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INDV Positive Sentiment Score: 75/100

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Key Takeaway: Indivior PLC reported strong financial performance in Q3 2023, with SUBLOCADE's net revenue up 55% year-over-year, driving a total net revenue increase of 21% for the year to date. The launch of OPVEE and securing a BARDA contract signify important strategic advancements for the company. However, despite some positive financial indicators, Indivior faced significant operating losses primarily due to legal expenditures related to antitrust claims and lower guidance for PERSERIS revenue. Overall, Indivior maintains an optimistic outlook for FY 2023, projecting continued growth in its revenue streams.

Market Sentiment Analysis

POSITIVE FACTORS

  • SUBLOCADE net revenue increased by 55% year-over-year, highlighting strong market performance.
  • Indivior secured a BARDA contract underlining its strategic advancement in emergency opioid treatment.
  • Adjusted net income for YTD 2023 grew by 25%, showcasing financial resilience despite challenges.

CONCERNS & RISKS

  • The company reported an operating loss of $65 million YTD 2023, indicating financial strain.
  • Legal costs related to antitrust litigation have significantly impacted operating margins.
  • Expectations for PERSERIS revenue are at the lower end of guidance, reflecting increased competitive pressures.

Full Press Release Details

November 9, 2023
Strong Top-line Performance and Strategic Progress in Q3 2023 Q3 2023 SUBLOCADE Net Revenue (NR) of $167m, +55% versus Q3 2022 FY 2023 SUBLOCADE NR now expected to be $610m to $630m (vs. $590m to $630m) OPVEE launched U.S. Biomedical Advanced Research and Development Authority (BARDA) contract secured
Period to September 30th (Unaudited) Q3 2023 $m Q3 2022 $m % Change YTD 2023 $m YTD 2022 $m % Change
Net Revenue 271 232 17% 800 659 21%
Operating (Loss) Profit 1 (183) 56 NM (65) 173 NM
Net (Loss) Income 1 (135) 41 NM (52) 130 NM
Diluted (LPS) EPS 1 2 ($) $(0.98) $0.28 NM $(0.38) $0.89 NM
Adjusted Basis
Adj. Operating Profit 3 60 58 3% 202 172 17%
Adj. Net Income 3 49 43 14% 162 130 25%
Adj. Diluted EPS 2 3 ($) $0.34 $0.29 17% $1.14 $0.89 28%
1 Includes the impacts of exceptional 2023 provision increases of $228m and $12m related to certain antitrust multi-district class claims ( Antitrust MDL ) and an intellectual property-related litigation matter, respectively. See Note 11 and Note 13 for additional details.
2 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.
3 Adjusted Basis excludes the impact of exceptional items and other adjustments as referenced and reconciled in the Adjusted Results appendix on page 27. Adjusted results are not a substitute for, or superior to, reported results presented in accordance with International Financial Reporting Standards.
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 quarter has again demonstrated the commitment and capabilities of the Indivior team. We delivered double-digit top-line performance led by strong growth of SUBLOCADE (buprenorphine extended release), which continues to shift the paradigm for the treatment of opioid use disorder (OUD). Additionally, we made good progress against our strategic priorities, with the launch of OPVEE (nalmefene) nasal spray as well as key transactions to strengthen our pipeline and to secure long-term product supply. Lastly, we settled the antitrust multi-district litigation, which provides more certainty for our stakeholders and allows for even greater focus on serving the needs of patients with substance use disorders and mental illness.
YTD Q3 2023 Financial Highlights
YTD 2023 total net revenue (NR) of $800m increased 21% (YTD 2022 $659m) Q3 2023 total NR of $271m increased 17% (Q3 2022 $232m).
YTD 2023 reported operating loss was $65m (YTD 2022 $173m profit) Q3 2023 reported operating loss was $183m (Q3 2022 $56m profit). On an adjusted basis, YTD 2023 operating profit of $202m increased 17% (Adjusted YTD 2022 $172m). Adjusted Q3 2023 operating profit of $60m increased 3% (Adjusted Q3 2022 $58m).
YTD 2023 reported net loss was $52m (YTD 2022 $130m net income) Q3 2023 reported net loss was $135m (Q3 2022 $41m net income). On an adjusted basis, YTD 2023 net income of $162m increased 25% (Adjusted YTD 2022 $130m). Adjusted Q3 2023 net income of $49m increased 14% (Adjusted Q3 2022 $43m).
Cash and investments totaled $774m at the end of Q3 2023 (including $26m restricted for self-insurance) (FY 2022 $991m), primarily reflecting the YTD 2023 net cash outflow of $124m for the Opiant acquisition and litigation settlement related outflows of $207m.
