Alvotech Stock Price, News & Analysis

Alvotech (NASDAQ: ALVO) reported exceptional financial results for 2024, with total revenues reaching $492 million, a 427% increase year-over-year. Product revenues surged 462% to $273 million, while the company achieved positive Adjusted EBITDA of $108.3 million, compared to negative $291 million in 2023.

Key highlights include the successful submission and acceptance of three new proposed biosimilars in major global markets, the launch of SELARSDI™ (ustekinumab-aekn) in the U.S., and the acquisition of XBrane's R&D operations. The company reported an operating profit of $69.6 million, marking a significant improvement from the previous year's loss of $354.9 million.

Despite strong operational performance, Alvotech recorded a net loss of $231.9 million ($0.87 per share) for 2024, primarily due to finance costs and debt refinancing impacts. The company ended the year with $51.4 million in cash and cash equivalents.

Alvotech (NASDAQ: ALVO), along with Kashiv Biosciences and Advanz Pharma, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted their marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab).

The biosimilar is intended for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. The original drug, Xolair, generated global sales of approximately $4.4 billion in 2024.

This development follows strategic partnerships formed in 2023, including a commercialization agreement between Alvotech and Advanz Pharma for AVT23 in February, an expanded partnership in May covering five additional biosimilar candidates, and a licensing agreement between Alvotech and Kashiv in October.

Alvotech (NASDAQ: ALVO) has announced the acquisition of Xbrane Biopharma AB's R&D operations and biosimilar candidate XB003 for approximately SEK 275 million (USD 27 million). The deal includes Xbrane's R&D facilities at Campus Solna, Karolinska Institute, Stockholm, establishing Alvotech's presence in the Swedish life science sector.

The purchase will be completed through SEK 102.2 million in cash and SEK 172.8 million in debt assumption, with creditors agreeing to accept SEK 152.8 million in Alvotech equity shares. The acquisition is expected to close in April 2025, pending regulatory and shareholder approvals.

This strategic move expands Alvotech's development capabilities and strengthens its position in the biosimilars market. The company currently operates with 19 commercial partners worldwide and has invested approximately $1.9 billion in its biosimilars platform since 2013. Xbrane will retain some pre-clinical development programs and continue as a listed company, maintaining over 75% of its portfolio's addressable market.

The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.

Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.

Alvotech (NASDAQ: ALVO) and Dr. Reddy's announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). The biosimilar aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.

Under their License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in key markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has announced its participation in the Barclays 27th Annual Global Healthcare Conference in Miami, Florida from March 11-13, 2025.

The company's founder, chairman and CEO Robert Wessman, along with management team members, will conduct one-on-one meetings during the event. Additionally, Alvotech will participate in a fireside chat on March 12, 2025, from 9:30-9:55 am EDT. The session will be available via audio webcast in the Events Section of Alvotech's Investor Portal, with the recording accessible for 90 days post-event.

Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.

The announcement follows positive top-line results from clinical studies in April 2024 for rheumatoid arthritis patients and pharmacokinetic studies in November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now encompasses nine biosimilar products.

The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024. SIMLANDI launched in May 2024, while SELARSDITM is planned for U.S. market entry in February 2025.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its full year 2024 financial results announcement for March 26, 2025, after U.S. markets close. The company will host an analyst conference call on March 27, 2025, at 8:00 am ET (12 noon GMT).

A live audio webcast of the conference call will be available to investors, media, and the public. The webcast recording will remain accessible for 90 days after the event on Alvotech's investor website. Additionally, the company will host a local investor event in Icelandic at Sæmundargata 15-19, Reykjavik, on March 27, 2025, at 4:00 pm GMT.

Teva Pharmaceuticals and Alvotech have announced the U.S. availability of SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara®. The FDA approved SELARSDI in October 2024 for treating psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis in adults and certain pediatric patients.

SELARSDI is the second biosimilar launched under the Teva-Alvotech partnership, which includes nine products. The FDA has provisionally determined SELARSDI's interchangeability with Stelara® following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.

The drug is available in four presentations: 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in single-dose vials for subcutaneous injection, and 130 mg/26 mL for intravenous infusion. Alvotech develops and manufactures the product, while Teva handles U.S. commercialization.