OPNT Opiant Pharmaceuticals Inc

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

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Opiant Pharmaceuticals, Inc.

(Name of Registrant as Specified In Its Charter)

Indivior PLC

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On February 16, 2023, Indivior PLC (“Indivior”) published a press release and related presentation materials announcing financial results for the period ended December 31, 2022. Indivior also hosted a conference call to discuss such results. During the earnings call, Indivior management referenced the proposed acquisition of Opiant Pharmaceuticals, Inc. (“Opiant”) by Indivior. As a result, Indivior may be deemed a participant in Opiant’s solicitation of Opiant’s shareholders. Therefore, Indivior files (i) a transcript of the relevant portion of the conference call, (ii) the press release, and (iii) the presentation materials as additional soliciting materials pursuant to Rule 14a-12 under the Securities Exchange Act of 1934, as amended.

Cautionary Statement Regarding Forward-Looking Statements

Statements included in these communications that are not a description of historical facts are forward-looking statements. Words or phrases such as “believe,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “should,” “would” or similar expressions are intended to identify forward-looking statements, and are based on our current beliefs and expectations. These forward-looking statements include, without limitation, statements regarding the proposed acquisition of Opiant, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined businesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements. These factors include risks and uncertainties related to, among other things: uncertainties as to the timing of the Merger; the possibility that competing acquisition proposals will be made; the inability to complete the Merger due to the failure to obtain Opiant’s stockholder adoption of the Merger Agreement or the failure to satisfy other conditions to completion of the Merger, including required regulatory clearances or approvals; the potential that the expected benefit and opportunities of the transaction, if completed, may not be realized or may take longer to realize than expected; the risk that OPNT003 does not receive FDA approval in the expected timeline, or at all; challenges inherent in product research and development, including uncertainty of clinical successes and obtaining regulatory approval and challenges to patents; the failure of the transaction to close for any other reason; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, customers, vendors and other business partners; the risk that stockholder litigation in connection with the Merger may result in significant delay or costs of defense, indemnification and liability; diversion of management’s attention from ongoing business concerns and other risks and uncertainties that may affect future results of the combined company, including the risks described in Indivior’s Annual Report and Accounts 2021 and Opiant’s Annual Report on Form 10-K for the year ended December 31, 2021 and Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2022.

All forward-looking statements are qualified in their entirety by this cautionary statement and neither Indivior or Opiant undertake any obligation to revise or update this report to reflect events or circumstances after the date hereof, except as required by law.

Transcript excerpt from Indivior Earnings Conference Call held February 16, 2023.

Q - Christian Glennie

Thank you. And then finally, if I can. I know the Opiant deal hasn’t gone through yet, but any comment on a couple of things as it relates ‘003 [OPNT003 - Nasal Nalmefene for Opioid Overdose Reversal]. The likely move of NARCAN to OTC, does the Advisory Committee overnight in favor of that shift the potential impact of that as it relates to ‘003? And then just to clarify what you said on ‘003, assuming approval launch second half of the year or even into 2024, just to clarify what sort of — what are the things you need to get in place in order to start rolling out that launch? Why wouldn’t be — if it was ‘24 that would be a sort of six months preparation? Thank you.

A - Mark Crossley

Certainly. And I applaud the expansion of all treatments to help patients that deal across the continuum of care. I mean, overdose is a horrible thing and with Naloxone and its safety profile, having that be OTC, we applaud that broad access to treatment.

As it relates to Opiant003, which is Nalmefene, we just don’t see the real impact with regards to the launch on that. For us this is a differentiated asset that has a quicker onset of action, we believe a quicker onset of action, a longer half-life, longer than fentanyl, and a stronger sort of indication that we think is suited towards the synthetic opioids like fentanyl that are kind of ravaging the drug supply. And so we think, in those first responders, which is where the vast majority of the volume is flowing today, we think it is going to be a great opportunity for them to use that for treatment of those patients. So we just — we don’t see a major impact.

As a result, as it relates to the timing of the launch; listen, we’ll get into this more once the acquisition is complete, but we do anticipate a second-half launch there in the majority of cases.

Q - Christian Glennie

Okay, thank you. That’s helpful.

A - Mark Crossley

Thanks, Christian.

