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Xencor (XNCR) Reports Q4 Loss, Tops Revenue Estimates
ZACKS· 2025-02-27 15:15
Company Performance - Xencor reported a quarterly loss of $0.62 per share, which was better than the Zacks Consensus Estimate of a loss of $0.83, but worse than the loss of $0.31 per share from a year ago [1] - The quarterly report represented an earnings surprise of 25.30%, with the company previously expected to post a loss of $0.98 per share but actually reporting a loss of $0.71, resulting in a surprise of 27.55% [2] - Xencor's revenues for the quarter ended December 2024 were $52.79 million, exceeding the Zacks Consensus Estimate by 293.40%, compared to $44.69 million in the same quarter last year [3] Market Performance - Xencor shares have declined approximately 37.4% since the beginning of the year, while the S&P 500 has gained 1.3% [4] - The current consensus EPS estimate for the upcoming quarter is -$0.88 on revenues of $12.11 million, and for the current fiscal year, it is -$3.64 on revenues of $59.03 million [8] Industry Outlook - The Medical - Drugs industry, to which Xencor belongs, is currently ranked in the top 50% of over 250 Zacks industries, indicating that companies in this segment are expected to outperform those in the bottom 50% by a factor of more than 2 to 1 [9]
Xencor(XNCR) - 2024 Q4 - Annual Report
2025-02-27 13:05
Drug Development and Clinical Trials - The company is focused on developing engineered antibody therapeutics for cancer and autoimmune diseases, advancing multiple drug candidates into clinical development[13]. - The XmAb 2+1 bispecific antibody format has shown potential in preclinical models, effectively targeting tumor cells while sparing normal cells[21]. - XmAb657 demonstrated over 99.98% reduction in B cells in non-human primate studies, with a half-life estimated at 15 days, indicating potential for durable B-cell depletion[23]. - The company plans to initiate a first-in-human study for XmAb657 in the second half of 2025[23]. - XmAb819 has shown initial evidence of anti-tumor activity in advanced clear cell renal cell carcinoma (ccRCC) patients, with some patients experiencing treatment durations extending beyond one year[33]. - XmAb541 is in a Phase 1 study for ovarian cancer, with the first patient dosed in April 2024[34]. - The company has paused further development of vudalimab to prioritize other pipeline programs, with safety data remaining consistent[38]. - New XmAb drug candidates, including XmAb942 and XmAb657, are being evaluated for autoimmune and inflammatory diseases[39]. - Plamotamab demonstrated encouraging clinical activity in heavily pretreated patients with advanced lymphoma, with patient enrollment in subcutaneous dose escalation cohorts completed in 2023[41]. - A Phase 1b/2a proof-of-concept study for plamotamab in rheumatoid arthritis (RA) is planned for the first half of 2025, with efficacy evaluated at week 12[42]. - XmAb7195 was reacquired in 2024, and development opportunities are being evaluated after being licensed to Aimmune Therapeutics in 2020[43]. - Xaluritamig showed a median overall survival of 17.7 months in a Phase 1 study for mCRPC, with a PSA90 rate of 45.1% observed in high-dose cohorts[50]. - Obexelimab is in a Phase 3 study for IgG4-related disease and Phase 2 studies for relapsing multiple sclerosis and systemic lupus erythematosus[51]. Financial Performance and Projections - The company has incurred significant losses since its inception and anticipates continuing to incur significant losses for the foreseeable future[168]. - For the year ended December 31, 2024, the company incurred a net loss of $232.6 million and had an accumulated deficit of $704.0 million[179]. - As of December 31, 2024, the company had $706.7 million in cash, cash equivalents, and marketable debt securities, which is expected to fund operations into 2028[184]. - The company anticipates incurring additional net losses in future years as it continues its research and development activities[180]. - The company expects its financial condition and operating results to fluctuate significantly from quarter to quarter and year to year due to various uncontrollable factors[172]. - The company may require additional financing to support its research and development programs, which could lead to dilution of existing shareholders[168]. - The company may require additional financing to complete the clinical development of its product candidates, which may not be available on favorable terms[186]. - The market price of the company's common stock is likely to be highly volatile, influenced by various factors including market conditions and operational performance[189]. - The trading price of the company's common stock has ranged from a low of approximately $5.75 to a high of approximately $58.345 since its IPO[188]. - Approximately 56.8% of the company's voting stock is owned by executive officers, directors, and