REG - Indivior PLC - 1st Quarter Results
25/04/2024 07:00
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RNS Number : 9418L Indivior PLC 25 April 2024
April 25, 2024
Delivered Double-Digit Net Revenue Growth in Q1 2024; FY 2024 Guidance
Reconfirmed
• Total net revenue (NR) of $284m (+12% versus Q1 2023); SUBLOCADE® NR of
$179m (+36% versus Q1 2023)
• FY 2024 guidance reconfirmed - NR and adjusted operating profit expected
to accelerate through the year
• Board confirms intention to seek shareholder approval in May 2024 to
facilitate a primary listing in the U.S.
2023
Comment by Mark Crossley, CEO of Indivior PLC
"Our first quarter results reflect continued double-digit top-line momentum
led by SUBLOCADE (buprenorphine extended-release). The underlying demand for
this transformative treatment for moderate-to-severe opioid use disorder (OUD)
remains strong and our strategy to expand prescribing in the justice system is
delivering excellent results. SUBLOCADE's reported growth was, however,
adversely impacted by transitory items, including accelerating Medicaid
patient disenrollments, a cyberattack on the largest U.S. medical claims
processor and abnormal trade destocking. We fully expect these items to
resolve as the year progresses and, combined with the benefits of recent
commercial investments behind SUBLOCADE, we anticipate an acceleration in our
top- and bottom-line growth over the remainder of 2024, particularly in the
second half. We therefore reconfirm our 2024 guidance, including SUBLOCADE net
revenue of $820m to $880m and approximately 300 basis points of margin
expansion at the mid-points of our guidance range.
Lastly, after receiving strong indications of support from our shareholders,
we are confirming our intention to seek shareholder approval in May 2024 to
facilitate a primary listing in the U.S. while maintaining a secondary listing
in the U.K."
Quarter to March 31 (Unaudited) 2024 2023 % Change
$m $m
Net Revenue 284 253 12%
Operating Profit 65 57 14%
Net Income 47 44 7%
Diluted EPS ($) $0.34 $0.31 10%
Adjusted Basis
Adj. Operating Profit(1) 70 71 -1%
Adj. Net Income(1) 51 56 -9%
Adj. Diluted EPS(1) ($) $0.37 $0.40 -8%
1 Adjusted Basis excludes the impact of exceptional items and other
adjustments as referenced and reconciled in the "Adjusted Results" appendix on
page 24. 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.
Q1 2024 Financial Highlights
• Q1 2024 total net revenue (NR) of $284m increased 12% (Q1 2023:
$253m).
• Q1 2024 reported operating profit was $65m (Q1 2023: $57m). Q1
2024 adjusted operating profit of $70m represented a decrease of 1% (Adjusted
Q1 2023: $71m).
• Q1 2024 reported net income was $47m (Q1 2023: $44m). Q1 2024
adjusted net income of $51m represented a decrease of 9% (Adjusted Q1 2023:
$56m).
• Cash and investments totaled $356m at the end of Q1 2024
(including $27m restricted for self-insurance) (FY 2023: $451m), primarily
reflecting the Q1 2024 net cash outflows related to scheduled litigation
settlement payments, shares repurchased and canceled, and taxes paid.
Q1 2024 Product Highlights
• SUBLOCADE: Q1 2024 NR of $179m (+36% vs. Q1 2023; +2%vs. Q4
2023). Continued growth primarily reflects further organized health system
(OHS) and justice system channel penetration in the U.S. and increased new
U.S. patient enrollments. Q1 2024 U.S. units dispensed were approx. 148,600
(+38% vs. Q1 2023 and +4% vs. Q4 2023). Total U.S. patients on a 12-month
rolling basis at the end of Q1 2024 were approximately 150,300 (+59% vs. Q1
2023 and +10% vs. Q4 2023).
• OPVEE®: Q1 2024 NR was modest (under $1m), as expected;
near-term launch focus is on supporting foundational policy changes to enable
nalmefene opioid rescue treatments.
• PERSERIS®: Q1 2024 NR of $11m (+38% vs. Q1 2023; -8% vs. Q4
2023) reflects increasing awareness of the treatment across the U.S.
healthcare system versus last year.
• SUBOXONE® (buprenorphine/naloxone) Film: U.S. share in Q1 2024
averaged 17% (Q1 2023: 19%).
FY 2024 Guidance
The Group reconfirms its financial guidance for 2024, as set forth in its
press release dated February 22, 2024.
Pursuing Shareholder Approval for a Primary Listing in the U.S. in the Summer
of 2024
On February 22, 2024, Indivior announced the commencement of shareholder
consultations to effect a primary listing in the U.S. in the summer of 2024.
The Group believes a primary U.S. listing could be beneficial to Indivior
stakeholders as it would better align with the Group's current and future
growth opportunities, attract more U.S. investors and analysts, allow for
inclusion in U.S. indices over time and better reflect the growing proportion
of the Group's share capital owned by U.S. based investors.
Since the February 22, 2024 announcement, the Group has consulted extensively
with shareholders and, together with its advisers, has carefully considered
the shareholder feedback received. Having largely completed this consultation
process, the Board confirms its intention to seek shareholder approval in May
2024 to facilitate a shift to a primary listing in the U.S., which would be
expected to take place in the summer of 2024.
The Board intends to maintain Indivior's U.K. listing as a secondary listing
following the transition to a primary U.S. listing.
