Xencor(US:XNCR)2019-05-10 14:35Financial Data and Key Metrics Changes - As of March 31, 2019, the company reported cash, cash equivalents, marketable securities, and receivables totaling $650.5 million, an increase from $540.7 million at December 31, 2018, reflecting an increase due to upfront proceeds from collaborations [35] - Total revenue for Q1 2019 was $111.9 million, a significant increase compared to no revenue reported for the same period in 2018 [36] - Net income for Q1 2019 was $80 million or $1.38 per fully diluted share, compared to a net loss of $29.5 million or $0.62 per fully diluted share for the same period in 2018 [40] Business Line Data and Key Metrics Changes - Research and development expenditures for Q1 2019 were $28.2 million, up from $26.1 million in the same period in 2018, primarily focused on bispecific technologies and pipeline [38] - General and administrative expenses for Q1 2019 were $5.5 million, compared to $4.6 million in the same period in 2018, reflecting increased spending on professional fees [39] Market Data and Key Metrics Changes - The company is eligible to receive low-single digit royalties from the sales of Ultomiris, which was approved by the FDA in March 2018, although no royalty income was reported for Q1 2019 [37] Company Strategy and Development Direction - The company is focused on expanding its pipeline of bispecific antibody-drug candidates, particularly in oncology, leveraging its XmAb engineering platform to create improved therapeutic antibodies [9][11] - Partnerships with companies like Genentech and Astellas are seen as crucial for funding the development of internal product candidates, with significant milestone payments and royalties expected from these collaborations [17][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of bispecific antibodies and cytokine therapies, highlighting the importance of ongoing clinical trials and partnerships to advance their pipeline [9][14] - The company expects to have sufficient cash to fund research and development programs beyond 2024, projecting to end 2019 with between $550 million and $575 million in cash and equivalents [42] Other Important Information - The FDA lifted a partial clinical hold on the Phase 1 study of XmAb14045, allowing the company to resume patient enrollment [24] - The company is actively seeking a partner for obexelimab to maximize its potential in late-stage development [33] Q&A Session Summary Question: Impact of clinical hold on CD123 data readouts - Management indicated that the clinical hold would likely result in a couple of quarters' setback for data readouts and patient enrollment [45] Question: Updates on CD20 and competitive data - Management noted that recent competitor data on CD20-CD3 combinations highlighted the importance of immune activation and careful dosing strategies [51] Question: Modifications to the CD14045 study protocol - Management confirmed enhancements in monitoring and guidance on the treatment of cytokine release syndrome and other toxicities across CD3 bispecific studies [56] Question: Updates on obexelimab partnership discussions - Management stated that discussions are ongoing, focusing on aligning with partners for the next phases of development [57] Question: Key targets for cytokine bispecific technology - Management emphasized the importance of tuning cytokine potency for tolerability and effective immune cell activation, with ongoing research in collaboration with Genentech [70] Question: Clinical plan for IL-15 program - Management indicated that detailed plans for the IL-15 program would not be available until after initial dose escalation, likely in the second half of 2020 [75] Question: Comparison of obexelimab and MOR208 - Management confirmed that both antibodies bind to the same CD19 epitope but function differently due to their Fc domains [81] Question: Structure of CD3 bispecific antibodies compared to competitors - Management discussed the advantages of their Fc domain technology in terms of stability and manufacturability compared to other bispecific platforms [86]