NM - Not meaningful

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

“I am pleased to report another strong year of execution against our strategic priorities, resulting in double-digit underlying growth across our key financial metrics. We saw excellent momentum from our increased efforts to access the millions of opioid use disorder (OUD) patients in Organized Health Systems (OHS) and the U.S. Justice System. This helped SUBLOCADE^® (buprenorphine extended-release) injection become our largest selling product with annual net revenue (NR) of $408 million, an increase of 67% versus 2021. At our Capital Markets Day in December, we increased our peak annual NR expectations for SUBLOCADE to more than $1.5 billion and reiterated our confidence in achieving peak annual NR for PERSERIS^® (risperidone) extended-release injection for schizophrenia of $200 to $300 million. Additionally, because we are attempting to settle our outstanding legacy multidistrict antitrust litigation, we recorded a provision related to these matters.

Looking ahead, we expect 2023 to be another year of progress for Indivior, marked by continued strong NR growth of SUBLOCADE and PERSERIS, the planned integration of Opiant and the listing of our shares on NASDAQ. As a proven leader in addiction treatment and science, Indivior is well-positioned to deliver for patients and drive long term value creation for all our stakeholders. I believe our prospects have never been brighter.”

Initial mediation sessions in late January 2023 regarding legacy civil multidistrict antitrust litigation provided the Group with new information on the previously disclosed contingent liability. Accordingly, the Group recorded an exceptional provision of $290m in FY 2022. Because these matters are in various stages, Indivior cannot predict with any certainty how these matters

will ultimately be resolved, or the costs, or timing of such resolution. In particular, any final aggregate costs of these matters, whether resolved by settlement or trial, may be materially different from this provision. The Group cannot predict with any certainty whether it will reach settlement with the antitrust claimants (refer to Note 12 for further information).

FY 2022 / Q4 2022 Financial Highlights

FY 2022 / Q4 2022 Operating Highlights

US Listing

In September 2022, the Company received shareholder approval to additionally list its shares in the US. The Company has chosen NASDAQ as its trading venue. The listing is expected to take place in Spring 2023.

Share Repurchase Program

On May 3, 2022, Indivior announced a second share repurchase program of up to $100m. Reflecting the 5:1 share consolidation (completed on October 10, 2022), the Group repurchased and cancelled 4,792,710 Indivior ordinary shares, equivalent to approximately 3% of diluted shares outstanding, through December 31, 2022 at a daily weighted average purchase price of 1,537p. The cost was approximately $90m, which includes directly attributable transaction costs. Refer to Note 14 for further discussion.

FY 2023 Guidance

The Group is introducing the below guidance for FY 2023. Guidance excludes the impact of the pending completion of the acquisition of Opiant Pharmaceuticals, Inc.

Total FY 2023 expected NR range of $950m to $1,020m (+9% vs. FY 2022 at the mid-point), reflecting continued strong SUBLOCADE and PERSERIS growth and accelerated share erosion for US SUBOXONE Film.

US OUD Market Update

In Q4 2022, the US buprenorphine medication-assisted treatment (BMAT) market grew in mid-single digits. The Group continues to expect long-term US 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 that have expanded OUD treatment funding and treatment capacity.

The December 29, 2022 enactment of the Consolidated Appropriations Act, 2023 (P.L. 117-328), including the Mainstreaming Addiction Treatment Act (MAT Act), eliminated the requirement for health care practitioners (HCP) to apply for a separate waiver through the Drug Enforcement Administration (DEA) to dispense certain treatments for maintenance or detoxification of patients with OUD, including buprenorphine. Historically, HCPs treating patients with OUD with buprenorphine had to undertake special additional registration, meet training requirements that did not apply to any other medicine class, and limit the number of patients they could treat. Indivior believes the elimination of these requirements as part of this legislation will help to normalize the chronic disease of addiction and expand access to evidence-based buprenorphine treatment. The Group supports efforts to encourage more HCPs to provide BMAT as a treatment option, and the Group continues to expand its compliance capabilities for the growing number of BMAT prescribers and patients.

Financial Performance FY 2022 and Q4 2022

Total NR in FY 2022 increased 14% to $901m (FY 2021: $791m) at actual exchange rates (+16% at constant exchange rates). In Q4 2022, total NR increased 9% at actual exchange rates (+11% at constant exchange rates) to $241m (Q4 2021: $222m).

US NR increased 21% in FY 2022 to $731m (FY 2021: $603m) and by 13% in Q4 2022 to $198m (Q4 2021: $176m). Strong year-over-year unit volume growth for SUBLOCADE and PERSERIS, along with underlying BMAT market growth were the principal drivers of the increase in both periods. Price changes were insignificant to changes in NR.

