item provisions and other liabilities for
YTD 2024 also include litigation settlement payments totaling $158m
(YTD 2023: $177m). $3m of interest paid on the DOJ Resolution in
YTD 2024 has been recorded in the interest paid line item (YTD
2023: $3m).
The
notes are an integral part of these unaudited condensed
consolidated interim financial statements.
Notes to the unaudited
condensed consolidated interim financial
statements
1. BASIS OF PREPARATION AND ACCOUNTING
POLICIES
Indivior PLC (the 'Company') is a
public limited company incorporated on September 26, 2014 and
domiciled in the United Kingdom. In these unaudited condensed
consolidated interim financial statements ('Condensed Financial
Statements'), reference to the 'Group' means the Company and all
its subsidiaries.
The Condensed Financial Statements
have been prepared in accordance with U.K. adopted International
Accounting Standard 34, Interim
Financial Reporting. The Condensed Financial Statements have
been reviewed and are unaudited and do not include all the
information and disclosures required in the annual financial
statements. Therefore, the Condensed Financial Statements should be
read in conjunction with the Group's Annual Report and Accounts for
the year ended December 31, 2023, which were prepared in
accordance with U.K. adopted International Accounting Standards and
in conformity with the Companies Act 2006
as applicable to companies reporting under those standards. These
Condensed Financial Statements were approved for issue on
October 23, 2024.
In preparing these
Condensed Financial Statements, the significant judgments made by
management in applying the Group's accounting policies and the key
sources of estimation uncertainty were the same as those that
applied to the consolidated financial statements for the year ended
December 31, 2023, except for changes in estimates that
are required in determining the provision for income taxes and
resolution of uncertainties for certain contingent
liabilities.
In 2023, the Group acquired an
aseptic manufacturing facility which was accounted for as a
business combination. As the acquisition was completed in late
2023, a provisional fair value of assets acquired and liabilities
assumed at the date of acquisition was disclosed in the
consolidated financial statements for the year ended December 31,
2023. In Q1 2024, based on new information obtained about facts and
circumstances that existed as of the acquisition date, the Group
adjusted the provisional fair values for acquired property, plant
and equipment and the assumed onerous contract provision, with an
adjustment to goodwill equal to the change in the net assets
acquired. These measurement period adjustments are reflected in the
comparative period presented in the Condensed Financial Statements
in accordance with IFRS 3 Business Combinations. The effect on
depreciation and other changes in the related balances from the
acquisition date to December 31, 2023 was immaterial. Refer to Note
17 for a reconciliation of the previously reported provisional fair
value of net assets acquired to the adjusted provisional fair
value.
Effective January 1, 2024, the
functional currency of Indivior U.K. Limited, one of the Group's
significant subsidiaries, changed from U.K. pound sterling to U.S.
dollar (USD). This was the result of a change in the primary
economic environment in which Indivior U.K. Limited operates,
driven by growth of USD-denominated net revenue combined with an
increase in USD-denominated costs and culminating with a shift in
investing activities. The Group determined the USD had become the
dominant currency from January 2024.
The Directors have assessed the
Group's ability to maintain sufficient liquidity to fund its
operations, fulfill financial and compliance obligations as set out
in Note 11, and comply with the minimum liquidity covenant in the
Group's term loan for the period to March 2026 (the going concern
period). A base case model was produced reflecting:
• Board
reviewed financial plans for the period; and
• settlement of
liabilities and provisions in line with contractual
terms.
The Directors also assessed a
'severe but plausible' downside scenario which included the
following key changes to the base case within the going concern
period:
• the risk that
SUBLOCADE will not meet revenue growth expectations by modeling a
15% decline on forecasts;
• an
accelerated decline in U.S. SUBOXONE Film net revenue to generic
analogues; and
• a further
decline in rest of world sublingual product net
revenues.
Under both the base case and the
downside scenario and acknowledging the Group's net liability
position, sufficient liquidity exists and is generated from
operations such that all business and covenant requirements are met
for the going concern period. Additionally, no material legal cases
are expected to come to trial during the going concern period. As a
result of the analysis described above, the Directors reasonably
expect the Group to have adequate resources to continue in
operational existence for at least one year from the approval of
these Condensed Financial Statements and therefore consider the
going concern basis to be appropriate for the accounting and
preparation of these Condensed Financial Statements.
The financial information contained
in this document does not constitute statutory accounts as defined
in section 434 and 435 of the Companies Act 2006. The Group's
statutory financial statements for the year ended December 31,
2023, were approved by the Board of Directors on March 5, 2024 and
were delivered to the Registrar of Companies. The auditor's report
on those accounts was unqualified, did not contain an emphasis of
matter paragraph and did not contain any statement under
section 498 of the Companies Act 2006.
2. SEGMENT INFORMATION
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 and allocates resources on a functional basis between
Commercial, Supply, Research and Development, and other Group
functions. Financial results are reviewed on a consolidated basis
for evaluating financial performance and allocating resources.
Accordingly, the Group operates in a single reportable
segment.
Net revenue
Revenue is attributed
geographically based on the country where the sale originates. The
following table represents net revenue by country:
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
United States
|
261
|
227
|
755
|
662
|
Rest of World
|
46
|
44
|
134
|
138
|
Total
|
307
|
271
|
889
|
800
|
On a disaggregated basis, the
Group's net revenue by major product line:
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
SUBLOCADE®
|
191
|
167
|
562
|
454
|
OPVEE®1
|
15
|
-
|
15
|
-
|
Sublingual/other
|
93
|
93
|
281
|
316
|
PERSERIS®2
|
8
|
11
|
31
|
30
|
Total
|
307
|
271
|
889
|
800
|
1Net revenue for OPVEE® consists of two 100,000 unit product
orders from the U.S. Biomedical Advancement Research and
Development Authority (BARDA).
2 Marketing and promotion for PERSERIS® have been discontinued.
Refer to Note 18.
Non-current assets
The following
table represents 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, investments, and other
assets.
|
Sep 30,
2024
|
Dec 31,
2023 (Retrospectively
adjusted1)
|
|
$m
|
$m
|
United States
|
203
|
209
|
Rest of World
|
158
|
209
|
Total
|
361
|
418
|
1 The non-current asset balance in the United States as of
December 31, 2023 was retrospectively adjusted in Q1 2024 to
reflect measurement period adjustments of $2m to property, plant
and equipment and $3m to intangible assets related to the November
2023 acquisition of an aseptic manufacturing facility. Refer to
Note 17.
3.
OPERATING EXPENSES
The table below sets out selected
operating costs and expense information:
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Research and development expenses
|
(22)
|
(18)
|
(76)
|
(77)
|
|
|
|
|
|
Selling and marketing
expenses
|
(54)
|
(57)
|
(186)
|
(168)
|
Administrative and general
expenses1
|
(154)
|
(333)
|
(479)
|
(486)
|
Selling, general, and administrative
expenses
|
(208)
|
(390)
|
(665)
|
(654)
|
|
|
|
|
|
Depreciation and
amortization2
|
(3)
|
(3)
|
(11)
|
(11)
|
1 Administrative and general expenses in the 2024 periods
include legal settlement costs (see notes
11 and 13), impacts related to discontinuation of sales and
marketing for PERSERIS and the impairment of a product in
development (refer to note 7). Expenses in the 2023 periods include
legal settlement costs and the acquisition of
Opiant Pharmaceuticals, Inc. ("Opiant", refer to note
16).
2 Depreciation and amortization expense represents amounts
included in research and development and selling, general and
administrative expenses. In addition, depreciation and amortization
expense in YTD 2024 of $30m (YTD 2023: $8m) and Q3 2024 of $3m (Q3
2023: $3m)
for intangible assets, certain plant and equipment
and right-of-use assets is included within cost of sales. YTD 2024
includes $17m related to the impairment of the Perseris marketed
product intangible and plant and equipment (refer to Note
18).
