Company Overview - Teva Pharmaceutical Industries Limited is a global, profitable biopharmaceutical company with a growing and exciting innovative business [4] - The company has undergone significant changes under the leadership of CEO Richard Francis, who joined approximately two years ago [2][3] - Teva's strategy, referred to as the "Pivot to Growth," has been a key focus for employees worldwide, driving substantial transformation within the company [3] Leadership and Strategy - Richard Francis, President and CEO of Teva, has led the company through a period of significant change and improvement over the past two years [2][3] - The company's strategic focus on growth has been a major driver of its recent success, with employees globally aligning with this vision [3] Product Portfolio - Teva's innovative business includes key products such as AUSTEDO, AJOVY, and UZEDY, which are central to its growth strategy [4]

Key Points Company and Industry Overview 1. **Company**: Teva Pharmaceutical Industries Limited (NYSE:TEVA) 2. **Event**: 43rd Annual J.P. Morgan Healthcare Conference 3. **Date**: January 13, 2025 4. **Time**: 11:15 AM ET 5. **Participants**: - Richard Francis - President and CEO - Eric Hughes - Head of R&D and Chief Medical Officer - Chris Schott - J.P. Morgan [2] Company Performance and Strategy 1. **Richard Francis' Background**: Joined Teva about two years ago 2. **Teva's Transformation**: Focused on the Pivot to Growth strategy, driving significant change within the company 3. **Teva's Status**: Global, profitable biopharmaceutical company 4. **Innovative Business**: Growing and exciting innovative business segments, including AUSTEDO, AJOVY, and UZEDY [3][5]

Strategic Collaboration - Teva Pharmaceuticals International GmbH has entered into a strategic collaboration with Klinge Biopharma GmbH and Formycon AG for the semi-exclusive commercialization of FYB203, a biosimilar candidate to Eylea (aflibercept), in Europe (excluding Italy) and Israel [1] - The collaboration leverages Teva's commercial experience in biosimilars and its extensive distribution network across Europe, combined with Formycon's expertise in biosimilar development for highly regulated markets [2] - Klinge holds the exclusive global commercialization rights for FYB203, which will be marketed under the brand name AHZANTIVE, subject to regulatory approval [3][8] Product and Market Context - FYB203 is a biosimilar to Eylea (aflibercept), a drug used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases by inhibiting vascular endothelial growth factor (VEGF) [6] - Eylea achieved global sales of approximately USD 9 billion in 2023, including USD 2.9 billion in the European market, making it the highest-revenue drug in the anti-VEGF therapy sector [6] - The U.S. FDA approved FYB203 in June 2024, and the European Medicines Agency's CHMP issued a positive recommendation for its marketing authorization in November 2024, with a final decision expected in the second half of January 2025 [5] Company Profiles - Teva Pharmaceutical Industries Ltd is a global pharmaceutical leader with over 120 years of experience, employing approximately 37,000 people across 58 markets, and is known for its generics expertise and innovation in modern medicine [7] - Formycon AG is a leading independent developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, and immuno-oncology, with a portfolio that includes FYB201 (ranibizumab biosimilar) and FYB203 (aflibercept biosimilar) [4][9] - Klinge Biopharma GmbH holds the exclusive global commercialization rights for FYB203 and has a proven track record in the commercialization of biosimilars, including FYB201 in Europe [8] Strategic Implications - The collaboration builds on the successful commercialization of FYB201 (ranibizumab biosimilar) in Europe, leveraging Teva's existing commercial infrastructure and distribution channels in the ophthalmology field [5][8] - Formycon will manage the entire commercial supply chain of FYB203 for the first time, marking a significant step in its operational capabilities [5] - The partnership aligns with Teva's Pivot to Growth strategy, expanding its biosimilars portfolio and reinforcing its commitment to providing access to innovative medicines [8]

