Glatiramer Acetate

☝ 点击上方 一键预约 ☝   最新最热的医药健康新闻政策根据2023年医保目录调整工作安排，11月即将进入谈判/竞价等阶段，最迟将在12月初将公布药品调整结果，发布新版目录。作为保障人民健康的重要组成部分，医保目录的调整牵动着广大患者、医疗机构和药品企业的心。据此前医保局发布的《国家医疗保障局关于公布2023年国家基本医疗保险、工伤保险和生育保险药品目录调整通过形式审查药品名单的公告》显示，2023年医保目录共有386个药品通过形式审查，其中目录外药品222个（西药208个，中成药14个），目录内药品164个（西药136个，中成药28个）。以下我们重点分析下222个目录外药品。图1 2021-2023年通过形式审查药品数量来源：国家医保局，中康产业研究院整理2023年形式审查通过率较2022年小幅下降。纵观最近5年的谈判情况，平均降幅均在50%以上，成功率近两年较为稳定。今年是创新药医保谈判第八年头，随着时间的推移，竞价谈判规则逐渐完善，降价幅度在稳步预期范围内。图2 2018-2022年医保谈判情况来源：粤开证券01肿瘤领域风云再起“ADC神药”有望被纳入今年肿瘤药物依然是最值得关注的领域，共有40款药物通过形审，其中除3款以外，其余均为独家品种，形式相同。表1 通过形式审查肿瘤药品信息来源：国家医保局，中康产业研究院整理ADC竞争格局将大变天？目前，国内批准的ADC共有7款，其中3款纳入国家医保，分别为维迪西妥单抗（2021年谈判，3种适应症），恩美曲妥珠单抗（2022年谈判，2种适应症），维布妥昔单抗（2022年，4种适应症）。今年，其他四款奥加伊妥珠单抗、维泊妥珠单抗、戈沙妥珠单抗及德曲妥珠单抗均已通过形式审查。图3 三款ADC进入医保前后降幅来源：中康开思系统，公开数据，中康产业研究院整理注：恩美曲妥珠单抗仅列出100mg价格；维迪西妥单抗销量对比使用2021及2022年数据，恩美曲妥珠单抗、维布妥昔单抗使用2022Q2及2023Q2数据参考这3款进入医保的ADC药品，降幅均在50%以上，据不完全统计销量增加至少2倍。目前以零售市场2023年Q2价格参考，奥加伊妥珠单抗平均单价61874元/盒、维泊妥珠单抗平均单价10377元/盒、戈沙妥珠单抗平均单价8400元/盒、德曲妥珠单抗平均单价3261元/盒。根据猜测，奥加伊妥珠单抗恐因价格过高问题经过评审无法谈判，后三者进入谈判概率大，尤其看好德曲妥珠单抗，作为“ADC神药”，若谈判成功进入医保，无疑将会给ADC药物领域格局带来不小的变化。两款CAR-T再战医保今年已经是阿基仑赛注射液自2021年已经第三次通过形式审查，瑞基奥仑赛注射液也非首次通过形审，这两款产品均都即将来到下一阶段。但是，今年是否能够进入谈判环节依然犹未可知。根据往年的情况，医保目录内所有药品年治疗费用均未超过30万元。按照药品降幅50%来看，“百万抗癌药”药品价格下降难度大，谈判难度很大。价格过高，即使纳入也将给医保基金带来很大压力。再者，CAR-T目前的市场渗透率较其他药品并不高，“以价换量”的意义可能还需要多方面考虑。02备受关注的21款罕见病用药根据国家医保局统计，截至今年8月底，已累计有26种罕见病用药通过医保目录准入谈判纳入医保药品目录，平均降幅超过50%。目前获批在我国上市的75种罕见病用药已有50余种纳入医保药品目录，这一数字预计在2023年会有进一步的升高。本次目录外通过形审的罕见病用药有21个（即条件5）。表2 通过形审目录外条件5药品来源：国家医保局，中康产业研究院整理目前医保目录内暂无戈谢病用药，连续两年与医保目录“无缘”的维拉苷酶α今年又出现在了初审名单中。治疗重症肌无力的品种4款，其中石杉碱甲注射液、注射用石杉碱甲在2023H1中国等级医院销售额较上年同期增长67%及22%，依库珠单抗注射液及新获批上市的艾加莫德α注射液也在名单上。但由于价格问题，也由于石杉碱甲注射液、注射用石杉碱甲较其他两种有着较强的使用基础，若这两款注射剂能顺利进入医保，产品市场有望进一步放量。其他新获批的盐酸奥扎莫德胶囊、尼替西农胶囊、醋酸格拉替雷都出现了名单上，有望参与本轮医保谈判，值得期待。作为一项长期而复杂的系统工程，医保谈判制度在不断完善，考虑到临床需求、医保基金负担等因素，将更多符合条件的罕见病用药按程序纳入医保药品目录。在价格测算上，罕见病药物也有相应的优惠和折算方式，来保障罕见病患者的。结语自23年前第一版发布以来，国家医保药品目录至今已更新8版，目录内药品从最初的1535个增至2967个，增幅为93%。今年的医保谈判即将开始，除了前文所属的领域及药物外，还需要重点关注2022.7.1-2023.6.30期间内获批的通过初审名单的品种，结合近年来新药常为医保药品目录调整重点，这些药物存在较大机会。（来源:新康界  作者:六爻)药闻康策新媒体矩阵微信公众号点击下方  一键关注  【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、收藏、点赞、点在看

2023 revenues outlook revised to $15.1 - $15.5 billion from $15.0 - $15.4 billion Global revenues of $3.9 billion, reflect an increase of 7% from the third quarter of 2022 Increased revenues reflect sustained growth of AUSTEDO ® , AJOVY ® and global generics business: Growth of AUSTEDO in North America Growth of AJOVY globally Stable and sustainable generics business in the U.S.; continued growth in Europe and International Markets GAAP diluted EPS of $0.07 Non-GAAP diluted EPS of $0.60 Cash flow generated from operating activities of $5 million Free cash flow of $229 million Exclusive collaboration with Sanofi on Anti TL1-A (TEV-‘574) entered into in October 2023 ( PR ) Olanzapine LAI (TEV-‘749) Phase 3 results accelerated; now expected in the second half of 2024 Teva api new CEO and management team announced ( PR ) 2023 revenues outlook revised to $15.1-$15.5 billion from $15.0-$15.4 billion; all other key components reaffirmed: Non-GAAP operating Income of $4.0 - $4.4 billion Adjusted EBITDA of $4.5 - $4.9 billion Non-GAAP diluted EPS of $2.25 - $2.55 Free cash flow of $1.7 - $2.1 billion TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended September 30, 2023. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231108857866/en/ Mr. Richard Francis, Teva's President and CEO, commenting on the war in Israel, said: "Following the terror attacks in Israel on October 7, 2023, Teva’s Board, leadership team, and I have made the safety of our Israeli employees our utmost priority. As a company with deep roots in Israel, we are humbled by the incredible resilience, care and resolve being shown in delivering our medicines to the millions of patients around the world who count on us. Currently, our production remains largely unaffected, and we have increased our emergency medical supplies, product donations and other supporting activities." Commenting on Teva's results for the third quarter of 2023, Mr. Francis said: "In Q3 2023, Teva delivered strong financial and business results, with revenues increasing by 7% compared to Q3 2022, to a total of $3.9 billion. Continued solid performance of AUSTEDO, AJOVY and our generics business delivered growth across all geographies. Based on these strong and consistent results, we are increasing our revenue outlook for 2023 for the second consecutive quarter." Mr. Francis continued, "Over the six months since our Pivot to Growth strategy was launched, we made significant progress in executing on all four pillars, as well as realizing our goal of becoming a stronger, bolder and simpler organization. Last month, we announced an exclusive collaboration with Sanofi for our promising Anti TL1-A asset, leveraging the innovative R&D and commercial expertise of both companies. We have accelerated our olanzapine LAI progress, with Phase 3 results now expected in the second half of 2024. In addition, we are on track to reach our 2023 growth targets through continued optimization of sales and marketing efforts. In our generics business, we are focusing our portfolio on high value complex products and optimizing our network. We are advancing toward Teva api becoming a stand-alone unit, and we are announcing the appointment of Dr. R. Ananthanarayanan (Ananth) as CEO of Teva api." Pivot to Growth Strategy In May 2023, we introduced our new “Pivot to Growth” strategy, which is based on four key pillars: (i) delivering on our growth engines, mainly AUSTEDO, AJOVY, UZEDY TM 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. Third Quarter 2023 Consolidated Results Revenues in the third quarter of 2023 were $3,850 