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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company dedicated to improving patient access to affordable biologic medicines through the development, manufacturing, and commercialization of high-quality biosimilars. Founded in 2013, Alvotech operates as a fully integrated organization, controlling every step of the biosimilar value chain, from cell line development to large-scale commercial production. Headquartered in Reykjavik, Iceland, the company leverages its state-of-the-art manufacturing facilities and R&D capabilities across Europe to ensure cost-effective and timely delivery of its products.
Alvotech’s core mission is to transform access to life-altering therapies by addressing the rising costs of biologic treatments. The company specializes in biosimilars, which are highly similar, clinically equivalent, and more cost-effective alternatives to branded biologic drugs. Its portfolio spans multiple therapeutic areas, including autoimmune disorders, oncology, respiratory diseases, osteoporosis, and ophthalmology. Two of its biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), have already been approved and launched in key global markets, with several others in advanced stages of development.
End-to-End Capabilities and Competitive Advantage
Alvotech’s vertically integrated approach is a cornerstone of its business model, enabling it to maintain complete control over the biosimilar development process. This includes proprietary cell line development, clinical trials, regulatory submissions, and commercial manufacturing. Its flexible manufacturing platform in Reykjavik is designed to accommodate the production of multiple biosimilar candidates simultaneously, ensuring scalability and cost efficiency. This operational model not only reduces time-to-market but also ensures consistent product quality, a critical factor in gaining regulatory and market acceptance.
Global Partnerships and Market Reach
To maximize its global footprint, Alvotech has established a robust network of strategic partnerships with leading pharmaceutical companies, including Teva Pharmaceuticals, Stada Arzneimittel AG, and Advanz Pharma. These collaborations allow Alvotech to leverage local expertise and distribution networks in regions such as North America, Europe, Asia, and South America. This strategy has enabled the company to navigate complex regulatory landscapes and accelerate the commercialization of its biosimilars in diverse markets.
Pipeline and Future Growth
Alvotech’s development pipeline includes nine disclosed biosimilar candidates targeting high-demand biologics such as Eylea® (aflibercept), Prolia®/Xgeva® (denosumab), and Simponi® (golimumab). These candidates address critical therapeutic areas, including autoimmune diseases, retinal disorders, and bone-related conditions. The company’s ongoing clinical trials and regulatory filings demonstrate its commitment to expanding its portfolio and delivering innovative, cost-effective solutions to patients worldwide.
Industry Challenges and Differentiation
Operating in the highly competitive biosimilars market, Alvotech faces challenges such as stringent regulatory requirements, the complexities of biologic manufacturing, and competition from both branded biologics and other biosimilar manufacturers. However, its integrated platform, focus on high-value therapeutic areas, and strategic partnerships position it as a strong contender in the global biosimilars landscape.
Through its unwavering commitment to quality, innovation, and accessibility, Alvotech continues to play a pivotal role in addressing the global healthcare challenge of rising biologic drug costs, making life-altering therapies more accessible to patients worldwide.
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.
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea® (aflibercept). The regulatory approval process is expected to complete in Q4 2025.
AVT06 is designed to treat eye disorders that can lead to vision loss or blindness. In January 2024, Alvotech reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea®, meeting its primary endpoint and demonstrating therapeutic equivalence and comparable safety.
Additionally, Alvotech is developing AVT29, a biosimilar candidate for Eylea® HD (8 mg), with Teva holding U.S. commercialization rights. Eylea® sales (low dose and HD combined) in the U.S. reached $4.77 billion in 2024.
Alvotech (NASDAQ: ALVO) 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 filing acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from a confirmatory clinical study in April 2024 comparing AVT05 with Simponi® in rheumatoid arthritis patients, and successful pharmacokinetic study results from November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now includes 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.
Alvotech (NASDAQ: ALVO) announced its addition to the Nasdaq Biotechnology Index (NBI), effective December 23, 2024, as part of the index's annual reconstitution. The inclusion reflects Alvotech's meeting of eligibility requirements, including minimum market capitalization and average daily trading volume criteria. The NBI comprises Nasdaq-listed companies classified as Biotechnology or Pharmaceuticals according to the Industry Classification Benchmark and is calculated using a modified capitalization-weighted methodology.
Senti Biosciences (SNTI) announced the first patient dosing in a clinical trial of SN301A for hepatocellular carcinoma (HCC) in mainland China, in collaboration with Celest Therapeutics. The trial aims to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of SN301A, a CAR-NK cell therapy utilizing Senti's Gene Circuit platform, in patients with advanced GPC3-expressing HCC across multiple dose cohorts.
Celest is leading the clinical development, operations, and manufacturing in China, with Senti Bio providing technical and strategic input. The study will assess adverse events, dose-limiting toxicities, and efficacy using standard liver cancer response criteria. The collaboration may expand to Hong Kong, Macau, and Taiwan, while Senti Bio retains rights outside these regions.
Dominion Energy (NYSE: D) announced that Diane Leopold, Executive Vice President and Chief Operating Officer, will retire on June 1, 2025, after a 36-year career in energy, including 30 years at Dominion. During the transition, Ed Baine will become President-Utility Operations and Dominion Energy Virginia, while Eric Carr will become Chief Nuclear Officer and President-Nuclear Operations and Contracted Energy. Leopold will maintain oversight of major construction projects including the Coastal Virginia Offshore Wind project and Charybdis. She joined Dominion in 1995, became an officer in 2004, and has held various executive roles before assuming her current position in 2020.
Lazydays Holdings (Nasdaq: GORV) reported challenging Q3 2024 results with total revenue declining to $213.5 million from $280.7 million in Q3 2023. The company posted a net loss of $17.7 million ($1.37 per diluted share) compared to a $5.6 million loss in Q3 2023. For the nine months ended September 30, 2024, revenue decreased to $722.7 million from $884.7 million, with a net loss of $83.9 million. The company recently completed recapitalization transactions to strengthen its financial foundation, streamline its balance sheet, and enhance liquidity.
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.
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