Share Repurchase Program
On November 17, 2023, Indivior announced a third share repurchase program of
up to $100m. Through April 19, 2024, the Group repurchased and canceled
3,761,052 Indivior ordinary shares, equivalent to approximately 3% of diluted
shares outstanding, at a daily weighted average purchase price of 1,373p. The
cost was approximately $66m, which includes directly attributable transaction
costs. The program is expected to conclude no later than August 30, 2024.
Refer to Note 15 for further discussion.
U.S. OUD Market Update
In Q1 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, such as the late
2022 enactment of the Mainstreaming Addiction Treatment Act, that have
expanded OUD treatment funding and treatment capacity. The Group believes
these regulatory and legislative actions will help to normalize the view of
addiction as a chronic disease and expand access to evidence-based
buprenorphine treatment in the U.S. and supports these actions.
Financial Performance in Q1 2024
Total net revenue in Q1 2024 increased 12% to $284m (Q1 2023: $253m) at actual
exchange rates (+12% at constant exchange rates(1)).
U.S. net revenue increased 15% in Q1 2024 to $241m (Q1 2023: $209m). Strong
year-over-year SUBLOCADE volume growth primarily drove the net revenue
increase. Pricing was not a material factor in revenue growth.
Rest of World (ROW) net revenue decreased 2% at actual exchange rates in Q1
2024 to $43m (Q1 2023: $44m) (-2% at constant exchange rates(1)). In the
period, positive contributions from new products (SUBLOCADE / SUBUTEX®
Prolonged Release and SUBOXONE Film) were more than offset primarily by the
timing of shipments of certain products as well as ongoing generic erosion of
the legacy tablet business. Q1 2024 SUBLOCADE / SUBUTEX Prolonged Release net
revenue in ROW was $12m (Q1 2023: $9m) at actual exchange rates.
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 net revenue in
the currencies of the foreign entities.
Gross margin as reported in Q1 2024 was 84% (Q1 2023: 85%). Excluding $3m of
other adjustments for amortization of acquired intangible assets within cost
of sales primarily related to the acquisition of Opiant, adjusted gross margin
in Q1 2024 was 85%. There were no adjustments to Q1 2023 gross margin. The
adjusted gross margin in Q1 2024 primarily reflects an improved product mix
from the continued growth of SUBLOCADE offset by cost inflation. Additionally,
both periods benefited from favorable manufacturing variances.
SG&A expenses as reported in Q1 2024 were $145m (Q1 2023: $131m). Q1 2024
included $2m of exceptional integration costs related to the aseptic
manufacturing site in Raleigh, NC acquired in November 2023. The Group expects
to incur approximately $3m in additional pre-tax integration related costs in
FY 2024 which would be recorded as exceptional. Q1 2023 included $14m of
exceptional items related to non-recurring costs associated with the
acquisition of Opiant ($12m) and the additional U.S. listing ($2m).
Excluding exceptional items, Q1 2024 adjusted SG&A expense increased 22%
to $143m (Adjusted Q1 2023: $117m). The increase in Q1 2024 reflects increased
sales and marketing investments primarily related to SUBLOCADE, the addition
of the Opiant business, OPVEE launch expenses and cost inflation.
R&D expenses in Q1 2024 were $28m (Q1 2023: $27m), an increase of 4%. The
increase was primarily due to the progression of pipeline assets partially
offset by a reduction in activity related to post-marketing studies for
SUBLOCADE.
Net other operating income in Q1 2024 was nil (Q1 2023: $1m).
Operating profit as reported was $65m in Q1 2024 (Q1 2023: $57m). The change
on a reported basis reflects higher NR and gross margin as described above,
offset by investments in sales and marketing primarily related to SUBLOCADE.
The Q1 2023 period included exceptional administrative costs relating to the
Opiant acquisition.
Q1 2024 adjusted operating profit decreased 1% to $70m (Q1 2023: $71m),
excluding exceptional items and other adjustments of $5m and $14m in Q1 2024
and Q1 2023, respectively. The decrease primarily reflects increased SG&A
expenses, as described above, partly offset by higher total NR and gross
margin from an improved product mix.
Net finance expense was $2m in Q1 2024 (Q1 2023: $1m income) reflecting a
decrease in interest income on lower cash and investment balances.
Reported tax expense was $16m in Q1 2024 and the effective tax rate was 25%
(Q1 2023 tax expense/rate: $14m, 24%). Q1 2024 adjusted tax expense was $17m,
and the adjusted effective tax rate was 25% (Q1 2023 adjusted tax
expense/rate: $16m, 22%). The adjusted results exclude tax benefit on
exceptional items and other adjustments. The movement in the effective tax
rate on adjusted profits is impacted by an increase in the U.K. corporation
tax rate from 23.5% to 25%.
Reported net income in Q1 2024 was $47m and adjusted net income was $51m (Q1
2023 reported net income: $44m; Q1 2023 adjusted net income: $56m). The 9%
decrease in net income on an adjusted basis primarily reflected the increase
in operating expense, partly offset by higher total NR.
Diluted earnings per share were $0.34 on a reported basis and $0.37 on an
adjusted basis in Q1 2024 (Q1 2023: $0.31 diluted earnings per share and $0.40
adjusted diluted earnings per share).
