Xencor(XNCR) - 2023 Q4 - Annual Report

Part I Business Xencor is a clinical-stage biopharmaceutical company focused on engineered antibody therapeutics, advancing its pipeline and leveraging partnerships - Xencor focuses on discovering and developing engineered antibody therapeutics using its XmAb® protein engineering capabilities to create drug candidates with improved properties[15] - In 2023, the company received $111.7 million in upfront payments, milestones, and royalties from collaboration arrangements, and an additional $215.0 million from the sale of future royalty rights[19] - Three marketed medicines (Sotrovimab, Ultomiris, Monjuvi) incorporating XmAb Fc domains generated $49.5 million in royalty revenue for Xencor in 2023[29][30] - As of December 31, 2023, the company had 280 full-time employees, with 231 in R&D. A reduction in force in January 2024 affected approximately 10% of the workforce, bringing the total to 256 as of February 1, 2024[80][82] Strategy and Technology Platforms Xencor's strategy focuses on advancing XmAb antibody programs and leveraging proprietary technology for multi-specific antibodies and engineered cytokines - The company's strategy focuses on advancing its oncology and serious disease pipeline, diversifying its portfolio, and leveraging partnerships for revenue and development[18] - Key technology platforms include the XmAb Bispecific Fc Domain for creating multi-specific antibodies (e.g., CD3 and CD28 engagers) and engineered cytokines[22][23][25] - The XmAb 2+1 bispecific antibody format is designed to selectively target high antigen-expressing tumor cells over normal cells, which is particularly important for solid tumor targets[24] - Other XmAb Fc domains provide functionalities such as immune inhibition (FcγRIIb), increased cytotoxicity (FcγRIIIa/FcγRIIa), and extended half-life (Xtend™ Fc Domain)[30] Clinical Development Pipeline Xencor and partners are advancing 22 clinical-stage drug candidates, including wholly-owned vudalimab, XmAb819, and XmAb808, while strategically pausing some cytokine programs Overview of Clinical Pipeline Status | Category | Count | Key Candidates | | :--- | :--- | :--- | | Wholly Owned | 6 | Vudalimab, XmAb819, XmAb808, XmAb564, XmAb662, XmAb541 | | Co-developed | 1 | Plamotamab | | Developed by Partners | 12 | Obexelimab, Xaluritamig, Efbalropendekin alfa, etc. | | Marketed by Partners | 3 | Ultomiris, Monjuvi, Sotrovimab | - Key wholly-owned candidates in clinical development include Vudalimab (Phase 2 for mCRPC and NSCLC), XmAb819 (Phase 1 for RCC), and XmAb808 (Phase 1 for solid tumors)[36] - The company plans to pause development of cytokine candidates XmAb564 (IL-2-Fc) and XmAb662 (IL-12-Fc) in the first half of 2024 after concluding their Phase 1b and Phase 1 studies, respectively, to review competitive data[39] - The collaboration on efbalropendekin alfa with Genentech will convert to a royalty/milestone arrangement effective June 1, 2024, with Genentech assuming full development responsibility[34][39] Collaborations and Partnerships Xencor leverages partnerships for revenue and pipeline advancement, securing significant milestone payments and selling royalty rights, while also forming a new subsidiary - The collaboration with Janssen (J&J) on plamotamab involves a 20/80 cost-sharing arrangement. The CD28 bispecific collaborations with J&J led to $47.5 million in milestone payments in 2023[45][46][60] - The Genentech partnership for efbalropendekin alfa is transitioning from a 45% cost/profit share to a milestone/royalty model, with Xencor eligible for up to $600 million in milestones and tiered royalties[48] - The company earned $38.6 million in royalties and a $20.0 million sales milestone from Alexion for Ultomiris in 2023. A portion of these future royalties was sold for $192.5 million[70] - In Q4 2023, Xencor formed a subsidiary, Gale Therapeutics Inc., licensing preclinical assets to it in exchange for future royalties and an option on future drug candidates. Xencor acquired a majority stake for $7.5 million[78] Intellectual Property Xencor's IP strategy protects its novel antibody and cytokine therapeutics, holding over 1,500 patents globally with key technology protection extending beyond 2030 Key Technology and Product Patent Expiry | Technology / Product | U.S. Expiry (Year) | Ex-U.S. Expiry (Year) | | :--- | :--- | :--- | | Bispecific | 2034 | 2034 | | CD3 T Cell Engagers | 2035 | 2035 | | CD28 T Cell Engagers | 2041 | 2041 | | Vudalimab | 2037 | 2037 | | XmAb808 | 2041 | 2041 | | Monjuvi (tafasitamab) | 2029 | 2027 | - The company's global patent estate includes over 1,500 issued patents and pending applications[89] - The company seeks patent term extensions under the Hatch-Waxman Act for approved