Ranibizumab biosimilar (Midas Pharma GmbH)

MUNICH, Germany I February 06, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea ® . The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea ® in patients with neovascular age-related macular degeneration (nAMD). The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity. Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia® 2 (UK), Ranivisio® 3 (EU), and Cimerli TM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area. Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050. [i] Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc. Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.” [i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077 . Last accessed in January 2023. 1 Eylea ® is a registered trademark of Regeneron Pharmaceuticals Inc. 2 Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd. 3 Ranivisio® is a registered trademark of Bioeq AG 4 Cimerli TM is a trademark of Coherus BioSciences, Inc About Formycon: Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207. About Biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion. SOURCE: Formycon

Key financial highlights and outlook Revenues of $3.6 billion GAAP diluted EPS of $0.05 Non-GAAP diluted EPS of $0.59 Cash flow generated from operating activities of $543 million Free cash flow of $685 million 2022 revenues outlook revised mainly due to continued foreign exchange headwinds; non-GAAP tax rate outlook range revised to 12% - 14%; operating income, Adjusted EBITDA, EPS and free cash flow reaffirmed: Revenues of $14.8 - $15.4 billion vs. previous range of $15.0 - $15.6 billion Adjusted EBITDA of $4.7 - $5.0 billion Non-GAAP diluted EPS of $2.40 - $2.60 Free cash flow of $1.9 - $2.2 billion Non-GAAP tax rate of 12% - 14% vs. previous range of 13%-14% TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceuticals Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended September 30, 2022. This press release features multimedia. View the full release here: Mr. Kåre Schultz, Teva's President and CEO: "Teva delivered a solid third quarter on the backdrop of significant foreign exchange headwinds due to appreciation of the U.S. dollar. Generics revenues grew in Europe and International Markets in local currency terms, reflecting market growth and successful new product launches. Our key specialty brands also performed well, with continued growth momentum across all regions - AUSTEDO® showed 30% U.S. revenue growth and is on track to reach ~$1 billion 2022 annual revenues. AJOVY® shows continued growth in revenues and market share in U.S. and Europe, and reached 28% volume market share in Japan.” Opioid Litigation Updates: Substantial progress toward a nationwide settlement In July 2022, the parties reached an agreement in principle on the financial terms of a nationwide settlement similar in structure to the nationwide settlements of other defendants. During the third quarter of 2022, Teva, the working group of States’ Attorneys General and the Multi-District Litigation Plaintiffs’ Executive Committee made substantial progress toward finalizing the non-financial terms of the proposed nationwide settlement agreement. Teva and Allergan have resolved their dispute with respect to Teva's indemnification obligations. Teva has also reached an agreement in principle with the Attorney General of New York that settles the state’s and its subdivisions’ opioid-related claims. We have updated the reserve to account for the premium. Immediately following the finalization of the documentation for the nationwide settlement agreement, the sign-on process for states will begin, followed by a similar sign-on process for the states’ subdivisions and special districts. Given the high participation rate in other nationwide opioids settlements and Teva’s settlements with Florida, Louisiana, Rhode Island, Texas, West Virginia and San Francisco and agreement in principle with New York, we remain optimistic that we will see a high participation rate in this nationwide settlement, enabling us to put these cases behind us and continue to focus on the patients we serve every day. Third Quarter 2022 Consolidated Results Revenues in the third quarter of 2022 were $3,595 million, a decrease of 8% compared to the third quarter of 2021. In local currency terms, revenues decreased by 2%, mainly due to a decrease in revenues from generic products in our North America segment, COPAXONE® in our North America and Europe segments, and BENDEKA® and TREANDA® in our North America segment, partially offset by higher revenues from AUSTEDO in our North America segment and generic products in our Europe segment. Exchange rate movements during the third quarter of 2022, net of hedging effects, negatively impacted our revenues by $215 million compared to the third quarter of 2021. Exchange rate movements during the third quarter of 2022, net of hedging effects, negatively impacted our GAAP and non-GAAP operating income by $53 million and $58 million, respectively, compared to the third quarter of 2021. GAAP gross profit was $1,669 million in the third quarter of 2022, a decrease of 7% compared to the third quarter of 2021. GAAP gross profit margin was 46.4% in the third quarter of 2022, compared to 46.2% in the third quarter of 2021. This increase was mainly driven by higher revenues from AUSTEDO, a favorable mix of generic products in our Europe segment, and higher revenues from the positive impact of hedging activities, partially offset mainly by higher operational costs due to macroeconomic headwinds and lower revenues from COPAXONE. Non-GAAP gross profit was $1,906 million in the third quarter of 2022, a decrease of 9% compared to the third quarter of 2021. Non-GAAP gross profit margin was 53.0% in the third quarter of 2022, compared to 53.6% in the third quarter of 2021. This decrease was mainly driven by higher operational costs due to macroeconomic headwinds and lower revenues from COPAXONE, partially