Rest of World (ROW) NR decreased 10% at actual exchange rates in FY 2022 to $170m (FY 2021: $188m) (+1% at constant exchange rates). In Q4 2022, ROW NR decreased 7% at actual exchange rates to $43m (Q4 2021: $46m) (+4% at constant exchange rates). In FY 2022 and in Q4 2022, positive contributions from product launches in new markets (SUBLOCADE / SUBUTEX Prolonged Release and SUBOXONE Film) were more than offset by unfavorable foreign currency translation and ongoing competitive pressure on legacy tablet products. FY 2022 and Q4 2022 SUBLOCADE / SUBUTEX^® Prolonged Release NR in ROW were $27m and $8m (at actual exchange rates), respectively. NR at a constant exchange rate is an alternative performance measure used by Management to evaluate underlying performance of the business and is calculated by applying the FY 2021 exchange rate to NR in the currency of the foreign entity.

Gross margin as reported in FY 2022 was 82% (FY 2021: 84%) and 82% in Q4 2022 (Q4 2021: 83%). Gross margin declined slightly as expected in both FY 2022 and Q4 2022, reflecting a higher mix of less profitable government channels for SUBOXONE film in the US and some cost impacts from inflation.

SG&A expenses as reported in FY 2022 were $763m (FY 2021: $431m) and $431m as reported in Q4 2022 (Q4 2021: $132m). FY 2022 and Q4 2022 both included exceptional items of $296m for litigation provisions primarily related to the antitrust litigation and consumer protection claims. FY 2022 and Q4 2022 also included $6m and $2m, respectively, of exceptional legal and consulting costs incurred in preparation for the planned additional listing of Indivior shares on a US exchange. FY 2021 included exceptional costs of $6m due to a non-cash adjustment to the provision for ANDA litigation offset by release of provisions.

Excluding exceptional items, FY 2022 SG&A expense increased 8% to $461m (Adj. FY 2021: $425m). Excluding exceptional items, Q4 2022 SG&A expense was unchanged at $133m (Adj. Q4 2021: $133m). The increase in FY 2022 primarily reflects sales and marketing investments to grow the Group’s long-acting injectable products, SUBLOCADE and PERSERIS, along with cost inflation.

FY 2022 and Q4 2022 R&D expenses were $72m and $29m, respectively (FY 2021: $52m; Q4 2021: $19m). The increases over the year-ago periods reflect higher R&D activity for SUBLOCADE studies (safety and efficacy and Post Marketing Requirement (PMR) studies), process validation testing related to LAI capacity expansion and continued early-stage asset development.

FY 2022 and Q4 2022 net other operating income was $8m and $4m, respectively, (FY 2021: $32m; Q4 2021: $12m). Q4 2022 included a fair value gain on equity investments and FY 2022 included the net proceeds received from the out-licensing of nasal naloxone opioid overdose patents and a Directors’ & Officers’ insurance claim settlement that were recorded as exceptional other operating income. FY 2021 and Q4 2021 included $32m and $12m, respectively, of net exceptional benefits primarily due to the net proceeds received from the sale of the legacy TEMGESIC^®/ BUPREX^® / BUPREXX^® (buprenorphine) franchise outside of North America and a Directors’ & Officers’ insurance claim settlement.

FY 2022 operating loss as reported was $85m (FY 2021 operating profit: $213m). Net exceptional costs of $297m are included in the current period. Net exceptional benefits of $26m were included in FY 2021. On an adjusted basis, FY 2022 adjusted operating profit increased 13% to $212m (FY 2021: $187m). The loss in FY 2022 on a reported basis primarily reflected the exceptional litigation provision. The increase in FY 2022 on an adjusted basis reflected strong NR growth partially offset by higher operating expenses, mainly related to increased sales and marketing investments to grow the Group’s long-acting injectable technologies, SUBLOCADE and PERSERIS, and higher R&D expenses.

Q4 2022 operating loss as reported was $258m (Q4 2021 operating profit: $45m). Exceptional costs of $298m are included in the current period while exceptional benefit items of $13m are included in Q4 2021. On an adjusted basis, Q4 2022 operating profit increased 25% to $40m (Adj. Q4 2021: $32m). The loss in Q4 2022 on a reported basis primarily reflected the exceptional litigation provision. The increase in Q4 2022 on an adjusted basis primarily reflected strong NR growth partially offset by higher operating expenses, principally increased R&D activity.

FY 2022 net finance expense as reported was $10m (FY 2021: $23m expense). The reduction in net finance expense reflected higher interest income earned on the Group’s investments and rising interest rates.

