Xencor(XNCR)
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Xencor(XNCR) - 2020 Q2 - Earnings Call Transcript
2020-08-05 05:50
Financial Data and Key Metrics Changes - For Q2 2020, revenues were $13.1 million, a decrease from $19.5 million in Q2 2019 [48] - For the first six months of 2020, revenues totaled $45.5 million, down from $131.4 million in the same period in 2019 [49] - The net loss for Q2 2020 was $35 million, or $0.61 per share, compared to a net loss of $16 million, or $0.28 per share in Q2 2019 [53] - For the first six months of 2020, the net loss was $43.1 million, or $0.76 per share, compared to net income of $64 million, or $1.10 per share in the same period in 2019 [54] - Cash and cash equivalents as of June 30, 2020, totaled $587.4 million, down from $601.3 million at the end of 2019 [47] Business Line Data and Key Metrics Changes - Research and development expenditures for Q2 2020 were $43.5 million, up from $33.3 million in Q2 2019 [50] - General and administrative expenses for Q2 2020 were $7.2 million, compared to $5.8 million in Q2 2019 [52] - The increase in R&D spending was primarily due to advancements in clinical programs such as plamotamab and XmAb2717 [51] Market Data and Key Metrics Changes - The company has 11 ongoing partnerships for XmAb technology, resulting in two marketed products and seven clinical stage candidates [15] - The partnership with Alexion's Ultomiris continues to receive marketing authorizations worldwide, with the latest approval for atypical hemolytic uremic syndrome [23] Company Strategy and Development Direction - The company is focusing on expanding its XmAb bispecific platform to create antibodies targeting multiple mechanisms simultaneously [10] - Xencor aims to selectively license access to its XmAb technologies for developing antibodies, emphasizing the importance of partnerships to complement its internal portfolio [22] - The recent FDA approval of MorphoSys's Tafasitamab, a product developed under Xencor's technology, highlights the potential of its platform [17] Management's Comments on Operating Environment and Future Outlook - Management noted that the COVID-19 pandemic did not significantly disrupt patient enrollment in ongoing clinical trials, although some trial initiations were delayed [11] - The company expects to have sufficient cash to fund operations into 2024, projecting a year-end cash balance between $525 million and $575 million [56] Other Important Information - The company is advancing its pre-clinical programs, including XmAb30819, which targets ENPP3 and is expected to file an IND in 2021 [31] - The collaboration with Atreca aims to develop bispecific antibodies targeting novel tumor antigens, leveraging Atreca's discovery platform [33] Q&A Session Summary Question: Can you provide details on the royalties and future milestones related to Monjuvi? - The royalties are in the high-single to low-double digit range, with significant milestones for development and sales in oncology [61][62] Question: What data can we expect from Tidutamab? - The upcoming data will focus on safety and efficacy in the neuroendocrine tumor population, with a low standard-of-care response rate around 10% [70][71] Question: What is the development strategy for plamotamab? - The company sees promising activity in late-line lymphoma and plans to announce specific trials for combination and monotherapy approaches later this year [84][85] Question: Can you comment on the adverse events observed with AMG 424? - The adverse events were likely CD38 mediated, and the company is assessing potential next steps for the program [89] Question: What is the status of the Atreca collaboration? - The collaboration utilizes existing antibodies from Atreca's screening work, with ongoing discovery activities to replenish the antibody basket [140][141]
Xencor(XNCR) - 2020 Q2 - Quarterly Report
2020-08-04 21:56
