INDIVIOR PLC
For the period ended Dec 31, 2024. Filed Mar 3, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 3, 2025
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IMPORTANT CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: the Company’s financial guidance including revenue, operating and profit/gross margins for 2025 and its medium- and long-term growth outlook; expected operational savings and expected benefits from our reinvestment efforts; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition and near-term Criminal Justice System funding challenges; assumptions regarding future exchange rates; our assumptions regarding the absence of material changes to Medicaid eligibility and/or other changes to federal funding levels due to executive actions; strategic priorities, strategies for value creation, and operational goals; our expectations that we can reach a final settlement related to the provision we recorded regarding opioid litigation (including the Opioid MDL) brought by certain municipalities and tribal nations and the material terms and conditions of the final settlement agreement, including the ultimate timing and structure of payments and product distribution, injunctive relief, and scope of releases; expected future growth and expectations for sales levels for particular products, and expectations regarding the future impact of factors that have affected sales in the past; expected 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 and costs at the Company’s Raleigh Manufacturing Facility; expected capital expenses and investments; our expectation that we will meet our obligations as they come due over the next 12 months from cash on hand and operations, 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, such 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 these forward-looking statements.
The forward-looking statements in this annual report are made based upon our current expectations and beliefs concerning future events and involve a number of known and unknown risks and uncertainties. Such forward-looking statements are based on numerous assumptions regarding our present and future business strategy and the environment in which we operate, which may prove to be inaccurate. In particular, our actual results, performance or achievements or industry results could be affected by, among other things:
The substantial litigation 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 number 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 pandemics and government responses thereto;
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;
Volatility in our share price due to factors unrelated to our operating performance; and
Such other factors as set out in “Item 1A. Risk Factors” and “Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.”
Forward-looking statements contained in this annual report apply only at the date of this annual report. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future developments, or otherwise.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.