Full Press Release Details
| February 22, 2024 | ||||
| Strong Underlying Financial Performance and Execution Against Strategic Priorities in 2023 Achieved 21% net revenue (NR) growth expanded adjusted operating margin while investing for future growth FY 2023 SUBLOCADE NR of $630m at top end of range and +54% versus FY 2022 FY 2024 guidance introduced - expect to deliver 18% NR growth and 300 basis points of operating margin expansion at the mid-points Initiating shareholder consultations to potentially transition to a primary listing in the U.S. in 2024 while maintaining a secondary listing in the U.K. |
Comment by Mark Crossley, CEO of Indivior PLC
At our December 2022 Capital Markets Day, we laid out Indivior's strategy and medium term financial goals targeting double-digit top line growth, operating margin expansion and strengthened cash flow. By executing against our strategic priorities, we delivered strongly against these goals in 2023. We grew SUBLOCADE and PERSERIS net revenue by 54% and 50%, respectively, we acquired Opiant and launched OPVEE , and we expanded our pipeline of innovative potential treatments for substance use disorders. Furthermore, we converted 21% net revenue growth into adjusted operating profit growth of 27% (reported operating loss of $4m), despite significant incremental operating costs from the acquisition of Opiant and targeted investments in our U.S. commercial organization. Among other highlights, we listed our shares on NASDAQ, continued to de-risk legacy liabilities, and we initiated a third $100m share repurchase program. 2023 was a year of considerable achievement and I want to thank all Indivior employees for their efforts."
"Our guidance for 2024 builds off this momentum with expected double-digit net revenue growth and meaningful operating margin expansion. We are also excited to announce that we are initiating consultations with shareholders on potentially transitioning to a primary listing in the U.S. in 2024 while maintaining a secondary listing in the U.K. I look forward to reporting on our strong progress in 2024.
| Period to December 31st (Unaudited) | Q4 2023 $m | Q4 2022 $m | % Change | FY 2023 $m | FY 2022 $m | % Change | |
| Net Revenue | 293 | 241 | 22% | 1,093 | 901 | 21% | |
| Operating Profit (Loss) 1 | 60 | (258) | NM | (4) | (85) | -95% | |
| Net Income (Loss) 1 | 54 | (183) | NM | 2 | (53) | NM | |
| Diluted EPS (LPS) 1 ($) | $0.38 | $(1.34) | NM | $0.01 | $(0.38) | NM | |
| Adjusted Basis | |||||||
| Adj. Operating Profit 2 | 66 | 40 | 65% | 269 | 212 | 27% | |
| Adj. Net Income 2 | 61 | 39 | 56% | 223 | 169 | 32% | |
| Adj. Diluted EPS 2 ($) | $0.43 | $0.27 | 59% | $1.57 | $1.16 | 35% |
1 Includes the impact of exceptional provision increases of $240m for the FY 2023 and $290m for the FY 2022 and Q4 2022 periods, respectively, related to certain antitrust multidistrict class claims ( Antitrust MDL ) and an intellectual property-related litigation matter. See Note 11 and Note 13 for additional details including the timing of final settlement.
2 Adjusted Basis excludes the impact of exceptional items and other adjustments as referenced and reconciled in the Adjusted Results appendix on page 25. 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.
FY Q4 2023 Financial Highlights
FY 2023 total net revenue (NR) of $1,093m increased 21% (FY 2022 $901m) Q4 2023 total NR of $293m increased 22% (Q4 2022 $241m).
FY 2023 reported operating loss was $4m (FY 2022 $85m loss) Q4 2023 reported operating profit was $60m (Q4 2022 $258m loss). FY 2023 adjusted operating profit of $269m represented an increase of 27% (Adjusted FY 2022 $212m). Q4 2023 adjusted operating profit of $66m increased 65% (Adjusted Q4 2022 $40m).
FY 2023 reported net income was $2m (FY 2022 $53m net loss) Q4 2023 reported net income was $54m (Q4 2022 $183m net loss). FY 2023 adjusted net income of $223m represented an increase of 32% (Adjusted FY 2022 $169m). Q4 2023 adjusted net income of $61m increased 56% (Adjusted Q4 2022 $39m).
