A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.

Start Date01 Sep 2025

Sponsor / Collaborator

University Hospital of Montpellier

NCT05344469

/ Active, not recruitingNot Applicable

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable Disease-modifying Therapy (DMT) for Relapsing Multiple Sclerosis in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to approx. two years of treatment. Additionally, medical history of participants will be collected including disease duration, EDSS, MRI parameters and relapses.

Start Date10 May 2022

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05688436

/ RecruitingNot Applicable

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:
* Those who took DRF during their pregnancy
* Those who took other drugs for RMS during their pregnancy, but not DRF
* Those who did not take any drugs for RMS during their pregnancy
The main question researchers want to learn about in this study is:
• How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.
Researchers will also learn more about:
* Loss of the baby before 20 weeks of pregnancy
* Loss of the baby at and after 20 weeks of pregnancy
* How many babies are born early (at or before 37 weeks)
* How many babies are small for their age while in the participant's uterus
* How many babies are born with any sign of life
This study will be done as follows:
* Participants with RMS can join this study if they become pregnant from 29th October 2019 to 31st July 2030. Information will start being collected when the participant decides to join the study.
* The participants' medical records will be reviewed 2 times during the study - once when the study is halfway done, and one at the end of the study.
* Each participant will be in the study until the end of their pregnancy. Each baby will be in the study for up to 1 year after birth.
* The study is planned to end by 30th April 2031.

Start Date24 Sep 2021

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Glatiramer Acetate

100 Translational Medicine associated with Glatiramer Acetate

100 Patents (Medical) associated with Glatiramer Acetate

1,959

Literatures (Medical) associated with Glatiramer Acetate

01 Jan 2026·Multiple Sclerosis and Related Disorders

Sex differences in multiple sclerosis treatment with disease modifying drugs: a step towards gender neurology

Article

Author: Vaccaro, Marco ; Salemi, Giuseppe ; Ragonese, Paolo ; Baiamonte, Ludovico ; Enea, Marco

INTRODUCTION:

Multiple sclerosis (MS) is an immune-mediated demyelinating disorder of the central nervous system. Relevant differences between men and women are known in MS epidemiology, disease course, clinical manifestations and instrumental findings. However, differences in response to disease-modifying treatments (DMTs) have been rarely assessed.

METHODS:

We performed a registry-based study on patients of our reference center in Palermo, Italy. Only patients with relapsing-remitting course or clinically isolated syndrome were included. Efficacy endpoints we considered were confirmed disease progression risk, first relapse risk and magnetic resonance imaging active lesion risk during treatment with each DMT. An exploratory analysis on annualized relapse risk was also performed. For safety analysis, withdrawal due to adverse events was considered. Cox multivariable survival analysis was performed to assess the impact of sex on each endpoint.

RESULTS:

one thousand eight hundred five records were retrieved. However, due to low sample size, only data regarding some drugs (dimethylfumarate, glatiramer acetate, beta interferon and partially natalizumab and S1PR modulators) were analyzed. No significant differences between the two sexes were found for efficacy endpoints. Men showed a significantly lower risk of withdrawal from glatiramer acetate due to adverse events than women (p = 0.002, hazard ratio 0.32, 95 %confidence interval 0.16-0.65); dyspnea was the most frequent cause of interruption in both sexes.

DISCUSSION AND CONCLUSION:

Our results show limited differences in response to DMTs between men and women for the drugs we took into account. Interpretation of these findings is challenging due to limited evidence available about this topic and to sexual dysmorphism involving many aspects of the disease. Small sample size, preventing the analysis of other DMTs (especially high-efficacy ones) and disease courses, is the main limit of this study. Further evidence will be needed in the future.

01 Jan 2026·CLINICAL THERAPEUTICS

Assessing the Role of Cannabis in Managing Spasticity in Multiple Sclerosis: A Systematic Review and Meta-Analysis

Review

Author: AlHabil, Yazan ; Saadeddin, Liza ; Alqam, Mariam ; Bahbah, Anita ; Mosa, Hanadi ; Yacoub, Hamzeh ; Yasin, Diana ; Hossoon, Obada ; Hameedi, Seema ; Oweidat, Majd ; Ishkirat, Hana

BACKGROUND:

Multiple sclerosis (MS) is a complex, heterogeneous disease, and its management remains challenging due to varying symptoms and patient responses to treatments. While injectable therapies like glatiramer acetate and beta-interferon are common, they have limitations such as side effects and varying efficacy. Cannabis has garnered attention as a potential alternative treatment, particularly for symptoms like spasticity and pain.

OBJECTIVE:

This study aims to evaluate the efficacy of cannabis-based therapies for managing MS-related spasticity.

METHODS:

Nine clinical trials involving 2544 MS patients were included, with studies conducted between 2003 and 2021 across multiple countries. Cannabinoid therapies studied included whole-plant extracts, oils, and smoked cannabis containing delta-9-tetrahydrocannabinol and/or cannabidiol. Spasticity was assessed using standardized scales, including the Ashworth scale (AS), visual analog scale, and numeric rating scale (NRS). Effect sizes were pooled using random or fixed effects models, and heterogeneity and publication bias were evaluated using I², Tau², and funnel plots.

RESULTS:

The overall meta-analysis revealed a standardized mean difference (MD) of 39.19 (95% CI: 34.32-44.05) in spasticity scores, indicating notable improvement post-treatment. Subgroup analyses showed a MD of 20.36 (95% CI: 20.35-20.37) for AS and 1.18 (95% CI: 1.16-1.21) for NRS. However, substantial heterogeneity (I² = 100% for overall and AS analyses; 91% for NRS) and asymmetry in funnel plots suggest possible publication bias and study variability. Short-term studies demonstrated modest changes (MD = 4.53, 95% CI: -0.06 to 9.12), while long-term studies yielded larger effects (MD = 75.81, 95% CI: 66.39-85.22). Adverse events were generally mild, including dizziness and dry mouth.

CONCLUSION:

Cannabis-based therapies are associated with clinically meaningful improvements in MS-related spasticity, particularly over longer durations. Despite the promising findings, high heterogeneity and suspected bias necessitate caution. Further high-quality randomized trials with standardized protocols and comprehensive safety assessments are warranted to validate efficacy and long-term outcomes.

01 Dec 2025·INFLAMMOPHARMACOLOGY

Multiple sclerosis pathophysiology: a comprehensive review of genetic, environmental, and immunological drivers

Review

Author: Najmuldeen, Hastyar H ; Mustafa, Fryad S ; Jalal, Paywast J ; Mohammed, Sewara J ; Ghafoor, Dlzar D ; Al-Bajalan, Sarwer J ; Zangana, Bahashty A ; Alghofaili, Fayez ; Ahmad, Dlshad O

Multiple sclerosis (MS) is a complex, chronic neuroinflammatory and neurodegenerative disorder of the central nervous system. This comprehensive review synthesizes evidence to argue that the paramount challenge in MS is bridging the disconnect between anti-inflammatory therapies and ineffective neuroprotective strategies, necessitating a dual-target approach. The paper discusses the crucial roles of genetic predisposition, highlighting the HLA-DRB1*15:01 allele and other non-HLA loci, and environmental triggers, such as Epstein-Barr virus infection, vitamin D deficiency, and smoking. We detail the dysregulation of both T-cells (Th1 and Th17 subsets) and B-cells in the autoimmune attack on myelin, as well as the intricate mechanisms of neurodegeneration, axonal damage, and the challenges of remyelination. The review also incorporates emerging insights into the role of the gut microbiome and epigenetic modifications, underscoring the necessity of an integrative model to understand MS pathogenesis. Ultimately, this review provides a foundational understanding of converging biological drivers of MS. Therapeutically, currently approved disease-modifying therapies (DMTs)-including interferon-β, glatiramer acetate, oral S1P modulators, fumarates, teriflunomide, cladribine, natalizumab, and anti-CD20 monoclonals-reduce relapse frequency and MRI activity but do not eliminate disability progression, particularly in progressive MS. Acute relapses are treated with high-dose corticosteroids, with plasma exchange reserved for steroid-refractory cases. We therefore argue that future success requires integrated strategies that couple sustained control of peripheral inflammation with CNS-intrinsic neuroprotection and remyelination. Therapeutically, modern disease-modifying therapies (interferon-β, glatiramer acetate, oral S1P modulators, fumarates, teriflunomide, cladribine, natalizumab, anti-CD20 monoclonals including ocrelizumab, ofatumumab, and ublituximab) reduce relapse rates and MRI activity yet do not consistently prevent disability progression-particularly in non-active progressive MS. Acute relapses are treated with high-dose corticosteroids; plasma exchange is reserved for steroid-refractory attacks. These realities motivate mechanism-informed strategies that pair sustained immune control with CNS-intrinsic neuroprotection and remyelination.

