Public companies are required to disclose risks that can affect the business and impact the stock. These disclosures are known as “Risk Factors”. Companies disclose these risks in their yearly (Form 10-K), quarterly earnings (Form 10-Q), or “foreign private issuer” reports (Form 20-F). Risk factors show the challenges a company faces. Investors can consider the worst-case scenarios before making an investment. TipRanks’ Risk Analysis categorizes risks based on proprietary classification algorithms and machine learning.
Indivior disclosed 22 risk factors in its most recent earnings report. Indivior reported the most risks in the “Finance & Corporate” category.
Risk Overview Q4, 2023
Risk Distribution
68% Finance & Corporate
14% Legal & Regulatory
9% Production
5% Tech & Innovation
5% Macro & Political
0% Ability to Sell
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
This chart displays the stock's most recent risk distribution according to category. TipRanks has identified 6 major categories: Finance & corporate, legal & regulatory, macro & political, production, tech & innovation, and ability to sell.
Risk Change Over Time
S&P500 Average
Sector Average
Risks removed
Risks added
Risks changed
Indivior Risk Factors
New Risk (0)
Risk Changed (0)
Risk Removed (0)
No changes from previous report
The chart shows the number of risks a company has disclosed. You can compare this to the sector average or S&P 500 average.
The quarters shown in the chart are according to the calendar year (January to December). Businesses set their own financial calendar, known as a fiscal year. For example, Walmart ends their financial year at the end of January to accommodate the holiday season.
Risk Highlights Q4, 2023
Main Risk Category
Finance & Corporate
With 15 Risks
Finance & Corporate
With 15 Risks
Number of Disclosed Risks
22
S&P 500 Average: 31
22
S&P 500 Average: 31
Recent Changes
0Risks added
0Risks removed
0Risks changed
Since Dec 2023
0Risks added
0Risks removed
0Risks changed
Since Dec 2023
Number of Risk Changed
0
S&P 500 Average: 3
0
S&P 500 Average: 3
See the risk highlights of Indivior in the last period.
Risk Word Cloud
The most common phrases about risk factors from the most recent report. Larger texts indicate more widely used phrases.
Risk Factors Full Breakdown - Total Risks 22
Finance & Corporate
Total Risks: 15/22 (68%)Above Sector Average
Accounting & Financial Operations5 | 22.7%
Accounting & Financial Operations - Risk 1
Cash flow
The following table summarizes the principal components of our cash flows for the periods under review:
For the years endedDecember 31,(in millions)202320222021Net cash (outflow)/inflow from operating activities(315)(4)353 Net cash outflow from investing activities(98)(223)(14)Net cash outflow from financing activities(46)(100)(94)Exchange difference on cash and cash equivalents1 (1)(1)Net (decrease)/increase in and cash equivalents $(458)$(328)$244
Accounting & Financial Operations - Risk 2
Net cash (used in)/provided by operating activities
The net cash outflow from operating activities was $315 million in 2023, a decrease of $311 million, compared to the net cash outflow of $4 million in 2022. The decrease was primarily due to litigation settlement outflows of $610 million ,partially offset by increased accruals for government rebates and trade payables. The litigation settlement related outflows include the Antitrust MDL settlement payment of $103 million with States, transfer of $415 million into an escrow account for the settlement with the Antitrust MDL end payors and direct purchasers, subject to final court approval, settlement payments of $24 million for intellectual property-related and other legal matters, in addition to the Group's previously scheduled litigation settlement payments totaling $68 million for the Department of Justice (DOJ), Reckitt Benckiser (RB) and Dr. Reddy's Laboratories (DRL) matters. Refer to "
As of December 31, 2023, the Group's gross borrowings under its Term Loan were $239 million. The table below sets out the current and non-current obligations of the Term Loan as presented in the balance sheet as of December 31, 2023, and December 31, 2022:
Term loan (in millions)Dec 312023Dec 312022Term loan – current(3)(3)Term loan – non-current(236)(237)Total term loan $(239)$(240)________________*
Total term loan borrowings reflect the principal amount drawn net of debt issuance cost s of $5 million in 2023 and $6 million in 2022.
Accounting & Financial Operations - Risk 5
. Financial Statements—
Financial Statements-
Debt & Financing5 | 22.7%
Debt & Financing - Risk 1
Net cash used in financing activities
Net cash used in financing activities decreased by $54 million, from $100 million in 2022 to $46 million in 2023. Net cash used in financing activities in the current period reflects shares repurchased and canceled, 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 canceled.
Net cash used in financing activities increased by $6 million, to $100 million in 2022 from $94 million in 2021. This is primarily a reflection of an increase in payments made for the Group's share repurchase program.
Cash used in investing activities in both 2022 and 2023 also was elevated due to share repurchase programs. Net cash used in financing activities in 2024 is expected to reflect additional share repurchases of up to $78 million , and we may elect to repurchase additional shares in the future.
