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AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine
Globenewswire· 2026-01-14 22:02
Core Insights - Teva Pharmaceuticals announced the publication of pivotal Phase 3 data on AJOVY in the New England Journal of Medicine, demonstrating its efficacy and safety for treating episodic migraine in children and adolescents aged 6-17 years [1][2] Efficacy and Safety - The SPACE trial showed that AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo, with a statistically significant difference of 1.1 days (P = 0.02) [2] - AJOVY also reduced monthly headache days (MHD) of at least moderate severity by 2.6 days versus 1.5 days with placebo, again showing a significant difference of 1.1 days (P = 0.02) [2] - A higher percentage of participants achieved a ≥ 50% reduction in MMD with AJOVY (47.2%) compared to placebo (27.0%), with P = 0.002 indicating statistical significance [2] - The safety profile of AJOVY remained consistent with previous adult studies, with no new safety signals identified [2][5] Study Details - The SPACE trial was a 3-month, randomized, placebo-controlled study involving 237 children and adolescents aged 6-17 years with episodic migraine [2][5] - Participants received monthly subcutaneous injections of fremanezumab (120 mg for those weighing < 45 kg; 225 mg for those weighing ≥ 45 kg) or matched placebo [2] Market Context - With an estimated 1 in 10 children and adolescents in the U.S. suffering from migraines, the need for effective preventive treatments is critical [2] - Teva aims to lead innovation in the migraine treatment space, building on the established use of AJOVY in adults [2][3] Product Information - AJOVY is the first and only CGRP antagonist approved for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more [1][5] - The product is available as a 225 mg/1.5 mL single-dose injection in a pre-filled autoinjector or syringe, and can be administered by healthcare professionals or at home by patients aged 13 and older [7]
Teva Is No Longer A Turnaround Story, It's A Growth One
Seeking Alpha· 2026-01-14 13:01
Core Viewpoint - Teva Pharmaceutical (TEVA) has shown significant improvement since being rated a Buy at $15.45 last July, transitioning from a perception of being "damaged goods" to a more favorable outlook [1]. Company Analysis - The company is focusing on getting its operations in order, which has positively impacted its stock performance [1]. - The analyst emphasizes a disciplined approach to evaluating companies, prioritizing numerical data and underlying business performance over narratives [1]. Market Context - With over 15 years of market experience, the analyst aims to provide individual investors with a clear and honest perspective on investment opportunities and risks [1].
Teva's Plans to Pivot to Growth
Yahoo Finance· 2026-01-13 21:48
Core Insights - Teva Pharmaceuticals is focusing on innovation and sales growth as key drivers for the company's future success [1] Group 1: Company Strategy - The CEO Richard Francis emphasized the importance of innovation in driving sales growth for Teva Pharmaceuticals [1] - The company is actively participating in the annual JPMorgan Healthcare Conference to showcase its strategies and developments [1] Group 2: Industry Context - The discussion at the conference highlights the competitive landscape of the pharmaceutical industry, where innovation is crucial for maintaining market position [1]
Teva Pharmaceutical Industries Limited (TEVA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-13 19:46
Core Insights - Teva Pharmaceuticals is undergoing a strategic transformation from a leading global generics company to a leading biopharma company, initiated three years ago with a pivot to growth strategy [2][3] - The company has faced skepticism regarding its growth strategy but has executed a clear plan year-on-year, leading to significant progress in its transition [3] Company Strategy - The pivot to growth strategy was designed to return Teva to growth and fundamentally transform its business model [2] - The CEO emphasized the importance of this strategy in positioning Teva as a world-leading biopharma company [3]
Teva Pharmaceutical Industries (NYSE:TEVA) FY Conference Transcript
2026-01-13 17:17
Teva Pharmaceutical Industries FY Conference Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **CEO**: Richard Francis - **Conference Date**: January 13, 2026 Core Industry and Company Strategy - Teva is transitioning from a leading global generics company to a leading biopharma company, a strategy initiated three years ago [2][3] - The "pivot to growth" strategy is based on four pillars: 1. Deliver on growth engines 2. Step up innovation 3. Create a generics powerhouse 4. Focus the business [3] Financial Performance - Teva has achieved 11 consecutive quarters of growth since early 2023, reversing a previous decline [5] - The company is experiencing a transformation in financials, with improvements in gross margin, free cash flow, EBITDA, and operating margin while reducing debt [6][30] - Revenue growth is primarily driven by the innovative business, which has doubled in the last three years [11] Innovative Products and Pipeline - Key innovative products include: - **Austedo**: Revenue expectations have increased from $1.4 billion to potentially $3 billion [9] - **Ajovy**: Targeting $1 billion in revenue with double-digit growth [9] - **Uzedy**: Projected to achieve $1.5-$2 billion in revenue [10] - Teva's pipeline includes several promising products: - **Duvakitug**: Entering phase 3 studies for ulcerative colitis (UC) and Crohn's disease (CD) [4] - **Anle138b**: Treatment for multiple system atrophy (MSA) with a significant unmet need [23] - **Anti-IL-15**: Targeting celiac disease and vitiligo, with multiple indications expected [19][25] Market Position and Competitive Landscape - Teva is positioning itself in high-value markets, including a $9 billion market for schizophrenia treatments [14] - The company aims for over $10 billion in peak sales across its innovative portfolio [13] - Teva's generics business is expected to grow at a low CAGR of 1%-2%, with a focus on biosimilars [26] Future Outlook - Teva anticipates a stable generics business while focusing on innovative growth, with a long-term vision extending over 20 years [5][31] - The company expects to maintain a 30% operating margin and continue growing EBITDA and free cash flow through 2027 [30] - Upcoming product launches include Olanzapine in 2026 and Daria in 2027, with a steady cadence of new products expected [36][38] Key Financial Metrics and Guidance - Revenue for 2026 is projected to be at the lower end of guidance due to the loss of $1.1 billion from generic Revlimid [29][41] - Despite this loss, Teva expects to grow EBITDA and operating margin, indicating a successful transformation of its portfolio [30] Conclusion - Teva is on a transformative journey towards becoming a leading biopharma company, with a strong focus on innovation and a robust pipeline of products that address significant unmet medical needs. The company is well-positioned for future growth, despite challenges in the generics market.
