QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification Number) | |
(Address of principal executive offices) |
(Zip code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
☒ | Accelerated filer | ☐ | ||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||
Emerging growth company |
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
INDEX
PART I. |
Financial Statements (unaudited) | |||||
Item 1. |
Financial Statements (unaudited) | |||||
Consolidated Balance Sheets | 3 | |||||
Consolidated Statements of Income (loss) | 4 | |||||
Consolidated Statements of Comprehensive Income (loss) | 5 | |||||
Consolidated statements of changes in equity | 6 | |||||
Consolidated Statements of Cash Flows | 7 | |||||
Notes to Consolidated Financial Statements | 8 | |||||
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 44 | ||||
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk | 63 | ||||
Item 4. |
Controls and Procedures | 63 | ||||
PART II. |
OTHER INFORMATION | |||||
Item 1. |
Legal Proceedings | 64 | ||||
Item 1A. |
Risk Factors | 64 | ||||
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds | 64 | ||||
Item 3. |
Defaults Upon Senior Securities | 64 | ||||
Item 4. |
Mine Safety Disclosures | 64 | ||||
Item 5. |
Other Information | 64 | ||||
Item 6. |
Exhibits | 65 | ||||
Signatures | 66 |
• | our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, to sustain and focus our portfolio of generic medicines, and to execute on our organizational transformation and to achieve expected cost savings; and the effectiveness of our patents and other measures to protect our intellectual property rights, including any potential challenges to our Orange Book patent listings in the U.S.; |
• | our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all; |
• | our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; effectiveness of our optimization efforts; significant disruptions of information technology systems, including cybersecurity attacks and breaches of our data security; interruptions in our supply chain or problems with internal or third party manufacturing; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism, such as the ongoing conflict between Russia and Ukraine and the state of war declared in Israel; our ability to attract, hire, integrate and retain highly skilled personnel; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities, as well as our ability to successfully and cost-effectively consummate such sales and divestitures, including our planned divestiture of our API business; |
• | compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; the effects of governmental and civil proceedings and litigation which we are, or in the future become, party to; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; increased legal and regulatory action in connection with public concern over the abuse of opioid medications; our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan ® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of such agreement; scrutiny from competition and pricing authorities around the world, including our ability to comply with and operate under our deferred prosecution agreement (“DPA”) with the U.S. Department of Justice (“DOJ”); potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare, Medicaid and other governmental programs reporting and payment obligations; compliance with sanctions and trade control laws; environmental risks; and the impact of ESG issues; |
• | the impact of the state of war declared in Israel and the military activity in the region, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel, the impact of our employees who are military reservists being called to active military duty, and the impact of the war on the economic, social and political stability of Israel; |
• | other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine; potential significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; our exposure to changes in international trade policies, including the imposition of tariffs in the jurisdictions in which we operate, and the effects of such developments on sales of our products and the pricing and availability of our raw materials; and the impact of any future failure to establish and maintain effective internal control over our financial reporting; |
March 31, 2025 |
December 31, 2024 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | $ | ||||||
Accounts receivables, net of allowance for credit losses of $ |
||||||||
Inventories |
||||||||
Prepaid expenses |
||||||||
Other current assets |
||||||||
Assets held for sale |
||||||||
Total current assets |
||||||||
Deferred income taxes |
||||||||
Other non-current assets |
||||||||
Property, plant and equipment, net |
||||||||
Operating lease right-of-use |
||||||||
Identifiable intangible assets, net |
||||||||
Goodwill |
||||||||
Total assets |
$ | $ | ||||||
LIABILITIES AND EQUITY |
||||||||
Current liabilities: |
||||||||
Short-term debt |
$ | $ | ||||||
Sales reserves and allowances |
||||||||
Accounts payables |
||||||||
Employee-related obligations |
||||||||
Accrued expenses |
||||||||
Other current liabilities |
||||||||
Liabilities held for sale |
||||||||
Total current liabilities |
||||||||
Long-term liabilities: |
||||||||
Deferred income taxes |
||||||||
Other taxes and long-term liabilities |
||||||||
Senior notes and loans |
||||||||
Operating lease liabilities |
||||||||
Total long-term liabilities |
||||||||
Commitments and contingencies |
||||||||
Total liabilities |
||||||||
Redeemable non-controlling interests |
||||||||
Equity: |
||||||||
Teva shareholders’ equity: |
||||||||
Ordinary shares of NIS |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
Treasury shares as of March 31, 2025 and December 31, 2024: |
( |
) | ( |
) | ||||
Non-controlling interests |
||||||||
Total equity |
||||||||
Total liabilities, redeemable non-controlling interests and equity |
$ | $ | ||||||
Three months ended |
||||||||
March 31, |
||||||||
2025 |
2024 |
|||||||
Net revenues |
$ | $ | ||||||
Cost of sales |
||||||||
|
|
|
|
|||||
Gross profit |
||||||||
Research and development expenses |
||||||||
Selling and marketing expenses |
||||||||
General and administrative expenses |
||||||||
Intangible assets impairments |
||||||||
Other assets impairments, restructuring and other items |
( |
) | ||||||
Legal settlements and loss contingencies |
||||||||
Other loss (income) |
||||||||
|
|
|
|
|||||
Operating income (loss) |
( |
) | ||||||
Financial expenses, net |
||||||||
|
|
|
|
|||||
Income (loss) before income taxes |
( |
) | ||||||
Income taxes (benefit) |
( |
) | ||||||
Share in (profits) losses of associated companies, net |
* |
|||||||
|
|
|
|
|||||
Net income (loss) |
( |
) | ||||||
Net income (loss) attributable to redeemable and non-redeemable non-controlling interests |
( |
) | ||||||
|
|
|
|
|||||
Net income (loss) attributable to Teva |
( |
) | ||||||
|
|
|
|
|||||
Earnings (loss) per share attributable to ordinary shareholders: |
||||||||
Basic |
$ | $ | ( |
) | ||||
|
|
|
|
|||||
Diluted |
$ | $ | ( |
) | ||||
|
|
|
|
|||||
Weighted average number of shares (in millions): |
||||||||
Basic |
||||||||
|
|
|
|
|||||
Diluted |
||||||||
|
|
|
|
* |
Represents an amount less than $ |
Three months ended |
||||||||
March 31, |
||||||||
2025 |
2024 |
|||||||
Net income (loss) |
$ | $ | ( |
) | ||||
Other comprehensive income (loss), net of tax: |
||||||||
Currency translation adjustment |
( |
) | ||||||
Unrealized gain (loss) from derivative financial instruments, net |
||||||||
Unrealized loss on defined benefit plans |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total other comprehensive income (loss) |
( |
) | ||||||
|
|
|
|
|||||
Total comprehensive income (loss) |
( |
) | ||||||
Comprehensive income (loss) attributable to redeemable and non-redeemable non-controlling interests |
( |
) | ||||||
|
|
|
|
|||||
Comprehensive income (loss) attributable to Teva |
$ | $ | ( |
) | ||||
|
|
|
|
Teva shareholders’ equity |
||||||||||||||||||||||||||||||||||||
Ordinary shares |
||||||||||||||||||||||||||||||||||||
Number of shares (in millions) |
Stated value |
Additional paid-in capital |
Retained earnings (accumulated deficit) |
Accumulated other comprehensive income (loss) |
Treasury shares |
Total Teva shareholders’ equity |
Non- controlling interests |
Total equity |
||||||||||||||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||||||||||||||||||
Balance at December 31, 2024 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Net Income (loss) |
* | |||||||||||||||||||||||||||||||||||
Other comprehensive income (loss) |
* | |||||||||||||||||||||||||||||||||||
Issuance of Shares |
* | * | * | |||||||||||||||||||||||||||||||||
Proceeds from exercise of options |
||||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
||||||||||||||||||||||||||||||||||||
Purchase of shares from redeemable non-controlling interests** |
||||||||||||||||||||||||||||||||||||
Balance at March 31, 2025 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | $ | $ | ||||||||||||||||||||||
* | Represents an amount less than $ |
** | In connection with the sale of Teva’s business venture in Japan. See note 17. |
Teva shareholders’ equity |
||||||||||||||||||||||||||||||||||||
Ordinary shares |
||||||||||||||||||||||||||||||||||||
Number of shares (in millions) |
Stated value |
Additional paid-in capital |
Retained earnings (accumulated deficit) |
Accumulated other comprehensive income (loss) |
Treasury shares |
Total Teva shareholders’ equity |
Non- controlling interests |
Total equity |
||||||||||||||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||||||||||||||||||
Balance at December 31, 2023 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Net Income (loss) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Other comprehensive income (loss) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Issuance of shares |
* | |||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
||||||||||||||||||||||||||||||||||||
Proceeds from exercise of options |
||||||||||||||||||||||||||||||||||||
Dividend to non-controlling interests** |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||
Purchase of shares from non-controlling interests*** |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||
Balance at March 31, 2024 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | $ | $ | ||||||||||||||||||||||
* | Represents an amount less than $ |
** | In connection with the dividend to non-controlling interest in Teva’s business venture in Japan. |
*** | Purchase of shares from non-controlling interests in Teva’s subsidiary in Switzerland. |
Three months ended |
||||||||
March 31, |
||||||||
2025 |
2024 |
|||||||
Operating activities: |
||||||||
Net income (loss) |
$ | ( |
) | |||||
Adjustments to reconcile net income (loss) to net cash provided by operations: |
||||||||
Depreciation and amortization |
||||||||
Impairment of long-lived assets and assets held for sale |
||||||||
Net change in operating assets and liabilities |
( |
) | ( |
) | ||||
Deferred income taxes – net and uncertain tax positions |
( |
) | ||||||
Stock-based compensation |
||||||||
Other items |
( |
) | ||||||
|
|
|
|
|||||
Net cash provided by (used in) operating activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Investing activities: |
||||||||
Beneficial interest collected in exchange for securitized trade receivables |
||||||||
Purchases of property, plant and equipment and intangible assets |
( |
) | ( |
) | ||||
Proceeds from sale of business and long-lived assets, net |
||||||||
Acquisition of businesses, net of cash acquired |
( |
) | ||||||
