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Document The information contained within this announcement is deemed by the Company to constitute inside information as stipulated by the Market Abuse Regulation (EU) No.596 2014, as it forms part of UK law by virtue of

Key Takeaway: The information contained within this announcement is deemed by the Company to constitute inside information as stipulated by the Market Abuse Regulation (EU) No.596 2014, as it forms part of UK law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"). Upon the publicati

Full Press Release Details

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated by the Market Abuse Regulation (EU) No.596 2014, as it forms part of UK law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"). Upon the publication of this announcement, the inside information is now considered to be in the public domain.
July 27, 2023
Strong H1 and Q2 2023 Financial Results FY 2023 Guidance Raised Q2 2023 SUBLOCADE Net Revenue (NR) of $155m, +58% versus Q2 2022 OPVEE launch projected for Q4 2023 FY 2023 SUBLOCADE NR and overall NR guidance raised FY 2023 adjusted operating income now expected to be higher than FY 2022
Period to June 30th (Unaudited) Q2 2023 $m Q2 2022 $m % Change H1 2023 $m H1 2022 $m % Change
Net Revenue 276 221 25% 529 428 24%
Operating Profit 61 63 -3% 118 117 1%
Net Income 39 48 -19% 83 89 -7%
Diluted EPS 1 ($) $0.27 $0.33 -18% $0.59 $0.61 -3%
Adjusted Basis
Adj. Operating Profit 2 71 60 18% 142 114 25%
Adj. Net Income 2 56 45 24% 112 86 30%
Adj. Diluted EPS 1 2 ($) $0.39 $0.31 26% $0.79 $0.59 34%
1 On October 10, 2022, Indivior PLC completed a 5 1 share consolidation. The Company's basic and diluted weighted average number of shares outstanding, basic earnings per share, diluted earnings per share and adjusted earnings per share (basic and diluted) have been retrospectively adjusted to reflect the share consolidation in all the periods presented. See Note 6 for further discussion.
2 Adjusted Basis excludes the impact of exceptional items and other adjustments as referenced and reconciled in the Adjusted Results appendix on page 28. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with International Financial Reporting Standards.
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
This has been another strong quarter of financial results and delivery against our strategic priorities, and I would like to thank our teams for their unwavering dedication to our patients. The growth of SUBLOCADE (buprenorphine extended release) continues as we further increased the depth of prescribing in Organized Health Systems (OHS), in line with our strategy, and reached a major milestone of over 100,000 U.S. SUBLOCADE patients.
We also achieved additional key milestones to help secure our future growth potential and were pleased with the decision of the U.S. Food Drug Administration (FDA) to approve OPVEE (nalmefene) nasal spray, our new and differentiated overdose reversal agent for natural and synthetic opioids, such as fentanyl, and we remain on track for a fourth quarter launch. We were also excited to complete our additional listing on Nasdaq which we believe will provide us with a broadened platform to increase awareness of Indivior in the U.S. and the substance use disorder disease space. Finally, we made significant progress in addressing legacy litigation. As previously disclosed, during the quarter we were able to reach a settlement with a class of anti-trust plaintiffs, and are focused on resolving outstanding matters at the right value.
Our progress in the first six months and positive expectations for the remainder of the year support an increase to our guidance for 2023, and further reinforce our confidence in our attractive medium-term profitable growth aspirations.
H1 Q2 2023 Financial Highlights
H1 2023 total net revenue (NR) of $529m increased 24% (H1 2022 $428m) Q2 2023 total NR of $276m increased 25% (Q2 2022 $221m).
H1 2023 reported operating profit of $118m increased 1% (H1 2022 $117m) Q2 2023 reported operating profit of $61m declined 3% (Q2 2022 $63m). On an adjusted basis, H1 2023 operating profit of $142m increased 25% (Adjusted H1 2022 $114m). Adjusted Q2 2023 operating profit of $71m increased 18% (Adjusted Q2 2022 $60m).