million, an increase of 7% in both U.S. dollars and local currency terms compared to the third quarter of 2022. This increase was mainly due to higher revenues from generic products in all our segments, AUSTEDO in our North America segment and AJOVY in all our segments, partially offset by lower revenues from BENDEKA and TREANDA in our North America segment as well as from API sales to third parties. Exchange rate movements during the third quarter of 2023, net of hedging effects, negatively impacted our revenues by $9 million, compared to the third quarter of 2022. Exchange rate movements during the third quarter of 2023, including hedging effects, negatively impacted our operating income and non-GAAP operating income by $53 million and $51 million, respectively, compared to the third quarter of 2022. Gross profit in the third quarter of 2023 was $1,851 million, an increase of 11% compared to $1,669 million in the third quarter of 2022. Gross profit margin was 48.1% in the third quarter of 2023, compared to 46.4% in the third quarter of 2022. Non-GAAP gross profit was $2,060 million in the third quarter of 2023, an increase of 8% compared to the third quarter of 2022. Non-GAAP gross profit margin was 53.5% in the third quarter of 2023, compared to 53.0% in the third quarter of 2022. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products in our North America segment primarily driven by an increase in revenues from AUSTEDO, partially offset by higher costs due to inflationary and other macroeconomic pressures. Research and Development (R&D) expenses in the third quarter of 2023 were $253 million, an increase of 44% compared to $175 million in the third quarter of 2022 as we continue to execute on our Pivot to Growth Strategy. Our higher R&D expenses in the third quarter of 2023, compared to the third quarter of 2022, were mainly due to an increase related to our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), in immunology and immuno-oncology. In addition, in the third quarter of 2022 our R&D expenses were lower due to an adjustment in payments pursuant to a contract with one of our R&D partners. Selling and Marketing (S&M) expenses in the third quarter of 2023 were $576 million, an increase of 7% compared to the third quarter of 2022. General and Administrative (G&A) expenses in the third quarter of 2023 were $268 million, a decrease of 5% compared to the third quarter of 2022. Other income in the third quarter of 2023 was $9 million, compared to $2 million in the third quarter of 2022. Operating income in the third quarter of 2023 was $355 million, compared to an operating income of $419 million in the third quarter of 2022. Operating income as a percentage of revenues was 9.2% in the third quarter of 2023, compared to 11.6% in the third quarter of 2022. The lower operating income in the third quarter of 2023 was mainly due to higher legal settlements and loss contingencies, higher R&D and S&M expenses in the third quarter of 2023, partially offset by higher gross profit in the third quarter of 2023. Non-GAAP operating income in the third quarter of 2023 was $1,020 million representing a non-GAAP operating margin of 26.5% compared to non-GAAP operating income of $977 million representing a non-GAAP operating margin of 27.2% in the third quarter of 2022. The decrease in non-GAAP operating margin in the third quarter of 2023 was mainly impacted by an increase in R&D expenses, partially offset by higher non-GAAP gross profit margin, as discussed above, as well as lower G&A expenses. Adjusted EBITDA was $1,134 million in the third quarter of 2023, an increase of 4%, compared to $1,089 million in the third quarter of 2022. Financial expenses, net in the third quarter of 2023 were $280, mainly comprised of net-interest expenses of $247 million and a negative exchange rate impact driven mainly from currencies which we were unable to hedge. In the third quarter of 2022, financial expenses were $252 million, mainly comprised of net-interest expenses of $229 million. In the third quarter of 2023, we recognized a tax benefit of $12 million, on a pre-tax income of $75 million. In the third quarter of 2022, we recognized a tax expense of $107 million, on a pre-tax income of $166 million. Our tax rate for the third quarter of 2023 was mainly affected by deferred tax benefits resulting from intellectual property related integration plans. Such integration plans have been adopted, among others, in an effort to address the global adoption of the Organization for Economic Co-operation and Development (OECD) Pillar Two minimum effective corporate tax, commencing in 2024. Non-GAAP tax rate in the third quarter of 2023 was 9%, compared to 10% in the third quarter of 2022. Our non-GAAP tax rate in the third quarter of 2023 was mainly affected by the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, deferred tax benefits resulting from intellectual property related integration plans, as well as infrequent or non-recurring items. Our non-GAAP tax rate in the third quarter of 2022 was mainly affected by the mix of products we sold, interest expense disallowances and adjustments to valuation allowances on deferred tax assets. We expect our annual non-GAAP tax rate for 2023 to be between 12%-15%, higher than our non-GAAP tax rate for 2022, which was 12%, mainly due to the effect of a portion of the realization of losses related to an investment in one of our U.S. subsidiaries in 2022. Net income attributable to Teva and diluted earnings per share in the third quarter of 2023 were $80 million and $0.07, respectively, compared to $56 million and $0.05, respectively, in the third quarter of 2022. The higher net income in the third quarter of 