Deutetrabenazine

None By Dr. L. Alison McInnes and Jimmy QianWe’re finally moving towards a causality-based nosology for psychiatry: specific symptoms with defined biological underpinnings can now be targeted by new therapies. But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines? Below, we dig into the widening gap between research and clinical care. No consensus on how to measure transdiagnostic symptomsExcitingly, researchers have been able to characterize underlying neural circuitry for certain symptoms. The NIMH Fast-Fail Trials initiative, which stipulated that a drug candidate should alter a biomarker in an objectively measurable fashion, accelerated this movement. For anhedonia, investigators identified ventral striatum abnormalities during reward anticipation that normalized in response to kappa opioid receptor (KOR) antagonists. Despite this advancement, there has yet to be consensus on how to measure anhedonia in the clinic. Many clinicians do not practice measurement-based care, and even amongst those who do, measurement of anhedonia is typically confined to the first question of the PHQ-9. Moreover, anhedonia is a transdiagnostic symptom that should be measured across multiple diagnoses, not just depression.Progress has also been made in elucidating the neurocircuitry of cognition in depression. Leanne Williams’ group has identified biotypes with distinct fMRI signatures and associated cognitive abnormalities that may predict differential response to treatment. Meanwhile, Alto Neuroscience is developing cognitive profiling tools to subtype patients for enriched response to its pipeline agents. However, there is no consensus approach to measure cognition in the real-world. Furthermore, tools for characterizing cognitive deficits in depression do not necessarily capture the deficits observed in other disorders. Today, real-world clinicians often miss subtle but disabling cognitive symptoms for lack of appropriate measurement tools.Researchers have made additional advancements in precision measurement spanning EEG, fMRI, digital phenotyping, proteomics, and more. Yet as research progresses, the gap to real-world care widens. New mechanisms of action require more from cliniciansNovel mechanisms of action are also being developed, often enabling precise targeting of pharmacotherapies to specific symptoms. Continuing the anhedonia example, the phase 3 KOR antagonists aticaprant and navacaprant leverage the fact that elevated levels of dynorphin, which activates KORs, are associated with stress, anhedonia, and dysregulation of reward processing.Seltorexant, a selective orexin-2 receptor antagonist, is being studied specifically for depression with insomnia symptoms. Xanomeline-trospium, a dual M1/M4 muscarinic agonist, has shown promise in treating positive, negative, and cognitive symptoms of schizophrenia, with scientists speculating that dual agonism confers broad activity while M1 agonism may be more involved in cognitive improvements.Additional novel mechanisms are being studied or have been recently approved, spanning NMDA and AMPA receptor modulators, dual orexin receptor antagonists, 5HT2a receptor antagonists, GABAA receptor modulators, digital therapeutics, and more. New treatment options coupled with the complexity of treatment pathways and symptom clusters mean clinicians will need to know how to prioritize different mechanisms, measure success, and monitor side effects.Most patients have constellations of symptoms, so how are clinicians to make decisions about which to treat first with these targeted therapies? A hospitalist has objective physiological measures to help prioritize interventions to stabilize an inpatient; similarly, psychiatrists need novel objective measures to select the best treatment pathway for individual patients. Diagnosing and measuring previously untreatable conditions is a challengeIt is wonderful to see therapies for hitherto untreatable indications. Tardive dyskinesia is an example of a historically-neglected condition as there were no effective therapeutics. Why should clinicians and patients spend time measuring symptoms if there is no solution? Though valbenazine and deutetrabenazine have recently been approved for tardive dyskinesia, it is under-diagnosed in the real-world. The symptom measures used in trials are not typically used – or even known – by real-world clinicians. Similar dynamics exist for negative symptoms of schizophrenia, cognitive impairment, and other conditions. Our solution: a Learning Health SystemWe appreciate an analogy by one of the leaders of precision psychiatry, “You wouldn't want to launch electric vehicles without building an EV charging network first.” With breakthroughs in drug development comes an increased need for connectivity across biopharma, regulators, clinicians, payers, and clinical societies.At Osmind, our Learning Health System approach lowers barriers between research and patient care. By building consensus around the same precision measurements, we align evidence goalposts and generate cohorts of well-characterized patients for research. We deploy these measures directly at the point of care through our technology and EHR. Our collaboration with the American Psychiatric Association is an example of this approach.“As we advance in understanding the biological underpinnings of mental illness, an important challenge – and opportunity – will be to ensure that these insights translate into improvements in patient care,” says Husseini Manji, MD, a Strategic Advisor at Osmind. “We must work collaboratively across sectors to create a seamless integration of precision diagnostics and targeted therapeutics into everyday practice and real-world outcomes.” 