4. NET FINANCE
(EXPENSE)/INCOME
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Finance income
|
|
|
|
|
Interest income on cash and cash
equivalents/investments
|
5
|
12
|
17
|
33
|
Other finance income
|
-
|
-
|
1
|
-
|
Total finance income
|
5
|
12
|
18
|
33
|
Finance expense
|
|
|
|
|
Interest expense on
borrowings
|
(7)
|
(8)
|
(19)
|
(21)
|
Interest expense on lease
liabilities
|
(1)
|
(1)
|
(2)
|
(2)
|
Interest expense on legal matters,
including the effect of discounting
|
(1)
|
(1)
|
(4)
|
(5)
|
Other interest expense
|
(1)
|
-
|
(3)
|
(1)
|
Total finance expense
|
(10)
|
(10)
|
(28)
|
(29)
|
Net finance (expense)/income
|
(5)
|
2
|
(10)
|
4
|
5. TAXATION
The Group calculates tax expense
for interim periods using the expected full year rates, considering
the pre-tax income and statutory rates for each jurisdiction. To
the extent practicable, a separate estimated average annual
effective income tax rate is determined for each taxing
jurisdiction and applied individually to the interim period pre-tax
income of each jurisdiction. Similarly, if different income tax
rates apply to different categories of income (such as capital
gains or income earned in particular industries), to the extent
practicable a separate rate is applied to each individual category
of interim period pre-tax income. The resulting expense is
allocated between current and deferred taxes based on actual
movement in deferred tax for the quarter, with the balance recorded
to the current tax accounts.
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Income tax benefit
|
5
|
46
|
17
|
9
|
Effective tax rate (%)
|
nm
|
25
%
|
23 %
|
15
%
|
In the nine months ended
September 30, 2024, the effective tax rate benefit is higher
as the amount of disallowed expenses are lower than in the prior
year. The prior year included higher disallowed executive
compensation relating to the U.S. listing and certain litigation
expenses.
|
Sep 30,
2024
|
Dec 31,
2023 (Retrospectively
adjusted1)
|
|
$m
|
$m
|
Current tax receivable
|
20
|
-
|
Current tax liabilities
|
(9)
|
(18)
|
Deferred tax assets
|
304
|
267
|
1 The deferred tax assets balance as of December 31, 2023 has
been retrospectively adjusted to reflect a measurement period
adjustment related to the November 2023 acquisition of an aseptic
manufacturing facility. Refer to Note 17.
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 September 30, 2024, the Group's net deferred tax assets of
$304m relate primarily to net operating loss carryforwards,
inventory costs capitalized for tax purposes, and litigation
liabilities. Recognition of deferred tax assets 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 net revenues. These forecasts are subject to similar
uncertainties to those assessments. This is reviewed each quarter
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 realizable, management
have concluded full recognition of deferred tax assets to be
appropriate and do not believe a significant risk of material
change in their assessment exists in the next 12 months from the
balance sheet date.
Other tax matters
The Group is subject to Pillar Two
legislation effective January 1, 2024. As such, the Group performed
an assessment of the potential exposure to Pillar Two income taxes
including modeling of adjusted accounting data for the period ended
December 31, 2023 and a review of forecasts for the year ended
December 31, 2024. Based on the assessment, the Group did not
record any current tax liability related to Pillar Two. The Group
has applied the recent amendment to IAS 12 which provides temporary
relief to the recognition of deferred taxes relating to top-up
income taxes.
As a multinational group, tax
uncertainties remain in relation to Group financing, intercompany
pricing, the location of taxable operations, and certain
non-recurring costs. Management have concluded tax provisions made
to be appropriate and do not believe a significant risk of material
change to uncertain tax positions exists in the next 12 months from
the balance sheet date. Including matters under audit, an estimate
of reasonably possible additional tax liabilities and interest that
could arise in later periods on resolution of these uncertainties
is in the range from nil to $58m.
6. EARNINGS PER
SHARE
The table below sets out basic and
diluted earnings (loss) per share for each period:
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$
|
$
|
$
|
$
|
Basic earnings/(loss) per
share
|
$0.03
|
$(0.98)
|
$(0.42)
|
$(0.38)
|
Diluted earnings/(loss) per
share
|
$0.03
|
$(0.98)
|
$(0.42)
|
$(0.38)
|
Weighted average number of shares
The weighted average number of
ordinary shares outstanding (on a basic basis) for YTD 2024 includes the favorable
impact of 8,407k ordinary shares
repurchased in YTD 2024 and 1,413k ordinary shares
repurchased from April to December 2023. See Note 15 for further
discussion. Conditional awards of 1,700k and 1,761k were granted under the Group's Long-Term
Incentive Plan in YTD 2024 and YTD 2023, respectively.
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
thousands
|
thousands
|
thousands
|
thousands
|
Weighted average shares on a basic
basis
|
132,103
|
137,694
|
134,222
|
137,299
|
Dilution from share awards and
options
|
1,449
|
5,502
|
1,625
|
5,040
|
Weighted average shares on a
diluted basis
|
133,552
|
143,196
|
135,847
|
142,339
|
7. INTANGIBLE
ASSETS
|
Sep 30,
2024
|
Dec 31,
2023 (Retrospectively
adjusted1)
|
Intangible assets, net of accumulated amortization and
impairment
|
$m
|
$m
|
Products in development
|
51
|
79
|
Marketed products
|
135
|
150
|
Goodwill
|
2
|
2
|
Software
|
2
|
3
|
Total
|
190
|
234
|
1 The goodwill balance as of December 31, 2023 was
retrospectively adjusted to reflect measurement period adjustments
related to the November 2023 acquisition of an aseptic
manufacturing facility. Refer to Note 17.
The decrease in products in
development reflects the impairment of AEF0117 for cannabis use
disorder ($28m), as the clinical Phase 2B study announced in
September 2024 did not demonstrate the anticipated
results.
The $15m decrease in marketed
products relates to the discontinuation of PERSERIS sales and
marketing (refer to note 18), which resulted in impairment of the
related intangible asset of $9m, and ongoing amortization of other
products.
8.
INVESTMENTS
|
Sep 30,
2024
|
Dec
31,
2023
|
Current and non-current investments
|
$m
|
$m
|
Equity securities at
FVPL
|
4
|
10
|
Debt securities held at amortized
cost
|
26
|
84
|
Total investments, current
|
30
|
94
|
Debt securities held at amortized
cost
|
26
|
41
|
Total investments, non-current
|
26
|
41
|
Total
|
56
|
135
|
The Group's investments in debt and
equity securities do not create significant credit risk, liquidity
risk, or interest rate risk. Debt
securities held at amortized cost consist of investment-grade debt.
As of September 30, 2024, expected
credit losses for the Group's investments held at amortized cost
are immaterial.
Fair value hierarchy
Fair value is the price that would
be received to sell an asset or transfer a liability in an orderly
transaction between market participants at the measurement date.
The different levels have been defined as follows:
• Level 1: Quoted prices
(unadjusted) in active markets for identical assets or
liabilities
• Level 2: Inputs other than quoted
prices included within Level 1 that are observable for the asset or
liability, either directly or indirectly
• Level 3: Unobservable inputs for
the asset or liability
The Group's only financial
instruments which are measured at fair value are equity securities
at FVPL. The fair value of equity securities at FVPL is based on
quoted market prices on the measurement date. The following table
categorizes the Group's financial assets measured at fair value by
valuation methodology used in determining their fair
value:
At
September 30, 2024
|
Level
1
$m
|
Level
2
$m
|
Level
3
$m
|
Total
$m
|
Equity securities at
FVPL
|
4
|
-
|
-
|
4
|
At December 31, 2023
|
Level
1
$m
|
Level
2
$m
|
Level
3
$m
|
Total
$m
|
Equity securities at
FVPL
|
10
|
-
|
-
|
10
|
The decrease in equity securities
at FVPL reflects the change in market price of Aelis Farma shares
from the September 2024 announcement that study results for their
cannabis use disorder pipeline drug did not demonstrate the
anticipated results.