2023 was mainly due to the tax benefit in 2023 and tax expense in 2022, partially offset by lower operating income, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the third quarter of 2023 were $677 million and $0.60, respectively, compared to $658 million and $0.59, respectively, in the third quarter of 2022. As of September 30, 2023 and 2022, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,157 million and 1,144 million, respectively. Non-GAAP information : net non-GAAP adjustments in the third quarter of 2023 were $598 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the third quarter of 2023 were adjusted to exclude the following items: Amortization of purchased intangible assets of $145 million, of which $130 million is included in cost of sales and the remaining $15 million in S&M expenses; Impairment of long-lived assets of $48 million; Legal settlements and loss contingencies of $314 million; Contingent consideration expenses of $16 million; Equity compensation expenses of $31 million; Restructuring expenses of $27 million; Accelerated depreciation of $25 million; Financial expenses of $14 million; Costs related to regulatory actions taken in facilities of $1 million; Gain on sale of business of $5 million; Other non-GAAP items of $63 million; Items attributable to non-controlling interests of $1 million; and Corresponding tax effects and unusual tax items of $80 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 further information, see the tables below for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and the information 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 third quarter of 2023 was $5 million, compared to $543 million in the third quarter of 2022. The lower cash flow generated in the third quarter of 2023 resulted mainly from changes in working capital items, including a negative impact from accounts receivables, net of SR&A, higher inventory levels, and higher legal payments, partially offset by a positive impact from accounts payables. During the third quarter of 2023, we generated free cash flow of $229 million, which we define as comprising $5 million in cash flow generated from operating activities, $362 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $10 million in proceeds from divestitures of businesses and other assets, partially offset by $149 million in cash used for capital investment. During the third quarter of 2022, we generated free cash flow of $685 million, which we define as comprising $543 million in cash flow generated from operating activities, $262 million in beneficial interest collected in exchange for securitized accounts receivables and $2 million in proceeds from divestitures of businesses and other assets, partially offset by $122 million in cash used for capital investment. The decrease in the third quarter of 2023, resulted mainly from lower cash flow generated from operating activities as explained above. As of September 30, 2023, our debt was $19,974 million, compared to $21,212 million as of December 31, 2022. This decrease was mainly due to $1,646 million senior notes repaid at maturity and $54 million of exchange rate fluctuations, partially offset by $500 million outstanding under our $1.8 billion unsecured syndicated sustainability-linked revolving credit facility, entered into in April 2022, as amended in February 2023 (“RCF”). Additionally, during the first quarter of 2023, we repurchased $2,506 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,445 million of sustainability-linked senior notes net of issuance costs. In July 2023, a total amount of $700 million was withdrawn under the RCF, of which $200 million was repaid in September 2023. As of September 30, 2023 and as of the date of this Press Release, $500 million is outstanding under the RCF. The portion of total debt classified as short-term as of September 30, 2023 was 7% compared to 10% as of December 31, 2022. Our average debt maturity was approximately 6.1 years as of September 30, 2023, compared to 5.8 years as of December 31, 2022. In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of this Press Release, the situation is evolving. Israel is included in Teva’s International Markets segment results. Teva’s global headquarters and several manufacturing and R&D facilities are located in Israel. Currently, such activities in Israel remain largely unaffected. Teva continues to maintain contingency plans with backup production locations for key products. As of the date of this Press Release, the impact of the war on Teva’s results of operations and financial condition is immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of such war. Segment Results for the Third Quarter of 2023 North America Segment Our North America segment includes the United States and Canada. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada will be reported as part of our International Markets segment. The following table presents revenues, expenses and profit for our North America segment for the three months ended September 30, 2023 and 2022: Three months ended September 30, 2023 2022 (U.S. $ in millions / % of Segment Revenues) Revenues $ 2,002 100% $ 1,809 100% Gross profit 1,093 54.6% 942 52.1% R&D expenses 163 8.1% 111 6.1% S&M expenses 257 12.8% 232 12.8% G&A expenses 98 4.9% 122 6.8% Other income (2) § § § Segment profit * $ 577 28.8% $ 477 26.3% * 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 North America segment in the third quarter of 2023 were $2,002 million, an increase of $193 million, or 11%, compared to the third quarter of 2022. This increase was mainly due to higher revenues from generic products and certain innovative products, primarily AUSTEDO and AJOVY, partially