Deutetrabenazine

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

编者按：进博6年，进入中国已经超过40年的跨国药企已经成为一支重要的参与力量，他们在这个平台从世界探向中国，从中国相连世界；他们首发新药、首推新的解决方案，牵手产业上下游各方达成合作；他们通过这样或那样的现场活动持续发出独属于MNC的声音。自从1980年日本大冢制药株式会社作为首家外资药企签约进入中国，伴随国内改革开放，跨国药企耕耘中国市场长达43年，斗转星移，他们已从如梦似幻的黄金十年经历蛰伏蓄力的去而复来走向等风来之后的凭栏万里......以改革开放40年为起点的进博6年，也是跨国药企在中国医药创新市场风起云涌的6年。黄金十年已逝，摆在跨国药企面前的全球第二大医药市场已经发生深刻变化。挥别重金加注的高速发展阶段，他们也在收缩边界，聚焦目光，重新探寻中国市场的潜力与诉求。面对全球和中国医药环境的风云变换，贪吃蛇式的游戏养成的这批巨无霸们，也开始大象跳舞，甩掉包袱。进入今年，跨国药企密集展开在中国市场的调整：架构变革、人事重组、交易再评估......下一个发展周期，跨国药企将如何看待中国市场？如何解读中国的医药改革？又将定义出怎样的发展路径？续写出怎样的商海故事？01跨国药企在中国仍然充满市场机会去年RDPAC的一份调研显示，超过90%的跨国药企表示中国市场在其全球的战略重要性将在未来3—5年保持稳定。诺华中国总裁张颖说道，中国在近年来已经成为全球第二大医药市场，随着一系列改革措施的推出，行业也逐步进入了高质量发展阶段。过去几年，市场竞争环境发生了一些变化，但未满足的患者需求依然巨大，尤其是在一些如心血管、肿瘤等高发的疾病领域。过去几年中国医药市场不断向创新药市场转型，但创新药占比依然较低。像诺华这样的创新药企业，有着丰富的产品组合和在研产品线。对跨国药企来说，中国医药市场依然有着很大的想象空间和市场机会。据RDPAC调研，2020年，42%的跨国药企默认中国应被纳入全球关键研究。2021年，这一比例上升至67%以上。张颖提出，挑战是如何更快更好地将创新药带入中国，并尽可能惠及更多患者。赛诺菲中国在赛柏蓝的调研中表示，随着全面推进健康中国建设的不断深入，目前中国市场正在不断促进医药卫生高质量发展，这推动着包括赛诺菲在内的跨国药企与中国医药市场一同快速进入创新转型阶段，进一步加速创新药的引入和研发。梯瓦大中华区总经理黄迪仁也对赛柏蓝分享到，近年来，中国医药市场保持着全球第二大市场的地位。对于跨国药企来说，中国市场所代表的无限机遇具有重要的战略意义。如何及时洞察、敏捷应对日新月异的中国市场的需求，也是对企业整体能力的考验。梯瓦自2018年正式进入中国，已将中国确定为公司在全球的核心市场之一，对中国市场的潜力和发展充满信心。拜耳表示，中国经济长期向好、产业结构加速转型，给各国企业发展提供了广阔机遇，这也坚定了包括拜耳在内的在华外资企业深耕中国市场的信心。拜耳在中国已经扎根了140多年。今天，中国已成为拜耳全球业务最重要的战略支柱之一，是拜耳处方药全球最大市场之一、健康消费品全球第二大市场，也是作物科学全球十大市场之一。拜耳认为，中国市场的巨大潜力和持续增长态势将为其在医疗健康和农业科技领域的业务带来更多机遇。拜耳将持续挖掘国内大市场潜力，充分发挥医疗健康和农业科技领域的优势，与中国共同迈进新发展时期。拜耳集团正在通过战略收购、合作共赢和产品线的调整积极推进公司向新技术转型。拜耳几乎在所有业务部门都投资了新技术，为未来增长奠定了基础。在中国的本土化发展中，跨国药企呈现出进一步加快创新速度以及创新药引入速度的趋势。