YTD Q3 2023 Product Highlights
SUBLOCADE YTD 2023 NR of $454m (+57% vs. YTD 2022) Q3 2023 NR of $167m (+55% vs. Q3 2022 and +8% vs. Q2 2023). Continued strong growth primarily reflects further organized health system (OHS) channel penetration in the U.S. and increased new U.S. patient enrollments. Q3 2023 U.S. dispenses were approx. 133,600 units (+59% vs. Q3 2022 and +7% vs. Q2 2023). Total U.S. patients on a 12-month rolling basis at the end of Q3 2023 were approximately 121,600 (+65% vs. Q3 2022 and +13% vs. Q2 2023).
PERSERIS (risperidone extended release) YTD 2023 NR of $30m (+50% vs. YTD 2022) Q3 2023 NR of $11m (+38% vs. Q3 2022 and unchanged vs. Q2 2023) reflects increasing awareness of the treatment across the U.S. healthcare system.
SUBOXONE (buprenorphine naloxone) Film U.S. share in Q3 2023 averaged 18% (Q3 2022 19%) and exited the quarter at 19% (Q3 2022 19%).
Resolution of Antitrust Multi-District Litigation
On October 22, Indivior reached an agreement to resolve the claims brought by the direct purchasers in the Antitrust MDL. The agreement with the direct purchasers will mark the conclusion of the MDL, once the settlements for the direct purchasers and end payors are finally approved by the United States District Court for the Eastern District of Pennsylvania. As part of the Agreement with the direct purchasers, Indivior will pay $385m and has taken a charge of $228m in the third quarter, which is excluded from adjusted earnings and represents the additional amount above the previously recorded provision for the Antitrust MDL. Payment of $385m is expected to be made in November 2023 and funded from Indivior's existing cash.
Key Corporate Developments
Launched OPVEE in October for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids and was awarded a contract1 up to 10 years by the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50123C00068 initially worth up to $32m to support FDA-required post-marketing requirement studies, 3-year stability study to support shelf-life extension, real world evidence studies, and potential procurement of finished, packaged OPVEE held as vendor-managed inventory (VMI) as a medical counter measure in the event of an opioid community or mass casualty event.
Acquired full ownership of INDV-2000 (oral Orexin-1 receptor antagonist - non opioid mechanism for OUD) from C4X Discovery.
Secured global rights to Alar Pharmaceuticals' portfolio of buprenorphine-based ultra long-acting injectables to help address unmet patient needs. This includes Alar's lead asset, ALA-1000, which is potentially the first three-month long-acting injectable for OUD.
Acquired, in the fourth quarter, an aseptic manufacturing facility in Raleigh, North Carolina to secure long-term production and supply of SUBLOCADE and PERSERIS.
The Group continues to expect FY 2023 net revenue (NR) in the range of $1,030m to $1,090m, reflecting growth of 18% at the mid-point compared with FY 2022. Within the total, the Group now expects SUBLOCADE NR to be $610m to $630m (versus the previous range of $590m to $630m), based on continued strong performance in the OHS channel (including the Criminal Justice System), while PERSERIS NR is expected to be at the lower end of the $45m to $55m guidance range, reflecting YTD results and near-term competitive pressures. The Group now expects adjusted SG A of $540m to $550m, modestly above previous guidance of $530m to $540m, reflecting targeted investments to accelerate SUBLOCADE growth as well as higher legal defense expenses. Overall, the Group continues to expect adjusted operating profit to be higher than FY 2022. Guidance continues to assume no material change in exchange rates for key currencies compared with FY 2022 average rates, notably USD GBP and USD EUR.
1 This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services Administration for Strategic Preparedness and Response Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00068.
Updated (November 9, 2023) July 27, 2023
Net Revenue (NR) 1 No change $1,030m to $1,090m (+18% vs. FY 2022 at the mid-point)
SUBLOCADE NR $610m to $630m (+52% vs. FY 2022 at the mid-point) $590m to $630m (+50% vs. FY 2022 at the mid-point)
PERSERIS NR Lower end of $45m to $55m $45m to $55m (+79% vs. FY 2022 at the mid-point)
SUBOXONE Film Market Share Accelerated rate of share decline in Q4 2023 2 , including the impact from the launch of a fourth buprenorphine naloxone sublingual film generic in the U.S. market 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
Adjusted Gross Margin No change Low to mid 80% range
Adjusted SG A $540m to $550m (+$10m) $530m to $540m
R D No change $90m to $100m