For an accessible version of this Press Release, please visit www.tevapharm.com Q2 2024 revenues of $4.2 billion reflecting an increase of 7% in U.S. dollars or 11% in local currency terms compared to Q2 2023.Generics business grows across all regions – increased in local currency terms by 16% in the U.S., 8% in Europe and 22% in International Markets, compared to Q2 2023.AUSTEDO – continued growth, U.S. revenue of $407 million in Q2 2024, an increase of 32% compared to Q2 2023; raising 2024 revenue outlook to ~$1.6 billion.AJOVY® – global revenues of $115 million in Q2 2024, an increase of 12% in local currency terms compared to Q2 2023.Announced acceleration of development timeline for duvakitug (Anti-TL1A) – top-line results now expected in Q4 2024, with full data expected next year.Announced positive Phase 3 efficacy results for olanzapine LAI (TEV' 749); so far completed ~95% of target injections with no PDSS observed.SIMLANDI® (adalimumab-ryvk) injection launched in May 2024 as an interchangeable biosimilar to Humira®.SELARSDI™ (ustekinumab-aekn) injection for subcutaneous use, preparing for February 2025 launch as a biosimilar to Stelara®. Q2 2024 Highlights: Revenues of $4.2 billionGAAP loss per share of $0.75Non-GAAP diluted EPS of $0.61Cash flow generated from operating activities of $103 millionFree cash flow of $324 millionBuilding on Teva's strong performance in the first half of2024 and expected developments in the second half of the year, Teva's full year 2024 business outlook is raised to: Revenues of $16.0 - $16.4 billionAUSTEDO revenues of ~$1.6 billionAdjusted EBITDA of $4.6 - $5.0 billionNon-GAAP diluted EPS of $2.30 - $2.50 TEL AVIV, Israel, July 31, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended June 30, 2024. Mr. Richard Francis, Teva's President and CEO, said, "In the second quarter of 2024, we are encouraged by the positive momentum across each of the four pillars of our Pivot to Growth strategy. Teva's global revenues of $4.2 billion increased by 7% in U.S. dollars, or 11% in local currency terms compared to the second quarter of 2023, delivering strong growth driven mainly by our generics and innovative business, with AUSTEDO growing 32% in the U.S. compared to Q2 2023." Mr. Francis continued, "We are also showing significant progress in on our late-stage innovative pipeline, underscored by the acceleration of the development timeline of duvakitug (Anti-TL1A), with top-line results now expected in the fourth quarter of 2024, and full data expected next year. "With these robust results, we are raising 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. Second Quarter 2024 Consolidated Results(1) Revenues in the second quarter of 2024 were $4,164 million, an increase of 7% in U.S. dollars or 11% in local currency terms compared to the second quarter of 2023. This increase was mainly due to higher revenues from generic products in all our segments, and from AUSTEDO in our United States and International Markets segments. Exchange rate movements during the second quarter of 2024, including hedging effects, negatively impacted overall revenues by $122 million compared to the second quarter of 2023. Exchange rate movements during the second quarter of 2024, including hedging effects, negatively impacted our operating income and non-GAAP operating income each by $56 million compared to the second quarter of 2023. Gross profit in the second quarter of 2024 was $2,024 million, an increase of 13% compared to $1,796 million in the second quarter of 2023. Gross profit margin was 48.6% in the second quarter of 2024, compared to 46.3% in the second quarter of 2023. Non-GAAP gross profit was $2,205 million in the second quarter of 2024, an increase of 9% compared to $2,023 million in the second quarter of 2023. Non-GAAP gross profit margin was 52.9% in the second quarter of 2024, compared to 52.2% in the second 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, primarily driven by growth in AUSTEDO revenues. Research and Development (R&D) expenses, net in the second quarter of 2024 were $269 million, an increase of 12% compared to $240 million in the second quarter of 2023 as we continue to execute on our Pivot to Growth Strategy. Our higher R&D expenses, net in the second quarter of 2024, compared to the second quarter of 2023, were mainly due to an increase related to our late-stage innovative pipeline in immunology, as well as related to immuno-oncology and neuroscience projects. Selling and Marketing (S&M) expenses in the second quarter of 2024 were $656 million, an increase of 9% compared to the second quarter of 2023. This increase was mainly due to promotional activities in our innovative products. General and Administrative (G&A) expenses in the second quarter of 2024 were $283 million, a decrease of 8% compared to the second quarter of 2023, mainly due to lower litigation costs in the second quarter of 2024. Other income in the second quarter of 2024 was $2 million, compared to $33 million in the second quarter of 2023. Other income in the second quarter of 2023 included a capital gain from the sale of assets related to our International Markets segment. Operating loss in the second quarter of 2024 was $5 million, compared to an operating loss of $654 million in the second quarter of 2023. Operating loss as a percentage of revenues was 0.1% in the second quarter of 2024, compared to 16.9% of revenues in the second quarter of 2023. The higher operating loss in the second quarter of 2023 was mainly due to higher legal settlements and loss contingencies as well as higher goodwill impairment charges. Non-GAAP operating income in the second quarter of 2024 was $1,056 million representing a non-GAAP operating margin of 25.3% compared to non-GAAP operating income of $1,011 million representing a non-GAAP operating margin of 26.1% in the second quarter of 2023. The decrease in non-GAAP operating margin in the second quarter of 2024 was mainly due to higher operational expenses as a percentage of revenues, partially offset by higher gross profit margin. Financial expenses, net in the second quarter of 2024 were $241 million, mainly comprised of net-interest expenses of $233 million. In the second quarter of 2023, financial expenses, net were $268 million, mainly comprised of net-interest expenses of $240 million. In the second quarter of 2024, we recognized a tax expense of $630 million, on a pre-tax loss of $246 million. Our tax rate for the second quarter of 2024 was mainly affected by a settlement agreement with the Israeli Tax Authorities (“ITA”) and impairments. The settlement agreement with the ITA resulted in an increase of $506 million in Teva's total income taxes in the second quarter of 2024, as certain elements had been recognized in previous periods. For additional information on the settlement agreement, see our Current Report on Form 8-K filed with the SEC on June 25, 2024. In the second quarter of 2023, we recognized a tax benefit of $16 million, on a pre-tax loss of $923 million. Our tax rate for the second quarter of 2023 was mainly affected by impairments, legal settlements, amortization, and interest expense disallowances. Non-GAAP tax rate in the second quarter of 2024 was 15.4%, compared to 15.2% in the second quarter of 2023. Our non-GAAP tax rate in the second quarter of 2024 was mainly affected by 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 second quarter of 2023 was mainly affected by the generation of profits in various jurisdictions with different tax rates, interest expense disallowances, tax benefits in Israel and other countries, as well as infrequent or non-recurring items. 