FY 2022 reported tax benefit was $42m, or a rate of 44% (FY 2021 tax benefit: $15m, -8%). FY 2022 adjusted tax expense was $33m, excluding the $75m tax benefit on exceptional items, an effective tax rate of 16%. FY 2021 adjusted tax expense amounted to $25m, excluding the $40m tax benefit on exceptional items, an effective tax rate of 15%. The Q4 2022 reported tax benefit was $73m, or a rate of 29% (Q4 2021: $4m, 10%). Q4 2022 adjusted tax expense was $3m, excluding the $76m tax benefit on exceptional items, an effective tax rate of 7%. The Q4 2022 adjusted tax rate was positively impacted by revaluation of deferred taxes for US state rate and nexus changes.

FY 2022 reported net loss was $53m (FY 2021 reported net income: $205m) primarily reflecting the exceptional litigation provision. Excluding the net after tax impact from exceptional items, FY 2022 adjusted net income increased 21% to $169m (Adj. FY 2021: $140m). The increase in net income on an adjusted basis primarily reflected higher NR partially offset by the increase in operating expense, primarily SG&A investments behind SUBLOCADE and PERSERIS. Q4 2022 net loss on a reported basis was $183m (Q4 2021 reported net income: $35m). On an adjusted basis excluding the net after-tax impact from exceptional items, Q4 2022 net income increased 56% to $39m (Adj. Q4 2021: $25m). Higher Q4 2022 net income on an adjusted basis was primarily due to strong NR growth and lower net finance expense.

Diluted (loss)/earnings per share were $(0.38) on a reported basis and $1.16 on an adjusted basis in FY 2022 (FY 2021: $1.35 earnings per share on a diluted basis and $0.92 earnings per share adjusted diluted basis). In Q4 2022, diluted (loss)/earnings per share were $(1.34) and adjusted diluted earnings per share were $0.27 (Q4 2021: $0.23 and $0.17 earnings per share on a diluted and adjusted diluted basis, respectively).

Balance Sheet & Cash Flow

Cash and investments totaled $991m at the end of Q4 2022 (including $26m restricted for self-insurance) (FY 2021: $1,102m). Cash generated from operations in FY 2022 was $63m (FY 2021: $395m). This included exceptional cash litigation settlement payments totaling $108m in H1 2022, partially offset by the return of surety bond cash collateral of $64m. Excluding these items, the remaining decrease in cash generated from operations was primarily due to the timing of settlement of trade payables. Gross borrowings, before issuance costs, were $246m at December 31, 2022 (ending FY 2021: $249m).

Net working capital, defined by management as inventory plus trade receivables, less trade and other payables, was negative $283m on December 31, 2022, versus negative $423m at the end of FY 2021. The change in the period was primarily the result of the timing of settlement of trade payables.

Net cash outflow from operating activities was $4m in FY 2022 (FY 2021 cash inflow: $353m) reflecting the changes in cash generated from operations and higher interest paid on the Group’s term loan facility, interest paid on settlement payments and income taxes paid in FY 2022 vs. income tax refunds received in FY 2021.

FY 2022 cash outflow from investing activities was $223m (FY 2021 cash outflow: $14m) which reflected the net investment in a portfolio of investment-grade debt and treasury securities. See Note 7 for further discussion on investments.

FY 2022 cash outflow from financing activities was $100m (FY 2021 cash outflow: $94m) which primarily reflected an increase in payments made for the Group’s share repurchase program.

R&D / Pipeline Update

Indivior’s quarterly R&D and pipeline update may be found here.

Risk Factors Update

The Board of Directors oversees the approach to risk management so that the principal risks, including those that would threaten the Group’s business model, future performance or viability, are effectively managed and/or mitigated. While the Group aims to identify and manage such risks, no risk management strategy can provide absolute assurance against loss.

The principal risks facing the Group have not significantly changed over the year and will be set out in the Group’s Annual Report for the 2022 financial year available in March 2023. However, as mentioned in Note 1, “Basis of Preparation and Accounting Policies”, and Note 12, “Legal Proceedings”, if the Group was found liable in the currently scheduled September 18, 2023 multidistrict litigation trial to any of the Plaintiffs and was unable to reduce the claimed damages of such Plaintiffs group or groups during such trial (or in any subsequent proceeding), which the Directors believe is beyond ‘severe but plausible’ (and therefore remote) within the going concern period, then its financial position, results and future cash flows could be materially adversely impacted. If the Group continues with mediation or other settlement discussions, it makes no guarantee as to whether any settlement can be reached and if so, what amounts, if any, it may agree to pay, or what amounts the Plaintiffs will demand. The set of principal risks should not be considered as an exhaustive list of all risks the Group faces.

Webcast Details

A live webcast presentation will be held on February 16, 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.

Webcast link: https://edge.media-server.com/mmc/p/7wfjw5s4

Participants may access the presentation telephonically by registering with the following link:

https://register.vevent.com/register/BI6229b9170b5d4c04924cf0da6c6c7016

Registrants will have an option to be called back immediately prior to the call or be provided a call-in # with a unique pin code following their registration).