Cash and investments totaled $451m at the end of 2023 (including $27m restricted for self-insurance) (FY 2022 $991m), primarily reflecting the FY 2023 net cash outflows related to litigation settlements of $610m and $124m for the Opiant acquisition.
FY Q4 2023 Product Highlights
SUBLOCADE FY 2023 NR of $630m (+54% vs. FY 2022) Q4 2023 NR of $176m (+49% vs. Q4 2022 and +5% vs. Q3 2023). Continued strong growth primarily reflects further organized health system (OHS) channel penetration in the U.S. and increased new U.S. patient enrollments. FY 2023 units dispensed were approx. 509,000 (+61% vs. FY 2022). Q4 2023 U.S. units dispensed were approx. 142,700 (+53% vs. Q4 2022 and +7% vs. Q3 2023). Total U.S. patients on a 12-month rolling basis at the end of Q4 2023 were approximately 136,900 (+66% vs. Q4 2022 and +13% vs. Q3 2023).
PERSERIS FY 2023 NR of $42m (+50% vs. FY 2022) Q4 2023 NR of $12m (+50% vs. Q4 2022 and 9% vs. Q3 2023) reflects increasing awareness of the treatment across the U.S. healthcare system.
SUBOXONE (buprenorphine naloxone) Film U.S. share in Q4 2023 averaged 18% (Q4 2022 19%).
The Group is introducing the below guidance for FY 2024 which reflects top line growth of 18% and adjusted operating margin expansion of approximately 300 basis points (at the midpoint) versus FY 2023.
Guidance assumes no material change in exchange rates for key currencies compared with FY 2023 average rates, notably USD GBP and USD EUR.
| FY 2024 | ||
| Net Revenue (NR) 1 | $1,240m to $1,330m (+18% at midpoint vs. FY 2023) | |
| SUBLOCADE NR | $820m to $880m (+35% at midpoint vs. FY 2023) | |
| OPVEE NR | $15m to $25m 1 | |
| PERSERIS NR | $55m to $65m (+43% at midpoint vs. FY 2023) | |
| SUBOXONE Film Market Share | Assumes historic rate of share decline in FY 2024 of 1 to 2 percentage points and the potential impact from a fourth buprenorphine naloxone sublingual film generic in the U.S. market | |
| Adjusted Gross Margin | Low to mid-80s range | |
| Adjusted SG A | ($575m) to ($590m) | |
| R D | ($120m) to ($130m) | |
| Adjusted Operating Profit | $330m to $380m |
1 The OPVEE NR guidance for FY 2024 includes approximately $8m as part of a multi-year agreement with the U.S. Biomedical Advancement Research and Development Authority (BARDA).
Initiating the Process for a Potential Primary Listing in the U.S. in the Summer of 2024
Indivior is initiating formal shareholder consultations on potentially moving Indivior's primary listing from the U.K. to the U.S. in the Summer of 2024. The Board believes a primary U.S. listing could be beneficial to Indivior as it would
Reflect the Group's current and future growth opportunities for its proprietary treatments (SUBLOCADE, PERSERIS and OPVEE), which are centered in the U.S.
Be expected to attract more U.S. investors and analysts by further elevating the Group's leadership profile in addiction treatment in the U.S. capital markets
Allow for inclusion in major U.S. indices over time, and
Reflect the growing proportion of the Group's share capital owned by U.S.-based investors, which is currently approaching 50%.
The Board is aware that this is an important topic for shareholders and is mindful that a resolution to move forward requires the support of 75% of shareholders present and voting (in person or by proxy). If the consultations indicate a strong level of support from shareholders, the Group intends to put forward a formal resolution that would facilitate a primary U.S. listing in the Summer of 2024. The Board intends to maintain Indivior's U.K. listing as a secondary listing following any 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 February 16, 2024, the Group repurchased and cancelled 2,619,596 Indivior ordinary shares, equivalent to approximately 2% of diluted shares outstanding, at a daily weighted average purchase price of 1,265p. The cost was approximately $42m, which includes directly attributable transaction costs. Refer to Note 15 for further discussion.