drugs and relies on the 12-year data exclusivity period for biologics under the ACA[91][92] Risk Factors Xencor faces significant risks including pipeline success uncertainty, financial losses, capital needs, IP protection challenges, third-party reliance, and intense industry competition Risks Related to Business Operations Xencor's success is uncertain due to reliance on its XmAb platform, limited operational history as a clinical-stage company, and potential changes in preliminary clinical data - Success depends on the ability to use the XmAb platform to build a pipeline and develop marketable products, which is uncertain[149] - The company's clinical-stage operations make it difficult to evaluate its business success and future viability, as it has not yet completed any pivotal trials or commercialized a wholly-owned product[150] - Preliminary, interim, and topline data from clinical trials are subject to change as more data becomes available, which could lead to material changes in final results[153] Risks Related to Financial Position and Capital Requirements Xencor faces financial risks including a history of net losses, the need for additional capital beyond 2027, and significant control by principal stockholders - The company incurred a net loss of $126.1 million for the year ended December 31, 2023, and had an accumulated deficit of $464.4 million[157] - Existing cash, cash equivalents, and marketable securities of $697.4 million as of December 31, 2023, are expected to fund operations into 2027, but additional financing will be required to complete clinical development[161][163] - As of December 31, 2023, executive officers, directors, and 5% stockholders beneficially owned approximately 64.8% of the company's voting stock, enabling significant control over corporate matters[168] Risks Related to Intellectual Property Xencor's success relies on IP protection, facing risks of patent invalidation, compliance with in-licensed IP, and potential infringement litigation from third parties like Merus B.V - The company's ability to compete is dependent on protecting its IP, but the patent landscape for biopharmaceuticals is highly uncertain and subject to legal challenges[189] - The company is aware of issued patents owned by Merus B.V. that may relate to its bispecific antibody candidates, which could lead to infringement litigation upon commercialization[200] - Failure to protect trade secrets and proprietary information could significantly diminish the value of the company's technology and products[206] Risks Related to Dependence on Third Parties Xencor heavily relies on third-party partners for funding and commercialization, contract manufacturers for supplies, and CROs for clinical trials, increasing operational risks - Existing partnerships with companies like J&J, Genentech, and Alexion are crucial for funding and development, but these partners may delay, de-prioritize, or terminate programs[214][215] - The company relies entirely on third-party manufacturers for clinical drug supplies, and any production issues, compliance failures (cGMP), or contract terminations could halt or delay development[209][223] - Outsourcing to CROs for clinical trial execution reduces control over these activities and does not relieve Xencor of its regulatory responsibilities (GCP), posing risks of delays or failures if contractors do not perform adequately[221][222] Risks Related to Industry The biopharmaceutical industry poses risks including uncertain clinical trial outcomes, intense competition from larger companies, and extensive government regulation and pricing pressures - Clinical trials are expensive, lengthy, and their outcomes are uncertain; they may fail to demonstrate the required safety and efficacy for regulatory approval[225] - The company faces intense competition in cancer drug development, particularly in bispecific antibodies and immuno-oncology, from large pharmaceutical and smaller biotech companies[235][236] - The business is subject to extensive regulation, potential healthcare reforms, and pricing pressures from government and third-party payors, which could hinder commercialization and affect profitability[233][241][242] Unresolved Staff Comments The company reports that there are no unresolved staff comments - None[266] Cybersecurity Xencor's Board and Audit Committee oversee cybersecurity risk management, implementing safeguards and incident response, with no material impact on business reported to date - The Board of Directors, via the Audit Committee, oversees cybersecurity risk management, with policies based on the Center for Internet Security (CIS) Critical Security Controls framework[267][275] - The company's cybersecurity strategy includes technical safeguards, incident