Purchases of investments and other assets |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Net cash provided by (used in) investing activities |
||||||||
|
|
|
|
|||||
Financing activities: |
||||||||
Repayment of senior notes and loans and other long-term liabilities |
( |
) | ||||||
Purchase of shares from redeemable and non-redeemable non-controlling interests |
( |
) | ( |
) | ||||
Dividends paid to redeemable and non-redeemable non-controlling interests |
( |
) | ( |
) | ||||
Other financing activities |
( |
) | ||||||
|
|
|
|
|||||
Net cash provided by (used in) financing activities |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Translation adjustment on cash and cash equivalents |
( |
) | ||||||
|
|
|
|
|||||
Net change in cash, cash equivalents and restricted cash |
( |
) | ( |
) | ||||
Balance of cash, cash equivalents at beginning of period |
||||||||
|
|
|
|
|||||
Balance of cash, cash equivalents at end of period |
$ | |||||||
|
|
|
|
|||||
Non-cash financing and investing activities: |
||||||||
Beneficial interest obtained in exchange for securitized accounts receivables |
$ |
March 31, |
December 31, |
|||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Accounts receivables |
$ | $ |
||||||
Inventories |
||||||||
Property, plant and equipment, net and others |
||||||||
Identifiable intangible assets, net |
||||||||
Goodwill |
||||||||
Other current assets |
||||||||
Other non-current assets |
||||||||
Expected loss on sale* |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total assets of the disposal group classified as held for sale in the consolidated balance sheets |
$ | $ | ||||||
|
|
|
|
|||||
Accounts payables |
( |
) | ( |
) | ||||
Other current liabilities |
( |
) | ( |
) | ||||
Other non-current liabilities |
( |
) | ( |
) | ||||
Expected loss on sale* |
( |
) | ||||||
|
|
|
|
|||||
Total liabilities of the disposal group classified as held for sale in the consolidated balance sheets |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
* | Includes an expected loss from reclassification of currency translation adjustments to the consolidated statements of income (loss) upon sale. |
Three months ended March 31, 2025 |
||||||||||||||||||||
United States |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||
Sale of goods |
||||||||||||||||||||
Licensing arrangements |
||||||||||||||||||||
Distribution |
§ | — | ||||||||||||||||||
Other |
( |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
§ | Represents an amount less than $0.5 million. |
Three months ended March 31, 2024 |
||||||||||||||||||||
United States |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||
Sale of goods |
||||||||||||||||||||
Licensing arrangements |
§ | |||||||||||||||||||
Distribution |
§ | — | ||||||||||||||||||
Other |
§ | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
§ | Represents an amount less than $0.5 million. |
Sales Reserves and Allowances |
||||||||||||||||||||||||||||||||
Reserves included in Accounts Receivable, net |
Rebates |
Medicaid and other governmental allowances |
Chargebacks |
Returns |
Other |
Total reserves included in Sales Reserves and Allowances |
Total |
|||||||||||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||||||||||||||
Balance at January 1, 2025 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Provisions related to sales made in current year period |
||||||||||||||||||||||||||||||||
Provisions related to sales made in prior periods |
— | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||||||||||
Credits and payments |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
Translation differences |
— | |||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at March 31, 2025 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales Reserves and Allowances |
||||||||||||||||||||||||||||||||
Reserves included in Accounts Receivable, net |
Rebates |
Medicaid and other governmental allowances |
Chargebacks |
Returns |
Other |
Total reserves included in Sales Reserves and Allowances |
Total |
|||||||||||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||||||||||||||
Balance at January 1, 2024 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
Provisions related to sales made in current year period |
||||||||||||||||||||||||||||||||
Provisions related to sales made in prior periods |
— | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||
Credits and payments |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
Translation differences |
— | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at March 31, 2024 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
December 31, |
|||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Finished products |
$ | $ | ||||||
Raw and packaging materials |
||||||||
Products in process |
||||||||
Materials in transit and payments on account |
||||||||
|
|
|
|
|||||
$ | $ | |||||||
|
|
|
|
Gross carrying amount net of impairment |
Accumulated amortization |
Net carrying amount |
||||||||||||||||||||||
March 31, |
December 31, |
March 31, |
December 31, |
March 31, |
December 31, |
|||||||||||||||||||
2025 |
2024 |
2025 |
2024 |
2025 |
2024 |
|||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
Product rights |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
Trade names |
||||||||||||||||||||||||
In process research and development |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
(a) | Identifiable product rights of $ |
(b) | IPR&D assets of $ |
(a) | Identifiable product rights of $ |
(b) | IPR&D assets of $ |
United States |
Europe |
International Markets |
Other |
Total |
||||||||||||||||||||
Teva’s API |
Medis |
|||||||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
Balance as of December 31, 2024 (1) |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
Other changes during the period: |
||||||||||||||||||||||||
Translation differences and other |
||||||||||||||||||||||||
Balance as of March 31, 2025 (1) |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
(1) | Cumulative goodwill impairment as of March 31, 2025 and December 31, 2024, was each approximately $ |
a. |
Short-term debt: |
March 31, |
December 31, |
|||||||||||||||
Interest rate as of March 31, 2025 |
Maturity |
2025 |
2024 |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Convertible senior debentures |
% | |||||||||||||||
Current maturities of long-term liabilities |
||||||||||||||||
Total short-term debt |
$ | $ | ||||||||||||||
b. |
Long-term debt: |
Interest rate as of March 31, 2025 |
Maturity |
March 31, 2025 |
December 31, 2024 |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Senior notes EUR |
% | |||||||||||||||
Senior notes USD |
% | |||||||||||||||
Senior notes EUR |
% | |||||||||||||||
Senior notes CHF |
% | |||||||||||||||
Senior notes USD |
% | |||||||||||||||
Senior notes EUR |
% | |||||||||||||||
Sustainability-linked senior notes USD |
% | |||||||||||||||
Sustainability-linked senior notes EUR |
% | |||||||||||||||
Senior notes USD |
% | |||||||||||||||
Senior notes EUR |
% | |||||||||||||||
Sustainability-linked senior notes USD |
% | |||||||||||||||
Sustainability-linked senior notes USD |
% | |||||||||||||||
Sustainability-linked senior notes EUR |
% | |||||||||||||||
Sustainability-linked senior notes EUR |
% | |||||||||||||||
Sustainability-linked senior notes USD |
% | |||||||||||||||
Sustainability-linked senior notes EUR |
% | |||||||||||||||
Senior notes USD |
% | |||||||||||||||
Senior notes USD |
% | |||||||||||||||
Total senior notes |
||||||||||||||||
Less current maturities |
( |
) | ( |
) | ||||||||||||
Less debt issuance costs |
( |
) | ( |
) | ||||||||||||
Total senior notes and loans |
$ | $ | ||||||||||||||
(1) | If Teva fails to achieve certain sustainability performance targets, a one-time premium payment of |
(2) | If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by |
(3) | If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by |
(4) | In January 2025, Teva repaid $ |
(5) | In January 2025, Teva repaid $ |
(6) | In March 2025, Teva repaid $ |
* | Interest rate adjustments and a potential one-time premium payment related to the sustainability-linked bonds are treated as bifurcated embedded derivatives. See note 8c. |
a. |
Foreign exchange risk management: |
b. |
Interest risk management: |
c. |
Bifurcated embedded derivatives: |
d. |
Derivative instruments outstanding: |
Fair value |
||||||||
Not designated as hedging instruments |
||||||||
March 31, 2025 |
December 31, 2024 |
|||||||
Reported under |
(U.S. $ in millions) |
|||||||
Asset derivatives: |
||||||||
Other current assets: |
||||||||
Option and forward contracts |
$ | $ | ||||||
Liability derivatives: |
||||||||
Other current liabilities: |
||||||||
Option and forward contracts |
( |
) | ( |
) |
Financial expenses, net |
Other comprehensive income (loss) |
|||||||||||||||
Three months ended, |
Three months ended, |
|||||||||||||||
March 31, 2025 |
March 31, 2024 |
March 31, 2025 |
March 31, 2024 |
|||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||
Line items in which effects of hedges are recorded |
$ | $ | $ | $ | ( |
) | ||||||||||
Cross-currency swaps - cash flow hedge (1) |
( |
) |
Financial expenses, net |
Net revenues |
|||||||||||||||
Three months ended, |
Three months ended, |
|||||||||||||||
March 31, 2025 |
March 31, 2024 |
March 31, 2025 |
March 31, 2024 |
|||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||
Line items in which effects of hedges are recorded |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||
Option and forward contracts (2) |
( |
) | ||||||||||||||
Option and forward contracts economic hedge (3) |
( |
) |
(1) | On March 31, 2023, Teva entered into a cross-currency interest rate swap agreement, designated as cash flow hedge for accounting purposes with respect to an intercompany loan due October 2026, denominated in Japanese yen. The agreement was terminated in the first quarter of 2024 and resulted in cash proceeds of $ |
(2) | Teva uses foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, Teva recognizes gains or losses that offset the revaluation of the balance sheet items also recorded under financial expenses, net. |
(3) | Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on projected revenues and expenses recorded in euro, Swiss franc, British pound, Russian ruble, Canadian dollar, Polish zloty, Japanese yen, new Israeli shekel, Indian rupee and some other currencies to protect its projected operating results for 2025. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as an economic hedge. These derivative instruments, which may include hedging transactions against future projected revenues and expenses, are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. In the three months ended March 31, 2025, the negative impact from these derivatives recognized under was $ |
e. |
Amortizations due to terminated derivative instruments: |
f. |
Securitization: |
g. |
Supplier Finance Program Obligation |
Three months ended March 31, |
||||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
of (*) |
$ | ( |
) | $ | ||||
Contingent consideration |
||||||||
Restructuring |
||||||||
Other |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Total |
$ | ( |
) | $ | ||||
|
|
|
|
(*) | Including impairments related to exit and disposal activities. |
Three months ended March 31, |
||||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Restructuring |
||||||||
Employee termination |
$ | $ | ||||||
Other |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions) |
||||||||||||
Balance as of January 1, 2025 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Provision |
( |
) | ( |
) | ( |
) | ||||||
Utilization and other* |
||||||||||||