Balance Sheet & Cash Flow
Cash and investments totaled $356m at the end of Q1 2024, a decrease of $95m
versus the $451m position at the end of 2023. The decrease was primarily due
to the Group's litigation settlement payments of $70m for the Department of
Justice (DOJ), Reckitt Benckiser (RB) and Dr. Reddy's Laboratories (DRL)
matters.
Net working capital, defined by management as inventory plus trade
receivables, less trade and other payables, was negative $342m on March 31,
2024, versus negative $347m at the end of FY 2023.
Cash used in operations in Q1 2024 was $25m (Q1 2023 cash used in operations:
$16m), primarily due to litigation settlement payments, partially offset by
income from operations. Before these litigation settlement payments, cash
generated from operations in the current period was $45m. Net cash outflow
from operating activities was $55m in Q1 2024 (Q1 2023 cash outflow: $36m)
reflecting tax payments and interest paid on the Group's term loan facility
and settlement payments, partially offset by interest received on investments.
Cash inflow from investing activities was $25m (Q1 2023 cash outflow: $127m)
reflecting the reduction in invested liquidity. In the prior year period, the
outflow from investing activities primarily reflected the Opiant acquisition,
net of cash assumed.
Cash outflow from financing activities was $38m (Q1 2023 cash outflow: $22m)
reflecting shares repurchased and canceled, the principal portion of lease
payments and quarterly amortization of the Group's term loan facility,
partially offset by proceeds received from the issuance of shares for employee
compensation agreements. 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 Board of Directors oversees the approach to risk management so that the
principal risks, including those that would threaten the Group's business
model, future performance or viability, are effectively managed and/or
mitigated. While the Group aims to identify and manage such risks, no risk
management strategy can provide absolute assurance against loss. The principal
risks facing the Group have not significantly changed over the period and are
set out in the Group's Annual Report for the 2023 financial year.
Exchange Rates
The average and period end exchange rates used for the translation of
currencies into U.S. dollars that have most significant impact on the Group's
results were:
Q1 2024 Q1 2023
GB £ period end 1.2627 1.2309
GB £ average rate 1.2683 1.2149
€ Euro period end 1.0830 1.0828
€ Euro average 1.0859 1.0726
Webcast Details
A live webcast presentation will be held on April 25, 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 (//www.indivior.com) . Please copy and paste the below web
links into your browser.
The webcast link: https://edge.media-server.com/mmc/p/hktzzit4
(https://edge.media-server.com/mmc/p/hktzzit4)
Participants may access the presentation telephonically by registering with
the following link (please cut and paste into your browser):
https://register.vevent.com/register/BI2351ee9819db40d1a28c31f75cece519
(https://register.vevent.com/register/BI2351ee9819db40d1a28c31f75cece519)
(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 +1 804 402 7123
Indivior PLC jason.thompson@indivior.com
Tim Owens Director, Investor Relations Indivior PLC +1 804 263 3978
timothy.owens@indivior.com
Media Enquiries Jonathan Sibun Teneo +44 (0)20 7353 4200
U.S. Media Inquiries +1 804 594 0836
Indiviormediacontacts@indivior.com
Corporate Website www.indivior.com
This announcement does not constitute an offer to sell, or the solicitation of
an offer to subscribe for or otherwise acquire or dispose of shares in the
Group to any person in any jurisdiction to whom it is unlawful to make such
offer or solicitation.
About Indivior
Indivior is a global pharmaceutical company working to help change patients'
lives by developing medicines to treat substance use disorders (SUD) 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, including alcohol use disorder and cannabis use disorder. Headquartered
in the United States in Richmond, VA, Indivior employs more than 1,000
individuals globally and its portfolio of products is available in 37
countries worldwide. Visit www.indivior.com (//www.indivior.com) to learn
more. Connect with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior (//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, statements regarding:
the Indivior Group's financial guidance including operating and profit margins
for 2024 and its medium- and long-term growth outlook; 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; expected
future growth and expectations for sales levels for particular products, and
expectations regarding the future impact of factors that have affected sales
in the past; expected growth rates, growing normalization of medically
assisted treatment for opioid use disorder, and expanded access to treatment;
our product development pipeline and potential future products, expectations
regarding regulatory approval of such product candidates, the timing of such
approvals, and the timing of commercial launch of such products or product
candidates, and eventual annual revenues of such future products; expectations
regarding future production at the Group's Raleigh, North Carolina
manufacturing facility; our intention to seek shareholder approval in May 2024
to facilitate a primary listing in the U.S. while maintaining a secondary
listing in the U.K., and the expected timing and potential benefits of such
listing; and other statements containing the words "believe," "anticipate,"
"plan," "expect," "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 such
statements because they relate to future events. Various factors may cause
differences between Indivior's expectations and actual results, including,
among others, the material risks described in the most recent Indivior PLC
Annual Report and in subsequent releases; the substantial litigation and
ongoing investigations to which we are or may become a party; our reliance on
third parties to manufacture commercial supplies of most of our products,
conduct our clinical trials and at times to collaborate on products in our
pipeline; our ability to comply with legal and regulatory settlements,
healthcare laws and regulations, requirements imposed by regulatory agencies
and payment and reporting obligations under government pricing programs; risks
related to the manufacture and distribution of our products, most of which
contain controlled substances; market acceptance of our products as well as
our ability to commercialize our products and compete with other market
participants; competition; the uncertainties related to the development of new
products, including through acquisitions, and the related regulatory approval
process; our dependence on third-party payors for the reimbursement of our
products and the increasing focus on pricing and competition in our industry;
unintended side effects caused by the clinical study or commercial use of our
products; our ability to successfully execute acquisitions, partnerships,
joint ventures, dispositions or other strategic acquisitions; our ability to
protect our intellectual property rights and the substantial cost of
litigation or other proceedings related to intellectual property rights; the
risks related to product liability claims or product recalls; the significant
amount of laws and regulations that we are subject to, including due to the
international nature of our business; macroeconomic trends and other global
developments such as armed conflicts and pandemics; the terms of our debt
instruments, changes in our credit ratings and our ability to service our
indebtedness and other obligations as they come due; changes in applicable tax
rate or tax rules, regulations or interpretations and our ability to realize
our deferred tax assets; and volatility in our share price due to factors
unrelated to our operating performance or that may result from the potential
move of our primary listing to the U.S.