Adjusted Operating Profit No change Higher than FY 2022's adjusted operating income of $212m, as a result of 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
YTD 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 YTD and Q3 2023
Total net revenue in YTD 2023 increased 21% to $800m (YTD 2022 $659m) at actual exchange rates (+22% at constant exchange rates2). In Q3 2023, total net revenue increased 17% at actual exchange rates (+16% at constant exchange rates2) to $271m (Q3 2022 $232m).
U.S. net revenue increased 24% in YTD 2023 to $662m (YTD 2022 $533m) and by 20% in Q3 2023 to $227m (Q3 2022 $189m). 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 10% at actual exchange rates in YTD 2023 to $138m (YTD 2022 $126m) (+10% at constant exchange rates2). In Q3 2023, ROW net revenue increased 2% at actual exchange rates to $44m (Q3 2022 $43m) (unchanged at constant exchange rates2). In both the period and quarter, positive contributions from new products (SUBLOCADE SUBUTEX Prolonged Release and SUBOXONE Film) were essentially offset primarily by ongoing competitive pressure on legacy tablet products. YTD 2023 and Q3 2023 SUBLOCADE SUBUTEX Prolonged Release net revenue in ROW were $30m (YTD 2022 $19m) and $10m (Q3 2022 $7m) at actual exchange rates, respectively.
Gross margin as reported in YTD 2023 and Q3 2023 was 83% (YTD 2022 and Q3 2022 83%), respectively. Excluding $5m and $3m of other adjustments for amortization of acquired intangible assets within cost of sales, adjusted gross margin in YTD 2023 and Q3 2023 was 84%, respectively. There were no adjustments to YTD 2022 or Q3 2022 gross margin. The increase in the adjusted gross margin rate in 2023 primarily reflects an improved product mix from the continued growth of SUBLOCADE. These benefits were partially offset by cost inflation.
2 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.
SG A expenses as reported in YTD 2023 were $654m (YTD 2022 $331m) and $390m as reported in Q3 2023 (Q3 2022 $115m). YTD 2023 and Q3 2023 included $240m, respectively, of exceptional costs related to the increase in provisions related to the Antitrust MDL and an intellectual property-related matter. YTD 2023 also included $22m of exceptional costs related to the acquisition of Opiant and U.S. listing costs (YTD 2022 and Q3 2022 included $4m and $2m of exceptional U.S. listing costs, respectively).
Excluding exceptional items, YTD 2023 SG A expense increased 20% to $392m (Adjusted YTD 2022 $327m) Q3 2023 SG A expense increased 33% to $150m (Adjusted Q3 2022 $113m). The increases in both periods primarily reflect higher expenses related to increased legal defense costs, the addition of the Opiant business and launch expenses for OPVEE, increased SUBLOCADE commercial investments, and cost inflation.
R D expenses in YTD 2023 and Q3 2023 were $77m and $18m, respectively (YTD 2022 $43m Q3 2022 $20m) and represented an increase of 79% and a decrease of 10%, respectively. The increase in the YTD period was primarily due to a greater activity level related to post-marketing studies for SUBLOCADE, process validation testing related to LAI (long-acting injectable) capacity expansion and phasing of ongoing early-stage pipeline activities. The decline in Q3 2023 was primarily due to high-single digit credits from previously expensed process validation activities related to the LAI capacity expansion for SUBLOCADE, which is now substantially complete.
Net other operating income in YTD 2023 and Q3 2023 was $1m and $nil, respectively, (YTD 2022 $3m income Q3 2022 $1m loss). YTD 2022 included $5m of exceptional benefit related to a Directors' Officers' insurance claim settlement.
Operating loss as reported was $65m in YTD 2023 (YTD 2022 $173m profit). Exceptional costs and other adjustments of $267m primarily related to the settlement of the Antitrust MDL are included in the current period. Net exceptional benefits of $1m were included in YTD 2022. The change on a reported basis reflects the exceptional charges related to legal matters. On an adjusted basis, YTD 2023 operating profit increased 17% to $202m (YTD 2022 $172m). The increases on an adjusted basis primarily reflected higher NR from the Group's LAI products, partially offset by increased SG A (including Opiant business and launch expenses for OPVEE) and R D expenses, as described above.
