Israel-based pharmaceutical giant Teva Pharmaceutical Industries Ltd (NYSE:TEVA) is preparing for its latest quarterly earnings report, due out before the open Wednesday, Jan. 29. The stock snapped its positive post-earnings streak in November with a 7.1% loss, marking its first negative earnings reaction in six quarters. This time around, analysts expect the company to post earnings of 70 cents per share, and a 7.3% decrease in revenue from a year ago, per Reuters. On the charts, TEVA is still above its De ...

FDA Review and Biosimilar Development - The FDA has accepted Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi and Simponi Aria (golimumab), with the review process expected to be completed in Q4 2025 [1] - AVT05 is the first biosimilar candidate to golimumab to have its BLA filings accepted in the U S [1] - Alvotech's in-house capability to match the cell line and process used to manufacture the reference biologic has provided a significant advantage in developing AVT05 [2] Strategic Partnership and Commercialization - Alvotech and Teva Pharmaceuticals entered into a strategic partnership in August 2020 for the exclusive commercialization of five biosimilar product candidates, which has since expanded to include nine products [3] - Under the partnership, Alvotech handles development and manufacturing, while Teva is responsible for commercialization in the U S [3] - Two biosimilars developed under the partnership, SIMLANDI (adalimumab-ryvk) and SELARSDI (ustekinumab-aekn), have already received FDA approval [4] Clinical and Regulatory Progress - Alvotech announced positive top-line results from a confirmatory clinical study comparing AVT05 to Simponi in patients with moderate to severe rheumatoid arthritis in April 2024 [2] - A pharmacokinetic study comparing AVT05 to Simponi in healthy adults also showed positive results in November 2023 [2] - SIMLANDI, a biosimilar to Humira, was launched in the U S in May 2024, while SELARSDI, a biosimilar to Stelara, is planned for U S market entry in February 2025 [4] Product Pipeline and Market Reach - Alvotech's current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [9] - The company has formed a network of strategic commercial partnerships to provide global reach, covering markets in the U S, Europe, Japan, China, and other regions [9] - SIMLANDI and SELARSDI are already approved and marketed in multiple global markets under various brand names [6][7] Industry Impact and Future Outlook - Biosimilars are becoming an integral part of the healthcare ecosystem, offering cost-saving options and better outcomes for patients with inflammatory conditions [2] - The strategic partnership between Alvotech and Teva underscores the commitment to expanding access to biosimilars and leveraging Teva's extensive sales and marketing infrastructure [3] - The FDA's acceptance of AVT05's BLA filings marks a significant step toward providing U S patients with access to biosimilar golimumab [1][2]

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 ...