Collaboration Overview - Teva collaborates with Formycon and Klinge for the commercialization of FYB203, a biosimilar to Eylea® (aflibercept), in Europe (excluding Italy) and Israel [12] - Teva will lead the commercialization of FYB203 under the brand name AHZANTIVE®3, subject to regulatory approval [2] - Klinge holds exclusive global commercialization rights for FYB203 and will receive milestone payments and a portion of the product's revenue [1][2][7] Company Profiles - Teva is a global pharmaceutical leader with over 120 years of experience, employing ~37,000 people across 58 markets, and focuses on generics and innovative medicines [6] - Formycon is a leading independent developer of high-quality biosimilars, focusing on ophthalmology, immunology, and immuno-oncology, with a strong presence in Europe and the USA [3][8] - Klinge Biopharma GmbH holds exclusive global commercialization rights for FYB203 and has a proven track record in biosimilar commercialization [7] Product and Market Context - FYB203 is a biosimilar to Eylea® (aflibercept), which is used to treat neovascular age-related macular degeneration (nAMD) and other severe retinal diseases [5] - Eylea® achieved global sales of approximately USD 9 billion in 2023, including USD 2.9 billion in the European market, making it the highest-revenue drug in the anti-VEGF therapy sector [5] - FYB203 received FDA approval in June 2024 and a positive recommendation from the EMA's CHMP in November 2024, with European Commission approval expected in January 2025 [4] Strategic Implications - The collaboration builds on the successful commercialization of FYB201 (ranibizumab biosimilar) in Europe, leveraging Teva's existing commercial infrastructure and distribution channels [4][7] - Formycon will manage the entire commercial supply chain of FYB203 for the first time, marking a significant step in its operational capabilities [4] - The partnership aligns with Teva's Pivot to Growth strategy, expanding its biosimilars portfolio and enhancing access to innovative medicines [7]

Partnership Agreement - Samsung Bioepis and Teva Pharmaceutical Industries have entered into a license, development, and commercialization agreement for EPYSQLI®, a biosimilar to Soliris®, in the US [1] - Samsung Bioepis will handle development, regulatory registration, manufacturing, and supply, while Teva will manage commercialization in the US [2] - EPYSQLI is indicated for treating rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) [3] Strategic Importance - The partnership aims to increase access to treatment for rare disease patients, addressing high costs and limited availability [4] - The collaboration aligns with Teva's Pivot to Growth strategy, expanding its biosimilar portfolio to 18 assets [5] - Samsung Bioepis' biosimilars portfolio now includes nine biosimilars available in over 40 countries, covering therapeutic areas such as immunology, oncology, and hematology [5] Regulatory Approvals - EPYSQLI was approved by the US FDA in July 2024 for PNH and aHUS, with an expanded indication for gMG in November 2024 [4] - The product received approval from the European Commission in May 2023 and Korea's Ministry of Food and Drug Safety in January 2024 [4] - EPYSQLI has been commercially available in Europe since July 2023 and in Korea since April 2024 [4] Product Details - EPYSQLI is a complement inhibitor used to treat PNH, aHUS, and gMG in adult patients who are anti-acetylcholine receptor (AchR) antibody positive [3][6] - The product is not indicated for Shiga toxin E coli-related hemolytic uremic syndrome (STEC-HUS) [8] - EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections [10][17] Safety Information - EPYSQLI increases the risk of serious infections caused by Neisseria meningitidis, which can be life-threatening or fatal [9][12] - Patients must complete or update meningococcal vaccination at least two weeks prior to the first dose of EPYSQLI [13][15] - Monitoring for early signs of meningococcal infection is critical, and treatment should be interrupted if serious infection occurs [16] Adverse Reactions - Common adverse reactions in PNH trials include headache, nasopharyngitis, back pain, and nausea [27] - In aHUS trials, frequent adverse reactions include headache, diarrhea, hypertension, and upper respiratory infection [27] - In gMG trials, musculoskeletal pain was the most frequently reported adverse reaction [28]

Since the publication of my last article , "Teva's Transformation: From Generics Leader To Branded Drug Innovator," Teva Pharmaceutical Industries Limited's (NYSE: TEVA ) stock price has risen by more than 25%. Despite the continued caution and even pessimism ofWith over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realm ...

TEL AVIV, Israel, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that Richard Francis, Teva's President and CEO, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025. The presentation will begin at 8:15 A.M. Pacific Time (11:15 A.M. Eastern Time). To access a live webcast of the presentation, visit Teva’s Investor Relations website at https://ir.tevapharm.com/Events-and-Presentations. An archived version of ...

TEL AVIV, Israel, Dec. 20, 2024 (GLOBE NEWSWIRE) --  Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its fourth quarter and full year 2024 financial results, as well as on its financial guidance for 2025, on Wednesday, January 29, 2025, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on the same day, at 8:00 a.m. ET. In order to participate, please register in advance here to obtain a local or toll-f ...

Teva Pharmaceutical Industries Ltd. TEVA and Sanofi SA’s SNY Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD).In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.BofA Securities raised the price target for Teva to $25 from $23 wit ...

Teva Pharmaceutical Industries Ltd. (TEVA) shares rallied 26.5% in the last trading session to close at $20.88. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 0.1% gain over the past four weeks.This jump in share price came after management reported positive results from a mid-stage study on its experimental anti-TL1A therapy, duvakitug, in Ulcerative Colitis and Crohn's disease, which are the two main types ...