Teva Pharmaceutical Industries (NYSE:TEVA) FY Earnings Call Presentation
2026-01-13 16:15
Cautionary Note Regarding Forward-Looking Statements This presentation 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 significant ly from that expressed or implied by such forward -looking statements. Important factors that c ...
Teva Taps Royalty Pharma For $500M To Advance Skin Disease Drug
Benzinga· 2026-01-12 17:26
Core Insights - Teva Pharmaceutical Industries Ltd. and Royalty Pharma plc have entered into a funding agreement of up to $500 million to expedite the clinical development of Teva's anti-IL-15 antibody, TEV-'408, which targets autoimmune diseases [1][3] - Preliminary Phase 1b data from the TEV-'408 vitiligo study supports IL-15 as a potential therapeutic target for various autoimmune conditions [1][2] Funding Agreement - Royalty Pharma will provide Teva with up to $500 million, including $75 million for R&D co-funding to initiate a Phase 2b study in vitiligo, expected to start in 2026 [3] - Based on the results from the Phase 2b study, Royalty Pharma has the option to contribute an additional $425 million for the Phase 3 development program [3] Clinical Development and Future Outlook - Teva anticipates sharing results from the TEV-'408 trials in 2026 and is also evaluating the candidate in a Phase 2a study for celiac disease [2] - The company expects fiscal 2026 sales to be flat to slightly down compared to 2025, with low-single digit growth projected for fiscal 2027 and mid-single digit CAGR for fiscal 2030 [4] Financial Projections - Teva forecasts around 30% operating profit in 2026 and over 30% in 2027 [5] - The company reaffirmed its fiscal year 2025 adjusted earnings guidance to a range of $2.55-$2.65 per share, slightly above the consensus of $2.58 [5] - Teva narrowed its 2025 sales guidance to $16.8 billion-$17 billion, compared to the consensus of $16.89 billion [5] Credit Ratings - In December 2025, S&P Global Ratings upgraded Teva's long-term issuer credit rating to BB+ from BB, maintaining a stable outlook, while Moody's affirmed its Ba1 rating with a positive outlook [6]
TEVA Signs Deal With RPRX to Accelerate Development of Vitiligo Drug
ZACKS· 2026-01-12 16:10
Core Insights - Teva Pharmaceuticals has entered a funding agreement with Royalty Pharma to receive up to $500 million for the development of its anti-IL-15 antibody, TEV-'408, which is in early-stage development for vitiligo and other autoimmune diseases [1][2] Funding Agreement Details - The agreement includes $75 million for R&D co-funding of a phase IIb vitiligo study expected to start in 2026, with an option for an additional $425 million to co-fund phase III development based on phase IIb results [2] - Teva will retain rights to the drug while being responsible for milestone payments and ongoing royalties on global net sales if the drug is approved [5][11] Strategic Benefits for Teva - The collaboration with Royalty Pharma strengthens Teva's immunology pipeline, reduces financial exposure, and accelerates the development of TEV-'408, allowing for faster clinical progression [3][4] - Teva's shares have increased by 95% over the past six months, outperforming the industry growth of 54.1% [4] Market Potential - Vitiligo is a chronic autoimmune condition with a global prevalence of 0.5% to 2%, representing a significant unmet medical need due to limited treatment options [7] - TEV-'408 aims to address both the physical and psychosocial burdens of vitiligo by targeting the IL-15 pathway responsible for immune-driven melanocyte destruction [7] Ongoing Research and Development - Teva is also evaluating TEV-'408 in a phase IIa study for celiac disease, which received Fast Track designation from the FDA in 2025 [8] - The current collaboration with Royalty Pharma marks Teva's second agreement, following a previous deal for the development of TEV-'749 for schizophrenia [9]
Why Investors Are So Optimistic on Teva
Barrons· 2026-01-12 15:46
Teva Pharmaceuticals stock jumped Monday after the drugmaker issued upbeat guidance and targets for the years ahead. ...