U.S. OUD Market Update
In FY 2023, U.S. buprenorphine medication-assisted treatments (BMAT) grew in mid-single digits. 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 FY and Q4 2023
Total net revenue in FY 2023 increased 21% to $1,093m (FY 2022 $901m) at actual exchange rates (+21% at constant exchange rates1). In Q4 2023, total net revenue increased 22% at actual exchange rates (+21% at constant exchange rates1) to $293m (Q4 2022 $241m).
U.S. net revenue increased 25% in FY 2023 to $912m (FY 2022 $731m) and by 26% in Q4 2023 to $249m (Q4 2022 $198m). 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 6% at actual exchange rates in FY 2023 to $181m (FY 2022 $170m) (+6% at constant exchange rates1). In Q4 2023, ROW net revenue increased 2% at actual exchange rates to $44m (Q4 2022 $43m) (-2% at constant exchange rates1). In both the period and quarter, positive contributions from new products (SUBLOCADE SUBUTEX Prolonged Release and SUBOXONE Film) were offset primarily by ongoing competitive pressure on legacy tablet products. FY 2023 and Q4 2023 SUBLOCADE SUBUTEX Prolonged Release net revenue in ROW was $41m (FY 2022 $27m) and $11m (Q4 2022 $8m) at actual exchange rates, respectively.
Gross margin as reported in FY 2023 and Q4 2023 was 83% and 82% (FY 2022 and Q4 2022 82%), respectively. Excluding $8m and $3m, respectively, of other adjustments for amortization of acquired intangible assets within cost of sales, adjusted gross margin in FY 2023 and Q4 2023 was 84% and 83%, respectively. There were no adjustments to FY 2022 or Q4 2022 gross margin. The increase in the adjusted gross margin in 2023 primarily reflects an improved product mix from the continued growth of SUBLOCADE. These benefits were partially offset by cost inflation.
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.
SG A expenses as reported in FY 2023 were $811m (FY 2022 $763m) and $157m as reported in Q4 2023 (Q4 2022 $431m). FY 2023 included $240m of exceptional costs for the increase in provisions related to the Antitrust MDL and an intellectual property-related matter and $28m of acquisition-related and U.S. listing exceptional costs. Q4 2023 included $6m of exceptional acquisition costs related to the acquisition of a business consisting of a manufacturing facility, workforce, and supply contracts (refer to Note 17). FY 2022 and Q4 2022 included $296m of exceptional legal costs, respectively, and $6m and $2m of exceptional U.S. listing costs, respectively.
Excluding exceptional items, FY 2023 SG A expense increased 18% to $543m (Adjusted FY 2022 $461m) adjusted Q4 2023 SG A expense increased 14% to $151m (Adjusted Q4 2022 $133m). The increase in FY 2023 primarily reflects higher expenses related to increased SUBLOCADE commercial investments, the addition of the Opiant business and subsequent launch expenses for OPVEE, legacy legal defense costs and cost inflation. The increase in Q4 2023 primarily reflects the addition of the Opiant business and subsequent launch expenses for OPVEE, SUBLOCADE commercial investments, and cost inflation.
R D expenses in FY 2023 and Q4 2023 were $106m and $30m, respectively (FY 2022 $72m Q4 2022 $29m) and represented an increase of 47% and an increase of 3%, respectively. The increases in both periods were 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.
Net other operating income in FY 2023 and Q4 2023 was $6m and $6m, respectively, (FY 2022 $8m Q4 2022 $4m). FY 2023 included $3m of exceptional income recognized in relation to a supply agreement and FY 2022 included $5m of exceptional benefit related to a Directors' Officers' insurance claim settlement.
Operating loss as reported was $4m in FY 2023 (FY 2022 $85m loss). Exceptional costs and other adjustments of $273m and $297m in FY 2023 and FY 2022, respectively, were primarily related to the Antitrust MDL, which was settled in 2023. The change on a reported basis reflects the exceptional charges related to legal matters.
FY 2023 adjusted operating profit increased 27% to $269m (FY 2022 $212m). The increases primarily reflected higher NR from the Group's LAI products, partially offset by increased SG A and R D expenses, as described above.