H1 2023 reported net income of $83m decreased 7% (H1 2022 $89m) Q2 2023 reported net income of $39m declined 19% (Q2 2022 $48m). On an adjusted basis, H1 2023 net income of $112m increased 30% (Adjusted H1 2022 net income $86m). Adjusted Q2 2023 net income of $56m increased 24% (Adjusted Q2 2022 $45m).
Cash and investments totaled $782m at the end of H1 2023 (including $26m restricted for self-insurance) (FY 2022 $991m), primarily reflecting the net cash outflow of $124m for the Opiant acquisition and litigation settlement payments of $177m.
H1 Q2 2023 Operating Highlights
H1 2023 SUBLOCADE NR of $287m (+57% vs. H1 2022) Q2 2023 SUBLOCADE NR of $155m (+58% vs. Q2 2022 and +17% vs. Q1 2023). The strong growth primarily reflects further OHS channel penetration in the U.S. and increased new U.S. patient enrollments. Q2 2023 U.S. dispenses were approx. 124,800 units (+65% vs. Q2 2022 and +16% vs. Q1 2023). Total U.S. SUBLOCADE patients on a 12-month rolling basis at the end of Q2 2023 were approximately 107,600 (+65% vs. Q2 2022 and +14% vs. Q1 2023).
H1 2023 PERSERIS NR of $19m (+58% vs. H1 2022) Q2 2023 PERSERIS NR of $11m (+57% vs. Q2 2022 and +38% vs. Q1 2023) reflects increasing awareness of the treatment across the U.S. healthcare system.
SUBOXONE (buprenorphine naloxone) Film share in Q2 2023 averaged 19% (Q2 2022 19%) and exited the quarter at 19% (Q2 2022 19%).
FDA approval of OPVEE for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids.
On June 12, 2023, the Company's shares began trading on the Nasdaq Global Select Market under the symbol INDV . Indivior has retained its premium listing status on the London Stock Exchange and inclusion on the FTSE 250 index. No shares were offered as part of the additional U.S. listing.
Updated FY 2023 Guidance
The Group is updating its FY 2023 guidance to primarily reflect 1) increased NR expectations for SUBLOCADE based on the strong H1 2023 performance and expectations for the remainder of the year and 2) increased NR expectations for SUBOXONE Film due to the anticipated delayed timing of an approved fourth generic buprenorphine naloxone sublingual film entrant to the U.S. market. Guidance continues to assume 1) commercial launch of OPVEE in the fourth quarter and 2) no material change in exchange rates for key currencies compared with FY 2022 average rates, notably USD GBP and USD EUR.
Updated (July 27, 2023) Previous (April 27, 2023)
Net Revenue (NR) 1 $1,030m to $1,090m (+18% vs. FY 2022 at the mid-point) $970m to $1,040m (+12% vs. FY 2022 at the mid-point)
SUBLOCADE NR $590m to $630m (+50% vs. FY 2022 at the mid-point) $550m to $600m (+41% vs. FY 2022 at the mid-point)
PERSERIS NR No change $45m to $55m (+82% vs. FY 2022 at the mid-point)
SUBOXONE Film Market Share Accelerated rate of share decline in Q4 2023 2 , including the assumed impact from the launch of a fourth buprenorphine naloxone sublingual film generic entering the U.S. market in early Q4 2023 Accelerated rate of share decline in the H2 2023 2 , along with the assumed impact from the launch of a fourth buprenorphine naloxone sublingual film generic entering the U.S. market in H2 2023
Adjusted Gross Margin No change Low to mid 80% range
Adjusted SG A No change $530m to $540m
R D No change $90m to $100m
Adjusted Operating Profit Higher than FY 2022's adjusted operating income of $212m, as a result of higher NR guidance Slightly below FY 2022's adjusted operating income of $212m, as a result of the additional operating expenses associated with the Opiant acquisition, partially offset by higher NR guidance
1 FY 2023 NR from OPVEE is expected to be immaterial given the Q4 2023 launch timing
2 Reflecting underlying share erosion at a similar rate to the last two years (approximately 2 share points p.a.)
U.S. OUD Market Update
In Q2 2023, the U.S. buprenorphine medication-assisted treatment (BMAT) market grew in mid-single digits. The Group continues to expect long-term U.S. market 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 chronic disease of addiction and expand access to evidence-based buprenorphine treatment in the U.S. and supports these actions.