offset by higher revenues from AUSTEDO, a favorable mix of generic products in our Europe segment and higher revenues from the positive impact of hedging activities. GAAP Research and Development (R&D) expenses in the third quarter of 2022 were $175 million or 4.9% of quarterly revenues, a decrease of 21%, compared to $222 million, or 5.7% of quarterly revenues in the third quarter of 2021. Non-GAAP R&D expenses were $171 million, or 4.8% of quarterly revenues, in the third quarter of 2022, compared to $217 million, or 5.6%, in the third quarter of 2021. In the third quarter of 2022, our R&D expenses related primarily to specialty product candidates in neuroscience (such as migraine, movement disorders/ neurodegeneration and neuropsychiatry, including post-approval commitments), immunology (such as respiratory medicines) and selected other areas, as well as generic products and biosimilars. Our lower R&D expenses in the third quarter of 2022, compared to the third quarter of 2021, were mainly due to a decrease in neuroscience (in the pain and migraine and headache therapeutic areas) and immunology (in the respiratory therapeutic area) as well as various generics projects, and an adjustment in payments pursuant to a contract with one of our R&D partners in the third quarter of 2022, partially offset by higher R&D expenses related to our biosimilar products pipeline. GAAP Selling and Marketing (S&M) expenses in the third quarter of 2022 were $539 million, a decrease of 10% compared to the third quarter of 2021. Non-GAAP S&M expenses were $510 million, or 14.2% of quarterly revenues, in the third quarter of 2022, compared to $567 million, or 14.6%, in the third quarter of 2021. GAAP General and Administrative (G&A) expenses in the third quarter of 2022 were $283 million, a decrease of 3% compared to the third quarter of 2021. Non-GAAP G&A expenses were $250 million, or 7.0% of quarterly revenues, in the third quarter of 2022, compared to $275 million, or 7.1%, in the third quarter of 2021. GAAP other income in the third quarter of 2022 was $2 million, compared to $25 million in the third quarter of 2021. Non-GAAP other income in the third quarter of 2022 was $2 million, compared to $18 million in the third quarter of 2021. GAAP operating income in the third quarter of 2022 was $419 million, compared to $623 million in the third quarter of 2021. The decrease in operating income in the third quarter of 2022 compared to the third quarter of 2021 was mainly due to legal settlements and loss contingencies as well as lower gross profit, partially offset by lower S&M and R&D expenses. Non-GAAP operating income in the third quarter of 2022 was $977 million, a decrease of 6%, compared to $1,042 million in the third quarter of 2021. This decrease in non-GAAP operating income was mainly due to lower gross profit, as discussed above. Non-GAAP operating margin was 27.2% in the third quarter of 2022, compared to 26.8% in the third quarter of 2021 mainly due to lower S&M and R&D expenses, partially offset by lower gross margin. Adjusted EBITDA was $1,089 million in the third quarter of 2022, a decrease of 7% compared to $1,170 million in the third quarter of 2021. GAAP financial expenses, net were $252 million in the third quarter of 2022, compared to $241 million in the third quarter of 2021. Non-GAAP financial expenses, net were $238 million in the third quarter of 2022, compared to $235 million in the third quarter of 2021. Financial expenses in the third quarters of 2022 and 2021 were mainly comprised of interest expenses of $230 million and $232 million, respectively. In the third quarter of 2022, we recognized a GAAP tax expense of $107 million, on pre-tax income of $166 million. In the third quarter of 2021, we recognized a tax expense of $76 million, on pre-tax income of $382 million. Non-GAAP income taxes in the third quarter of 2022 were $74 million, or 10%, on pre-tax non-GAAP income of $739 million. Non-GAAP income taxes in the third quarter of 2021 were $137 million, or 17%, on pre-tax non-GAAP income of $807 million. 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 2022 to be 12%-14%, lower than our non-GAAP tax rate for 2021, which was 16.4%, mainly due to the effect of a portion of the realization of losses related to an investment in one of our U.S. subsidiaries. GAAP net income attributable to Teva and GAAP diluted earnings per share were $56 million and $0.05, respectively, in the third quarter of 2022, compared to net income of $292 million and diluted earnings per share of $0.26 in the third quarter of 2021. The decrease in net income in the third quarter of 2022 was mainly due to lower operating income and higher income taxes, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the third quarter of 2022 were $658 million and $0.59, respectively, compared to $651 million and $0.59 in the third quarter of 2021. The weighted average diluted shares outstanding used for the fully diluted share calculation for the three months ended September 30, 2022 and 2021 were 1,119 million and 1,109 million shares, respectively. The weighted average diluted shares outstanding used for the fully diluted share calculation on a non-GAAP basis for the three months ended September 30, 2022 and 2021 was 1,119 million and 1,109 million shares, respectively. As of September 30, 2022 and 2021, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,144 million and 1,128 million shares, respectively. Non-GAAP information: Net non-GAAP adjustments in the third quarter of 2022 were $602 million. Non-GAAP net income and non-GAAP EPS for the third quarter of 2022 were adjusted to exclude the following items: Legal settlements and loss contingencies of $195 million; Amortization of purchased intangible assets of $165 million, of which $145 million is included in cost of sales and the remaining $20 million in S&M expenses; Accelerated depreciation of $45 million; Impairment of long-lived assets of $28 