Q3 2023 operating loss as reported was $183m (Q3 2022 $56m profit). Exceptional costs and other adjustments of $243m are included in the current period and exceptional costs of $2m were included in the year-ago period. The change on a reported basis reflects the exceptional charges related to legal matters. On an adjusted basis, Q3 2023 operating profit increased 3% to $60m (Adjusted Q3 2022 $58m). The increases on an adjusted basis primarily reflected higher NR from the Group's LAI products, partially offset by increased SG A (including Opiant business and launch expenses for OPVEE), as described above.
Net finance income as reported was $4m in YTD 2023 (YTD 2022 $13m expense). The change in net finance income (expense) reflected higher interest rates on the Group's investments. We expect investment income may not offset interest expense in the medium-term as we use cash for the litigation settlements.
Reported tax benefit was $9m in YTD 2023, or a rate of 15% (YTD 2022 tax expense $30m, 19%). Adjusted YTD 2023 tax expense was $44m, excluding the $53m in tax benefit on exceptional items and other adjustments net of exceptional tax items, an effective tax rate of 21%. 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. Adjusted YTD 2022 tax expense was $29m, excluding the $1m tax expense on exceptional items and other adjustments, an effective tax rate of 18%. 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.
The Q3 2023 reported tax benefit was $46m, or a rate of 25% (Q3 2022 $13m expense, 24%). The tax expense on Q3 2023 adjusted profits amounted to $13m, excluding the $59m tax benefit on exceptional items and other adjustments, which represented an effective tax rate of 21%. There were no exceptional tax items recorded in Q3 2022.
Reported net loss in YTD 2023 was $52m and adjusted net income was $162m (YTD 2022 reported net income $130m YTD 2022 Adjusted net income $130m). The 25% increase in net income on an adjusted basis primarily reflected higher NR partially offset by the increase in operating expense. Q3 2023 net loss on a reported basis was $135m (Q3 2022 net income $41m), and $49m net income on an adjusted basis excluding the net after-tax impact from exceptional items and other adjustments (Adjusted Q3 2022 $43m profit). Higher Q3 2023 net income on an adjusted basis was primarily due to strong NR growth.
Diluted (loss) earnings per share were $(0.38) on a reported basis and $1.14 on an adjusted basis in YTD 2023 (YTD 2022 $0.89 earnings per share on a diluted basis and $0.89 earnings per share adjusted diluted basis). In Q3 2023, diluted (loss) earnings per share were $(0.98) and adjusted diluted earnings per share were $0.34 (Q3 2022 $0.28 earnings per share on a diluted basis and $0.29 earnings per share adjusted diluted basis).
Balance Sheet Cash Flow
Cash and investments totaled $774m at the end of Q3 2023, a decrease of $217m versus the $991m position at year-end 2022. The decrease was primarily due to the net cash outflow of $124m for the Opiant acquisition, including the transferred cash balance, and litigation settlement related outflows of $207m, partially offset by beneficial timing of payments made on government rebate and trade payables. The litigation settlement related outflows include the Antitrust MDL settlement payment of $103m with States (refer to Note 13), transfer of $30m into an escrow account for the settlement with the Antitrust MDL end payors, subject to final court approval (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.
Net working capital, defined by management as inventory plus trade receivables, less trade and other payables, was negative $327m on September 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 YTD 2023 was $2m (YTD 2022 cash provided by operations $63m), primarily due to payments related to the Antitrust MDL, 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 $205m. Net cash outflow from operating activities was $34m in YTD 2023 (YTD 2022 cash inflow $14m) reflecting tax payments and interest paid on the Group's term loan facility and settlement payments, partially offset by interest received on investments.
YTD 2023 cash outflow from investing activities was $104m (YTD 2022 cash outflow $221m) 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 (net) and ordinary shares of Aelis Farma.
YTD 2023 cash outflow from financing activities was $25m (YTD 2022 cash outflow $72m) reflecting the extinguishment of debt assumed in the Opiant acquisition, 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 for employee compensation agreements. In the prior year period, the outflow from financing activities primarily reflects shares repurchased and cancelled.
Indivior's 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 Group utilizes a formal process to identify, evaluate and manage significant risks. The Directors have reviewed the principal risks and uncertainties for the remainder of the 2023 financial year. The principal risks and uncertainties affecting the Group's business activities are detailed on pages 58 to 66 of the Indivior PLC Annual Report and Accounts 2022.