Q4 2023 operating profit as reported was $60m (Q4 2022 $258m loss). Exceptional costs and other adjustments of $6m are included in the current period and exceptional costs of $298m were included in the year-ago period. The change on a reported basis reflects the exceptional charges related to legal matters. Q4 2023 adjusted operating profit increased 65% to $66m (Adjusted Q4 2022 $40m). The increases on an adjusted basis primarily reflected higher NR from the Group's LAI products, partially offset by increased SG A, as described above.
Net finance income as reported was $5m in FY 2023 (FY 2022 $10m expense). The change in net finance income (expense) reflected higher interest rates on the Group's investments. We expect investment income will not offset interest expense in the near-term following the litigation cash settlement payments.
Reported tax benefit was $1m in FY 2023 and the effective tax rate was -100%, which is not meaningful as a percentage due to the profit before taxation being close to nil (FY 2022 tax benefit rate $42m, 44%). FY 2023 adjusted tax expense was $51m, and the effective tax rate was 19% (FY 2022 tax expense rate $33m, 16%). The adjusted results exclude $11m in exceptional tax items and a $63m tax benefit on exceptional items and other adjustments. 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, $3m change in estimate as to the tax benefit of legal provisions booked in the prior year, and $3m accrual for adjustments to Opiant predecessor period taxes. Adjusted FY 2022 tax expense was $33m, excluding the $75m tax benefit on exceptional items and other adjustments, an effective tax rate of 16%. The movement in the effective tax rate on adjusted profits is impacted by an increase in the U.K. corporation tax rate from 19% to 23.5% and a temporary reduction in U.K. innovation incentives due to 2022 and 2023 losses.
The Q4 2023 reported tax expense was $7m, or a rate of 11% (Q4 2022 $73m benefit, 29%). The tax benefit on Q4 2023 adjusted profits amounted to $6m, excluding the $1m tax expense on exceptional items and other adjustments, which represented an effective tax rate of 9% (Q4 2022 $3m expense, 7%).
Reported net income in FY 2023 was $2m and adjusted net income was $223m (FY 2022 reported net loss $53m FY 2022 adjusted net income $169m). The 32% increase in net income on an adjusted basis primarily reflected higher NR partially offset by the increase in operating expense. Q4 2023 net income on a reported basis was $54m (Q4 2022 net loss $183m), and $61m adjusted net income excluding the net after-tax impact from exceptional items and other adjustments (Adjusted Q4 2022 $39m profit). Higher Q4 2023 adjusted net income was primarily due to strong NR growth.
Diluted earnings per share were $0.01 on a reported basis and $1.57 on an adjusted basis in FY 2023 (FY 2022 $(0.38) loss per share on a diluted basis and $1.16 earnings per share adjusted diluted basis). In Q4 2023, diluted earnings per share were $0.38 and adjusted diluted earnings per share were $0.43 (Q4 2022 $(1.34) loss per share on a diluted basis and $0.27 earnings per share on an adjusted diluted basis).
Balance Sheet Cash Flow
Cash and investments totaled $451m at the end of Q4 2023, a decrease of $540m versus the $991m position at the end of 2022. The decrease was primarily due to litigation settlement related outflows of $610m and the net cash outflow of $124m for the Opiant acquisition, including the transferred cash balance, partially offset by beneficial timing of payments made on government rebates and trade payables. The litigation settlement related outflows include the Antitrust MDL settlement payment of $103m with States (refer to Note 13), transfer of $415m into escrow accounts for the settlement with the Antitrust MDL end payors and direct payors, subject to final court approval (refer to Note 13), settlement payments of $24m for intellectual property-related and other legal matters, in addition to the Group's scheduled litigation settlement payments totaling $68m for the Department of Justice (DOJ), Reckitt Benckiser (RB) and Dr. Reddy's Laboratories (DRL) matters. Gross borrowings before issuance costs were $244m at December 31, 2023 (ending FY 2022 $246m).
Net working capital, defined by management as inventory plus trade receivables, less trade and other payables, was negative $347m on December 31, 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 rebates and trade payables.