million; Equity compensation expenses of $26 million; Restructuring expenses of $25 million; Finance expenses of $14 million; Contingent consideration expense of $6 million; Costs related to regulatory actions taken in facilities of $2 million; Other non-GAAP items of $68 million; Items attributable to non-controlling interests of $4 million; and Tax expense of $33 million. Teva believes that excluding such items facilitates investors’ understanding of its business. Commencing the first quarter of 2022, we no longer exclude IPR&D acquired in development arrangements from our non-GAAP financial measures. In our comparable non-GAAP financial measures for the third quarter of 2021, no IPR&D acquired in development arrangements was recorded. We have made this change to our presentation of non-GAAP financial measures to improve comparability of our non-GAAP presentation to those of other companies in the pharmaceutical industry that made a similar change to their presentations beginning in the first quarter of 2022. 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 2022 was $543 million, compared to $529 million in the third quarter of 2021. The increase in the third quarter of 2022 resulted mainly from changes in the deferred purchase price under our securitization agreement, partially offset by changes in working capital items, primarily a lower reduction in our inventory levels compared to the third quarter of 2021. Free cash flow (defined as cash flow generated from operating activities, cash used for capital investments, beneficial interest collected in exchange for securitized accounts receivables, proceeds from divestitures of businesses and other assets and cash used for acquisition of businesses, net of cash acquired) was $685 million in the third quarter of 2022, compared to $795 million in the third quarter of 2021. This decrease in the third quarter of 2022 resulted mainly from changes in working capital items, primarily a lower reduction in our inventory levels compared to the third quarter of 2021. As of September 30, 2022, our debt was $21,266 million, compared to $23,043 million as of December 31, 2021. This decrease was mainly due to $1,139 million from exchange rate fluctuations and $661 million senior notes repaid at maturity. Our debt as of September 30, 2022 was effectively denominated in the following currencies: 65% in U.S. dollars, 33% in euros and 2% in Swiss francs. The portion of total debt classified as short-term as of September 30, 2022 was 13%, compared to 6% as of December 31, 2021. Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 69% as of September 30, 2022, compared to 67% as of December 31, 2021. Our average debt maturity was approximately 5.9 years as of September 30, 2022, compared to 6.4 years as of December 31, 2021. Segment Results for the third Quarter of 2022 North America Segment Our North America segment includes the United States and Canada. The following table presents revenues, expenses and profit for our North America segment for the three months ended September 30, 2022 and 2021: Three months ended September 30, 2022 2021 (U.S. $ in millions / % of Segment Revenues) Revenues $ 1,809 100% $ 1,875 100% Gross profit 942 52.1% 967 51.6% R&D expenses 111 6.1% 146 7.8% S&M expenses 232 12.8% 250 13.3% G&A expenses 122 6.8% 121 6.4% Other income § § (7) § Segment profit* $ 477 26.3% $ 458 24.4% * 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 2022 were $1,809 million, a decrease of $66 million, or 4%, compared to the third quarter of 2021, mainly due to a decrease in revenues from generic products, COPAXONE and BENDEKA and TREANDA, partially offset by higher revenues from AUSTEDO. On October 1, 2022, we discontinued marketing ProAir® HFA, while focusing our marketing efforts on albuterol sulfate inhalation aerosol (our ProAir authorized generic) and ProAir Digihaler® (albuterol sulfate 117 mcg). ProAir HFA and ProAir Digihaler results are included in “Other” in the revenues table below, and were not material during the third quarter of 2022. Revenues in the United States, our largest market, were $1,685 million in the third quarter of 2022, a decrease of $69 million or 4% compared to the third quarter of 2021. 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, 2022 and 2021: Three months ended September 30, Percentage Change 2022 2021 2022-2021 (U.S. $ in millions) Generic products $ 806 $ 859 (6%) AJOVY 57 46 23% AUSTEDO 260 201 30% BENDEKA/TREANDA 77 95 (20%) COPAXONE 105 133 (21%) Anda 371 363 2% Other 133 178 (25%) Total $ 1,809 $ 1,875 (4%) Generic products revenues in our North America segment (including biosimilars) in the third quarter of 2022 were $806 million, a decrease of 6% compared to the third quarter of 2021, mainly due to increased competition. In the third quarter of 2022, our total prescriptions were approximately 303 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions according to IQVIA data. AJOVY revenues in our North America segment in the third quarter of 2022 increased by 23% to $57 million, compared to the third quarter of 2021, mainly due to growth in volume. In the third quarter of 2022, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 25% compared to 21% in the third quarter of 2021. AUSTEDO revenues in our North America segment in the third quarter of 2022 increased by 30%, to $260 million, compared to $201 million in the third quarter of 2021, mainly due to growth in volume. BENDEKA and TREANDA combined revenues in our North America segment in the third quarter of 2022 decreased by 20% to $77 million, compared to the third quarter of 2021, mainly due to the availability of alternative therapies and intense competition in anticipation of the orphan drug exclusivity expiration in December 2022. COPAXONE revenues in our North America segment in the third quarter of 2022 decreased by 21% to $105 million, compared to the third quarter of 2021, mainly due to generic competition in the United States and a decrease in glatiramer acetate market share due to availability of alternative therapies. Anda revenues in our North America segment in the third quarter of 2022 increased by 2% to $371 million, compared to $363 million in the third quarter of 2021, mainly due to higher demand. North America Gross Profit Gross profit from our North America segment in the third quarter of 2022 was $942 million, a decrease of 3%, compared to $967 million in the third quarter of 2021. Gross profit margin for our North America segment in the third quarter of 2022 increased to 52.1%, compared to 51.6% in the third quarter of 2021. This increase was mainly due to a favorable change in the mix of products. 