As reported with our half-year results, the nature and potential impact of the principal risks, uncertainties, and emerging risks facing the Group did not change, and were not expected to change for the remainder of 2023, except for legal and intellectual property related risks because of the Antitrust MDL. However, as discussed in Note 11 "Provisions and Other Liabilities" and Note 13 "Legal Proceedings", on October 22, 2023, the Group entered into a settlement agreement with the remaining plaintiff, and settlement agreements have now been entered with all classes of plaintiffs to fully resolve anti-trust claims without the need for any trial. The settlement with the last class of plaintiffs removed the uncertainties related to the Antitrust MDL and the material uncertainty about the Group's ability to continue to adopt the going concern basis of accounting.
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
9 Months to September 30, 2023 9 Months to September 30, 2022
GB period end 1.2125 1.1170
GB average rate 1.2444 1.2609
Euro period end 1.0503 0.9807
Euro average 1.0835 1.0664
A live webcast presentation will be held on November 9th, 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 stcq4w5c
Participants may access the presentation telephonically by registering with the following link
https register.vevent.com register BIf8e71289ddc241b399540e669d753461
(Registrants will have an option to be called back directly immediately prior to the call or be provided a call-in # with a unique pin code following their registration)
For Further Information
Investor Enquiries Jason Thompson VP, Investor Relations Indivior PLC +1 804 402 7123 jason.thompson indivior.com
Tim Owens Director, Investor Relations Indivior PLC +1 804 263 3978 timothy.owens indivior.com
Media Enquiries Jonathan Sibun Teneo U.S. Media Inquiries +44 (0)20 7353 4200 +1 804 594 0836 Indiviormediacontacts indivior.com
Corporate Website www.indivior.com
This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Group to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.
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 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 and operational goals expectations for sales levels for particular products 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 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
Q3 2023 Q3 2022 YTD 2023 YTD 2022
For the three and nine months ended September 30 Notes $m $m $m $m
Net Revenue 2 271 232 800 659
Cost of sales (46) (40) (135) (115)
Gross Profit 225 192 665 544
Selling, general and administrative expenses 3 (390) (115) (654) (331)
Research and development expenses 3 (18) (20) (77) (43)
Net other operating (loss) income - (1) 1 3
Operating (Loss) Profit (183) 56 (65) 173
Finance income 4 12 6 33 8
Finance expense 4 (10) (8) (29) (21)
Net Finance Income (Expense) 2 (2) 4 (13)
(Loss) Profit Before Taxation (181) 54 (61) 160
Income tax benefit (expense) 5 46 (13) 9 (30)
Net (Loss) Income (135) 41 (52) 130
(Loss) Earnings per ordinary share (in dollars)*
Basic (loss) earnings per share 6 $(0.98) $0.29 $(0.38) $0.93
Diluted (loss) earnings per share 6 $(0.98) $0.28 $(0.38) $0.89
* Basic and diluted (loss) 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 (loss) income
Q3 2023 Q3 2022 YTD 2023 YTD 2022
For the three and nine months ended September 30 $m $m $m $m
Net (loss) income (135) 41 (52) 130
Other comprehensive loss
Items that may be reclassified to profit or loss in subsequent years
Foreign currency translation adjustment, net (13) (16) (9) (36)
Other comprehensive loss (13) (16) (9) (36)
Total comprehensive (loss) income (148) 25 (61) 94
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated interim balance sheet
Sep 30, 2023 Dec 31, 2022
Notes $m $m
ASSETS
Non-current assets
Intangible assets 7 218 70
Property, plant and equipment 53 54
Right-of-use assets 32 31
Deferred tax assets 5 252 219
Investments 8 52 98
Other assets 9 25 38
632 510
Current assets
Inventories 142 114
Trade receivables 245 220
Other assets 9 95 27
Current tax receivable 5 16 5
Investments 8 112 119
Cash and cash equivalents 610 774
1,220 1,259
Total assets 1,852 1,769
LIABILITIES
Current liabilities
Borrowings 10 (3) (3)
Provisions 11 (438) (303)
Other liabilities 11 (71) (79)
Trade and other payables 14 (714) (617)
Lease liabilities (8) (8)
Current tax liabilities 5 (5) (9)
(1,239) (1,019)
Non-current liabilities
Borrowings 10 (236) (237)
Provisions 11 (2) (5)
Other liabilities 11 (369) (428)