Balance as of March 31, 2025 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions) |
||||||||||||
Balance as of January 1, 2024 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Provision |
( |
) | ( |
) | ( |
) | ||||||
Utilization and other* |
||||||||||||
Balance as of March 31, 2024 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
* | Includes adjustments for foreign currency translation. |
Net Unrealized Gains (Losses) |
Benefit Plans |
|||||||||||||||
Foreign currency translation adjustments |
Derivative financial instruments |
Actuarial gains (losses) and prior service (costs) credits |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Balance as of December 31, 2024, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Other comprehensive income (loss) before reclassifications |
— | |||||||||||||||
Amounts reclassified to the statements of income |
( |
) | ||||||||||||||
Release of cumulative translation adjustments** |
— | — | ||||||||||||||
Net other comprehensive income (loss) before tax |
( |
) | ||||||||||||||
Corresponding income tax |
( |
) | — | — | ( |
) | ||||||||||
Net other comprehensive income (loss) after tax* |
( |
) | ||||||||||||||
Balance as of March 31, 2025, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
* | Amounts do not include a $ non-redeemable non-controlling interests. |
** | In connection with the sale of Teva’s business venture in Japan. |
Net Unrealized Gains (Losses) |
Benefit Plans |
|||||||||||||||
Foreign currency translation adjustments |
Derivative financial instruments |
Actuarial gains (losses) and prior service (costs) credits |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Balance as of December 31, 2023, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Other comprehensive income (loss) before reclassifications |
( |
) | — | ( |
) | |||||||||||
Amounts reclassified to the statements of income |
— | ( |
) | |||||||||||||
Net other comprehensive income (loss) before tax |
( |
) | ( |
) | ( |
) | ||||||||||
Corresponding income tax |
— | — | ||||||||||||||
Net other comprehensive income (loss) after tax* |
( |
) | ( |
) | ( |
) | ||||||||||
Balance as of March 31, 2024, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
* | Amounts do not include a $ non-controlling interests. |
(a) | United States segment. |
(b) | Europe segment, which includes the European Union, the United Kingdom and certain other European countries. |
(c) | International Markets segment, which includes all countries other than the United States and countries included in the Europe segment. |
Three months ended March 31, |
||||||||||||
2025 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Cost of sales |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other |
§ | ( |
) | |||||||||
|
|
|
|
|
|
|||||||
Segment profit |
$ | $ | $ | |||||||||
|
|
|
|
|
|
§ |
Represents an amount less than $0.5 million. |
Three months ended March 31, |
||||||||||||
2024 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Cost of sales |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other |
§ | |||||||||||
|
|
|
|
|
|
|||||||
Segment profit |
$ | $ | $ | |||||||||
|
|
|
|
|
|
§ |
Represents an amount less than $0.5 million. |
Three months ended |
||||||||
March 31, |
||||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
United States profit |
$ | $ | ||||||
Europe profit |
||||||||
International Markets profit |
||||||||
|
|
|
|
|||||
Total reportable segments profit |
||||||||
Profit (loss) of other activities |
( |
) | ||||||
|
|
|
|
|||||
Amounts not allocated to segments: |
||||||||
Amortization |
||||||||
Other assets impairments, restructuring and other items |
( |
) | ||||||
Intangible assets impairments |
||||||||
Legal settlements and loss contingencies |
||||||||
Other unallocated amounts |
||||||||
|
|
|
|
|||||
Consolidated operating income (loss) |
( |
) | ||||||
|
|
|
|
|||||
Financial expenses, net |
||||||||
|
|
|
|
|||||
Consolidated income (loss) before income taxes |
$ | $ | ( |
) | ||||
|
|
|
|
United States | Three months ended March 31, |
|||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Generic products (including biosimilars) |
$ | $ | ||||||
AJOVY ® |
||||||||
AUSTEDO |
||||||||
BENDEKA ® and TREANDA® |
||||||||
COPAXONE |
||||||||
UZEDY |
||||||||
Anda |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
Europe | Three months ended March 31, |
|||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Generic products (including OTC and biosimilars) |
$ | $ | ||||||
AJOVY |
||||||||
COPAXONE |
||||||||
Respiratory products |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
International markets | Three months ended March 31, |
|||||||
2025 |
2024 |
|||||||
(U.S. $ in millions) |
||||||||
Generic products (including OTC and biosimilars) |
$ | $ | ||||||
AJOVY |
||||||||
AUSTEDO |
||||||||
COPAXONE |
||||||||
Other* |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
* |
Other revenues in the first quarter of 2025 include the sale of certain product rights. |
March 31, 2025 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money markets |
$ | $ | — | $ | — | $ | ||||||||||
Cash, deposits and other |
— | — | ||||||||||||||
Investment in securities: |
||||||||||||||||
Equity securities |
— | — | ||||||||||||||
Other |
— | — | ||||||||||||||
Derivatives: |
||||||||||||||||
|
||||||||||||||||
Options and forward contracts |
— | — | ||||||||||||||
|
||||||||||||||||
Options and forward contracts |
— | ( |
) | — | ( |
) | ||||||||||
Bifurcated embedded derivatives |
— | — | § | — | ||||||||||||
Contingent consideration* |
— | — | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||
|
|
|
|
|
|
|
|
December 31, 2024 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money markets |
$ | $ | — | $ | — | $ | ||||||||||
Cash, deposits and other |
— | — | ||||||||||||||
Investment in securities: |
||||||||||||||||
Equity securities |
— | — | ||||||||||||||
Other |
— | — | ||||||||||||||
Derivatives: |
||||||||||||||||
|
||||||||||||||||
Options and forward contracts |
— | — | ||||||||||||||
|
||||||||||||||||
Options and forward contracts |
— | ( |
) | — | ( |
) | ||||||||||
Bifurcated embedded derivatives |
— | — | § | — | ||||||||||||
Contingent consideration* |
$ | — | — | ( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | $ | ( |
) | $ | |||||||||||
|
|
|
|
|
|
|
|
§ | Represents an amount less than $0.5 million. |
* | Contingent consideration represents liabilities recorded at fair value in connection with acquisitions. |
Three months ended March 31, 2025 |
Three months ended March 31, 2024 |
|||||||
(U.S. $ in millions) |
||||||||
Fair value at the beginning of the period |
$ | ( |
) | ( |
) | |||
Bifurcated embedded derivatives |
§ | |||||||
Adjustments to provisions for contingent consideration: |
||||||||
Allergan transaction |
( |
) | ( |
) | ||||
Eagle transaction |
( |
) | ( |
) | ||||
Novetide transaction |
( |
) | ( |
) | ||||
Settlement of contingent consideration: |
||||||||
Allergan transaction |
||||||||
Eagle transaction |
||||||||
Novetide transaction |
||||||||
|
|
|
|
|||||
Fair value at the end of the period |
$ | ( |
) | $ | ( |
) | ||
|
|
|
|
§ | Represents an amount less than $0.5 million. |
Estimated fair value* |
||||||||
March 31, 2025 |
December 31, 2024 |
|||||||
(U.S. $ in millions) |
||||||||
Senior notes and sustainability-linked senior notes included under senior notes and loans |
$ | $ | ||||||
Senior notes and convertible senior debentures included under short-term debt |
||||||||
|
|
|
|
|||||
Total |
$ | $ | ||||||
|
|
|
|
* | The fair value was estimated based on quoted market prices. |
Redeemable non-controlling interests |
||||
(U.S. $ in millions) |
||||
Balance as of December 31, 2024 |
$ | |||
|
|
|||
Changes during the period: |
||||
Share in comprehensive income (loss) |
||||
Dividend payment |
( |
) | ||
Purchase of shares from redeemable non-controlling interests |
( |
) | ||
Other adjustments related to redeemable non-controlling interests |
||||
|
|
|||
Balance as of March 31, 2025 |
$ | |||
|
|
ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Business Overview
We are a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered.
Today, the company’s global network of capabilities enables its approximately 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve.
Teva was incorporated in Israel on February 13, 1944 and is the successor to a number of Israeli corporations, the oldest of which was established in 1901.
Our Business Segments
We operate our business through three segments: United States, Europe and International Markets. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and OTC products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.
In addition to these three segments, we have other activities, primarily the sale of API to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.
Pivot to Growth Strategy
In the first quarter of 2025, we continued to execute on the four key pillars of our “Pivot to Growth” strategy, which we announced in May 2023. Teva is moving into the second phase of our Pivot to Growth strategy – Acceleration. During this next phase of our Pivot to Growth Strategy, we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in the highest value activities, and optimizing our organization and operations for cost savings. We expect to achieve cost savings through reduction in headcount and optimizing our external spend during this next phase.
44
Macroeconomic and Geopolitical Environment
In recent years, the global economy has been impacted by fluctuating foreign exchange rates. In the first quarter of 2025, approximately 48% of our revenues were denominated in currencies other than the U.S. dollar and we manufacture our products largely outside of the United States. Fluctuations in the U.S. dollar versus other currencies in which we operate may materially impact our revenues, results of operations, profits and cash flows. Additionally, in recent years, in many of the markets in which we operate we experienced higher levels of inflation resulting in higher interest rates, though in certain other markets, such as the EU, we recently experienced a decrease in inflation which resulted in lower interests rates. However, although inflationary and other macroeconomic pressures have and may continue to ease, the higher costs we have experienced during recent periods have already impacted our operations and may continue to have an effect on our financial results. The global economy has also been impacted by geopolitical tensions which have resulted in disruptions to global supply chains, including our internal supply chain, as well as ongoing developments regarding international trade policies. The U.S. government recently announced tariffs on products imported from several jurisdictions in which we operate and source our raw materials from, and has made announcements regarding the potential imposition of tariffs on other jurisdictions. Certain of the announced tariffs have been delayed and we are currently assessing the potential impact on our supply chain and our global operations. However, the U.S. government may in the future pause, reimpose or increase tariffs, and countries subject to such tariffs have and in the future may impose reciprocal tariffs or other restrictive trade measures in response. Any of these actions could impact our costs and our global operations. In October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts, which as of the date of this Quarterly Report on Form 10-Q is ongoing. Our global headquarters as well as several of our manufacturing and R&D facilities are located in Israel and operations there currently remain largely unaffected.