Financial Performance H1 and Q2 2023
Total net revenue in H1 2023 increased 24% to $529m (H1 2022 $428m) at actual exchange rates (+25% at constant exchange rates). In Q2 2023, total net revenue increased 25% at actual exchange rates (+25% at constant exchange rates) to $276m (Q2 2022 $221m).
U.S. net revenue increased 26% in H1 2023 to $435m (H1 2022 $344m) and by 26% in Q2 2023 to $226m (Q2 2022 $179m). Strong year-over-year SUBLOCADE and PERSERIS volume growth, along with underlying BMAT market growth were the principal drivers of the net revenue increase in both periods.
Rest of World (ROW) net revenue increased 12% at actual exchange rates in H1 2023 to $94m (H1 2022 $84m) (+18% at constant exchange rates1). In Q2 2023, ROW net revenue increased 19% at actual exchange rates to $50m (Q2 2022 $42m) (+20% at constant exchange rates1). In both the period and quarter, positive contributions from new products (SUBLOCADE SUBUTEX Prolonged Release and SUBOXONE Film) were partially offset by ongoing competitive pressure on legacy tablet products. Unfavorable foreign currency translation also impacted underlying growth. H1 2023 and Q2 2023 SUBLOCADE SUBUTEX Prolonged Release net revenue in ROW were $20m (H1 2022 $12m) and $10m (Q2 2022 $6m) at actual exchange rates, respectively.
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 H1 2023 was 83% (H1 2022 82%) and 82% in Q2 2023 (Q2 2022 83%), respectively. Excluding $2m of other adjustments for amortization of acquired intangible assets within cost of sales, adjusted gross margin in H1 2023 and Q2 2023 was 84% and 83%, respectively. The adjusted gross margin improvement for H1 2023 primarily reflects an improved product mix from the continued growth of SUBLOCADE. These benefits were partially offset by cost inflation. Adjusted Q2 2023 gross margin was essentially unchanged versus the same year-ago quarter.
SG A expenses as reported in H1 2023 were $264m (H1 2022 $217m) and $133m as reported in Q2 2023 (Q2 2022 $109m). H1 2023 and Q2 2023 included $22m and $8m, respectively, of exceptional costs related to the acquisition of Opiant Pharmaceuticals, Inc. and to the preparation of the additional listing of Indivior shares on Nasdaq. H1 2022 and Q2 2022 included $2m of exceptional consulting costs incurred in preparation for the additional listing of Indivior shares on the Nasdaq.
Excluding exceptional items, H1 2023 SG A expense increased 13% to $242m (Adjusted H1 2022 $215m) Q2 2023 SG A expense increased 17% to $125m (Adjusted Q2 2022 $107m). The increases in both periods primarily reflect higher personnel related expenses, legal defense costs, and cost inflation.
R D expenses in H1 2023 and Q2 2023 were $59m and $32m, respectively (H1 2022 $23m Q2 2022 $14m), and represented increases of 157% and 129%, respectively. The increases in both periods were primarily due to a greater activity level related to certain post-marketing studies for SUBLOCADE and PERSERIS, process validation testing related to LAI (long-acting injectable) capacity expansion and the start-up of OPVEE production, as well as ongoing early-stage pipeline activities, including pipeline assets from the Opiant acquisition.
Net other operating income in H1 2023 and Q2 2023 was $1m and $nil, respectively, (H1 2022 $4m income Q2 2022 $3m income). H1 2022 and Q2 2022 included $5m of exceptional benefit related to a Directors' Officers' insurance claim settlement.
Operating profit as reported was $118m in H1 2023 (H1 2022 $117m). Exceptional costs and other adjustments of $24m are included in the current period. Net exceptional benefits of $3m were included in H1 2022. On an adjusted basis, H1 2023 operating profit increased 25% to $142m (H1 2022 $114m). The increases on a reported and adjusted basis primarily reflected higher NR from the Group's LAI products, partially offset by increased SG A and R D expenses, as described above.