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 2022 was $477 million, an increase of 4% compared to $458 million in the third quarter of 2021, mainly due to a favorable change in the mix of products, cost efficiencies and lower R&D expenses, as discussed above. 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, 2022 and 2021: Three months ended September 30, 2022 2021 (U.S. $ in millions / % of Segment Revenues) Revenues $ 1,069 100% $ 1,220 100% Gross profit 634 59.3% 714 58.6% R&D expenses 44 4.1% 55 4.5% S&M expenses 169 15.8% 204 16.7% G&A expenses 61 5.7% 64 5.2% Other income § § (2) § Segment profit* $ 360 33.7% $ 394 32.3% ___________ * 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 Europe segment in the third quarter of 2022 were $1,069 million, a decrease of 12%, or $151 million, compared to the third quarter of 2021. In local currency terms, revenues increased by 1%, mainly due to higher demand for generic products, together with higher revenues from generic product launches. In the third quarter of 2022, our revenues were negatively impacted by exchange rate fluctuations of $162 million, net of hedging effects, compared to the third quarter of 2021. 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, 2022 and 2021: Three months ended September 30, Percentage Change 2022 2021 2022-2021 (U.S. $ in millions) Generic products $ 803 $ 895 (10%) AJOVY 30 23 31% COPAXONE 63 95 (34%) Respiratory products 62 85 (27%) Other 111 122 (9%) Total $ 1,069 $ 1,220 (12%) Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2022, decreased by 10% to $803 million, compared to the third quarter of 2021. In local currency terms, revenues increased by 5%, mainly due to higher demand for generic and OTC products, together with higher revenues from generic product launches. On August 29, 2022 the European Commission granted a marketing authorization for RANIVISIO® (ranibizumab), a biosimilar to Lucentis®, across all five indications in adults for which Lucentis® is authorized, including age-related macular degeneration (AMD) and four other ophthalmology indications. AJOVY revenues in our Europe segment in the third quarter of 2022 increased to $30 million, compared to $23 million in the third quarter of 2021, mainly due to growth in European countries in which AJOVY had previously been launched, as well as launches and reimbursements in additional European countries. COPAXONE revenues in our Europe segment in the third quarter of 2022 decreased by 34% to $63 million, compared to the third quarter of 2021. In local currency terms, revenues decreased by 23%, 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 2022 decreased by 27% to $62 million compared to the third quarter of 2021. In local currency terms, revenues decreased by 15%, mainly due to net price reductions and lower volumes. Europe Gross Profit Gross profit from our Europe segment in the third quarter of 2022 was $634 million, a decrease of 11% compared to $714 million in the third quarter of 2021, mainly due to exchange rate fluctuations. Gross profit margin for our Europe segment in the third quarter of 2022 increased to 59.3%, compared to 58.6% in the third quarter of 2021. This increase was mainly due to higher revenues from the positive impact of hedging activities discussed above, as well as lower cost of goods sold, mainly due to a better mix of products and decrease in write-offs. 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 2022 was $360 million, a decrease of 8%, compared to $394 million in the third quarter of 2021. This decrease was mainly due to exchange rate fluctuations. International Markets Segment Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics-oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan. In February 2022, Russia launched an invasion of Ukraine. As of the date of this press release, sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results. We have no manufacturing or R&D facilities in these markets. During the third quarter of 2022, the impact of this conflict on our International Markets segment results of operations and financial condition was immaterial. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2022 and 2021: Three months ended September 30, 2022 2021 (U.S. $ in millions / % of Segment Revenues) Revenues $ 475 100% $ 530 100% Gross profit 252 53.0% 296 55.9% R&D expenses 15 3.2% 16 3.0% S&M expenses 97 20.5% 102 19.2% G&A expenses 30 6.2% 29 5.4% Other income (2) § (2) § Segment profit* $ 112 23.5% $ 152 28.8% __________ * 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 2022 were $475 million, a decrease of 10% in U.S. dollars, or 3% in local currency terms compared to the third quarter of 2021. Revenues in the third quarter of 2021 included a milestone payment of $35 million received from Otsuka related to the launch of AJOVY in Japan. In the third quarter of 2022, revenues were negatively impacted by exchange rate fluctuations of $38 million, net of hedging effects, compared to the third quarter of 2021. Revenues in the third quarter of 2022 included $4 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 International Markets segment by major products and activities for the three months ended September 30, 2022 and 2021: Three months ended September 