offset by lower revenues from BENDEKA and TREANDA. Revenues in the United States , our largest market, were $1,898 million in the third quarter of 2023, an increase of $125 million or 7% compared to the third quarter of 2022. Revenues by Major Products and Activities The following table presents revenues for our North America segment by major products and activities for the three months ended September 30, 2023 and 2022: Three months ended September 30, Percentage Change 2023 2022 2023-2022 (U.S. $ in millions) Generic products $ 929 $ 806 15% AJOVY 61 57 8% AUSTEDO 339 260 30% BENDEKA and TREANDA 57 77 (26%) COPAXONE ® 103 105 (2%) Anda 367 371 (1%) Other * 146 133 10% Total $ 2,002 $ 1,809 11% * Other revenues in the third quarter of 2023 increased mainly due to a reduction in estimated liabilities in connection with ProAir ® HFA following its discontinuation on October 1, 2022. Generic products revenues in our North America segment (including biosimilars) in the third quarter of 2023 were $929 million, an increase of 15% compared to the third quarter of 2022, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid ® ), partially offset by increased competition to other generic products. In the third quarter of 2023, our total prescriptions were approximately 320 million (based on trailing twelve months), representing 8.4% of total U.S. generic prescriptions, compared to approximately 302 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions in the third quarter of 2022, all according to IQVIA data. AJOVY revenues in our North America segment in the third quarter of 2023 increased by 8% to $61 million, compared to the third quarter of 2022, mainly due to growth in volume. In the third quarter of 2023, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 24.9% compared to 24.7% in the third quarter of 2022. AUSTEDO revenues in our North America segment in the third quarter of 2023 increased by 30%, to $339 million, compared to $260 million in the third quarter of 2022, mainly due to growth in volume with the launch of AUSTEDO XR in May 2023. 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 nine 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 the first 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. BENDEKA and TREANDA combined revenues in our North America segment in the third quarter of 2023 decreased by 26% to $57 million, compared to the third quarter of 2022, 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 North America segment in the third quarter of 2023 decreased by 2% to $103 million, compared to the third quarter of 2022, mainly due to generic competition in the United States and a decrease in glatiramer acetate market share due to availability of alternative therapies. COPAXONE revenues in the third quarter of 2023 were also positively impacted by a reduction in sales allowance. Anda revenues from third-party products in our North America segment in the third quarter of 2023 decreased by 1% to $367 million, compared to $371 million in the third quarter of 2022, mainly due to lower demand. North America Gross Profit Gross profit from our North America segment in the third quarter of 2023 was $1,093 million, an increase of 16%, compared to $942 million in the third quarter of 2022. Gross profit margin for our North America segment in the third quarter of 2023 increased to 54.6%, compared to 52.1% in the third quarter of 2022. This increase was mainly due to a favorable mix of products primarily driven by an increase in revenues from AUSTEDO. North America Profit Profit from our North America 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 North America segment in the third quarter of 2023 was $577 million, an increase of 21% compared to $477 million in the third quarter of 2022. This increase was mainly due to higher gross profit, partially offset by higher R&D 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 September 30, 2023 and 2022: Three months ended September 30, 2023 2022 (U.S. $ in millions / % of Segment Revenues) Revenues $ 1,146 100% $ 1,069 100% Gross profit 648 56.6% 634 59.3% R&D expenses 62 5.4% 44 4.1% S&M expenses 184 16.0% 169 15.8% G&A expenses 66 5.7% 61 5.7% Other income § § § § Segment profit* $ 338 29.5% $ 360 33.7% ___________ * 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 third quarter of 2023 were $1,146 million, an increase of 7%, or $77 million, compared to the third quarter of 2022. In local currency terms, revenues were flat compared to the third quarter of 2022. Revenues in the third quarter of 2023 included $15 million from a positive hedging impact, which is included in “Other” in the table below. Revenues in the third quarter of 2022 included $24 million from a positive 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 September 30, 2023 and 2022: Three months ended September 30, Percentage Change 2023 2022 2023-2022 (U.S. $ in millions) Generic products $ 886 $ 803 10% AJOVY 41 30 36% COPAXONE 55 63 (13%) Respiratory products 61 62 (2%) Other 104 111 (7%) Total $ 1,146 $ 1,069 7% Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2023, increased by 10% to $886 million, compared to the third quarter of 2022. In local currency terms, revenues increased by 2%, mainly due to higher volumes of generic products and OTC price increases. AJOVY revenues in our Europe segment in the third quarter of 2023 increased by 36% in U.S. dollars. In local currency terms revenues increased by 28% to $41 million, compared to $30 million in the third quarter of 2022. This increase was mainly due to growth in the European countries in which AJOVY had previously been launched. COPAXONE revenues in our Europe segment in the third quarter of 2023 decreased