Ustekinumab biosimilar (Alvotech)

For an accessible version of this Press Release, please visit Generics business and AUSTEDO® growth lead Q1 2024 performance. Q1 2024 revenues of $3.8 billion reflect an increase of 5% in local currency terms, compared to Q1 2023. Generics business growth across all regions – increased by 9% in local currency terms globally, compared to Q1 2023. AUSTEDO – continued growth, up 67% (in the U.S.) from Q1 2023; reaffirming 2024 revenue outlook of ~$1.5 billion. AJOVY® – revenues of $113 million in Q1 2024, up 18% from Q1 2023. Recent FDA approvals of SIMLANDI® and SELARSDI™, biosimilars to Humira® and Stelara®, respectively. Announced positive Phase 3 efficacy results for olanzapine LAI (TEV' 749); no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date. Q1 2024 Highlights: Revenues of $3.8 billion GAAP loss per share of $0.12 Non-GAAP diluted EPS of $0.48 Cash flow used in operating activities of $124 million Free cash flow of $32 million Full year 2024 business outlook reaffirmed: Revenues of $15.7 - $16.3 billion Adjusted EBITDA of $4.5 - $5.0 billion Non-GAAP diluted EPS of $2.20 - $2.50 Free cash flow of $1.7 - $2.0 billion TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2024. This press release features multimedia. View the full release here: Mr. Richard Francis, Teva's President and CEO, said, "In 2024 Teva is off to a good start, with global revenues of $3.8 billion showing growth of 5% in local currency terms compared to Q1 2023, fueled by robust growth in our generics business across all regions, and continued growth of our innovative brands AUSTEDO and AJOVY." Mr. Francis continued, “As we mark the first anniversary of our Pivot to Growth Strategy, I am proud of the significant strides we have been making in realizing the goals and milestones we set out to achieve on our journey to growth, including the progression of our innovative pipeline and growth drivers, as well as the recent FDA approvals of SIMLANDI and SELARSDI, the biosimilars to Humira® and Stelara®, respectively, and the positive Phase 3 efficacy results for olanzapine Once-Monthly LAI announced this morning. The study met its primary endpoint, demonstrating a well-tolerated effective long-acting treatment option for schizophrenia, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date. As we continue to accelerate our growth progress, we reaffirm our financial guidance for 2024." Pivot to Growth Strategy In May 2023, we introduced our “Pivot to Growth” strategy, which is based on four key pillars: (i) delivering on our growth engines, mainly AUSTEDO, AJOVY, UZEDY® and our late-stage pipeline of biosimilars; (ii) stepping up innovation through delivering on our late-stage innovative pipeline assets as well as building up our early-stage pipeline organically and potentially through business development activities; (iii) sustaining our generics medicines powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint; and (iv) focusing our business by optimizing our portfolio and global manufacturing footprint to enable strategic capital deployment to accelerate our near and long-term growth engines and reorganizing certain of our business units to a more optimal structure, while also reorganizing key business units to enhance operational efficiency. First Quarter 2024 Consolidated Results The data presented in this press release with respect to operating income (loss), income (loss) before income taxes, income taxes (benefit), net income (loss) attributable to Teva and earnings (loss) per share for prior period has been revised to reflect a revision in relation to a contingent consideration and related expenses. For additional information, see note 1b to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 and note 1c to our consolidated financial statements included in our Quarterly Report on Form 10-Q for the period ended March 31, 2024. Revenues in the first quarter of 2024 were $3,819 million, an increase of 4% in U.S. dollars or 5% in local currency terms compared to the first quarter of 2023. This increase was mainly due to higher revenues from generic products in all our segments, from AUSTEDO, as well as from AJOVY in our Europe and International Markets segments, partially offset by lower revenues from COPAXONE®, and from Anda, our distribution business in the U.S. Exchange rate movements during the first quarter of 2024, net of hedging effects, negatively impacted overall revenues by $39 million, compared to the first quarter of 2023. Exchange rate movements during the first quarter of 2024, including hedging effects, negatively impacted our operating income and non-GAAP operating income each by $11 million compared to the first quarter of 2023. Gross profit in the first quarter of 2024 was $1,771 million, an increase of 12% compared to $1,582 million in the first quarter of 2023. Gross profit margin was 46.4% in the first quarter of 2024, compared to 43.2% in the first quarter of 2023. Non-GAAP gross profit was $1,963 million in the first quarter of 2024, an increase of 9% compared to $1,796 million in the first quarter of 2023. Non-GAAP gross profit margin was 51.4% in the first quarter of 2024, compared to 49.1% in the first quarter of 2023. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products as well as a decrease in our operational costs. Research and Development (R&D) expenses, net in the first quarter of 2024 were $242 million, an increase of 4% compared to $234 million in the first quarter of 2023, as we continued to execute on our Pivot to Growth Strategy. Our higher R&D expenses, net in the first quarter of 2024, compared to the first quarter of 2023, were mainly due to an increase related to our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry) and in immunology and immuno-oncology. Our R&D expenses, net in the first quarter of 2024 were also impacted by reimbursements from our strategic partnerships. Selling and Marketing (S&M) expenses in the first quarter of 2024 were $608 million, an increase of 11% compared to the first quarter of 2023 to support our Pivot to Growth strategy, mainly related to commercial activities for AUSTEDO and UZEDY in the U.S. General and Administrative (G&A) expenses in the first quarter of 2024 were $278 million, a decrease of 6% compared to the first quarter of 2023, mainly due to lower litigation fees in the first quarter of 2024. Operating loss in the first quarter of 2024 was $218 million, compared to an operating