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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines aimed at enhancing patient access to affordable treatments worldwide. Established in 2013, the company has committed itself to becoming a leader in biogenerics, focusing on the creation of cost-effective biosimilars that meet stringent quality standards. Alvotech operates through a fully integrated model, addressing every step from cell line development to commercial manufacturing.
Alvotech's headquarters in Reykjavik, Iceland hosts a state-of-the-art flexible manufacturing facility that underscores the company's commitment to high-quality and efficient production. The company's portfolio includes biosimilars for autoimmune disorders, eye conditions, osteoporosis, respiratory diseases, and cancer. Alvotech has successfully launched two biosimilars and is actively working on nine more candidates.
In recent developments, Alvotech announced positive top-line results for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and has received FDA approval for AVT04, a biosimilar to Stelara®. The company is also advancing in its U.S. strategic partnership with Teva Pharmaceuticals for the high-concentration interchangeable biosimilar to Humira®, marketed under Quallent’s private label. Financially, Alvotech reported increased revenues of $37 million in Q1 2024 and strengthened its position with a strategic refinancing transaction led by GoldenTree Asset Management, enhancing its financial flexibility and reducing upcoming debt maturities.
Alvotech's global reach is bolstered by strategic commercial partnerships with renowned pharmaceutical companies like Teva, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and many others. These collaborations extend across the United States, Europe, Japan, China, and several other regions, leveraging local expertise to provide expansive market access.
For more information on Alvotech and to stay updated with the latest news, visit www.alvotech.com.
Alvotech (NASDAQ: ALVO) will announce its full-year 2022 financial results after U.S. markets close on March 1, 2023. Following this, a business update conference call is scheduled for March 2, 2023, at 8:00 am ET. Investors and media can access the live webcast and subsequent replay for 90 days on Alvotech's investor website. Alvotech specializes in biosimilars aimed at treating various diseases, including autoimmune disorders, cancer, and respiratory diseases. The company aims to lead the biosimilar market with a pipeline of eight candidates and strategic partnerships across global markets.
Alvotech (Nasdaq: ALVO) has updated its market making agreement with Landsbankinn hf., effective February 15, 2023. This agreement, which has been in place since Alvotech's shares began trading in Iceland on June 23, 2022, ensures that Landsbankinn will make bids and offers for ALVO shares on Nasdaq Iceland.
The new terms raise the bidding and offering amounts from ISK 5 million to ISK 10 million, and the daily trading cap increases from ISK 10 million to ISK 20 million. The spread between bid and ask prices remains tied to the shares' trailing volatility.
Alvotech (NASDAQ: ALVO) announced the successful completion of a Private Share Placement, where 11,834,061 treasury shares were transferred to counterparties. The net cash proceeds will be used for general corporate purposes and to reduce reliance on the Standby Equity Purchase Agreement with YA II PN, Ltd. This transaction is directed solely into Iceland to qualified clients. Alvotech aims to be a global leader in biosimilar medicine, with a pipeline of eight candidates targeting various diseases. The company emphasizes that this communication does not constitute an offer to sell securities in the U.S.
Alvotech and STADA have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT04, a proposed biosimilar to Stelara (ustekinumab). This milestone could lead to a recommendation for approval by the EMA in the second half of 2023. AVT04 aims to provide an affordable treatment option for various inflammatory conditions. The partnership has previously launched high-concentration adalimumab in 16 countries. Alvotech's comprehensive biosimilar platform supports the development of multiple products, enhancing accessibility to biologic medicines across Europe.
Alvotech (NASDAQ: ALVO) has formed an exclusive partnership with Advanz Pharma for the commercialization of AVT23, a proposed biosimilar to Xolair® (omalizumab), across several regions including the UK, Canada, and Australia. Advanz will manage registration and commercial efforts, while Alvotech focuses on development and manufacturing. The addressable market for this product exceeds $1 billion, indicating significant revenue potential. AVT23 targets conditions such as allergic asthma and chronic spontaneous urticaria. However, it remains investigational and has not yet received regulatory approval.
Alvotech (NASDAQ: ALVO) and Bioventure have secured approval from the Saudi Food & Drug Authority (SFDA) for AVT02, a biosimilar to Humira®, now marketed as Simlandi™ in Saudi Arabia. This milestone represents a significant step in enhancing patient access to affordable biologics in the region, as Humira was a top-grossing pharmaceutical product with $21 billion in global sales. Alvotech will focus on development and manufacturing, while Bioventure handles commercialization. This strategic partnership aims to improve healthcare affordability and quality.
Alvotech (NASDAQ: ALVO) has successfully completed a private placement of approximately $137 million through the issuance of ordinary shares at a price of $11.57 per share. The placement occurred between January 19 and January 22, 2023, with expected settlement on February 10, 2023. The shares will be derived from treasury shares held by Alvotech's subsidiary and were offered exclusively in Iceland to professional clients in compliance with local laws. Proceeds will be utilized for general corporate purposes, which may enhance the company’s operational capabilities in the biosimilar medicines sector.
Alvotech (NASDAQ: ALVO) has expanded its exclusive commercialization partnership with Fuji Pharma Co., Ltd. in Japan, adding a new biosimilar candidate. This follows a recent application for marketing approval in Japan for a previously developed candidate. The collaboration aims to boost patient access to biologic medicines in the rapidly growing Japanese market. Alvotech and Fuji have worked together since November 2018, with the current agreement now covering seven biosimilars.
Alvotech (NASDAQ: ALVO) has announced the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab), aiming to evaluate its pharmacokinetics, safety, and tolerability in healthy adults. This marks the company's fifth biosimilar candidate to enter clinical studies, following its commitment to expand access to affordable biologics. The global net revenues for Simponi and Simponi Aria exceeded $2.2 billion in the last year. Alvotech's pipeline includes eight products targeting various diseases, with its first launched product being a biosimilar to Humira®.
Alvotech (NASDAQ: ALVO) has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab), assessing its pharmacokinetics, safety, and tolerability in healthy adults. The candidate addresses chronic inflammatory diseases, and combined net revenues from Simponi® and Simponi Aria® exceeded $2.2 billion up to October 2022. Alvotech aims to enhance access to affordable biologics through its growing portfolio of eight products targeting various ailments. Regulatory approval for AVT05 is pending.
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