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 intellectual property related integration plans in 2024 compared to 2023. Net loss attributable to Teva and loss per share in the second quarter of 2024 were $846 million and $0.75, respectively, compared to net loss attributable to Teva and loss per share of $872 million and $0.78, respectively, in the second quarter of 2023. The lower net loss in the second quarter of 2024 was mainly due to lower operating loss, partially offset by higher income taxes, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the second quarter of 2024 were $697 million and $0.61, respectively, compared to $629 million and $0.56, respectively, in the second quarter of 2023. Adjusted EBITDA was $1,168 million in the second quarter of 2024, an increase of 4%, compared to $1,125 million in the second quarter of 2023. As of June 30, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,167 million shares and 1,157 million shares, respectively. Non-GAAP information: net non-GAAP adjustments in the second quarter of 2024 were $1,542 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the second quarter of 2024 were adjusted to exclude the following items: Amortization of purchased intangible assets of $146 million, of which $135 million is included in cost of sales and the remaining $11 million in S&M expenses; Impairment of long-lived assets of $130 million; Goodwill impairment charge of $400 million related to the Teva API reporting unit; Legal settlements and loss contingencies of $83 million; Contingent consideration expenses of $192 million, which primarily consisted of $174 million related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid®); Equity compensation expenses of $32 million; Restructuring expenses of $18million; Financial expenses of $12 million; Other non-GAAP items of $59 million; Items attributable to non-controlling interests of$33 million; and Corresponding tax effects and unusual tax items of $503 million, of which $495 million is related to the settlement agreement with the ITA discussed above. 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 generated from operating activities during the second quarter of 2024 was $103 million, compared to $324 million of cash flow generated from operating activities in the second quarter of 2023. The lower cash flow generated from operating activities in the second quarter of 2024 resulted mainly from changes in working capital items, including a negative impact from accounts receivables, net of SR&A, driven mainly from higher sales during the second quarter of 2024 with extended payment terms into the third quarter, and from accounts payables, as well as higher tax payments. During the second quarter of 2024, we generated free cash flow of $324 million, which we define as comprising $103 million in cash flow generated from operating activities, $317 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $1 million in divestitures of businesses and other assets, partially offset by $97 million in cash used for capital investment. During the second quarter of 2023, we generated free cash flow of $632 million, which we define as comprising $324 million in cash flow generated from operating activities, $371 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $56 million in proceeds from divestitures of businesses and other assets, partially offset by $119 million in cash used for capital investment. The decrease in free cash flow in the second quarter of 2024, resulted mainly from lower cash flow generated from operating activities, as well as lower proceeds from divestitures of businesses and other assets. As of June 30, 2024, our debt was $18,640 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to repayment of $956 million of 6% senior notes at maturity and a positive impact of $247 million from exchange rate fluctuations. The portion of total debt classified as short-term as of June 30, 2024 was 11% compared to 8% as of December 31, 2023. Our average debt maturity was approximately 5.8 years as of June 30, 2024, compared to 6.0 years as of December 31, 2023. _________ (1) The data presented in this press release with respect to comparative periods include revised figures. 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 June 30, 2024. Segment Results for the Second Quarter of 2024 United States Segment As part of the previously announced 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. 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 June 30, 2024 and 2023: Three months ended June 30, 2024 2023 (U.S. $ in millions / % of Segment Revenues)Revenues$2,110100%$1,892100%Gross profit 1,16755.3% 1,01753.8%R&D expenses 1708.1% 1568.2%S&M expenses 27012.8% 25013.2%G&A expenses 1004.7% 1015.3%Other income (1)§ (1)§Segment profit*$62929.8%$51127.0% * Segment profit does not include amortization and certain other items.§ Represents an amount less than 0.5%. Revenues from our United States segment in the second quarter of 2024 were $2,110 million, an increase of $218 million, or 12%, compared to the second quarter of 2023. This increase was mainly due to higher revenues from generic products, AUSTEDO and COPAXONE®, partially offset by lower revenues from certain innovative products, primarily 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 June 30, 2024 and 2023: Three months endedJune 30, Percentage Change 2024 2023 2024-2023 (U.S. $ in millions) Generic products $1,023 $884 16%AJOVY 42 52 (20%)AUSTEDO 407 308 32%BENDEKA and TREANDA 41 67 (39%)COPAXONE 81 56 44%Anda 373 392 (5%)Other 144 131 9%Total $2,110 $1,892 12% Generic products revenues in our United States segment (including biosimilars) in the second quarter of 2024 were $1,023 million, an increase of 16% compared to the second quarter of 2023, the majority of which was driven by higher revenues from lenalidomide capsules (the generic version of Revlimid®), and the remaining primarily by the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®), partially offset by increased competition to other generic products. Among the most significant generic products we sold in the United States in the second quarter of 2024 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic version of EpiPen® and EpiPen Jr®), liraglutide injection (an authorized generic of Victoza®), and Truxima® (the biosimilar to Rituxan®). In the second quarter of 2024, our total prescriptions were approximately 303 million (based on trailing twelve months), representing 7.9% of total U.S. generic prescriptions, compared to approximately 319 million (based on trailing twelve months), representing 8.4% of total U.S. generic prescriptions in the second 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 17, 2024, Alvotech and Teva amended their collaboration agreement to enable the purchase by Quallent of a private label adalimumab-ryvk injection from Alvotech for the U.S. market, with Alvotech sharing profits with Teva on the private label sales. On May 20, 2024, Alvotech and Teva announced that SIMLANDI is available in the United States. 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 six years and older. On June 24, 2024, Teva announced the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®) in the United States. Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. AJOVY revenues in our United States segment in the second quarter of 2024 were $42 million, a decrease of 20% compared to $52 million in the second quarter of 2023, mainly due to an increase in sales allowance due to a non-recurring item, partially offset by higher demand. In the second quarter of 2024, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 28.6% compared to 25.1% in the second quarter of 2023. AUSTEDO revenues in our United States segment in the second quarter of 2024 increased by 32%, to $407 million, compared to $308 million in the second quarter of 2023, mainly due to growth in volume, 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. In May 2024, the FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg. In July 2024, the FDA approved the 18 mg dosage for AUSTEDO XR making it a one pill, once-daily for all available doses. 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 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. UZEDY faces competition from multiple other products. BENDEKA and TREANDA combined revenues in our United States segment in the second quarter of 2024 were $41 million, a decrease of 39% compared to $67 million in the second 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 second quarter of 2024 were $81 million, an increase of 44% compared to $56 million in the second quarter of 2023, mainly due to a decrease in sales allowance due to a non-recurring item. Anda revenues from third-party products in our United States segment in the second quarter of 2024 were $373 million, a decrease of 5% compared to $392 million in the second quarter of 2023, mainly due to lower demand in the second quarter of 2024. 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 second quarter of 2024 was $1,167 million, an increase of 15%, compared to $1,017 million in the second quarter of 2023. Gross profit margin for our United States segment in the second quarter of 2024 increased to 55.3%, compared to 53.8% in the second quarter of 2023. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from lenalidomide capsules (the generic version of Revlimid®) and AUSTEDO. 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 second quarter of 2024 was $629 million, an increase of 23% compared to $511 million in the second quarter of 2023. This increase was mainly due to higher gross profit, partially offset by higher operational 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 June 30, 2024 and 2023: Three months ended June 30, 2024 2023 (U.S. $ in millions / % of Segment Revenues)Revenues$1,213100%$1,163100%Gross profit 67755.8% 64055.0%R&D expenses 625.1% 534.5%S&M expenses 20917.2% 19416.7%G&A expenses 645.3% 615.2%Other income §§ (1)§Segment profit*$34228.2%$33428.7%___________ * 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 second quarter of 2024 were $1,213 million, an increase of 4%, or $50 million, compared to the second quarter of 2023. In local currency terms, revenues increased by 5% compared to the second quarter of 2023, mainly due to higher revenues from generic products and AJOVY. 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 June 30, 2024 and 2023: Three months endedJune 30, PercentageChange 2024 2023 2024-2023 (U.S. $ in millions) Generic products $970 $909 7%AJOVY 52 39 33%COPAXONE 53 60 (11%)Respiratory products 57 66 (14%)Other 81 89 (10%)Total $1,213 $1,163 4% Generic products revenues (including OTC and biosimilar products) in our Europe segment in the second quarter of 2024, increased by 7% to $970 million, compared to the second quarter of 2023. In local currency terms, revenues increased by 8%, mainly due to price increases as a result of market conditions such as inflationary pressures in certain markets, as well as higher revenues from recently launched products. AJOVY revenues in our Europe segment in the second quarter of 2024 increased by 33% to $52 million, compared to $39 million in the second quarter of 2023. In local currency terms revenues increased by 34%, mainly due to growth in European countries in which AJOVY had previously been launched. COPAXONE revenues in our Europe segment in the second quarter of 2024 were $53 million, a decrease of 11% compared to the second quarter of 2023. In local currency terms, revenues decreased by 9%, 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 second quarter of 2024 were $57 million, a decrease of 14% compared to the second quarter of 2023. In local currency terms, revenues decreased by 13% compared to the second quarter of 2023, mainly due to net price reductions and lower volumes. Europe Gross Profit Gross profit from our Europe segment in the second quarter of 2024 was $677 million, an increase of 6% compared to $640 million in the second quarter of 2023. Gross profit margin for our Europe segment in the second quarter of 2024 increased to 55.8%, compared to 55.0% in the second quarter of 2023. This increase was mainly due to price increases of generic products as a result of market conditions such as inflationary pressures in certain markets. 