Alvotech(ALVO)
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Granting of Stock Options and Vesting of Restricted Share Units
Globenewswire· 2025-07-01 23:54
Core Points - The stock option grants aim to align the long-term interests of the board members with those of the Company [2] - Four independent board directors received stock option grants allowing the purchase of up to 24,784 shares each [1] - The exercise price for the stock options is set at USD 9.28 per share [5] Summary by Sections Stock Option Grants - The stock options are part of the Company's Equity Incentive Plan approved on June 13, 2022 [2] - The options are subject to a three-year vesting period, with one-third vesting each year starting from the AGM where the options were awarded [5] - The options can only be exercised if the grantee remains a board member at the time of vesting [5] Financial Details - The exercise price is determined by the opening price of the Company's ordinary shares on the Nasdaq on the grant date, which is June 25, 2025 [3] - Filings related to the vested RSUs of the independent board directors have been made with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) [2]
Alvotech and Advanz Pharma Enter into European Supply and Commercialization Agreement for Biosimilar Candidate to Cimzia® (certolizumab pegol)
Globenewswire· 2025-07-01 08:00
Core Insights - Alvotech and Advanz Pharma have entered into a supply and commercialization agreement for AVT10, a biosimilar candidate to Cimzia® (certolizumab pegol) [1][3] - This agreement is significant as AVT10 is the only biosimilar candidate referencing Cimzia® under development globally, targeting chronic rheumatic diseases [2][3] - The partnership aims to expand access to high-quality biologics for patients in Europe, with plans to launch their first biosimilars in Q4 2025 [4] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, with a pipeline that includes eight disclosed biosimilar candidates for various diseases [6] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries and a diverse product portfolio [7][8] Market Context - Cimzia® generated worldwide sales of US$2.3 billion in 2024, indicating a substantial market opportunity for Alvotech's biosimilar candidate [3] - The strategic partnership between Alvotech and Advanz Pharma is expected to enhance their biosimilars pipeline and strengthen their market position in Europe [3][4]
Alvotech's Lenders Lower Interest on Senior Secured Term Loan Facility
GlobeNewswire News Room· 2025-06-26 08:15
Core Viewpoint - Alvotech has successfully negotiated a reduction in the interest rate on its senior secured term loan facility, resulting in significant cost savings and reflecting improved financial performance and operational efficiency [1][2][3] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [4] - The company has launched two biosimilars and has a pipeline of nine disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [4] Financial Details - The senior secured term loan facility, originally funded in July 2024, has been restructured to lower the interest rate from SOFR plus 6.5% to SOFR plus 6.0%, simplifying the capital structure by consolidating two tranches into one [3] - The estimated reduction in interest payments for the first year is approximately US$8.2 million, contributing to a more favorable financial outlook [1][3] - As of June 25, 2025, the balance of the facility is approximately $1,081 million, with a cash balance of around $152 million [3] Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships across various regions, including the United States, Europe, and Asia, to enhance its market reach and leverage local expertise [4]
Alvotech’s Lenders Lower Interest on Senior Secured Term Loan Facility
Globenewswire· 2025-06-26 08:15
Core Viewpoint - Alvotech has successfully negotiated a reduction in the interest rate on its senior secured term loan facility, resulting in significant cost savings and reflecting improved financial performance and operational efficiency [1][2][3]. Financial Performance - Alvotech's lenders have agreed to lower the interest payments by an estimated US$8.2 million in the first year due to the company's sustained operational improvements [1]. - The company reported significant revenue growth, operating profits, and positive adjusted EBITDA over the past year, indicating strong financial health [2]. Loan Facility Details - The senior secured term loan facility, originally funded in July 2024, consists of a $900 million first tranche and a $65 million second tranche, which have now been consolidated into a single tranche [3]. - The new interest rate for the facility is set at SOFR plus 6.0% per annum, down from SOFR plus 6.5% for the first tranche and SOFR plus 10.5% for the second tranche [3]. - As of June 25, 2025, the balance of the facility is approximately $1,081 million, with a cash balance of approximately $152 million [3]. Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [4]. - The company has launched two biosimilars and has a pipeline of nine disclosed biosimilar candidates targeting various diseases [4]. - Alvotech has established strategic commercial partnerships across multiple regions, including the United States, Europe, and Asia, to enhance its market reach [4]. Asset Management Partner - GoldenTree Asset Management, which manages $58 billion for institutional investors, is one of the lenders involved in the refinancing agreement with Alvotech [5].
