REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibe ...

Regulatory Approvals and Partnerships - Teva and Alvotech announced FDA approval of SIMLANDI® (adalimumab-ryvk) as an interchangeable biosimilar to Humira® for multiple conditions, with availability in the U.S. starting May 21, 2024[53]. - FDA approved SELARSDITM (ustekinumab-aekn) for subcutaneous use as a biosimilar to Stelara® for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients[54]. - Teva entered a strategic partnership with Samsung Bioepis for the commercialization of EPYSQLI® (eculizumab) in the U.S. for treating PNH, aHUS, and gMG[55]. - Teva announced a collaboration with Formycon for the commercialization of FYB203, a biosimilar candidate to Eylea® in Europe and other regions[56]. Intellectual Property and Patent Protection - AUSTEDO® (deutetrabenazine) is protected by 14 Orange Book patents expiring between 2031 and 2038, with agreements allowing generic sales starting in April 2033[65]. - UZEDY® (risperidone) was launched in the U.S. in May 2023, protected by four Orange Book patents expiring between 2027 and 2040[67]. - AJOVY® (fremanezumab-vfrm) is the only anti-CGRP subcutaneous product indicated for quarterly treatment, with patents expiring in 2026 at the earliest and extensions until 2031[69]. - Teva has 18 patents for BENDEKA expiring in 2026 and 2031, with recent court affirmations of patent validity[10]. Business Strategy and Operations - Teva intends to divest its API business, aligning with its Pivot to Growth strategy, announced on January 31, 2024[80]. - In 2024, Teva produced approximately 72 billion tablets and capsules, and 547 million sterile units across 34 plants in 27 countries[96]. - Teva's R&D pipeline includes over 1,000 generic products in various stages of approval, focusing on high-value generics and complex formulations[84]. - The innovative medicines pipeline includes projects in neuroscience and immunology, with collaborations with Sanofi and Modag[91]. Employee and Workforce Management - As of December 31, 2024, the total global workforce consisted of 36,830 employees, with a full-time equivalent of 36,167[119]. - The company reported a total of 33,892 full-time employees, a decrease from 35,001 in 2023[120]. - The employee turnover rate is monitored continuously as an important indicator of retention and engagement[120]. - The company has implemented a new talent development system based on AI capabilities, rolled out to approximately 12,000 employees globally by the end of 2024[132]. Financial Performance and Market Challenges - In 2024, total revenues from sales of generic medicines were $9,461 million, representing 57.2% of total revenues[196]. - The U.S. generics market is expected to face significant adverse challenges, including limitations on pricing influence and decreased value from future launches[197]. - Pricing pressures from customers and market competition are expected to continue affecting revenues and profits from generic products[198]. - The company may face challenges in raising additional funds in the future, impacting growth strategies and potential acquisitions[226]. Compliance and Regulatory Environment - The company is subject to extensive regulation by the FDA and DEA, which governs the development, manufacture, and distribution of its products, with noncompliance potentially leading to severe penalties[141]. - The Hatch-Waxman Act provides a five-year data exclusivity for new chemical entities and a three-year market exclusivity for certain NDAs, impacting the company's product approval timelines[145]. - The company is required to rebate 13% of the average manufacturer price for generic drugs and 23.1% or the difference between the average manufacturer price and the commercial best price for products marketed under NDAs or BLAs[155]. - The company is subject to inspections and compliance reviews by the FDA, which can impact its ability to market new products[142]. Supply Chain and Operational Risks - Supply chain disruptions due to macroeconomic issues and regulatory actions have impacted the company's ability to meet demand[230]. - The company is implementing measures to ensure continuous supply amidst increasing medicine shortages globally, which may involve legal and regulatory compliance challenges[245]. - Supply chain interruptions, particularly for key raw materials, could adversely affect cash flows and operational results, especially given the reliance on single sources for some materials[244]. - The complexity of product manufacturing processes and reliance on third-party suppliers may lead to operational disruptions if not managed effectively[243]. Market Competition and Product Performance - COPAXONE faces increasing competition from generic versions and other MS treatments, impacting its market position[10]. - AJOVY faces strong competition from two recently launched products and emerging oral CGRP therapies, impacting market share[213]. - UZEDY, a late entrant in the long-acting injectables market, faces significant competition from established products, which may hinder growth[213]. - The market for biosimilars is facing intense competition, and the company aims to capitalize on late-stage biosimilar opportunities[209].

