Alvotech Stock Price, News & Analysis

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.

The FDA has accepted the Biologics License Application (BLA) for AVT04, a proposed biosimilar to Stelara® (ustekinumab), developed by Alvotech and Teva Pharmaceuticals. The regulatory review is expected to complete in the second half of 2023. AVT04 aims to treat inflammatory conditions and has shown therapeutic equivalence in clinical trials. This partnership was formed in August 2020 to commercialize Alvotech’s biosimilar products in the U.S. Both companies are focused on expanding access to cost-effective biosimilar treatments.

Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application (BLA) for Alvotech’s proposed biosimilar AVT04, a candidate to Stelara^® (ustekinumab), intended to treat various inflammatory conditions. The FDA’s review is expected to conclude in the second half of 2023. This development reflects Alvotech's capabilities in biosimilars and aims to enhance patient access to affordable treatments.

Alvotech (NASDAQ: ALVO) has received confirmation from the FDA regarding its license application for AVT02, targeting an approval decision by April 13, 2023. The FDA's review of AVT02 as an interchangeable biosimilar to Humira^® is complete, pending a successful facility reinspection scheduled for the first quarter of 2023. Alvotech anticipates the launch of AVT02 in the U.S. on July 1, 2023, having already launched it in 17 international markets and secured marketing approval in 35 countries.

Alvotech (NASDAQ: ALVO) has completed a private placement of approximately US$70 million in subordinated convertible bonds, correcting an earlier reported amount of US$59.7 million. The offering includes two tranches: Tranche A, denominated in ISK with a 15% annual payment-in-kind (PIK) coupon, and Tranche B, in USD with a 12.5% PIK coupon. Proceeds will primarily restructure a US$50 million unsecured loan from Alvogen, eliminating associated warrants. Bonds can be converted into shares at US$10 each in 2023 or 2024.