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argenx(ARGX) - 2023 Q3 - Earnings Call Transcript
2023-10-31 19:32
argenx SE (NASDAQ:ARGX) Q3 2023 Earnings Conference Call October 31, 2023 8:30 AM ET Company Participants Beth DelGiacco - VP and Global Head, Corporate Communications and IR Tim Van Hauwermeiren - CEO Karl Gubitz - CFO Karen Massey - COO Conference Call Participants Yatin Suneja - Guggenheim Partners Tazeen Ahmad - Bank of America Derek Archila - Wells Fargo Thomas Smith - Leerink Partners James Gordon - JPMorgan Amy Li - Jefferies Danielle Brill - Raymond James Yaron Werber - TD Cowen Myles Minter - Willi ...
argenx(ARGX) - 2023 Q2 - Earnings Call Transcript
2023-07-27 22:57
argenx SE (NASDAQ:ARGX) Q2 2023 Earnings Conference Call July 27, 2023 8:30 AM ET Company Participants Beth DelGiacco - VP and Global Head, Corporate Communications & IR Tim Van Hauwermeiren - CEO & Executive Director Karl Gubitz - CFO Karen Massey - COO Conference Call Participants Tazeen Ahmad - Bank of America Merrill Lynch Derek Archila - Wells Fargo Securities Yaron Werber - TD Cowen Danielle Brill - Raymond James & Associates Amy Li - Jefferies Xian Deng - UBS Joon Lee - Truist Securities Samantha Sem ...
argenx(ARGX) - 2023 Q2 - Earnings Call Presentation
2023-07-27 16:24
Half Year 2023 Financial Results and Second Quarter Business Update 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 a ...
argenx(ARGX) - 2023 Q2 - Quarterly Report
2023-06-29 16:00
Exhibit 99.1 argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China ● First-and-only approved FcRn antagonist for gMG patients by NMPA ● 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 patients treated with placebo (n=19/64) (p<0.0001) during the first treatment cycle in the Phase 3 ADAPT trial ● Zai Lab to s ...
argenx(ARGX) - 2023 Q1 - Quarterly Report
2023-06-21 12:52
Exhibit 99.2 argenx Announces U.S. Food and Drug Administration Approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis Regulated Information/Inside Information Amsterdam, the Netherlands—June 20, 2023—argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) approved VYVGAR ...
argenx(ARGX) - 2023 Q1 - Earnings Call Transcript
2023-05-06 21:57
argenx SE (NASDAQ:ARGX) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Beth DelGiacco - Vice President of Corporate Communications and Investor Relations Tim Van Hauwermeiren - Chief Executive Officer Karl Gubitz - Chief Financial Officer Karen Massey - Chief Operating Officer Conference Call Participants Derek Archila - Wells Fargo Tazeen Ahmad - Bank of America Rajan Sharma - Goldman Sachs Yatin Suneja - Guggenheim Akash Tewari - Jefferies Thomas Smith - SVB Security Danielle ...
argenx(ARGX) - 2023 Q1 - Earnings Call Presentation
2023-05-06 18:38
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 10:44
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
2023-03-15 16:00
Drug Approval and Indications - VYVGART is the first neonatal Fc receptor (FcRn) blocker approved in the UK for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive[1]. - VYVGART is approved in the US, Europe, and the UK for treating adults with gMG who are AChR antibody positive, and in Japan for those not responding adequately to steroids or non-steroidal immunosuppressive therapies[7]. Clinical Trial Results - In the Phase 3 ADAPT trial, 68% of anti-AChR antibody positive gMG patients treated with VYVGART were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, compared to 30% for placebo (p<0.0001)[3]. - The ADAPT trial also showed 63% of patients treated with VYVGART were responders on the Quantitative Myasthenia Gravis (QMG) scale, versus 14% for placebo (p<0.0001)[4]. - The Phase 3 ADAPT trial enrolled 167 adult patients with gMG across North America, Europe, and Japan, randomized in a 1:1 ratio to receive either VYVGART or placebo[6]. Safety and Adverse Reactions - The most common adverse reactions for VYVGART included upper respiratory tract infections (10.7% vs. 4.8% for placebo) and urinary tract infections (9.5% vs. 4.8% for placebo)[4]. Regulatory Designations and Access - VYVGART received a Promising Innovative Medicine (PIM) designation from the MHRA in November 2021 and a positive scientific opinion under the Early Access to Medicines Scheme in May 2022[5]. - argenx aims to collaborate with local authorities to ensure broad and rapid access to VYVGART for eligible patients in the UK[1]. Impact on the Myasthenia Gravis Community - The approval of VYVGART is expected to provide a new treatment option for the gMG community in the UK, potentially reducing the burden of this debilitating disease[5]. - Approximately 85% of people with myasthenia gravis progress to gMG within 24 months, with 85% of gMG patients having confirmed AChR antibodies[8].
argenx(ARGX) - 2022 Q4 - Annual Report
2023-03-15 16:00
Financial Position - As of December 31, 2022, cash and cash equivalents amounted to $800.7 million, while total capital was $4,316.5 million[978]. - The company has no financial debt, which mitigates interest rate risk on borrowings[978]. - The company raised approximately $662 million from a global offering of 2,333,334 ordinary shares, including ADSs[996]. - The net proceeds from the offering have been invested in cash and cash equivalents and current financial assets[997]. Interest Rate and Currency Risk - For the year ended December 31, 2022, a 25 basis points change in interest rates would have a positive/negative impact of $6.2 million[984]. - On December 31, 2022, a 10% increase/decrease in the EUR/USD exchange rate would have resulted in a negative/positive impact of $61.39 million[985]. Credit Risk Management - The company has adopted a policy to only deal with creditworthy counterparties, minimizing credit risk exposure[979]. - The provision for expected credit losses was not significant, as there have been no credit losses over the last three years[980]. - The company has a significant concentration of credit risk due to a limited number of collaboration and license partners[979]. Liquidity Risk Management - The company maintains liquidity risk management by monitoring cash flows and maintaining adequate reserves[982].