The Group also has certain
financial instruments which are not measured at fair value. The
carrying value of cash and cash equivalents, trade receivables,
other assets, and trade and other payables is assumed to
approximate fair value due to their short-term nature. At
September 30, 2024, the carrying value of investments held at
amortized cost approximated the fair value. The fair value of
investments held at amortized cost was calculated based on quoted
market prices which would be classified as Level 1 in the fair
value hierarchy above.
9. CURRENT AND NON-CURRENT
OTHER ASSETS
|
Sep 30,
2024
|
Dec
31,
2023
|
Current and non-current other assets
|
$m
|
$m
|
Current prepaid expenses
|
18
|
23
|
Other current assets
|
14
|
434
|
Total other current assets
|
32
|
457
|
Non-current prepaid
expenses
|
17
|
19
|
Other non-current assets
|
12
|
9
|
Total other non-current assets
|
29
|
28
|
Total
|
61
|
485
|
The decrease in other current
assets primarily relates to release of escrow funding of $415m for
the Antitrust MDL (direct purchaser and end payor class
settlements) since the courts provided final approval of the
settlements during Q1 2024. Refer to Note 13. Long-term prepaid
expenses primarily relate to payments for contract
manufacturing capacity.
10. FINANCIAL LIABILITIES -
BORROWINGS
The table below sets out the
current and non-current portion obligation of the Group's term
loan:
|
Sep 30,
2024
|
Dec
31,
2023
|
Term loan
|
$m
|
$m
|
Term loan - current
|
(3)
|
(3)
|
Term loan - non-current
|
(235)
|
(236)
|
Total term loan
|
(238)
|
(239)
|
*Total term loan borrowings reflect
the principal amount drawn including debt issuance costs of $4m (FY 2023:
$5m).
At September 30, 2024, the
term loan fair value was approximately 100% (FY
2023: 100%) of par value. The key terms of this loan in
effect at September 30, 2024, are as follows:
|
|
Currency
|
Nominal interest
margin
|
Maturity
|
Required annual
repayments
|
Minimum
liquidity
|
Term loan facility
|
|
USD
|
SOFR +
0.11% + 5.25%
|
2026
|
1%
|
Larger
of $100m or 50% of loan balance
|
The term loan amounting to $242m
(FY 2023: $244m) is secured against the
assets of certain subsidiaries of the Group in the form of
guarantees issued by respective subsidiaries.
• Nominal interest margin is
monthly USD SOFR plus 0.11%, subject to a floor of 0.75%, plus a
credit spread adjustment of 5.25%.
• There are no revolving
credit commitments.
11. PROVISIONS AND OTHER
LIABILITIES
Provisions
|
|
|
Total
|
|
|
Total
|
|
Current
|
Non-Current
|
Sep 30,
2024
|
Current
|
Non-Current
|
Dec 31, 2023
(Retrospectively
adjusted1)
|
Current and non-current provisions
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Multi-district antitrust class and
state claims
|
-
|
-
|
-
|
(385)
|
-
|
(385)
|
Other antitrust matters
|
(20)
|
(19)
|
(39)
|
-
|
-
|
-
|
Opioid litigation
|
(15)
|
(63)
|
(78)
|
-
|
-
|
-
|
Onerous contracts
|
(13)
|
-
|
(13)
|
(19)
|
(3)
|
(22)
|
False claims allegations
|
-
|
-
|
-
|
(4)
|
-
|
(4)
|
Other
|
-
|
(2)
|
(2)
|
-
|
(2)
|
(2)
|
Total provisions
|
(48)
|
(84)
|
(132)
|
(408)
|
(5)
|
(413)
|
1 The provision for onerous contracts as of December 31, 2023
was retrospectively adjusted during the first quarter of 2024 to
reflect a measurement period adjustment related to the November
2023 acquisition of an aseptic manufacturing facility. Refer to
Note 17.
Multi-district antitrust class and state
claims
Settlement agreements were entered
into during 2023 with three plaintiff classes to fully resolve
certain multi-district antitrust claims. Indivior has no further
obligations related to these matters.
Other antitrust matters
The provision of $39m at September
30, 2024 reflects the present value of the agreed amount in an
expected settlement of the last remaining antitrust litigation with
(i) Humana, Inc. and certain of its affiliates (collectively,
"Humana") and (ii) Centene Corporation, Wellcare Healthcare Plans,
Inc., New York Quality Healthcare Corp. (d/b/a Fidelis Care), and
Health Net, LLC (collectively, "Centene"). The $39m provision
reflects the net present value (NPV) at the risk-free rate of the
agreed amounts to be paid in 2024 and 2025. The parties to the
settlement still must negotiate material terms and conditions of
the final settlement agreement, which Indivior expects to resolve
shortly (See Note 13). Final settlement, if reached, would resolve
all of the Group's remaining legacy antitrust litigation, including
all claims in the Kentucky and Pennsylvania state court actions
filed by Humana, and all claims in the Virginia state court action
filed by Centene.
Opioid litigation
The provision of $78m at September
30, 2024 reflects the present value of the agreed amount in a
preliminary settlement between Indivior, the plaintiffs' executive
committee and certain state attorneys general covering certain
opioid litigation (including cases in the Opioid MDL) brought by
municipalities and tribes. The outflow of resources is expected to
occur over five years. The parties still must negotiate material
terms and conditions of the final settlement agreement, including
structure, and scope of releases. The provision is
measured using a risk free rate and will be remeasured at a
risk-adjusted rate upon reaching a final settlement agreement, at
which time the Group expects to make a further disclosure.
Refer to Note 13.
Onerous contracts
In November 2023, the Group
acquired a business consisting of a manufacturing facility,
workforce, and supply contracts. The facility is obligated to
fulfill contracts that existed pre-acquisition for which the
expected costs are in excess of the consideration expected to be
received. The Group recorded a provision for these onerous
contracts in the allocation of purchase price, with a balance at
the end of the quarter of $13m (FY 2023: $22m). During the quarter, net operating losses
attributable to the contracts of $2m were recorded against the
provision. Refer to Note 17. Manufacturing under the onerous
contracts is expected to be completed during Q1 2025 and the
provision is recorded at its discounted value, using a market rate
at the time of the transaction determined to be 7.6%.
False Claims Act allegations
During the quarter, the Group
released a provision of $4m pertaining to an
outstanding False Claims Act allegation considering an updated
probability assessment at this early stage of litigation. No
estimate of possible loss can be made at this time. See Note
13.
Other
Other provisions of $2m (FY 2023:
$2m) represent retirement benefit costs which are not expected to
be settled within one year.
Other liabilities
|
|
|
Total
|
|
|
Total
|
|
Current
|
Non-Current
|
Sep 30,
2024
|
Current
|
Non-Current
|
Dec 31,
2023
|
Current and non-current other liabilities
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
DOJ resolution
|
(52)
|
(295)
|
(347)
|
(53)
|
(344)
|
(397)
|
Multi-district antitrust class and
state claims
|
-
|
-
|
-
|
(30)
|
-
|
(30)
|
Other antitrust matters
|
-
|
-
|
-
|
-
|
-
|
-
|
Intellectual property related
matters
|
-
|
-
|
-
|
(11)
|
-
|
(11)
|
RB indemnity settlement
|
(8)
|
(7)
|
(15)
|
(8)
|
(15)
|
(23)
|
Share repurchase
|
(16)
|
-
|
(16)
|
(23)
|
-
|
(23)
|
Other
|
-
|
(13)
|
(13)
|
-
|
(8)
|
(8)
|
Total other liabilities
|
(76)
|
(315)
|
(391)
|
(125)
|
(367)
|
(492)
|
DOJ Resolution Agreement
In July 2020, the Group settled
criminal and civil liability with the United States Department of
Justice (DOJ), the U.S. Federal Trade Commission (FTC), and U.S.
state attorneys general. Pursuant to the resolution agreement,
aggregate payments of $263m (including interest) have been made
through September 30, 2024, including a payment of $53m in January
2024. Annual installments of $50m plus interest are due every
January 15 from 2025 to 2027, with the final installment of $200m
due in December 2027. The Group has the option to prepay. Interest
accrues at 1.25% on certain portions of the
resolution and will be paid with the installment payments. For
non-interest-bearing portions, the liability has been recorded at
the net present value based on timing of the estimated payments
using a discount rate equal to the interest rate on the
interest-bearing portions. In YTD 2024, the Group recorded interest
expense totaling $3m (YTD 2023: $4m).