Main Results of 2025 Annual and Extraordinary General Meeting
Globenewswire· 2025-06-25 20:45
Group 1 - The 2025 Annual and Extraordinary General Meeting of Alvotech was held on June 25, 2025, in Luxembourg [1] - All draft resolutions on the agenda of the 2025 AGM were approved [1] - Notarized meeting minutes and voting results will be published on the Company's special web portal [1]
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
GlobeNewswire News Room· 2025-06-25 08:00
Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) who were symptomatic despite H1 antihistamine treatment [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a confirmatory dose of 300 mg over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of the study results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted the milestone in expanding patient access to specialty medicines in key markets [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing to the European Medicines Agency (EMA) expected by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with a pipeline that includes nine disclosed biosimilar candidates targeting various therapeutic areas [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a robust infrastructure for R&D, clinical, manufacturing, and regulatory capabilities [16] - Advanz Pharma aims to improve patient lives through specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [14]
Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)
Globenewswire· 2025-06-25 08:00
Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a 300 mg dose over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of these results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted that the results mark a significant milestone in expanding access to specialty medicines [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing expected with the European Medicines Agency (EMA) by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma and other conditions [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a strong focus on biosimilars and advanced clinical-stage assets [16] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a global presence in over 90 countries [14]
European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)
Globenewswire· 2025-06-23 08:00
Core Viewpoint - Alvotech and Advanz Pharma have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval for AVT06, a proposed biosimilar to Eylea® [1][5] Group 1: Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines [11] - Advanz Pharma is a UK-based pharmaceutical company specializing in specialty, hospital, and rare disease medicines [13] Group 2: Product Details - AVT06 is intended for treating various eye disorders, including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) [4][8] - The global sales of Eylea® were approximately US$9 billion in 2024, with one-third of these sales occurring in Europe [5] Group 3: Clinical Study and Development - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6] - Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, with Advanz holding distribution rights for both biosimilar candidates [7]
European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)
Globenewswire· 2025-06-23 08:00
Core Viewpoint - Alvotech and Advanz Pharma have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of AVT06, a proposed biosimilar to Eylea® [1][5]. 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 eight candidates targeting various diseases [11][12]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [13]. Product Details - AVT06 is intended for treating adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization [4][8]. - In 2024, global sales of Eylea® were approximately US$9 billion, with one-third of these sales occurring in Europe [5]. Clinical Study Results - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6]. Commercialization Rights - Alvotech is responsible for the development and commercial supply of AVT06, while Advanz Pharma holds exclusive commercialization rights in most European countries [5][7].
Alvotech's Private Placement Completed with Delivery of SDRs and Shares to Investors
Globenewswire· 2025-06-11 20:20
Core Insights - Alvotech has successfully completed a private placement aimed at Swedish and international institutional investors, with participation from approximately 40 institutional investors [1][2] - The placement saw about 60% of demand from investors based in Sweden, Norway, or the UK, and around 30% from US-based funds, indicating a strong interest from both European and American markets [1] - Over 80% of the shares and Swedish Depositary Receipts (SDRs) allocated were sold to new investors who were not previously shareholders in Alvotech, enhancing the company's shareholder base [1][2] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to lead the biosimilars industry with high-quality, cost-effective products [13] - The company has two approved biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), and has a pipeline of nine disclosed biosimilar candidates for various diseases [13] - Alvotech has established strategic commercial partnerships across multiple regions, including the US, Europe, and Asia, to enhance its market reach and leverage local expertise [13] Shareholder Base and Market Impact - The recent private placement is expected to diversify and strengthen Alvotech's shareholder base, increasing the free float of SDRs on Nasdaq Stockholm, where approximately 8.5 million SDRs are already trading [2] - The transfer of 7.5 million treasury shares from Alvotech's subsidiary to the new investors has been completed, indicating a significant movement of shares within the market [3]