Advanz Pharma secures rights to commercialize Alvotech’s biosimilar candidate for Eylea® in Europe Advanz Pharma will leverage its existing specialty and hospital capabilities in Europe to ensure successful market registration, commercialization, and patient access REYKJAVIK, Iceland and LONDON, June 18, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartere ...

文章核心观点 - 阿尔沃泰克和史达制药加强了现有的战略联盟 [1][2][3] - 双方扩大了在欧洲、中亚和中东地区的商业权利 [2][3] - 这次合作涉及阿尔沃泰克的生物类似药AVT03,参照普洛利亚/施达维(denosumab)开发 [1][7] 行业概况 - 欧洲有3200万人患有骨质疏松症,其中80%为女性 [6] - 2019年欧洲骨折导致的直接成本达到569亿欧元 [6] - denosumab是一种靶向RANKL蛋白的单克隆抗体,可抑制骨吸收 [4][5] 公司信息 - 阿尔沃泰克是一家专注于生物类似药开发和制造的生物技术公司 [9] - 阿尔沃泰克与多家公司建立了战略商业合作伙伴关系 [10] - 史达制药是一家总部位于德国的制药公司,主营三大业务:消费者保健品、仿制药和专科药品 [11]

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 East This 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 par ...

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 East This 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 par ...

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 maturit ...

Key Points Teva Pharmaceuticals has a portfolio of 500 generic medications as well as its own branded drugs. Teva Pharmaceuticals has settled 99% of its opioid litigation for $4.25 billion paid out over 13 years. Alvotech is a biosimilar biopharmaceutical company producing generic Humira and Stelara versions. 5 stocks we like better than Teva Pharmaceutical Industries Brand-name drug costs continue to climb, but patients and insurers find respite by migrating to generic or biosimilar versions as patents run ...

财务数据和关键指标变化 - 公司Q1 2024年总收入为3690万美元,同比增长132%,主要来自里程碑收入和AVT04在加拿大和日本的销售 [48][49] - 产品收入为1240万美元,同比下降3400万美元,主要由于公司集中资源用于FDA审批准备 [49] - 毛利率从上年同期负23%提升至正17%,增加4000万美元,主要由于里程碑收入时间性和加拿大AVT04销售 [52] - 调整后EBITDA为负3800万美元,同比改善2700万美元,主要由于毛利率提升和研发及管理费用下降 [54] - 公司现金余额为6500万美元,另有2500万美元受限现金 [47] 各条业务线数据和关键指标变化 - AVT02(阿达木单抗)在美国市场获得互换性,已开始供货给合作伙伴,并获得超过100万支的订单 [9][14][28] - AVT04(司替拉单抗)已在加拿大和日本上市,并计划在今年第三季度在欧洲上市 [30][31][50] - SELARSDI(尤司奴单抗)已获美国批准,计划2025年2月在美国上市 [29] 各个市场数据和关键指标变化 - 美国市场:与Quallent(Cigna集团旗下)达成私有品牌合作,Cigna Accredo药房的1000多名患者可以零自付费获得 [10][11][25] - 加拿大市场:AVT04已于今年3月上市,由JAMP公司销售 [31] - 日本市场:AVT04已于本月上市,由Fuji Pharma公司销售 [31] - 欧洲市场:AVT04计划于今年第三季度上市 [31] 公司战略和发展方向及行业竞争 - 公司目标是建立广泛的产品组合,在全球几乎所有市场销售 [15] - 2024年是公司历史上最繁忙的一年,预计至少有3个新产品在主要市场提交申请 [33] - 公司与Dr. Reddy's合作开发AVT03(普罗力/Xgeva生物类似药),在美国和欧洲市场 [18][36] - 公司正在积极寻求其他管线产品的全球商业化合作伙伴 [44] 管理层对经营环境和未来前景的评论 - 公司正从研发型向全球商业生物制药公司转型,这是公司一直希望成为的 [20] - 生物类似药市场正在快速发展,公司看好未来前景 [12][20] - 公司2024年收入指引上调至4-5亿美元,调整后EBITDA指引上调至1-1.5亿美元 [56][57] - 公司正在探索再融资选择,以降低资本成本,增强财务灵活性 [74][75] 问答环节重要的提问和回答 问题1 **Balaji Prasad 提问** 提问的内容1:指引上调是否主要由于Quallent的私有品牌交易贡献? [78] **Joel Morales 回答** 回答的内容1:是的,指引上调主要由于美国市场02产品的合同情况,STELARA产品在美国的假设未发生变化 [80][81] 问题2 **Vineet Agrawal 提问** 提问的内容2:AVT06(艾力雅生物类似药)在美国的上市时间线如何? [89] **Anil Okay 回答** 回答的内容2:公司已经制定了相应的知识产权策略,将在适当时机公布具体的上市时间 [93] 问题3 **Vineet Agrawal 提问** 提问的内容3:公司是否有GLP-1类产品的能力和计划? [89] **Anil Okay 回答** 回答的内容3:公司目前还没有GLP-1类产品在管线中,但公司有相关的技术能力,正在考虑在这一领域的长期发展 [94]

业绩总结 - 公司在2024年第一季度实现总收入3,690万美元，同比增长132%[17] - 2024年营收预期为4-5亿美元，现金利息支付为7-8百万美元[21] - 2024年调整后的EBITDA预期为1-1.5亿美元，税率约为20%[21] 用户数据 - AVT04在日本市场推出，是Stelara®的首个生物类似药[22] - AVT16临床试验启动，计划成为前两家将生物类似药引入Entyvio®市场的公司之一[23] 未来展望 - 2024/25财年第一季度调整条目包括产品收入、研发、一次性费用等方面的调整[25] 市场扩张和并购 - 获得来自冰岛和其他欧洲投资者的售股报价，总额为1.66亿美元[18] 负面信息 - 截至3月31日，公司手头现金约6500万美元，不包括2500万美元的受限制现金[19]

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 ...