144

News (Medical) associated with Glatiramer Acetate

16 Jan 2026

·www.fiercepharma.com

JPM26: What’s in a biopharma? CEO says Teva has the goods

Richard Francis headed to Teva to right the ship in 2022. Three years into his strategy shift, the CEO says that the company is stepping into a starring role as an innovative biopharma company. In 2023, Teva made a pledge to bolster its innovative medicines portfolio without leaving behind its century-long legacy as a leading generics drugmaker. Now with its innovative drug franchise increasingly coming into its own, the Israeli drugmaker is eager to showcase itself as a formidable biopharma company.To hear CEO Richard Francis tell it, “we are there,“ he said in an interview on the sidelines of the J.P. Morgan Healthcare Conference. Give it 18 months and a few more data drops, and “we’ll be there in everyone’s eyes,” according to the CEO.Francis was referring to the “biopharma identity“ that Teva is looking to step into. Under its ongoing "Pivot to Growth" strategy shift, the company is well on track to claim the title of “innovative biopharma company“ in 2027 before evolving further to become a “leading biopharma“ in 2030, Teva laid out in its Jan. 13 JPM presentation (PDF). Based on “the fundamentals” that define a biopharma company—namely, an innovative pipeline and a portfolio driving “significant growth”—Teva meets the requirements to be considered an innovative drugmaker, Francis said. In fact, the company's JPM presentation contends that several facets of its business make Teva “more attractive” than other large biopharma companies.To put it another way, “if they look like a biopharma company, act like a biopharma company, have the numbers of a biopharma company, have a pipeline of a biopharma company … then maybe they’re a biopharma company,” Francis mused. One example the CEO listed was Teva’s Jan. 11 deal with Royalty Pharma. The exchange saw Royalty handing over up to $500 million to help along the development of Teva’s TEV-‘408 in vitiligo, with the first $75 million tranche funding a phase 2b study.Royalty is known for helping fund promising assets in exchange for royalty commitments, but these deals typically occur closer to the regulatory finish line. The company has rarely inked such deals this early on in development, Francis said, suggesting that for a company whose entire purpose is to invest in biopharma, Royalty’s multimillion-dollar commitment to Teva's in-house asset speaks for itself. Becoming an innovative biopharma companyTeva first broke from its prior reliance on generic medicines in the late 1990s with the launch of its multiple sclerosis med Copaxone. Today, the company’s innovative drug portfolio centers on migraine med Ajovy, long-acting schizophrenia med Uzedy and tardive dyskinesia treatment Austedo.Each has posted significant gains since 2022, Teva noted in its presentation, with Austedo sales more than doubling over that timeframe, Uzedy becoming the “fastest-growing antipsychotic” in the market and Ajovy holding a leading position in certain markets, according to the company.If all goes according to plan, Teva will add to its lineup of marketed new therapies yearly for the next five to seven years, save for the “odd gap” here and there, Francis said. It’s an “incredible” feat for a company of its size, he said. This year in particular may be when “people start to highlight that we have a really exciting, innovative portfolio in the market that’s growing rapidly.”One major goalpost this year is the planned rollout of long-acting schizophrenia med olanzapine, which will join Uzedy to form a powerhouse long-acting franchise that could generate between $1.5 billion and $2 billion at peak, according to Teva. The company is already undergoing launch preparations after submitting its FDA approval bid last year, according to the presentation.The other side of the “Pivot to Growth“ plan was to “go big” into biosimilars, the CEO said. The biosimilar market requires an understanding of the “very fragmented” U.S. healthcare system, Francis explained, but “I think we’ve cracked that.”Teva plans to launch a handful of biosimilars nearly every year “for the foreseeable future,” according to Francis. By 2027, the company expects its biosimilar sales to reach $800 million, or about double its biosim sales haul from 2024. Teva's “Pivot to Growth“ strategy isn’t nearly over yet, and neither are Francis’ internal goals for the company. To Francis, the ultimate measure of his success as a leader will be if he can leave the company better than he found it, beyond the metrics of revenue and valuation (although grown in these areas are certainly part of the plan, too).When he joined, he was met with a team that was “demotivated” and “worked really hard just to stay afloat,” the CEO said.“The biggest responsibility I felt was ‘I need to make sure that never happens again,’” he said. “I want them to be proud again.”

Phase 2

05 Jan 2026

·www.prnewswire.com

ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis

TAINAN, Jan. 5, 2026 /PRNewswire/ -- ScinoPharm Taiwan (TWSE: 1789) today announced a landmark achievement in the global pharmaceutical landscape, securing U.S. Food and Drug Administration (FDA) approval for Glatiramer Acetate Injection, a treatment for Multiple Sclerosis (MS), making it the only pharmaceutical company in Taiwan to achieve this historic milestone. This achievement underscores ScinoPharm's leadership in complex generics and highlights Taiwan's growing recognition as a trusted contributor to the global pharmaceutical industry. Multiple Sclerosis affects approximately 2.9 million people worldwide. According to the U.S. National MS Society, there are nearly 1 million patients in the United States alone. Verified Market Reports estimates that the global market size for Glatiramer Acetate was USD 1.5 billion in 2024 and is projected to reach USD 2.8 billion by 2033. In response to this significant opportunity, ScinoPharm has invested heavily in its process development and manufacturing capabilities, successfully mastering this high-barrier process after years of dedicated R&D and ultimately positioning itself to compete in its USD ~700 million U.S. market. Pioneering R&D: ScinoPharm Scientists Decode the Complexity of Glatiramer Acetate Manufacturing Since its approval in 1996, Glatiramer Acetate (GA) has been recognized as one of the most challenging complex synthetic polypeptides globally. To address the unique nature of such products, the U.S. FDA even established a dedicated regulatory pathway for Non-Biological Complex Drugs (NBCDs). Unlike conventional small molecules, GA is not a single defined entity but a peptide copolymer mixture composed of millions of polypeptide chains with varying lengths and amino acid sequences. It lacks a fixed molecular structure, a specific sequence, and a uniform molecular weight, so it cannot be fully characterized using standard analytical methods typically applied to biologics such as monoclonal antibodies. This complexity results in significant challenges for quality control, manufacturing reproducibility, and equivalence assessment. Due to the inherent diversity generated through the random copolymerization of amino acids, the final product may contain countless potential variants. Therefore, manufacturers must thoroughly validate the consistency and stability of all process parameters. More than 40 advanced analytical techniques, supported by statistical modeling, are required to establish product equivalence with biological activity assays necessary to confirm that the final product is indeed comparable to the reference listed drug (Teva Pharmaceutical's Copaxone®). Even today, only a handful of companies worldwide possess the scientific and manufacturing capabilities required to produce and commercialize Glatiramer Acetate. Leveraging its integrated strengths in R&D, manufacturing, and advanced analytical capabilities, ScinoPharm has taken the lead in Taiwan by successfully obtaining U.S. FDA approval for this product. This achievement not only underscores ScinoPharm's world-class innovation capabilities, but also validates its competitiveness alongside leading global pharmaceutical companies in a multibillion-dollar market, injecting powerful momentum into the company's global expansion and sustained growth. Vision for the Future: Beyond the U.S. Horizon While the U.S. FDA approval marks a historic first, ScinoPharm is already executing its next phase of global growth. The company is actively advancing regulatory submissions and forging strategic partnerships across Europe, Asia, and emerging markets to broaden its international presence in the generic drug product market and build on its already strong position on the generic API front. Guided by its mission—"We apply our expertise with rigorous standards and continuous improvements to deliver safe, effective, and high-quality medicines."—the company will continue transforming scientific innovation into meaningful outcomes for patients worldwide. SOURCE ScinoPharm Taiwan Ltd. 21% more press release views with Request a Demo

Drug Approval

05 Nov 2025

·www.globenewswire.com

Teva's Innovative Portfolio Drives 11th Consecutive Quarter of Growth in Q3 2025; Increases 2025 Outlook for Austedo® and Non-GAAP EPS