Forward-looking statements speak only as of the date that they are made and
should be regarded solely as our current plans, estimates and beliefs. Except
as required by law, we do not undertake and specifically decline any
obligation to update, republish or revise forward-looking statements to
reflect future events or circumstances or to reflect the occurrences of
unanticipated events.
Unaudited condensed consolidated interim income statement
2024 2023
For the three months ended March 31 Notes $m $m
Net Revenue 2 284 253
Cost of sales (46) (39)
Gross Profit 238 214
Selling, general and administrative expenses 3 (145) (131)
Research and development expenses 3 (28) (27)
Net other operating income - 1
Operating Profit 65 57
Finance income 4 7 11
Finance expense 4 (9) (10)
Net Finance (Expense)/Income (2) 1
Profit Before Taxation 63 58
Income tax expense 5 (16) (14)
Net Income 47 44
Earnings per ordinary share (in dollars)
Basic earnings per share 6 $0.35 $0.32
Diluted earnings per share 6 $0.34 $0.31
Unaudited condensed consolidated interim statement of comprehensive income
2024 2023
For the three months ended March 31 $m $m
Net income 47 44
Other comprehensive loss
Items that may be reclassified to profit or loss in subsequent years:
Foreign currency translation adjustment, net (3) -
Other comprehensive loss (3) -
Total comprehensive income 44 44
The notes are an integral part of these unaudited condensed consolidated
interim financial statements.
Unaudited condensed consolidated interim balance sheet
Mar 31, 2024 Dec 31, 2023 (Retrospectively adjusted(1))
Notes $m $m
ASSETS
Non-current assets
Intangible assets 7 230 234
Property, plant and equipment 81 82
Right-of-use assets 31 33
Deferred tax assets 5 260 267
Investments 8 26 41
Other assets 9 29 28
657 685
Current assets
Inventories 163 142
Trade receivables 249 254
Other assets 9 45 457
Current tax receivable 5 9 -
Investments 8 82 94
Cash and cash equivalents 248 316
796 1,263
Total assets 1,453 1,948
LIABILITIES
Current liabilities
Borrowings 10 (3) (3)
Provisions 11 (21) (408)
Other liabilities 11 (67) (125)
Trade and other payables 14 (754) (743)
Lease liabilities (9) (9)
Current tax liabilities 5 (7) (18)
(861) (1,306)
Non-current liabilities
Borrowings 10 (235) (236)
Provisions 11 (2) (5)
Other liabilities 11 (313) (367)
Lease liabilities (32) (34)
(582) (642)
Total liabilities (1,443) (1,948)
Net assets 10 -
EQUITY
Capital and reserves
Share capital 15 68 68
Share premium 11 11
Capital redemption reserve 8 7
Other reserve (1,295) (1,295)
Foreign currency translation reserve (38) (35)
Retained earnings 1,256 1,244
Total equity 10 -
(1)The unaudited condensed consolidated interim balance sheet as of December
31, 2023 has been retrospectively adjusted 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 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 income - - - - - 44 44
Other comprehensive loss - - - - - - -
Total comprehensive income - - - - - 44 44
Transactions recognized directly in equity
Shares issued 1 1 - - - - 2
Share-based plans - - - - - 5 5
Settlement of tax on equity awards - - - - - (21) (21)
Shares repurchased and canceled - - - - - (11) (11)
Transfer to share repurchase liability - - - - - 9 9
Taxation on share-based plans - - - - - (7) (7)
Balance at March 31, 2023 69 9 6 (1,295) (39) 1,322 72
Balance at January 1, 2024 68 11 7 (1,295) (35) 1,244 -
Comprehensive income
Net income - - - - - 47 47
Other comprehensive loss - - - - (3) - (3)
Total comprehensive income - - - - (3) 47 44
Transactions recognized directly in equity
Shares issued 1 - - - - - 1
Share-based plans - - - - - 5 5
Settlement of tax on equity awards - - - - - (20) (20)
Shares repurchased and canceled (1) - 1 - - (36) (36)
Transfer to share repurchase liability - - - - - (9) (9)
Transfer from share repurchase liability - - - - - 23 23
Taxation on share-based plans - - - - - 2 2
Balance at March 31, 2024 68 11 8 (1,295) (38) 1,256 10
The notes are an integral part of these unaudited condensed consolidated
interim financial statements.
