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argenx(ARGX) - 2022 Q4 - Earnings Call Presentation
2023-03-02 13:18
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
2022-07-28 17:00
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 ...
argenx(ARGX) - 2022 Q2 - Earnings Call Presentation
2022-07-28 13:55
Financial Performance - Argenx reported Q2 2022 net product revenues of $75 million[9], primarily driven by VYVGART sales[25] - US product net sales were $73.2 million in Q2 2022[20] - Japan product net sales were $1.5 million in Q2 2022[20] - The company ended Q2 with $2.6 billion in cash[7, 21] - R&D expenses for the second quarter were $126.9 million[21] - SG&A expenses for the second quarter were $127.8 million[21] VYVGART Launch and Expansion - Approximately 1400 patients are on VYVGART globally[27] - 85% of covered lives have broad coverage for VYVGART[34] - A J-Code for VYVGART went into effect on July 1, 2022[34] Pipeline Progress - A BLA submission for subcutaneous efgartigimod (SC) in gMG is expected by the end of 2022[7, 11] - ADHERE (CIDP) data is expected in Q1 2023[7] - ADVANCE-SC (ITP) and ADDRESS (PV) data are expected in the second half of 2023[7]
argenx(ARGX) - 2022 Q1 - Earnings Call Transcript
2022-05-07 23:38
argenx SE (NASDAQ:ARGX) Q1 2022 Earnings Conference Call May 5, 2022 8:30 AM ET Corporate Participants Beth DelGiacco - VP Corporate Communications and Investor Relations Tim Van Hauwermeiren - Chief Executive Officer Luc Truyen - Chief Medical Officer Karl Gubitz - Chief Financial Officer Keith Woods - Chief Operating Officer Conference Call Participants Yatin Suneja - Guggenheim Matthew Harrison - Morgan Stanley Tazeen Ahmad - Bank of America Akash Tewari - Jefferies Yaron Werber - Cowen James Gordon - JP ...
argenx(ARGX) - 2021 Q4 - Earnings Call Transcript
2022-03-03 20:13
Financial Data and Key Metrics Changes - For the full year 2021, total revenues were $497.3 million, primarily from collaboration income, including a one-time recognition of $315.1 million from the termination of a Janssen collaboration agreement and $177.5 million from Zai Lab [22][23] - Total R&D expenses were $580.5 million, while SG&A expenses were $307.6 million [22][23] - The company ended the year with cash, cash equivalents, and current financial assets totaling $2.3 billion, positioning it strongly for its first commercial launch [22] Business Line Data and Key Metrics Changes - The launch of VYVGART, an FcRn blocker for generalized myasthenia gravis (gMG), began with initial demand generation focused on education and awareness [6][7] - The salesforce has engaged with approximately 60% of the top 1000 neurologists, with scripts coming from a broad range of prescribers [19][20] - Approximately 90% of prescriptions have come through the My VYVGART Path patient support program, translating into infusions [18][19] Market Data and Key Metrics Changes - The company is seeing a breadth of patient profiles reflective of the ADAPT trial population, including patients who are refractory to other treatments [17][55] - The TPO market is valued at over $2 billion globally, with efgartigimod expected to play a role after initial TPO treatments [33] Company Strategy and Development Direction - The company aims to empower patients, provide best-in-class support, ensure rapid adoption from healthcare professionals, and enable appropriate access [16][20] - Upcoming regulatory milestones include the launch in Japan, which is pending pricing, and expected approval in Europe in the second half of the year [21] - The company is focused on building a comprehensive offering for patients, including both IV and subcutaneous dosing options [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the launch trajectory, acknowledging challenges such as COVID restrictions and the need for physician education [8][9] - The company is preparing for a busy first half of the year with multiple data readouts and ongoing engagement with healthcare professionals [15][25] - Management highlighted the importance of individualized dosing and the positive feedback from physicians regarding the treatment's efficacy and safety profile [9][10] Other Important Information - Personnel updates include the departure of Yvonne Greenstreet from the board and the appointment of Malini Moorthy as General Counsel [24] - The company is planning to utilize up to half of its available cash in 2022 for R&D, inventory, and infrastructure for its global launch [22] Q&A Session Summary Question: Are you comfortable with consensus estimates for VYVGART? - Management is not providing revenue projections at this time, but they are comfortable with analyst consensus estimates of $97 million for the full year [30] Question: What are your expectations for the ITP study? - The primary endpoint is challenging due to significant placebo effects, and secondary endpoints will provide additional insights into the treatment's potential [31][32] Question: Can you clarify the next steps for the subcutaneous data set? - The subcutaneous product will be submitted as a separate BLA, and the company anticipates reusing sections of the existing BLA for the submission [36] Question: What percentage of early scripts are from ultra-refractory patients? - The company noted a surprising number of patients who have not responded to other therapies, indicating pent-up demand [40] Question: How do you view the competitive landscape with UCB's upcoming data? - Management believes VYVGART's efficacy, safety profile, and individualized dosing provide a strong competitive advantage [60] Question: What is the impact of the J Code on reimbursement? - The absence of a J Code adds complexity to the reimbursement process but does not prevent reimbursement; the company expects to have a J Code by Q3 [56]