For an accessible version of this Press Release, please visit www.tevapharm.com Teva reports revenues of $4.5 billion in the third quarter of 2025, an increase of 3% year-over-year (YoY) in U.S. dollars or 1% in local currency (LC). Excluding Japan BV in Q3 2024, revenues increased 5% in U.S. dollars or 3% in LC. United States segment increased by 12%; Europe segment decreased by 10% in LC; and International Markets segment decreased by 10% in LC, or increased by 2% in LC excluding Japan BV in Q3 2024, all compared to the third quarter of 2024.GAAP operating income margin of 19.7% and non-GAAP operating income margin of 28.9% (+86 bps YoY), driven by our key innovative brands’ growth. On track for non-GAAP operating profit margin target of 30% by 2027, in line with our Pivot to Growth Strategy.Key Innovative brands continue to drive growth, with revenues +33% YoY in LC to $830 million, and to provide value to diverse and critical patient populations: AUSTEDO® – shows continued strong growth with global revenues of $618 million in Q3 2025 (+38% in LC YoY); led by U.S. revenue growth (+38% YoY). Increasing AUSTEDO 2025 revenue outlook by $50 million - $100 million to a new range of $2,050 million - $2,150 million. Inflation Reduction Act (IRA) price-setting reinforces confidence in our long-term outlook; on track for 2027 revenue target of >$2.5 billion and beyond 2027 peak year revenue target of >$3 billion. AJOVY® – global revenues of $168 million (+19% LC YoY). Reaffirming 2025 revenue outlook of $630 million - $640 million.UZEDY® – revenues of $43 million (+24% YoY). Reaffirming 2025 revenue outlook of $190 million - $200 million and long-term LAI schizophrenia franchise expectations of $1.5 billion - $2.0 billion, including olanzapine LAI, subject to regulatory approvals. Generics portfolio shows stable growth: Global generics increased by 2% year-over-year in the third quarter of 2025 in LC excluding Japan BV in Q3 2024; launch of liraglutide injection (the generic version of Saxenda®), the first-ever generic GLP-1 treatment for weight loss, strengthening Teva’s complex generics portfolio. Biosimilars strategic portfolio shows strong growth, with revenues on track for 2027 expectations, subject to regulatory product approvals. Innovative pipeline achieves key milestones: Phase 3 SOLARIS clinical trial data for olanzapine LAI (TEV-‘749) as a treatment for schizophrenia showing no PDSS(1) cases (link).emrusolmin (TEV-’286) receiving U.S. FDA ‘Fast Track’ designation for Multiple System Atrophy (link).Phase 3 programs for duvakitug (anti-TL1A) in ulcerative colitis (UC) and Crohn’s disease (CD) initiated by Sanofi and Teva in October 2025. Transforming and modernizing our business through Teva Transformation programs – combined with innovative product growth expected to achieve 30% non-GAAP operating income margin by 2027. On track to deliver ~$700 million of net savings by 2027. We are on track to achieving our targeted savings for 2025.Exclusive discussions with selected buyer on TAPI sale have terminated; Teva to initiate a renewed sales process, maintaining strategic intention to divest. Q3 2025 Highlights: Revenues of $4.5 billionGAAP diluted EPS of $0.37Non-GAAP diluted EPS of $0.78Cash flow generated from operating activities of $369 millionFree cash flow of $515 millionUpdating full-year outlook(2)(3): Revenues of $16.8 billion ‐ $17.0 billion (tightening high-end of the range by -$200 million versus our prior expectations)Non‐GAAP operating income of $4.4 billion ‐ $4.6 billion (+$100 million at the low-end; mid-point increased by $50 million)Adjusted EBITDA of $4.8 billion ‐ $5.0 billion (+$100 million at the low-end; mid-point increased by $50 million)Non‐GAAP diluted EPS of $2.55 ‐ $2.65 (+$0.05 at the low-end, mid-point increased by $0.025)Free cash flow of $1.6 billion ‐ $1.9 billion (unchanged) 1 PDSS = post-injection delirium/sedation syndrome2 Revised 2025 outlook includes no contribution from the Japan BV after Q1 2025 and continues to include a full year contribution from TAPI, as well as exclude the expected income from development milestone payments from Sanofi in connection with the duvakitug Phase 3 study initiation for ulcerative colitis and Crohn’s disease. Japan BV revenues were $73 million in Q3 2024 and $75 million in Q1 2025.3 This outlook is based on the existing tariff and trade environment as of November 5, 2025. TEL AVIV, Israel, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended September 30, 2025. Mr. Richard Francis, Teva's President and CEO, said, “Our innovative portfolio driving the 11th consecutive quarter of growth in the third quarter reflects the accelerating momentum of our transformation and the strength of our innovation-led Pivot to Growth strategy. Our key growth drivers—particularly our innovative medicines—delivered a 33% increase in local currency, underscoring their impact on both patient outcomes and our financial performance. As we continue executing our strategy, we remain firmly on track to reach our 30% non-GAAP operating profit margin by 2027 and ~$700 million of net savings target.” Mr. Francis added, “Following the conclusion of the IRA pricing negotiations, we are reiterating our strong confidence in our AUSTEDO 2027 target. Our differentiated innovative portfolio is now a defining strength for Teva as we transform into a leading innovative biopharma, while our world-class generics business continues to provide a resilient foundation. With our talented team and unwavering commitment to patients, we are confident about Teva’s future and our ability to deliver enduring value to all our stakeholders.” Pivot to Growth Strategy In the third quarter of 2025, we continued to execute on the four key pillars of our “Pivot to Growth” strategy, announced in May 2023. As part of this strategy, in the second quarter of 2025 Teva entered its "Accelerate Growth" phase, during which we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in activities we expect to have the highest value, and modernizing our organization and operations to drive both efficiency and cost savings. Delivering on our Growth Engines - on the first pillar, our key innovative brands – AUSTEDO, AJOVY and UZEDY – continued to demonstrate strong performance. Collectively, these products grew ~33% in Q3 2025 YoY in local currency. For AUSTEDO, we are raising the 2025 revenue outlook by $50 million - $100 million to a new range of $2,050 million - $2,150 million. For AJOVY and UZEDY, we are reaffirming our previous outlooks of $630 million - $640 million and $190 million - $200 million, respectively. The conclusion of the IRA pricing negotiations reinforces confidence in our long-term outlook for AUSTEDO. We are on track for our 2027 revenue target of >$2.5 billion for AUSTEDO and peak year revenue target of >$3 billion. During the third quarter of 2025, the FDA approved an expansion of AJOVY's indication, to include its use as an anti-CGRP preventive treatment for pediatric episodic migraine in patients aged 6 to17 years who weigh 45 kg or more. This approval marks an important step in Teva’s efforts to advance care for neurological conditions.Stepping Up Innovation - on the second pillar, we continued to accelerate the development of certain key pipeline assets. For olanzapine LAI, we presented new long-term safety data from the SOLARIS Trial with no PDSS observed and anticipate filing its New Drug Application (NDA) in Q4 2025. Teva’s investigational therapy emrusolmin (TEV-56286) received U.S. FDA Fast Track designation for the treatment of Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disease with no approved treatments to slow its progression —another step forward in Teva’s commitment to advancing innovative neuroscience therapies. Phase 3 programs for duvakitug (anti-TL1A) in UC and CD were initiated by Sanofi and Teva in October 2025; on track to achieve target enrollment levels in the adult and pediatric populations for DARI’s (Dual-action Asthma Rescue Inhaler) Phase 3 trial at the end of 2025.Sustaining Our Generics Powerhouse - on the third pillar, we remain focused on strengthening our world-class global generics business with a streamlined portfolio of high-value complex generics and biosimilars, a robust pipeline, and an integrated global manufacturing and commercial footprint. In the U.S., we received FDA approval and launched liraglutide injection (the generic version of Saxenda®), the first-ever generic GLP-1 treatment indicated for weight loss. This milestone strengthens Teva’s complex generics portfolio, expanding access to effective weight management options for adults and adolescents. Our recently launched biosimilars – SIMLANDI® (adalimumab-ryvk), SELARSDITM (ustekinumab-aekn) and EPYSQLI® (eculizumab-aagh) – continue to grow as does our legacy biosimilar portfolio.Focusing our Business - Lastly, on the fourth pillar, to accelerate our growth, we are actively transforming and modernizing our business through Teva Transformation programs. On May 7, 2025, we announced that these programs are expected to generate ~$700 million of net savings through 2027. We are on track to achieving our targeted savings for 2025.Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business. Exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. On December 31, 2024, Teva classified the business (including its R&D, manufacturing and commercial activities) as held for sale. Third Quarter 2025 Consolidated Results Revenues in the third quarter of 2025 were $4,480 million, an increase of 3% in U.S. dollars, or 1% in local currency terms compared to the third quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO and from generic products including biosimilars in our U.S. segment, partially offset by lower revenues from generic products in our International Markets segment due to the divestment of our business venture in Japan, from generic products in our Europe segment, and from certain other innovative products in all of our segments, as well as lower year-over-year proceeds from the sale of certain product rights. Exchange rate movements during the third quarter of 2025, net of hedging effects, positively impacted revenues by $106 million, compared to the third quarter of 2024. Exchange rate movements during the third quarter of 2025, including hedging effects, had a positive impact of $21 million on our operating income and non-GAAP operating income compared to the third quarter of 2024. Gross profit in the third quarter of 2025 was $2,304 million, an increase of 7% compared to $2,148 million in the third quarter of 2024. Gross profit margin was 51.4% in the third quarter of 2025, compared to 49.6% in the third quarter of 2024. Non-GAAP gross profit was $2,475 million in the third quarter of 2025, an increase of 6% compared to $2,327 million in the third quarter of 2024. Non-GAAP gross profit margin was 55.3% in the third quarter of 2025, compared to 53.7% in the third quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to higher revenues from AUSTEDO. Research and