loss of $13 million in the first quarter of 2023. Operating loss as a percentage of revenues was 5.7% in the first quarter of 2024, compared to an operating loss as a percentage of revenues of 0.4% in the first quarter of 2023. The higher operating loss in the first quarter of 2024 was mainly due to higher other assets impairments, restructuring costs and other items, as well as higher S&M expenses in the first quarter of 2024, partially offset by higher gross profit, lower legal settlements and loss contingencies and lower intangible asset impairments in the first quarter of 2024. Non-GAAP operating income in the first quarter of 2024 was $892 million representing a non-GAAP operating margin of 23.4% compared to non-GAAP operating income of $785 million representing a non-GAAP operating margin of 21.4% in the first quarter of 2023. The increase in non-GAAP operating margin in the first quarter of 2024 was mainly impacted by an increase in non-GAAP gross profit margin, partially offset by higher S&M expenses as a percentage of revenues. Financial expenses, net in the first quarter of 2024 were $250 million, mainly comprised of net-interest expenses of $233 million. In the first quarter of 2023, financial expenses, net were $260 million, mainly comprised of net-interest expenses of $236 million. In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million. In the first quarter of 2023, we recognized a tax benefit of $19 million, on a pre-tax loss of $272 million. Our tax rate for the first quarter of 2024 was mainly affected by deferred tax benefits resulting from Intellectual Property ("IP")- related integration plans. Such integration plans have been adopted, among others, in an effort of addressing the global adoption of the Organization for Economic Co-operation and Development (OECD) Pillar Two minimum effective corporate tax, commencing in 2024. Tax rate in the first quarter of 2024 was 11.1%, compared to 7.1% in the first quarter of 2023. Our tax rate for the first quarter of 2024 was mainly affected by deferred tax benefits resulting from intellectual property related integration plans. Non-GAAP tax rate in the first quarter of 2024 was 15.0%, compared to 15.5% in the first quarter of 2023. Our non-GAAP tax rate in the first quarter of 2024 was mainly affected by deferred tax benefits resulting from IP-related integration plans, the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, as well as infrequent or non-recurring items. Our non-GAAP tax rate in the first quarter of 2023 was mainly affected by the geographic mix of earnings and interest expense disallowances. We expect our annual non-GAAP tax rate for 2024 to be between 14%-17%, higher than our non-GAAP tax rate for 2023, which was 13%, mainly due to a reduced net tax benefit related to deferred tax resulting from IP-related integration plans in 2024 compared to 2023. Net loss attributable to Teva and loss per share in the first quarter of 2024 were $139 million and $0.12, respectively, compared to net loss attributable to Teva and loss per share of $220 million and $0.20, respectively, in the first quarter of 2023. The lower net loss in the first quarter of 2024 was mainly due to higher net loss attributable to non-controlling interests, higher gross profit and lower legal settlements and loss contingencies, partially offset by higher other asset impairments, restructuring and other items, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2024 were $548 million and $0.48, respectively, compared to $457 million and $0.40, respectively, in the first quarter of 2023. Net loss attributable to non-controlling interests was $280 million in the first quarter of 2024, compared to a net loss attributable to non-controlling interests of $33 million in the first quarter of 2023. The higher net loss in the first quarter of 2024 was mainly due to higher impairments of tangible assets largely related to the classification of a business in our International Markets segment as held for sale. Adjusted EBITDA was $1,005 million in the first quarter of 2024, an increase of 12% compared to $899 million in the first quarter of 2023. As of March 31, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,167 million and 1,158 million, respectively. Non-GAAP information: net non-GAAP adjustments in the first quarter of 2024 were $688 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2024 were adjusted to exclude the following items: Amortization of purchased intangible assets of $152 million, of which $138 million is included in cost of sales and the remaining $14 million in S&M expenses; Impairment of long-lived assets of $679 million primarily, which primarily consisted of $577 million related to the classification of a business in our International Markets segment as held for sale; Legal settlements and loss contingencies of $106 million, which primarily consisted of $64 million 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); Contingent consideration expenses of $79 million primarily consisted of $64 million related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®); Equity compensation expenses of $28 million; Restructuring expenses of $13 million; Accelerated depreciation of $7 million; Financial expenses of $12 million; Costs related to regulatory actions taken in facilities of $3 million; Other non-GAAP items of $44 million; Items attributable to non-controlling interests of $284 million; and Corresponding tax effects and unusual tax items of $150 million. We believe that excluding such items facilitates investors’ understanding of our business including underlying performance trends, thereby improving the comparability of our business performance results between reporting periods. For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under “Non-GAAP Financial Measures.” Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP. Cash flow used in operating activities during the first quarter of 2024 was $124 million, compared to $145 million of cash flow used in operating activities in the first quarter of 2023. The lower cash flow used in operating activities in the first quarter of 2024 resulted mainly from higher profit in our Europe segment, partially offset by changes in certain working capital items, including a negative impact from accounts payables. 