Debt & Financing - Risk 2
Capital Expenditure
The Group's capital expenditures for the years ended 2023, 2022, and 2021 were $8 million, $5 million, and $4 million, respectively. These capital expenditures were primarily for equipment used in the manufacture of our products. The Group funded these expenditures from its existing cash balances.
Intangible asset purchases for the years ended 2023, 2022, and 2021 were $171 million, $1 million, and $30 million, respectively, and were funded from existing cash balances. The 2023 intangible asset purchases include $126 million related to the in-process research and development value for OPVEE (nalmefene) nasal spray recognized through the Opiant acquisition. Refer to
Debt & Financing - Risk 3
The Term Loan
Indivior Finance S.àr.l., Indivior SMTM LLC, RBP Global Holdings Limited, which are subsidiaries of Indivior PLC, entered into a Credit Agreement, originally dated as of December 19, 2014, as amended and restated from time to time with Morgan Stanley Senior Funding, Inc., Morgan Stanley Bank, N.A., and Deutsche Bank AG New York Branch as lenders (the "Credit Agreement"). The Credit Agreement provides for a $250 million term loan. The obligations of the borrowers are secured by substantially all the assets of the borrowers, including a pledge of all of the equity interests of the borrowers. In April 2022, the Group completed an amendment to its existing term loan which provides the Group greater flexibility in the use of cash being generated and changes the variable interest rate base from USD LIBOR to USD SOFR plus a credit spread adjustment of 26 basis points. As part of the modification, the Group incurred $1 million of issuance costs, banking fees and legal fees which were capitalized, netted against the total amount borrowed and are amortized over the maturity period using the effective interest method.
The Term Loan has a 1% annual amortization feature with a quarterly payment of $0.625 million, with the remaining principal amount outstanding due on June 30, 2026. Nominal interest margin is calculated as USD SOFR plus 0.26%, subject to a floor of 0.75%, plus a credit spread adjustment of 5.25%. The average interest rate during 2023 and 2022 was 10.54% and 7.22%, respectively.
The Credit Agreement includes the following:
an accordion feature such that $75 million of additional incremental loans are permitted plus additional further incremental loans up to amounts based on various leverage ratios and subject to various conditions.
a minimum liquidity covenant requiring that the borrowers and their restricted subsidiaries not allow liquidity to be less than the greater of $100 million or 50% of the aggregate amount of loans outstanding on the last day of each fiscal quarter.
customary events of default including non-payment of principal, interest, fees or any other amounts when due, breach of certain covenants or representations, cross event of default and cross acceleration, insolvency and insolvency events, material monetary judgments, pension defaults, material invalidity of guarantees or security, ranking and change of control. In the event of an event of default, the administrative agent under the Credit Agreement may terminate the debt facilities and/or demand repayment in full of any borrowings outstanding under the debt facilities, together with accrued interest thereon and all fees and other accrued obligations of the borrowers.
Debt & Financing - Risk 4
Net cash used in investing activities
Net cash used in investing activities was $98 million in 2023, a decrease of $125 million, compared to net cash used of $223 million in 2022, reflecting a $124 million outflow 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 and treasury securities.
Net cash used in investing activities was $223 million in 2022, an increase of $209 million, compared to net cash used of $14 million in 2021. This reflects the net investment in a portfolio of investment grade debt and treasury securities. See "
Debt & Financing - Risk 5
. Investments”
Investments"for further discussion.
We expect to make capital expenditures of $45 million to $55 million over the next three years to establish and scale manufacturing of SUBLOCADE and PERSERIS at the Raleigh, NC manufacturing facility (r efer to
Corporate Activity and Growth5 | 22.7%
Corporate Activity and Growth - Risk 1
"i
"I
Corporate Activity and Growth - Risk 2
Acquisition of Opiant”.
Acquisition of Opiant".
Additionally, 2023 intangible assets purchases include $21 million for the acquisition of INDV-2000 (oral Orexin-1 receptor antagonist) from C4X Discovery and $15 million to secure the global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of buprenorphine-based ultra long-acting injectables, including a lead asset (INDV-6001) which is potentially the first three-month long-acting injectable for OUD. In 2021, the intangible assets purchase of $30 million related to a payment made to Aelis Farma for an exclusive option and license agreement to develop its leading compound (AEF0117) targeting cannabis use disorders.
Capital ExpendituresFor the years endedDecember 31,(in millions)202320222021Purchases of property, plant and equipment(8)(5)(4)Purchases of intangible assets(171)(1)(30)Total $(179)$(6)$(34)
Corporate Activity and Growth - Risk 3
. Business Combinations.”),
Business Combinations."),after which time we expect capital expenditures to revert to levels more in line with Indivior's history.