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 second quarter of 2024 was $342 million, an increase of 2%, compared to $334 million in the second 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 the countries included in our Europe segment. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical industry. As part of the previously announced 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 following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2024 and 2023: Three months ended June 30, 2024 2023 (U.S. $ in millions / % of Segment Revenues)Revenues$593100%$578100%Gross profit 28648.3% 28349.0%R&D expenses 305.1% 234.0%S&M expenses 14524.5% 12521.6%G&A expenses 386.4% 345.9%Other income §§ (31)(5.4%)Segment profit*$7312.3%$13222.8%__________ * 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 second quarter of 2024 were $593 million, an increase of 3% compared to the second quarter of 2023. In local currency terms, revenues increased by 22% compared to the second 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 second quarter of 2024, revenues were negatively impacted by exchange rate fluctuations of $114 million, including hedging effects, compared to the second quarter of 2023. Revenues in the second quarter of 2024 included $5 million from a negative hedging impact, compared to a positive hedging impact of $5 million in the second 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 June 30, 2024 and 2023: Three months endedJune 30, PercentageChange 2024 2023 2024-2023 (U.S. $ in millions) Generic products $486 $478 2%AJOVY 22 14 58%COPAXONE 14 17 (20%)Other 71 69 2%Total $593 $578 3% Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $486 million in the second quarter of 2024, an increase of 2% compared to the second quarter of 2023. In local currency terms, revenues increased by 22% compared to the second 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 in certain markets and higher volumes, partially offset by regulatory price reductions and generic competition to off-patented products in Japan. AJOVY revenues in our International Markets segment in the second quarter of 2024 were $22 million, compared to $14 million in the second quarter of 2023. AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. COPAXONE revenues in our International Markets segment in the second quarter of 2024 were $14 million compared to $17 million in the second 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 second quarter of 2024 was $286 million, an increase of 1% compared to $283 million in the second quarter of 2023. Gross profit margin for our International Markets segment in the second quarter of 2024 decreased to 48.3%, compared to 49.0% in the second quarter of 2023. This decrease was mainly due to a negative hedging impact, regulatory price reductions and generic competition to off-patented products in Japan, as well as higher costs due to inflationary and other macroeconomic pressures, partially offset by price increases largely as a result of inflationary pressures in certain markets and a favorable mix of products. 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 second quarter of 2024 was $73 million, a decrease of 45%, compared to $132 million in the second quarter of 2023. This decrease was mainly due to lower other income as well as higher S&M expenses in the second quarter of 2024. 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 second quarter of 2024 were $249 million, an increase of 2% in U.S. dollars and in local currency terms, compared to the second quarter of 2023. API sales to third parties in the second quarter of 2024 were $151 million, reflecting an increase of 5% in both U.S. dollars and local currency terms, compared to the second quarter of 2023, following a reallocation of an immaterial business within our other activities, in line with our intention to divest our API business. Outlook for 2024 Non-GAAP Results $ billions, except EPS or as notedJuly 2024 OutlookJanuary 2024 OutlookRevenues*$16.0 - $16.4$15.7 - $16.3AUSTEDO ($m)*~1,600~1,500AJOVY ($m)*~500~500UZEDY ($m)*~80~80COPAXONE ($m)*~450~400Operating Income4.1 - 4.54.0 - 4.5Adjusted EBITDA4.6 - 5.04.5 - 5.0Finance Expenses ($m)~1,000~1,000Tax Rate14% - 17%14% - 17%Diluted EPS ($)2.30 - 2.502.20 - 2.50Free Cash Flow**1.7 - 2.01.7 - 2.0CAPEX*~0.5~0.5Foreign ExchangeVolatile swings in FX can negatively impact revenue and income * Revenues and CAPEX presented on a GAAP basis. ** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables Conference Call Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its second quarter 2024 financial results on Wednesday, July 31, 2024, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET. 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: https://ir.tevapharm.com/Events-and-Presentations 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 www.tevapharm.com. http://www.tevapharm.com. 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 second quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned "Risk Factors.” 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 Six months ended June 30, June 30, 2024 2023 2024 2023Net revenues 4,164 3,878 7,983 7,539Cost of sales 2,140 2,082 4,188 4,161Gross profit 2,024 1,796 3,795 3,378Research and development expenses 269 240 511 473Selling and marketing expenses 656 603 1,265 1,149General and administrative expenses 283 307 561 602Intangible assets impairments 61 63 141 241Goodwill impairment 400 700 400 700Other asset impairments, restructuring and other items 280 108 954 218Legal settlements and loss contingencies 83 462 188 695Other income (2) (33) (1) (34)Operating income (loss) (5) (654) (223) (667)Financial expenses, net 241 268 491 528Income (loss) before income taxes (246) (923) (713) (1,195)Income taxes (benefit) 630 (16) 578 (35)Share in (profits) losses of associated companies, net (2) (1) 2 (1)Net income (loss) (874) (906) (1,294) (1,159)Net income (loss) attributable to non-controlling interests (29) (35) (309) (68)Net income (loss) attributable to Teva (846) (872) (985) (1,091) Earnings (loss) per share attributable to Teva:Basic ($)(0.75) (0.78) (0.87) (0.98) Diluted ($)(0.75) (0.78) (0.87) (0.98)Weighted average number of shares (in millions):Basic1,133 1,120 1,128 1,118 Diluted1,133 1,120 1,128 1,118 Non-GAAP net income attributable to Teva for diluted earnings per share:* 697 629 1,245 1,085 Non-GAAP earnings per share attributable to Teva:*Diluted ($)0.61 0.56 1.09 0.96 Non-GAAP average number of shares (in millions):Diluted1,151 1,129 1,146 1,127 Amounts may not add up due to rounding. * See reconciliation attached. CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data)(Unaudited) June 30, December 31, 2024 2023ASSETS Current assets: Cash and cash equivalents $2,258 $3,226Accounts receivables, net of allowance for credit losses of $95 million as of June 30, 2024 and as of December 31, 2023. 