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. During the first quarter of 2023, we generated free cash flow of $41 million, which we define as comprising $145 million in cash flow used in operating activities, $323 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $2 million in proceeds from divestitures of businesses and other assets, partially offset by $139 million in cash used for capital investment. As of March 31, 2024, our debt was $19,643 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to $193 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2024 was 16% compared to 8% as of December 31, 2023. Our average debt maturity was approximately 5.7 years as of March 31, 2024, compared to 6.0 years as of December 31, 2023. On May 3, 2024, the terms of our revolving credit facility ("RCF") were amended to update the Company’s maximum permitted leverage ratio under the RCF for certain periods. Under the terms of the RCF, as amended, the Company’s leverage ratio shall not exceed (i) 4.00x in 2024, 2025 and in the first quarter of 2026, (ii) 3.75x in the second, third and fourth quarters of 2026, and (iii) 3.50x in the first quarter of 2027 and onwards. The RCF permits the Company to increase the maximum leverage ratio if it consummates or commences certain material transactions. Segment Results for the first Quarter of 2024 United States Segment As part of a recent shift in executive management responsibilities and in line with our Pivot to Growth strategy, commencing January 1, 2024, Canada is reported as part of our International Markets segment and the segment previously known as our “North America” segment is now referred to as our “United States” segment. Prior period amounts were recast to reflect this change. The following table presents revenues, expenses and profit for our United States segment for the three months ended March 31, 2024 and 2023: Three months ended March 31, 2024 2023 (U.S. $ in millions / % of Segment Revenues) Revenues $ 1,725 100% $ 1,677 100% Gross profit 858 49.8% 789 47.0% R&D expenses 154 8.9% 149 8.9% S&M expenses 261 15.1% 207 12.4% G&A expenses 93 5.4% 95 5.7% Other income 1 § § § Segment profit* $ 350 20.3% $ 338 20.2% * Segment profit does not include amortization and certain other items § Represents an amount less than $0.5 million or 0.5%, as applicable Revenues from our United States segment in the first quarter of 2024 were $1,725 million, an increase of $48 million, or 3%, compared to the first quarter of 2023. This increase was mainly due to higher revenues from AUSTEDO, and higher revenues from generic products, partially offset by lower revenues from certain innovative products, primarily COPAXONE and BENDEKA® and TREANDA®, as well as from Anda, our distribution business. 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, 2024 and 2023: Three months ended March 31, Percentage Change 2024 2023 2024-2023 Generic products $ 808 $ 747 8% AJOVY 45 46 (3%) AUSTEDO 282 170 67% BENDEKA and TREANDA 46 62 (26%) COPAXONE 30 71 (58%) Anda 381 424 (10%) Other* 133 158 (16%) Total $ 1,725 $ 1,677 3% * Other revenues in the first quarter of 2023 were higher compared to the first quarter of 2024, mainly due to a reduction in estimated liabilities in connection with ProAir® HFA during the first quarter of 2023 following its discontinuation. Generic products revenues in our United States segment (including biosimilars) in the first quarter of 2024 were $808 million, an increase of 8% compared to the first quarter of 2023, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid®), partially offset by increased competition to other generic products. In the first quarter of 2024, our total prescriptions were approximately 314 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions, compared to approximately 312 million (based on trailing twelve months), representing 8.3% of total U.S. generic prescriptions in the first quarter of 2023, all according to IQVIA data. On February 24, 2024, Alvotech and Teva announced that the FDA approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira®, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. On April 16, 2024, Alvotech and Teva announced that the FDA has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. In June 2023, Alvotech and Teva reached a settlement and license agreement with Johnson & Johnson, granting a licensed entry date in the U.S. no later than February 21, 2025. AJOVY revenues in our United States segment in the first quarter of 2024 were $45 million, flat compared to the first quarter of 2023. In the first quarter of 2024, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 27.4% compared to 24.5% in the first quarter of 2023. AUSTEDO revenues in our United States segment in the first quarter of 2024 increased by 67%, to $282 million, compared to $170 million in the first quarter of 2023, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023, as well as expanded access for patients and increased investment to support higher demand. AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023, and became commercially available in the U.S. in May 2023. AUSTEDO XR is a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by ten Orange Book patents expiring between 2031 and 2041. 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 nine Orange Book patents expiring between 2025 and 2033. We are moving forward with plans to launch UZEDY in other countries around the world. BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2024 decreased by 26% to $46 million, compared to the first quarter of 2023, mainly due to generic bendamustine products entry into the market. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022. COPAXONE revenues in our United States segment in the first quarter of 2024 decreased by 58% to $30 million, compared to the first quarter of 2023, mainly due to generic competition and a decrease in glatiramer acetate market share due to availability of alternative therapies. COPAXONE revenues in the first quarter of 2024 were also negatively impacted by an increase in sales allowance due to a non-recurring item. Anda revenues from third-party products in our United States segment in the first quarter of 2024 decreased by 10% to $381 million, compared to $424 million in the first quarter of 2023, mainly due to lower demand from seasonal and other market conditions. 