significant stockholders, allowing them to exert significant control over corporate matters[191]. Regulatory and Compliance - Regulatory compliance is critical, with extensive requirements from the FDA and other authorities for drug development, including preclinical studies and clinical trials[105][106]. - The process for obtaining FDA approval involves multiple steps, including submission of a Biologics License Application (BLA) and compliance with Good Manufacturing Practices (GMP)[107][110]. - The FDA requires that all clinical trials conducted under an IND must meet specific requirements unless waived[113]. - Clinical trials are conducted in three phases, with Phase 1 focusing on safety and dosage, Phase 2 on efficacy and safety in a larger patient population, and Phase 3 on substantial evidence of clinical efficacy and safety[115]. - The standard FDA review process for a BLA is 10 months once accepted, but it can take longer depending on various factors[121]. - The FDA may require post-marketing studies to further assess drug safety and effectiveness, which can impact the commercial value of the product[125]. - Material changes in manufacturing processes post-approval may necessitate additional regulatory review and approval[121]. - Biologic product manufacturers must comply with comprehensive FDA regulations, including cGMP compliance and periodic reporting requirements[136]. - The company is subject to extensive regulations governing the development and commercialization of its products, which may complicate compliance efforts[163]. Intellectual Property and Market Position - The company aims to expand its patent portfolio to protect its proprietary Fc technologies and drug candidates[26]. - The company has filed patent applications for thousands of specific Fc domain variants, enhancing its intellectual property position[73]. - The patent expiration for key technologies includes bispecific (2034 U.S. and Ex-U.S.) and CD3 T-Cell Engagers (2035 U.S. and Ex-U.S.)[74]. - The company relies on third-party vendors for research, development, and clinical activities, maintaining flexibility in its infrastructure[80]. - The company has agreements with KBI Biopharma and WuXi Biologics for manufacturing and development services for its antibody candidates[81][88]. - The company is developing bispecific antibody drug candidates targeting solid tumor cells and B cells, competing with major companies like Amgen, Genmab, and Roche[101][102]. - The company is also working on antibody drug candidates targeting the cytokine TL1A for potential IBD treatment, facing competition from firms like Merck and Roche[103]. Workforce and Internal Controls - As of December 31, 2024, the company had 250 full-time employees, with 203 engaged in research and development activities[64]. - The workforce was 58% non-white and 59% women as of December 31, 2024, with women making up 30% of the senior leadership team[65]. - The company completed a reduction in force (RIF) affecting approximately 10% of the total employee headcount in January 2024[66]. - The company has identified material weaknesses in its internal control over financial reporting, which could affect the accuracy and timeliness of its financial reports[168]. - The company is subject to additional internal control requirements under the Sarbanes-Oxley Act of 2002 as a large accelerated filer[200]. Market and Economic Factors - The market size for the treatment of Crohn's disease and ulcerative colitis is projected to reach $40 billion worldwide by 2032[71]. - The American Cancer Society estimates approximately 2.0 million new cases of cancer and about 618,120 cancer deaths in the U.S. by 2025[69]. - Medical expenditures for cancer in the U.S. are projected to reach at least $245.6 billion by 2030[69]. - The company is susceptible to adverse impacts from inflation and economic volatility, which could affect its financial performance[175]. - Legislative and regulatory proposals aimed at healthcare cost containment could impact the company's ability to sell product candidates profitably[150]. Stock and Shareholder Matters - The company has never declared or paid any cash dividend on its common stock and does not anticipate doing so in the foreseeable future[205]. - The company is authorized to grant equity awards covering up to 18,367,000 shares of its common stock under its equity compensation plans[195]. - The company has options to purchase 12,370,081 shares outstanding under its equity compensation plans[195]. - The company may offer and sell shares of its common stock with an aggregate offering price of up to $200 million through an ATM Offering[198]. - No shares of common stock were sold pursuant to the ATM Offering from the date of the ATM Prospectus through December 31, 2024[198]. - Provisions in the company’s charter documents may make it more difficult for third parties to acquire the company, potentially affecting stockholder value[206].