by 13% to $55 million, compared to the third quarter of 2022. In local currency terms, revenues decreased by 19%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products. Respiratory products revenues in our Europe segment in the third quarter of 2023 decreased by 2% to $61 million compared to the third quarter of 2022. In local currency terms, revenues decreased by 9% compared to the third quarter of 2022, mainly due to lower volumes. Europe Gross Profit Gross profit from our Europe segment in the third quarter of 2023 was $648 million, an increase of 2% compared to $634 million in the third quarter of 2022. Gross profit margin for our Europe segment in the third quarter of 2023 decreased to 56.6%, compared to 59.3% in the third quarter of 2022. This decrease was mainly due to higher cost of goods sold, mainly driven by higher costs due to inflationary and other macroeconomic pressures. 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 third quarter of 2023 was $338 million, a decrease of 6%, compared to $360 million in the third quarter of 2022. This decrease was mainly due to higher operating expenses partially driven by exchange rate fluctuations, as described above. International Markets Segment Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada will be reported under our International Markets segment and will no longer be included as part of our North America segment. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2023 and 2022: Three months ended September 30, 2023 2022 (U.S. $ in millions / % of Segment Revenues) Revenues $ 485 100% $ 475 100% Gross profit 261 53.8% 252 53.0% R&D expenses 23 4.8% 15 3.2% S&M expenses 102 21.0% 97 20.5% G&A expenses 27 5.6% 30 6.2% Other income (2) § (2) § Segment profit* $ 111 22.8% $ 112 23.5% __________ * Segment profit does not include amortization and certain other items. § Represents an amount less than 0.5%. Revenues from our International Markets segment in the third quarter of 2023 were $485 million, an increase of 2% compared to the third quarter of 2022. In local currency terms, revenues increased by 20% compared to the third quarter of 2022, 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 third quarter of 2023, revenues were negatively impacted by exchange rate fluctuations of $83 million, net of hedging effects, compared to the third quarter of 2022. Revenues in the third quarter of 2023 included a positive hedging impact of $6 million compared to a positive hedging impact of $4 million in the third quarter of 2022, 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 September 30, 2023 and 2022: Three months ended September 30, Percentage Change 2023 2022 2023-2022 (U.S. $ in millions) Generic products $ 381 $ 393 (3%) AJOVY 12 6 113% COPAXONE 10 9 10% Other 82 67 21% Total $ 485 $ 475 2% Generic products revenues in our International Markets segment were $381 million in the third quarter of 2023 compared to $393 million in the third quarter of 2022. In local currency terms, revenues increased by 17% compared to the third quarter of 2022, mainly due to higher revenues in most markets, largely driven by price increases largely as a result of higher costs due to inflationary pressure, 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 Japan in August 2021. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in the third quarter of 2023 were $12 million, compared to $6 million in the third quarter of 2022. COPAXONE revenues in our International Markets segment in the third quarter of 2023 were $10 million compared to $9 million in the third quarter of 2022. AUSTEDO was launched in China and Israel during 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. We continue with additional submissions in various other markets. International Markets Gross Profit Gross profit from our International Markets segment in the third quarter of 2023 was $261 million, an increase of 4% compared to $252 million in the third quarter of 2022. Gross profit margin for our International Markets segment in the third quarter of 2023 increased to 53.8%, compared to 53.0% in the third quarter of 2022. This increase was mainly due to price increases largely as a result of inflationary pressures and a favorable product mix, 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 third quarter of 2023 was $111 million, a decrease of 1%, compared to $112 million in the third quarter of 2022. 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 North America, Europe or International Markets segments described above. R evenues from other activities in the third quarter of 2023 were $217 million, a decrease of 10% in U.S. dollars. In local currency terms revenues decreased by 12% compared to the third quarter of 2022. API sales to third parties in the third quarter of 2023 were $131 million, a decrease of 12% in both U.S. dollars and local currency terms, compared to the third quarter of 2022. Outlook for 2023 Non-GAAP Results $ billions, except EPS or as noted November 2023 Outlook* August 2023 Outlook February 2023 Outlook 2022 Actual Revenues* $15.1 – $15.5 $15.0 – $15.4 $14.8 – $15.4 $14.9 COPAXONE ($m)* ~550 ~500 ~500 691 AUSTEDO ($m)* ~1,200 ~1,200 ~1,200 971 AJOVY ($m)* ~400 ~400 ~400 377 Operating Income 4.0 – 4.4 4.0 – 4.4 4.0 – 4.4 4.1 Adjusted EBITDA 4.5 – 4.9 4.5 – 4.9 4.5 – 4.9 4.6 Finance Expenses ($m) ~1,000 ~1,000 ~1,000 904 Tax Rate 12% – 15% 14% – 17% 14% – 17% 11.7% Diluted EPS ($) 2.25 – 2.55 1,132 million shares 2.25 – 2.55 1,123 million shares 2.25 – 2.55 1,123 million shares 2.52 1,115 million shares Free Cash Flow** 1.7 – 2.1 1.7 – 2.1 1.7 – 2.1 2.2 CAPEX* 0.5 0.5 0.5 0.5 Foreign Exchange Volatile swings in FX can negatively impact revenue and income Revenue, operating income, adjusted EBITDA, diluted EPS and free cash flow outlook range does not take into account execution and upfront milestone for Anti-TL1A under collaboration agreement with Sanofi. * 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 will host a conference call and live webcast including a slide presentation on November 8, 2023, at 8:00 a.m. ET to discuss its third quarter 2023 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: ir.tevapharm.com . 