Unaudited condensed consolidated cash flow statement
2024 2023
For the three months ended March 31 $m $m
CASH FLOWS FROM OPERATING ACTIVITIES
Operating Profit 65 57
Depreciation and amortization of property, plant and equipment and intangible 7 4
assets
Depreciation of right-of-use assets 2 2
Share-based payments 5 5
Impact from foreign exchange movements (3) -
Unrealized gain on equity investment - (1)
Settlement of tax on employee awards (20) (21)
Decrease in trade receivables 5 7
Decrease/(increase) in current and non-current other assets(1) 408 (23)
Increase in inventories (21) (5)
Increase in trade and other payables 13 30
Decrease in provisions and other liabilities(1 2) (486) (71)
Cash used in operations (25) (16)
Interest paid (11) (10)
Interest received 8 11
Taxes paid (27) (21)
Net cash outflow from operating activities (55) (36)
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of assets, net of cash acquired - (124)
Purchase of property, plant and equipment (2) (1)
Purchase of investments (4) (33)
Maturity of investments 31 36
Purchase of intangible asset - (5)
Net cash inflow/(outflow) from investing activities 25 (127)
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of borrowings (1) (11)
Principal elements of lease payments (2) (2)
Shares repurchased and canceled (36) (11)
Proceeds from the issuance of ordinary shares 1 2
Net cash outflow from financing activities (38) (22)
Exchange difference on cash and cash equivalents - (1)
Net decrease in cash and cash equivalents (68) (186)
Cash and cash equivalents at beginning of the period 316 774
Cash and cash equivalents at end of the period 248 588
(1)Changes in the line items current and non-current other assets and
provisions and other liabilities for Q1 2024 include the utilization of the
Antitrust MDL liabilities (refer to Note 13) and release of related escrow
funding following final court approval.
(2)Changes in the line item provisions and other liabilities for Q1 2024 also
include litigation settlement payments totaling $70m (Q1 2023: $74m). $3m of
interest paid on the DOJ Resolution in Q1 2024 has been recorded in the
interest paid line item (Q1 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 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 April 24, 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.
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 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 have been 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 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 to USD securities. 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 September 2025 (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 10% 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, sufficient liquidity
exists and is generated from operations such that all business and covenant
requirements are met for 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 will be delivered to the Registrar of Companies in due course. 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:
2024 2023
For the three months ended March 31 $m $m
United States 241 209
Rest of World 43 44
Total 284 253
On a disaggregated basis, the Group's net revenue by major product line:
2024 2023
For the three months ended March 31 $m $m
SUBLOCADE® 179 132
PERSERIS® 11 8
Sublingual/other(1) 94 113
Total 284 253
(1) Net revenue for OPVEE® was not material for the period ended March 31,
2024 and has therefore been included within sublingual/other.
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.
Mar 31, Dec 31, 2023 (Retrospectively adjusted(1))
2024
$m $m
United States 206 209
Rest of World 191 209
Total 397 418
(1) The non-current asset balance in the United States as of December 31, 2023
has been retrospectively adjusted 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:
2024 2023
For the three months ended March 31 $m $m
Research and development expenses (28) (27)
Selling and marketing expenses (66) (53)
Administrative and general expenses(1) (79) (78)
Selling, general, and administrative expenses (145) (131)
Depreciation and amortization(2) (3) (4)
(1) Administrative and general expenses include acquisition-related costs of
$12m in Q1 2023 related to 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 Q1 2024 of $6m (Q1 2023:
$2m) for intangible assets and right-of-use assets is included within cost of
sales.
4. NET FINANCE (EXPENSE)/INCOME
2024 2023
For the three months ended March 31 $m $m
Finance income
Interest income on cash and cash equivalents/investments 6 11
Other finance income 1 -
Total finance income 7 11
Finance expense
Interest expense on borrowings (6) (7)
Interest expense on lease liabilities (1) (1)
Interest expense on legal matters, including the effect of discounting (1) (2)
Other interest expense (1) -
Total finance expense (9) (10)
Net finance (expense)/income (2) 1
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.
2024 2023
For the three months ended March 31 $m $m
Total tax expense (16) (14)
Effective tax rate (%) 25% 24%
In the three months ended March 31, 2024, the effective tax rate was
primarily driven by statutory tax. In the three months ended March 31, 2023,
the effective tax rate was primarily driven by an increase in the U.K. tax
rate from 19% to 23.5%, and the temporary reduction in innovation incentives
due to 2022 losses.
Mar 31, Dec 31, 2023 (Retrospectively adjusted(1))
2024
$m $m
Current tax receivable 9 -
Current tax liabilities (7) (18)
Deferred tax assets 260 267
(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 March 31, 2024, the Group's net deferred tax assets of $260m
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 that could arise in later periods on resolution of
these uncertainties is in the range from nil to $38m.
6. EARNINGS PER SHARE
The table below sets out basic and diluted earnings per share for each period:
2024 2023
For the three months ended March 31 $ $
Basic earnings per share $0.35 $0.32
Diluted earnings per share $0.34 $0.31
Weighted average number of shares
The weighted average number of ordinary shares outstanding (on a basic basis)
for Q1 2024 includes the favorable impact of 1,988k ordinary shares
repurchased in Q1 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
Q1 2024 and Q1 2023, respectively.
2024 2023
For the three months ended March 31 thousands thousands
Weighted average shares on a basic basis 135,737 136,536
Dilution from share awards and options 2,973 4,452
Weighted average shares on a diluted basis 138,710 140,988
7. INTANGIBLE ASSETS
Mar 31, Dec 31, 2023 (Retrospectively adjusted(1))
2024
Intangible assets, net of accumulated amortization and impairment $m $m
Products in development 79 79
Marketed products 147 150
Goodwill 2 2
Software 2 3
Total 230 234
(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.