Multi-district antitrust class and state
claims
Settlement agreements were entered
into during 2023 with three plaintiff classes to fully resolve
certain multi-district antitrust claims. Indivior has no further
obligations related to this matter.
Other antitrust matters
Certain antitrust cases filed in
Virginia state court by Health Care Service Corp. (HCSC), Blue
Cross Blue Shield of Massachusetts, Blue Cross Blue Shield of
Florida, Molina, and Aetna were settled and paid during the third
quarter by agreement of the parties for $85m and mutual releases of
claims and counterclaims. Refer to note 13.
IP
related matters
Other liabilities for intellectual
property related matters relate to the settlement of litigation
with DRL in June 2022. Under the settlement agreement, the Group
made a final payment to DRL of $12m during Q1 2024 and has no
further obligations related to this matter.
RB
indemnity settlement
Under the RB indemnity settlement,
the Group has paid $34m of the $50m settlement agreement through
September 30, 2024 including $8m paid in January 2024.
Remaining annual installment payments of $8m are due in January
2025 and 2026. The Group carries a liability totaling $15m (FY
2023: $23m) related to this settlement. This liability has been
recorded at the net present value, using a market interest rate at
the time of the settlement determined to be 3.75%, considering the
timing of payments and other factors.
Share repurchase
In August 2024, the Group commenced
a share repurchase program of $100m. As of September 30, 2024,
the liability of $16m represents the amount to be spent under the
program through October 25, 2024, after which date the Company has
the ability to modify or terminate the program. As of December 31,
2023, the current liability of $23m represented the amount to be
spent under the previous share repurchase program through February
23, 2024.
Other
Other liabilities primarily
represent employee related liabilities which are non-current as of
September 30, 2024.
12. 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. Where liabilities related
to these matters are determined to be possible, they represent
contingent liabilities. Except for those matters discussed in Note
13 under "Civil Opioid Litigation" and "Antitrust Litigation and
Consumer Protection," for which a provision has been recognized,
Note 13 sets out the details for legal and other disputes which the
Group has assessed as contingent liabilities. Where the Group
believes it is possible to reasonably estimate a range for the
contingent liability, this has been disclosed.
13. LEGAL PROCEEDINGS
Certain ongoing legal proceedings
or threats of legal proceedings to which the Group is a party, but
in which the Group believes the possibility of an adverse impact is
remote, are not discussed in this Note.
Antitrust Litigation and Consumer Protection
•
Beginning in
2020, cases 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. were filed
in the Circuit Court for the County of Roanoke, Virginia.
See Health Care Services Corp. v.
Indivior Inc., No. CL20-1474 (Lead Case) (Va. Cir. Ct.)
(Roanoke Cnty) (collectively, the "HCSC Consolidated
Litigation"). In July 2023, Indivior Inc.,
BCBSM, Inc., and HMO Minnesota agreed to mutual releases and
settlement. The remaining plaintiffs 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. On
July 8, 2024, the parties reached an agreement to settle all
remaining claims and counterclaims in the HCSC Consolidated
Litigation for $85m.
• The Group
reached agreement on the amount of a potential settlement
("Humana/Centene Settlement") with Humana, Inc. and certain of its
affiliated entities (collectively, the "Humana Entities") and
Centene Corporation, Wellcare Healthcare Plans, Inc., New York
Healthcare Corp (d/b/a Fidels Care) and Healthnet, LLC
(collectively, the "Centene Entities"). The Group has recorded a
related provision of $39m,
reflecting the net present value (NPV) of the agreed amount (See
Note 11). The parties, however, still must negotiate material terms
and conditions of the final settlement agreement, including the
structure and scope of the release.
â—¦
As background, Humana, Inc. filed a complaint in
state court in Kentucky on August 20, 2021 with claims
substantially similar to those asserted by other end payors in the
HCSC Consolidated Litigation. See
Humana Inc. v. Indivior Inc., No. 21-CI-004833 (Ky. Cir.
Ct.) (Jefferson Cnty). The court lifted a stay on October 30, 2023.
Indivior moved to dismiss the complaint in February 2024. A hearing
on Indivior's motion to dismiss has been set for December 9, 2024.
This action would be dismissed if the Humana/Centene Settlement is
finalized.
â—¦ As further
background, the Centene Entities filed a complaint on January 13,
2023 in the Circuit Court for the County of Roanoke, Virginia
alleging similar claims as in the HCSC Consolidated Litigation.
See Centene Corp. v. Indivior
Inc., No. CL23000054-00 (Va. Cir. Ct.) (Roanoke Cnty). This
action would be dismissed if the Humana/Centene Settlement is
finalized.
â—¦
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 included approximately 79 entities, most of which
appeared to be insurance companies or other providers of health
benefits plans. The claims of all plaintiffs in the Carefirst action except the Humana
Entities were resolved in connection with final approval of the end
payor settlement in the Antitrust MDL, and accordingly dismissed on
February 14, 2024. The claims of the Humana Entities in the
Carefirst action remain
pending, but would be dismissed if the Humana/Centene Settlement is
finalized.
• As previously
disclosed in 2023, Indivior Inc. settled claims of all plaintiff
groups in the company's antitrust multi-district litigation
("Antitrust MDL") namely, (i) 41 states and the
District of Columbia (the "States"), (ii) end payors, and (iii)
direct purchasers (collectively, the "Plaintiffs"). Indivior
Inc. reached a settlement with the States for $103m on June 1,
2023. Indivior Inc. entered into a settlement agreement with the
end payor class for $30m on August 14, 2023 and received final
court approval on December 5, 2023. On October 22, 2023, Indivior
Inc. entered into a settlement agreement with the remaining direct
purchaser class for $385m, which received final court approval on
February 27, 2024.
Civil Opioid Litigation
• The Group has
been named as a defendant in more than 400 civil lawsuits alleging
that manufacturers, distributors, and retailers of opioids engaged
in a longstanding practice to market opioids as safe and effective
for the treatment of long-term chronic pain to increase the market
for opioids and their own market shares for opioids, or alleging
individual personal injury claims. Most of these cases have been
consolidated and are pending in a federal multi-district litigation
in the U.S. District Court for the Northern District of Ohio.
See In re National Prescription
Opiate Litigation, MDL No. 2804 (N.D. Ohio) (the "Opioid
MDL"). Nearly two-thirds of the cases in the Opioid MDL were filed
by cities and counties, while nearly one-third of the cases were
filed by individual plaintiffs, most of whom assert claims relating
to neonatal abstinence syndrome ("NAS"). Litigation against the
Group in the Opioid MDL is stayed.
• Pursuant to
mediation, the Group, the Plaintiffs' Executive Committee in the
Opioid MDL, Tribal Leadership Committee, and certain state
attorneys general reached agreement on the amount of a potential
settlement. The Group has recorded a related provision of
$78m, reflecting the net present
value (NPV) of the agreed amount (See Note 11). The parties,
however, still must negotiate material terms and conditions of the
final settlement agreement, including the structure and scope of
the release. The proposed settlement does not include private
plaintiffs.