Highlights
Significant highlights in the first quarter of 2025 included:
• | Revenues in the first quarter of 2025 were $3,891 million, an increase of 2% in U.S. dollars or 5% in local currency terms, compared to the first quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO in our United States segment, from generic products in all our segments, from AJOVY in all our segments, as well as from UZEDY in our U.S. segment, partially offset by lower revenues from the sale of mature innovative product rights in 2024. |
• | Our United States segment generated revenues of $1,910 million and segment profit of $532 million in the first quarter of 2025. Revenues increased by 11% and segment profit increased by 52%, compared to the first quarter of 2024. |
• | Our Europe segment generated revenues of $1,194 million and segment profit of $329 million in the first quarter of 2025. Revenues decreased by 6% in U.S. dollars, or 2% in local currency terms, compared to the first quarter of 2024. Segment profit decreased by 22% compared to the first quarter of 2024. |
• | Our International Markets segment generated revenues of $582 million and segment profit of $97 million in the first quarter of 2025. Revenues decreased by 2% in U.S. dollars, compared to the first quarter of 2024. In local currency terms revenues increased by 5%, compared to the first quarter of 2024. Segment profit decreased by 17% compared to the first quarter of 2024. |
• | Our revenues from other activities in the first quarter of 2025 were $206 million, a decrease of 9% in U.S. dollars or 8% local currency terms, compared to the first quarter of 2024. |
• | Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted revenues by $101 million and operating income by $50 million, compared to the first quarter of 2024. |
• | Gross profit margin was 48.2% in the first quarter of 2025, compared to 46.4% in the first quarter of 2024. |
• | R&D expenses, net in the first quarter of 2025 were $247 million, an increase of 2% compared to $242 million in the first quarter of 2024. |
• | Impairments of identifiable intangible assets were $121 million in the first quarter of 2025, compared to $80 million in the first quarter of 2024. See note 5 to our consolidated financial statements. |
45
• | We recorded legal settlements and loss contingencies of $86 million in the first quarter of 2025, compared to $106 million in the first quarter of 2024. See note 9 to our consolidated financial statements. |
• | Operating Income was $519 million in the first quarter of 2025, compared to an operating loss of $218 million in the first quarter of 2024. |
• | In the first quarter of 2025, we recognized a tax expense of $74 million, on a pre-tax income of $294 million. In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million. See note 11 to our consolidated financial statements. |
• | As of March 31, 2025, our debt was $16,651 million, compared to $17,783 million as of December 31, 2024. See note 7 to our consolidated financial statements. |
• | Cash flow used in operating activities during the first quarter of 2025 was $105 million, compared to $124 million of cash flow used in operating activities in the first quarter of 2024. The lower cash flow used in operating activities in the first quarter of 2025, resulted mainly from higher profit in our U.S. segment, partially offset by higher tax payments. Net changes in working capital items were neutral. |
• | During the first quarter of 2025, we generated free cash flow of $107 million, which we define as comprising $105 million in cash flow used in operating activities, $322 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $17 million proceeds from divestitures of businesses and other assets, partially offset by $127 million in cash used for capital investment. During the first quarter of 2024, we generated free cash flow of $32 million. The increase in the first quarter of 2025, resulted mainly from higher proceeds from divestitures of businesses and other assets and lower cash used for acquisition of businesses, net of cash acquired, as well as from lower cash flow used in operating activities. |
Results of Operations
Comparison of Three Months Ended March 31, 2025 to Three Months Ended March 31, 2024
Segment Information
United States Segment
The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
||||||||||||||||
2025 | 2024 | |||||||||||||||
(U.S. $ in millions / % of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 1,910 | 100 | % | $ | 1,725 | 100 | % | ||||||||
Cost of sales |
851 | 44.6 | % | 867 | 50.2 | % | ||||||||||
Gross profit |
1,058 | 55.4 | % | 858 | 49.8 | % | ||||||||||
R&D expenses |
154 | 8.1 | % | 154 | 8.9 | % | ||||||||||
S&M expenses |
273 | 14.3 | % | 261 | 15.1 | % | ||||||||||
G&A expenses |
96 | 5.0 | % | 93 | 5.4 | % | ||||||||||
Other |
3 | § | 1 | § | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment profit* |
$ | 532 | 27.9 | % | $ | 350 | 20.3 | % | ||||||||
|
|
|
|
|
|
|
|
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
United States Revenues
Revenues from our United States segment in the first quarter of 2025 were $1,910 million, an increase of $184 million, or 11%, compared to the first quarter of 2024. This increase was mainly due to higher revenues from our innovative products, mainly AUSTEDO and UZEDY, as well as higher revenues from generic products.
46
Revenues by Major Products and Activities
The following table presents revenues for our United States segment by major products and activities for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
Percentage Change |
|||||||||||
2025 | 2024 | 2025-2024 | ||||||||||
(U.S. $ in millions) | ||||||||||||
Generic products (including biosimilars) |
$ | 849 | $ | 808 | 5 | % | ||||||
AJOVY |
53 | 45 | 18 | % | ||||||||
AUSTEDO |
396 | 282 | 40 | % | ||||||||
BENDEKA and TREANDA |
36 | 46 | (20 | %) | ||||||||
COPAXONE |
54 | 30 | 79 | % | ||||||||
UZEDY |
39 | 15 | 156 | % | ||||||||
Anda |
373 | 381 | (2 | %) | ||||||||
Other |
109 | 117 | (7 | %) | ||||||||
|
|
|
|
|||||||||
Total |
$ | 1,910 | $ | 1,725 | 11 | % | ||||||
|
|
|
|
Generic products (including biosimilars) revenues in our United States segment in the first quarter of 2025 were $849 million, an increase of 5% compared to the first quarter of 2024. This increase was mainly driven by higher revenues from lenalidomide capsules (the generic version of Revlimid®) and the launch of SIMLANDI (adalimumab-ryvk) injection (the biosimilar to Humira®).
Among the most significant generic products we sold in the United States in the first quarter of 2025 were lenalidomide capsules (the generic version of Revlimid®), Truxima® (the biosimilar to Rituxan®) and epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®). In the first quarter of 2025, our total prescriptions were approximately 273 million (based on trailing twelve months), representing 7.1% of total U.S. generic prescriptions, compared to approximately 314 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions in the first quarter of 2024, all according to IQVIA data.
On February 21, 2025, Teva launched SELARSDI (ustekinumab-aekn) injection for subcutaneous use in the U.S., as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older. On May 5, 2025, Teva and Alvotech announced that the FDA has approved SELARSDI (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025.
AJOVY revenues in our United States segment in the first quarter of 2025 were $53 million, an increase of 18% compared to the first quarter of 2024, mainly due to growth in volume. In the first quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 30.2% compared to 27.4% in the first quarter of 2024.
AJOVY is indicated for the preventive treatment of migraine in adults, and was launched in the U.S. in 2018. AJOVY is the only anti-CGRP subcutaneous product indicated for quarterly treatment.
AJOVY is protected worldwide by patents expiring in 2026 at the earliest; extensions have been granted in several countries, including the United States and in Europe, until 2031. Additional patents relating to the use of AJOVY in the treatment of migraine have also been issued in the United States and Europe and will expire between 2035 and 2039. Such patents are also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States (obtained in September 2018) and 10 years from marketing approval in Europe (obtained in April 2019).
In October 2017, we filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents, including three method of treatment patents and six composition of matter patents. Lilly then submitted IPR petitions to the PTAB, challenging the validity of the nine Teva patents. The PTAB issued decisions upholding the three method of treatment patents but finding the six composition of matter patents invalid, which decisions were affirmed by the Court of Appeals for the Federal Circuit on August 16, 2021. A jury trial regarding the three method of treatment patents resulted in a verdict in Teva’s favor on November 9, 2022, in which the three method of treatment patents were determined to be valid and infringed by Lilly, and Teva was awarded $176.5 million in damages. On September 26, 2023, the U.S. District Court for the District of Massachusetts issued a decision that reversed the jury’s verdict and damages award, finding Teva’s method of treatment patents to be invalid. Teva appealed this ruling on October 24, 2023, and the matter is fully briefed. No date has been set for the appeal hearing.
47
In addition, in 2018 we entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.
AUSTEDO revenues in our United States segment in the first quarter of 2025 were $396 million, an increase of 40%, compared to $282 million in the first quarter of 2024. This increase was mainly due to growth in volume, including the approval of AUSTEDO XR one pill, once-daily treatment in May 2024.
AUSTEDO was launched in the U.S. in 2017. It is indicated for the treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in adults.
AUSTEDO is protected in the United States by 14 Orange Book patents expiring between 2031 and 2038. We received notice letters from two ANDA filers regarding the filing of their ANDAs with paragraph (IV) certifications for certain of the patents listed in the Orange Book for AUSTEDO. On April 29, 2022 and June 8, 2022, we reached agreements with Lupin and Aurobindo, respectively, to sell their generic products beginning in April 2033, or earlier under certain circumstances. In addition, Apotex filed a petition for inter partes review (“IPR”) by the Patent and Trial Appeal Board (“PTAB”) of the patent covering the deutetrabenazine compound that expires in 2031. On March 9, 2022, the U.S. Patent and Trademark Office denied Apotex’s petition and declined to institute a review of the deutetrabenazine patent. In China, invalidity proceedings were initiated against the deutetrabenazine compound patent by a local Chinese pharmaceutical company, and were discontinued following a settlement between the parties. There are no further patent litigations pending regarding AUSTEDO at this time.
AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in 18 mg in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.