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. United States Gross Profit Gross profit from our United States segment in the first quarter of 2024 was $858 million, an increase of 9% compared to $789 million in the first quarter of 2023. Gross profit margin for our United States segment in the first quarter of 2024 increased to 49.8%, compared to 47.0% in the first quarter of 2023. This increase was mainly due to a favorable mix of products primarily driven by an increase in revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid®), as well as a decrease in our operational costs. United States Profit Profit from our United States segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other 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 2024 was $350 million, an increase of 4% compared to $338 million in the first quarter of 2023. This increase was mainly due to higher gross profit, partially offset by higher S&M expenses. Europe Segment Our Europe segment includes the European Union, the United Kingdom and certain other European countries. The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31, 2024 and 2023: Three months ended March 31, 2024 2023 (U.S. $ in millions / % of Segment Revenues) Revenues $ 1,272 100% $ 1,184 100% Gross profit 738 58.0% 655 55.3% R&D expenses 56 4.4% 53 4.5% S&M expenses 194 15.2% 187 15.8% G&A expenses 65 5.1% 70 5.9% Other income 1 § § § Segment profit* $ 423 33.2% $ 345 29.1% ___________ * Segment profit does not include amortization and certain other items § Represents an amount less than $0.5 million or 0.5%, as applicable Revenues from our Europe segment in the first quarter of 2024 were $1,272 million, an increase of 7%, or $88 million, compared to the first quarter of 2023. In local currency terms, revenues increased by 4% compared to the first quarter of 2023, mainly due to higher revenues from generic products and AJOVY. In the first quarter of 2024, revenues from our Europe segment were positively impacted by exchange rate fluctuations of $43 million, including hedging effects, compared to the first quarter of 2023. Revenues in the first quarter of 2024 included $8 million from a positive hedging impact, which is included in “Other” in the table below. Revenues in the first quarter of 2023 included $6 million from a negative hedging impact, which is included in “Other” in the table below. 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, 2024 and 2023: Three months ended March 31, Percentage Change 2024 2023 2024-2023 (U.S. $ in millions) Generic products $ 1,004 $ 932 8% AJOVY 51 36 42% COPAXONE 57 59 (4%) Respiratory products 66 68 (3%) Other 94 89 6% Total $ 1,272 $ 1,184 7% Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2024, were $1,004 million, an increase of 8% compared to the first quarter of 2023. In local currency terms, revenues increased by 5%, mainly due to higher volumes. AJOVY revenues in our Europe segment in the first quarter of 2024 increased by 42% to $51 million, compared to $36 million in the first quarter of 2023. In local currency terms revenues increased by 40%, mainly due to growth in European countries in which AJOVY had previously been launched. COPAXONE revenues in our Europe segment in the first quarter of 2024 decreased by 4% to $57 million, compared to the first quarter of 2023. In local currency terms, revenues decreased by 5%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products and availability of alternative therapies. Respiratory products revenues in our Europe segment in the first quarter of 2024 decreased by 3% to $66 million compared to the first quarter of 2023. In local currency terms, revenues decreased by 5% compared to the first quarter of 2023, mainly due to net price reductions and lower volumes. Europe Gross Profit Gross profit from our Europe segment in the first quarter of 2024 was $738 million, an increase of 13% compared to $655 million in the first quarter of 2023. Gross profit margin for our Europe segment in the first quarter of 2024 increased to 58.0%, compared to 55.3% in the first quarter of 2023. This increase was mainly due to a favorable mix of products as well as a decrease in our operational costs. Europe Profit Profit from our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other 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 2024 was $423 million, an increase of 22%, compared to $345 million in the first quarter of 2023. This increase was mainly due to higher gross profit, as described above. International Markets Segment Our International Markets segment includes all countries in which we operate other than the United States and countries included in our Europe segment. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada is reported under our International Markets segment and is no longer included as part of our United States segment. Prior period amounts were recast to reflect this change. 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. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2024 and 2023: Three months ended March 31, 2024 2023 (U.S. $ in millions / % of Segment Revenues) Revenues $ 597 100% $ 581 100% Gross profit 297 49.7% 285 49.0% R&D expenses 28 4.6% 27 4.7% S&M expenses 118 19.8% 113 19.4% G&A expenses 35 5.8% 38 6.6% Other income § § (1) § Segment profit* $ 117 19.6% $ 108 18.5% __________ * Segment profit does not include amortization and certain other items. § Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our International Markets segment in the first quarter of 2024 were $597 million, an increase of 3% compared to the first quarter of 2023. In local currency terms, revenues increased by 17% compared to the first quarter of 2023, mainly due to higher revenues from 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 2024, revenues were negatively impacted by exchange rate fluctuations of $82 million, net of hedging effects, compared to the first quarter of 2023. Revenues in the first quarter of 2024 included $4 million from a positive hedging impact, compared to a minimal hedging impact in the first quarter of 2023, which are included in “Other” in the table below. 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, 2024 and 2023: Three months ended March 31, Percentage Change 2024 2023 2024-2023 (U.S. $ in millions) Generic products $ 477 $ 477 § AJOVY 17 13 26% COPAXONE 12 17 (32%) Other 91 74 24% Total $ 597 $ 581 3% Generic products revenues (including OTC products) in our International Markets segment were $477 million in the first quarter of 2024, flat compared to the first quarter of 2023. In local currency terms, revenues increased by 16% compared to the first quarter of 2023, mainly due to higher revenues in most markets, largely driven by price increases as a result of higher costs due to inflationary pressure 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. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in the first quarter of 2024 were $17 million, compared to $13 million in the first quarter of 2023. COPAXONE revenues in our International Markets segment in the first quarter of 2024 were $12 million compared to $17 million in the first quarter of 2023. 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 with additional submissions in various other markets. International Markets Gross Profit Gross profit from our International Markets segment in the first quarter of 2024 was $297 million, an increase of 4% compared to $285 million in the first quarter of 2023. Gross profit margin for our International Markets segment in the first quarter of 2024 increased to 49.7%, compared to 49.0% in the first quarter of 2023. This increase was mainly due to price increases largely as a result of inflationary pressures and a favorable mix of products, partially offset by regulatory price reductions and generic competition to off-patented products in Japan, as well as higher costs due to inflationary and other macroeconomic pressures. International Markets Profit Profit from our International Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other 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 2024 was $117 million, an increase of 8%, compared to $108 million in the first quarter of 2023. 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, which divestment is expected to be completed in the first half of 2025. 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. Revenues from other activities in the first quarter of 2024 were $225 million, an increase of 3% in U.S. dollars, or 2% in local currency terms compared to the first quarter of 2023. API sales to third parties in the first quarter of 2024 were $128 million, reflecting an increase of 2% in both U.S. dollars and local currency terms, compared to the first quarter of 2023, following a reallocation of an immaterial business within our other activities, in line with our intention to divest our API business. Conference Call Teva will host a conference call and live webcast including a slide presentation on May 8, 2024, at 8:00 a.m. ET to discuss its first quarter 2024 results and overall business environment. A question & answer session will follow. In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will be available on Teva’s website at: Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva's website. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit . . Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts. Non-GAAP Financial Measures This press release contains certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("GAAP"). These non-GAAP financial measures, including, but not limited to, non-GAAP operating income, non-GAAP operating margin, non-GAAP gross profit, non-GAAP gross profit margin, Adjusted EBITDA, free cash flow, non-GAAP tax rate, non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS, are presented in order to facilitate investors' understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP measures. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items including, but not limited to, the amortization of purchased intangible assets, legal settlements and loss contingencies, impairment of long-lived assets and goodwill impairment, without unreasonable effort. These items are uncertain, depend on various factors, and could be material to our results computed in accordance with GAAP. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: 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; delays in launches of new generic products; our ability to develop and commercialize biopharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; 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, and to sustain and focus our portfolio of generics medicines; 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 substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a future downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; 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; our ability to attract, hire, integrate and retain highly skilled personnel; interruptions in our supply chain or problems with internal or third party manufacturing; disruptions of information technology systems; breaches of our data security; 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; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; 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; 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 anti-corruption, sanctions and trade control laws; environmental risks; and the impact of sustainability 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 and our ability to remediate an existing material weakness in our internal control over financial reporting; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Consolidated Statements of Income (U.S. dollars in millions, except share and per share data) (Unaudited) Three months ended March 31, 2024 2023 Net revenues 3,819 3,661 Cost of sales 2,048 2,079 Gross profit 1,771 1,582 Research and development expenses 242 234 Selling and marketing expenses 608 546 General and administrative expenses 278 296 Intangible assets impairments 80 178 Other asset impairments, restructuring and other items 673 110 Legal settlements and loss contingencies 106 233 Other income 1 (2) Operating income (loss) (218) (13) Financial expenses, net 250 260 Income (loss) before income taxes (467) (272) Income taxes (benefit) (52) (19) Share in (profits) losses of associated companies, net 4 (0) Net income (loss) (419) (253) Net income (loss) attributable to non-controlling interests (280) (33) Net income (loss) attributable to Teva (139) (220) Earnings (loss) per share attributable to Teva: Basic ($) (0.12) (0.20) Diluted ($) (0.12) (0.20) Weighted average number of shares (in millions): Basic 1,123 1,115 Diluted 1,123 1,115 Non-GAAP net income attributable to Teva for diluted earnings per share:* (139) (220) Non-GAAP earnings per share attributable to Teva:* Diluted ($) 0.48 0.40 Non-GAAP average number of shares (in millions): Diluted 1,143 1,128 Amounts may not add up due to rounding. * See reconciliation attached. CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data) (Unaudited) March 31, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents $ 2,991 $ 3,226 Accounts