Alvotech - ALVO STOCK NEWS

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 and STADA are expanding their strategic alliance for biosimilars by extending their partnership to include AVT03, a biosimilar candidate for Prolia®/Xgeva® (denosumab). This medication targets osteoporosis and cancer-related bone loss. Under the agreement, Alvotech will handle development and manufacturing, while STADA will manage commercialization in Europe, including Switzerland and the UK, as well as selected countries in Central Asia and the Middle East.

The partnership also extends STADA's commercial rights for Humira® and Stelara® biosimilars to CIS countries in Central Asia. Alvotech regains commercial rights to AVT06, a proposed Eylea® biosimilar. This expansion builds on their successful collaboration, which has already launched Hukyndra®, a high-concentration Humira® biosimilar, in Europe.

Alvotech (NASDAQ: ALVO), a global biotech firm, has successfully secured a strategic refinancing deal led by GoldenTree Asset Management, involving multiple institutional investors. This transaction provides a senior secured first lien term loan of up to $965 million in two parts: a $900 million term loan at SOFR plus 6.5% interest, and a $65 million optional term loan at SOFR plus 10.5% interest. The funding is set to mature in June 2029, with disbursement expected in July 2024.

Alvotech aims to utilize these funds to refinance outstanding debts maturing in 2025 and bolster its working capital for upcoming product launches. Chief Finance Officer Joel Morales emphasized that the facility would enhance financial flexibility and support long-term growth, projecting significant revenue growth and market expansion for Alvotech's biosimilars.

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®.