Q2 2023 operating profit as reported was $61m (Q2 2022 $63m). Exceptional costs and other adjustments of $10m are included in the current period while exceptional benefits of $3m were included in the year-ago period. On an adjusted basis, Q2 2023 operating profit increased 18% to $71m (Adjusted Q2 2022 $60m). The increase on an adjusted basis primarily reflected the same factors as noted above.
Net finance income as reported was $2m in H1 2023 (H1 2022 $11m expense). The change in net finance income (expense) reflected higher interest income earned on the Group's investments.
Reported tax expense was $37m in H1 2023, or a rate of 31% (H1 2022 tax expense $17m, 16%). Adjusted H1 2023 tax expense was $32m, excluding the $5m in exceptional tax items and tax expense on exceptional items and other adjustments, an effective tax rate of 22%. Exceptional tax items are comprised of a $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. The Q2 2023 reported tax expense was $23m, or a rate of 37% (Q2 2022 $10m, 17%). The tax expense on Q2 2023 adjusted profits amounted to $16m, excluding the $7m in tax related exceptional items and other adjustments, which represented an effective tax rate of 22%. There were no exceptional tax items recorded in H1 2022 and Q2 2022, respectively. The increase in the effective tax rate on adjusted profits was primarily driven by the increase in the UK corporation tax rate from 19% to 23.5%, and the temporary reduction in UK innovation incentives due to 2022 losses.
Reported and adjusted net income in H1 2023 was $83m and $112m, respectively (H1 2022 reported net income $89m H1 2022 Adjusted net income $86m). The increase in net income on an adjusted basis of 30% primarily reflected higher NR partially offset by the increase in operating expense. Q2 2023 net income on a reported basis was $39m (Q2 2022 $48m), and $56m on an adjusted basis excluding the net after-tax impact from exceptional items and other adjustments (Adjusted Q2 2022 $45m). Higher Q2 2023 net income on an adjusted basis was primarily due to strong NR growth.
Diluted earnings per share on a reported and adjusted basis were $0.59 and $0.79 in H1 2023, respectively (H1 2022 $0.61 earnings per share on a diluted basis and $0.59 earnings per share adjusted diluted basis). In Q2 2023, diluted earnings per share and adjusted diluted earnings per share were $0.27 and $0.39, respectively (Q2 2022 $0.33 earnings per share on a diluted basis and $0.31 earnings per share adjusted diluted basis).
Balance Sheet Cash Flow
Cash and investments totaled $782m at the end of Q2 2023, a decrease of $209m versus the $991m position at year-end 2022. Generation of cash primarily from operating profit of $118m in H1 2023 was offset by the net cash outflow of $124m for the Opiant acquisition, including the transferred cash balance, settlement payment of $103m related to the multidistrict antitrust class state claims (refer to Note 13), in addition to the Group's scheduled litigation settlement payments totaling $74m primarily for the Department of Justice (DOJ), Reckitt Benckiser (RB) and Dr. Reddy's Laboratories (DRL) matters.
See also Risk Factor Update below.
Net working capital, defined by management as inventory plus trade receivables, less trade and other payables, was negative $329m on June 30, 2023, versus negative $283m at the end of FY 2022. The change in the period was primarily a result of timing of payments made on government rebate and trade payables.
Cash used in operations in H1 2023 was $26m (H1 2022 cash used $14m), primarily due to settlement payments related to the multidistrict antitrust class state claims, DOJ Resolution, DRL settlement, RB settlement and timing of payments made on government rebate and trade payables. Before these settlement related items, cash generated from operations in the current period was $151m. Net cash outflow from operating activities was $55m in H1 2023 (H1 2022 cash outflow $48m) reflecting tax payments and interest paid on the Group's term loan facility and settlement payments, partially offset by interest received on investments.
H1 2023 cash outflow from investing activities was $103m (H1 2022 cash outflow $162m) which reflects $124m for the Opiant acquisition, net of cash assumed. In the prior year period, the outflow from investing activities primarily reflects the net investment in a portfolio of investment-grade debt securities and ordinary shares of Aelis Farma.
