TEVA Pharmaceutical Industries (TEVA) risk factors, FY2024 10-K

Risks related to our ability to successfully compete in the marketplace

1. 01Sales of our generic medicines comprise a significant portion of our business, and we are subject to the significant risks associated with the generic pharmaceutical business
2. 02Sales of our generic products may be adversely affected by the concentration of our customer base and commercial alliances among our customers
3. 03Our revenues and profits from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy
4. 04We have experienced, and may continue to experience, delays in launches of our new generic products
5. 05We may be unable to take advantage of the increasing number of high-value biosimilars opportunities
6. 06Our innovative medicines face intense competition from companies that have greater resources and capabilities and we must make significant investments in our pipeline of innovative medicines to address such competition, which may not achieve expected results
7. 07there is a trend in the innovative medicines industry of seeking to “outsource” drug development by acquiring companies with promising drug candidates and we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets
8. 08If generic or biosimilar products that compete with any of our innovative medicines are approved and sold, sales of our innovative medicines will be adversely affected
9. 09Our success depends on our ability to develop and commercialize additional pharmaceutical products
10. 10We depend on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectual property rights

Risks related to our significant indebtedness

1. 11We have significant debt outstanding, which requires significant interest and principal payments, requires compliance with certain covenants and restricts our ability to incur additional indebtedness or engage in other transactions
2. 12We may need to raise additional funds in the future, which may not be available on acceptable terms or at all

Risks related to our general business and operations

1. 13Global economic conditions may negatively affect us and may magnify certain risks that affect our business
2. 14The widespread outbreak of an illness or any other communicable disease, or any other public health crisis, and the governmental and societal responses thereto, could adversely affect our business, results of operations and financial condition
3. 15Implementation of ongoing optimization efforts may adversely affect our business, financial condition and results of operations
4. 16Significant disruptions of our information technology systems could adversely affect our business
5. 17A data security breach could adversely affect our business and reputation
6. 18The manufacture of our products is highly complex, and an interruption in our supply chain or problems with internal or third party manufacturing could adversely affect our results of operations
7. 19We also rely on complex shipping arrangements to and from the various facilities of our supply chain. Customs clearance and shipping by land, air or sea routes rely on and may be affected by factors that are not in our full control or are hard to predict
8. 20We have significant operations globally, including in countries that may be adversely affected by political or economic instability, major hostilities or acts of terrorism, which exposes us to risks and challenges associated with conducting business internationally
9. 21Our continued success depends on our ability to attract, hire, integrate and retain highly skilled key personnel
10. 22We may not be able to find or successfully bid for suitable acquisition targets or licensing opportunities, or consummate and integrate future acquisitions
11. 23We may decide to sell, close or otherwise divest business units, assets or facilities, and any failure to successfully and cost-effectively consummate such divestitures could adversely affect our prospects and opportunities for growth

Risks related to compliance, regulation and litigation

1. 24Our operations are subject to complex legal and regulatory environments. If we fail to comply with applicable laws and regulations we may suffer legal consequences that may have a material effect on our business, operations or reputation
2. 25other government purchasers, or other regulatory changes impacting reimbursement or competitive dynamics in multisource markets
3. 26Governmental and civil proceedings and litigation which we are, or in the future become, party to may have an adverse impact on our business
4. 27Healthcare reforms, and related reductions in pharmaceutical pricing, reimbursement and coverage, by governmental authorities and third-party payers may adversely affect our business
5. 28Under federal law, companies participating in the Medicaid Drug Rebate program must also participate in the Public Health Service’s 340B drug pricing program. See “Item 1—Business—Regulation” for more information
6. 29Public concern over the abuse of opioid medications, increased legal and regulatory action and the nationwide settlement could negatively affect our business
7. 30Additionally, we are defending claims and putative class action lawsuits in Canada in relation to the manufacture, sale, marketing and distribution of opioid medications. The loss or settlement of any such claims related to opioids could have a material adverse impact on our liquidity
8. 31The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, which may expose us to significant damages and commercial restrictions that can materially and adversely affect our business
9. 32We may be susceptible to significant product liability claims that are not covered by insurance
10. 33Any failure to comply with the complex reporting and payment obligations under the Medicare and Medicaid programs may result in further litigation or sanctions, in addition to those that we have announced in previous years
11. 34Sanctions and trade control laws create the potential for significant liabilities, penalties and reputational harm
12. 35Our failure to comply with applicable environmental, health and safety laws and regulations worldwide could adversely impact our business and results of operations
13. 36Our business could be negatively impacted by ESG issues

Risks related to our financial condition

1. 37Because we have substantial international operations, our sales, profits and cash flow may be adversely affected by currency fluctuations and restrictions as well as credit risks
2. 38Fluctuations in exchange rates between the currencies in which we operate in, and the U.S. dollar, may have a material adverse effect on our results of operations, the value of balance sheet items denominated in foreign currencies and our financial condition
3. 39Our long-lived assets may continue to lead to significant impairments in the future
4. 40Our tax liabilities could be larger than anticipated
5. 41The termination or expiration of governmental programs or tax benefits, or a change in our business, could adversely affect our overall effective tax rate
6. 42Failure to establish and maintain effective internal control over financial reporting could have a material adverse effect on our ability to report our financial condition, results of operations, or cash flows accurately and on a timely basis and could harm our reputation

Risks related to equity ownership

1. 43Shareholder rights and responsibilities as a shareholder are governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies
2. 44Provisions of Israeli law and our articles of association may delay, prevent or make difficult an acquisition of us, prevent a change of control and negatively impact our share price
3. 45Our American Depositary Shares (“ADSs”) and ordinary shares are traded on different stock exchanges and this may result in price variations
4. 46It may be difficult to enforce non-Israeli judgments in Israeli courts against us, our officers and our directors