Cash used in operations in FY 2023 was $292m (FY 2022 cash provided by operations $63m), primarily due to payments related to the Antitrust MDL, DOJ Resolution, DRL settlement and RB settlement, partially offset by timing of payments made on government rebates and trade payables. Before these settlement related items, cash generated from operations in the current period was $318m. Net cash outflow from operating activities was $315m in FY 2023 (FY 2022 cash outflow $4m) reflecting tax payments and interest paid on the Group's term loan facility and settlement payments, partially offset by interest received on investments.
FY 2023 cash outflow from investing activities was $98m (FY 2022 cash outflow $223m) reflecting $124m for the Opiant acquisition, net of cash assumed. In the prior year period, the outflow from investing activities primarily reflected the net investment in a portfolio of investment-grade debt securities (net) and ordinary shares of Aelis Farma.
FY 2023 cash outflow from financing activities was $46m (FY 2022 cash outflow $100m) reflecting shares repurchased and cancelled, the extinguishment of debt assumed in the Opiant acquisition, 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 cancelled.
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 will be set out in the Group's Annual Report for the 2023 financial year available in March 2024. They remain broadly unchanged compared to the prior year, except for two principal risks. With the continued worldwide pricing and reimbursement pressure on pharmaceuticals products, combined with the entrance by another company of a long-acting injectable for the treatment of opioid use disorder (OUD) in the U.S., the Commercialization principal risk has increased. Conversely, the Supply principal risk has decreased, given the U.S. FDA regulatory approval of an alternate third-party filling site for SUBLOCADE and PERSERIS and the acquisition of the Group's aseptic manufacturing site in November 2023, which, although not able to manufacture our products today, now provides an opportunity for the Group to bring such manufacturing in-house in the future.
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
| Full Year to December 31, 2023 | Full Year to December 31, 2022 | |
| GB period end | 1.2731 | 1.2083 |
| GB average rate | 1.2435 | 1.2386 |
| Euro period end | 1.1037 | 1.0698 |
| Euro average | 1.0814 | 1.0545 |
A live webcast presentation will be held on February 22nd, 2024, at 13 00 GMT (8 00 am EST) hosted by Mark Crossley, CEO. The details are below. All materials will be available on the Group's website prior to the event at www.indivior.com. Please copy and paste the below web links into your browser.
The webcast link https edge.media-server.com mmc p kymnerij
Participants may access the presentation telephonically by registering with the following link (please cut and paste into your browser)
https register.vevent.com register BI7bc18cb84a3744af8c4ad20973d37a5a
(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 including operating and profit margins for 2024 and its medium- and long-term growth outlook assumptions regarding expected changes in market 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 expected market 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 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 the fact that a substantial portion of our revenue derives from a small number of key proprietary products 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 use of hazardous materials in our manufacturing facilities 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 income statement
| Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | ||
| For the three and twelve months ended December 31 | Notes | $m | $m | $m | $m |
| Net Revenue | 2 | 293 | 241 | 1,093 | 901 |
| Cost of sales | (52) | (43) | (186) | (159) | |
| Gross Profit | 241 | 198 | 907 | 742 | |
| Selling, general and administrative expenses | 3 | (157) | (431) | (811) | (763) |