receivables, net of allowance for credit losses of $98 million and $95 million as of March 31, 2024 and December 31, 2023, respectively 3,456 3,408 Inventories 3,949 4,021 Prepaid expenses 1,336 1,255 Other current assets 495 504 Assets held for sale 70 70 Total current assets 12,297 12,485 Deferred income taxes 1,960 1,812 Other non-current assets 470 470 Property, plant and equipment, net 5,618 5,750 Operating lease right-of-use assets, net 364 397 Identifiable intangible assets, net 5,056 5,387 Goodwill 17,007 17,177 Total assets $ 42,773 $ 43,479 LIABILITIES AND EQUITY Current liabilities: Short-term debt $ 3,060 $ 1,672 Sales reserves and allowances 3,594 3,535 Accounts payables 2,439 2,602 Employee-related obligations 492 611 Accrued expenses 2,784 2,771 Other current liabilities 1,161 1,044 Liabilities held for sale 262 13 Total current liabilities 13,792 12,247 Long-term liabilities: Deferred income taxes 569 606 Other taxes and long-term liabilities 3,991 4,019 Senior notes and loans 16,584 18,161 Operating lease liabilities 294 320 Total long-term liabilities 21,438 23,106 Equity: Teva shareholders’ equity: 7,278 7,506 Non-controlling interests 265 620 Total equity 7,543 8,126 Total liabilities and equity $ 42,773 $ 43,479 Amounts may not add up due to rounding. TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in millions) (Unaudited) Three months ended March 31, 2024 2023 Operating activities: Net income (loss) $ (419) (253) Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 272 304 Impairment of goodwill, long-lived assets and assets held for sale 679 189 Net change in operating assets and liabilities (497) (349) Deferred income taxes – net and uncertain tax positions (189) (106) Stock-based compensation 28 32 Other items 2 34 Net loss (gain) from investments and from sale of long lived assets - 4 Net cash provided by (used in) operating activities (124) (145) Investing activities: Beneficial interest collected in exchange for securitized trade receivables 295 323 Purchases of property, plant and equipment and intangible assets (124) (139) Proceeds from sale of business and long lived assets - 2 Acquisition of businesses, net of cash acquired (15) - Purchases of investments and other assets . (12) (4) Other investing activities - (1) Net cash provided by (used in) investing activities 144 181 Financing activities: Purchase of shares from non-controlling interests (64) - Dividends paid to non-controlling interests (78) - Repayment of senior notes and loans and other long term liabilities - (3,152) Proceeds from senior notes, net of issuance costs - 2,451 Other financing activities (9) (5) Net cash provided by (used in) financing activities (151) (706) Translation adjustment on cash and cash equivalents (104) 12 Net change in cash, cash equivalents and restricted cash (236) (658) Balance of cash, cash equivalents and restricted cash at beginning of period 3,227 2,834 Balance of cash, cash equivalents and restricted cash at end of period $ 2,991 2,176 Cash and cash equivalents 2,991 2,143 Restricted cash included in other current assets — 33 Total cash, cash equivalents and restricted cash shown in the statement of cash flows 2,991 2,176 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables $ 312 334 Amounts may not add up due to rounding The accompanying notes are an integral part of the financial statements. Reconciliation of gross profit to Non-GAAP gross profit (Unaudited) Three months ended March 31, ($ in millions) 2024 2023 Gross profit $ 1,771 1,582 Gross profit margin 46.4% 43.2% Increase (decrease) for excluded items: Amortization of purchased intangible assets 137 145 Costs related to regulatory actions taken in facilities 3 1 Equity compensation 5 5 Accelerated depreciation 7 25 Other non-GAAP items (1) 41 38 Non-GAAP gross profit $ 1,963 1,796 Non-GAAP gross profit margin (2) 51.4% 49.1% (1) 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, certain inventory write-offs and other unusual events. (2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue. Reconciliation of operating income (loss) to Non-GAAP operating income (loss) (Unaudited) Three months ended March 31, ($ in millions) 2024 2023 Operating income (loss)(1) ($) (218) (13) Operating margin (5.7%) (0.4%) Increase (decrease) for excluded items: Amortization of purchased intangible assets 152 165 Legal settlements and loss contingencies(2) 106 233 Impairment of long-lived assets (3) 679 188 Restructuring costs 13 56 Costs related to regulatory actions taken in facilities 3 1 Equity compensation 28 32 Contingent consideration(1)(4) 79 35 Accelerated depreciation 7 25 Other non-GAAP items(5) 44 63 Non-GAAP operating income (loss) ($) 892 785 Non-GAAP operating margin(6) ($) 23.4% 21.4% (1) The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1b to our consolidated financial statements included in our 2023 Annual Report on Form 10-K. (2) For the three months ended March 31, 2024, adjustments for legal settlements and loss contingencies primarily consisted of $64 million 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). For the three months ended March 31, 2023, adjustments for legal settlements and loss contingencies primarily consisted of $100 million related to an estimated provision recorded in connection with the U.S. DOJ patient assistance program litigation, $50 million related to a provision for the reverse-payment antitrust litigation over certain HIV medicines, as well as $36 million attributable to an update to the estimated settlement provision related to the remaining opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments). (3) 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 a business in Teva’s International Markets segment as held for sale. For the three months ended March 31, 2023, adjustments for impairment of long-lived assets primarily consisted of $112 million mainly related to regulatory pricing reductions in Japan. (4) For the three months ended March 31, 2024, adjustments for contingent consideration primarily consisted of $64 million related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®). (5) Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, certain inventory write-offs, material litigation fees and other unusual events. (6) Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues. Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva (Unaudited) Three months ended March 31, ($ in millions except per share amounts) 2024 2023 Net income (Loss) attributable to Teva(1) ($) (139) (220) Increase (decrease) for excluded items: Amortization of purchased intangible assets 152 165 Legal settlements and loss contingencies(2) 106 233 Impairment of long-lived assets(3) 679 188 Restructuring costs 13 56 Costs related to regulatory actions taken in facilities 3 1 Equity compensation 28 32 Contingent consideration(1)(4) 79 35 Accelerated depreciation 7 25 Financial expenses 12 23 Items attributable to non-controlling interests (284) (40) Other non-GAAP items(5) 44 63 Corresponding tax effects and unusual tax items(6) (150) (104) Non-GAAP net income attributable to Teva ($) 548 457 Non-GAAP tax rate(7) 15.0% 15.5% GAAP diluted earnings (loss) per share attributable to Teva ($) (0.12) (0.20) EPS difference(8) 0.60 0.60 Non-GAAP diluted EPS attributable to Teva(8) ($) 0.48 0.40 Non-GAAP average number of shares (in millions)(8) 1,143 1,128 (1) The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1c to our consolidated financial statements. (2) For the three months ended March 31, 2024, adjustments for legal settlements and loss contingencies primarily consisted of $64 million 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). For the three months ended March 31, 2023, adjustments for legal settlements and loss contingencies primarily consisted of $100 million related to an estimated provision recorded in connection with the U.S. DOJ patient assistance program litigation, $50 million related to a provision for the reverse-payment antitrust litigation over certain HIV medicines, as well as $36 million attributable to an update to the estimated settlement provision related to the remaining opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments). (3) 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 a business in Teva’s International Markets segment as held for sale. For the three months ended March 31, 2023, adjustments for impairment of long-lived assets primarily consisted of $112 million mainly related to regulatory pricing reductions in Japan. (4) For the three months ended March 31, 2024, adjustments for contingent consideration primarily consisted of $64 million related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®). (5) Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, certain inventory write-offs, material litigation fees and other unusual events. (6) For the three months ended March 31, 2024 and March 31, 2023, adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table. (7) Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. GAAP tax rate for the three months ended March 31, 2024 and March 31, 2023 was 11.1% and 7.1%, respectively. (8) EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. Reconciliation of net income (loss) to adjusted EBITDA (Unaudited) Three months ended March 31, ($ in millions) $ 2024 2023 Net income (loss)(1) (419) (253) Increase (decrease) for excluded items: Financial expenses 250 260 Income taxes (52) (19) Share in profits (losses) of associated companies –net 4 (0) Depreciation 119 139 Amortization 152 165 EBITDA 54 291 Legal settlements and loss contingencies(2) 106 233 Impairment of long lived assets(3) 679 188 Restructuring costs 13 56 Costs related to regulatory actions taken in facilities(4) 3 1 Equity compensation 28 32 Contingent consideration 79 35 Other non-GAAP items (5) 44 62 Adjusted EBITDA $ 1,005 899 (1) The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1b to our consolidated financial statements included in our 2023 Annual Report on Form 10-K. (2) For the three months ended March 31, 2024, adjustments for legal settlements and loss contingencies primarily consisted of $64 million 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). For the three months ended March 31, 2023, adjustments for legal settlements and loss contingencies primarily consisted of $100 million related to an estimated provision recorded in connection with the U.S. DOJ patient assistance program litigation, $50 million related to a provision for the reverse-payment antitrust litigation over certain HIV medicines, as well as $36 million attributable to an update to the estimated settlement provision related to the remaining opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments). (3) 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 a business in Teva’s International Markets segment as held for sale. For the three months ended March 31, 2023, adjustments for impairment of long-lived assets primarily consisted of $112 million mainly related to regulatory pricing reductions in Japan. (4) For the three months ended March 31, 2024, adjustments for contingent consideration primarily consisted of $64 million related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®). (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, certain inventory write-offs, material litigation fees and other unusual events. Segment Information (Unaudited) United States Europe International Markets Three months ended March 31, Three months ended March 31, Three months ended March 31, 2024 2023 2024 2023 2024 2023 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues $ 1,725 $ 1,677 $ 1,272 $ 1,184 $ 597 $ 581 Gross profit 858 789 738 655 297 285 R&D expenses 154 149 56 53 28 27 S&M expenses 261 207 194 187 118 113 G&A expenses 93 95 65 70 35 38 Other income 1 § 1 § § (1) Segment profit $ 350 $ 338 $ 423 $ 345 $ 117 $ 108 § Represents an amount less than $0.5 million. Reconciliation of our segment profit to consolidated income before income taxes (Unaudited) Three months ended March 31, 2024 2023 (U.S.