• Separately, Indivior Inc. was named as one of numerous
defendants in civil opioid cases that are not part of the Opioid
MDL:
â—¦ Indivior was named as one of numerous defendants in various
other federal and state court cases that are not in the Opioid MDL
and were brought by municipalities. These cases include, for
example, 35 actions filed in New York state court that were removed
to federal court, as well as cases filed in federal district courts
sitting in Alabama, Florida, Georgia, and New Mexico. On motion of
the plaintiffs, the New York cases were remanded back to state
court. The plaintiffs in the case filed in the Northern District of
Alabama voluntarily dismissed their complaint, subject to certain
tolling agreements. The various other federal actions currently are
stayed, except Indivior moved to dismiss the complaint in
San Miguel Hospital Corp. d/b/a
Alta Vista Regional Medical Center v. Johnson & Johnson, et
al., No. 1:23-cv-00903 (D.N.M.) in May 2024. Indivior's
motion to dismiss remains pending.
â—¦ Indivior Inc. was named as a defendant in five individual
complaints filed in West Virginia state court that were transferred
to West Virginia's Mass Litigation Panel. See In re Opioid
Litigation, No. 22-C-9000 NAS (W.V.
Kanawha Cnty. Cir. Ct.) ("WV MLP Action"). All five of Indivior
Inc.'s cases in the WV MLP Action involve claims related to NAS.
Indivior Inc. moved to dismiss all five complaints
on January 30, 2023. By order dated April 17, 2023, the court
granted Indivior's motions to dismiss. The plaintiffs filed a
notice of appeal on June 30, 2023, and the appellate court heard
oral argument on September 17, 2024. The appellate court has not
yet ruled on the appeal.
• Additionally, on May 23, 2024, the Consumer Protection
Division of the Office of the Attorney General of Maryland served
on Indivior Inc. an administrative subpoena related generally to
opioid products marketed and sold in Maryland. Indivior Inc.'s response to the subpoena remains
ongoing.
• The Group has begun its evaluation of the claims, believes it
has meritorious defenses, and intends to vigorously defend itself
in the private plaintiff actions. Given the status and preliminary
stage of litigation in the separate federal and state court actions
for the private plaintiff cases, no estimate of possible loss
in the opioid litigation for the private plaintiffs can be made at
this time.
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.
See 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. The
Group filed a Motion to Dismiss in June 2021, which was granted in
part and denied in part on October 17, 2023. The relator filed a
sixth amended complaint against only Indivior Inc. on December 7,
2023. Indivior answered the sixth amended complaint on March 18,
2024. Discovery is ongoing. Given the status and preliminary stage
of the litigation, no estimate of possible loss can be made at
this time.
• In May 2018,
Indivior Inc. received an informal request from the United States
Attorney's Office ("USAO") for the Southern District of New York,
seeking records relating to the SUBOXONE Film manufacturing
process. The Group provided the USAO certain information regarding
allegations that the government received regarding SUBOXONE Film.
There has been no communication regarding this matter with the USAO
since 2022.
U.K. Shareholder Claims
•
On September 21, 2022, certain shareholders issued
representative and multiparty claims against Indivior PLC in the
High Court of Justice for the Business and Property Courts of
England and Wales, King's Bench Division. On January 16, 2023, the
representative served its Particular of Claims setting forth in
more detail the claims against the Group, while the same law firm
that represents the representative also sent its draft Particular
of Claims for the multiparty action. The claims made in both the
representative and multiparty actions generally allege that
Indivior PLC violated the U.K. Financial Services and Markets Act
2000 ("FSMA 2000") by making false or misleading statements or
material omissions in public disclosures, including the 2014
Demerger Prospectus, regarding an alleged product-hopping scheme
regarding the switch from SUBOXONE Tablets to SUBOXONE Film.
Indivior PLC filed an application to strike out the representative
action. On December 5, 2023, the court handed down a judgment
allowing the Group's application to strike out the representative
action. The court subsequently awarded certain costs to the Group.
On January 23, 2024, the claimants requested permission to appeal
the decision to the court of appeals. The appellate court has
indicated that it will hear the appeal between December 10 and 12,
2024. The Group has begun its evaluation of the
claims, believes it has meritorious defenses, and intends to
vigorously defend itself. Given the status and preliminary stage of
the litigation, no estimate of possible loss can be made at
this time.
U.S. Shareholder Claims
• A class
action lawsuit was filed against Indivior PLC, Mark Crossley (the
CEO of the Group), and Ryan Preblick (the CFO of the Group) on
August 2, 2024, alleging violations of certain United States
federal securities laws. The putative class, as alleged, includes
plaintiffs that purchased or otherwise acquired Indivior securities
between February 22, 2024 and July 8, 2024. The court entered an
order appointing a lead plaintiff on October 7, 2024. The lead
plaintiff must file an amended complaint on or before December 5,
2024, and the defendants must respond by January 10,
2025. Given the status and preliminary stage of
the litigation, no estimate of possible loss can be made at this
time.
Opiant Shareholder Claims
• On November
8, 2023, plaintiff James Litten filed a class action complaint in
the Delaware Court of Chancery alleging that former officers and
directors of Opiant Pharmaceuticals, Inc. ("Opiant") breached
fiduciary duties of care, loyalty, and good faith in connection
with Indivior PLC's 2022 acquisition of Opiant. The defendants
moved to dismiss the complaint on January 26, 2024. On March 21,
2024, the plaintiff filed an amended complaint, which added Lazard
Freres & Co. LLC, which was Opiant's advisor in the acquisition
as a defendant. The defendants moved to dismiss the amended
complaint on June 21, 2024. The motion to dismiss remains pending.
The Group has begun its evaluation of the claims, believes it has
meritorious defenses, and intends to vigorously defend itself.
Given the status and preliminary stage of the litigation, no
estimate of possible loss can be made at this time.
Dental Allegations
• The Group has
been named as a defendant in numerous lawsuits alleging that
Suboxone® Film was defectively designed and caused dental injury,
and that the Group failed to properly warn of the risks of such
injuries. The plaintiffs generally seek compensatory damages, as
well as punitive damages and attorneys' fees and costs. Plaintiffs
and potential plaintiffs related to these lawsuits generally can be
grouped as follows:
â–ª Dental MDL
Plaintiffs: More than 675 of these cases have been consolidated in
multi-district litigation in the Northern District of Ohio. See In
Re Suboxone (Buprenorphine/Naloxone) Film Products Liability
Litigation, MDL No. 3092 (N.D. Oh.) (the "Dental MDL").
â–ª Dental MDL
Schedule A Plaintiffs: One complaint filed in the Dental MDL on
June 14, 2024 attached a schedule of nearly 10,000 plaintiffs (the
"Schedule A Plaintiffs"). The parties are in the process of
negotiating a tolling agreement for the Schedule A Plaintiffs that
would permit plaintiffs' counsel additional time to investigate
issues such as whether and when the Schedule A Plaintiffs used any
Indivior product before determining whether to file individual
complaints that ultimately would be coordinated with the Dental
MDL. Plaintiffs indicated to the court they will dismiss more than
1,400 plaintiffs in the future, pursuant to a mechanism to be
provided by the court.
â–ª State Court
Plaintiffs: One complaint has been filed in New Jersey state court,
and the parties have agreed to toll the claims of more than 850
other individuals in Delaware, New Jersey, and Virginia. Complaints
have not yet been filed on behalf of the tolled
individuals.
• Product
liability cases such as these typically involve issues relating to
medical causation, label warnings and reliance on those warnings,
scientific evidence and findings, actual/provable injury and other
matters. These cases are in their preliminary stages. These
lawsuits and claims follow a June 2022 required revision to the
Prescribing Information and Patient Medication Guide about dental
problems reported in connection with buprenorphine medicines
dissolved in the mouth to treat opioid use disorder. This revision
was required by the FDA of all manufacturers of these products. The
Group has been informed by its primary insurance carrier that
defense costs for the Dental MDL should begin to be reimbursed now
that the Group's self-insurance retention has been exhausted.
