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Alvotech (NASDAQ: ALVO) is a global biopharmaceutical company specializing in the development and manufacturing of high-quality biosimilar medicines aimed at enhancing patient access to affordable treatments worldwide. Established in 2013, the company has committed itself to becoming a leader in biogenerics, focusing on the creation of cost-effective biosimilars that meet stringent quality standards. Alvotech operates through a fully integrated model, addressing every step from cell line development to commercial manufacturing.
Alvotech's headquarters in Reykjavik, Iceland hosts a state-of-the-art flexible manufacturing facility that underscores the company's commitment to high-quality and efficient production. The company's portfolio includes biosimilars for autoimmune disorders, eye conditions, osteoporosis, respiratory diseases, and cancer. Alvotech has successfully launched two biosimilars and is actively working on nine more candidates.
In recent developments, Alvotech announced positive top-line results for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and has received FDA approval for AVT04, a biosimilar to Stelara®. The company is also advancing in its U.S. strategic partnership with Teva Pharmaceuticals for the high-concentration interchangeable biosimilar to Humira®, marketed under Quallent’s private label. Financially, Alvotech reported increased revenues of $37 million in Q1 2024 and strengthened its position with a strategic refinancing transaction led by GoldenTree Asset Management, enhancing its financial flexibility and reducing upcoming debt maturities.
Alvotech's global reach is bolstered by strategic commercial partnerships with renowned pharmaceutical companies like Teva, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and many others. These collaborations extend across the United States, Europe, Japan, China, and several other regions, leveraging local expertise to provide expansive market access.
For more information on Alvotech and to stay updated with the latest news, visit www.alvotech.com.
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.
AECOM (NYSE: ACM) has been selected by the City of Austin as the prime consultant for the expansion of the Walnut Creek Wastewater Treatment Plant (WWTP) in Austin, Texas. The project aims to increase the plant's capacity from 75 million gallons per day (MGD) to 100 MGD, addressing the needs of Austin's growing population and enhancing the resilience of its wastewater infrastructure.
The scope of work includes process, mechanical, civil, electrical, and structural engineering services to modernize and upgrade existing infrastructure. Key components of the expansion include:
- Replacing aging equipment
- Constructing a new 25 MGD treatment train
- Building a new 120-inch outfall line and structure
- Providing wet weather treatment with new 100 MGD cloth filters
- Building a flood wall for protection against 100-year floods
The Walnut Creek WWTP, originally built in 1977, has undergone three previous expansions. The facility is expected to remain operational throughout the upgrade process.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. The company's management team will engage in an in-person fireside chat on September 5, 2024, at 5:35 pm EDT (21:35 GMT).
Investors and interested parties can access a live audio webcast of the fireside chat through Alvotech's investor website in the events section. For those unable to attend live, a recording will be archived and available for at least 90 days after the event, providing an opportunity to gain insights into Alvotech's strategies and developments in the biosimilar market.
Alvotech (NASDAQ: ALVO) reported record financial results for Q2 and H1 2024, with total revenues reaching $236 million in H1, a ten-fold increase year-over-year. Product revenues grew 190% to $66 million, while license and other revenues surged to $170 million. The company achieved positive Adjusted EBITDA of $64 million in H1, compared to a loss of $147 million in the same period last year.
Key highlights include:
- U.S. order book for biosimilar Humira increased to 1.3 million units for 2024
- Successful launches of biosimilars in multiple markets
- Positive clinical results for AVT03, a proposed biosimilar to Prolia® and Xgeva®
- Expanded partnerships with STADA and Advanz Pharma
- Refinancing of debt obligations, improving overall debt profile
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept). The approval process is expected to be completed by Q3 2025. This development marks a significant step towards making AVT06 available in Europe, potentially benefiting patients and caregivers.
Alvotech is responsible for AVT06's development and commercial supply, while Advanz Pharma holds exclusive commercialization rights in Europe, except for France and Germany. In 2023, Eylea® sales in Europe reached $2.9 billion, with global sales totaling $5.9 billion. Alvotech recently reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea in patients with neovascular (wet) AMD, demonstrating therapeutic equivalence and comparable safety.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines, has closed a senior secured first lien term loan facility. This refinancing move has allowed Alvotech to reduce its cost of capital and improve its debt maturity profile. The company now has total gross borrowings of $1,035 million and a cash balance of $185 million. The new facility includes a $900 million term loan at SOFR plus 6.5% and a $65 million term loan at SOFR plus 10.5%, both maturing in June 2029. Alvotech plans to use the available cash to advance its development pipeline and support working capital requirements for ongoing and upcoming biosimilar launches.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines, has announced its schedule for reporting financial results for the first half of 2024. The company will release its financial results on August 15, 2024, after U.S. markets close. Following this, Alvotech will host a conference call on August 16, 2024, at 8:00 am EDT (12 noon GMT) to present the financial results and recent business highlights to analysts.
The conference call will be accessible via webcast to news media, investors, and the general public. Details for accessing the webcast or participating in the conference call are available on Alvotech's investor website. A replay of the webcast will be archived and available for 90 days after the event.
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