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) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at 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; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our innovative medicines, including AUSTEDO, AJOVY and COPAXONE; 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 launch and execute our new 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 further 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; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; 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; compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; 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 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 government programs reporting and payment obligations; compliance with anti-corruption, sanctions and trade control laws; environmental risks; and the impact of ESG issues; the impact of the state of war declared in Israel and the military activity in the region, including the risk of disruptions to our operations and facilities, such as our manufacturing and R&D facilities, located in Israel, the impact of our employees who are military reservists being called to active military duty, and the impact of the war on the economic, social and political stability of Israel; other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine; potential significant increases in tax liabilities; and 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 other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, 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. For an accessible version of this Press Release, please visit www.tevapharm.com Consolidated Statements of Income (U.S. dollars in millions, except share and per share data) (Unaudited) Three months ended Nine months ended September 30, September 30, 2023 2022 2023 2022 Net revenues 3,850 3,595 11,389 11,041 Cost of sales 1,999 1,926 6,159 5,839 Gross profit 1,851 1,669 5,230 5,203 Research and development expenses 253 175 726 628 Selling and marketing expenses 576 539 1,726 1,716 General and administrative expenses 268 283 870 892 Intangible assets impairments 47 24 289 223 Other asset impairments, restructuring and other items 46 36 241 282 Goodwill impairment - - 700 745 Legal settlements and loss contingencies 314 195 1,009 2,048 Other income (9) (2) (43) (88) Operating income (loss) 355 419 (289) (1,244) Financial expenses, net 280 252 808 721 Income (loss) before income taxes 75 166 (1,097) (1,964) Income taxes (benefit) (12) 107 (48) (792) Share in (profits) losses of associated companies, net § 1 (1) (20) Net income (loss) 88 58 (1,048) (1,152) Net income (loss) attributable to non-controlling interests 8 3 (60) (21) Net income (loss) attributable to Teva 80 56 (988) (1,132) Earnings (loss) per share attributable to Teva: Basic ($) 0.07 0.05 (0.88) (1.02) Diluted ($) 0.07 0.05 (0.88) (1.02) Weighted average number of shares (in millions): Basic 1,121 1,111 1,119 1,109 Diluted 1,135 1,119 1,119 1,109 Non-GAAP net income attributable to Teva for diluted earnings per share:* 677 658 1,763 2,021 Non-GAAP earnings per share attributable to Teva:* Diluted ($) 0.60 0.59 1.56 1.81 Non-GAAP average number of shares (in millions): Diluted 1,135 1,119 1,131 1,114 Amounts may not add up due to rounding. * See reconciliation attached. CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data) (Unaudited) September 30, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 2,249 $ 2,801 Accounts receivables, net of allowance for credit losses of $86 million and $91 million as of September 30, 2023 and December 31, 2022 3,385 3,696 Inventories 4,051 3,833 Prepaid expenses 1,168 1,162 Other current assets 520 549 Assets held for sale 51 10 Total current assets 11,425 12,051 Deferred income taxes 1,748 1,453 Other non-current assets 477 441 Property, plant and equipment, net 5,622 5,739 Operating lease right-of-use assets, net 406 419 Identifiable intangible assets, net 5,525 6,270 Goodwill 16,885 17,633 Total assets $ 42,088 $ 44,006 LIABILITIES AND EQUITY Current liabilities: Short-term debt $ 1,479 $ 2,109 Sales reserves and allowances 3,351 3,750 Accounts payables 2,280 1,887 Employee-related obligations 530 566 Accrued expenses 2,741 2,151 Other current liabilities 1,011 1,005 Total current liabilities 11,394 11,469 Long-term liabilities: Deferred income taxes 544 548 Other taxes and long-term liabilities 3,818 3,847 Senior notes and loans 18,495 19,103 Operating lease liabilities 324 349 Total long-term liabilities 23,182 23,846 Equity: Teva shareholders’ equity: 6,929 7,897 Non-controlling interests 582 794 Total equity 7,512 8,691 Total liabilities and equity $ 42,088 $ 44,006 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 Nine months ended September 30, September 30, 2023 2022 2023 2022 Operating activities: Net income (loss) $ 88 58 $ (1,048) (1,152) Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 283 321 887 1,002 Impairment of goodwill, long-lived assets and assets held for sale 48 28 1,010 1,002 Net change in operating assets and liabilities (238) 93 (398) 1,007 Deferred income taxes – net and uncertain tax positions (199) 44 (349) (1,214) Stock-based compensation 