Additionally, the Group's primary insurance carrier has issued a
reservation of rights against payment of any liability costs. In
the event of a liability finding, various factors could affect
reimbursement or payment by insurers, if any, including (i) the
scope of the insurers' purported defenses and exclusions to avoid
coverage, (ii) the outcome of negotiations with insurers, (iii)
delays in or avoidance of payment by insurers and (iv) the extent
to which insurers may become insolvent in the future. The Group has
begun its evaluation of the claims, believes it has meritorious
defenses, and intends to vigorously defend itself. Given the status
and preliminary stage of the litigation, no estimate of possible
loss can be made at this time.
• Applications to file class actions based on similar
allegations as in the Dental MDL were filed in Quebec and British
Columbia against various subsidiaries of the Group, among other
defendants, in April 2024. The Group has begun its evaluation of
the claims, believes it has meritorious defenses, and intends to
vigorously defend itself. Given the status and preliminary stage of
the litigation, no estimate of possible loss can be made at this
time.
14. TRADE AND OTHER PAYABLES
|
Sep 30,
2024
|
Dec
31,
2023
|
|
$m
|
$m
|
Accrual for rebates, discounts and
returns
|
(564)
|
(507)
|
Rebates payable
|
(44)
|
(28)
|
Accounts payable
|
(50)
|
(39)
|
Accruals and other
payables
|
(138)
|
(150)
|
Other tax and social security
payable
|
(19)
|
(19)
|
Total trade and other
payables
|
(815)
|
(743)
|
15. SHARE
CAPITAL
|
Equity ordinary shares
(thousands)
|
Nominal value paid per
share
|
Aggregate nominal value
$m
|
Issued and fully paid
|
|
|
|
At
January 1, 2024
|
136,526
|
$0.50
|
68
|
Ordinary shares issued
|
1,456
|
$0.50
|
1
|
Shares repurchased and
canceled
|
(8,407)
|
$0.50
|
(4)
|
At
September 30, 2024
|
129,575
|
|
65
|
|
Equity
ordinary shares (thousands)
|
Nominal
value paid per share
|
Aggregate
nominal value $m
|
Issued and fully paid
|
|
|
|
At January 1, 2023
|
136,481
|
$0.50
|
68
|
Ordinary shares issued
|
1,943
|
$0.50
|
1
|
Shares repurchased and
canceled
|
(484)
|
$0.50
|
-
|
At September 30, 2023
|
137,940
|
|
69
|
Ordinary shares issued
During the period, 1,456k ordinary
shares at $0.50 each (YTD 2023: 1,943k at $0.50 each) were issued
to satisfy vesting/exercises under the Group's Long-Term Incentive
Plan, the Indivior U.K. Savings-Related Share Option Scheme, and
the U.S. Employee Stock Purchase Plan. In YTD 2024, net settlement
of tax on employee equity awards was $20m (YTD 2023:
$22m).
Shares repurchased and canceled
On November 17, 2023, the Group
commenced a share repurchase program for an aggregate purchase
price up to no more than $100m or 13,632k of ordinary shares which
concluded on August 2,
2024. During the period, the Group repurchased and canceled
a total of 4,532k of ordinary shares at $0.50 per share under this
program.
On August 5, 2024, the Group
commenced a share repurchase program for an aggregate purchase
price of no more than $100m or 13,649k of ordinary shares and
ending no later than January 31, 2025. During the period, the Group
repurchased and canceled a total of 3,875k of ordinary shares at
$0.50 per share under this program.
The aggregate nominal value of
shares repurchased during 2024 under the November 2023 and August
2024 programs was $4m.
All ordinary shares repurchased
during the period under share repurchase programs were canceled
resulting in a transfer of the aggregate nominal value to a capital
redemption reserve. The total cost of the purchases made under the
share repurchase program during the period, including directly
attributable transaction costs, was $122m (YTD 2023: $11m). A net
repurchase amount of $16m has been recorded as a financial
liability and reduction of retained earnings which represents the
amount to be spent under the program through October 24, 2024,
after which date the Company has the ability to modify or terminate
the program. Total purchases under the share
repurchase program will be made out of distributable
profits.
16. ACQUISITION OF
OPIANT
On March 2, 2023, the Group
acquired 100% of the share capital of
Opiant for upfront cash consideration of $146m and
an additional maximum amount of $8.00 per share in
Contingent Value Rights (CVR) to be potentially
paid upon achievement of net sales milestones. As a result of the
acquisition, the Group added OPVEE
(nalmefene nasal spray), an opioid overdose
treatment well-suited to confront illicit synthetic opioids like
fentanyl, to its addiction science portfolio. OPVEE
was approved by the FDA in May 2023 and launched
in October 2023.
Since substantially all of the fair
value of the gross assets acquired was concentrated in the OPVEE
in-process research and development, the Group accounted for the
transaction as an asset acquisition and recorded an intangible
asset of $126m.
The cash outflow for the
acquisition was $124m in Q1 2023, net of cash acquired, and
inclusive of direct transaction costs. As part of the acquisition,
the Group assumed outstanding debt of $10m which was settled and
included as a cash outflow from financing activities.
Additional acquisition-related
costs of $16m were incurred in 2023 and included in selling,
general, and administrative expenses, primarily relating to
severance, acceleration of vesting of Opiant employee share
compensation, and short-term retention accruals.
17. BUSINESS COMBINATION
On November 1, 2023, the Group
acquired an aseptic manufacturing facility (the "Facility") in the
United States for upfront consideration of $5m in cash and
assumption of certain contract manufacturing obligations. The
Facility will be further developed to secure the long-term
production and supply of SUBLOCADE.
The acquisition was accounted for
as a business combination using the acquisition method of
accounting in accordance with IFRS 3 Business Combinations. The assets
acquired and liabilities assumed were recorded at fair value, with
the excess of the purchase price over the fair value of the
identifiable assets and liabilities recognized as goodwill. An
onerous contract provision was recorded at fair value to reflect
the present value of the expected losses from assumed contractual
manufacturing obligations. Net operating losses attributable to
these contractual obligations will be recorded against the onerous
contract provision from the date of acquisition through fulfillment
of the contracts in early 2025.
As of September 30, 2024,
committed capital spend for the Facility is approximately
$22m.
Identifiable assets acquired and liabilities
assumed
As the acquisition was completed in
late 2023, the provisional fair value of assets acquired and
liabilities assumed at the date of acquisition was disclosed in the
consolidated financial statements for the year ended December 31,
2023. During Q1 2024, based on new information obtained about facts
and circumstances that existed as of the acquisition date, the
Group adjusted the provisional fair values for acquired property,
plant and equipment and the assumed onerous contract provision,
with an adjustment to goodwill equal to the change in the net
assets acquired. These measurement period adjustments were
reflected in the comparative period presented in the Condensed
Financial Statements in accordance with IFRS 3 Business Combinations. The following
table provides a reconciliation from the provisional fair values of
assets acquired and liabilities assumed at the date of acquisition
as reported in the 2023 annual financial statements to the
provisional fair values as adjusted during Q1 2024:
|
Provisional
values
|
|
As Previously
Reported
|
Measurement period
adjustment
|
As adjusted
|
Net assets acquired
|
$m
|
$m
|
$m
|
Property, plant and
equipment
|
28
|
(2)
|
26
|
Deferred tax assets
|
2
|
(1)
|
1
|
Trade and other payables
|
(1)
|
-
|
(1)
|
Provisions
|
(29)
|
6
|
(23)
|
Total net assets acquired
|
-
|
3
|
3
|
Goodwill
Goodwill arising from the
acquisition has been recognized as follows, reflecting the Q1 2024
measurement period adjustments:
|
Provisional
values
|
|
As Previously
Reported
|
Measurement period
adjustment
|
As adjusted
|
|
$m
|
$m
|
$m
|
Consideration
transferred
|
5
|
-
|
5
|
Less: Fair value of net assets
acquired
|
-
|
(3)
|
(3)
|
Goodwill
|
5
|
(3)
|
2
|
The goodwill is primarily
attributable to Indivior-specific synergies relating to accelerated
in-sourcing of SUBLOCADE production and the skills and technical
talent of the Facility's workforce.