| Research and development expenses | 3 | (30) | (29) | (106) | (72) |
| Net other operating income | 6 | 4 | 6 | 8 | |
| Operating Profit (Loss) | 60 | (258) | (4) | (85) | |
| Finance income | 4 | 10 | 10 | 43 | 19 |
| Finance expense | 4 | (9) | (8) | (38) | (29) |
| Net Finance Income (Expense) | 1 | 2 | 5 | (10) | |
| Profit (Loss) Before Taxation | 61 | (256) | 1 | (95) | |
| Income tax (expense) benefit | 5 | (7) | 73 | 1 | 42 |
| Net Income (Loss) | 54 | (183) | 2 | (53) | |
| Earnings (Loss) per ordinary share (in dollars) | |||||
| Basic earnings (loss) per share | 6 | $0.39 | $(1.34) | $0.01 | $(0.38) |
| Diluted earnings (loss) per share | 6 | $0.38 | $(1.34) | $0.01 | $(0.38) |
Unaudited condensed consolidated statement of comprehensive income (loss)
| Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | |
| For the three and twelve months ended December 31 | $m | $m | $m | $m |
| Net income (loss) | 54 | (183) | 2 | (53) |
| Other comprehensive income (loss) | ||||
| Items that may be reclassified to profit or loss in subsequent years | ||||
| Foreign currency translation adjustment, net | 13 | 17 | 4 | (19) |
| Other comprehensive income (loss) | 13 | 17 | 4 | (19) |
| Total comprehensive income (loss) | 67 | (166) | 6 | (72) |
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated balance sheet
| Dec 31, 2023 | Dec 31, 2022 | ||
| Notes | $m | $m | |
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 7 | 237 | 70 |
| Property, plant and equipment | 84 | 54 | |
| Right-of-use assets | 33 | 31 | |
| Deferred tax assets | 5 | 268 | 219 |
| Investments | 8 | 41 | 98 |
| Other assets | 9 | 28 | 38 |
| 691 | 510 | ||
| Current assets | |||
| Inventories | 142 | 114 | |
| Trade receivables | 254 | 220 | |
| Other assets | 9 | 457 | 27 |
| Current tax receivable | 5 | - | 5 |
| Investments | 8 | 94 | 119 |
| Cash and cash equivalents | 316 | 774 | |
| 1,263 | 1,259 | ||
| Total assets | 1,954 | 1,769 | |
| LIABILITIES | |||
| Current liabilities | |||
| Borrowings | 10 | (3) | (3) |
| Provisions | 11 | (407) | (303) |
| Other liabilities | 11 | (125) | (79) |
| Trade and other payables | 14 | (743) | (617) |
| Lease liabilities | (9) | (8) | |
| Current tax liabilities | 5 | (18) | (9) |
| (1,305) | (1,019) | ||
| Non-current liabilities | |||
| Borrowings | 10 | (236) | (237) |
| Provisions | 11 | (12) | (5) |
| Other liabilities | 11 | (367) | (428) |
| Lease liabilities | (34) | (29) | |
| (649) | (699) | ||
| Total liabilities | (1,954) | (1,718) | |
| Net assets | - | 51 | |
| EQUITY | |||
| Capital and reserves | |||
| Share capital | 15 | 68 | 68 |
| Share premium | 11 | 8 | |
| Capital redemption reserve | 7 | 6 | |
| Other reserve | (1,295) | (1,295) | |
| Foreign currency translation reserve | (35) | (39) | |
| Retained earnings | 1,244 | 1,303 | |
| Total equity | - | 51 |
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, 2022 | 70 | 7 | 3 | (1,295) | (20) | 1,438 | 203 | ||||||||
| Comprehensive loss | |||||||||||||||
| Net loss | - | - | - | - | - | (53) | (53) | ||||||||
| Other comprehensive loss | - | - | - | - | (19) | - | (19) | ||||||||
| Total comprehensive loss | - | - | - | - | (19) | (53) | (72) | ||||||||
| Transactions recognized directly in equity | |||||||||||||||
| Shares issued | 1 | 1 | - | - | - | - | 2 | ||||||||
| Share-based plans | - | - | - | - | - | 16 | 16 | ||||||||
| Settlement of tax on equity awards | - | - | - | - | - | (10) | (10) | ||||||||
| Shares repurchased and cancelled | (3) | - | 3 | - | - | (90) | (90) | ||||||||
| Transfer to share repurchase liability | - | - | - | - | - | (9) | (9) | ||||||||
| Taxation on share-based plans | - | - | - | - | - | 11 | 11 | ||||||||
| Balance at December 31, 2022 | 68 | 8 | 6 | (1,295) | (39) | 1,303 | 51 | ||||||||
| Balance at January 1, 2023 | 68 | 8 | 6 | (1,295) | (39) | 1,303 | 51 | ||||||||
| Comprehensive income | |||||||||||||||
| Net income | - | - | - | - | - | 2 | 2 | ||||||||
| Other comprehensive income | - | - | - | - | 4 | - | 4 | ||||||||