Development (R&D) expenses, net in the third quarter of 2025 were $256 million, an increase of 7% compared to $240 million in the third quarter of 2024. Our higher R&D expenses, net in the third quarter of 2025 compared to the third quarter of 2024, were mainly due to an increase in immunology projects, partially offset by a decrease in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), which was also impacted by a reimbursement from our strategic partnerships in the third quarter of 2024. Selling and Marketing (S&M) expenses in the third quarter of 2025 were $656 million, an increase of 5% compared to the third quarter of 2024. This increase was mainly to support revenue growth in our key innovative products and in generic products. General and Administrative (G&A) expenses in the third quarter of 2025 were $317 million, an increase of 6% compared to the third quarter of 2024. This increase was mainly due to costs related to optimization activities of Teva’s global organization and operations in connection with Teva’s Transformation programs, as well as a negative impact from exchange rate fluctuations. Other loss in the third quarter of 2025 was $7 million, compared to other income of $21 million in the third quarter of 2024. Other income in the third quarter of 2024 included a capital gain from the sale of a business in our International Markets segment. Operating income in the third quarter of 2025 was $882 million, compared to an operating loss of $51 million in the third quarter of 2024. Operating income as a percentage of revenues was 19.7% in the third quarter of 2025, compared to an operating loss as a percentage of revenues of 1.2% in the third quarter of 2024. This increase was mainly due to the goodwill impairment charge and higher legal settlements and loss contingencies recorded in the third quarter of 2024. Non-GAAP operating income in the third quarter of 2025 was $1,294 million representing a non-GAAP operating margin of 28.9% compared to $1,214 million representing 28.0%, respectively, in the third quarter of 2024. The increase in non-GAAP operating margin in the third quarter of 2025 was due to higher gross profit margin, partially offset by an increase in operating expenses as a percentage of revenues. Financial expenses, net in the third quarter of 2025 were $237 million, mainly comprised of net-interest expenses of $209 million. In the third quarter of 2024, financial expenses, net were $272 million, mainly comprised of net-interest expenses of $225 million and a negative exchange rate impact, driven mainly from currencies which we were unable to hedge. In the third quarter of 2025, we recognized a tax expense of $214 million, on a pre-tax income of $646 million. In the third quarter of 2024, we recognized a tax expense of $69 million, on a pre-tax loss of $324 million. Non-GAAP tax rate in the third quarter of 2025 was 14.7%, compared to 16.0% in the third quarter of 2024. Our non-GAAP tax rate in the third quarter of 2025 was mainly affected by changes in deferred tax balances due to statutory tax rate changes and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities. Our non-GAAP tax rate in the third quarter of 2024 was mainly affected by the generation of profits in various jurisdictions with different tax rates, an adjustment to Teva’s corporate tax rate in Israel on losses related to non-qualified tax incentive activities in Israel, recording of valuation allowance with respect to certain carry over credits outside of Israel, as well as infrequent or non-recurring items. We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to a net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024. Net income attributable to Teva and diluted earnings per share in the third quarter of 2025 were $433 million and $0.37, respectively, compared to a net loss attributable to Teva and loss per share of $437 million and $0.39, respectively, in the third quarter of 2024. This change was mainly due to higher operating income in the third quarter of 2025, partially offset by higher income taxes, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the third quarter of 2025 were $910 million and $0.78, respectively, compared to $798 million and $0.69, respectively, in the third quarter of 2024. Adjusted EBITDA was $1,394 million in the third quarter of 2025, an increase of 5%, compared to $1,327 million in the third quarter of 2024. As of September 30, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,184 million shares and 1,167 million shares, respectively. Non-GAAP information: non-GAAP adjustments for non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the third quarter of 2025 were $478 million and consisted of the following adjustments: Amortization of purchased intangible assets of $144 million, of which $134 million is included in cost of sales and the remaining $10 million in S&M expenses;Impairment of long-lived assets of $79 million;Legal settlements and loss contingencies of $60 million;Contingent consideration expenses of $16 million;Equity compensation expenses of $34 million;Restructuring expenses of $29 million;Financial expenses of $7 million;Other non-GAAP items of $51 million; andCorresponding tax effects and unusual tax items of $58 million. We believe that excluding such items facilitates investors’ understanding of our business including underlying trends, thereby improving the comparability of our business performance results between reporting periods. For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under “Non-GAAP Financial Measures.” Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP. Cash flow generated from operating activities during the third quarter of 2025 was $369 million, compared to $693 million in the third quarter of 2024. The lower cash flow generated from operating activities in the third quarter of 2025 was mainly due to timing of sales and collections, as well as higher legal settlement payments, partially offset by lower tax payments and higher profit. During the third quarter of 2025, we generated free cash flow of $515 million, which we define as comprising $369 million in cash flow generated from operating activities, $274 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $8 million of proceeds from divestitures of businesses and other assets, partially offset by $136 million in cash used for capital investment. During the third quarter of 2024, we generated free cash flow of $922 million, which we define as comprising $693 million in cash flow generated from operating activities, $339 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $38 million in divestitures of businesses and other assets, partially offset by $148 million in cash used for capital investment. The decrease in the third quarter of 2025 mainly resulted from lower cash flow generated from operating activities, as well as a decrease in proceeds from divestitures of businesses and other assets. As of September 30, 2025, our debt was $16,790 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,812 million of our senior notes, partially offset by an increase of $791 million due to exchange rate fluctuations. Additionally, during the second quarter of 2025, we repurchased $2,290 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,298 million of senior notes, net of discount and issuance costs. The portion of total debt classified as short-term as of September 30, 2025 was negligible compared to 10% as of December 31, 2024. Our average debt maturity was approximately 5.85 years as of September 30, 2025, compared to 5.5 years as of December 31, 2024. Segment Results for the Third Quarter of 2025 United States Segment The following table presents revenues, expenses and profit for our United States segment for the three months ended September 30, 2025 and 2024: Three months ended September 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues $2,483100%$2,225100%Cost of sales 99640.1% 96043.1%Gross profit 1,48659.9% 1,26556.9%R&D expenses 1616.5% 1516.8%S&M expenses 27811.2% 25911.6%G&A expenses 1144.6% 1074.8%Other (3)§ §§Segment profit* $93737.7%$74833.6%* Segment profit does not include amortization and certain other items.§ Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our United States segment in the third quarter of 2025 were $2,483 million, an increase of $257 million, or 12%, compared to the third quarter of 2024. This increase was mainly due to higher revenues from our key innovative products, primarily AUSTEDO, and generic products including biosimilars. Revenues by Major Products and Activities The following table presents revenues for our United States segment by major products and activities for the three months ended September 30, 2025 and 2024: Three months endedSeptember 30, PercentageChange 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including biosimilars) $1,175 $1,094 7%AJOVY 73 58 27%AUSTEDO 601 435 38%BENDEKA® and TREANDA® 35 40 (13%)COPAXONE 62 69 (9%)UZEDY 43 35 24%Anda 392 380 3%Other 101 115 (13%)Total $2,483 $2,225 12% Generic products (including biosimilars) revenues in our United States segment in the third quarter of 2025 were $1,175 million, an increase of 7% compared to the third quarter of 2024. This increase was mainly driven by higher revenues from our portfolio of biosimilar products. Among the most significant generic products we sold in the United States in the third quarter of 2025 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®) and Truxima® (the biosimilar to Rituxan®). In the third quarter of 2025, our total prescriptions were approximately 261 million (based on trailing twelve months), representing 6.7% of total U.S. generic prescriptions, compared to approximately 292 million (based on trailing twelve months), representing 7.6% of total U.S. generic prescriptions in the third quarter of 2024, all according to IQVIA data. AJOVY revenues in our United States segment in the third quarter of 2025 were $73 million, an increase of 27% compared to the third quarter of 2024, mainly due to growth in volume. In the third quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.0% out of the subcutaneous injectable anti-CGRP class, compared to 29.1% in the third quarter of 2024. In August 2025, the FDA approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6 to 17 years. AUSTEDO revenues (which include AUSTEDO XR®) in our United States segment in the third quarter of 2025 were $601 million, an increase of 38%, compared to $435 million in the third quarter of 2024. This increase was mainly due to growth in volumes. During the third quarter of 2025, Teva and the Centers for Medicare and Medicaid Services (“CMS”) negotiated a maximum fair price for the AUSTEDO products, based on CMS’s list of prescription medicines selected for price-setting discussions, in which they were originally included. The agreement is expected to be announced by CMS in November 2025. The revised prices set by the U.S. Government, will become effective January 1, 2027 and will apply to eligible Medicare