18. DISCONTINUATION OF
PERSERIS SALES & MARKETING
As announced in July 2024, the
Group discontinued promotion and marketing support for PERSERIS,
resulting in a headcount reduction of approximately 130 employees
and termination of related contract manufacturing agreements. The
decision was taken in consideration of regulatory changes announced
during Q2 2024 which are expected to adversely intensify payor
management of the treatment category in which PERSERIS competes and
would make PERSERIS no longer financially viable. While the Group
will continue to supply PERSERIS for the foreseeable future, the
expected adverse impacts represented an impairment indicator for
PERSERIS-related assets, resulting in year to date impairment
charges and other expenses as detailed below. Charges of $42m
recorded in Q2 included inventory provisions and impairment of
tangible and intangible assets. Charges of $21m recorded in Q3
included contract termination costs and severance.
|
Q3 2024
|
YTD 2024
|
Impairment charges, write downs and other
charges
|
$m
|
$m
|
Charged to cost of goods sold
|
|
|
Marketed product
intangible
|
-
|
9
|
Plant and equipment
|
-
|
8
|
Inventory
|
(2)
|
22
|
Contract termination
fees
|
12
|
12
|
Sub-total: Cost of goods sold
|
10
|
51
|
Charged to SG&A:
|
|
|
Severance
|
7
|
7
|
Other expenses
|
4
|
5
|
Sub-total: SG&A
|
11
|
12
|
Total charges
|
21
|
63
|
19. SUBSEQUENT
EVENTS
CT-102 Digital Therapeutic Product
Subsequent to September 30, 2024,
as part of strategic streamlining actions, the Group discontinued
its collaboration agreement for the development and
commercialization of the prescription digital therapeutic product,
CT-102. As a result, contract termination fees of approximately $7m
and a non-cash impairment charge of approximately $8m will be
incurred in Q4 2024.
DIRECTORS' RESPONSIBILITY STATEMENT
The Directors declare that, to the
best of their knowledge, this set of condensed consolidated interim
financial statements, which have been prepared in accordance with
UK adopted International Accounting Standard 34, Interim Financial Reporting, gives a
true and fair view of the assets, liabilities, financial position,
and profit or loss of Indivior.
The Directors are responsible for
the maintenance and integrity of the Group's website. Legislation
in the United Kingdom governing the preparation and dissemination
of financial statements may differ from legislation in other
jurisdictions.
Details of Indivior PLC's Directors
are available on our website at www.indivior.com.
By order of the Board
Mark Crossley
|
Ryan Preblick
|
Chief Executive Officer
|
Chief Financial Officer
|
October 23, 2024
Independent review report to
Indivior PLC
Report on the condensed consolidated interim financial
statements
We have reviewed Indivior PLC's
condensed consolidated interim financial statements (the "interim
financial statements") in the Q3 and YTD 2024 Financial Results of
Indivior PLC for the three and nine month periods ended
30 September 2024.
Based on our review, nothing has
come to our attention that causes us to believe that the interim
financial statements are not prepared, in all material respects, in
accordance with UK adopted International Accounting Standard 34,
'Interim Financial Reporting'.
The interim financial statements
comprise:
• the Condensed
consolidated interim balance sheet as at 30 September
2024;
• the Condensed
consolidated interim income statement and Condensed consolidated
interim statement of comprehensive income for the three and nine
month periods then ended;
• the Condensed
consolidated interim cash flow statement for the nine month period
then ended;
• the Condensed
consolidated interim statement of changes in equity for the nine
month period then ended; and
• the
explanatory notes to the interim financial statements.
The interim financial statements
included in the Q3 and YTD 2024 Financial Results of Indivior PLC
have been prepared in accordance with UK adopted International
Accounting Standard 34, 'Interim Financial Reporting'.
We conducted our review in
accordance with International Standard on Review Engagements (UK)
2410, 'Review of Interim Financial Information Performed by the
Independent Auditor of the Entity' issued by the Financial
Reporting Council for use in the United Kingdom ("ISRE (UK) 2410").
A review of interim financial information consists of making
enquiries, primarily of persons responsible for financial and
accounting matters, and applying analytical and other review
procedures.
A review is substantially less in
scope than an audit conducted in accordance with International
Standards on Auditing (UK) and, consequently, does not enable us to
obtain assurance that we would become aware of all significant
matters that might be identified in an audit. Accordingly, we do
not express an audit opinion.
We have read the other information
contained in the Q3 and YTD 2024 Financial Results and considered
whether it contains any apparent misstatements or material
inconsistencies with the information in the interim financial
statements.
Conclusions relating to going concern
|
Based on our review procedures,
which are less extensive than those performed in an audit as
described in the Basis for conclusion section of this report,
nothing has come to our attention to suggest that the directors
have inappropriately adopted the going concern basis of accounting
or that the directors have identified material uncertainties
relating to going concern that are not appropriately disclosed.
This conclusion is based on the review procedures performed in
accordance with ISRE (UK) 2410. However, future events or
conditions may cause the group to cease to continue as a going
concern.
Responsibilities for the interim financial statements and the
review
|
Our responsibilities and those of the
directors
|
The Q3 and YTD 2024 Financial
Results, including the interim financial statements, is the
responsibility of, and has been approved by the directors. The
directors are responsible for preparing the Q3 and YTD 2024
Financial Results in accordance with the Disclosure Guidance and
Transparency Rules sourcebook of the United Kingdom's Financial
Conduct Authority. In preparing the Q3 and YTD 2024 Financial
Results, including the interim financial statements, the directors
are responsible for assessing the group'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 to cease
operations, or have no realistic alternative but to do
so.
Our responsibility is to express a
conclusion on the interim financial statements in the Q3 and YTD
2024 Financial Results based on our review. Our conclusion,
including our Conclusions relating to going concern, is based on
procedures that are less extensive than audit procedures, as
described in the Basis for conclusion paragraph of this report.
This report, including the conclusion, has been prepared for and
only for the company for the purpose of complying with the
Disclosure Guidance and Transparency Rules sourcebook of the United
Kingdom's Financial Conduct Authority and for no other purpose. We
do not, in giving this conclusion, accept or assume responsibility
for any other purpose or to any other person to whom this report is
shown or into whose hands it may come save where expressly agreed
by our prior consent in writing.
PricewaterhouseCoopers
LLP
Chartered Accountants
London
23 October 2024
APPENDIX:
ADJUSTED RESULTS
Exceptional items and other adjustments
Exceptional items and other
adjustments represent significant expenses or income that do not
reflect the Group's ongoing operations or the adjustment of which
may help with the comparison to prior periods. Exceptional items
and other adjustments are excluded from adjusted results consistent
with the internal reporting provided to management and the
Directors. Examples of such items could include income or
restructuring and related expenses from the reconfiguration of the
Group's activities and/or capital structure, amortization of
acquired intangible assets, impairment of current and non-current
assets, gains and losses from the sale of intangible assets,
certain costs arising as a result of significant and non-recurring
regulatory and litigation matters, and certain tax related
matters.
