Alvotech develops and manufactures biosimilar medicines for global markets. Company news centers on its approved and marketed biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, along with disclosed candidates for autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Recurring updates cover financial results, annual reporting, FDA interactions tied to the Reykjavik manufacturing facility, biosimilar study results such as AVT80, supply and commercialization partnerships, intellectual-property settlements, executive changes and manufacturing-platform developments. Alvotech also reports on global commercial reach through partners across the United States, Europe, Japan, China and other international markets.
Alvotech reported a 114% increase in total revenue for the full year 2022, reaching $85.0 million compared to $39.7 million in 2021. The growth was driven by milestone and product revenue from the commercialization of AVT02, a biosimilar to Humira®, across 17 countries. The company advanced three biosimilar candidates into clinical development and submitted marketing applications for AVT04, a proposed biosimilar to Stelara®. Despite the revenue growth, Alvotech reported a net loss of $513.6 million. The FDA has set an action date of April 13, 2023, for AVT02's licensing application, and a reinspection of the Reykjavik manufacturing site is scheduled for March 6, 2023.
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®.