The Group expects to continue investing in development stage assets from time to time but presently has no commitment to do so.
Corporate Activity and Growth - Risk 4
CVR Agreement
In connection with the acquisition of Opiant, a subsidiary of Indivior issued Contingent Value Rights ("CVRs") to the stockholders of Opiant. Each CVR represents the obligation of Indivior Inc. to make cash payments upon achievement of certain worldwide net sales milestones during the period from October 1, 2023 to September 30, 2030.
We estimate total potential payments to be up to an additional $68 million over a period of up to 7 years from the date of the first commercial sales of a new Opiant product. Refer to
Corporate Activity and Growth - Risk 5
Acquisition of Opiant”
Acquisition of Opiant"for additional details on the CVR agreement.
C.
Research and Development Expenses, Patents and Licenses, etc.
See "
Legal & Regulatory
Total Risks: 3/22 (14%)Below Sector Average
Regulation1 | 4.5%
Regulation - Risk 1
"
"
Litigation & Legal Liabilities2 | 9.1%
Litigation & Legal Liabilities - Risk 1
. Provisions and other liabilities
" for additional details on the litigation-related settlement payments.
The net cash outflow from operating activities was $4 million in 2022, a decrease of $357 million, compared to the net cash inflow of $353 million in 2021. $299 million of this change results from a decrease in trade spend accruals in 2022 versus the increase experienced in 2021. The remaining decrease in cash from operating activities results from settlement payments and increased income taxes paid (net of refunds) in 2022.
Net cash from operations was an outflow in 2022 and 2023, primarily due to the litigation costs. We expect such costs to be substantially less in 2024. Refer to "
Litigation & Legal Liabilities - Risk 2
Risk Factors—We are currently, in the past have been, and in the future may be, subject to substantial litigation and ongoing litigation that could cause us to incur significant legal expenses, divert management’s attention, and result in harm to our business.”
- Risk Factors-We are currently, in the past have been, and in the future may be, subject to substantial litigation and ongoing litigation that could cause us to incur significant legal expenses, divert management's attention, and result in harm to our business."
Indivior PLC is a holding company with no direct source of operating income. It is therefore dependent on its capital-raising abilities and dividend payments from its subsidiaries. The ability of subsidiaries within the Group to pay dividends and Indivior PLC's ability to receive distributions from its investments in other entities are subject to restrictions, including, but not limited to, covenants in our Term Loan and the existence of sufficient distributable reserves.
Production
Total Risks: 2/22 (9%)Below Sector Average
Supply Chain2 | 9.1%
Supply Chain - Risk 1
Contractual Obligations
The table below sets forth the Group's anticipated contractual cash flows including bank borrowings, legal settlement payments (including expected interest payments), share repurchase liabilities and lease liabilities on an undiscounted basis as of December 31, 2023. The end payor and direct purchaser settlements of $30 million and $385 million are excluded as the Group funded these into qualified settlement escrow accounts in 2023.
Total1 year or less2-5 yearsMore than 5 years(in millions)At December 31, 2023Borrowings311 30 281 - DOJ resolution410 53 357 - RB indemnity settlement24 8 16 - Intellectual property matters12 12 - - Lease liabilities49 11 36 2 Share repurchase liabilities23 23 - - Other(1)8 - - 8 Total $837 $137 $690 $10 _______________
Other liabilities primarily represent employee related liabilities.
We expect our cash and cash equivalents, together with our cash flows generated from operations and borrowings from banks and other financial institutions to be sufficient to fund additional planned capital requirements, which may include additional capital expenditures, share repurchases, milestone and royalty payments (described below) in addition to the contractual obligations noted above.
Potential milestone and royalty payments
The Group is party to collaboration and license arrangements for the development of pharmaceutical and digital products. Milestone payments will be due if various developmental, regulatory and commercial goals are achieved and in certain cases royalties will be payable as a percentage of net revenue, although the Group generally has the right to terminate these agreements at no cost. Since some of these products are in the early stages of development, the potential obligation to make milestone payments will be carried for a number of years if the products move successfully through the development process. The development of any pharmaceutical product is risky and may fail at any stage, whether from failure to meet key study endpoints, safety concerns, or failure to obtain regulatory approval. Therefore, the probability of success and timing of any potential payments is inherently uncertain. See generally, "
Supply Chain - Risk 2
Item 3.D—Risk Factors—Most of our pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of our products.”
Item 3.D-Risk Factors-Most of our pharmaceutical pipeline relies on collaborations with third parties, which may adversely affect the development and sale of our products."
In 2021, the Group entered a strategic collaboration with Aelis Farma that includes a $100 million option for an exclusive global license to develop, make and commercialize AEF0117 , a leading compound to treat cannabis-related disorders.