30, Percentage Change 2022 2021 2022-2021 (U.S. $ in millions) Generic products $ 393 $ 412 (5%) AJOVY 6 39 (85%) COPAXONE 9 10 (4%) Other 67 69 (2%) Total $ 475 $ 530 (10%) Generic products revenues in our International Markets segment in the third quarter of 2022, which include OTC products, decreased by 5% in U.S. dollars to $393 million. In local currency terms, revenues increased by 3% compared to the third quarter of 2021. This increase was mainly due to higher revenues in certain markets, as well as price increases largely as a result of rising costs due to inflationary pressure, partially offset by lower sales in Japan due to 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 2022 were $6 million, compared to $39 million in the third quarter of 2021. Revenues in the third quarter of 2021 included a milestone payment of $35 million received from Otsuka related to the launch of AJOVY in Japan. COPAXONE revenues in our International Markets segment in the third quarter of 2022 were $9 million compared to $10 million in the third quarter of 2021. AUSTEDO was launched in early 2021 in China for the treatment of chorea associated with Huntington's disease and for the treatment of tardive dyskinesia, and was also launched in Israel during 2021. During the third quarter of 2022, AUSTEDO was launched in Brazil. 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 2022 was $252 million, a decrease of 15% compared to $296 million in the third quarter of 2021. Gross profit margin for our International Markets segment in the third quarter of 2022 decreased to 53.0%, compared to 55.9% in the third quarter of 2021. This decrease was mainly due to the impact of a milestone payment of $35 million related to AJOVY in the third quarter of 2021 mentioned above, as well as regulatory price reductions and generic competition to off-patented products in Japan in the third quarter of 2022, partially offset by price increases largely as a result of rising costs due to inflationary pressure. 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 2022 was $112 million, a decrease of 27%, compared to $152 million in the third quarter of 2021. This decrease was mainly due to lower gross profit, as discussed above. Other Activities We have other sources of revenues, primarily the sale of active pharmaceutical ingredients ("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. Our revenues from other activities in the third quarter of 2022 were $241 million, a decrease of 8% compared to the third quarter of 2021. In local currency terms, revenues decreased by 3%. API sales to third parties in the third of 2022 were $149 million, a decrease of 7% in both U.S. dollars and local currency terms, compared to the third quarter of 2021. Outlook for 2022 Non-GAAP Results $ billions, except EPS November 2022 Outlook July 2022 Outlook 2021 Actual Revenues* 14.8 - 15.4 15.0 - 15.6 15.9 COPAXONE ($m)* ~700 ~700 1,005 AUSTEDO ($m)* ~1,000 ~1,000 808 AJOVY ($m)* ~400 ~400 313 Operating Income 4.2-4.5 4.2-4.5 4.4 Adjusted EBITDA 4.7-5.0 4.7-5.0 4.9 EPS ($) 2.40-2.60 2.40-2.60 2.58 Share Count 1,114 million shares 1,114 million shares 1,107 million shares Free Cash Flow 1.9 - 2.2 1.9 - 2.2 2.2 CAPEX* 0.5 0.5 0.6 Tax Rate 12% - 14% 13% - 14% 16.4% * Revenues and CAPEX presented on a GAAP basis. Conference Call Teva will host a conference call and live webcast including a slide presentation on Thursday, November 3, 2022, at 8:00 a.m. ET to discuss its third quarter 2022 results and overall business environment. A questions and answers 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 specialty 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 specialty and biopharmaceutical products. Learn more at . 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 EPS, non-GAAP operating income, non-GAAP gross profit, non-GAAP gross profit margin, Adjusted EBITDA, free cash flow, non-GAAP R&D expenses, non-GAAP S&M expenses, non-GAAP G&A expenses, non-GAAP financial expenses, non-GAAP income taxes, non-GAAP income (loss) before income taxes, non-GAAP tax rate, non-GAAP net income (loss), non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS are presented in order to facilitates 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 figures. 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 without unreasonable effort. 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. 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; consolidation 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 specialty products, 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; and the effectiveness of our patents and other measures to protect our intellectual property rights; 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: uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire 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 or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; 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 and our ability to reach a final resolution of the remaining opioid-related litigation, including to finalize settlement documentation and obtain sufficient participation of plaintiffs for the proposed nationwide settlement to take effect; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; environmental risks; and the impact of ESG issues; other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; the impact of other macroeconomic developments such as rising inflation and geopolitical conflicts including the ongoing conflict between Russia and Ukraine; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); 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 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Consolidated Statements of Income (U.S. dollars in millions, except share and per share data) Three months ended Nine months ended September 30, September 30, 2022 2021 2022 2021 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Net revenues 3,595 3,887 11,041 11,778 