patients. AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in a 18 mg dose in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, in addition to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041. UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the third quarter of 2025 were $43 million, an increase of 24% compared to the third quarter of 2024, mainly due to growth in volume. BENDEKA and TREANDA combined revenues in our United States segment in the third quarter of 2025 were $35 million, a decrease of 13% compared to the third quarter of 2024, mainly due to competition from alternative therapies, as well as from generic bendamustine products. COPAXONE revenues in our United States segment in the third quarter of 2025 were $62 million, a decrease of 9% compared to the third quarter of 2024, mainly due to competition. Anda revenues from third-party products in our United States segment in the third quarter of 2025 were $392 million, an increase of 3%, compared to $380 million in the third quarter of 2024. This increase was mainly due to higher volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. United States Gross Profit Gross profit from our United States segment in the third quarter of 2025 was $1,486 million, an increase of 17%, compared to $1,265 million in the third quarter of 2024. Gross profit margin for our United States segment in the third quarter of 2025 increased to 59.9%, compared to 56.9% in the third quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO. United States Profit Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items. Profit from our United States segment in the third quarter of 2025 was $937 million, an increase of 25% compared to $748 million in the third quarter of 2024. This increase was mainly due to higher gross profit, 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, 2025 and 2024: Three months ended September 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues $1,235100%$1,265100%Cost of sales 57046.1% 56644.8%Gross profit 66553.9% 69855.2%R&D expenses 625.0% 554.3%S&M expenses 22518.2% 20316.0%G&A expenses 756.1% 675.3%Other §§ 1§Segment profit* $30324.5%$37329.5%* Segment profit does not include amortization and certain other items.§ Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our Europe segment in the third quarter of 2025 were $1,235 million, a decrease of 2%, or $30 million, compared to the third quarter of 2024. In local currency terms, revenues decreased by 10% compared to the third quarter of 2024, mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and lower revenues from generic products, partially offset by higher revenues from AJOVY. In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $91 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025, included $6 million from a positive hedging impact, which is included in “Other” in the table below. Revenues in the third quarter of 2024 included $10 million from a negative hedging impact, which is included in “Other” in the table below. Revenues by Major Products and ActivitiesThe following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2025 and 2024: Three months endedSeptember 30, PercentageChange 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including OTC and biosimilars) $982 $973 1%AJOVY 66 56 18%COPAXONE 44 53 (18%)Respiratory products 52 60 (13%)Other* 91 124 (26%)Total $1,235 $1,265 (2%)*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights. Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2025 were $982 million, an increase of 1% compared to the third quarter of 2024. In local currency terms, revenues decreased by 5%, mainly due to lower volumes and price reductions as a result of market dynamics and lower sales of seasonal OTC products, partially offset by higher revenues from recently launched products. AJOVY revenues in our Europe segment in the third quarter of 2025 increased by 18% to $66 million, compared to $56 million in the third quarter of 2024. In local currency terms revenues increased by 11% due to growth in volume. COPAXONE revenues in our Europe segment in the third quarter of 2025 were $44 million, a decrease of 18% compared to the third quarter of 2024. In local currency terms revenues decreased by 23%, due to price reductions and lower volumes resulting from the availability of alternative therapies. Respiratory products revenues in our Europe segment in the third quarter of 2025 were $52 million, a decrease of 13% compared to the third quarter of 2024. In local currency terms, revenues decreased by 18%, mainly due to net price reductions and lower volumes associated with the availability of alternative therapies. Europe Gross Profit Gross profit from our Europe segment in the third quarter of 2025 was $665 million, a decrease of 5% compared to $698 million in the third quarter of 2024. Gross profit margin for our Europe segment in the third quarter of 2025 decreased to 53.9%, compared to 55.2% in the third quarter of 2024. This decrease was mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and an unfavorable mix of products, partially offset by a positive impact from hedging activities. Europe Profit Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (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 2025 was $303 million, a decrease of 19%, compared to $373 million in the third quarter of 2024. This decrease was mainly due to lower gross profit and higher S&M expenses. International Markets Segment Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets. On March 31, 2025, we divested our Teva-Takeda business venture in Japan, which included generic products and legacy products. The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2025 and 2024: Three months ended September 30, 2025 2024 (U.S. $ in millions / % of Segment Revenues)Revenues $557100%$613100%Cost of sales 28050.2% 30750.1%Gross profit 27849.8% 30649.9%R&D expenses 264.6% 274.4%S&M expenses 12221.9% 13421.9%G&A expenses 366.4% 365.8%Other §§ §§Segment profit* $9517.0%$10917.8%* Segment profit does not include amortization and certain other items.§ Represents an amount less than $0.5 million or 0.5%, as applicable. Revenues from our International Markets segment in the third quarter of 2025 were $557 million, a decrease of 9%, or 10% in local currency terms compared to the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan, partially offset by higher revenues, mainly from generic products in other markets. In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $9 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025 included $2 million from a positive hedging impact, compared to a positive hedging impact of $1 million in the third quarter of 2024, which are included in “Other” in the table below The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2025 and 2024: Three months endedSeptember 30, PercentageChange 2025 2024 2025-2024 (U.S. $ in millions) Generic products (including OTC and biosimilars) $421 $477 (12%)AJOVY 30 24 23%AUSTEDO 17 13 32%COPAXONE 8 13 (40%)Other* 82 86 (4%)Total $557 $613 (9%)*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights. Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $421 million in the third quarter of 2025, a decrease of 12% in U.S. dollars. In local currency terms revenues decreased by 13%, compared to the third quarter of 2024, mainly due to the divestment of our business venture in Japan, partially offset by higher revenues in other markets. AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the third quarter of 2025 were $30 million, compared to $24 million in the third quarter of 2024. In local currency terms, revenues increased by 21%, mainly due to growth in existing markets in which AJOVY was launched. AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China with Jiangsu Nhwa Hexin Pharmaceutical Marketing Co., Ltd. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to pursue additional submissions in various other markets. AUSTEDO revenues in our International Markets segment in the third quarter of 2025 were $17 million compared to $13 million in the third quarter of 2024. In local currency terms, revenues increased by 31%. COPAXONE revenues in our International Markets segment in the third quarter of 2025 were $8 million compared to $13 million in the third quarter of 2024. International Markets Gross Profit Gross profit from our International Markets segment in the third quarter of 2025 was $278 million, a decrease of 9% compared to $306 million in the third quarter of 2024. Gross profit margin for our International Markets segment in the third quarter of 2025 decreased to 49.8%, compared to 49.9% in the third quarter of 2024. International Markets Profit Profit from our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (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 2025 was $95 million, a decrease of 13%, compared to $109 million in the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan. Other Activities We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above. On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. As of the date of this Press Release, exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all. Revenues from other activities in the third quarter of 2025 were $205 million, a decrease of 10% in U.S. dollars, or 13% in local currency terms, compared to the third quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the third quarter of 2025. API sales to third parties in the third quarter of 2025 were $125 million, a decrease of 4% in both U.S. dollars and local currency terms, compared to the third quarter of 2024. Outlook for 2025 Non-GAAP Results $ billions, except EPS or as noted January 2025 May 2025July 2025November 2025 Revenues* $16.8 - $17.4 $16.8 - $17.2$16.8 - $17.2$16.8 - $17.0 AUSTEDO ($m)* 1,900-2,050 1,950-2,0502,000-2,0502,050-2,150 AJOVY ($m)* ~600 ~600630-640630-640 UZEDY ($m)* ~160 ~160190-200190-200 COPAXONE ($m)* ~370 ~370~370~370 Operating Income 4.1 - 4.6 4.3 - 4.64.3 - 4.64.4 - 4.6 Adjusted EBITDA 4.5 - 5.0 4.7 - 5.04.7 - 5.04.8 - 5.0 Tax Rate 15%-18% 15%-18%15%-18%15%-18% Finance Expenses ~0.9 ~0.9~0.9~0.9 Diluted EPS ($) 2.35 - 2.65 2.45 - 2.652.50 - 2.652.55 - 2.65 Free Cash Flow** 1.6 – 1.9 1.6 – 1.91.6 – 1.91.6 – 1.9 CAPEX* ~0.5 ~0.5~0.5~0.5 Foreign Exchange Volatile swings in FX can negatively impact revenue and income* Revenues and CAPEX presented on a GAAP basis.** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables. Conference Call Teva will host a conference call and live webcast along with a slide presentation on Wednesday, November 5, 2025 at 8:00 a.m. ET to discuss its third quarter 2025 financial 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: www.