8. INVESTMENTS
Mar 31, Dec 31,
2024
2023
Current and non-current investments $m $m
Equity securities at FVPL 10 10
Debt securities held at amortized cost 72 84
Total investments, current 82 94
Debt securities held at amortized cost 26 41
Total investments, non-current 26 41
Total 108 135
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
March 31, 2024, expected credit losses for the Group's investments held at
amortized cost are deemed to be 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 March 31, 2024 Level 1 Level 2 Level 3 Total
$m $m $m $m
Equity securities at FVPL 10 - - 10
At December 31, 2023 Level 1 Level 2 Level 3 Total
$m $m $m $m
Equity securities at FVPL 10 - - 10
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 March 31, 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
Mar 31, Dec 31,
2024
2023
Current and non-current other assets $m $m
Current prepaid expenses 31 23
Other current assets 14 434
Total other current assets 45 457
Non-current prepaid expenses 18 19
Other non-current assets 11 9
Total other non-current assets 29 28
Total 74 485
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 have provided final approval of the settlements.
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:
Mar 31, Dec 31,
2024
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 $5m (FY 2023: $5m).
At March 31, 2024, the term loan fair value was approximately 100% (FY 2023:
100%) of par value. The key terms of this loan in effect at March 31, 2024,
are as follows:
Currency Nominal interest margin Maturity Required annual repayments Minimum
liquidity
Term loan facility USD SOFR + 0.26% + 5.25% 2026 1% Larger of $100m or 50% of loan balance
The term loan amounting to $243m (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 calculated as USD SOFR plus 26 bps, 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 Mar 31, 2024 Current Non-Current Dec 31, 2023 (Retrospectively adjusted(1))
Current and non-current provisions $m $m $m $m $m $m
Multi-district antitrust class and state claims - - - (385) - (385)
Onerous contracts (17) - (17) (19) (3) (22)
False claims allegations (4) - (4) (4) - (4)
Other - (2) (2) - (2) (2)
Total provisions (21) (2) (23) (408) (5) (413)
(1) The provision for onerous contracts 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.
Multi-district antitrust class and state claims
As previously disclosed, settlement agreements were entered into during 2023
with three plaintiff classes to fully resolve certain multi-district antitrust
claims. The $385m direct purchaser class settlement received final court
approval during the quarter. The provision and related other escrow settlement
asset have been offset and Indivior has no further obligations related to this
matter.
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 $17m (FY 2023: $22m). During the
quarter, net operating losses attributable to the contracts of $6m were
recorded against the provision. A measurement period adjustment to this
provision as of the acquisition date was recorded during the quarter and the
reported December 31, 2023 provision has been adjusted accordingly. Refer to
Note 17, Business Combination for additional details on this measurement
period adjustment. Product manufacturing under the onerous contracts is
expected to be completed prior to March 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
The Group carries a provision of $4m (FY 2023: $4m) pertaining to all
outstanding False Claims Act allegations as discussed in Note 13. These
matters are expected to be settled within the next 12 months.
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 Mar 31, 2024 Current Non-Current Dec 31, 2023
Current and non-current other liabilities $m $m $m $m $m $m
DOJ resolution (50) (295) (345) (53) (344) (397)
Multi-district antitrust class and state claims - - - (30) - (30)
Intellectual property related matters - - - (11) - (11)
RB indemnity settlement (8) (7) (15) (8) (15) (23)
Share repurchase (9) - (9) (23) - (23)
Other - (11) (11) - (8) (8)
Total other liabilities (67) (313) (380) (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
March 31, 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 annual 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 Q1 2024, the
Group recorded interest expense totaling $1m (Q1 2023: $1m).
Multi-district antitrust class and state claims
As noted above, certain multi-district antitrust claims were resolved during
2023 through settlement agreements entered into with three classes of
plaintiffs. The $30m end payor liability and related other escrow settlement
asset have been offset since final court approval was received and Indivior
has no further obligations related to this matter.
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 the quarter
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 March 31, 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. In Q1 2024, the
Group recorded nil of finance expense (Q1 2023: nil) for time value of money
on the liability.
Share repurchase
In November 2023, the Group commenced a share repurchase program of $100m. As
of March 31, 2024, the liability of $9m represents the amount to be spent
under the program through April 26, 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 program
through February 23, 2024.
Other
Other liabilities primarily represent employee related liabilities which are
non-current as of March 31, 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 "False Claims Act
allegations", for which provisions have been recognized, Note 13 sets out the
details for legal and other disputes for which the Group has assessed as
contingent liabilities. Where the Group believes that it is possible to
reasonably estimate a range for the contingent liability this has been
disclosed.
13. LEGAL PROCEEDINGS
There are certain ongoing legal proceedings or threats of legal proceedings in
which the Group is a party, but in which the Group believes the possibility of
an adverse impact is remote and they are not discussed in this Note.