H1 2023 cash outflow from financing activities was $24m (H1 2022 cash outflow $34m) reflecting the extinguishment of debt assumed in the Opiant acquisition, as well as shares repurchased and cancelled, 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.
Indivior's quarterly R D and pipeline update may be found on our website, www.indivior.com under the tab Our Science Pipeline. Information contained in or accessible through our website should not be considered a part of this press release.
The nature and potential impact of the principal risks, uncertainties, and emerging risks facing the Group did not change in the first half of 2023, and are not expected to change in the second half of 2023, except for legal and intellectual property
As discussed in Note 13 "Legal Proceedings", the Group is a party to legacy lawsuits filed by various private plaintiffs alleging violations of civil antitrust laws and other claims relating to the Group's marketing of SUBOXONE Film. A majority of those actions have been consolidated in multidistrict litigation (the "Antitrust MDL") in the Eastern District of Pennsylvania.
In 2022, the Group recorded a provision of $290m for the purpose of settlement with respect to the Antitrust MDL claims filed by all three plaintiff classes. On June 1, 2023, the Group reached a settlement with one of those classes, the states, for $103m. The settlement is consistent with the 2022 Provision, which has been reduced by the $103m payment made to the states.
As mentioned in Note 1, Basis of Preparation and Accounting Policies , and Note 13, Legal Proceedings , the Group has not reached a settlement with the end payors class or direct purchasers class.
The Directors continue to believe the near-term litigation outcomes can be appropriately managed and that, should such ongoing legal proceedings go to trial, the Group has meritorious defenses against liability, and meritorious arguments that could substantially reduce claimed damages, should liability be found. However, if Indivior Inc. were found liable in respect of the remaining claims filed by various private plaintiffs alleging violations of civil antitrust laws and other claims relating to the Group's marketing of SUBOXONE Film (the "Antitrust MDL ), if the Plaintiffs were awarded damages, and if the Group were to be unable to significantly reduce the claimed damages at trial or in any subsequent proceeding (and considering treble damages to be awarded under U.S. antitrust laws), then the Group's financial position, results and future cash flows would be materially adversely affected and the amount of damages would exceed the Group's resources to pay. There is a reasonable prospect the timing of any appeal (or any subsequent proceeding) and or required payment of the damages could now fall within the going concern period.
Notwithstanding the Group's belief that it can appropriately manage the remaining claims has not changed (including no change in the quantum of provision recognized for settlement purposes) and that it has meritorious defenses against liability and meritorious arguments that could substantially reduce the claimed damages and any resulting award should it be found liable at trial, the Directors have concluded the possibility the Group could be found liable at trial in respect of the remaining claims and could be unable to reduce the damages at trial (or in any subsequent proceeding) within the current going concern period represents a material uncertainty that may cast significant doubt upon the Group's ability to continue to adopt the going concern basis of accounting in the future. Nevertheless, the Directors have concluded the going concern basis of accounting remains appropriate for the accounting and preparation of these Condensed Financial Statements, with the addition of the material uncertainty as described above. See Note 1 Basis of Preparation and Accounting Policies".
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
6 Months to June 30, 2023 6 Months to June 30, 2022
GB period end 1.2648 1.2194
GB average rate 1.2329 1.3015
Euro period end 1.0911 1.0524
Euro average 1.0807 1.0952
A live webcast presentation will be held on July 27, 2023, at 13 00 BST (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.
The webcast link https edge.media-server.com mmc p z4yh2znf
Participants may access the presentation telephonically by registering with the following link
https register.vevent.com register BI80255ae130d847e3944c2584e201ae3e
(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
The person responsible for the release of this announcement on behalf of Indivior for the purposes of MAR is Kathryn Hudson (Company Secretary).
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.