02国内医药系列政策变革鼓励高临床价值创新药张颖认为，国内医药行业近年来的一系列制度改革，对推动行业健康发展，建立鼓励创新的行业环境起到了关键的积极作用，对于具有高临床价值的创新药研发和上市具有重要意义。诺华是药品审评审批制度改革的获益者。比如，2020年，中国成为诺华创新药物诺欣妥在全球首批申请高血压适应症的市场之一。降血脂药物乐可为®在今年8月，即递交新药申请9个月后就实现获批，可谓“中国速度”。此外，诺华一直以来也积极参加国家医保谈判，同时推进早期准入以及开展商业保险等多元化药品可及路径。自2017年以来，已有超过30款药物被纳入国家医保目录。2022年，诺华有14款创新药物及新适应症被纳入国家医保目录，谈判产品数量和被纳入产品的数量均位居前列。随着中国药品审评审批制度改革持续深化，审评审批程序更加高效。2020年，梯瓦创新药安泰坦®（氘丁苯那嗪片）——用于治疗与亨廷顿病（HD）有关的舞蹈病及成人迟发性运动障碍（TD），经过优先审评程序，历时仅4个月便获批。随着医保谈判、带量采购的落地实施，医疗产品在中国的可及性与可负担性得到了大幅提高。对于梯瓦来说，集采等政策并不是一个挑战，而是一个机会与使命。为助力更多中国患者负担得起优质医疗，梯瓦有多款产品在医保谈判和国家集中带量采购中取得亮眼成果。诺德诺德方面认为，挑战和机遇是并存的，如同硬币的两面。这提醒企业抓住机会，在业务成长的同时，看到挑战，未雨绸缪，布局未来。医药市场的变化前所未有，大部分是积极的变化，如创新药得以快速审评审批，医保动态准入，国家层面，扩大医保覆盖率。03外部环境生变必要调整助推持续发展对跨国药企而言，根据市场环境的变化和自身业务的需求进行适时必要的调整是持续发展的关键。张颖表示，诺华在过去的几年里，也启动了转型之旅，通过非核心业务剥离和内部整合，目前已成为一家完全专注于创新药的企业。诺华在中国的新药及新适应症开发自2022年以来已实现100%与全球保持同步。诺华致力于未来3年实现超过90%的中国新药及新适应症注册申请与全球保持同步，这将为诺华加速创新药的引入进一步提供助力。获批引进之后，加速推进上市供应，以惠及需要的患者也是诺华工作的重点。此外，在保持对重点城市关注的同时，诺华也进一步挖掘增长潜力，不断加大对于县域市场的布局和投入，目前已覆盖1000多个县域市场。过去几年，诺和诺德在中国的业务不断扩大。从2018年到2023年，诺和诺德六次投资中国，升级研发、生产、运营全产业链布局，在中国形成了“双中心，三引擎”的新战略布局，推动中国业务迈入新阶段。诺和诺德双中心指的是，天津和上海的法律实体被政府认定为跨国公司地区总部；三引擎分别是，在华贸易和创新引擎位于上海，生产引擎位于天津，研发引擎位于北京。诺和诺德的中国研发中心是全球研发链条不可或缺的一部分，也是全球五大研发中心之一。中国早期研发贡献全球创新管线——在研发中心的开放创新平台INNOVO®，已有约100个创新概念和构想得到评估，30多个项目展开了具体合作，其中2个被纳入全球研发管线。2023年4月，诺和诺德正式递交了每周注射一次的胰岛素Icodec上市申请。这是诺和诺德首次在中国、欧盟与美国同步完成临床试验，同步递交新药上市申请。从2019年至2023年，诺和诺德对生产厂持续投资，提升产能、打造数字化工厂、建设高架立体仓库等。近年来，诺和诺德还不断扩大在上海的业务足迹。诺和诺德是首家落户临港新片区的跨国制药企业。2022年，诺和诺德在第五届进博会宣布将在上海建设现代化物流仓储中心，今年9月，项目正式启动。艾伯维中国总部位于上海，成立十年来，艾伯维中国员工数从400多名大幅增长至2200多名，多个创新疗法在中国实现全球同步上市。