Alvotech Stock Price, News & Analysis

Alvotech (NASDAQ: ALVO) reported strong financial results for the first nine months of 2024. Total revenues increased by $300 million to $339 million compared to 2023. Product revenues grew over four-fold to $128 million, while license and other revenues rose by $203 million to $211 million. The company achieved positive adjusted EBITDA of $87 million, compared to negative $225 million in 2023. Marketing applications were accepted in Europe for biosimilar candidates to Prolia®/Xgeva® and Simponi®. The company initiated a confirmatory clinical study for AVT16, a biosimilar candidate to Entyvio®.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, announced its participation in two upcoming healthcare conferences. The company will attend Citi's Global Healthcare Conference in Miami on December 4, 2024, and Evercore's HealthCONx Conference in Coral Gables on December 5, 2024. Management will conduct one-on-one meetings at both events and participate in a fire-side chat at Evercore's conference at 12:55 ET. A live audio webcast of the fire-side chat will be available to investors through Alvotech's website, with the recording accessible for 90 days post-event.

Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi® (golimumab). This marks the first globally announced marketing authorization application for a Simponi biosimilar candidate. The approval process is expected to complete in Q4 2025.

The companies expanded their partnership in May to include AVT05 and other biosimilar candidates. Positive results from both a confirmatory clinical study in rheumatoid arthritis patients and a pharmacokinetic study in healthy participants were previously announced in April 2024 and November 2023, respectively.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its financial results release for the first nine months of 2024. The results will be announced after U.S. markets close on November 13, 2024, followed by an analyst conference call on November 14, 2024, at 8:00 am ET. The conference call will be accessible via webcast through Alvotech's investor portal, with replay available for 90 days after the event.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, announced its participation in the Jefferies London Healthcare Conference on November 19-20, 2024. The company's management will conduct one-on-one meetings during both days and deliver a presentation on November 19 at 9:00 AM GMT. An audio webcast will be available in the Investors Section of Alvotech's website, with the recording accessible for 90 days post-event.

Alvotech and Teva announce FDA approval of SELARSDI™ (ustekinumab-aekn) 130 mg/26 mL in a single-dose vial for intravenous infusion. This expands the label to include treatment of adults with Crohn's disease and ulcerative colitis. The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024.

SELARSDI's U.S. launch for all indications is expected in Q1 2025. This approval aligns SELARSDI's label with the indications of the reference product Stelara® (ustekinumab). Alvotech developed SELARSDI using Sp2/0 cells and a continuous perfusion process, similar to the reference product. Ustekinumab targets the p40 protein, important in treating immune-mediated diseases.

Alvotech and Teva's partnership now includes nine products, with Alvotech handling development and manufacturing, and Teva responsible for U.S. commercialization.

Alvotech (NASDAQ: ALVO) announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). This marks a significant step towards making AVT03 available in Europe. Alvotech develops and manufactures AVT03, while STADA Arzneimittel AG and Dr. Reddy's Laboratories SA have agreements for its commercialization in Europe.

In July 2024, Alvotech reported positive topline results from confirmatory studies demonstrating clinical similarity of AVT03 to Prolia and Xgeva. The European denosumab market is currently valued at approximately US$1 billion. Biosimilar competition could expand patient access at the same or lower costs, addressing the significant burden of osteoporosis in Europe, where an estimated 32 million individuals are affected.

Alvotech (NASDAQ: ALVO) announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). This marks a significant step towards making AVT03 available in Europe.

The company recently reported positive topline results from confirmatory studies for AVT03, demonstrating clinical similarity to Prolia in efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech develops and manufactures AVT03, with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA as commercial partners in Europe.

The European denosumab market is valued at approximately US$1 billion. Biosimilar competition could expand patient access at lower costs, addressing the significant burden of osteoporosis in Europe, where an estimated 32 million individuals are affected, but 70% of eligible women do not receive treatment.

Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT16, a proposed biosimilar to Entyvio® (vedolizumab). The study aims to demonstrate comparative efficacy, safety, and immunogenicity in participants aged 18-80 with moderate to severe active Ulcerative Colitis. Alvotech is one of only two companies known to have started such a study for an Entyvio biosimilar.

Entyvio, with global sales of about $5.4 billion in the last 12 months until June 30, 2024, is used to treat Ulcerative Colitis and Crohn's disease. The AVT16-GL-C01 study has a double-blind parallel design with two arms, comparing AVT16 to Entyvio.

Alvotech's growing pipeline includes biosimilars targeting autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. The company expects to file marketing applications for three biosimilar candidates in 2024, with AVT16 being one of six disclosed biosimilar programs in earlier development stages.