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) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit 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 and, to compare our results 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,” "outlook" 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; competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may result in additional costs and delays; delays in launches of new generic products; our ability to develop and commercialize additional pharmaceutical products; competition for our innovative medicines; our ability to achieve expected results from investments in our product pipeline; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines, and to execute on our organizational transformation and to achieve expected cost savings; 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 significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and our potential need to raise additional funds in the future, which may not be available on acceptable terms or at all;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; significant disruptions of information technology systems, including cybersecurity attacks and breaches of our data security; interruptions in our supply chain or problems with internal or third party manufacturing; any impact of a prolonged government shutdown; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism, such as the ongoing conflict between Russia and Ukraine and in the Middle East; our ability to attract, hire, integrate and retain highly skilled personnel; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities, as well as our ability to successfully and cost-effectively consummate such sales and divestitures, including our planned divestiture of our API business;compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory requirements and changes; the effects of governmental and civil proceedings and litigation which we are, or in the future become, party to; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage, including as a result of the One Big Beautiful Bill signed into law in the U.S. in July 2025 (“OBBBA”), which is expected to result in stricter Medicaid eligibility requirements and work requirements, which may result in reduced Medicaid enrollment and a resulting decline in coverage for purchases of our medicines, and U.S. Executive Orders issued in April and May 2025 intended to reduce the prices paid by Americans for prescription medicines, including most-favored-nation pricing; increased legal and regulatory action in connection with public concern over the abuse of opioid medications; our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of such agreement; scrutiny from competition and pricing authorities around the world, including our ability to comply with and operate under our deferred prosecution agreement (“DPA”) with the U.S. Department of Justice (“DOJ”); potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare, Medicaid and other governmental programs reporting and payment obligations; compliance with sanctions and trade control laws; environmental risks; and the impact of sustainability issues;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 in the Middle East and in Russia and Ukraine; potential significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; our exposure to changes in international trade policies, including the imposition of tariffs in the jurisdictions in which we operate, and the effects of such developments on sales of our products and the pricing and availability of our raw materials; and the impact of any future failure to establish and maintain effective internal control over our financial reporting; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Consolidated Statements of Income (U.S. dollars in millions, except share and per share data) (Unaudited) Three months ended Nine months ended September 30, September 30, 2025 2024 2025 2024 Net revenues 4,480 4,332 12,547 12,315 Cost of sales 2,176 2,183 6,264 6,372 Gross profit 2,304 2,148 6,282 5,943 Research and development expenses 256 240 746 751 Selling and marketing expenses 656 626 1,933 1,891 General and administrative expenses 317 298 920 859 Intangible assets impairments 64 28 227 169 Goodwill impairment - 600 - 1,000 Other asset impairments, restructuring and other items 62 (23) 272 931 Legal settlements and loss contingencies 60 450 312 638 Other loss (income) 7 (21) 15 (22) Operating income (loss) 882 (51) 1,857 (274) Financial expenses, net 237 272 714 763 Income (loss) before income taxes 646 (324) 1,143 (1,037) Income taxes (benefit) 214 69 210 648 Share in (profits) losses of associated companies, net (2) (3) (4) (1) Net income (loss) 434 (390) 937 (1,684) Net income (loss) attributable to redeemable and non-redeemable non-controlling interests 1 47 7 (262) Net income (loss) attributable to Teva 433 (437) 930 (1,422) Earnings (loss) per share attributable to Teva:Basic ($)0.38 (0.39) 0.81 (1.26) Diluted ($)0.37 (0.39) 0.80 (1.26) Weighted average number of shares (in millions):Basic1,147 1,133 1,144 1,130 Diluted1,164 1,133 1,160 1,130 Non-GAAP net income attributable to Teva for diluted earnings per share:* 910 798 2,281 2,043 Non-GAAP earnings per share attributable to Teva:*Diluted ($)0.78 0.69 1.97 1.78 Non-GAAP average number of shares (in millions):Diluted1,164 1,155 1,160 1,148 Amounts may not add up due to rounding. § Represents an amount less than $0.5 million. * See reconciliation attached. CONSOLIDATED BALANCE SHEETS (U.S. dollars in millions, except for share data) (Unaudited) September 30, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $2,203 $3,300 Accounts receivables, net of allowance for credit losses of $82 million and $78 million as of September 30, 2025 and December 31, 2024, respectively. 3,810 3,059 Inventories 3,323 3,007 Prepaid expenses 1,115 1,006 Other current assets 477 409 Assets held for sale 1,809 1,771 Total current assets 12,736 12,552 Deferred income taxes 1,634 1,799 Other non-current assets 444 462 Property, plant and equipment, net 4,820 4,581 Operating lease right-of-use assets, net 342 367 Identifiable intangible assets, net 3,936 4,418 Goodwill 15,945 15,147 Total assets $39,856 $39,326 LIABILITIES AND EQUITY Current liabilities: Short-term debt $24 $1,781 Sales reserves and allowances 4,134 3,678 Accounts payables 2,355 2,203 Employee-related obligations 561 624 Accrued expenses 2,989 2,792 Other current liabilities 1,103 1,020 Liabilities held for sale 324 698 Total current liabilities 11,491 12,796 Long-term liabilities: Deferred income taxes 399 483 Other taxes and long-term liabilities 3,664 4,028 Senior notes and loans 16,766 16,002 Operating lease liabilities 283 296 Total long-term liabilities 21,111 20,809 Total liabilities 32,602 33,606 Redeemable non-controlling interests - 340 Equity: Teva shareholders’ equity: 7,250 5,373 Non-controlling interests 4 7 Total equity 7,254 5,380 Total liabilities and equity $39,856 $39,326 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, 20252024 20252024Operating activities: Net income (loss)$434(390) $937 (1,684)Adjustments to reconcile net income (loss) to net cash provided by operations: Depreciation and amortization 249259 742 790Impairment of goodwill -600 - 1,000Impairment of long-lived assets and assets held for sale 79(51) 255 758Net change in operating assets and liabilities (561)317 (1,595) (190)Deferred income taxes – net and uncertain tax positions 107(53) (76) (666)Stock-based compensation 3429 106 89Other items* 272 122 597Net loss (gain) from sale of business and long-lived assets -(21) - (22)Net cash provided by (used in) operating activities 369693 491 672 Investing activities: Beneficial interest collected in exchange for securitized trade receivables 274339 932 951Purchases of property, plant and equipment and intangible assets (136)(148) (359) (369)Proceeds from sale of business and long-lived assets, net 838 34 39Acquisition of businesses, net of cash acquired -- - (15)Purchases of investments and other assets . (13)(1) (40) (56)Proceeds from sale of investments -40 - 40Other investing activities 2- 5 -Net cash provided by (used in) investing activities 135268 572 590 Financing activities: Repayment of senior notes and loans and other long-term liabilities (444)- (4,112) (956)Proceeds from senior notes, net of issuance costs (7)- 2,298 -Purchase of shares from redeemable and non-redeemable non-controlling interests-- (38) (64)Dividends paid to redeemable and non-redeemable non-controlling interests -- (340) (78)Other financing activities (2)- 1 (19)Net cash provided by (used in) financing activities (453)- (2,191) (1,117) Translation adjustment on cash and cash equivalents (9)100 31 (53) Net change in cash and cash equivalents 421,061 (1,097) 92Balance of cash, cash equivalents at beginning of period 2,1612,258 3,300 3,227 Balance of cash, cash equivalents at end of period$2,2033,319 $2,203 3,319 Non-cash financing and investing activities: Beneficial interest obtained in exchange for securitized accounts receivables$296332 $937 964 *Adjustment in the three months period ended September 30, 2024 was mainly related to an agreement with the Israeli Tax Authorities. Amounts may not add up due to rounding.The accompanying notes are an integral part of the financial statements. Reconciliation of net income (loss) attributable to Tevato Non-GAAP net income (loss) attributable to Teva Three months ended Nine months ended September 30, September 30, ($ in millions except per share amounts) 20252024 20252024 Net income (Loss) attributable to Teva($)433(437)($)930(1,422) Increase (decrease) for excluded items: Amortization of purchased intangible assets 144146 436444 Legal settlements and loss contingencies(1) 60450 309638 Goodwill impairment(2) -600 -1,000 Impairment of long-lived assets(3) 79(51) 255758 Restructuring costs(4) 2921 19652 Equity compensation 3429 10689 Contingent consideration(5) 1634 46305 Loss (Gain) on sale of business -(20) -(21) Financial expenses 711 5835 Redeemable and non-redeemable non-controlling interests(6)-41 2(276) Other non-GAAP items(7) 5157 167170 Corresponding tax effects and unusual tax items(8) 58(83) (225)270 Non-GAAP net income attributable to Teva($)910798($)2,2812,043 Non-GAAP tax rate(9) 14.7%16.0% 16.0%15.5% GAAP diluted earnings (loss) per share attributable to Teva($)0.37(0.39)($)0.80(1.26) EPS difference(10) 0.411.08 1.163.04 Non-GAAP diluted EPS attributable to Teva(10)($)0.780.69($)1.971.78 Non-GAAP average number of shares (in millions)(10) 1,1641,155 1,1601,148 (1)For the third quarter of 2025, adjustments of legal settlements and loss contingencies mainly consisted of an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments) of $42 million. Adjustments for legal settlements and loss contingencies in the third quarter of 2024 mainly related to a provision of $350 million recorded in connection with a decision by the European Commission in its antitrust investigation into COPAXONE, and to an update to the estimated settlement provision of $121 million for the opioid cases (mainly related to the settlement agreement with the city of Baltimore and the effect of the passage of time on the net present value of the discounted payments). For the nine months ended September 30, 2025, adjustments of legal settlements and loss contingencies mainly consisted of (a) an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments) of $139 million, and (b) an update to the estimated provision recorded for the claims brought by attorneys general representing states and territories throughout the United States in the generic drug antitrust litigation of $55 million. Adjustments for legal settlements and loss contingencies in the nine months ended September 30, 2024 were mainly related to a provision of $350 million recorded in connection with the decision by the European Commission in its antitrust investigation into COPAXONE, and to an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments and the settlement agreement with the city of Baltimore) of $239 million.