Alvotech develops and manufactures biosimilar medicines for global markets. Company news centers on its approved and marketed biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, along with disclosed candidates for autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Recurring updates cover financial results, annual reporting, FDA interactions tied to the Reykjavik manufacturing facility, biosimilar study results such as AVT80, supply and commercialization partnerships, intellectual-property settlements, executive changes and manufacturing-platform developments. Alvotech also reports on global commercial reach through partners across the United States, Europe, Japan, China and other international markets.
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 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.
STADA and Alvotech have launched Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across major European markets. This launch comes immediately after the expiry of exclusivity rights for the reference molecule, creating competition and potentially broadening patient access in a market estimated at €2.4 billion. Uzpruvo is indicated for Crohn's disease, psoriatic arthritis, and plaque psoriasis in adults and children from 6 years old.
Uzpruvo offers a pre-filled syringe with a thinner needle and is latex-free. It's the second immunology biosimilar brought to market through the STADA-Alvotech partnership, following the 2022 launch of Hukyndra (adalimumab). The biosimilar is developed, manufactured, and packaged entirely within Europe, with a 36-month shelf life.
Alvotech (NASDAQ: ALVO), a global biotech firm focused on biosimilar medicines, has finalized a senior secured first lien term loan facility. This refinancing includes a $900 million first lien term loan and a $65 million second lien, second out term loan. The total gross borrowings balance now stands at $1,035 million, with a cash balance of $185 million. The facility aims to reduce capital costs and improve debt maturity, with loans maturing in June 2029. The $900 million tranche bears an interest rate of SOFR plus 6.5% per annum, while the $65 million tranche bears SOFR plus 10.5% per annum. The funds will support Alvotech’s development pipeline and upcoming biosimilar product launches. CFO Joel Morales emphasized that this transaction enhances their long-term growth strategy.
Alvotech (NASDAQ: ALVO) has announced positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). The study successfully demonstrated clinical similarity in terms of efficacy, safety, immunogenicity, and pharmacokinetics in postmenopausal women with osteoporosis. Approximately 532 participants were involved, with results used to support additional indications for Xgeva. Two additional studies comparing pharmacokinetics, safety, and tolerability also met their primary endpoints. Alvotech plans to file marketing applications for AVT03 later this year targeting major global markets.
Alvotech (NASDAQ: ALVO), a global biotech firm specializing in biosimilar medicines, has issued 22,073,578 new ordinary shares to holders of subordinated convertible bonds. These bonds, originally issued on November 16, 2022, and December 20, 2022, mature on December 20, 2025. The shares were exchanged at a fixed price of $10.00 per share. Most bondholders converting to shares are existing shareholders. Post-conversion, Alvotech's total issued shares are 324,801,040, with 301,944,470 outstanding shares. The new shares will be delivered within seven business days.
Alvotech (NASDAQ: ALVO) announced record preliminary financial results for Q2 2024, highlighting significant growth in revenues and EBITDA. The company reported preliminary total revenues between $196 - $201 million for the second quarter and $233 - $238 million for the first six months, marking a tenfold increase year-over-year. Product revenues from biosimilars to Humira and Stelara reached $51 - $54 million for Q2 and $63 - $66 million for the first half, representing a 180% increase. Preliminary milestone revenues are $145 - $147 million for Q2 and $169 - $171 million for H1 2024. The company achieved a record preliminary adjusted EBITDA of $98 - $103 million for Q2 and $60 - $65 million for H1, reversing a loss of ($178) million in the same period of 2023. CEO Robert Wessman highlighted the role of debt refinancing in achieving these results and driving future growth.
Alvotech (NASDAQ: ALVO), a global biotech firm specializing in biosimilar medicines, announced that the majority of its subordinated convertible bonds will be converted into ordinary shares on July 1, 2024. The bonds, issued on November 16 and December 20, 2022, will mature on December 20, 2025. Conversion will occur at a fixed price of $10.00 per share. Approximately 22.1 million new shares are expected to be issued based on current exchange rates. The conversion involves two tranches: ISK-denominated bonds valued at ISK 25.5 billion (~$183 million), converting into 18.3 million shares, and USD-denominated bonds valued at $37.98 million, converting into 3.8 million shares. An additional $116.68 million in USD-denominated bonds remains unconverted.
Alvotech (NASDAQ: ALVO) and Advanz Pharma have signed a commercialization agreement for Alvotech's proposed biosimilar to Eylea® (aflibercept) in Europe. The biosimilars, AVT06 (low dose) and AVT29 (high dose), target eye disorders like wet AMD and diabetic retinopathy, with Eylea® sales in Europe reported at $2.9 billion in 2023. Alvotech will handle development and supply, while Advanz Pharma will manage registration and commercialization, with exclusive rights in Europe except for semi-exclusive rights in Germany and France. The agreement includes upfront and milestone payments to Alvotech. This partnership expands their collaboration to seven biosimilar candidates. Recent studies showed AVT06 met its primary endpoint, proving therapeutic equivalence to Eylea®.
Alvotech and STADA announced an expanded strategic alliance to market Alvotech’s biosimilar AVT03, referencing Prolia®/Xgeva® (denosumab), in Europe, including Switzerland and the UK, as well as selected markets in Central Asia and the Middle East. This partnership builds on their existing collaboration for biosimilars to Humira® and Stelara®. Alvotech will develop and manufacture AVT03, while STADA will handle marketing upon regulatory approval. Additionally, Alvotech regains commercial rights to its biosimilar AVT06, referencing Eylea® (aflibercept). The expansion aims to offer cost-effective biosimilars to patients, particularly for osteoporosis and cancer-related bone loss.