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 39 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, statements regarding the Indivior Group's financial guidance for 2023 and its medium- and long-term growth outlook strategies for value creation expectations for sales levels for particular products expectations regarding the cost to resolve the Group's legal proceedings and regulatory matters expected market growth rates, growing normalization of medically assisted treatment for opioid use disorder, and expanded access to treatment expected changes in market share future exchange rates operational goals 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 the extent and impact of competition 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, some of which are controlled substances market acceptance of our products as well as our ability to commercialize our products and compete with other market participants the uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process our dependence on a small number of significant customers our ability to retain key personnel or attract new personnel 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 use of hazardous materials in our manufacturing facilities our import, manufacturing and distribution of controlled substances 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 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.
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
Q2 2023 Q2 2022 H1 2023 H1 2022
For the three and six months ended June 30 Notes $m $m $m $m
Net Revenue 2 276 221 529 428
Cost of sales (50) (38) (89) (75)
Gross Profit 226 183 440 353
Selling, general and administrative expenses 3 (133) (109) (264) (217)
Research and development expenses 3 (32) (14) (59) (23)
Net other operating income 3 - 3 1 4
Operating Profit 61 63 118 117
Finance income 4 11 2 21 2
Finance expense 4 (10) (7) (19) (13)
Net Finance Income (Expense) 1 (5) 2 (11)
Profit Before Taxation 62 58 120 106
Income tax expense 5 (23) (10) (37) (17)
Net Income 39 48 83 89
Earnings per ordinary share (in dollars)*
Basic earnings per share 6 $0.28 $0.34 $0.61 $0.63
Diluted earnings per share 6 $0.27 $0.33 $0.59 $0.61
* Basic and diluted earnings per share reflect the impact of the Company's share consolidation for all periods presented. Refer to Note 6 for further details.
Unaudited condensed consolidated interim statement of comprehensive income
Q2 2023 Q2 2022 H1 2023 H1 2022
For the three and six months ended June 30 $m $m $m $m
Net income 39 48 83 89
Other comprehensive income (loss)
Items that may be reclassified to profit or loss in subsequent years
Foreign currency translation adjustment, net 4 (14) 4 (20)
Other comprehensive income (loss) 4 (14) 4 (20)
Total comprehensive income 43 34 87 69
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated interim balance sheet
Jun 30, 2023 Dec 31, 2022
Notes $m $m
ASSETS
Non-current assets
Intangible assets 7 199 70
Property, plant and equipment 54 54
Right-of-use assets 35 31
Deferred tax assets 5 210 219
Investments 8 93 98
Other assets 9 46 38
637 510
Current assets
Inventories 131 114
Trade receivables 229 220
Other assets 9 34 27
Current tax receivable 5 11 5
Investments 8 97 119
Cash and cash equivalents 592 774
1,094 1,259
Total assets 1,731 1,769
LIABILITIES
Current liabilities
Borrowings 10 (3) (3)
Provisions 11 (196) (303)
Other liabilities 11 (70) (79)
Trade and other payables 14 (689) (617)
Lease liabilities (9) (8)
Current tax liabilities 5 (5) (9)
(972) (1,019)
Non-current liabilities
Borrowings 10 (236) (237)
Provisions 11 (5) (5)
Other liabilities 11 (368) (428)
Lease liabilities (33) (29)
(642) (699)
Total liabilities (1,614) (1,718)
Net assets 117 51
EQUITY
Capital and reserves
Share capital 15 69 68
Share premium 9 8
Capital redemption reserve 6 6
Other reserve (1,295) (1,295)
Foreign currency translation reserve (35) (39)
Retained earnings 1,363 1,303
Total equity 117 51
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, 2022 70 7 3 (1,295) (20) 1,438 203
Comprehensive income
Net income - - - - - 89 89
Other comprehensive loss - - - - (20) - (20)
Total comprehensive income - - - - (20) 89 69
Transactions recognized directly in equity
Shares issued 1 - - - - - 1
Share-based plans - - - - - 7 7
Settlement of tax on equity awards - - - - - (10) (10)
Shares repurchased and cancelled (1) - 1 - - (29) (29)
Transfer to share repurchase liability - - - - - (13) (13)
Taxation on share-based plans - - - - - 2 2
Balance at June 30, 2022 70 7 4 (1,295) (40) 1,484 230
Balance at January 1, 2023 68 8 6 (1,295) (39) 1,303 51
Comprehensive income