31 26 93 88 Other items (3) (40) 20 (117) Net loss (gain) from investments and from sale of long lived assets (5) 13 (31) 1 Net cash provided by (used in) operating activities 5 543 184 617 Investing activities: Beneficial interest collected in exchange for securitized trade receivables 362 262 1,056 854 Purchases of property, plant and equipment and intangible assets (149) (122) (407) (406) Proceeds from sale of business and long lived assets 10 2 68 45 Acquisition of businesses, net of cash acquired - - - (7) Purchases of investments and other assets . (38) 2 (44) (2) Other investing activities (1) 3 (6) 4 Net cash provided by (used in) investing activities 184 147 667 488 Financing activities: Repayment of senior notes and loans and other long term liabilities (1,000) (365) (4,152) (661) Proceeds from senior notes, net of issuance costs - - 2,451 - Proceeds from short term debt 700 - 700 - Repayment of short term debt (200) - (200) - Other financing activities (76) (75) (136) (115) Net cash provided by (used in) financing activities (576) (439) (1,337) (776) Translation adjustment on cash and cash equivalents (33) (84) (98) (269) Net change in cash, cash equivalents and restricted cash (420) 167 (584) 60 Balance of cash, cash equivalents and restricted cash at beginning of period 2,670 2,091 2,834 2,198 Balance of cash, cash equivalents and restricted cash at end of period $ 2,250 2,258 2,250 2,258 Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets: Cash and cash equivalents 2,249 2,225 2,249 2,225 Restricted cash included in other current assets . . 1 33 1 33 Total cash, cash equivalents and restricted cash shown in the statement of cash flows 2,250 2,258 2,250 2,258 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables $ 376 293 1,090 883 Dividend declared to non-controlling interests $ 67 - 67 - Amounts may not add up due to rounding Reconciliation of gross profit to Non-GAAP gross profit Three months ended Nine months ended September 30, September 30, ($ in millions) 2023 2022 2023 2022 Gross profit $ 1,851 1,669 $ 5,230 5,203 Gross profit margin 48.1% 46.4% 45.9% 47.1% Increase (decrease) for excluded items: Amortization of purchased intangible assets 130 145 420 513 Costs related to regulatory actions taken in facilities 1 2 3 6 Equity compensation 5 5 15 16 Accelerated depreciation 25 44 74 77 Other non-GAAP items* 48 41 137 136 Non-GAAP gross profit $ 2,060 1,906 $ 5,878 5,951 Non-GAAP gross profit margin** 53.5% 53.0% 51.6% 53.9% * 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. ** 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) Three months ended Nine months ended September 30, September 30, ($ in millions) 2023 2022 2023 2022 Operating income (loss) ($) 355 419 ($) (289) (1,244) Operating margin 9.2% 11.6% (2.5%) (11.3%) Increase (decrease) for excluded items: Amortization of purchased intangible assets 145 165 471 576 Legal settlements and loss contingencies 314 195 1,009 2,048 Goodwill impairment - - 700 745 Impairment of long-lived assets 48 28 310 257 Restructuring costs 27 25 93 117 Costs related to regulatory actions taken in facilities 1 2 3 6 Equity compensation 31 26 93 88 Contingent consideration 16 6 106 100 Loss (gain) on sale of business (5) § (3) (31) Accelerated depreciation 25 45 74 78 Other non-GAAP items* 63 67 249 268 Non-GAAP operating income (loss) ($) 1,020 977 ($) 2,816 3,010 Non-GAAP operating margin** ($) 26.5% 27.2% ($) 24.7% 27.3% * 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. ** Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues. § Represents an amount less than $0.5 million. Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva Three months ended Nine months ended September 30, September 30, ($ in millions except per share amounts) 2023 2022 2023 2022 Net income (Loss) attributable to Teva ($) 80 56 ($) (988) (1,132) Increase (decrease) for excluded items: Amortization of purchased intangible assets 145 165 471 576 Legal settlements and loss contingencies 314 195 1,009 2,048 Goodwill impairment - - 700 745 Impairment of long-lived assets 48 28 310 257 Restructuring costs 27 25 93 117 Costs related to regulatory actions taken in facilities 1 2 3 6 Equity compensation 31 26 93 88 Contingent consideration 16 6 106 100 Loss (Gain) on sale of business (5) 0 (3) (31) Accelerated depreciation 25 45 74 78 Financial expenses 14 14 53 48 Share in profits (losses) of associated companies – net - - - (22) Items attributable to non-controlling interests (1) (4) (91) (54) Other non-GAAP items* 63 67 249 268 Corresponding tax effects and unusual tax items (80) 33 (315) (1,072) **** Non-GAAP net income attributable to Teva ($) 677 658 ($) 1,762 2,021 Non-GAAP tax rate** 9.0% 10.0% 13.0% 12.0% GAAP diluted earnings (loss) per share attributable to Teva ($) 0.07 0.05 ($) (0.88) (1.02) EPS difference*** 0.52 0.54 2.44 2.83 Non-GAAP diluted EPS attributable to Teva*** ($) 0.60 0.59 ($) 1.56 1.81 Non-GAAP average number of shares (in millions)*** 1,135 1,119 1,131 1,114 * 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. ** 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. *** 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. **** Includes a portion of the realization of a loss related to an investment in one of our U.S. subsidiaries as well as corresponding tax effects on non-GAAP items Reconciliation of net income (loss) to adjusted EBITDA Three months ended Nine months ended September 30, September 30, ($ in millions) $ 2023 2022 2023 2022 Net income (loss) 88 58 $ (1,048) (1,152) Increase (decrease) for excluded items: Financial expenses 280 252 808 721 Income taxes (12) 107 (48) (792) Share in profits (losses) of associated companies –net § 1 (1) (20) Depreciation 139 156 416 426 Amortization 145 165 471 576 EBITDA 639 740 599 (241) Legal settlements and loss contingencies 314 195 1,009 2,048 Goodwill impairment - - 700 745 Impairment of long lived assets 48 28 310 257 Restructuring costs 27 25 93 117 Costs related to regulatory actions taken in facilities 1 2 3 6 Equity compensation 31 26 93 88 Contingent consideration 16 6 106 100 Loss (gain) on sale of business (5) § (3) (31) Other non-GAAP items * 63 68 249 268 Adjusted EBITDA $ 1,134 1,089 $ 3,158 3,358 *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. § Represents an amount less than $0.5 million. Segment Information North America Europe International Markets Three months ended September 30, Three months ended September 30, Three months ended September 30, 2023 2022 2023 2022 2023 2022 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues $ 2,002 $ 1,809 $ 1,146 $ 1,069 $ 485 $ 475 Gross profit 1,093 942 648 634 261 252 R&D expenses 163 111 62 44 23 15 S&M expenses 257 232 184 169 102 97 G&A expenses 98 122 66 61 27 30 Other income (2) § § § (2) (2) Segment profit $ 577 $ 477 $ 338 $ 360 $ 111 $ 112 § Represents an amount less than $0.5 million. Segment Information North America Europe International Markets Nine months ended September 30, Nine months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 2023 2022 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues $ 5,759 $ 5,450 $ 3,493 $ 3,396 $ 1,456 $ 1,422 Gross profit 2,950 2,841 1,943 2,031 778 780 R&D expenses 478 401 168 157 64 54 S&M expenses 743 733 565 561 310 293 G&A expenses 306 361 196 183 87 89 Other income (6) (12) (2) (1) (31) (43) Segment profit $ 1,429 $ 1,359 $ 1,017 $ 1,130 $ 348 $ 386 Reconciliation of our segment profit to consolidated income before income taxes Three months ended September 30, 2023 2022 (U.S.$ in millions) North America profit $ 577 $ 477 Europe profit 338 360 International Markets profit 111 112 Total reportable segment profit 1,025 949 Profit of other activities (5) 29 1,020 977 Amounts not allocated to segments: Amortization 145 165 Other asset impairments, restructuring and other items 46 36 Intangible asset impairments 47 24 Legal settlements and loss contingencies 314 195 Other unallocated amounts 112 139 Consolidated operating income (loss) 355 419 Financial expenses - net 280 252 Consolidated income (loss) before income taxes $ 75 $ 166 Reconciliation of our segment profit to consolidated income before income taxes Nine months ended September 30, 2023 2022 (U.S.$ in millions) North America profit $ 1,429 $ 1,359 Europe profit 1,017 1,130 International Markets profit 348 386 Total reportable segment profit 2,794 2,875 Profit of other activities 22 135 Total segment profit 2,816 3,010 Amounts not allocated to segments: Amortization 471 576 Other asset impairments, restructuring and other items 241 282 Goodwill impairment 700 745 Intangible asset impairments 289 223 Legal settlements and loss contingencies 1,009 2,048 Other unallocated amounts 394 379 Consolidated operating income (loss) (289) (1,244) Financial expenses - net 808 721 Consolidated income (loss) before income taxes $ (1,097) $ (1,964) Segment revenues by major products and activities Three months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) North America segment Generic products $ 929 $ 806 15% AJOVY 61 57 8% AUSTEDO 339 260 30% BENDEKA/TREANDA 57 77 (26%) COPAXONE 103 105 (2%) Anda 367 371 (1%) Other 146 133 10% Total 2,002 1,809 11% Three months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) Europe segment Generic products $ 886 $ 803 10% AJOVY 41 30 36% COPAXONE 55 63 (13%) Respiratory products 61 62 (2%) Other 104 111 (7%) Total 1,146 1,069 7% Three months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) International Markets segment Generic products $ 381 $ 393 (3%) AJOVY 12 6 113% COPAXONE 10 9 10% Other 82 67 21% Total 485 475 2% Segment revenues by major products and activities Nine months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) North America segment Generic products $ 2,722 $ 2,731 0% AJOVY 168 142 18% AUSTEDO 817 618 32% BENDEKA / TREANDA 188 241 (22%) COPAXONE 242 285 (15%) Anda 1,183 1,021 16% Other 439 411 7% Total 5,759 5,450 6% Nine months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) Europe segment Generic products $ 2,727 $ 2,552 7% AJOVY 115 90 28% COPAXONE 174 207 (16%) Respiratory products 195 198 (2%) Other 282 349 (19%) Total 3,493 3,396 3% Nine months ended September 30, Percentage Change 2023 2022 2022-2023 (U.S.$ in millions) International Markets segment Generic products $ 1,175 $ 1,175 0% AJOVY 31 22 40% COPAXONE 32 29 9% Other 219 195 12% Total 1,456 1,422 2% Free cash flow reconciliation (Unaudited) Three months ended September 30, 2023 2022 (U.S. $ in millions) Net cash provided by (used in) operating activities 5 543 Beneficial interest collected in exchange for securitized trade receivables 362 262 Purchases of property, plant and equipment and intangible assets (149) (122) Proceeds from sale of business and long lived assets 10 2 Free cash flow $ 229 $ 685 Free cash flow reconciliation (Unaudited) Nine months ended September 30, 2023 2022 (U.S. $ in millions) Net cash provided by (used in) operating activities 184 617 Beneficial interest collected in exchange for securitized trade receivables 1,056 854 Purchases of property, plant and equipment and intangible assets (407) (406) Proceeds from sale of business and long lived assets 68 45 Acquisition of subsidiary, net of cash acquired - (7) Free cash flow $ 902 $ 1,103 View source version on businesswire.com : https://www.businesswire.com/news/home/20231108857866/en/ 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