| Total comprehensive income | - | - | - | - | 4 | 2 | 6 | ||||||||
| Transactions recognized directly in equity | |||||||||||||||
| Shares issued | 1 | 3 | - | - | - | - | 4 | ||||||||
| Share-based plans | - | - | - | - | - | 22 | 22 | ||||||||
| Settlement of tax on equity awards | - | - | - | - | - | (22) | (22) | ||||||||
| Shares repurchased and cancelled | (1) | - | 1 | - | - | (33) | (33) | ||||||||
| Transfer to share repurchase liability | - | - | - | - | - | (23) | (23) | ||||||||
| Transfer from share repurchase liability | - | - | - | - | - | 9 | 9 | ||||||||
| Taxation on share-based plans | - | - | - | - | - | (14) | (14) | ||||||||
| Balance at December 31, 2023 | 68 | 11 | 7 | (1,295) | (35) | 1,244 | - |
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Unaudited condensed consolidated cash flow statement
| 2023 | 2022 | ||
| For the twelve months ended December 31 | $m | $m | |
| CASH FLOWS FROM OPERATING ACTIVITIES | |||
| Operating Loss | (4) | (85) | |
| Depreciation and amortization of property, plant and equipment and intangible assets | 19 | 13 | |
| Depreciation of right-of-use assets | 9 | 8 | |
| Gain on disposal of intangible assets | - | (1) | |
| Share-based payments | 22 | 16 | |
| Impact from foreign exchange movements | (11) | (3) | |
| Settlement of tax on employee awards | (22) | (10) | |
| Increase in trade receivables | (33) | (21) | |
| (Increase) decrease in current and non-current other assets | (415) | 72 | |
| Increase in inventories | (21) | (25) | |
| Increase (decrease) in trade and other payables | 115 | (98) | |
| Increase in provisions and other liabilities 1 | 49 | 197 | |
| Cash (used in) provided by operations | (292) | 63 | |
| Interest paid | (32) | (24) | |
| Interest received | 42 | 15 | |
| Tax refunds | 19 | - | |
| Taxes paid | (52) | (57) | |
| Transaction costs related to debt refinancing | - | (1) | |
| Net cash outflow from operating activities | (315) | (4) | |
| CASH FLOWS FROM INVESTING ACTIVITIES | |||
| Acquisition of assets, net of cash acquired (refer to Note 16) | (124) | - | |
| Acquisition of business (refer to Note 17) | (5) | - | |
| Purchase of property, plant and equipment | (8) | (5) | |
| Purchase of investments | (45) | (245) | |
| Maturity of investments | 129 | 27 | |
| Purchase of intangible asset | (45) | (1) | |
| Proceeds from disposal of intangible assets | - | 1 | |
| Net cash outflow from investing activities | (98) | (223) | |
| CASH FLOWS FROM FINANCING ACTIVITIES | |||
| Repayment of borrowings | (12) | (3) | |
| Principal elements of lease payments | (8) | (9) | |
| Lease incentive received | 3 | - | |
| Shares repurchased and cancelled | (33) | (90) | |
| Proceeds from the issuance of ordinary shares | 4 | 2 | |
| Net cash outflow from financing activities | (46) | (100) | |
| Exchange difference on cash and cash equivalents | 1 | (1) | |
| Net decrease in cash and cash equivalents | (458) | (328) | |
| Cash and cash equivalents at beginning of the period | 774 | 1,102 | |
| Cash and cash equivalents at end of the period | 316 | 774 |
1Changes in the line item provisions and other liabilities for FY 2023 include litigation settlement payments totaling $195m (FY 2022 $108m). $3m of interest paid on the DOJ Resolution in FY 2023 has been recorded in the interest paid line item (FY 2022 $4m).
The notes are an integral part of these unaudited condensed consolidated interim financial statements.
Notes to the unaudited condensed consolidated 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 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 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 February 21, 2024.
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 estimates used in determining the fair value of the assets acquired and liabilities assumed in the acquisition of an aseptic manufacturing facility (refer to Note 17).
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 June 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, which are expected to be fully approved by the courts as agreed.