Cost of sales 1,926 2,093 5,839 6,234 Gross profit 1,669 1,794 5,203 5,544 Research and development expenses 175 222 628 723 Selling and marketing expenses 539 597 1,716 1,798 General and administrative expenses 283 291 892 822 Intangible assets impairments 24 21 223 295 Other asset impairments, restructuring and other items 36 62 282 227 Goodwill impairment - - 745 - Legal settlements and loss contingencies 195 3 2,048 113 Other income (2 ) (25 ) (88 ) (73 ) Operating income (loss) 419 623 (1,244 ) 1,638 Financial expenses, net 252 241 721 805 Income (loss) before income taxes 166 382 (1,964 ) 833 Income taxes (benefit) 107 76 (792 ) 235 Share in (profits) losses of associated companies, net 1 5 (20 ) (9 ) Net income (loss) 58 302 (1,152 ) 608 Net income (loss) attributable to non-controlling interests 3 11 (21 ) 32 Net income (loss) attributable to Teva 56 292 (1,132 ) 576 Earnings (loss) per share attributable to Teva: Basic ($) 0.05 0.26 (1.02 ) 0.52 Diluted ($) 0.05 0.26 (1.02 ) 0.52 Weighted average number of shares (in millions): Basic 1,111 1,103 1,109 1,102 Diluted 1,119 1,109 1,109 1,109 Non-GAAP net income attributable to Teva:* 658 651 2,021 2,001 Non-GAAP net income attributable to Teva for diluted earnings per share: 658 651 2,021 2,001 Non-GAAP earnings per share attributable to Teva:* Basic ($) 0.59 0.59 1.82 1.82 Diluted ($) 0.59 0.59 1.81 1.81 Non-GAAP average number of shares (in millions): Basic 1,111 1,103 1,109 1,102 Diluted 1,119 1,109 1,114 1,109 * See reconciliation attached. Condensed Consolidated Balance Sheets (U.S. dollars in millions) September 30, December 31, 2022 2021 ASSETS (Unaudited) (Audited) Current assets: Cash and cash equivalents 2,225 2,165 Accounts receivables, net of allowance for credit losses of $94 million and $90 million as of September 30, 2022 and December 31, 2021. 3,730 4,529 Inventories 3,859 3,818 Prepaid expenses 1,045 1,075 Other current assets 579 965 Assets held for sale 16 19 Total current assets 11,453 12,573 Deferred income taxes 1,546 596 Other non-current assets 438 515 Property, plant and equipment, net 5,568 5,982 Operating lease right-of-use assets 422 495 Identifiable intangible assets, net 6,393 7,466 Goodwill 18,433 20,040 Total assets 44,252 47,666 LIABILITIES & EQUITY Current liabilities: Short-term debt 2,769 1,426 Sales reserves and allowances 3,648 4,241 Accounts payables 1,635 1,686 Employee-related obligations 496 563 Accrued expenses 2,041 2,208 Other current liabilities 945 903 Total current liabilities 11,534 11,027 Long-term liabilities: Deferred income taxes 503 784 Other taxes and long-term liabilities 3,846 2,578 Senior notes and loans 18,497 21,617 Operating lease liabilities 354 416 Total long-term liabilities 23,200 25,395 Equity: Teva shareholders’ equity 8,767 10,278 Non-controlling interests 751 966 Total equity 9,519 11,244 Total liabilities and equity 44,252 47,666 TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in millions) (Unaudited) Nine months ended Three months ended September 30, September 30, 2022 2021 2022 2021 Operating activities: Net income (loss) $ (1,152 ) $ 608 $ 58 $ 302 Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 1,002 1,010 321 329 Impairment of goodwill, long-lived assets and assets held for sale 1,002 401 28 47 Net change in operating assets and liabilities 1,007 (1,881 ) 93 (202 ) Deferred income taxes – net and uncertain tax positions (1,214 ) 13 44 8 Stock-based compensation 88 86 26 26 Other items (117 ) (4 ) (40 ) 3 Net loss (gain) from investments and from sale of long lived assets 1 109 13 16 Net cash provided by (used in) operating activities 617 342 543 529 Investing activities: Beneficial interest collected in exchange for securitized accounts receivables 854 1,278 262 397 Purchases of property, plant and equipment (406 ) (409 ) (122 ) (146 ) Proceeds from sale of business and long-lived assets 45 269 2 15 Acquisition of businesses, net of cash acquired (7 ) - - - Proceeds from sale of investments 4 172 1 19 Purchases of investments and other assets (2 ) (36 ) 2 2 Other investing activities - 3 2 1 Net cash provided by (used in) investing activities 488 1,277 147 288 Financing activities: Redemption of convertible senior notes - (491 ) - - Proceeds from short term debt - 500 - 500 Repayment of short term debt - (200 ) - (200 ) Repayment of senior notes and loans (661 ) (1,475 ) (365 ) (1,475 ) Other financing activities (115 ) (5 ) (75 ) (2 ) Net cash provided by (used in) financing activities (776 ) (1,671 ) (439 ) (1,177 ) Translation adjustment on cash and cash equivalents (269 ) (80 ) (84 ) (31 ) Net change in cash, cash equivalents and restricted cash 60 (132 ) 167 (391 ) Balance of cash, cash equivalents and restricted cash at beginning of period. 2,198 2,177 2,091 2,436 Balance of cash, cash equivalents and restricted cash at end of period $ 2,258 $ 2,045 $ 2,258 $ 2,045 Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets: Cash and cash equivalents 2,225 2,045 2,225 2,045 Restricted cash included in other current assets 33 - 33 - Total cash, cash equivalents and restricted cash shown in the statements of cash flows 2,258 2,045 2,258 2,045 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables $ 883 $ 1,310 $ 293 $ 432 Three Months Ended September 30, 2022 U.S. $ and shares in millions (except per share amounts) GAAP Excluded for non-GAAP measurement Non-GAAP Amortization of purchased intangible assets Legal settlements and loss contingencies Impairment of long lived assets Restructuring costs Costs related to regulatory actions taken in facilities Equity compensation Contingent consideration Accelerated Depreciation Other non- GAAP items* Other items R&D expenses 175 4 171 S&M expenses 539 20 7 2 510 G&A expenses 283 9 1 23 250 Other (income) expense (2 ) (2 ) Financial expenses, net 252 14 238 Income taxes 107 33 74 Share in (profit) losses of associated companies – net 1 - 1 Gross profit 1,669 145 - - - 2 5 - 44 41 - 1,906 