STADA assumes marketing license for Alvotech's proposed biosimilar referencing Prolia®/Xgeva® (denosumab) in Europe, including Switzerland and the UK, as well as rights in selected markets in Central Asia and the Middle EastThis partnership for the osteoporosis and cancer-related molecule builds on the two company's existing strategic alliance in Europe. The first product launched through the alliance was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab)Extended alliance comes as the partne ...

REYKJAVIK, Iceland, June 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the "Lenders"), will enable Alvotech (the "Company") to improve cost of capital, address upcoming debt maturit ...

REYKJAVIK, Iceland, June 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the “Lenders”), will enable Alvotech (the “Company”) to improve cost of capital, address upcoming debt maturi ...

Company Overview - Teva Pharmaceuticals is a leading generic drug maker with a portfolio of 500 generic medications and its own branded drugs [2][3] - The company has a well-established global distribution network, ensuring medications reach a worldwide patient base [3] Opioid Litigation Settlement - Teva has settled 99% of its opioid litigation cases for a total of $4.25 billion, to be paid out over 13 years [4] - The settlement includes $1.25 billion allocated for its generic version of Narcan, an overdose reversal medicine [4] Financial Performance - In Q1 2024, Teva reported earnings per share (EPS) of 48 cents, missing consensus estimates by 3 cents [5] - Revenues grew 4.3% year-over-year to $3.82 billion, surpassing consensus estimates of $3.73 billion [5] - The generics business saw a revenue increase of 9% year-over-year across all regions [5] Key Product Growth - Teva's brand drug Austedo for Huntington's Disease saw a revenue increase of 67% year-over-year, with a forecast of around $1.5 billion for 2024 [5] - The migraine medication Ajovy experienced an 18% year-over-year revenue growth, reaching $113 million [5] - Teva received FDA approvals for Simlandi and Selarsdi, generic versions of Humira and Stelara, respectively [5][6] Market Position and Stock Performance - Teva's stock is currently forming a daily pennant pattern, indicating potential price movements [7] - The stock price is noted at $16.90, with a 52-week range between $7.09 and $17.13 [2][7] Alvotech Overview - Alvotech is a biopharmaceutical company producing biosimilar medications, including generic versions of Humira and Stelara [2][8] - The company reported Q1 2024 revenues of $37 million, more than doubling from $16 million in the previous year [8] - Alvotech raised its full-year revenue guidance to between $400 million and $500 million [8]

Company Overview - Alvotech is a biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [2] - The company aims to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services [2] - Alvotech's current pipeline includes eight biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [2] Strategic Partnerships - Alvotech has established a network of strategic commercial partnerships to enhance its global reach and leverage local expertise [2] - Key commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and several others across various regions including the US, Europe, Japan, China, and parts of South America, Africa, and the Middle East [2] Upcoming Events - Alvotech will participate in the Jefferies Healthcare Conference in New York on June 5-6, 2024, where it will present and host investor and business meetings [1] - Anil Okay, Chief Business Officer, is scheduled to present on June 6, 2024, at 1:00 pm EDT, with a live audio webcast available on Alvotech's investor website [1]

