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argenx(ARGX) - 2023 Q1 - Earnings Call Presentation
2023-05-07 02:38
First Quarter 2023 Financial Results and Business Update May 4, 2023 Forward Looking Statements This presentation has been prepared by argenx se ("argenx" or the "company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain ...
argenx (ARGX) Investor Presentation - Slideshow
2023-05-01 18:44
argenx • Together We Discover Corporate Presentation April 2023 Forward Looking Statements This presentation has been prepared by argenx se ("argenx" or the "company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusive or to contain all o ...
argenx(ARGX) - 2022 Q4 - Annual Report
2023-03-16 00:00
公司财务状况 - 公司自成立以来累计亏损21.098亿美元[39] - 公司在2022财年全球产品净销售额为4.07亿美元[39] - 公司截至2022年底现金及现金等价物为21.925亿美元[44] - 公司预计在短期内继续维持目前的现金流失[43] - 公司可能需要通过公开或私人股权或债务融资等方式筹集大量额外资金[42] 市场竞争和法规挑战 - 公司面临着成功推广产品和额外产品候选者的重大挑战[47] - 公司产品和产品候选者的商业成功将取决于市场接受程度[50] - 公司面临着来自其他生物制药公司的激烈竞争[52] - 美国《生物类产品价格竞争与创新法案》(BPCIA)规定,生物类产品的仿制药申请需在参考产品首次获得许可后四年提交给FDA[53] - 在欧盟,生物类似药物的竞争对创新产品的销售额产生影响,且生物类似药物的使用率和对创新产品销售额的影响逐渐增加[55] - 美国《通胀降低法案》(IRA)将影响医疗保健成本,包括药品价格谈判和Medicare Part D的福利设计变化[57] - 美国《美国复苏计划法案》将取消制造商向州医疗补助计划支付的医疗保险药品折扣的上限[60] - 公司需遵守政府价格报告和折扣义务,否则可能面临巨额罚款和处罚[59] 产品开发和监管挑战 - 临床试验可能失败,即使成功也可能无法获得产品候选药物的监管批准或批准可能会延迟[88] - 产品和产品候选药物可能会产生严重的不良、不可接受的副作用,甚至导致死亡[94] - 产品候选人的不良反应可能会影响临床试验的进行和未来发展[95] - 目标患者群体规模小于预期可能导致临床试验招募困难[97] - 临床试验完成的延迟将增加成本并延缓产品开发和批准过程[98] 风险管理和合规挑战 - 公司可能面临环境合规或整治活动方面的责任、罚款、处罚或其他制裁以及巨额费用[108] - 员工可能会参与不当行为,可能会严重损害公司业务[109] - 公司可能面临昂贵和有害的责任索赔,包括产品责任和专业赔偿风险[110] - 公司可能无法以合理成本维持或获得足够的保险覆盖以满足可能产生的责任[113] 技术和知识产权挑战 - 未能充分执行或保护产品、产品候选品和平台技术的知识产权可能会对公司开发和营销产品和产品候选品的能力产生不利影响[118] - 公司可能无法获得根据Hatch-Waxman法案和类似的非美国立法为延长专利期限提供保护[129] - 专利法律或专利法律解释的变化可能降低专利的价值,从而影响公司保护产品的能力[130] - 公司可能面临知识产权的发明权或所有权方面的索赔[123]
argenx(ARGX) - 2022 Q4 - Annual Report
2023-03-16 00:00
Exhibit 99.1 argenx Announces UK MHRA Approval of VYVGART for the Treatment of Generalized Myasthenia Gravis VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for the treatment of adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders (n=44/65) on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with 30% of patient ...
argenx(ARGX) - 2022 Q4 - Earnings Call Transcript
2023-03-03 01:29
argenx SE (NASDAQ:ARGX) Q4 2022 Earnings Conference Call March 2, 2023 8:30 AM ET Company Participants Beth DelGiacco - VP Corporate Communications and IR Tim Van Hauwermeiren - CEO Karl Gubitz - CFO Keith Woods - COO Conference Call Participants Tazeen Ahmad - Bank of America Securities Rajan Sharma - Goldman Sachs Thomas Smith - SVB Securities Brendan Smith - Cowen Yatin Suneja - Guggenheim Partners Myles Minter - William Blair Manos Mastorakis - Deutsche Bank Alex Nackenoff - Raymond James Allison Bratze ...
argenx(ARGX) - 2022 Q4 - Earnings Call Presentation
2023-03-02 21:18
Fourth Quarter and Full Year 2022 Financial Results and Business Update March 2, 2023 Forward Looking Statements This presentation has been prepared by argenx se ("argenx" or the "company") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or the company or any director, employee, agent, or adviser of the company. This presentation does not purport to be all-inclusi ...
argenx(ARGX) - 2022 Q2 - Earnings Call Transcript
2022-07-29 01:00
argenx SE (NASDAQ:ARGX) Q2 2022 Earnings Conference Call July 28, 2022 8:30 AM ET Company Participants Beth DelGiacco - VP Corporate Communications and IR Tim Van Hauwermeiren - CEO Karl Gubitz - CFO Keith Woods - COO Conference Call Participants Danielle Brill - Raymond James Yaron Werber - Cowen Yatin Suneja - Guggenheim Partners Derek Archila - Wells Fargo Allison Bratzel - Piper Sandler Akash Tewari - Jefferies Matthew Harrison - Morgan Stanley Tazeen Ahmad - Bank of America Securities Thomas Smith - SV ...