Corporate Website www.indivior.com

This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Group to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

About Indivior

Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 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; expectations for NR levels for particular products; the pending acquisition of Opiant; expectations regarding the Group’s provisions, legal proceedings and matters, the planned additional US stock exchange listing; expected exceptional and recurring costs related to a US stock exchange listing; expected market growth rates; expected changes in market share; future exchange rates; operational goals; its product development pipeline and potential future products; ongoing litigation; 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; 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; the substantial litigation and ongoing investigations to which we are or may become a party; 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 such as the COVID-19 pandemic; 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 such other factors as set out in this press release.

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

Unaudited condensed consolidated statement of comprehensive (loss)/income

The notes are an integral part of these unaudited condensed consolidated financial statements.

Unaudited condensed consolidated balance sheet

The notes are an integral part of these unaudited condensed consolidated financial statements.

Unaudited condensed consolidated statement of changes in equity

The notes are an integral part of these unaudited condensed consolidated financial statements.

Unaudited condensed consolidated cash flow statement

The notes are an integral part of these condensed consolidated financial statements.

Notes to the unaudited condensed consolidated financial statements

The financial information contained in this document does not constitute statutory accounts as defined in section 434 and 435 of the Companies Act 2006. The Group’s statutory financial statements for the year ended December 31, 2021, were approved by the Board of Directors on March 17, 2022, and delivered to the Registrar of Companies. The report of the auditors on those accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under section 498 of the Companies Act 2006.

2. SEGMENT INFORMATION

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker (‘CODM’). The CODM, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Chief Executive Officer (CEO). The Group is predominantly engaged in a single business activity, which is the development, manufacture, and sale of buprenorphine-based prescription drugs for treatment of opioid dependence and related disorders. The CEO reviews disaggregated net revenue on a geographical and product basis. Financial results are reviewed on a consolidated basis for evaluating financial performance and allocating resources. Accordingly, the Group operates in a single reportable segment.

Net revenue and non-current assets

Revenues are attributed to countries based on the country where the sale originates. The following tables represent net revenues from continuing operations and non-current assets, net of accumulated depreciation and amortization, by country. Non-current assets for this purpose consist of intangible assets, property, plant and equipment, right-of-use assets, investments, and other assets. Net revenues for the three and twelve months to and non-current assets as of December 31, 2022 and 2021 were as follows:

On a disaggregated basis, the Group’s net revenue by major product line:

Non-current assets:

Medical affairs functional costs are included in administrative and general expenses. Administrative and general expenses include exceptional items in the current and prior period as outlined in Note 4.

Net other operating income is credited to the income statement as earned. See further discussion in Note 4 and Note 7.

4. EXCEPTIONAL ITEMS AND ADJUSTED RESULTS

Exceptional items

Where significant expenses or income occur that do not reflect the Group’s ongoing operations or the adjustment of which may help with the comparison to prior periods, these items are disclosed as exceptional items in the income statement. Examples of such items could include income or restructuring and related expenses from the reconfiguration of the Group’s activities and/or capital structure, impairment of current and non-current assets, gains and losses from the sale of intangible assets, certain costs arising as a result of significant and non-recurring regulatory and litigation matters, and certain tax related matters. Exceptional items are excluded from adjusted results consistent with the internal reporting provided to management and the Directors. Adjusted results are not measures defined by IFRS and are not a substitute for, or superior to, reported results presented in accordance with IFRS. Management performs a quantitative and qualitative assessment to determine if an item should be considered for exceptional treatment.

The table below sets out exceptional income/(expense) recorded in each period:

Adjusted results

Management believes adjusted results may be useful to investors as they exclude items which do not reflect the Group’s day-to-day operations or may help with comparisons to prior periods. Similar concepts of adjusted results are frequently used by securities analysts, investors and other interested parties in their evaluation of the Group and in comparison to other companies, many of which also present adjusted performance measures when reporting their results. Adjusted results have limitations as analytical tools. They are not recognized terms under IFRS and therefore do not purport to be an alternative to operating profit as a measure of operating performance. Adjusted results as presented by the Group are not necessarily comparable to similarly titled measures used by other companies. As a result, these performance measures should not be considered in isolation from, or as a substitute analysis for, the Group’s reported results presented in accordance with IFRS.

The tables below show the list of adjustments between the reported and adjusted results for both Q4/FY 2022 and Q4/FY 2021.

Reconciliation of operating (loss)/ profit to adjusted operating profit