Xencor(US:XNCR)2022-11-07 22:25Revenue and Financial Performance - The company recorded royalty revenues of $70.3 million, $22.1 million, and $17.8 million in the first, second, and third quarters of 2022, respectively, related to sales of sotrovimab[133]. - Approximately $27.2 million in revenue was generated from partnerships and collaborations during the quarter ended September 30, 2022[131]. - Total revenues for the three months ended September 30, 2022, were $27.3 million, an increase of $7.6 million compared to $19.7 million in the same period of 2021[173]. - Royalty revenues for the three months ended September 30, 2022, were $27.2 million, up from $13.4 million in the same period of 2021, representing a 102.99% increase[173]. - Total revenues for the nine months ended September 30, 2022, were $143.0 million, up from $121.1 million in 2021, representing an increase of $21.9 million[183]. - Royalty revenue surged by $108.5 million to $135.9 million for the nine months ended September 30, 2022, compared to $27.4 million in 2021[183]. - The company reported a net loss of $43.1 million for the nine months ended September 30, 2022, compared to a net income of $9.6 million in 2021, a decline of $52.7 million[183]. - The net loss for the three months ended September 30, 2022, was $32.8 million, a reduction of $7.4 million compared to a net loss of $40.2 million in the same period of 2021[173]. - Other income, net decreased significantly to ($2.2) million for the nine months ended September 30, 2022, down from $57.5 million in 2021, a change of $59.7 million[189]. Research and Development - The company initiated a Phase 1 study of XmAb808, targeting B7-H3, and XmAb662, an IL12-Fc cytokine candidate[134]. - XmAb564 demonstrated a 117-fold mean peak expansion over baseline in CD25bright cells in a Phase 1a study, indicating significant Treg expansion[145]. - The company is currently enrolling patients in multiple clinical trials for six wholly owned or co-development candidates targeting various cancers and autoimmune diseases[135]. - The company plans to submit an IND application for XmAb662 and initiate a Phase 1 study in patients with advanced solid tumors in 2023[155]. - The company is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced clear cell renal cell carcinoma[147]. - The company has decided to discontinue further internal development of tidutamab and XmAb841 due to lack of competitive clinical profiles[148]. - The collaboration with Amgen for the development of AMG 509 has shown encouraging preliminary pharmacodynamic activity in a Phase 1 study for prostate cancer[161]. - The company plans to present data from the Phase 2 study of vudalimab at the Annual Meeting of the Society for Immunotherapy of Cancer in November 2022[136]. Expenses and Cash Flow - Operating expenses for the three months ended September 30, 2022, totaled $65.7 million, an increase of $4.7 million from $61.0 million in Q3 2021[173]. - Research and development expenses increased by $2.7 million to $53.3 million for the three months ended September 30, 2022, compared to $50.6 million in the same period in 2021[179]. - Total research and development expenses for the nine months ended September 30, 2022, were $148.1 million, an increase of $6.6 million from $141.5 million in 2021[187]. - External research and development expenses decreased by $9.0 million to $66.5 million for the nine months ended September 30, 2022, compared to $75.5 million in 2021[187]. - Cash provided by operating activities was $48.9 million for the nine months ended September 30, 2022, compared to cash used of $78.6 million in 2021, an improvement of $127.6 million[191]. - Cash used in investing activities increased by $90.2 million to ($144.3) million for the nine months ended September 30, 2022, compared to ($54.1) million in 2021[190]. - As of September 30, 2022, the company had $654.6 million in cash, cash equivalents, receivables, and marketable debt securities, a decrease from $664.1 million as of December 31, 2021[196]. - The company anticipates that existing cash, cash equivalents, marketable securities, and potential milestone payments will fund operating expenses through the end of 2025[198]. Regulatory and Compliance - Sotrovimab received an EUA from the FDA for treating mild-to-moderate COVID-19 in high-risk patients, with temporary authorization in over 40 countries[131]. - The company recorded a receivable of $3.2 million related to the U.S. Government Employee Retention Tax Credit (ERTC) Program[134]. - The company has over 1,300 issued and pending patents worldwide to protect its XmAb technology platform and drug candidates[169]. - There were no off-balance sheet arrangements during the periods presented[199]. - No material changes occurred in the company's contractual obligations during the three months ended September 30, 2022[200]. - There have been no material changes in the quantitative or qualitative aspects of the company's market risk profile[202]. - The company's disclosure controls and procedures were evaluated as effective as of September 30, 2022[204]. - There were no changes in internal control over financial reporting that materially affected the company during the three months ended September 30, 2022[206].