Gross profit margin 46.4 % 53.0 % Operating income (loss) 419 165 195 28 25 2 26 6 45 68 - 977 Net income (loss) attributable to Teva 56 165 195 28 25 2 26 6 45 68 43 658 EPS - Diluted 0.05 0.15 0.17 0.02 0.02 § 0.02 0.01 0.04 0.06 0.04 0.59 The non-GAAP diluted weighted average number of shares was 1,119 million for the three months ended September 30, 2022. Non-GAAP income taxes for the three months ended September 30, 2022 were 10% on pre-tax non-GAAP income. * 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, material litigation fees and other unusual events. § Represents an amount less than $0.01 Adjusted EBITDA reconciliation Net income (loss) 58 Add: Financial expenses 252 Share in losses of associated companies- net 1 Income taxes 107 Depreciation 156 Amortization 165 EBITDA 740 Legal settlements and loss contingencies 195 Impairment of long lived assets 28 Restructuring costs 25 Costs related to regulatory actions taken in facilities 2 Equity compensation 26 Contingent consideration 6 Other non-GAAP items * 68 Adjusted EBITDA 1,089 * Includes other items primarily related to the rationalization of our plants, material litigation fees and other exceptional events Nine Months Ended September 30, 2022 U.S. $ and shares in millions (except per share amounts) GAAP Excluded for non-GAAP measurement Non-GAAP Amortization of purchased intangible assets Legal settlements and loss contingencies Goodwill impairment Impairment of long- lived assets Restructuring costs Costs related to regulatory actions taken in facilities Equity compensation Contingent consideration Accelerated depreciation Other non- GAAP items* Other items R&D expenses 628 14 614 S&M expenses 1,716 63 23 5 1,625 G&A expenses 892 35 1 96 760 Other (income) expense (88 ) (31 ) (57 ) Financial expenses, net 721 48 673 Income taxes (792 ) ** (1,072 ) 280 Share in (profit) losses of associated companies – net (20 ) (22 ) 2 Gross profit 5,203 513 - - - - 6 16 - 77 136 - 5,951 Gross profit margin 47.1 % 53.9 % Operating income (loss) (1,244 ) 576 2,048 745 257 117 6 88 100 78 237 - 3,010 Net income (loss) attributable to Teva (1,132 ) 576 2,048 745 257 117 6 88 100 78 237 (1,101 ) 2,021 EPS - Diluted (1.02 ) 0.52 1.84 0.67 0.23 0.10 0.01 0.08 0.09 0.07 0.20 (0.99 ) 1.81 The non-GAAP diluted weighted average number of shares was 1,114 million for the nine months ended September 30, 2022. Non-GAAP income taxes for the nine months ended September 30, 2022 were 12% on pre-tax non-GAAP income. * 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, material litigation fees and other unusual events. ** 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 Adjusted EBITDA reconciliation Net income (loss) (1,152 ) Add: Financial expenses 721 Income taxes (792 ) Share in profits of associated companies- net (20 ) Depreciation 426 Amortization 576 EBITDA (241 ) Legal settlements and loss contingencies 2,048 Goodwill impairment 745 Impairment of long lived assets 257 Restructuring costs 117 Costs related to regulatory actions taken in facilities 6 Equity compensation 88 Contingent consideration 100 Other non-GAAP items* 237 Adjusted EBITDA 3,358 * Includes other items primarily related to the rationalization of our plants, material litigation fees and other exceptional events Three Months Ended September 30, 2021 U.S. $ and shares in millions (except per share amounts) GAAP Excluded for non-GAAP measurement Non-GAAP Amortization of purchased intangible assets Legal settlements and loss contingencies Impairment of long lived assets Restructuring costs Costs related to regulatory actions taken in facilities Equity compensation Contingent consideration Other non- GAAP items* Other items R&D expenses 222 4 217 S&M expenses 597 24 7 567 G&A expenses 291 10 6 275 Other (income) expense (25 ) (7 ) (18 ) Financial expenses, net 241 6 235 Income taxes 76 (62 ) 137 Share in (profit) losses of associated companies – net 5 § 4 Gross profit 1,794 175 - - - 5 5 - 104 - 2,083 Gross profit margin 46.2 % 53.6 % Operating income (loss) 623 199 3 47 28 5 26 9 103 - 1,042 Net income (loss) attributable to Teva 292 199 3 47 28 5 26 9 103 (60 ) 651 EPS - Diluted 0.26 0.18 § 0.04 0.03 § 0.02 0.01 0.09 (0.05 ) 0.59 The non-GAAP diluted weighted average number of shares was 1,109 million for the three months ended September 30, 2021. Non-GAAP income taxes for the three months ended September 30, 2021 were 17% on pre-tax non-GAAP income. * 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 and other unusual events. § Represents an amount less than $0.01 Adjusted EBITDA reconciliation Net income (loss) 302 Add: Financial expenses 241 Share in losses of associated companies- net 5 Income taxes 76 Depreciation 132 Amortization 199 EBITDA 954 Legal settlements and loss contingencies 3 Impairment of long lived assets 47 Restructuring costs 28 Costs related to regulatory actions taken in facilities 5 Equity compensation 26 Contingent consideration 9 Other non-GAAP items (excluding accelerated depreciation of $4 million)* 99 Adjusted EBITDA 1,170 * Includes other items primarily related to the rationalization of our plants and other exceptional events Nine months ended September 30, 2021 U.S. $ and shares in millions (except per share amounts) GAAP Excluded for non-GAAP measurement Non-GAAP Amortization of purchased intangible assets Legal settlements and loss contingencies Impairment of long- lived assets Restructuring costs Costs related to regulatory actions taken in facilities Equity compensation Contingent consideration Other non- GAAP items* Other items R&D expenses 723 14 5 704 S&M expenses 1,798 76 24 1,698 G&A expenses 822 31 7 785 Other (income) expense (73 ) (44 ) (29 ) Financial expenses, net 805 104 701 Income taxes 235 (182 ) 417 Share in (profit) losses of associated companies – net (9 ) (1 ) (8 ) Gross profit 5,544 538 - - - 17 17 - 195 - 6,311 Gross profit margin 47.1 % 53.6 % Operating income (loss) 1,638 613 113 401 96 17 86 (7 ) 194 - 3,153 