On January 17, 2025, the Centers for Medicare and Medicaid Services (“CMS”) released a list of prescription medicines selected for price-setting discussions, which included AUSTEDO and AUSTEDO XR. The price-setting process has commenced, and the revised prices set by the government, which will apply to eligible Medicare patients, are expected to become effective on January 1, 2027. As the price-setting process is still in its early stages, the extent to which prices for AUSTEDO and AUSTEDO XR will change as a result of such discussions remains uncertain.
UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the first quarter of 2025 were $39 million, an increase of 156% compared to the first quarter of 2024, mainly due to growth in volume.
UZEDY (risperidone) extended-release injectable suspension was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by four Orange Book patents expiring between 2027 and 2040. UZEDY is protected by regulatory exclusivity until April 28, 2026. We are moving forward with plans to launch UZEDY in other countries around the world. UZEDY faces competition from multiple other products.
BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2025 were $36 million, a decrease of 20% compared to the first quarter of 2024, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022.
In April 2019, we signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which we sell BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses.
There are 19 patents listed in the U.S. Orange Book for BENDEKA with expiration dates in 2026 and 2031. In August 2021, the Court of Appeals for the Federal Circuit affirmed the district court’s decision upholding the validity of all of the asserted patents and finding infringement by two remaining ANDA filers. Another ANDA filer did not join the appeal, and Teva also settled with two ANDA filers.
Teva also settled litigation against three 505(b)(2) applicants, Hospira, Inc. (“Hospira”), Dr. Reddy’s Laboratories (“DRL”) and Accord Healthcare (“Accord”). Based on these settlement agreements, Hospira, Accord and DRL can launch their products on November 17, 2027, or earlier under certain circumstances. In 2023, Teva and Eagle also filed suit against BendaRx Corp. in the U.S. District Court for the District of Delaware, following its filing of a 505(b)(2) NDA for a bendamustine product, and that litigation is still pending.
48
In addition to the settlement with Eagle regarding its bendamustine 505(b)(2) NDA, between 2015 and 2020, we reached final settlements with 22 ANDA filers for generic versions of the lyophilized form of TREANDA and one 505(b)-(2) NDA filer for a generic version of the liquid form of TREANDA, providing for the launch of generic versions of TREANDA prior to patent expiration. Currently, there are multiple generic TREANDA products on the market.
COPAXONE revenues in our United States segment in the first quarter of 2025 were $54 million, an increase of 79% compared to the first quarter of 2024, mainly due to reduction in sales allowance, partially offset by market share erosion and competition.
The market for MS treatments continues to develop, particularly with the approval of generic versions of COPAXONE. Oral branded and generic treatments for MS, such as Tecfidera® (generic: Dimethyl fumarate) and Gilenya® (generic: Fingolimod) continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus®, Kesimpta® and Tysabri®.
Anda revenues from third-party products in our United States segment in the first quarter of 2025 were $373 million, a decrease of 2%, compared to $381 million in the first quarter of 2024. This decrease was mainly due to lower volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.
Product Launches and Pipeline
In the first quarter of 2025, we launched the generic and biosimilar version of the following branded products in the United States:
Product Name |
Brand Name |
Launch Date |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA))* |
|||||
Octreotide Acetate for Injectable Suspension, 10mg/Vial |
Sandostatin® LAR Depot | March | $ | 21 | ||||
SELARSDI (ustekinumab-aekn) injection** |
N/A | February | No Data |
* | The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch. |
** | SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to Stelara®. |
As of March 31, 2025, our generic products pipeline in the United States includes 130 product applications awaiting FDA approval, including 68 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended December 31, 2024 of approximately $124 billion, according to IQVIA. Approximately 75% of pending applications include a paragraph IV patent challenge, and we believe we are first-to-file with respect to 56 of these products, or 84 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first-to-file opportunities represent over $81 billion in U.S. brand sales for the twelve months ended December 31, 2024, according to IQVIA.
IQVIA reported brand sales are one of the many indicators of future potential value of a launch, but equally important are the mix and timing of competition, as well as cost effectiveness. The potential advantages of being the first filer with respect to some of these products may be subject to forfeiture, shared exclusivity or competition from so-called “authorized generics,” which may ultimately affect the value derived.
49
In the first quarter of 2025, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a 30-month regulatory stay lapses or a 180-day exclusivity period awarded to another manufacturer either expires or is forfeited.
Generic Name |
Brand Name |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA))* |
||||
Rimegepant Orally Disintegrating Tablets, 75 mg |
Nurtec ODT® | $ | 4,100 | |||
Prucalopride Tablets, 1 mg and 2 mg |
Motegrity® | $ | 173 | |||
Elagolix Tablets, 150 mg and 200 mg |
Orilissa® | $ | 150 |
* | The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch. |
For information regarding our innovative and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
United States Gross Profit
Gross profit from our United States segment in the first quarter of 2025 was $1,058 million, an increase of 23%, compared to $858 million in the first quarter of 2024.
Gross profit margin for our United States segment in the first quarter of 2025 increased to 55.4%, compared to 49.8% in the first quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO.
United States R&D Expenses
R&D expenses relating to our United States segment in the first quarter of 2025 were $154 million, flat compared to the first quarter of 2024.
For a description of our R&D expenses in the first quarter of 2025, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
United States S&M Expenses
S&M expenses relating to our United States segment in the first quarter of 2025 were $273 million, an increase of 5%, compared to $261 million in the first quarter of 2024. This increase was mainly due to promotional activities related to AUSTEDO, primarily the direct-to-consumer advertising campaign.
United States G&A Expenses
G&A expenses relating to our United States segment in the first quarter of 2025 were $96 million, an increase of 3% compared to $93 million in the first quarter of 2024.
United States Profit
Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.
Profit from our United States segment in the first quarter of 2025 was $532 million, an increase of 52% compared to $350 million in the first quarter of 2024. This increase was mainly due to higher gross profit, as discussed above.
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Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
||||||||||||||||
2025 | 2024 | |||||||||||||||
(U.S. $ in millions / % of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 1,194 | 100 | % | $ | 1,272 | 100 | % | ||||||||
Cost of sales |
536 | 44.9 | % | 534 | 42.0 | % | ||||||||||
Gross profit |
658 | 55.1 | % | 738 | 58.0 | % | ||||||||||
R&D expenses |
60 | 5.1 | % | 56 | 4.4 | % | ||||||||||
S&M expenses |
199 | 16.7 | % | 194 | 15.2 | % | ||||||||||
G&A expenses |
69 | 5.8 | % | 65 | 5.1 | % | ||||||||||
Other |
§ | § | 1 | § | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment profit* |
$ | 329 | 27.6 | % | $ | 423 | 33.2 | % | ||||||||
|
|
|
|
|
|
|
|
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than $0.5 million or 0.5%, as applicable. |
Europe Revenues
Our Europe segment includes the European Union, the United Kingdom and certain other European countries.
Revenues from our Europe segment in the first quarter of 2025 were $1,194 million, a decrease of 6%, or $78 million, compared to the first quarter of 2024. In local currency terms, revenues decreased by 2% compared to the first quarter of 2024, mainly due to lower revenues from COPAXONE and from the sale of mature innovative product rights in 2024, partially offset by higher revenues from AJOVY.
In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $55 million, including hedging effects, compared to the first quarter of 2024. Revenues in the first quarter of 2025, included $12 million from a negative hedging impact, which is included in “Other” in the table below. Revenues in the first quarter of 2024 included $8 million from a positive hedging impact, which is included in “Other” in the table below. See note 8d to our consolidated financial statements.
Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
Percentage Change |
|||||||||||
2025 | 2024 | 2025-2024 | ||||||||||
(U.S. $ in millions) | ||||||||||||
Generic products (including OTC and biosimilars) |
$ | 989 | $ | 1,004 | (1 | %) | ||||||
AJOVY |
58 | 51 | 14 | % | ||||||||
COPAXONE |
42 | 57 | (27 | %) | ||||||||
Respiratory products |
55 | 66 | (18 | %) | ||||||||
Other |
50 | 94 | (46 | %) | ||||||||
|
|
|
|
|||||||||
Total |
$ | 1,194 | $ | 1,272 | (6 | %) | ||||||
|
|
|
|
Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2025, were $989 million, a decrease of 1% compared to the first quarter of 2024. In local currency terms, revenues increased by 1%, mainly due to higher volumes and price increases as a result of market conditions such as inflationary pressures in certain markets, as well as revenues from recently launched products.
51
AJOVY revenues in our Europe segment in the first quarter of 2025 increased by 14% to $58 million, compared to $51 million in the first quarter of 2024. In local currency terms revenues increased by 18% due to growth in volume.
For information about AJOVY patent protection, see “—United States Revenues—Revenues by Major Products and Activities” above.
COPAXONE revenues in our Europe segment in the first quarter of 2025 were $42 million, a decrease of 27% compared to the first quarter of 2024. In local currency terms, revenues decreased by 24%, due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products.
In certain countries, Teva remains in litigation against generic companies regarding COPAXONE.
Respiratory products revenues in our Europe segment in the first quarter of 2025 were $55 million, a decrease of 18% compared to the first quarter of 2024. In local currency terms, revenues decreased by 16%, mainly due to net price reductions and lower volumes.
Product Launches and Pipeline
As of March 31, 2025, our generic products pipeline in Europe included 128 generic approvals relating to 16 compounds in 35 formulations, with no European Medicines Agency (“EMA”) approvals received. In addition, approximately 1,508 marketing authorization applications are pending approval in 37 European countries, relating to 93 compounds in 219 formulations. No applications are pending with the EMA.
For information regarding our innovative medicines and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe Gross Profit
Gross profit from our Europe segment in the first quarter of 2025 was $658 million, a decrease of 11% compared to $738 million in the first quarter of 2024.
Gross profit margin for our Europe segment in the first quarter of 2025 decreased to 55.1%, compared to 58.0% in the first quarter of 2024. This decrease was mainly due to a negative impact from hedging activities and an unfavorable mix of products.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the first quarter of 2025 were $60 million, an increase of 9% compared to $56 million in the first quarter of 2024.