Down -21.69% in 4 Weeks, Here's Why Xencor (XNCR) Looks Ripe for a Turnaround
ZACKS· 2025-01-21 15:36
Group 1 - Xencor (XNCR) has experienced a significant decline of 21.7% over the past four weeks, but it is now in oversold territory, indicating a potential for a trend reversal [1] - The Relative Strength Index (RSI) for XNCR is currently at 27.45, suggesting that the heavy selling pressure may be exhausting, which could lead to a rebound [5] - There is a strong consensus among Wall Street analysts that XNCR will report better earnings than previously predicted, with a 1.6% increase in the consensus EPS estimate over the last 30 days [6] Group 2 - XNCR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7]
After Plunging -20.27% in 4 Weeks, Here's Why the Trend Might Reverse for Xencor (XNCR)
ZACKS· 2025-01-20 15:40
Core Viewpoint - Xencor (XNCR) has experienced a significant downtrend with a 20.3% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 indicating oversold conditions [2]. - XNCR's current RSI reading is 27.2, suggesting that the heavy selling pressure may be exhausting, indicating a possible price rebound [5]. Group 2: Fundamental Indicators - Analysts have raised earnings estimates for XNCR by 1.6% over the last 30 days, which typically correlates with price appreciation in the near term [6]. - XNCR holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7].
Here's Why Xencor (XNCR) is Poised for a Turnaround After Losing -23.68% in 4 Weeks
ZACKS· 2025-01-15 15:36
Group 1 - Xencor (XNCR) has experienced significant selling pressure, resulting in a 23.7% decline over the past four weeks, but it is now considered oversold, indicating potential for recovery as analysts expect improved earnings [1] - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - The RSI helps investors identify potential price reversals, suggesting that if a stock is undervalued due to excessive selling, it may present a buying opportunity [3] Group 2 - The RSI for XNCR is currently at 20.84, suggesting that the heavy selling may be nearing exhaustion and a trend reversal could occur soon [5] - Analysts have raised earnings estimates for XNCR, with a 1.6% increase in the consensus EPS estimate over the last 30 days, indicating potential price appreciation [6] - XNCR holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the likelihood of a turnaround [7]
Xencor (XNCR) Upgraded to Strong Buy: Here's What You Should Know
ZACKS· 2025-01-14 18:00
Core Viewpoint - Xencor (XNCR) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [3][5]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [3]. Company Performance and Outlook - The upgrade for Xencor reflects an improvement in the company's underlying business, suggesting that investor sentiment may drive the stock price higher [4]. - Xencor is projected to earn -$3.68 per share for the fiscal year ending December 2024, representing a year-over-year decline of 76.9% [7]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [6]. - Only the top 5% of Zacks-covered stocks receive a 'Strong Buy' rating, indicating superior earnings estimate revisions [8][9].