Brendan, a Pennsylvanian by birth:-Completed a Ph.D. at Stanford University in the field of organic synthesis (2009). -Worked for a major pharmaceutical company (Merck, 2009-2013).-Worked in biotech including start-ups (Theravance/Aspira) prior to securing employment at Caltech.-First employee and co-founder of 1200 Pharma as it spun out of Caltech garnering major investment (into the 8 figures).-Remains an avid investor, focused on market trends and especially biotechnology stocks.Analyst’s Disclosure: I/w ...

Teva Pharmaceutical Industries (TEVA) reported fourth-quarter 2024 adjusted earnings of 71 cents per share, which beat the Zacks Consensus Estimate of 70 cents. Adjusted earnings declined 29% year over year.See the Zacks Earnings Calendar to stay ahead of market-making news.Revenues for the fourth quarter were $4.23 billion, beating the Zacks Consensus Estimate of $4.10 billion. However, total revenues declined 5% from the year-ago quarter on both reported and constant currency basis. The decline is mainly ...

Stock Performance - Shares of Teva Pharmaceutical Industries lost 13.5% as of 1:15 p.m. ET, underperforming the S&P 500 and Nasdaq Composite, which lost 0.5% and 0.9%, respectively [1] Financial Results - Teva reported Q4 sales of $4.2 billion and fiscal year 2024 sales of $16.5 billion, up from 2023's revenue of $15.9 billion, slightly exceeding expectations [2] - Q4 EPS was $0.71, down significantly from Q4 2023's $1.00 but slightly exceeding the expected $0.70 [2] Guidance and Investor Sentiment - The company's 2025 EPS forecast disappointed investors, with the high end of the range ($2.65) coming in below the expected $2.76 [3] Strategic Initiatives - Teva is implementing its "Pivot to Growth strategy," focusing on cost reduction through reorganization, generics, and R&D pipeline success, though the latter has no guarantees or clear timeline [4] - The company has key drugs in later stages of trials, including treatments for ulcerative colitis and Crohn's disease, which show promise but require significant effort [5]

U.S. stocks traded lower toward the end of trading, with the Nasdaq Composite falling around 1% on Wednesday.The Dow traded down 0.16% to 44,778.55 while the NASDAQ fell 1% to 19,537.19. The S&P 500 also fell, dropping, 0.54% to 6,034.67.Check This Out: Jim Cramer: This Industrial Stock Is ‘Absolutely Terrific’, First Solar Is ‘Very Inexpensive’Leading and Lagging SectorsConsumer staples shares surged by 0.7% on Wednesday.In trading on Wednesday, information technology shares fell by 1.9%.Top HeadlineU.S. c ...

Teva Pharmaceutical Industries Limited (NYSE:TEVA) Q4 2024 Earnings Conference Call January 29, 2025 8:00 AM ET Company Participants Christopher Stevo - SVP, IR Richard Francis - President & CEO Eric Hughes - Head of R&D & Chief Medical Officer Eli Kalif - CFO Conference Call Participants Umer Raffat - Evercore ISI Jason Gerberry - Bank of America David Amsellem - Piper Sandler Balaji Prasad - Barclays Ash Verma - UBS Yifeng Liu - HSBC Glen Santangelo - Jefferies Chris Schulz - J.P. Morgan Operator Hello, a ...

Teva Pharmaceutical Industries Ltd. (TEVA) reported $4.23 billion in revenue for the quarter ended December 2024, representing a year-over-year decline of 5.1%. EPS of $0.71 for the same period compares to $1.00 a year ago.The reported revenue represents a surprise of +3.13% over the Zacks Consensus Estimate of $4.1 billion. With the consensus EPS estimate being $0.70, the EPS surprise was +1.43%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street exp ...

Teva Pharmaceutical Industries (TEVA) Q4 2024 Earnings Call January 29, 2025 08:00 AM ET Company Participants Christopher Stevo - SVP - Head of IRRichard Francis - President & CEOEric Hughes - Executive VP of Global R&D and Chief Medical OfficerEli Kalif - Chief Financial OfficerAshwani Verma - Executive DirectorGlen Santangelo - Managing DirectorChris Schott - Managing Director Conference Call Participants Umer Raffat - AnalystJason Gerberry - AnalystDavid Amsellem - Sr. Research AnalystBalaji Prasad - Ana ...

Non-GAAP Financial Measures This presentation includes certain non-GAAP financial measures as defined by SEC rules. Please see our press release reporting our financial results for 2024, as well as our Annual Report on Form 10-K for the year ended December 31, 2024, for a reconciliation of the non-GAAP financial measures to their nearest GAAP equivalents. Management believes that such non-GAAP financial measures provide useful information to investors to facilitate their understanding of our business becaus ...