For a description of our R&D expenses in the first quarter of 2025, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe S&M Expenses
S&M expenses relating to our Europe segment in the first quarter of 2025 were $199 million, an increase of 3% compared to $194 million in the first quarter of 2024. This increase was mainly to support revenue growth in generic products and AJOVY.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the first quarter of 2025 were $69 million, an increase of 5% compared to $65 million in the first quarter of 2024.
Europe Profit
Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.
Profit from our Europe segment in the first quarter of 2025 was $329 million, a decrease of 22%, compared to $423 million in the first quarter of 2024. This decrease was mainly due to lower gross profit, as discussed above.
52
International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
||||||||||||||||
2025 | 2024 | |||||||||||||||
(U.S. $ in millions / % of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 582 | 100 | % | $ | 597 | 100 | % | ||||||||
Cost of sales |
304 | 52.3 | % | 300 | 50.3 | % | ||||||||||
Gross profit |
278 | 47.7 | % | 297 | 49.7 | % | ||||||||||
R&D expenses |
25 | 4.3 | % | 28 | 4.6 | % | ||||||||||
S&M expenses |
118 | 20.2 | % | 118 | 19.8 | % | ||||||||||
G&A expenses |
39 | 6.7 | % | 35 | 5.8 | % | ||||||||||
Other |
(1 | ) | § | § | § | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment profit* |
$ | 97 | 16.7 | % | $ | 117 | 19.6 | % | ||||||||
|
|
|
|
|
|
|
|
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than $0.5 million or 0.5%, as applicable. |
International Markets Revenues
Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries.
The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, branded generics-oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.
On March 31, 2025, we closed the agreement with JKI Co. Ltd., established by the fund managed and operated by private equity firm J-Will Partners Co. Ltd., to sell our Teva-Takeda business venture in Japan, which includes generic products and legacy products. See note 2 and note 17 to our consolidated financial statements.
As of the date of this Quarterly Report on Form 10-Q, sustained conflict between Russia and Ukraine and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results and we have no manufacturing or R&D facilities in these markets. During the three months ended March 31, 2025, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, in the three months ended March 31, 2025 we partially hedged our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. However, as of the end of the first quarter of 2025, we hedge a small part of our projected net revenues in Russian ruble for 2025. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.
Revenues from our International Markets segment in the first quarter of 2025 were $582 million, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 5% compared to the first quarter of 2024. This decrease was mainly due to higher revenues from AJOVY as well as generic products in most markets, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.
In the first quarter of 2025, revenues were negatively impacted by exchange rate fluctuations of $44 million, including hedging effects, compared to the first quarter of 2024. Revenues in the first quarter of 2025 included $15 million from a negative hedging impact, compared to a positive hedging impact of $4 million in the first quarter of 2024, which are included in “Other” in the table below. See note 8d to our consolidated financial statements.
53
Revenues by Major Products and Activities
The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2025 and 2024:
Three months ended March 31, |
Percentage Change |
|||||||||||
2025 | 2024 | 2025-2024 | ||||||||||
(U.S. $ in millions) | ||||||||||||
Generic products (including OTC and biosimilars) |
$ | 468 | $ | 477 | (2 | %) | ||||||
AJOVY |
28 | 17 | 65 | % | ||||||||
AUSTEDO |
15 | 14 | 4 | % | ||||||||
COPAXONE |
10 | 12 | (11 | %) | ||||||||
Other* |
61 | 77 | (21 | %) | ||||||||
|
|
|
|
|||||||||
Total |
$ | 582 | $ | 597 | (2 | %) | ||||||
|
|
|
|
* | Other revenues in the first quarter of 2025 include the sale of certain product rights. |
Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $468 million in the first quarter of 2025, a decrease of 2% compared to the first quarter of 2024. In local currency terms, revenues increased by 2% compared to the first quarter of 2024, mainly due to higher revenues in most markets, largely driven by price increases as a result of higher costs due to inflationary pressure in certain markets and higher volumes, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.
AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the first quarter of 2025 were $28 million, compared to $17 million in the first quarter of 2024, due to growth in existing markets in which AJOVY was launched.
AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China. We continue to pursue additional submissions in various other markets.
AUSTEDO revenues in our International Markets segment in the first quarter of 2025 were $15 million compared to $14 million in the first quarter of 2024. In local currency terms, revenues increased by 6%, substantially due to the launch of a strategic partnership in China.
COPAXONE revenues in our International Markets segment in the first quarter of 2025 were $10 million compared to $12 million in the first quarter of 2024.
International Markets Gross Profit
Gross profit from our International Markets segment in the first quarter of 2025 was $278 million, a decrease of 6% compared to $297 million in the first quarter of 2024.
Gross profit margin for our International Markets segment in the first quarter of 2025 decreased to 47.7%, compared to 49.7% in the first quarter of 2024. This decrease was mainly due to a negative hedging impact, as well as regulatory price reductions and generic competition to off-patented products in Japan.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the first quarter of 2025 were $25 million, a decrease of 10% compared to the first quarter of 2024.
For a description of our R&D expenses in the first quarter of 2025, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
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International Markets S&M Expenses
S&M expenses relating to our International Markets segment in the first quarter of 2025 were $118 million, flat compared to the first quarter of 2024.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the first quarter of 2025 were $39 million, an increase of 13% compared to the first quarter of 2024.
International Markets Profit
Profit of our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.
Profit from our International Markets segment in the first quarter of 2025 was $97 million, a decrease of 17%, compared to $117 million in the first quarter of 2024. This decrease was mainly due to lower gross profit, as discussed above.
Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.
On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all. For further information, see note 2 to our consolidated financial statements.
Our revenues from other activities in the first quarter of 2025 were $206 million, a decrease of 9% in U.S. dollars or 8% in local currency terms, compared to the first quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the first quarter of 2025.
API sales to third parties in the first quarter of 2025 were $130 million, reflecting an increase of 2% in both U.S. dollars and local currency terms, compared to the first quarter of 2024.
Teva Consolidated Results
Revenues
Revenues in the first quarter of 2025, were $3,891 million, an increase of 2% in U.S. dollars or 5% in local currency terms, compared to the first quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO in our United States segment, from generic products in all our segments, from AJOVY in all our segments, as well as from UZEDY in our U.S. segment, partially offset by lower revenues from the sale of mature innovative product rights in 2024. See “—United States Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.
Exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted revenues by $101 million, compared to the first quarter of 2024. See note 8d to our consolidated financial statements.
Gross Profit
Gross profit in the first quarter of 2025, was $1,877 million, an increase of 6% compared to $1,771 million in the first quarter of 2024.
Gross profit margin was 48.2% in the first quarter of 2025, compared to 46.4% in the first quarter of 2024. This increase was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO, partially offset by a negative impact from foreign exchange rate movements including hedging effects.
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Research and Development (R&D) Expenses, net
Our R&D activities for innovative medicines and biosimilar products in each of our segments include costs of discovery research, preclinical work, drug formulation, early- and late-stage clinical development and product registration costs. These expenditures are reported net of contributions received from collaboration partners. Our spending takes place throughout the development process, including (i) early-stage projects in both discovery and preclinical phases; (ii) middle-stage projects in clinical programs up to Phase 3; (iii) late-stage projects in Phase 3 programs, including where a new drug application is currently pending approval; (iv) post-approval studies for marketed products; and (v) indirect expenses, such as costs of internal administration, infrastructure and personnel.
Our R&D activities for generic products in each of our segments include both (i) direct expenses relating to product formulation, analytical method development, stability testing, management of bioequivalence and other clinical studies and regulatory filings; and (ii) indirect expenses, such as costs of internal administration, infrastructure and personnel.
In the first quarter of 2025, our R&D expenses related primarily to innovative product candidates and marketed products in immunology and immuno-oncology, neuroscience (such as neuropsychiatry, including post-approval commitments) and selected other areas, as well as generic products and biosimilars.
R&D expenses, net in the first quarter of 2025, were $247 million, an increase of 2% compared to $242 million in the first quarter of 2024.
Our higher R&D expenses, net in the first quarter of 2025 compared to the first quarter of 2024, were mainly due to an increase in immunology and in immuno-oncology projects, as well as in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), partially offset by the non-recurrence of milestone payments related to certain biosimilar projects in the first quarter of 2025.
Our R&D expenses, net in the first quarter of 2025, were also impacted by reimbursements from our strategic partnerships entered in 2023 and 2024. See note 2 to our consolidated financial statements.
R&D expenses as a percentage of revenues were 6.3% in the first quarter of 2025, flat compared to the first quarter of 2024.
Innovative Medicines Pipeline
Below is a description of key products in our innovative medicines pipeline as of May 7, 2025:
Phase 2 |
Phase 3 | |||
Neuroscience | Olanzapine LAI (TEV-‘749) Schizophrenia (September 2022) | |||
Immunology | Duvakitug (anti-TL1A) (1) (TEV-’574) Inflammatory Bowel Disease |
Dual-Action Asthma Rescue Inhaler (DARI) (ICS/SABA; TEV-’248) (3) Asthma (February 2023) | ||
Anti-IL-15 (TEV-’408) Celiac |
||||
Emrusolmin(2) (TEV-‘286) Multiple System Atropy |
(1) | In collaboration with Sanofi. |
(2) | In collaboration with Modag. |
(3) | In collaboration with Launch Therapeutics. |
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Biosimilar Products Pipeline
We have additional biosimilar products in development internally and with our partners that are in various stages of clinical trials and regulatory review worldwide, including confirmatory clinical trials for biosimilars to Xolair® (omalizumab), to Xgeva® (denosumab), which was submitted for regulatory review in Europe, to Entyvio® (vedolizymab), which is in collaboration with Alvotech for the U.S. market, and TEV-‘333 a biosimilar in collaboration with mAbxience. Our proposed biosimilar to Prolia® (denosumab) was submitted for regulatory review in the U.S. and Europe. Our proposed biosimilars to Simponi®, Simponi Aria® (golimumab), and Eyla (aflibercept), which are in collaboration with Alvotech, were submitted for regulatory review in the U.S.
Selling and Marketing (S&M) Expenses
S&M expenses in the first quarter of 2025, were $622 million, an increase of 2% compared to the first quarter of 2024. This increase was mainly a result of the factors discussed above under “—United States segment—S&M Expenses,” and “—Europe segment— S&M Expenses”.