Clinical Development - The company has 17 antibody and cytokine drug candidates in clinical trials, with additional candidates expected to enter the clinic within the next year[127] - The company is currently enrolling patients in six clinical programs, with some experiencing slower patient enrollment due to COVID-19[123] - The company is advancing three CD3 bispecific antibody candidates in Phase 1 studies: vibecotamab, plamotamab, and tidutamab[128] - XmAb20717, a TME activator candidate, is currently enrolling patients in a Phase 1 study and has shown promising initial dose-escalation data[134] Financial Performance - Total revenues for the three months ended June 30, 2020, were $13.1 million, a decrease of $6.4 million compared to $19.5 million in the same period in 2019[149] - Total revenues for the six months ended June 30, 2020, were $45.5 million, a decrease of $85.9 million compared to $131.4 million in the same period of 2019[156] - The net loss for the three months ended June 30, 2020, was $35.0 million, compared to a net loss of $16.0 million in the same period in 2019, reflecting an increase of 118.8%[149] - Net loss for the six months ended June 30, 2020, was $43.0 million, compared to a net income of $64.0 million in 2019, a change of $107.0 million[156] Revenue Sources - Revenue from existing partnerships, including Alexion and Gilead, was recognized at $3.8 million and $7.5 million, respectively, for the quarter ended June 30, 2020[124] - The company received total payments of $9.6 million and $13.5 million from licensing transactions with Aimmune and Gilead in 2020[138] - Research collaboration revenue decreased from $14.4 million in Q2 2019 to $1.5 million in Q2 2020, a decline of 91.6%[149] - Licensing revenue increased to $7.5 million in Q2 2020, compared to no licensing revenue in Q2 2019[149] - Research collaboration revenue decreased from $14.7 million in 2019 to $2.4 million in 2020, a decline of $12.3 million[156] - Licensing revenue fell from $111.6 million in 2019 to $23.1 million in 2020, a decrease of $88.5 million[156] Expenses - Research and development expenses rose to $43.5 million in Q2 2020, up $10.2 million from $33.3 million in Q2 2019, primarily due to increased spending on plamotamab and XmAb20717 programs[151][152] - Operating expenses increased by $19.0 million, from $72.8 million in 2019 to $91.8 million in 2020[156] - Research and development expenses rose by $15.9 million, totaling $77.4 million in 2020 compared to $61.5 million in 2019[159] - General and administrative expenses increased to $7.2 million in Q2 2020, up $1.4 million from $5.8 million in Q2 2019, mainly due to higher staffing and professional fees[153][154] - General and administrative expenses increased by $3.1 million, from $11.3 million in 2019 to $14.4 million in 2020[161] Cash Position - As of June 30, 2020, the company had $587.4 million in cash, cash equivalents, and marketable securities, down from $601.3 million at the end of 2019[169] - Cash used in operating activities was $18.2 million in 2020, a decrease of $108.7 million compared to cash provided of $90.4 million in 2019[165] - The company expects existing cash and potential milestone payments to fund operations into 2024, although this is subject to uncertainty due to ongoing clinical development and the COVID-19 pandemic[172] Intellectual Property - The company has over 1,000 issued and pending patents worldwide to protect its XmAb technology platform and drug candidates[146] Collaborations and Milestones - The collaboration with Atreca involves a three-year research program to develop CD3 bispecific antibodies, with both companies sharing 50% of costs and profits[139] - The FDA approved MorphoSys' Monjuvi (tafasitamab-cxix) in July 2020, which will result in a $25.0 million milestone payment to the company and potential royalties on net sales[146] Tax and Receivables - The company has recorded a receivable of $0.8 million related to the corporate minimum tax credit, which will be refunded in 2020[120] - The company is eligible to receive a mid-single digit royalty on net sales of approved products for the VIR-7831 candidate developed by partner Vir Biotechnology[124]
Xencor(XNCR) - 2020 Q1 - Earnings Call Transcript
2020-05-09 09:14
Xencor, Inc. (NASDAQ:XNCR) Q1 2020 Earnings Conference Call May 7, 2020 4:30 PM ET Company Participants Charles Liles - Associate Director and Head, Corporate Communications and IR Bassil Dahiyat - President and CEO John Kuch - SVP and CFO Allen Yeng - SVP and Chief Medical Officer Conference Call Participants Jonathan Chang - SVB Leerink Arlinda Lee - Canaccord Gabriel Fung - Mizuho Securities Ed Tenthoff - Piper Jaffray Etzer Darout - Guggenheim Securities Operator Ladies and gentlemen, thank you for stan ...