Net income - - - - - 83 83
Other comprehensive income - - - - 4 - 4
Total comprehensive income - - - - 4 83 87
Transactions recognized directly in equity
Shares issued 1 1 - - - - 2
Share-based plans - - - - - 11 11
Settlement of tax on equity awards - - - - - (21) (21)
Shares repurchased and cancelled - - - - - (11) (11)
Transfer from share repurchase liability - - - - - 9 9
Taxation on share-based plans - - - - - (11) (11)
Balance at June 30, 2023 69 9 6 (1,295) (35) 1,363 117
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated interim cash flow statement
2023 2022
For the six months ended June 30 $m $m
CASH FLOWS FROM OPERATING ACTIVITIES
Operating Profit 118 117
Depreciation and amortization of property, plant and equipment and intangible assets 7 7
Depreciation of right-of-use assets 5 4
Gain on disposal of intangible assets - (1)
Share-based payments 11 7
Impact from foreign exchange movements 2 (6)
Unrealized (gain) loss on equity investment (1) 2
Settlement of tax on employee awards (21) (10)
(Increase) decrease in trade receivables (8) 3
(Increase) decrease in current and non-current other assets (8) 3
Increase in inventories (11) (10)
Increase (decrease) in trade and other payables 60 (29)
Decrease in provisions and other liabilities 1 (180) (101)
Cash used in operations (26) (14)
Interest paid (17) (13)
Interest received 21 1
Taxes paid (33) (21)
Transaction costs related to debt refinancing - (1)
Net cash outflow from operating activities (55) (48)
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of assets, net of cash acquired (refer to Note 16) (124) -
Purchase of property, plant and equipment (2) (2)
Purchase of investments (36) (171)
Maturity of investments 64 10
Purchase of intangible asset (5) -
Proceeds from disposal of intangible assets - 1
Net cash outflow from investing activities (103) (162)
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of borrowings (11) (1)
Principal elements of lease payments (4) (4)
Shares repurchased and cancelled (11) (29)
Proceeds from the issuance of ordinary shares 2 -
Net cash outflow from financing activities (24) (34)
Exchange difference on cash and cash equivalents - (1)
Net decrease in cash and cash equivalents (182) (245)
Cash and cash equivalents at beginning of the period 774 1,102
Cash and cash equivalents at end of the period 592 857
1Changes in the line item provisions and other liabilities for H1 2023 include litigation settlement payments totaling $177m (H1 2022 $108m). $3m of interest paid on the DOJ Resolution in H1 2023 has been recorded in the interest paid line item (H1 2022 $4m).
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 UK adopted International Accounting Standard 34, Interim Financial Reporting ("IAS 34"). 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, 2022, which were prepared in accordance with UK-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 July 26, 2023.
In May 2023, the International Accounting Standards Board issued International Tax Reform-Pillar Two Model Rules which amended IAS 12 Income Taxes. Refer to Note 5 for details.
In 2023, the Group acquired 100% of the share capital of Opiant Pharmaceuticals, Inc. ("Opiant") which has been accounted for as an asset acquisition as substantially all of the fair value of the gross assets acquired is concentrated in the value of the in-process research and development. The Group has disclosed new accounting policies in Note 16 regarding the policy elected for treatment of contingent consideration and the method used to evaluate whether an acquisition is a business combination or asset acquisition.
Following the effectiveness of the additional U.S. listing of Indivior shares, presentation of exceptional items and adjusted results has been removed from the Condensed Financial Statements. This change creates consistency with presentation of financial statements included in Indivior's SEC registration statement and better aligns to the market practice for companies with U.S. listings. The change has been applied to all periods presented.
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, 2022, except for estimates used in determining the valuation of the in-process research and development associated with the acquisition of Opiant and changes in estimates that are required in determining the provision for income taxes.
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 debt facility for the period to December 2024 (the going concern period). A base case model was produced reflecting
Board approved forecasts and financial plans for the period
Last updated: Jul 27, 2023