Adjusted results are not measures
defined by IFRS and are not a substitute for, or superior to,
reported results presented in accordance with IFRS. Adjusted
results as presented by the Group are not necessarily comparable to
similarly titled measures used by other companies. As a result,
these performance measures should not be considered in isolation
from, or as a substitute analysis for, the Group's reported results
presented in accordance with IFRS. Management performs a
quantitative and qualitative assessment to determine if an item
should be considered for adjustment. The table below sets out
exceptional items and other adjustments recorded in each
period:
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Exceptional items and other
adjustments within cost of sales
|
|
|
|
|
Amortization of acquired intangible
assets1
|
(3)
|
(3)
|
(9)
|
(5)
|
Discontinuation of sales and
marketing for PERSERIS2
|
(10)
|
-
|
(51)
|
-
|
Total exceptional items and other
adjustments within cost of sales
|
(13)
|
(3)
|
(60)
|
(5)
|
|
|
|
|
|
Exceptional items and other
adjustments within SG&A
|
|
|
|
|
Legal
costs/provisions3
|
(36)
|
(240)
|
(196)
|
(240)
|
Discontinuation of sales and
marketing for PERSERIS2
|
(11)
|
-
|
(12)
|
-
|
Impairment of products in
development4
|
(28)
|
-
|
(28)
|
-
|
Acquisition-related
costs6
|
-
|
-
|
(4)
|
(16)
|
U.S. listing
costs7
|
-
|
-
|
(4)
|
(6)
|
Total exceptional items and other
adjustments within SG&A
|
(75)
|
(240)
|
(244)
|
(262)
|
|
|
|
|
|
Exceptional items within
other (losses)/gains, net
|
|
|
|
|
Mark-to-market on equity
investments5
|
(5)
|
-
|
(5)
|
-
|
Total exceptional items within
other (losses)/gains, net
|
(5)
|
-
|
(5)
|
-
|
|
|
|
|
|
Total exceptional items and other adjustments before
taxes
|
(93)
|
(243)
|
(309)
|
(267)
|
Tax on exceptional items and other
adjustments
|
25
|
59
|
70
|
61
|
Exceptional tax
items8
|
-
|
-
|
-
|
(8)
|
Total exceptional items and other
adjustments
|
(68)
|
(184)
|
(239)
|
(214)
|
1. The
Group reported adjusted cost of sales to exclude amortization of
acquired intangible assets.
2. In
Q3 2024 and YTD
2024 the Group recognized $21m and $63m of
exceptional costs related to the discontinuation of sales and
marketing for PERSERIS, including contractual fees, impairment of
assets, inventory provisions and severance.
3. In
Q3 2024, the Group recognized exceptional
costs of $39m related to the expected settlement of certain
antitrust legal matters. YTD 2024 also includes $85m related to the July 8, 2024
settlement of certain antitrust legal matters and $75m related to
the Opioid MDL (refer to Notes 11 and 13).
4. In
Q3 2024, the Group impaired a product in
development resulting from a clinical study that did not
demonstrate the anticipated results.
5. In Q3
2024, a mark-to-market adjustment was
recorded related to the impact on the quoted
market price of the ordinary shares of Aelis Farma of the
announcement that the clinical Phase 2B study with AEF0117 in
participants with cannabis use disorder did not demonstrate the
anticipated results.
6. In
YTD 2024, the Group
recognized $4m of exceptional costs related
to the acquisition and integration of the aseptic manufacturing
site acquired in November 2023 (refer to note 17). In YTD 2023, the Group recognized
$16m of exceptional costs related to the
acquisition of Opiant (refer to Note 16).
7. The
Group recognized exceptional costs related to listing Indivior
shares on NASDAQ as the primary listing of $4m in YTD 2024 and $2m in Q3 2024
(YTD 2023: $6m).
8.
Exceptional tax items in
YTD 2023 are
comprised of $5m write off of deferred tax assets and tax expense
due to limitation on the deduction of executive compensation by
U.S. publicly traded companies and $3m change in estimate as to the
tax benefit of legal provisions booked in the prior
year.
Adjusted results
Management provides certain
adjusted financial measures which may be useful to investors. These
adjusted financial measures exclude items which do not reflect the
Group's day-to-day operations and therefore may help with
comparisons to prior periods or among companies. Management may use
these financial measures to better understand trends in the
business.
The tables below present the
adjustments between reported and adjusted results for both Q3/YTD
2024 and Q3/YTD 2023.
Reconciliation of gross profit to adjusted gross
profit
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Gross profit
|
238
|
225
|
681
|
665
|
Exceptional items and other
adjustments in cost of sales
|
13
|
3
|
60
|
5
|
Adjusted gross profit
|
251
|
228
|
741
|
670
|
We define adjusted gross margin as
adjusted gross profit divided by net revenue.
Reconciliation of selling, general and administrative expenses
to adjusted selling, general and administrative
expenses
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Selling, general and administrative expenses
|
(208)
|
(390)
|
(665)
|
(654)
|
Exceptional items and other
adjustments in selling, general and administrative
expenses
|
75
|
240
|
244
|
262
|
Adjusted selling, general and administrative
expenses
|
(133)
|
(150)
|
(421)
|
(392)
|
Reconciliation of operating profit/(loss) to adjusted
operating profit
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Operating profit/(loss)
|
4
|
(183)
|
(64)
|
(65)
|
Exceptional items and other
adjustments in cost of sales
|
13
|
3
|
60
|
5
|
Exceptional items and other
adjustments in selling, general and administrative
expenses
|
75
|
240
|
244
|
262
|
Exceptional items and other
adjustments in net other operating income
|
5
|
-
|
5
|
-
|
Adjusted operating profit
|
97
|
60
|
245
|
202
|
We define adjusted operating margin
as adjusted operating profit divided by net revenue.
Reconciliation of loss before taxation to adjusted profit
before taxation
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Loss before taxation
|
(1)
|
(181)
|
(74)
|
(61)
|
Exceptional items and other
adjustments in cost of sales
|
13
|
3
|
60
|
5
|
Exceptional items and other
adjustments in selling, general and administrative
expenses
|
75
|
240
|
244
|
262
|
Exceptional items and other
adjustments in net other operating income
|
5
|
-
|
5
|
-
|
Adjusted profit before taxation
|
92
|
62
|
235
|
206
|
Reconciliation of tax expense to adjusted tax
expense
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Tax benefit/(expense)
|
5
|
46
|
17
|
9
|
Tax on exceptional items and other
adjustments
|
(25)
|
(59)
|
(70)
|
(61)
|
Exceptional tax items
|
-
|
-
|
-
|
8
|
Adjusted tax (expense)
|
(20)
|
(13)
|
(53)
|
(44)
|
We define adjusted effective tax
rate as adjusted tax expense divided by adjusted profit before
taxation.
Reconciliation of net loss to adjusted net
income
|
Q3
2024
|
Q3
2023
|
YTD
2024
|
YTD
2023
|
For the three and nine months ended September
30
|
$m
|
$m
|
$m
|
$m
|
Net income/(loss)
|
4
|
(135)
|
(57)
|
(52)
|
Exceptional items and other
adjustments in cost of sales
|
13
|
3
|
60
|
5
|
Exceptional items and other
adjustments in selling, general and administrative
expenses
|
75
|
240
|
244
|
262
|
Exceptional items and other
adjustments in net other operating income
|
5
|
-
|
5
|
-
|
Tax on exceptional items and other
adjustments
|
(25)
|
(59)
|
(70)
|
(61)
|
Exceptional tax items
|
-
|
-
|
-
|
8
|
Adjusted net income
|
72
|
49
|
182
|
162
|
Adjusted diluted earnings per share
Management believes that diluted
earnings per share, adjusted for the impact of exceptional items
and other adjustments after the appropriate tax amount, may provide
meaningful information on underlying trends to shareholders in
respect of earnings per ordinary share. Weighted average shares
used in computing diluted earnings per share is included in Note 6.
A reconciliation of net income to adjusted net income is included
above.