Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockho ...

Core Insights - The FDA has accepted a Biologic License Application for AVT03, a proposed biosimilar of Prolia and Xgeva developed by Alvotech, in collaboration with Dr. Reddy's Laboratories [1][2][5] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, established in 1984, focusing on providing access to affordable and innovative medicines across various therapeutic areas [8] - Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [12] Product Details - AVT03 is a human monoclonal antibody and biosimilar candidate to denosumab, indicated for the treatment of osteoporosis and prevention of skeletal-related events in patients with advanced malignancies [6][4] - The product is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL solution in a single-dose vial after FDA approval [5] Strategic Partnership - Dr. Reddy's and Alvotech entered into a License and Supply Agreement in May 2024, where Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy's handles registration and commercialization in applicable markets [5]

Core Insights - The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar of Prolia® and Xgeva® developed by Alvotech, in collaboration with Dr. Reddy's Laboratories [1][2][5] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, established in 1984, focusing on providing access to affordable and innovative medicines across various therapeutic areas [8] - Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates [12] Product Details - AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia® and Xgeva®, which are both denosumab but in different presentations, targeting osteoporosis and skeletal-related events in patients with advanced malignancies [6][4] - The product is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial after FDA approval [5] Strategic Partnership - In May 2024, Dr. Reddy's and Alvotech entered into a License and Supply Agreement for AVT03, where Alvotech is responsible for development and manufacturing, while Dr. Reddy's handles registration and commercialization in applicable markets, including the U.S. [5]

Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [3] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach and broad in-house capabilities [3] - Alvotech has launched two biosimilars and has a development pipeline that includes nine disclosed biosimilar candidates targeting various diseases such as autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [3] Strategic Partnerships - Alvotech has formed a network of strategic commercial partnerships to enhance its global reach and leverage local expertise in multiple markets, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [3] - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and several others across various regions [3] Upcoming Events - Alvotech will participate in Barclays 27th Annual Global Healthcare Conference in Miami, Florida, from March 11-13, 2025, with CEO Robert Wessman and the management team hosting one-on-one meetings [1] - A fireside chat is scheduled for March 12, 2025, at 9:30-9:55 am EDT, which will be accessible via an audio webcast for investors and the general public [2]

Core Viewpoint - Alvotech is set to release its financial results for the full year 2024 on March 26, 2024, and will hold a conference call for analysts on March 27, 2025, indicating ongoing engagement with investors and analysts [1][2]. Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space by providing high-quality, cost-effective products [4]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), which are marketed in multiple global markets [4]. - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [4]. Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships to enhance its global reach and leverage local expertise across various regions, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [4]. - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and Dr. Reddy's, among others, each covering unique products and territories [4].

Core Insights - Teva Pharmaceutical Industries and partner Alvotech announced that the FDA has agreed to review their AVTO6 treatment for eye disorders, which is a biosimilar that could compete with Regeneron Pharmaceuticals' Eylea [1][3] - Eylea, which is used to treat conditions such as wet Age-related Macular Degeneration, had projected U.S. sales of $4.77 billion in 2024 [1] - Teva and Alvotech have been in a strategic partnership since August 2020, focusing on the U.S. biosimilar drug market and are developing a higher-dose version of the treatment to compete with Eylea HD [2][3] Market Reaction - Following the announcement, Teva's shares increased by approximately 3%, while Alvotech's shares decreased by 0.8% [2] - Regeneron Pharmaceuticals' shares rose by about 1.7% in response to the news [2]

Core Insights - Alvotech and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea, with regulatory approval expected by Q4 2025 [1][2] - Eylea, a biologic for treating eye disorders, generated $4.77 billion in sales in the U.S. in 2024 [3] - Alvotech is also developing AVT29, another biosimilar candidate for Eylea HD, with Teva holding commercialization rights in the U.S. [2] Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market with a fully integrated approach [7] - The company has two approved biosimilars for Humira and Stelara and a pipeline of nine additional candidates targeting various diseases [7] - Alvotech has established strategic partnerships for global reach, including collaborations with Teva, STADA, and others across multiple regions [7] Product Details - AVT06 and AVT29 are recombinant fusion proteins targeting vascular endothelial growth factors (VEGF) to inhibit neovascularization and vascular permeability [5] - A confirmatory clinical study showed that AVT06 met its primary endpoint, demonstrating therapeutic equivalence and comparable safety to Eylea [4]

Core Viewpoint - Alvotech and Teva Pharmaceuticals have announced that the FDA has accepted the Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, marking a significant step towards providing U.S. patients access to this biosimilar treatment for inflammatory conditions [1][2]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes nine disclosed candidates targeting various diseases [9]. - Teva Pharmaceuticals is a global pharmaceutical leader with a commitment to improving health outcomes through innovation and generics, employing approximately 37,000 people across 57 markets [10]. Strategic Partnership - Alvotech and Teva entered a strategic partnership in August 2020 for the exclusive commercialization of five biosimilar candidates, which has since expanded to nine products [3]. - Alvotech is responsible for development and manufacturing, while Teva handles commercialization in the U.S., leveraging its extensive sales and marketing infrastructure [3]. Regulatory Progress - The FDA review process for AVT05 is expected to be completed in the fourth quarter of 2025, with the applications being the first for a biosimilar candidate to golimumab [1]. - Alvotech has previously announced positive results from clinical studies comparing AVT05 to Simponi, indicating its efficacy and safety [2]. Market Developments - Two biosimilars developed under the Alvotech-Teva partnership have received FDA approval: SIMLANDI (adalimumab-ryvk) in February 2024 and SELARSDI (ustekinumab-aekn) in April 2024, with market entry planned for May 2024 and February 2025, respectively [4].

Company Performance - Alvotech (ALVO) has returned approximately 0.6% year-to-date, outperforming the average loss of 5.2% in the Medical sector [4] - The Zacks Consensus Estimate for Alvotech's full-year earnings has increased by 280% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [3] - Alvotech is currently ranked 2 (Buy) in the Zacks Rank, suggesting it is poised to outperform the broader market in the next one to three months [3] Industry Comparison - Alvotech belongs to the Medical - Biomedical and Genetics industry, which has seen an average loss of about 14.8% year-to-date, indicating that ALVO is performing better than its peers in this specific industry [5] - In contrast, Becton Dickinson (BDX), another stock in the Medical sector, has a year-to-date return of 3.9% and is also ranked 2 (Buy) [4][5] - The Medical - Dental Supplies industry, to which Becton Dickinson belongs, has moved up by 3.8% year-to-date, ranking 72 among 16 industries [6]

Group 1: Nasdaq Biotechnology Index Inclusion - Alvotech's stock will be added to the Nasdaq Biotechnology Index (NBI) as part of the annual reconstitution, effective December 23, 2024 [5] - The Nasdaq Biotechnology Index includes companies classified as Biotechnology or Pharmaceuticals, calculated under a modified capitalization-weighted methodology [1] Group 2: Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with high-quality, cost-effective products [2] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), marketed in multiple global markets [2] - Alvotech's development pipeline includes nine disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [2] Group 3: Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships to enhance its global reach, including collaborations with Teva Pharmaceuticals, STADA Arzneimittel AG, and others across various regions [2] - Each partnership covers unique products and territories, leveraging local expertise in markets such as the U.S., Europe, Japan, and parts of Asia and South America [2]