Antitrust Litigation and Consumer Protection
• Cases filed by (1) Blue Cross and Blue Shield of Massachusetts,
Inc., Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc., (2) Health
Care Service Corp., (3) Blue Cross and Blue Shield of Florida, Inc., Health
Options, Inc., (4) BCBSM, Inc. (d/b/a Blue Cross and Blue Shield of Minnesota)
and HMO Minnesota (d/b/a Blue Plus), (5) Molina Healthcare, Inc., and (6)
Aetna Inc. 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). In July 2023, Indivior Inc. and 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. The Group filed demurrers, which the
court sustained in part and overruled in part. Separately, Indivior Inc. filed
counterclaims against several plaintiffs alleging violations of certain
insurance fraud statutes. The plaintiffs demurred. The court overruled HCSC's
demurrer but sustained the demurrers of the remaining plaintiffs named in
Indivior Inc.'s counterclaims. A jury trial on the Group's pleas in bar to the
remaining plaintiffs' fraud claims was held on October 30 - November 3, 2023.
The jury rendered a verdict finding that the plaintiffs' fraud claims are not
barred by the statute of limitations. A jury trial on the merits has been set
for July 15, 2024 - August 15, 2024. The Group is still in the process of
evaluating the claims, believes it has meritorious defenses, and intends to
defend itself. No estimate of the range of potential loss can be made at
this time.
• 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. 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.
• Centene Corporation, Wellcare Healthcare Plans, Inc., New York
Quality Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC filed a
complaint in the Circuit Court for the County of Roanoke, Virginia alleging
similar claims on January 13, 2023. See Centene Corp. v. Indivior Inc., No.
CL23000054-00 (Va. Cir. Ct.) (Roanoke Cnty). Indivior demurred to the
complaint and asserted pleas in bar in early February 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.
• 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.
• In 2013, Reckitt Benckiser Pharmaceuticals Inc. "RBPI," 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 Humana Inc. and certain of its
affiliates 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 Humana Inc. and certain of its affiliates in the Carefirst
action remain 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.
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 ("the Opioid MDL") 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). 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.
• The court in the Opioid MDL has indicated that it does not
intend to set additional bellwether trials for Tier 2 and Tier 3 manufacturer
and distributor defendants, provided that those defendants remain actively
engaged in mediation.
• Separately, Indivior Inc. was named as one of numerous
defendants in civil opioid cases that are not part of the Opioid MDL:
◦ In 2017, Indivior Inc. was named as one of numerous defendants
in International Brotherhood of Electrical Workers Local 728 Family Healthcare
Plan v. Allergan, PLC et al., Case ID: 190303872 (C.P. Phila. Cnty). That case
was consolidated with Lead Case No. 2017-008095 in Delaware County and stayed,
remanded back to the Philadelphia Court by order dated December 29, 2023, and
ultimately dismissed with prejudice as to Indivior Inc. by agreement of the
parties on March 27, 2024.
◦ Indivior also 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. The plaintiffs filed motions to remand the New York cases,
which remain pending. The plaintiffs in the case filed in the Northern
District of Alabama have voluntarily dismissed their complaint, subject to
certain tolling agreements. The various other federal actions currently are
stayed, except Indivior's response to 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.) is due May 2, 2024.
◦ 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 involved 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. Appellate briefing in
various cases, including the cases involving Indivior, was stayed in view of
Rite-Aid's bankruptcy. However, on April 16, 2024, the court of appeals
granted the plaintiffs' motion to sever Rite-Aid and lift the stay. Plaintiffs
have until May 7, 2024 to perfect their appeal, and the Defendants' response
is due by June 21, 2024.
• Given the status and preliminary stage of litigation in both the
Opioid MDL and the separate federal and state court actions, no estimate of
possible loss in the opioid litigation 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.
• 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 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 more than 325
lawsuits that have been consolidated into a multi-district litigation in the
Northern District of Ohio ("Dental MDL"). See In Re Suboxone
(Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092
(N.D. Oh.). The plaintiffs generally allege that the Group failed to properly
warn physicians of the risk of dental injury, and further allege that SUBOXONE
products were defectively designed. The plaintiffs generally seek compensatory
damages, as well as punitive damages and attorneys' fees and costs. 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. The Group is evaluating the claims and its defenses,
believes it has meritorious defenses, and intends to defend itself. No
estimate of the range of potential loss can be made at this time. These
lawsuits 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. To date, no such reimbursement
has occurred. Additionally, the Group's insurance carrier has issued a
reservation of rights against payment of any finding of liability costs. 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
Mar 31, Dec 31,
2024
2023
$m $m
Accrual for rebates, discounts and returns (556) (507)
Rebates payable (4) (28)
Accounts payable (40) (39)
Accruals and other payables (129) (150)
Other tax and social security payable (25) (19)
Total trade and other payables (754) (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 1,356 $0.50 1
Shares repurchased and canceled (1,988) $0.50 (1)
At March 31, 2024 135,894 68
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 1,878 $0.50 1
Shares repurchased and canceled (484) $0.50 -
At March 31, 2023 137,875 69
Ordinary shares issued
During the period, 1,356k ordinary shares at $0.50 each (Q1 2023: 1,878k 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 Q1 2024, net settlement
of tax on employee equity awards was $20m (Q1 2023: $21m).
Shares repurchased and canceled
On May 3, 2022, the Group commenced a share repurchase program for an
aggregate purchase price up to no more than $100m or 39,699k of ordinary
shares, (equivalent shares post share consolidation: 7,940k) which concluded
on February 28, 2023. During the prior period, the Company repurchased and
canceled 484k ordinary shares with a nominal value of $0.50 each.
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 and ending no later than August 30, 2024. During the period, the Group
repurchased and canceled a total of 1,988k ordinary shares at $0.50 per share
under this program for an aggregate nominal value of $1m.
