Xencor(XNCR)2019-08-07 02:44Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities totaled 503.5 million at December 31, 2018, reflecting an increase due to upfront proceeds from collaborations [40] - Total revenue for Q2 2019 was 131.4 million, including revenue from Genentech, Astellas, and Alexion collaborations [41] - Net loss for Q2 2019 was 0.28 per share, compared to a net loss of 0.46 per share, for the same period in 2018 [44] - For the first half of 2019, net income was 1.10 per share, compared to a net loss of 1.07 per share, for the same period in 2018 [46] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2019 were 23.3 million in Q2 2018, reflecting increased spending on CD3 bispecific antibody and cytokine development [42] - General and administrative expenses for Q2 2019 were 5 million in Q2 2018, with total G&A expenses for the first half of 2019 at 9.5 million in the same period in 2018 [43] Market Data and Key Metrics Changes - The company reported low single-digit royalties of 1.1 million from Ultomiris for the first six months of 2019, based on sales reported by Alexion [50][51] Company Strategy and Development Direction - The company focuses on expanding its XmAb bispecific platform, with six Phase 1 clinical studies initiated over the past two years [11] - XmAb14045, a CD123 by CD3 bispecific antibody, is in an open-label Phase 1 study for relapsed or refractory acute myeloid leukemia, with initial patient dosing resuming after a partial clinical hold [14][15] - The company is also developing XmAb13676 for advanced B-cell malignancies and expects to present initial safety and clinical activity data later in 2019 [16][18] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of balancing resource allocation to generate comprehensive data sets while advancing multiple programs [52] - The collaboration with Genentech is progressing smoothly, with no shifts in timing for the IL15 program [56][58] - Management expressed optimism about the potential of bispecific antibodies in oncology, particularly in addressing the challenges of solid tumors [114] Other Important Information - The company announced the retirement of Chief Medical Officer Paul Foster, with a search for a successor underway [34] - New appointments include Jeremy Grunstein as Vice President of Business Development and Kirk Rosemark as Vice President of Regulatory Affairs and Quality Assurance [36][37] Q&A Session Summary Question: Can you provide details on Ultomiris royalties? - Management confirmed that royalties for the first six months of the year were 1.1 million, which is a low single-digit percentage based on sales reported by Alexion [50][51] Question: Is there a delay in tumor microenvironment data readouts? - Management indicated that the desire for a fuller data set has led to a shift in reporting timelines, but everything remains on track [52] Question: How is the collaboration with Genentech progressing? - Management stated that the collaboration is seamless, with no shifts in timing for the program [56][58] Question: What are the expectations for initial Phase 1 data for XmAb 13676? - Management expects to have data showing safety and efficacy as the dose escalation progresses, but not all data will be complete by the report [64] Question: How does the company view the competitive landscape for B-cell malignancies? - Management noted that the landscape is dense, with established therapies setting a high bar, but believes CD3 bispecifics will be compelling [66] Question: What are the safety considerations for tumor microenvironment antibodies? - Management highlighted the focus on immune-related adverse events (IRAEs) and the need for a balance between efficacy and safety [108]