Xencor(XNCR) - 2024 Q4 - Annual Results
2025-02-27 13:02
Financial Position - Xencor has a strong financial position with approximately $707 million in cash, cash equivalents, and marketable debt as of December 31, 2024[9]. Drug Development Pipeline - The company is advancing three novel T-cell engagers (TCEs) in Phase 1 studies focused on oncology, specifically targeting metastatic castration-resistant prostate cancer (mCRPC) and first-line non-small cell lung cancer (NSCLC)[7]. - XmAb942 (Xtend™ TL1A) is set to initiate studies in Q4 2024, while Plamotamab (CD20xCD3) is expected to enter Phase 1 in the first half of 2025[7]. - XmAb819 (ENPP3 x CD3) is currently in a Phase 1 dose escalation study for clear cell renal cell carcinoma (ccRCC), showing promising initial data with no maximum tolerated dose reached[21]. - XmAb541 (CLDN6 x CD3) is also in Phase 1, demonstrating high selectivity for CLDN6 over similar proteins, targeting ovarian and endometrial cancers[23]. - XmAb808 (B7-H3 x CD28) is in Phase 1, designed to enhance selective T cell activation in solid tumors, with ongoing patient enrollment[35]. - XmAb942 and XmAb TL1A x IL-23 are in development for ulcerative colitis, leveraging validated half-life extension technology[75]. - The first-in-human clinical study for XmAb942 is planned to initiate in Q4 2024[29]. - The initiation of Phase 1/2 study for Plamotamab (CD20 x CD3) in rheumatoid arthritis is set to begin[95]. - XmAb942 is expected to have single ascending dose (SAD) and multiple ascending dose (MAD) readouts in the immunology portfolio[95]. - XmAb717-04 and XmAb717-05 expansion readouts are anticipated in 1H 2025[93]. - The first-in-class potential for XmAb TL1A x IL-23 is being explored with a study planned for 2026[82]. Technology and Innovation - The company has a robust patent portfolio with over 1,600 patents issued and pending worldwide, enhancing its competitive edge in the market[7]. - Xencor's drug development strategy emphasizes rapid prototyping and strict evaluation of data to maximize outcomes for stakeholders[9]. - The company’s Xtend™ Fc technology has shown to significantly improve half-life and dosing frequency compared to traditional antibodies[77]. - XmAb942 utilizes Xtend™ Fc domain technology with a half-life of 23 days, supporting dosing every 8 to 12 weeks[29]. Collaborations and Market Strategy - The company is exploring technology licensing to expand its pipeline with minimal opportunity cost, indicating a strategic approach to market expansion[13]. - Xencor's collaborations with Johnson & Johnson focus on prostate cancer combinations, leveraging access to J&J's resources for enhanced development[34]. Market Opportunities - Current market for rheumatoid arthritis treatments exceeds $20 billion, with unmet needs for moderate-to-severe systemic lupus erythematosus (SLE) estimated at over $5 billion in the US[44]. - The global IBD drug market is projected to exceed $23 billion by 2030, highlighting significant unmet medical needs in inflammatory bowel disease[72]. - The bispecific antibody class is positioned to address significant limitations in current autoimmune disease treatments, with ongoing studies supporting its efficacy[43]. Clinical Outcomes - Vudalimab, a dual checkpoint inhibitor (PD-1 x CTLA-4), has shown a low rate of treatment discontinuation due to adverse events in ongoing studies[91]. - Vudalimab monotherapy has demonstrated clinical responses in 5 out of 12 evaluable patients with metastatic castration-resistant prostate cancer (mCRPC)[93]. - XmAb drug candidates are advancing with multiple dose expansions planned, including XmAb819 and XmAb808 in oncology[95]. - The company aims to evaluate the safety of Vudalimab in combination with chemotherapy for non-small cell lung cancer (NSCLC)[93]. - XmAb657, designed for autoimmune diseases, has demonstrated over 90% reduction in B-cell counts in both bone marrow and whole blood across dose cohorts[56]. - Plamotamab, a subcutaneous CD20 x CD3 bispecific antibody, is planned for Phase 1b/2a study initiation in the first half of 2025, focusing on rheumatoid arthritis[58].
All You Need to Know About Xencor (XNCR) Rating Upgrade to Buy
ZACKS· 2024-12-12 18:06
Core Viewpoint - Xencor (XNCR) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often adjust their valuations based on changes in earnings estimates, leading to significant stock price movements [4]. Company Performance and Outlook - Xencor is projected to earn -$3.71 per share for the fiscal year ending December 2024, reflecting a year-over-year decline of 78.4% [8]. - Despite the negative earnings projection, analysts have raised their estimates for Xencor, with the Zacks Consensus Estimate increasing by 11.1% over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - Xencor's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [11].
Wall Street Analysts Think Xencor (XNCR) Could Surge 31.58%: Read This Before Placing a Bet
ZACKS· 2024-12-04 15:56
Xencor (XNCR) closed the last trading session at $26.60, gaining 23.6% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $35 indicates a 31.6% upside potential.The average comprises 11 short-term price targets ranging from a low of $22 to a high of $60, with a standard deviation of $9.77. While the lowest estimate indicates a decline of 17.3% from the current price level, the most op ...
Xencor: Plamotamab NHL Data Leads To RA Program Advancement
Seeking Alpha· 2024-11-22 19:00
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...