(2)Goodwill impairment charges of $600 million and $1,000 million related to Teva’s API reporting unit were recorded in the three and nine months ended September 30, 2024, respectively.(3)For the nine months ended September 30, 2025, the adjustment for impairment of long-lived assets was mainly related to products in the U.S. and Europe. For the nine months ended September 30, 2024, adjustments for impairment of long-lived assets and redeemable and non-redeemable non-controlling interests, primarily consisted of $561 million and $275 million, respectively, related to the classification of the business venture in Japan as held for sale.(4)In the nine months ended September 30, 2025, Teva recorded $196 million, of restructuring expenses primarily related to optimization activities in connection with Teva's Transformation programs related to Teva’s global organization and operations, mainly through headcount reduction.(5)Adjustments for the nine months ended September 30, 2024 primarily related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid®) of $266 million.(6)For the nine months ended September 30, 2024, the redeemable and non-redeemable non-controlling interests portion of long-lived assets impairment related to the classification of our business venture in Japan as held for sale.(7)Other non-GAAP adjustments include other exceptional items for which their exclusion is important to facilitate an understanding of trends in our financial results and primarily related to the rationalization of our plants, accelerated depreciation, certain inventory write-offs, material litigation fees and other unusual events.(8)Adjustments for corresponding tax effects and unusual tax items exclusively consisted of the tax impact directly attributable to the pre-tax items that are excluded from non-GAAP net income included in the other adjustments to this table.(9)Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above.(10)EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. Reconciliation of gross profit to Non-GAAP gross profit (Unaudited) Three months ended Nine months ended September 30, September 30, ($ in millions) 20252024 20252024 Gross profit$2,3042,148 $6,2825,943 Gross profit margin 51.4%49.6% 50.1%48.3% Increase (decrease) for excluded items: (1) Amortization of purchased intangible assets 134136 406409 Equity compensation 65 1717 Other non-GAAP items 3238 101125 Non-GAAP gross profit$2,4752,327 $6,8076,495 Non-GAAP gross profit margin (2) 55.3%53.7% 54.3%52.7% (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. (2) Non-GAAP gross profit margin is non-GAAP gross profit as a percentage of revenue. Reconciliation of operating income (loss) to Non-GAAP operating income (loss)(Unaudited) Three months ended Nine months ended September 30, September 30, ($ in millions) 20252024 20252024 Operating income (loss)($)882(51) ($)1,857(274) Operating margin 19.7%(1.2%) 14.8%(2.2%) Increase (decrease) for excluded items: (1) Amortization of purchased intangible assets 144146 436444 Legal settlements and loss contingencies 60450 309638 Goodwill impairment -600 -1,000 Impairment of long-lived assets 79(51) 255758 Restructuring costs 2921 19652 Equity compensation 3429 10689 Contingent consideration 1634 46305 Loss (gain) on sale of business -(20) -(21) Other non-GAAP items 5156 167169 Non-GAAP operating income (loss)($)1,2941,214 ($)3,3733,162 Non-GAAP operating margin(2)($)28.9%28.0% ($)26.9%25.7% (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table.(2) Non-GAAP operating margin is Non-GAAP operating income as a percentage of revenues. Reconciliation of net income (loss) to adjusted EBITDA (Unaudited) Three months ended Nine months ended September 30, September 30, ($ in millions) 20252024 20252024 Net income (loss) $434(390) $937(1,684) Increase (decrease) for excluded items:(1) Financial expenses 237272 714763 Income taxes 21469 210648 Share in profits (losses) of associated companies –net (2)(3) (4)(1) Depreciation 105113 306346 Amortization 144146 436444 EBITDA 1,131208 2,599515 Legal settlements and loss contingencies 60450 309638 Goodwill impairment -600 -1,000 Impairment of long lived assets 79(51) 255758 Restructuring costs 2921 19652 Equity compensation 3429 10689 Contingent consideration 1634 46305 Loss (Gain) on sale of Business -(20) -(21) Other non-GAAP items 4656 156162 Adjusted EBITDA$1,3941,327 $3,6683,500 (1) For further explanations, refer to the footnotes under the "Reconciliation of net income (loss) attributable to Teva to Non-GAAP net income (loss) attributable to Teva" table. § Represents an amount of less than $0.5 million. Segment Information (Unaudited) United States Europe International Markets Three months ended September 30, Three months ended September 30, Three months ended September 30, 2025 2024 2025 2024 2025 2024 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$2,483 $2,225 $1,235 $1,265 $557 $613Cost of sales 996 960 570 566 280 307Gross profit 1,486- 1,265- 665- 698- 278- 306R&D expenses 161 151 62 55 26 27S&M expenses 278 259 225 203 122 134G&A expenses 114 107 75 67 36 36Other (3) § § 1 § §Segment profit$937 $748 $303 $373 $95 $109 § Represents an amount less than $0.5 million. Segment Information Unaudited United States Europe International Markets Nine months ended September 30, Nine months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 2025 2024 (U.S. $ in millions) (U.S. $ in millions) (U.S. $ in millions) Revenues$6,543 $6,060 $3,726 $3,749 $1,634 $1,802Cost of sales 2,748 2,769 1,687 1,637 835 914Gross profit 3,795 3,291 2,039 2,113 799 889R&D expenses 467 475 181 173 75 85S&M expenses 831 789 652 605 353 397G&A expenses 323 300 210 197 107 109Other (1) (1) § 1 (3) (1)Segment profit$2,175 $1,727 $996 $1,137 $266 $299 § Represents an amount less than $0.5 million. Reconciliation of our segment profitto consolidated income (loss) before income taxes Three months ended September 30, 2025 2024 (U.S.$ in millions) United States profit $937 $748Europe profit 303 373International Markets profit 95 109Total reportable segment profit 1,334 1,230Profit (loss) of other activities (40) (16)Total segment profit 1,294 1,214Amounts not allocated to segments: Amortization 144 146Other asset impairments, restructuring and other items 62 (23)Goodwill impairment - 600Intangible asset impairments 64 28Legal settlements and loss contingencies 60 450Other unallocated amounts 82 64Consolidated operating income (loss) 882 (51)Financial expenses - net 237 272Consolidated income (loss) before income taxes $646 $(324) Reconciliation of our segment profit to consolidated income (loss) before income taxes Nine months ended September 30, 2025 2024 (U.S.$ in millions) United States profit $2,175 $1,727 Europe profit 996 1,137 International Markets profit 266 299 Total reportable segment profit 3,437 3,163 Profit (loss) of other activities (64) (1) Total segment profit 3,373 3,162 Amounts not allocated to segments: Amortization 436 444 Other asset impairments, restructuring and other items272 931 Goodwill impairment - 1,000 Intangible asset impairments 227 169 Legal settlements and loss contingencies 309 638 Other unallocated amounts 272 254 Consolidated operating income (loss) 1,857 (274) Financial expenses - net 714 763 Consolidated income (loss) before income taxes $1,143 $(1,037) Segment revenues by major products and activities(Unaudited) Three months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) United States segment Generic products (including biosimilars) $1,175 $1,094 7%AJOVY 73 58 27%AUSTEDO 601 435 38%BENDEKA and TREANDA 35 40 (13%)COPAXONE 62 69 (9%)UZEDY 43 35 24%Anda 392 380 3%Other 101 115 (13%)Total 2,483 2,225 12% Three months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) Europe segment Generic products (including OTC and biosimilars) $982 $973 1%AJOVY 66 56 18%COPAXONE 44 53 (18%)Respiratory products 52 60 (13%)Other* 91 124 (26%)Total 1,235 1,265 (2%) *Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights. Three months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) International Markets segment Generic products (including OTC and biosimilars) $421 $477 (12%)AJOVY 30 24 23%AUSTEDO 17 13 32%COPAXONE 8 13 (40%)Other* 82 86 (4%)Total 557 613 (9%) *Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights. Segment revenues by major products and activities(Unaudited) Nine months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) United States segment Generic products $2,984 $2,924 2%AJOVY 190 144 31%AUSTEDO 1,492 1,124 33%BENDEKA / TREANDA 111 127 (13%)COPAXONE 179 179 0%UZEDY 136 75 82%Anda 1,130 1,134 0%Other 321 352 (9%)Total 6,543 6,060 8% Nine months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) Europe segment Generic products $3,011 $2,947 2%AJOVY 195 158 23%COPAXONE 135 163 (17%)Respiratory products 162 183 (12%)Other* 223 299 (25%)Total 3,726 3,749 (1%) *Other revenues in the first nine months of 2025 and 2024 include the sale of certain product rights. Nine months ended Percentage September 30, Change 2025 2024 2024-2025 (U.S.$ in millions) International Markets segment Generic products $1,298 $1,440 (10%)AJOVY 78 63 24%AUSTEDO 34 39 (12%)COPAXONE 25 38 (35%)Other* 199 222 (11%)Total 1,634 1,802 (9%) *Other revenues in the first nine months of 2025 and 2024 include the sale of certain product rights. Free cash flow reconciliation(Unaudited) Three months ended September 30, 2025 2024 (U.S. $ in millions) Net cash provided by (used in) operating activities 369 693Beneficial interest collected in exchange for securitized accounts receivables 274 339Capital investment (136) (148)Proceeds from divestitures of businesses and other assets, net 8 38Free cash flow$515 $922 Free cash flow reconciliation (Unaudited) Nine months ended September 30, 2025 2024 (U.S. $ in millions) Net cash provided by (used in) operating activities 491 672 Beneficial interest collected in exchange for securitized trade receivables 932 951 Capital investment (359) (369) Proceeds from divestitures of businesses and other assets, net 34 39 Acquisition of businesses, net of cash acquired - (15) Free cash flow$1,098 $1,278 Teva Media InquiriesTevaCommunicationsNorthAmerica@tevapharm.com Teva Investor Relations InquiriesTevaIR@Tevapharm.com A PDF accompanying this announcement is available at http://ml-eu.globenewswire.com/Resource/Download/cc1e9e1b-106f-4032-8294-dc114bd3e936

