argenx(ARGX) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total operating income for the first half of 2020 was EUR 31.1 million, a decrease of EUR 20.2 million from the same period in 2019 due to milestone payments received last year under the AbbVie collaboration agreement [38] - R&D expenses for the first half of 2020 were EUR 171.7 million, compared to EUR 78.3 million for the same period in 2019, while SG&A expenses were EUR 61.6 million compared to EUR 27.5 million in 2019 [39] - The total net loss for the first half of 2020 was EUR 205.6 million, compared to a net loss of EUR 45.1 million for the same period in 2019 [40] Business Line Data and Key Metrics Changes - The positive Phase III ADAPT trial data showed that 67.7% of acetylcholine receptor antibody positive gMG patients were responders on the MG-ADL score, compared to 29.7% on placebo [12] - In the ADAPT trial, 40% of efgartigimod treated patients achieved minimum symptom expression, compared to 11.1% treated with placebo [13] - The company plans to launch a Phase III trial for Pemphigus vulgaris in the second half of 2020, following positive results from the Phase II trial [20] Market Data and Key Metrics Changes - In the U.S., there are approximately 16,000 neurologists treating 65,000 adult MG patients, with 20,000 likely needing treatment beyond current options [33] - The annual sales of IVIg in CIDP in the U.S. exceed EUR 1.5 billion, indicating a substantial market opportunity for efgartigimod [55] Company Strategy and Development Direction - The company aims to be a fully integrated immunology company, focusing on the successful launch of efgartigimod and advancing its differentiated pipeline [10][41] - A strategic shift in the development plan for cusatuzumab was announced, prioritizing a Phase Ib trial in combination with venetoclax and azacitidine [22][24] - The company is committed to adapting its clinical trials to mitigate disruptions caused by COVID-19, including integrating telemedicine and home infusion opportunities [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate challenges posed by COVID-19 while maintaining operational standards [6] - The company is focused on executing its 2021 vision and believes it is well-positioned to generate long-term value for shareholders with a cash position of EUR 1.9 billion [41] Other Important Information - The company has been actively engaging with physicians and patients through virtual platforms during the pandemic [10][36] - The company is preparing for a fully virtual launch if necessary, ensuring readiness to reach patients effectively [36] Q&A Session All Questions and Answers Question: Impact of cusatuzumab update on J&J deal terms - The strategy change does not affect the terms of the deal with J&J, as the global development plan allows for navigation based on data [45] Question: Subcutaneous dosing strategy for MG - The company plans to discuss the bridging strategy for subcutaneous dosing with the FDA, with the possibility of individualized or fixed dosing [50] Question: CIDP trial expectations and market size - The go/no-go decision for the CIDP trial will be made public in 2021, with CIDP representing a significant market opportunity due to its chronic nature and reliance on IVIg [55] Question: Safety data from CULMINATE trial - The safety profile observed in the CULMINATE trial is consistent with earlier data, and detailed data will be disclosed in early 2021 [59] Question: Pricing strategy for efgartigimod - The company is evaluating current market dynamics and the value efgartigimod can bring, with IVIg therapy costs around EUR 140,000 annually in the U.S. [80]