3,766 3,408Inventories 3,927 4,021Prepaid expenses 1,096 1,255Other current assets 517 504Assets held for sale 69 70Total current assets 11,632 12,485Deferred income taxes 2,000 1,812Other non-current assets 434 470Property, plant and equipment, net 5,573 5,750Operating lease right-of-use assets, net 358 397Identifiable intangible assets, net 4,853 5,387Goodwill 16,488 17,177Total assets $41,338 $43,479 LIABILITIES AND EQUITY Current liabilities: Short-term debt $2,094 $1,672Sales reserves and allowances 3,700 3,535Accounts payables 2,366 2,602Employee-related obligations 492 611Accrued expenses 2,840 2,771Other current liabilities 1,191 1,044Liabilities held for sale 356 13Total current liabilities 13,037 12,247 Long-term liabilities: Deferred income taxes 553 606Other taxes and long-term liabilities 4,356 4,019Senior notes and loans 16,547 18,161Operating lease liabilities 281 320Total long-term liabilities 21,737 23,106Equity: Teva shareholders’ equity: 6,359 7,506Non-controlling interests 204 620Total equity 6,563 8,126Total liabilities and equity $41,338 $43,479 Amounts may not add up due to rounding. TEVA PHARMACEUTICAL INDUSTRIES LIMITEDCONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in millions)(Unaudited) Three months ended Six months ended June 30, June 30, 20242023 20242023Operating activities: Net income (loss)$(874)(906)$(1,294)(1,159)Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 259 300 531 604 Impairment of goodwill 400 700 400 700 Impairment of long-lived assets and assets held for sale 130 74 809 262 Net change in operating assets and liabilities (10)212 (507)(137)Deferred income taxes – net and uncertain tax positions (424)(44) (613)(150)Stock-based compensation 32 30 60 62 Other items * 592 (12) 594 23 Net loss (gain) from investments and from sale of long lived assets (1)(30) (1)(26)Net cash provided by (used in) operating activities 103 324 (21)179 Investing activities: Beneficial interest collected in exchange for securitized trade receivables 317 371 612 694 Purchases of property, plant and equipment and intangible assets (97)(119) (221)(258)Proceeds from sale of business and long lived assets 1 56 1 58 Acquisition of businesses, net of cash acquired - - (15)- Purchases of investments and other assets . (43)(2) (55)(6)Other investing activities - (4) - (5)Net cash provided by (used in) investing activities 178 302 322 483 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 (956)- (956)(3,152)Proceeds from senior notes, net of issuance costs - - - 2,451 Other financing activities (10)(55) (19)(60)Net cash provided by (used in) financing activities (966)(55) (1,117)(761) Translation adjustment on cash and cash equivalents (49)(77) (153)(65) Net change in cash, cash equivalents and restricted cash (733)494 (969)(164)Balance of cash, cash equivalents and restricted cash at beginning of period 2,991 2,176 3,227 2,834 Balance of cash, cash equivalents and restricted cash at end of period$2,258 2,670 $2,258 2,670 Cash and cash equivalents 2,258 2,669 2,258 2,669 Restricted cash included in other current assets — 1 — 1 Total cash, cash equivalents and restricted cash shown in the statement of cash flows 2,258 2,670 2,258 2,670 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables$320 380 $632 714 * Adjustment in the three months period ended June 30, 2024 mainly relate to an agreement with the Israeli Tax Authorities. Amounts may not add up due to roundingThe accompanying notes are an integral part of the financial statements. Reconciliation of gross profit to Non-GAAP gross profit(Unaudited) Three months ended Six months ended June 30, June 30,($ in millions) 20242023 20242023Gross profit $2,0241,796 $3,7953,378Gross profit margin 48.6%46.3% 47.5%44.8%Increase (decrease) for excluded items: Amortization of purchased intangible assets 136145 273290 Equity compensation 75 1310 Accelerated depreciation 024 749 Other non-GAAP items (1) 3752 8091Non-GAAP gross profit$2,2052,023 $4,1683,819Non-GAAP gross profit margin (2) 52.9%52.2% 52.2%50.7% (1) Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, certain inventory write-offs and other unusual events.(2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue. Reconciliation of operating income (loss) to Non-GAAP operating income (loss)(Unaudited) Three months ended Six months ended June 30, June 30,($ in millions) 20242023 20242023Operating income (loss)(1)($)(5)(654) ($)(223)(667)Operating margin (0.1%)(16.9%) (2.8%)(8.8%)Increase (decrease) for excluded items: Amortization of purchased intangible assets 146162 298326 Legal settlements and loss contingencies(2) 83462 188695 Goodwill impairment(3) 400700 400700 Impairment of long-lived assets(4) 13074 809262 Restructuring costs 1810 3166 Equity compensation 3230 6062 Contingent consideration(1)(5) 19278 271113 Accelerated depreciation 024 749 Other non-GAAP items(6) 59125 106189Non-GAAP operating income (loss)($)1,0561,011 ($)1,9481,796Non-GAAP operating margin(3)($)25.3%26.1% ($)24.4%23.8% (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) Adjustments for legal settlements and loss contingencies in the second quarter of 2023 were mainly related to a provision of $200 million in connection with the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products and an update to the estimated settlement provision of $170 million related to some of the remaining opioid cases including an agreement in principle on private hospital cases. Adjustments for legal settlements and loss contingencies in the first six months of 2023 were mainly related to an update to the estimated settlement provision of $206 million related to the remaining opioid cases, the provision of $210 million relating to the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products, an update to the estimated provision of $102 million related to the DOJ patient assistance program litigation, and the provision of $100 million related to the settlement of the reverse-payment antitrust litigation over certain HIV medicines.