Phase 3Drug ApprovalFast TrackFinancial StatementNDA

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KEGG	Wiki	ATC	Drug Bank
D04318	Glatiramer Acetate	L03AX13	DB05259

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Multiple Sclerosis	United States	Teva Pharmaceuticals USA, Inc.	28 Jan 2014
Multiple Sclerosis, Relapsing-Remitting	United States	Teva Pharmaceuticals USA, Inc.	20 Dec 1996

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 3	United States	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Belarus	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Bosnia and Herzegovina	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Bulgaria	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Estonia	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Israel	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Moldova	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Russia	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Ukraine	Mapi-Pharma Ltd.	19 Sep 2019
Rhabdomyosarcoma	Phase 3	United States	Mapi-Pharma Ltd.	19 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P8-6.018 (AAN2024)	Phase 3	Multiple sclerosis relapse	-	GA Depot	mmbmlwgsmm(pajlfzkhfm) = npkdfinmou ldjcxwqogf (avfydsubpw ) View more	Positive	09 Apr 2024
				Copaxone	mmbmlwgsmm(pajlfzkhfm) = hjhjhckyhu ldjcxwqogf (avfydsubpw ) View more
S31.010 (AAN2024)	Not Applicable	Multiple Sclerosis	930	Fingolimod	snxknwollz(fdltlojiaf) = ksrqrnbmjb qxzxmkpfgu (zzpatebuek )	Negative	09 Apr 2024
				Natalizumab	snxknwollz(fdltlojiaf) = bgeuhlpvrj qxzxmkpfgu (zzpatebuek )
GA Depot, Phase 3 (ACTRIMS2024)	Phase 3	Multiple sclerosis relapse	763	GA Depot	ytuszuifgy(qhhbbbabvt) = mean percent change 8.34 xiosoqugon (ryuvoaocqj )	Positive	29 Feb 2024
Phase III Open Label period (ACTRIMS2024)	Phase 3	-	821	Glatiramer Acetate Depot	psuyjnmdos(vdarqtcdyw) = The most frequent TEAEs reported (≥5% of the subjects in any treatment group), irrespective of the relatedness, were ISRs, pyrexia, influenza-like illness, body temperature increase, and headache sidiejzqbt (ujgazoiogr ) View more	Positive	29 Feb 2024
				Placebo
NCT04121221 (ECTRIMS2023)	Phase 3	Multiple sclerosis relapse	-	GA Depot	bwqzwmwkar(grfmqkyixq) = wytjxhrsxf jrydvywrpr (qjwnkqlryc ) View more	-	30 Sep 2023
				Copaxone®	bwqzwmwkar(grfmqkyixq) = yfzmmjqeep jrydvywrpr (qjwnkqlryc ) View more
AAN2022	Phase 2	Multiple Sclerosis, Relapsing-Remitting anti-GA antibodies	-	GA Depot 80mg	ibfdgonbib(gmqspytzpf) = mhvclcwgpx ypuniopwxv (hpuvyngrtn, +/ - 1.13) View more	Positive	03 May 2022
				GA Depot 40mg	ibfdgonbib(gmqspytzpf) = lpmkungswj ypuniopwxv (hpuvyngrtn, +/ - 1.25) View more
NCT00176592 (BECOME, CTgov)	Phase 4	Multiple Sclerosis \| Multiple Sclerosis, Relapsing-Remitting	75	Betaseron (Betaseron)	kqislqoppz(bicgvrmhlf) = uspzpnvsoo lbtiuisqbg (zhdvoshevw, 2.76) View more	-	16 Nov 2021
				Copaxone (Copaxone)	kqislqoppz(bicgvrmhlf) = omgboosnct lbtiuisqbg (zhdvoshevw, 2.46) View more
NCT00326625 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	366	Placebo	esfkpwgpcr(wvkmrghhxw) = bxsbwbarhi cmmineswcq (elsbxrfptz, 0.058) View more	-	20 Oct 2021
GA Depot phase IIa (ECTRIMS 12020 \| ECTRIMS 22020 \| AAN2020)	Phase 2	Multiple Sclerosis, Primary Progressive	11	GA Depot	dxtvrfpsro(yssaevflrl) = stable xqjeimqhiz (dqmxbjnmza ) View more	Positive	07 Dec 2020
NCT00211887 (CombiRx, Pubmed \| Neurology)	Phase 3	Multiple Sclerosis	959	Interferon-beta-1a	ctorycwhrn(zhdzlujbgi) = After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01-1.55) and dyslipidemia (HR 1.32, 95% CI 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67-0.97) was associated with a decreased hazard. wctlagiisb (spckfpnzhm )	Positive	04 Aug 2020
				Glatiramer acetate

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