The option becomes exercisable u pon completion of a successful Phase 2B trial and end-of-Phase 2 meeting with the FDA, estimated to occur in late 2024 or early 2025.
Tech & Innovation
Total Risks: 1/22 (5%)Below Sector Average
Trade Secrets1 | 4.5%
Trade Secrets - Risk 1
Information on the Company—B. Business Overview Background—8. Intellectual Property
Information on the Company-B. Business Overview Background-8. Intellectual Property ," "
Macro & Political
Total Risks: 1/22 (5%)Below Sector Average
Economy & Political Environment1 | 4.5%
Economy & Political Environment - Risk 1
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See a full breakdown of risk according to category and subcategory. The list starts with the category with the most risk. Click on subcategories to read relevant extracts from the most recent report.
FAQ
What are “Risk Factors”?
Risk factors are any situations or occurrences that could make investing in a company risky.
The Securities and Exchange Commission (SEC) requires that publicly traded companies disclose their most significant risk factors. This is so that potential investors can consider any risks before they make an investment.
They also offer companies protection, as a company can use risk factors as liability protection. This could happen if a company underperforms and investors take legal action as a result.
It is worth noting that smaller companies, that is those with a public float of under $75 million on the last business day, do not have to include risk factors in their 10-K and 10-Q forms, although some may choose to do so.
How do companies disclose their risk factors?
Publicly traded companies initially disclose their risk factors to the SEC through their S-1 filings as part of the IPO process.
Additionally, companies must provide a complete list of risk factors in their Annual Reports (Form 10-K) or (Form 20-F) for “foreign private issuers”.
Quarterly Reports also include a section on risk factors (Form 10-Q) where companies are only required to update any changes since the previous report.
According to the SEC, risk factors should be reported concisely, logically and in “plain English” so investors can understand them.
How can I use TipRanks risk factors in my stock research?
Use the Risk Factors tab to get data about the risk factors of any company in which you are considering investing.
You can easily see the most significant risks a company is facing. Additionally, you can find out which risk factors a company has added, removed or adjusted since its previous disclosure. You can also see how a company’s risk factors compare to others in its sector.
Without reading company reports or participating in conference calls, you would most likely not have access to this sort of information, which is usually not included in press releases or other public announcements.
A simplified analysis of risk factors is unique to TipRanks.
What are all the risk factor categories?
TipRanks has identified 6 major categories of risk factors and a number of subcategories for each. You can see how these categories are broken down in the list below.
1. Financial & Corporate
Accounting & Financial Operations - risks related to accounting loss, value of intangible assets, financial statements, value of intangible assets, financial reporting, estimates, guidance, company profitability, dividends, fluctuating results.
Share Price & Shareholder Rights – risks related to things that impact share prices and the rights of shareholders, including analyst ratings, major shareholder activity, trade volatility, liquidity of shares, anti-takeover provisions, international listing, dual listing.
Debt & Financing – risks related to debt, funding, financing and interest rates, financial investments.
Corporate Activity and Growth – risks related to restructuring, M&As, joint ventures, execution of corporate strategy, strategic alliances.
2. Legal & Regulatory
Litigation and Legal Liabilities – risks related to litigation/ lawsuits against the company.
Regulation – risks related to compliance, GDPR, and new legislation.
Environmental / Social – risks related to environmental regulation and to data privacy.
Taxation & Government Incentives – risks related to taxation and changes in government incentives.
3. Production
Costs – risks related to costs of production including commodity prices, future contracts, inventory.
Supply Chain – risks related to the company’s suppliers.
Manufacturing – risks related to the company’s manufacturing process including product quality and product recalls.
Human Capital – risks related to recruitment, training and retention of key employees, employee relationships & unions labor disputes, pension, and post retirement benefits, medical, health and welfare benefits, employee misconduct, employee litigation.
4. Technology & Innovation
Innovation / R&D – risks related to innovation and new product development.
Technology – risks related to the company’s reliance on technology.
Cyber Security – risks related to securing the company’s digital assets and from cyber attacks.
Trade Secrets & Patents – risks related to the company’s ability to protect its intellectual property and to infringement claims against the company as well as piracy and unlicensed copying.
5. Ability to Sell
Demand – risks related to the demand of the company’s goods and services including seasonality, reliance on key customers.
Competition – risks related to the company’s competition including substitutes.
Sales & Marketing – risks related to sales, marketing, and distribution channels, pricing, and market penetration.
Brand & Reputation – risks related to the company’s brand and reputation.
6. Macro & Political
Economy & Political Environment – risks related to changes in economic and political conditions.
Natural and Human Disruptions – risks related to catastrophes, floods, storms, terror, earthquakes, coronavirus pandemic/COVID-19.
International Operations – risks related to the global nature of the company.
Capital Markets – risks related to exchange rates and trade, cryptocurrency.