S&M expenses as a percentage of revenues were 16.0% in the first quarter of 2025, compared to 15.9% in the first quarter of 2024.
General and Administrative (G&A) Expenses
G&A expenses in the first quarter of 2025, were $297 million, an increase of 7% compared to the first quarter of 2024.
G&A expenses as a percentage of revenues were 7.6% in the first quarter of 2025 compared to 7.3% in the first quarter of 2024.
Intangible Asset Impairments
We recorded expenses of $121 million for identifiable intangible asset impairments in the first quarter of 2025, compared to expenses of $80 million in the first quarter of 2024. See note 5 to our consolidated financial statements.
Goodwill Impairment
No goodwill impairments were recorded in the first quarters of 2025 and 2024. See note 6 to our consolidated financial statements.
Other Asset Impairments, Restructuring and Other Items
We recorded income of $22 million for other asset impairments, restructuring and other items in the first quarter of 2025, compared to expenses of $673 million in the first quarter of 2024. See note 12 to our consolidated financial statements.
Legal Settlements and Loss Contingencies
We recorded expenses of $86 million in legal settlements and loss contingencies in the first quarter of 2025, compared to expenses of $106 million in the first quarter of 2024. See note 9 to our consolidated financial statements.
Other Loss (Income)
Other loss in the first quarter of 2025 was $5 million, compared to $1 million in the first quarter of 2024.
Operating Income (Loss)
Operating Income was $519 million in the first quarter of 2025, compared to an operating loss of $218 million in the first quarter of 2024. This increase was mainly due to other asset impairments, restructuring and other items in the first quarter of 2024, as well as higher gross profit in the first quarter of 2025.
Operating income as a percentage of revenues was 13.3% in the first quarter of 2025, compared to an operating loss as a percentage of revenues of 5.7% in the first quarter of 2024.
Financial Expenses, Net
In the first quarter of 2025, financial expenses, net were $225 million, mainly comprised of net-interest expenses of $212 million. In the first quarter of 2024, financial expenses, net were $250 million, mainly comprised of net-interest expenses of $233 million.
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Reconciliation Table to Consolidated Income (Loss) Before Income Taxes
The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three months ended March 31, 2025 and 2024:
Three months ended | ||||||||
March 31, | ||||||||
2025 | 2024 | |||||||
(U.S. $ in millions) | ||||||||
United States profit |
$ | 532 | $ | 350 | ||||
Europe profit |
329 | 423 | ||||||
International Markets profit |
97 | 117 | ||||||
|
|
|
|
|||||
Total reportable segments profit |
958 | 890 | ||||||
Profit (loss) of other activities |
(13 | ) | 2 | |||||
|
|
|
|
|||||
Total segments profit |
946 | 892 | ||||||
Amounts not allocated to segments: |
||||||||
Amortization |
145 | 152 | ||||||
Other assets impairments, restructuring and other items |
(22 | ) | 673 | |||||
Intangible assets impairments |
121 | 80 | ||||||
Legal settlements and loss contingencies |
83 | 106 | ||||||
Other unallocated amounts |
99 | 99 | ||||||
|
|
|
|
|||||
Consolidated operating income (loss) |
519 | (218 | ) | |||||
|
|
|
|
|||||
Financial expenses, net |
225 | 250 | ||||||
|
|
|
|
|||||
Consolidated income (loss) before income taxes |
$ | 294 | $ | (467 | ) | |||
|
|
|
|
Income Taxes
In the first quarter of 2025, we recognized a tax expense of $74 million, on a pre-tax income of $294 million. In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million. See note 11 to our consolidated financial statements.
Share in (Profits) Losses of Associated Companies, Net
Share in profits of associated companies, net in the first quarter of 2025 was negligible. Share in losses of associated companies, net in the first quarter of 2024, was $4 million.
Net Income (Loss) Attributable to Non-Controlling Interests Net Loss Attributable to Non-Controlling Interests
Net income attributable to redeemable and non-redeemable non-controlling interests was $6 million in the first quarter of 2025, compared to a net loss attributable to redeemable and non-redeemable non-controlling interests of $280 million in the first quarter of 2024. The net loss in first quarter of 2024, was mainly due to higher impairments of tangible assets largely related to the classification of our business venture in Japan as held for sale. See note 12 to our consolidated financial statements.
Net Income (Loss) Attributable to Teva
Net income attributable to Teva was $214 million in the first quarter of 2025, compared to a net loss of $139 million in the first quarter of 2024. This change was mainly due to higher operating income in the first quarter of 2025, partially offset by higher net loss attributable to redeemable and non-redeemable non-controlling interests in the first quarter of 2024 as well as higher income taxes in the first quarter of 2025, as discussed above.
Diluted Shares Outstanding and Earnings (Loss) per Share
The weighted average diluted shares outstanding used for the fully diluted share calculations for the three months ended March 31, 2025 and 2024 was 1,159 million shares and 1,123 million shares, respectively.
Diluted earnings per share was $0.18 in the first quarter of 2025, compared to diluted loss per share of $0.12 in the first quarter of 2024. See note 13 to our consolidated financial statements.
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Share Count for Market Capitalization
We calculate share amounts using the outstanding number of shares (i.e., excluding treasury shares) plus shares that would be outstanding upon the exercise of options and vesting of RSUs and PSUs, and the conversion of our convertible senior debentures, in each case, at period end.
As of March 31, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,178 million shares and 1,167 million shares, respectively.
Impact of Currency Fluctuations on Results of Operations
In the first quarter of 2025, approximately 48% of our revenues were denominated in currencies other than the U.S. dollar. Since our results are reported in U.S. dollars, we are subject to significant foreign currency risks. Accordingly, changes in the rate of exchange between the U.S. dollar and local currencies in the markets in which we operate (primarily the euro, British pound, Swiss franc, Russian ruble, Canadian dollar, New Israeli shekel, Japanese yen and Polish zloty impact our results.
During the first quarter of 2025, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each compared on a quarterly average basis): Argentinian peso by 21%, Mexican peso by 17%, Brazilian real by 16%, Turkish lira by 15%, Ukraine hryvna by 9%, Hungary forint by 7%, Canadian dollar by 6%, Russian ruble by 3% and euro by 3%. The following currency relevant to our operations increased in value against the U.S. dollar: New Israeli shekel by 1%.
As a result, exchange rate movements during the first quarter of 2025, including hedging effects, negatively impacted revenues by $101 million and operating income by $50 million, compared to the first quarter of 2024.
In the first quarter of 2025, a negative hedging impact of $27 million was recognized under revenues, and a negative hedging impact of $1 million was recognized under cost of sales. In the first quarter of 2024, a positive hedging impact of $13 million was recognized under revenues and a negative hedging impact of $3 million was recognized under cost of sales.
Hedging transactions against future projected revenues and expenses are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. See note 8d to our consolidated financial statements.
Commencing in the third quarter of 2018, the cumulative inflation in Argentina exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.
Commencing in the second quarter of 2022, the cumulative inflation in Turkey exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.
Liquidity and Capital Resources
Total balance sheet assets were $38,415 million as of March 31, 2025, compared to $39,326 million as of December 31, 2024.
Our working capital balance, which includes accounts receivables net of SR&A, inventories, prepaid expenses and other current assets, accounts payables, employee-related obligations, accrued expenses and other current liabilities, was negative $2,360 million as of March 31, 2025, compared to negative $2,837 million as of December 31, 2024. This increase was mainly due to an increase in accounts receivables, net of SR&A as well as in inventory levels and a decrease in employee related obligations, mainly due to performance incentive payments to employees for 2024, partially offset by an increase in accounts payables and accrued expenses.
Employee-related obligations, as of March 31, 2025 were $474 million, compared to $624 million as of December 31, 2024. The decrease in the first quarter of 2025 was mainly due to performance incentive payments to employees for 2024, partially offset by an accrual for performance incentive payments to employees for 2025.
Cash investment in property, plant and equipment and intangible assets in the first quarter of 2025 was $127 million compared to $124 million in the first quarter of 2024. Depreciation in the first quarter of 2025 was $99 million, compared to $120 million in the first quarter of 2024.
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Cash and cash equivalents as of March 31, 2025, were $1,697 million compared to $3,300 million as of December 31, 2024. See also the statement of cash flow to our consolidated financial statements.
In the first quarter of 2025, we paid a dividend of $340 million to redeemable non-controlling interests in our business venture in Japan.
Our cash on hand that is not used for ongoing operations is generally invested in bank deposits as well as liquid securities that bear fixed and floating rates.
Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid securities and available credit facilities, primarily our $1.8 billion unsecured syndicated sustainability-linked revolving credit facility, entered into in April 2022, as amended in February 2023 and in May 2024 (“RCF”). See note 7 to our consolidated financial statements.
Debt Balance and Movements
As of March 31, 2025, our debt was $16,651 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,368 million of our senior notes (as detailed below), partially offset by $233 million of exchange rate fluctuations.
In January 2025, we repaid $426 million of our 6% senior notes at maturity.
In January 2025, we repaid $427 million of our 7.13% senior notes at maturity.
In March 2025, we repaid $515 million of our 4.50% senior notes at maturity.
As of March 31, 2025, our debt was effectively denominated in the following currencies: 63% in U.S. dollars, 35% in euros and 2% in Swiss francs.
The portion of total debt classified as short-term as of March 31, 2025 was 3% compared to 10% as of December 31, 2024.
Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 73% as of March 31, 2025, compared to 77% as of December 31, 2024. Our average debt maturity was approximately 5.7 years as of March 31, 2025, compared to 5.5 years as of December 31, 2024.
Total Equity
Total equity was $6,269 million as of March 31, 2025, compared to $5,380 as of December 31, 2024. This increase was mainly due to a positive impact from exchange rate fluctuations of $467 million and a net income attributable to Teva of $214 million.
