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Xencor(XNCR) - 2019 Q2 - Earnings Call Transcript
2019-08-07 02:44
Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities totaled $626.1 million at June 30, 2019, compared to $503.5 million at December 31, 2018, reflecting an increase due to upfront proceeds from collaborations [40] - Total revenue for Q2 2019 was $19.5 million, with total revenue for the first half of 2019 at $131.4 million, including revenue from Genentech, Astellas, and Alexion collaborations [41] - Net loss for Q2 2019 was $16 million, or $0.28 per share, compared to a net loss of $25.9 million, or $0.46 per share, for the same period in 2018 [44] - For the first half of 2019, net income was $64 million, or $1.10 per share, compared to a net loss of $55.4 million, or $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 $33.3 million, up from $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 $5.8 million, compared to $5 million in Q2 2018, with total G&A expenses for the first half of 2019 at $11.3 million, up from $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]
Xencor(XNCR) - 2019 Q2 - Quarterly Report
2019-08-07 01:59
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (State or Other Jurisdiction of Incorporation or Organization) 111 West Lemon Avenue, Monrovia, CA 91016 (Address of Principal Executive Offices) (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 Xencor, Inc. (Exact Name of Registrant as Specified in its Charter) or ☐ TRANSITION REPORT PURSUANT TO SECTION ...
Xencor(XNCR) - 2019 Q1 - Earnings Call Transcript
2019-05-10 14:35
Financial 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]
Xencor(XNCR) - 2019 Q1 - Quarterly Report
2019-05-09 21:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36182 Xencor, Inc. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Organization) 111 West ...
Xencor(XNCR) - 2018 Q4 - Annual Report
2019-02-26 15:22
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10‑K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT For the fiscal year ended December 31, 2018 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001‑36182 Xencor, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of Incorporation or Organizati ...
Xencor(XNCR) - 2018 Q4 - Earnings Call Transcript
2019-02-26 03:03
Xencor, Inc. (NASDAQ:XNCR) Q4 2018 Results Earnings Conference Call February 25, 2019 4:30 PM ET Company Participants Charles Liles - Associate Director and Head of Corporate Communications and IR Bassil Dahiyat - President and CEO Paul Foster - SVP and Chief Medical Officer John Kuch - SVP, Finance and CFO Conference Call Participants Ted Tenthoff - Piper Jaffray Alethia Young - Cantor Fitzgerald Arlinda Lee - CG Jonathan Chang - CVB Leerink Jackson Harvey - Nomura David Nierengarten - Wedbush Securities O ...