Net income (loss) attributable to Teva 576 613 113 401 96 17 86 (7 ) 194 (90 ) 2,001 EPS - Diluted 0.52 0.55 0.10 0.36 0.09 0.02 0.08 (0.01 ) 0.19 (0.08 ) 1.81 The non-GAAP diluted weighted average number of shares was 1,109 million for the nine months ended September 30, 2021. Non-GAAP income taxes for the nine months ended September 30, 2021 were 17% on pre-tax non-GAAP income. * 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 and other unusual events. Adjusted EBITDA reconciliation Net income (loss) 608 Add: Financial expenses 805 Share in profits of associated companies- net (9 ) Income taxes 235 Depreciation 398 Amortization 613 EBITDA 2,650 Legal settlements and loss contingencies 113 Impairment of long lived assets 401 Restructuring costs 96 Costs related to regulatory actions taken in facilities 17 Equity compensation 86 Contingent consideration (7 ) Other non-GAAP items (excluding accelerated depreciation of $13 million)* 181 Adjusted EBITDA 3,538 * Includes other items primarily related to the rationalization of our plants and other exceptional events Segment Information North America Europe International Markets Three months ended September 30, Three months ended September 30, Three months ended September 30, 2022 2021 2022 2021 2022 2021 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues $ 1,809 $ 1,875 $ 1,069 $ 1,220 $ 475 $ 530 Gross profit 942 967 634 714 252 296 R&D expenses 111 146 44 55 15 16 S&M expenses 232 250 169 204 97 102 G&A expenses 122 121 61 64 30 29 Other income § (7 ) § (2 ) (2 ) (2 ) Segment profit $ 477 $ 458 $ 360 $ 394 $ 112 $ 152 § 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, 2022 2021 2022 2021 2022 2021 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues $ 5,450 $ 5,807 $ 3,396 $ 3,618 $ 1,422 $ 1,505 Gross profit 2,841 3,081 2,031 2,063 780 826 R&D expenses 401 467 157 184 54 51 S&M expenses 733 734 561 628 293 303 G&A expenses 361 338 183 180 89 79 Other income (12 ) (14 ) (1 ) (3 ) (43 ) (5 ) Segment profit $ 1,359 $ 1,556 $ 1,130 $ 1,074 $ 386 $ 398 Reconciliation of our segment profit to consolidated income before income taxes Three months ended September 30, 2022 2021 (U.S.$ in millions) North America profit $ 477 $ 458 Europe profit 360 394 International Markets profit 112 152 Total reportable segment profit 949 1,004 Profit of other activities 29 38 Total segment profit 977 1,042 Amounts not allocated to segments: Amortization 165 199 Other asset impairments, restructuring and other items 36 62 Intangible asset impairments 24 21 Legal settlements and loss contingencies 195 3 Other unallocated amounts 139 134 Consolidated operating income (loss) 419 623 Financial expenses - net 252 241 Consolidated income (loss) before income taxes $ 166 $ 382 Reconciliation of our segment profit to consolidated income before income taxes Nine months ended September 30, 2022 2021 (U.S.$ in millions) North America profit $ 1,359 $ 1,556 Europe profit 1,130 1,074 International Markets profit 386 398 Total reportable segment profit 2,875 3,028 Profit of other activities 135 125 Total segment profit 3,010 3,153 Amounts not allocated to segments: Amortization 576 613 Other asset impairments, restructuring and other items 282 227 Goodwill impairment 745 - Intangible asset impairments 223 295 Legal settlements and loss contingencies 2,048 113 Other unallocated amounts 379 266 Consolidated operating income (loss) (1,244 ) 1,638 Financial expenses - net 721 805 Consolidated income (loss) before income taxes $ (1,964 ) $ 833 Segment revenues by major products and activities (Unaudited) Three months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) North America segment Generic products $ 806 $ 859 (6 %) AJOVY 57 46 23 % AUSTEDO 260 201 30 % BENDEKA/TREANDA 77 95 (20 %) COPAXONE 105 133 (21 %) Anda 371 363 2 % Other 133 178 (25 %) Total 1,809 1,875 (4 %) Three months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) Europe segment Generic products $ 803 $ 895 (10 %) AJOVY 30 23 31 % COPAXONE 63 95 (34 %) Respiratory products 62 85 (27 %) Other 111 122 (9 %) Total 1,069 1,220 (12 %) Three months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) International Markets segment Generic products $ 393 $ 412 (5 %) AJOVY 6 39 (85 %) COPAXONE 9 10 (4 %) Other 67 69 (2 %) Total 475 530 (10 %) Revenues by Activity and Geographical Area (Unaudited) Nine months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) North America segment Generic products $ 2,731 $ 2,864 (5 %) AJOVY 142 123 16 % AUSTEDO 618 520 19 % BENDEKA / TREANDA 241 292 (17 %) COPAXONE 285 448 (36 %) Anda 1,021 968 5 % Other 411 592 (31 %) Total 5,450 5,807 (6 %) Nine months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) Europe segment Generic products $ 2,552 $ 2,637 (3 %) AJOVY 90 58 55 % COPAXONE 207 296 (30 %) Respiratory products 198 263 (25 %) Other 349 364 (4 %) Total 3,396 3,618 (6 %) Nine months ended September 30, Percentage Change 2022 2021 2021-2022 (U.S.$ in millions) International Markets segment Generic products $ 1,175 $ 1,211 (3 %) AJOVY 22 46 (51 %) COPAXONE 29 29 1 % Other 195 219 (11 %) Total 1,422 1,505 (6 %) Free cash flow reconciliation (Unaudited) Three months ended September 30, 2022 2021 (U.S. $ in millions) Net cash provided by (used in) operating activities 543 529 Beneficial interest collected in exchange for securitized trade receivables 262 397 Purchases of property, plant and equipment (122 ) (146 ) Proceeds from sale of business and long lived assets 2 15 Free cash flow $ 685 $ 795 Free cash flow reconciliation (Unaudited) Nine months ended September 30, 2022 2021 (U.S. $ in millions) Net cash provided by (used in) operating activities 617 342 Beneficial interest collected in exchange for securitized accounts receivables 854 1,278 Purchases of property, plant and equipment (406 ) (409 ) Proceeds from sale of business and long lived assets 45 269 Acquisition of businesses, net of cash acquired (7 ) - Free cash flow $ 1,103 $ 1,479