$ in millions) United States profit $ 350 $ 338 Europe profit 423 345 International Markets profit 117 108 Total reportable segment profit 890 791 Profit of other activities 2 (6) 892 785 Amounts not allocated to segments: Amortization 152 165 Other asset impairments, restructuring and other items* 673 110 Intangible asset impairments 80 178 Legal settlements and loss contingencies 106 233 Other unallocated amounts 99 112 Consolidated operating income (loss) (218) (13) Financial expenses - net 250 260 Consolidated income (loss) before income taxes* $ (467) $ (272) *The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1c to our consolidated financial statements. Segment revenues by major products and activities (Unaudited) Three months ended March 31, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) United States segment Generic products $ 808 $ 747 8% AJOVY 45 46 (3%) AUSTEDO 282 170 67% BENDEKA/TREANDA 46 62 (26%) COPAXONE 30 71 (58%) Anda 381 424 (10%) Other 133 158 (16%) Total 1,725 1,677 3% Three months ended March 31, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) Europe segment Generic products $ 1,004 $ 932 8% AJOVY 51 36 42% COPAXONE 57 59 (4%) Respiratory products 66 68 (3%) Other 94 89 6% Total 1,272 1,184 7% Three months ended March 31, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) International Markets segment Generic products $ 477 $ 477 § AJOVY 17 13 26% COPAXONE 12 17 (32%) Other 91 74 24% Total 597 581 3% Free cash flow reconciliation (Unaudited) Three months ended March 31, 2024 2023 (U.S. $ in millions) Net cash used in operating activities (124) (145) Beneficial interest collected in exchange for securitized accounts receivables 295 323 Capital investment (124) (139) Acquisition of businesses, net of cash acquired (15) - Proceeds from divestitures of businesses and other assets - 2 Free cash flow $ 32 $ 41 View source version on businesswire.com: Contacts IR Contacts Ran Meir (215) 591-8912 Yael Ashman +972 (3) 914 8262 Sanjeev Sharma (267) 658-2700 PR Contacts Kelley Dougherty (973) 832-2810 Eden Klein +972 (3) 906 2645 Source: Teva Pharmaceutical Industries Limited Smart Multimedia Gallery Document Logo View this news release online at:

全球药物批准/研发动态01全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）共有8个新药获批上市。其中，NDA批准1个，BLA批准1个，新适应症批准5个，新剂型批准1个。与上个统计周期相比，本增加4个批准新药。4月16日，Teva宣布FDA已批准SELARSDI（Ustekinumab-aekn）注射液皮下使用，作为Stelara的生物类似药，用于治疗成人和6岁及以上成人和儿童患者的中度至重度斑块状银屑病和活动性银屑病关节炎。Ustekinumab 是一种人源单克隆抗体（mAb），可选择性靶向p40蛋白，p40蛋白是白细胞介素（IL）-12 和 IL-23 细胞因子的共同成分，在治疗免疫介导的疾病（如银屑病和银屑病关节炎）中起着至关重要的作用。4月18日，Genentech宣布FDA已批准Alecensa（Alectinib）用于肿瘤切除后的辅助治疗，用于间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）（肿瘤≥4厘米或淋巴结阳性）患者。Alecensa是目前第一个也是唯一一个被批准用于接受手术切除肿瘤的ALK阳性早期NSCLC患者的ALK抑制剂。ALINA的III期研究显示Alecensa将ALK NSCLC患者的疾病复发或死亡风险降低了76%。全球（不含中国）新药批准情况（部分）02全球新药申报进展本周暂无相关药物申报。根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）共有7个药物获监管机构特殊资格认定。其中，化学药2个，生物药5个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。4月17日，加科思药业宣布其自主研发的KRAS G12C抑制剂Glecirasib胰腺癌适应症被FDA授予了孤儿药资格认定。此前，Glecirasib已被CDE授予用于KRAS G12C突变的二线或以上胰腺癌患者治疗的突破性治疗药物认定。此前在2024年美国临床肿瘤学会胃肠癌研讨会年会（2024 ASCO GI）以口头报告形式公布了二线及以上的KRAS G12C突变胰腺癌患者数据，确认客观缓解率为41.9%（13/31），疾病控制率为93.5%（29/31），中位无进展生存期（mPFS）为5.6个月，中位总生存期（mOS）为10.7个月。4月18日，恒瑞医药宣布其自主研发的Nectin-4抗体偶联药物（Antibody-drug-conjugate, ADC）注射用SHR-A2102获FDA授予快速通道资格，用于治疗晚期尿路上皮癌。SHR-A2102是靶向Nectin-4的抗体药物偶联物（ADC），其有效载荷是拓扑异构酶抑制剂（TOPi），多种研究表明Nectin-4在肿瘤中的高表达与肿瘤的发展和不良预后密切相关。特殊资格认定情况（部分）03全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）新药临床研发状态更新共计44条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、精神疾病、神经疾病以及眼部疾病等共计12个领域。其中，神经疾病领域临床进展更新居各领域之首，涉及化学药3条，生物药5条，细胞疗法2条。4月19日，劲方医药宣布KRAS G12C抑制剂GFH925单药疗法获得FDA临床试验许可，可针对KRAS G12C突变型难治、转移性结直肠癌患者开展一项多中心、开放标签、随机对照III期试验。这是全球首个临床获批的KRAS G12C抑制剂单药治疗结直肠癌III期试验，GFH925也是国内首个获得晚期结直肠癌突破性疗法认定的KRAS G12C抑制剂。。同日，丹码生物宣布在DM919的一项首次在人体中进行的I期的临床试验中, 首例受试者在美国已完成入组。DM919是D2M 自主研发的、靶向MICA/B蛋白的人源化单克隆抗体，通过恢复和促进T细胞和自然杀伤（NK）细胞的抗肿瘤反应，用于治疗晚期实体肿瘤。此外，当DM919与抗PD1药物联合应用时，已经表现出了显著的协同抗肿瘤效果。全球新药研发进展详情（部分）04全球医药交易事件本次统计周期（2024.04.13-04.19）全球（含中国）医药交易时间共计12起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分） 国内药物批准/研发动态01国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有1个新药获NMPA批准上市。其中， NDA批准1个。与上次统计周期相比，本次减少5个NMPA批准新药。4月16日，康哲药业宣布澳门特别行政区批准磷酸芦可替尼乳膏新药上市申请，用于治疗12岁及以上青少年和成人患者伴面部受累的非节段型白癜风。该产品是第一种也是唯一一种在美国获批使用的局部JAK抑制剂，用于12岁及以上非节段型白癜风患者的局部治疗，以及传统外用处方疗法不可取或不能充分控制病情之12岁及以上成人和儿童非免疫功能低下的轻中度特应性皮炎（AD）患者的短期和非持续性慢性治疗。两项国际多中心（包含美国和欧洲中心）关键临床研究显示：治疗24周后，与赋形剂组相比，芦可替尼乳膏治疗组患者面部和全身皮损有显著复色；52周数据表明，随着治疗时间的延长，患者皮损持续复色。中国新药批准情况（部分）02国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有43个新药获临床默示许可，涉及70个受理号。其中，化学药20个，治疗用生物制品21个，预防用生物制品2个。与上个统计周期相比，本次增加17个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分）03国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有4个新药申报上市，涉及6个受理号。其中，化学药2个，治疗用生物制品2个。与上个统计周期相比，本次减少8个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有43个新药申报临床，涉及68个受理号。其中，化学药23个，治疗用生物制品17个，预防用生物制品3个。与上个统计周期相比，本次增加12个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有3个药物获NMPA特殊资格认定。其中，化学药3个。与上个统计周期相比，本次增加1个获监管机构特殊资格认定的药物。4月19日， CDE官网公示，恒瑞医药两款创新药拟纳入优先审评，针对适应症为：氟唑帕利胶囊单药或联合甲磺酸阿帕替尼用于伴有胚系BRCA突变（gBRCAm）的HER2阴性乳腺癌患者的治疗。值得一提的是，这两款药针对该适应症的申请已于今年3月被CDE纳入突破性治疗品种。氟唑帕利是恒瑞医药研发的1类创新药，为一种新型口服PARP抑制剂。该药已经在中国获批用于胚系BRCA1/2（gBRCA1/2）突变的铂敏感复发性卵巢癌治疗，以及铂类敏感复发性卵巢癌维持治疗，无论胚系BRCA1/2突变状态如何。阿帕替尼是恒瑞医药研发一种高选择性的靶向血管内皮细胞生长因子受体2（VEGFR2）的抗血管生成药物，已经在中国获批单药治疗晚期胃腺癌或胃-食管结合部腺癌、晚期肝细胞癌，以及联合卡瑞利珠单抗治疗不可切除或转移性肝细胞癌。NMPA特殊资格认定情况（部分）04国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内新药临床研发状态更新共计2条，涉及肿瘤、血液和淋巴疾病共计2个领域。其中，化学药2个。4月17日，诺诚健华布鲁顿酪氨酸激酶（BTK）抑制剂奥布替尼治疗慢性原发性血小板减少症（ITP）患者的II期临床研究结果。该研究旨在评估奥布替尼治疗慢性ITP成人患者的疗效和安全性。结果显示，奥布替尼有望为ITP患者提供安全有效的治疗方案。此次研究的主要终点是血小板计数至少连续两周达到≥50×109/L（前4周内未使用补救药物）的患者比例。总共入组33例患者。在每天一次口服50毫克和30毫克的奥布替尼治疗ITP患者的两个组别中，奥布替尼都展现了良好的安全性。奥布替尼治疗ITP患者的III期注册临床正加速推进中，预计2024年年底完成患者入组。国内新药研发进展情况05国内新药研发领域政策法规动态国家药监局药审中心关于发布《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》的通知（药审业〔2024〕162号）为落实《已上市药品说明书增加儿童用药信息工作程序（试行）》中药品审评中心制定品种遴选范围、说明书修订与审核流程，以及品种申报程序等相关配套文件的要求，我中心制定了《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》（见附件），经国家药品监督管理局审核同意，现予发布，自发布之日起施行。06国内新药研发领域热点新闻Novartis超10亿美元押注PROTAC---蛋白水解靶向嵌合体诺华于本周四（4月11日）与Arvinas建立独家战略合作伙伴关系，推进前列腺癌的口服蛋白降解剂（PROteolysis TArgeting Chimera，PROTAC）。诺华公司将支付给Arvinas1.5亿美元的预付款，并承诺在开发、监管和商业里程碑上支付超过10亿美元的费用，外加分级特许权使用费。根据上述协议，诺华公司将负责ARV-766的全球临床开发和商业化。该交易还包括销售Arvinas在mCRPC中的临床前AR-V7项目（针对全长AR及其剪接变体AR-V7的下一代蛋白质降解剂）。诺华将拥有AR-V7项目的所有研究、开发、制造和商业化权利。更多资讯，请阅读原文TYK2：家族“异类”，大有可为进入2024年以来，三家Biotech的多轮融资将酪氨酸激酶2（TYK2）靶点的热度再次点燃。2024年1月，Sudo Biosciences宣布完成了第二次B轮融资，并在2月额外筹集了3000万美元，使这家TYK2开发公司的B轮融资额达到了1.47亿美元。同样在1月份，TYK2公司Myrobalan Therapeutics宣布完成2400万美元的A轮融资，用于开发口服神经修复疗法，包括用于减少神经炎症的TYK2变构抑制剂。更多资讯，请阅读原文聚焦抗病毒，凯因生物「赢得市场」在新冠疫情之前，抗病毒药物一直未得到充分的重视，全球抗病毒药物研发相比癌症、慢性病领域少之又少。近年来，新冠病毒的全球流行让抗病毒药物研发得到大量关注，资本快速流入，相关研发项目加速上马。同样在1月份，TYK2公司Myrobalan Therapeutics宣布完成2400万美元的A轮融资，用于开发口服神经修复疗法，包括用于减少神经炎症的TYK2变构抑制剂。更多资讯，请阅读原文喜大普奔！恒瑞医药终于营利双增重回正轨终于止跌回升，恒瑞医药的拐点要来了。根据最新年报显示，2023年，恒瑞医药总营收228.2亿元，同比增长7.26%；净利润43.02亿元，增长10.14%；归母扣非净利润41.41亿元，增长21.46%。在连续两年总营收和净利润下跌之后，恒瑞医药终于再度雄起，强势扭转下滑趋势，回到增长正轨。虽然这是恒瑞医药一家药企的喜讯，但作为最能代表中国制药行业的风向标，也昭示着集采对整个制药行业的影响基本出清，历史包袱已经卸下。长风破浪会有时，直挂云帆济沧海。更多资讯，请阅读原文不只有八因子，神州细胞还有秘密武器近日，神州细胞公布最新年报数据，2023年，其总营收18.87亿元，同比增长84.46%；净亏损3.96亿元，同比缩小23.70%；归母扣非净亏损6368.05万元，同比缩小83.91%。随着八因子的大爆量，以这样的增长速度进行下去，神州细胞很快就要实现扭亏为盈，实在不易。但这是意料之中的事，毕竟其八因子实在过于强悍。但与开挂式的营收增长趋势不符，神州细胞在资本市场的表现实在不能令人满意。不过在另一“爆款”即将浮现之际，或许神州细胞将会再展雄风。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0424创新药周报”，即可下载。