Exchange rate fluctuations affected our balance sheet, as approximately 95% of our net assets as of March 31, 2025 (including both monetary and non-monetary assets) were in currencies other than the U.S. dollar. When compared to December 31, 2024, changes in currency rates as of March 31, 2025 had a positive impact of $467 million on our equity. The following main currencies increased in value against the U.S. dollar: Russian ruble by 23%, Polish zloty by 6%, Japanese yen by 4%, Chilean peso by 4%, Bulgarian lev by 4%, euro by 4%, British pound by 3% and Mexican peso by 1%. All comparisons are on a year-to-date basis.
Cash Flow
We continually seek to improve the efficiency of our working capital management. Periodically, as part of our cash and commercial relationship management activities, we make decisions in our commercial and supply chain activities which drive an acceleration of receivable payments from customers, or deceleration of payments to vendors. This has the effect of increasing or decreasing cash from operations during any given period. Increased cash from operations has the effect of reducing our leverage ratio, which is measured net of cash and cash equivalents, as of the end of such period. In connection with strategic continual improvement, we obtained more favorable payment terms from many of our vendors which are expected to continue in future periods. In addition, in periods in which receivable payments from customers are delayed, we have and expect we may in the future extend the time to pay certain vendors, so as to balance our liquidity position. Such decisions have had and may in the future have a material impact on our annual operating cash flow measurement, as well as on our quarterly results.
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Cash flow used in operating activities during the first quarter of 2025 was $105 million, compared to $124 million of cash flow used in operating activities in the first quarter of 2024. The lower cash flow used in operating activities in the first quarter of 2025 resulted mainly from higher profit in our U.S. segment, partially offset by higher tax payments. Net changes in working capital items were neutral.
During the first quarter of 2025, we generated free cash flow of $107 million, which we define as comprising $105 million in cash flow used in operating activities, $322 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $17 million proceeds from divestitures of businesses and other assets, partially offset by $127 million in cash used for capital investment. During the first quarter of 2024, we generated free cash flow of $32 million, which we define as comprising $124 million in cash flow used in operating activities, $295 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program), partially offset by $124 million in cash used for capital investment and $15 million in cash used for acquisition of businesses, net of cash acquired. The increase in 2025 resulted mainly from higher proceeds from divestitures of businesses and other assets and lower cash used for acquisition of businesses, net of cash acquired, as well as from lower cash flow used in operating activities.
Dividends
We have not paid dividends on our ordinary shares or ADSs since December 2017.
Commitments
In addition to financing obligations under short-term debt and long-term senior notes and loans, debentures and convertible debentures, our major contractual obligations and commercial commitments include leases, royalty payments, contingent payments pursuant to acquisition agreements, collaboration agreements, development funding agreements and participation in joint ventures associated with R&D activities. For further information on our agreements with mAbxience, Launch Therapeutics and Abingworth, Biolojic Design, Royalty Pharma, Sanofi, Modag, Alvotech, Takeda and MedinCell, see note 2 to our consolidated financial statements.
We are committed to paying royalties to owners of know-how, partners in alliances and certain other arrangements, and to parties that financed R&D at a wide range of rates as a percentage of sales of certain products, as defined in the agreements. In some cases, the royalty period is not defined; in other cases, royalties will be paid over various periods not exceeding 20 years.
In connection with certain development, supply and marketing, and research and collaboration or services agreements, we are required to indemnify, in unspecified amounts, the parties to such agreements against third-party claims relating to (i) infringement or violation of intellectual property or other rights of such third party; or (ii) damages to users of the related products. Except as described in our financial statements, we are not aware of any material pending action that may result in the counterparties to these agreements claiming such indemnification.
Non-GAAP Net Income and Non-GAAP EPS Data
We present non-GAAP net income and non-GAAP earnings per share (“EPS”) as management believes that such data provide useful information to investors because they are used by management and our Board of Directors, in conjunction with other performance metrics, to evaluate our operational performance, to prepare and evaluate our work plans and annual budgets and ultimately to evaluate the performance of management, including annual compensation. While other qualitative factors and judgment also affect annual compensation, the principal quantitative element in the determination of such compensation are performance targets tied to the work plan, which are based on these non-GAAP measures.
Non-GAAP financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. Investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using non-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry. Investors should consider non-GAAP net income and non-GAAP EPS in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP.
In preparing our non-GAAP net income and non-GAAP EPS data, we exclude items that either have a non-recurring impact on our financial performance or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not excluded, potentially cause investors to extrapolate future performance from an improper base that is not reflective of our underlying business performance. Certain of these items are also excluded because of the difficulty in predicting their timing and scope. The items excluded from our non-GAAP net income and non-GAAP EPS include:
• | amortization of purchased intangible assets; |
• | certain legal settlements and material litigation fees and/or loss contingencies, due to the difficulty in predicting their timing and scope; |
• | impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill; |
• | restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities; |
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• | acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees and inventory step-up; |
• | expenses related to our equity compensation; |
• | significant one-time financing costs, amortization of issuance costs and terminated derivative instruments, and marketable securities investment valuation gains/losses; |
• | unusual tax items; |
• | other awards or settlement amounts, either paid or received; |
• | other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as impacts due to significant costs for remediation of plants, or other unusual events; and |
• | corresponding tax effects of the foregoing items. |
The following tables present our non-GAAP net income and non-GAAP EPS for the three months ended March 31, 2025 and 2024, as well as reconciliations of each measure to their nearest GAAP equivalents:
Three months ended March 31, |
||||||||||
($ in millions except per share amounts) | 2025 | 2024 | ||||||||
Net income (Loss) attributable to Teva |
($) | 214 | (139 | ) | ||||||
Increase (decrease) for excluded items: |
||||||||||
Amortization of purchased intangible assets |
145 | 152 | ||||||||
Legal settlements and loss contingencies(1) |
83 | 106 | ||||||||
Impairment of long-lived assets(2) |
77 | 679 | ||||||||
Restructuring costs |
14 | 13 | ||||||||
Equity compensation |
34 | 28 | ||||||||
Contingent consideration(3) |
11 | 79 | ||||||||
Financial expenses |
14 | 12 | ||||||||
Redeemable and non-redeemable non-controlling interests(4) |
2 | (284 | ) | |||||||
Other non-GAAP items(5) |
63 | 53 | ||||||||
Corresponding tax effects and unusual tax items(6) |
(55 | ) | (150 | ) | ||||||
Non-GAAP net income attributable to Teva |
($) | 602 | 548 | |||||||
Non-GAAP tax rate(7) |
17.5 | % | 15.0 | % | ||||||
GAAP diluted earnings (loss) per share attributable to Teva |
($) | 0.18 | (0.12 | ) | ||||||
EPS difference(8) |
0.33 | 0.60 | ||||||||
Non-GAAP diluted EPS attributable to Teva(8) |
($) | 0.52 | 0.48 | |||||||
Non-GAAP average number of shares (in millions)(8) |
1,159 | 1,143 |
(1) | For the three months ended March 31, 2025 and March 31, 2024, adjustments for legal settlements and loss contingencies primarily consisted of $50 million and $64 million, respectively, attributable to an update to the estimated settlement provision for the Company’s opioid litigation (mainly the effect of the passage of time on the net present value of the discounted payments). |
(2) | For the three months ended March 31, 2025, adjustments for impairment of long-lived assets consisted of (a) $121 million impairments of long-lived intangible assets mainly related to products in the U.S. and Europe, (b) a favorable adjustment of $46 million related to the classification of the API business (including its R&D, manufacturing and commercial activities) as held for sale. For the three months ended March 31, 2024, adjustments for impairment of long-lived assets primarily consisted of $577 million related to the classification of our business venture in Japan as held for sale. |
(3) | For the three months ended March 31, 2024, adjustments for contingent consideration primarily related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid®) of $64 million. |
(4) | For the three months ended March 31, 2024, related to non-controlling interests portion of long-lived assets impairment of $577 million related to the classification of our business venture in Japan as held for sale. |
(5) | Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, accelerated depreciation, certain inventory write-offs, material litigation fees and other unusual events. |
(6) | For the three months ended March 31, 2025 and March 31, 2024, adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table. |
(7) | Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. |
(8) | EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. |
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Off-Balance Sheet Arrangements
We do not have any material off-balance sheet arrangements, except for: (i) surety underwritten guarantees Teva has provided the European Commission in an amount of euro 462.6 million, together with specified post-decision interest, which remain in force for three years, and which includes substantially similar covenants as our RCF, as disclosed in note 10 to our consolidated financial statements; and (ii) securitization transactions, which are disclosed in note 10f to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Critical Accounting Policies
For a summary of our significant accounting policies, see note 1 to our consolidated financial statements and “Critical Accounting Policies” included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Recently Issued Accounting Pronouncements
See note 1 to our consolidated financial statements.
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There has not been any material change in our assessment of market risk as set forth in Item 7A to our Annual Report on Form 10-K for the year ended December 31, 2024.
ITEM 4. | CONTROLS AND PROCEDURES |
Disclosure Controls and Procedures
Teva maintains “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) that are designed to provide reasonable assurance that information required to be disclosed in Teva’s reports filed or submitted under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Teva’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.
After evaluating the effectiveness of our disclosure controls and procedures as of March 31, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, Teva’s disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the three months ended March 31, 2025, there were no changes in internal control over financial reporting that materially affected or are reasonably likely to materially affect Teva’s internal control over financial reporting.
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ITEM 1. |
LEGAL PROCEEDINGS |
ITEM 1A. |
RISK FACTORS |
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES |
ITEM 4. |
MINE SAFETY DISCLOSURES |
ITEM 5. |
OTHER INFORMATION |
Name and Title |
Date |
Action |
Expiration Date |
Maximum Shares Subject to Plan (1) |
||||||
|
(1) |
The plan includes shares to be sold solely to cover tax withholding obligations. |
ITEM 6. | EXHIBITS |
31.1 | Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * | |
31.2 | Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * | |
32 | Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 * | |
101.INS | Inline XBRL Taxonomy Instance Document | |
101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED | ||||||
Date: May 7, 2025 | By: | /s/ Eli Kalif | ||||
Name: | Eli Kalif | |||||
Title: | Executive Vice President, Chief Financial Officer (Duly Authorized Officer) |
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