作为艾伯维全球的重要市场之一，艾伯维一直致力于主动融入中国的高质量发展进程，将艾伯维同类最佳(Best-in-class)创新药第一时间带入中国。瑞福是首个在华获批的口服选择性JAK抑制剂，同时也是中国首个获批用于治疗特应性皮炎、类风湿关节炎、克罗恩病及溃疡性结肠炎的口服选择性JAK抑制剂，中国首个也是唯一一个获批用于治疗银屑病关节炎的靶向疗法，中国与美国、欧洲等其他市场同步研发、注册和上市，并通过更早地纳入医保目录，提高患者可及性。目前，艾伯维中国已进入2.0时代，有望在新十年实现新的腾飞。艾伯维计划到2030年，在华推出超过30个新产品或新适应症，正在进行与计划中的临床研究项目约有60个，全力加速满足中国患者巨大的临床需求。艾伯维未来将继续立足上海、深耕中国，借助进博会的平台及溢出效应，把更多的创新产品和治疗方案带到中国，同时，致力于把更多的中国临床经验与学识带向全球。作为改革开放后最早一批来华的跨国药企，赛诺菲至今扎根中国40余年。赛诺菲目前在华拥有12处多元模式的办公室、3大生产基地、4处研发基地以及1个数字化创新中心。三大生产基地持续投入——2007年起，先后投资12亿元人民币建立深圳工厂；2023年宣布增资3300万欧元，在杭州工厂新建用于治疗心血管类药物的包装车间；2022年宣布投资5亿元人民币，在北京工厂落地糖尿病领域创新复方制剂赛益宁®的本土生产。2021年启用在中国的首个全球研究院（SIBR），专注于免疫炎症、罕见病罕见血液病、神经、肿瘤等前沿性生物研究。赛诺菲还前瞻布局大湾区，于2021年底在深圳落成大湾区国际疫苗创新中心，致力于构建疫苗行业全链路创新升级。赛诺菲努力以更快的速度将全球资产引入中国，并成为全球创新的新引擎。至今赛诺菲已为中国患者引进40余种慢性病、特药、疫苗和消费者保健领域的药物。自2019年，赛诺菲已将中国作为全球同步研发的必要选项，到今年已实现中国参与全球90%的同步开发项目。随着全球市场的需求和环境不断变化，企业需要为不同的发展阶段调整策略。自2018年进入中国市场，梯瓦制定了“在中国，为中国”的战略，积极响应中国国家政策，在进入中国市场时，梯瓦选择以“特药”作为突破口。这一决策不仅是考虑到市场环境、竞争格局的因素，还包含对患者需求的考量，针对的是中国患者在许多罕见病、肿瘤领域亟待解决的需求。在2018～2021年构建起完整的组织架构之后，梯瓦中国完成了起步阶段的工作。目前，梯瓦在中国的发展已进入到新的阶段，“新增长、新发展”是这一阶段的关键词。在新阶段，梯瓦将持续深化贯彻“在中国，为中国”关键战略，全面开放在华合作，深入洞察中国百姓未被满足的健康需求。在精神、神经、呼吸、免疫、肿瘤等领域，梯瓦将推动创新管线的落地，为中国患者提供更多优质的创新产品。梯瓦也将继续引进包括非处方药和仿制药等在内的全球产品资源，打造更多元化的优质产品矩阵。04医药行业深度转型跨国药企本土化下一步中国医药行业不断向创新转型。在这一转型过程中寻找和抓住机会，筛选并布局赛道至关重要。2023年，诺华正式成为一家完全专注于创新药的公司。现在和未来，除了继续“加速创新”和“提升可及性”，诺华的关键词是“聚焦”，诺华聚焦患者需求最为迫切的治疗领域和关键技术平台，开发并引入高临床价值的创新药物及疗法。第六届进博会上，诺华将展示多款未来几年计划引入中国的创新药——包括放射配体疗法领域的全球首创的一款靶向前列腺特异性膜抗原（PSMA）创新药物；全球首创的小分子补体因子B抑制剂Iptacopan；有望成为全球第一款有效降低脂蛋白(a)的新型降脂药Pelacarsen；有望成为全球首个口服治疗CSU的BTK抑制剂Remibrutinib。未来三到五年，诺和诺德将不断深化布局，更深入地参与到全球创新链、生产链和健康链中。