Financial Data and Key Metrics Changes - Total revenues for Q1 2024 were $36.9 million, a 132% increase from $15.9 million in the prior year, driven by milestone revenues from the AVT16 program and European approval for AVT04 [29] - Product revenues in Q1 were $12.4 million, down $3.4 million from the prior year, due to resource allocation for FDA inspection readiness [29] - Gross margin improved from negative $23 million in Q1 2023 to positive $17 million in Q1 2024, an increase of $40 million [30] - Adjusted EBITDA for Q1 2024 was negative $38 million, an improvement of $27 million year-over-year [31] - The company raised its revenue guidance for 2024 to between $400 million and $500 million and tightened EBITDA guidance to $100 million to $150 million [32] Business Line Data and Key Metrics Changes - The company has received binding purchase orders for over 1 million units of its Humira biosimilar, indicating strong market commitment [9][17] - AVT04, the biosimilar to Stelara, has been launched in Canada and is set to launch in Japan and Europe, with expectations for revenue growth throughout 2024 [30][36] - The company plans to file three additional biosimilar candidates in major markets this year, including AVT03 for Prolia and Xgeva, and AVT05 for Simponi [39] Market Data and Key Metrics Changes - The partnership with Quallent, a private label unit for Cigna, allows Alvotech's Humira biosimilar to be offered at zero out-of-pocket costs, enhancing market access [7][15] - The company is positioned to compete effectively in the U.S. market for biosimilars, particularly with the interchangeability designation for its products [63] Company Strategy and Development Direction - Alvotech aims to transition from an R&D-focused company to a full-scale global commercial biologics company, with multiple product launches planned for 2024 [13] - The company is focused on expanding its portfolio and establishing itself as a preferred partner in the biosimilars market [10] - The strategy includes ongoing business development efforts to secure partnerships for future pipeline programs, including AVT33, a biosimilar candidate to KEYTRUDA [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving pharmacy benefit biosimilars landscape in the U.S., which is expected to drive growth for Alvotech's products [8][16] - The company anticipates a significant increase in product revenues as commercial partners launch AVT02 and AVT04 in various markets [34] - Management highlighted the importance of achieving positive adjusted EBITDA for the first time in the company's history in Q2 2024 [34] Other Important Information - The company has established a global commercial presence through partnerships, now totaling 19 partners across over 90 markets [27] - Alvotech is exploring refinancing options for its current debt to enhance financial flexibility and support long-term growth [40] Q&A Session Summary Question: Is the guidance revision primarily due to the private label deal with Quallent? - Yes, the guidance change was driven by contracting outcomes in the U.S., particularly related to AVT02 [44] Question: Can you clarify the 1 million purchase orders for Humira biosimilar? - The 1 million units refer to pens, confirming that these are expected to be sold in 2024 [60] Question: How significant is the interchangeability designation for market share? - Interchangeability is viewed as a significant advantage, reducing conversion friction and providing exclusivity until May 2025 [63]

Q1 2024 Earnings MAY 22ND, 2024 Disclaimer This presentation (“Presentation”) does not contain or expressed or implied by such forward-looking statements. future litigation regarding the Company’s products and product to, Adjusted EBITDA and certain ratios and other metrics constitute an offer to sell, a solicitation of an offer to buy, or a These forward-looking statements are based upon estimates candidates; (17) the potential impact of the ongoing COVID-19 derived therefrom. These non-IFRS financial meas ...

Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year. Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year. Alvotech signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira® in the U.S. and for its proposed biosimilar to Prolia® and Xgeva® in the U.S. and Europe. Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line ...

Financial Performance - Total revenues in Q1 2024 increased to $37 million compared to $16 million in the same period last year [1] - Gross margin in Q1 2024 increased to $17 million, up by $40 million compared to the same period last year [1] - Product revenue was $12.4 million for the three months ended March 31, 2024, compared to $15.7 million for the same period in 2023 [8] - License and other revenue was $24.4 million for the three months ended March 31, 2024, with no license and other revenue recognized in the same period of 2023 [9] - Reported net loss was $218.7 million, or ($0.89) per share for Q1 2024, compared to a net loss of $276.2 million, or ($1.24) per share for the same period in 2023 [14] Business Developments - Alvotech signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira® in the U.S. and for its proposed biosimilar to Prolia® and Xgeva® in the U.S. and Europe [1] - The FDA approved AVT04, a biosimilar to Stelara®, for marketing in the U.S. under the tradename Selarsdi, with launches planned in Canada, Japan, Europe, and the U.S. [5] - Alvotech announced a strategic partnership with Quallent Pharmaceuticals for the distribution of its high-concentration interchangeable biosimilar to Humira [5] - A commercial partnership agreement was signed with Dr. Reddy's Laboratories for the commercialization of AVT03, a biosimilar candidate to Prolia® and Xgeva® [6] Guidance and Future Outlook - Alvotech raised topline revenue guidance for 2024 to $400-$500 million and tightened guidance for EBITDA to $100-$150 million for the full year [1][4] - Management will conduct a business update conference call on May 22, 2024, to discuss further developments [1][15]