(3) A goodwill impairment charge of $400 million related to our Teva's API reporting unit was recognized in the three and six months ended June 2024, compared to a goodwill impairment charge of $700 million related to our International Markets reporting unit recognized in the three and six months ended June 2023.(4) Adjustments for impairment of long-lived assets, for the six months ended June 30, 2024, primarily consisted of $644 million related to the classification of our business venture in Japan as held for sale.(5) 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 $174 million and $238 million, respectively for the three and six months ended June 30, 2024, and of $64 million and $88 million, respectively for the three and six months ended June 30, 2023.(6) Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, certain inventory write-offs, material litigation fees and other unusual events. Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva(Unaudited) Three months ended Six months ended June 30, June 30,($ in millions except per share amounts) 20242023 20242023Net income (Loss) attributable to Teva(1)($)(846)(872) ($)(985)(1,091)Increase (decrease) for excluded items: Amortization of purchased intangible assets 146162 298326 Legal settlements and loss contingencies(2) 83462 188695 Goodwill impairment(3) 400700 400700 Impairment of long-lived assets(4) 13074 809262 Restructuring costs 1810 3166 Equity compensation 3230 6062 Contingent consideration(1)(5) 19278 271113 Accelerated depreciation -24 749 Financial expenses 1216 2439 Items attributable to non-controlling interests(4) (33)(49) (317)(90) Other non-GAAP items(6) 59125 106189 Corresponding tax effects and unusual tax items(7) 503(131) 353(235)Non-GAAP net income attributable to Teva($)697629 ($)1,2451,085Non-GAAP tax rate(8) 15.4%15.2% 15.2%15.3%GAAP diluted earnings (loss) per share attributable to Teva($)(0.75)(0.78) ($)(0.87)(0.98)EPS difference(9) 1.351.34 1.961.94Non-GAAP diluted EPS attributable to Teva(9)($)0.610.56 ($)1.090.96Non-GAAP average number of shares (in millions)(9) 1,1511,129 1,1461,127 (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)Adjustments for legal settlements and loss contingencies in the second quarter of 2023 were mainly related to a provision of $200 million in connection with the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products and an update to the estimated settlement provision of $170 million related to some of the remaining opioid cases including an agreement in principle on private hospital cases. Adjustments for legal settlements and loss contingencies in the first six months of 2023 were mainly related to an update to the estimated settlement provision of $206 million related to the remaining opioid cases, the provision of $210 million relating to the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products, an update to the estimated provision of $102 million related to the DOJ patient assistance program litigation, and the provision of $100 million related to the settlement of the reverse-payment antitrust litigation over certain HIV medicines.(3)A goodwill impairment charge of $400 million related to our Teva's API reporting unit was recognized in the three and six months ended June 30, 2024, compared to a goodwill impairment charge of $700 million related to our International Markets reporting unit recognized in the three and six months ended June 2023.(4)Adjustments for impairment of long-lived assets and items attributable to non-controlling interests for the six months ended June 30, 2024, primarily consisted of $644 million and $317 million, respectively, related to the classification of our business venture in Japan as held for sale.(5)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 $174 million and $238 million, respectively for the three and six months ended June 30, 2024, and of $64 million and $88 million, respectively for the three and six months ended June 30, 2023.(6)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.(7)Adjustments for corresponding tax effects and unusual tax items for the three months ended June 30,2024 mainly related to the settlement agreement with the ITA to settle certain litigation with respect to taxes payable for the Company’s taxable years 2008 through 2020, in an amount of $495 million.(8)Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. GAAP tax rate for the three and six months ended June 30, 2024 was 256% and 81% respectively and for the three and six months ended June 30, 2023 was 2% and 3% respectively.(9)EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. Reconciliation of net income (loss) to adjusted EBITDA(Unaudited) Three months ended Six months ended June 30, June 30,($ in millions) 2024 2023 2024 2023 Net income (loss)(1) $(874)(906)$(1,294)(1,159)Increase (decrease) for excluded items: Financial expenses 241 268 491 528 Income taxes 630 (16) 578 (35) Share in profits (losses) of associated companies –net (2)(1) 2 (1) Depreciation 113 138 233 278 Amortization 146 162 298 326 EBITDA 254 (355) 308 (63) Legal settlements and loss contingencies(2)83 462 188 695 Goodwill impairment(3) 400 700 400 700 Impairment of long lived assets(4)130 74 809 262 Restructuring costs 18 10 31 66 Equity compensation 32 30 60 62 Contingent consideration(5) 192 78 271 113 Other non-GAAP items (6) 59 125 106 189 Adjusted EBITDA$1,168 1,125 $2,173 2,024 (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) Adjustments for legal settlements and loss contingencies in the second quarter of 2023 were mainly related to a provision of $200 million in connection with the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products and an update to the estimated settlement provision of $170 million related to some of the remaining opioid cases including an agreement in principle on private hospital cases. Adjustments for legal settlements and loss contingencies in the first six months of 2023 were mainly related to an update to the estimated settlement provision of $206 million related to the remaining opioid cases, the provision of $210 million relating to the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products, an update to the estimated provision of $102 million related to the