作为行业领军者，诺和诺德希望继续深耕中国市场，实现互利共赢，助力打造健康中国，造福中国患者。中国糖尿病和其他严重慢性疾病领域，尚有巨大的未被满足的医疗需求，植根中国29年的诺和诺德，2023年，发布“赢+2030”长期战略，致力于做值得信赖的合作伙伴，让更多中国患者获益于诺和诺德的创新产品。诺和诺德还将持续投资，深化全产业链布局升级，更好地服务中国患者。加速创新，继续推进“中国同创”计划，争取实现国内外同步临床，同步获批，患者同步受益，持续引进更多、更好的创新药品，扩大药品可及性。支持政府精准防治糖尿病和肥胖症，携手领域专家、医疗专业人士，推动治疗理念的更新，推动诊疗水平的提高，努力实现“早诊、早治、有效控制”，助力“健康中国2030”。携手行业内外合作伙伴，构建“线上+线下”一体化的数字化慢病管理模式，助力医生，赋能患者，利用数字化手段更好地帮助患者进行疾病自我管理。通过预防的方式，扭转糖尿病患病率上升的曲线，例如，对肥胖症的探索等。面对近几年医改政策的变化，赛诺菲正积极抓住机遇，参与到中国医药市场创新转型进程中。进一步加速推进赛诺菲全球创新药进入中国市场，契合国家以临床价值为导向来评估确定纳入医保的药物，确保有效、先进的药物和疗法实现公平可及，加速将更多创新方案落地中国。赛诺菲至今已为中国人民引入40余种高质量的创新药物和疫苗，提供从预防到治疗、再到自我保健的全面健康解决方案，不断拓展端到端的健康现代化模式，致力于成为本土化全方位健康守护者。赛诺菲将加强本土创新与合作，持续完善本土化产业链，并充分发扬全球研发实力和本地洞见的优势，积极参与到中国创新生态体系中。经过在中国40余年的孕育和发展，赛诺菲中国研发中心的员工已参与并领导全球研发工作，成为全球及本土医药人才发展的孵化器和加速器。如何更好地进行本土化发展是在华跨国企业必须思考的课题。艾伯维的探索是，在中国携手多方，共筑生态圈，展开多元化合作。自2021年起，艾伯维连续3年举办“中国合作日”活动，并成功与多家中国企业达成合作协议。艾伯维通过“中国合作日”这一创新合作平台，在自身深耕的研究和治疗领域——免疫学、肿瘤学、神经科学、眼科学、美学，与中国产业链、资本链、创新链的合作伙伴一起，深度合作，携手“出海”，深耕“蓝海”，加速推动中国医药市场的发展。梯瓦已全面开放在中国的合作，积极与不同的本土企业构建长期互惠合作关系。中国是梯瓦的战略市场，特别是在创新药方面，中国是梯瓦全球创新药研发的优先市场。因此，我们致力于与本土伙伴紧密合作，为中国百姓带来更多优质优价的创新药。在创新药研发方面，中国是梯瓦高度重视的全球四个重要区域之一，致力创新药管线落地中国，达成创新药在中国与美国、欧洲、日本同步上市。除创新药以外，梯瓦也将继续引进包括非处方药和仿制药等在内的梯瓦全球产品资源，满足中国百姓日益多元的健康需求。梯瓦的高质量仿制药为中国患者提供在原研药之外的治疗选择，梯瓦也将加速引进高质量仿制药品。梯瓦拥有行业内规模领先的仿制药研发管线，包含1100多个在研项目。梯瓦将积极引入高质量且具有竞争力价格的仿制药进入中国市场，为广大中国患者提供更多经济可负担的治疗选择。 今年，梯瓦首次在中国市场引入首款健康消费品。经典产品Sudocrem®通过跨境电商渠道，在阿里、京东等平台触达消费者，丰富中国百姓健康消费选择。一方面，梯瓦将整合与本土伙伴在渠道网络、供应链体系等方面的优势，拓展药品全国覆盖范围，提升优质药品的患者可及性；另一方面，梯瓦也将携手多家本土合作伙伴，依托其注册、准入和商业化团队等优势力量，以多元化的合作模式在中国共同确定、开发和商业化梯瓦全球已上市产品，满足中国百姓多元健康需求。下一个周期，跨国药企在中国的故事还在继续。END作者 | 遥望来源 | 赛柏蓝