Xencor(XNCR) - 2020 Q1 - Quarterly Report
2020-05-07 21:54
[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD%20LOOKING%20STATEMENTS) Forward-looking statements are subject to risks and uncertainties, including COVID-19 impacts, and the company disclaims any obligation to update them - Forward-looking statements are based on current expectations and projections, subject to risks and uncertainties that could cause actual results to differ materially[10](index=10&type=chunk) - Key risk factors include the effects of the COVID-19 pandemic, plans for product candidate development and commercialization, timing of regulatory approvals, estimates for expenses and revenue, competition, and intellectual property position[10](index=10&type=chunk) - The company does not undertake any obligation to update or revise forward-looking statements[12](index=12&type=chunk) [Part I. Financial Information](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents Xencor's unaudited interim financial statements, management's discussion, market risk, and controls, detailing financial performance and COVID-19 considerations [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section provides unaudited interim financial statements, including Balance Sheets, Statements of Comprehensive Income (Loss), Statement of Stockholders' Equity, Statements of Cash Flows, and detailed notes [Balance Sheets](index=6&type=section&id=Balance%20Sheets%20as%20of%20March%2031%2C%202020%20(unaudited)%20and%20December%2031%2C%202019) Cash and current marketable securities increased, leading to a rise in total current assets, while total assets slightly decreased and liabilities remained stable | Asset/Liability Category | March 31, 2020 (in thousands) | December 31, 2019 (in thousands) | Change (in thousands) | | :----------------------- | :---------------------------- | :------------------------------- | :-------------------- | | Cash and cash equivalents | $73,808 | $50,312 | $23,496 | | Marketable securities (current) | $497,841 | $479,470 | $18,371 | | Total current assets | $588,107 | $558,405 | $29,702 | | Total assets | $666,963 | $670,250 | $(3,287) | | Total current liabilities | $65,917 | $66,558 | $(641) | | Total liabilities | $73,958 | $77,049 | $(3,091) | | Total stockholders' equity | $593,005 | $593,201 | $(196) | [Statements of Comprehensive Income (Loss)](index=7&type=section&id=Statements%20of%20Comprehensive%20Income%20(Loss)%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202020%20and%202019%20(unaudited)) Revenue significantly decreased year-over-year, shifting from net income to a net loss, primarily due to a non-recurring licensing payment in Q1 2019 and increased operating expenses | Metric (in thousands) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | Change (YoY) | | :-------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenue | $32,385 | $111,939 | $(79,554) | | R&D Expenses | $33,943 | $28,183 | $5,760 | | G&A Expenses | $7,219 | $5,512 | $1,707 | | Total Operating Expenses | $41,162 | $33,695 | $7,467 | | Income (loss) from operations | $(8,777) | $78,244 | $(87,021) | | Net income (loss) | $(8,074) | $80,045 | $(88,119) | | Basic EPS | $(0.14) | $1.42 | $(1.56) | | Diluted EPS | $(0.14) | $1.38 | $(1.52) | [Statement of Stockholders' Equity](index=8&type=section&id=Statement%20of%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202020%20and%202019%20(unaudited)) Total stockholders' equity saw a minor decrease, influenced by a comprehensive loss, while additional paid-in capital increased due to stock award exercises and stock-based compensation | Stockholders' Equity Item (in thousands) | December 31, 2019 | March 31, 2020 | Change | | :--------------------------------------- | :---------------- | :------------- | :----- | | Common Stock (shares) | 56,902,301 | 57,001,253 | 98,952 | | Common Stock (amount) | $569 | $570 | $1 | | Additional Paid-in Capital | $887,873 | $895,855 | $7,982 | | Accumulated Other Comprehensive Income (Loss) | $1,161 | $1,056 | $(105) | | Accumulated Deficit | $(296,402) | $(304,476) | $(8,074) | | Total Stockholders' Equity | $593,201 | $593,005 | $(196) | [Statements of Cash Flows](index=9&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202020%20and%202019%20(unaudited)) Cash flow from operating activities significantly improved, shifting from a net use of **$18.7 million** in Q1 2019 to a net provision of **$9.5 million** in Q1 2020, primarily driven by upfront and milestone payments from collaborations, leading to a substantial net increase in cash and cash equivalents | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Operating Activities | $9,460 | $(18,728) | $28,188 | | Investing Activities | $12,565 | $13,673 | $(1,108) | | Financing Activities | $1,471 | $667 | $804 | | Net Increase (Decrease) in Cash | $23,496 | $(4,388) | $27,884 | | Cash and cash equivalents, end of period | $73,808 | $21,858 | $51,950 | [Notes to Financial Statements](index=10&type=section&id=Notes%20to%20Financial%20Statements%20(unaudited)) This section details accounting policies, fair value measurements, stock-based compensation, lease obligations, and collaboration agreements, noting no material impact from new accounting standards and the effect of the CARES Act on income taxes - The financial statements are prepared in accordance with U.S. GAAP for interim financial information, including normal recurring adjustments and management estimates[26](index=26&type=chunk) - The company adopted several new accounting pronouncements effective January 1, 2020, none of which had a significant impact on the financial statements[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) Fair Value Hierarchy | Fair Value Hierarchy (in thousands) | March 31, 2020 Total Fair Value | March 31, 2020 Level 1 | March 31, 2020 Level 2 | December 31, 2019 Total Fair Value | December 31, 2019 Level 1 | December 31, 2019 Level 2 | | :---------------------------------- | :------------------------------ | :--------------------- | :--------------------- | :--------------------------------- | :------------------------ | :------------------------ | | Money Market Funds | $49,800 | $49,800 | $— | $32,009 | $32,009 | $— | | Corporate Securities | $332,691 | $— | $332,691 | $281,751 | $— | $281,751 | | Government Securities | $203,382 | $— | $203,382 | $269,245 | $— | $269,245 | | Equity Securities | $2,253 | $2,253 | $— | $— | $— | $— | | Total | $588,126 | $52,053 | $536,073 | $583,005 | $32,009 | $550,996 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%
Xencor(XNCR) - 2019 Q4 - Earnings Call Transcript
2020-02-25 04:11
Xencor, Inc. (NASDAQ:XNCR) Q4 2019 Earnings Conference Call February 24, 2020 4:30 PM ET Corporate Participants Charles Liles - Associate Director and Head, Corporate Communications & Investor Relations Bassil Dahiyat - President and Chief Executive Officer John Kuch - Senior Vice President & Chief Financial Officer Allen Yeng - Chief Medical Officer Conference Call participants Alethia Young - Cantor Fitzgerald Ted Tenthoff - Piper Jaffray Mara Goldstein - Mizuho Gregory Renzo - RBC Capital Markets Arlinda ...
Xencor(XNCR) - 2019 Q4 - Annual Report
2020-02-25 00:56
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 OF 1934 For the fiscal year ended December 31, 2019 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 Or ...
Xencor (XNCR) Presents At Jefferies 2019 London Healthcare Conference - Slideshow
2019-12-04 20:27
Antibodies by Design™ XmAb® Antibody Therapeutics Corporate Overview November 2019 Forward-Looking Statements Certain statements contained in this presentation, other than statements of historical fact, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Xencor's development plans and timelines; potential regulatory actions; expected use of cash resources; the timing and re ...
Xencor(XNCR) - 2019 Q3 - Earnings Call Transcript
2019-11-06 04:21
Xencor, Inc. (NASDAQ:XNCR) Q3 2019 Earnings Conference Call November 5, 2019 4:30 PM ET Company Participants Charles Liles - Associate Director and Head, Corporate Communications & Investor Relations Bassil Dahiyat - President & Chief Executive Officer John Kuch - Senior Vice President, Finance & Chief Financial Officer Conference Call Participants Alethia Young - Cantor Fitzgerald Etzer Darout - Guggenheim Securities Shanshan Xu - Berenberg Capital Market Mara Goldstein - Mizuho David Ruch - SVB Leerink Ar ...
Xencor(XNCR) - 2019 Q3 - Quarterly Report
2019-11-05 22:06
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 September 30, 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) Delaware 20-1622502 (State or Other Jurisdiction of Incorporation o ...
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]