DOJ patient assistance program litigation, and the provision of $100 million related to the settlement of the reverse-payment antitrust litigation over certain HIV medicines. (3) A goodwill impairment charge of $400 million related to our Teva's API reporting unit was recognized in the three and six months ended June 2024, compared to a goodwill impairment charge of $700 million related to our International Markets reporting unit recognized in the three and six months ended June 2023. (4) Adjustments for impairment of long-lived assets, for the six months ended June 30, 2024, primarily consisted of $644 million related to the classification of our business venture in Japan as held for sale (5) 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 $174 million and $238 million, respectively for the three and six months ended June 30, 2024, and of $64 million and $88 million, respectively for the three and six months ended June 30, 2023. (6) 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 June 30, Three months ended June 30, Three months ended June 30, 2024 2023 2024 2023 2024 2023 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$2,110 $1,892 $1,213 $1,163 $593 $578 Gross profit 1,167 1,017 677 640 286 283 R&D expenses 170 156 62 53 30 23 S&M expenses 270 250 209 194 145 125 G&A expenses 100 101 64 61 38 34 Other income (1) (1) § (1) § (31)Segment profit$629 $511 $342 $334 $73 $132 § Represents an amount less than $0.5 million. Segment Information (Unaudited) United States Europe International Markets Six months ended June 30, Six months ended June 30, Six months ended June 30, 2024 2023 2024 2023 2024 2023 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$3,835 $3,569 $2,485 $2,347 $1,190 $1,159 Gross profit 2,025 1,806 1,415 1,294 583 568 R&D expenses 324 305 118 106 58 51 S&M expenses 530 457 403 381 263 238 G&A expenses 193 196 130 130 73 72 Other income (1) (1) § (1) (1) (33)Segment profit$979 $850 $764 $679 $190 $240 § Represents an amount less than $0.5 million. Reconciliation of our segment profitto consolidated income before income taxesUnaudited Three months ended June 30, 2024 2023 (U.S.$ in millions) United States profit $629 $511 Europe profit 342 334 International Markets profit 73 132 Total reportable segment profit 1,043 977 Profit of other activities 12 33 1,056 1,011 Amounts not allocated to segments: Amortization 146 162 Other asset impairments, restructuring and other items* 280 108 Goodwill impairment 400 700 Intangible asset impairments 61 63 Legal settlements and loss contingencies 83 462 Other unallocated amounts 91 170 Consolidated operating income (loss) (5) (654)Financial expenses - net 241 268 Consolidated income (loss) before income taxes* $(246) $(923) *The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1b to our consolidated financial statements included in our 2023 Annual Report on Form 10-K. Reconciliation of our segment profitto consolidated income before income taxesUnaudited Six months ended June 30, 2024 2023 (U.S.$ in millions) United States profit $979 $850 Europe profit 764 679 International Markets profit 190 240 Total reportable segment profit 1,933 1,769 Profit of other activities 15 27 Total segment profit 1,948 1,796 Amounts not allocated to segments: Amortization 298 326 Other asset impairments, restructuring and other items* 954 218 Goodwill impairment 400 700 Intangible asset impairments 141 241 Legal settlements and loss contingencies 188 695 Other unallocated amounts 190 282 Consolidated operating income (loss) (223) (667)Financial expenses - net 491 528 Consolidated income (loss) before income taxes* $(713) $(1,195) The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1b to our consolidated financial statements included in our 2023 Annual Report on Form 10-K. Segment revenues by major products and activities(Unaudited) Three months ended June 30, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) United States segment Generic products $1,023 $884 16%AJOVY 42 52 (20%)AUSTEDO 407 308 32%BENDEKA/TREANDA 41 67 (39%)COPAXONE 81 56 44%Anda 373 392 (5%)Other 144 131 9%Total 2,110 1,892 12% Three months ended June 30, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) Europe segment Generic products $970 $909 7%AJOVY 52 39 33%COPAXONE 53 60 (11%)Respiratory products 57 66 (14%)Other 81 89 (10%)Total 1,213 1,163 4% Three months ended June 30, Percentage Change 2024 2023 2023-2024 (U.S.$ in millions) International Markets segment Generic products $486 $478 2%AJOVY 22 14 58%COPAXONE 14 17 (20%)Other 71 69 2%Total 593 578 3% Revenues by Activity and Geographical Area(Unaudited) Six months ended June 30, Percentage Change 2024 2023 2024-2023 (U.S.$ in millions) North America segment Generic products $1,831 $1,631 12%AJOVY 87 98 (12%)AUSTEDO 689 478 44%BENDEKA / TREANDA 87 129 (33%)COPAXONE 111 127 (13%)Anda 754 816 (8%)Other 276 289 (4%)Total 3,835 3,569 7% Six months ended June 30, Percentage Change 2024 2023 2024-2023 (U.S.$ in millions) Europe segment Generic products $1,974 $1,841 7%AJOVY 102 74 37%COPAXONE 110 119 (7%)Respiratory products 123 134 (8%)Other 175 178 (2%)Total 2,485 2,347 6% Six months ended June 30, Percentage Change 2024 2023 2024-2023 (U.S.$ in millions) International Markets segment Generic products $963 $955 1%AJOVY 39 27 42%COPAXONE 25 34 (26%)Other 162 142 14%Total 1,190 1,159 3% Free cash flow reconciliation(Unaudited) Three months ended June 30, 2024 2023 (U.S. $ in millions) Net cash provided by (used in) operating activities 103 324 Beneficial interest collected in exchange for securitized accounts receivables 317 371 Capital investment (97) (119)Proceeds from divestitures of businesses and other assets 1 56 Free cash flow$324 $632 Free cash flow reconciliation(Unaudited) Six months ended June 30, 2024 2023 (U.S. $ in millions) Net cash provided by (used in) operating activities (21) 179 Beneficial interest collected in exchange for securitized trade receivables 612 694 Capital investment (221) (258)Proceeds from divestitures of business and other assets 1 58 Acquisition of subsidiary, net of cash acquired (15) - Free cash flow$356 $673 IR ContactsRan Meir (215) 591-8912Yael Ashman +972 (3) 914 8262Sanjeev Sharma (267) 658-2700 PR ContactsKelley Dougherty (973) 832-2810Eden Klein +972 (3) 906 2645 A PDF accompanying this announcement is available at: http://ml-eu.globenewswire.com/Resource/Download/3b1553b7-359d-4dae-86c1-9fe532ff3836