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 $36m (FY 2023: $33m). A net repurchase
amount of $9m has been recorded as a financial liability and reduction of
retained earnings which represents the amount to be spent under the program
through April 26, 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 $12m were incurred in Q1 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
and PERSERIS.
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 March 31, 2024, committed capital spend for the Facility is
approximately $7m.
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. In 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
have been 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 the quarter:
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 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.
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 U.K. 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; and
• The interim management report gives a fair review of the
information in line with regulations 4.2.7 and 4.2.8 of the Disclosure
Guidance and Transparency Rules.
The Directors are responsible for the maintenance and integrity of the Group's
website. Legislation in the United Kingdom governing the preparation and
dissemination of financial statements may differ from legislation in other
jurisdictions.
Details of Indivior PLC's Directors are available on our website at
www.indivior.com (//www.indivior.com)
By order of the Board
Mark Crossley Ryan Preblick
Chief Executive Officer Chief Financial Officer
April 24, 2024
Independent review report to Indivior PLC
Report on the condensed consolidated interim financial statements
Our conclusion
We have reviewed Indivior PLC's condensed consolidated interim financial
statements (the "interim financial statements") in the Q1 2024 Financial
Results of Indivior PLC for the three month period ended 31 March 2024 (the
"period").
Based on our review, nothing has come to our attention that causes us to
believe that the interim financial statements are not prepared, in all
material respects, in accordance with UK adopted International Accounting
Standard 34, 'Interim Financial Reporting'.
The interim financial statements comprise:
• the Condensed consolidated interim balance sheet as at 31 March
2024;
• the Condensed consolidated interim income statement and
Condensed consolidated interim statement of comprehensive income for the three
month period then ended;
• the Condensed consolidated interim cash flow statement for the
three month period then ended;
• the Condensed consolidated interim statement in changes in
equity for the three month period then ended; and
• the explanatory notes to the interim financial statements.
The interim financial statements included in the Q1 2024 Financial Results of
Indivior PLC have been prepared in accordance with UK adopted International
Accounting Standard 34, 'Interim Financial Reporting'.
Basis for conclusion
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 Q1 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 Q1 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 Q1 2024 Financial Results in accordance with
UK adopted International Accounting Standard 34, 'Interim Financial
Reporting'. In preparing the Q1 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 Q1 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 UK adopted International Accounting Standard 34, 'Interim
Financial Reporting' 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
24 April 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:
2024 2023
For the three months ended March 31 $m $m
Exceptional items and other adjustments within cost of sales
Amortization of acquired intangible assets(1) (3) -
Total exceptional items and other adjustments within cost of sales (3) -
Exceptional items and other adjustments within SG&A
Acquisition-related costs(2) (2) (12)
U.S. listing costs(3) - (2)
Total exceptional items and other adjustments within SG&A (2) (14)
Total exceptional items and other adjustments before taxes (5) (14)
Tax on exceptional items and other adjustments 1 2
Total exceptional items and other adjustments (4) (12)
1. The Group reported adjusted cost of sales to exclude
amortization of acquired intangible assets.
2. In Q1 2024, the Group recognized $2m of exceptional costs
related to the acquisition and integration of the aseptic manufacturing site
acquired in November 2023. In Q1 2023, the Group recognized $12m of
exceptional costs related to the acquisition of Opiant.
3. In Q1 2023, the Group recognized $2m of exceptional costs in
preparation for an additional listing of Indivior shares on a major U.S.
exchange.
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 Q1 2024 and Q1 2023.
Reconciliation of gross profit to adjusted gross profit
2024 2023
For the three months ended March 31 $m $m
Gross profit 238 214
Exceptional items and other adjustments in cost of sales 3 -
Adjusted gross profit 241 214
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
2024 2023
For the three months ended March 31 $m $m
Selling, general and administrative expenses (145) (131)
Exceptional items and other adjustments in selling, general and administrative 2 14
expenses
Adjusted selling, general and administrative expenses (143) (117)
Reconciliation of operating profit to adjusted operating profit
2024 2023
For the three months ended March 31 $m $m
Operating profit 65 57
Exceptional items and other adjustments in cost of sales 3 -
Exceptional items and other adjustments in selling, general and administrative 2 14
expenses
Adjusted operating profit 70 71
We define adjusted operating margin as adjusted operating profit divided by
net revenue.
Reconciliation of profit before taxation to adjusted profit before taxation
2024 2023
For the three months ended March 31 $m $m
Profit before taxation 63 58
Exceptional items and other adjustments in cost of sales 3 -
Exceptional items and other adjustments in selling, general and administrative 2 14
expenses
Adjusted profit before taxation 68 72
Reconciliation of tax expense to adjusted tax expense
2024 2023
For the three months ended March 31 $m $m
Tax expense (16) (14)
Tax on exceptional items and other adjustments (1) (2)
Adjusted tax expense (17) (16)
We define adjusted effective tax rate as adjusted tax expense divided by
adjusted profit before taxation.
Reconciliation of net income to adjusted net income
2024 2023
For the three months ended March 31 $m $m
Net income 47 44
Exceptional items and other adjustments in cost of sales 3 -
Exceptional items and other adjustments in selling, general and administrative 2 14
expenses
Tax on exceptional items and other adjustments (1) (2)
Adjusted net income 51 56
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.
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