Lease liabilities (30) (29)
(637) (699)
Total liabilities (1,876) (1,718)
Net (liabilities) assets (24) 51
EQUITY
Capital and reserves
Share capital 15 69 68
Share premium 11 8
Capital redemption reserve 6 6
Other reserve (1,295) (1,295)
Foreign currency translation reserve (48) (39)
Retained earnings 1,233 1,303
Total equity (24) 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 - - - - - 130 130
Other comprehensive loss - - - - (36) - (36)
Total comprehensive income - - - - (36) 130 94
Transactions recognized directly in equity
Shares issued 1 1 - - - - 2
Share-based plans - - - - - 12 12
Settlement of tax on equity awards - - - - - (10) (10)
Shares repurchased and cancelled (2) - 2 - - (66) (66)
Transfer to share repurchase liability - - - - - (8) (8)
Balance at September 30, 2022 69 8 5 (1,295) (56) 1,496 227
Balance at January 1, 2023 68 8 6 (1,295) (39) 1,303 51
Comprehensive loss
Net loss - - - - - (52) (52)
Other comprehensive loss - - - - (9) - (9)
Total comprehensive loss - - - - (9) (52) (61)
Transactions recognized directly in equity
Shares issued 1 3 - - - - 4
Share-based plans - - - - - 16 16
Settlement of tax on equity awards - - - - - (22) (22)
Shares repurchased and cancelled - - - - - (11) (11)
Transfer from share repurchase liability - - - - - 9 9
Taxation on share-based plans - - - - - (10) (10)
Balance at September 30, 2023 69 11 6 (1,295) (48) 1,233 (24)
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 nine months ended September 30 $m $m
CASH FLOWS FROM OPERATING ACTIVITIES
Operating (Loss) Profit (65) 173
Depreciation and amortization of property, plant and equipment and intangible assets 13 11
Depreciation of right-of-use assets 6 6
Gain on disposal of intangible assets - (1)
Share-based payments 16 12
Impact from foreign exchange movements (11) (9)
Unrealized loss on equity investment - 3
Settlement of tax on employee awards (22) (10)
(Increase) decrease in trade receivables (26) 2
(Increase) decrease in current and non-current other assets (50) 73
Increase in inventories (26) (22)
Increase (decrease) in trade and other payables 91 (75)
Increase (decrease) in provisions and other liabilities 1 72 (100)
Cash (used in) provided by operations (2) 63
Interest paid (24) (18)
Interest received 32 5
Taxes paid (40) (35)
Transaction costs related to debt refinancing - (1)
Net cash (outflow) inflow from operating activities (34) 14
CASH FLOWS FROM INVESTING ACTIVITIES
Acquisition of assets, net of cash acquired (refer to Note 16) (124) -
Purchase of property, plant and equipment (4) (4)
Purchase of investments (40) (233)
Maturity of investments 95 15
Purchase of intangible asset (31) -
Proceeds from disposal of intangible assets - 1
Net cash outflow from investing activities (104) (221)
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of borrowings (12) (2)
Principal elements of lease payments (6) (6)
Shares repurchased and cancelled (11) (66)
Proceeds from the issuance of ordinary shares 4 2
Net cash outflow from financing activities (25) (72)
Exchange difference on cash and cash equivalents (1) (2)
Net decrease in cash and cash equivalents (164) (281)
Cash and cash equivalents at beginning of the period 774 1,102
Cash and cash equivalents at end of the period 610 821
1Changes in the line item provisions and other liabilities for YTD 2023 include litigation settlement payments totaling $177m (YTD 2022 $108m). $3m of interest paid on the DOJ Resolution in YTD 2023 has been recorded in the interest paid line item (YTD 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 November 8, 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 March 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 March 2025 (the going concern period). The base case scenario reflects
Board reviewed forecasts and financial plans for the period and
settlement of liabilities and provisions in line with contractual terms, which are expected to be fully approved by the courts as agreed.

Frequently Asked Questions

What was SUBLOCADE's Q3 2023 net revenue?

SUBLOCADE's net revenue for Q3 2023 was $167 million, a 55% increase from Q3 2022.

What does OPVEE treat?

OPVEE is a nasal spray launched for the emergency treatment of opioid overdose.

How did Indivior's operating profit change in Q3 2023?

Indivior reported an operating loss of $183 million in Q3 2023, compared to a profit in Q3 2022.

What are the updated FY 2023 revenue expectations?

Indivior expects FY 2023 net revenue between $1,030 million and $1,090 million.

How many units of SUBLOCADE were dispensed in Q3 2023?

Approximately 133,600 units of SUBLOCADE were dispensed in Q3 2023.

Last updated: Nov 9, 2023