response planning, third-party risk management, and employee education[268][269][270] - The company reports that risks from cybersecurity threats have not materially affected and are not reasonably likely to materially affect its business strategy, results of operations, or financial condition[277] Properties Xencor leases its principal laboratory and administrative facilities in Pasadena, CA, with additional leased spaces in Monrovia and San Diego, deemed adequate for operations - The principal laboratory and administrative facilities are located in Pasadena, CA, comprising a lease for 83,083 sq. ft. effective August 1, 2022, for a 13-year term[278] - An additional 46,460 sq. ft. of adjacent space in Pasadena will be leased starting July 1, 2025, for a 10-year term co-terminous with the initial lease[278] - The company also leases 24,000 sq. ft. in Monrovia, CA (expiring Dec 2025) and 9,400 sq. ft. in San Diego, CA (expiring Dec 2027)[279][280] Legal Proceedings The company reports that there are no legal proceedings - None[282] Mine Safety Disclosures This item is not applicable to the company - Not applicable[283] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Xencor's common stock trades on Nasdaq under 'XNCR', with approximately 170 stockholders, and the company has no plans to pay cash dividends - The company's common stock trades on The Nasdaq Global Market under the symbol "XNCR"[285] - As of February 15, 2024, there were 61,120,272 shares of common stock outstanding held by approximately 170 stockholders of record[286] - The company has never declared or paid cash dividends and intends to retain all future earnings to support operations and growth[287] Management's Discussion and Analysis of Financial Condition and Results of Operations Xencor strategically prioritized T-cell bispecific programs in 2023, increasing revenues to $168.3 million but widening net loss to $126.1 million, with a projected funding runway into 2027 Results of Operations (2023 vs 2022) In 2023, total revenues slightly increased to $168.3 million due to higher milestones offsetting lower royalties, while operating expenses rose, leading to a widened net loss of $126.1 million Comparison of Results of Operations ($ in millions) | Account | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $168.3 | $164.6 | $3.7 | | Milestone Revenue | $88.5 | $5.5 | $83.0 | | Royalty Revenue | $49.5 | $152.1 | $(102.6) | | Total Operating Expenses | $307.0 | $247.1 | $59.9 | | Research and Development | $253.6 | $199.6 | $54.0 | | General and Administrative | $53.4 | $47.5 | $5.9 | | Net Loss Attributable to Xencor | $(126.1) | $(55.2) | $(70.9) | - The increase in R&D expenses was primarily driven by increased spending on bispecific development programs, including XmAb541 and vudalimab, and early-stage research[371] Liquidity and Capital Resources Xencor's cash and equivalents increased to $697.4 million by year-end 2023, primarily from royalty sales and milestones, providing a projected funding runway into 2027 - The company had $697.4 million in cash, cash equivalents, and marketable debt securities as of December 31, 2023[378] - Management projects the current funding is sufficient to support operations into 2027[380] Summary of Cash Flows ($ in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash from Operating Activities | $85,111 | $24,485 | | Net cash used in Investing Activities | $(111,065) | $(119,725) | | Net cash from Financing Activities | $26,182 | $5,702 | - In 2023, the company received $215.0 million from the sale of future royalty interests for Monjuvi and Ultomiris[376] Critical Accounting Policies Xencor's critical accounting policies involve significant judgment in revenue recognition, future royalty sales, capitalized IP costs, R&D accruals, and stock-based compensation valuation - Revenue from collaborations is recognized under ASC 606, involving complex estimates for performance obligations and transaction prices[347][348] - The sale of future royalties from Ultomiris was accounted for as deferred income, while the sale of Monjuvi royalties was classified as debt, reflecting different underlying contractual terms and risks[351][352][353] - Third-party intellectual property costs are capitalized and amortized, with regular reviews for impairment or abandonment. In 2023, $1.3 million in capitalized assets were written off[354][356] - Accrued R&D expenses are estimated based on services performed by CROs and other vendors, requiring judgment on the level of service completed[358] Quantitative and Qualitative Disclosures About Market Risk Xencor's primary market risk is interest rate sensitivity on its investment portfolio, deemed immaterial due to short-term, low-risk holdings, with inflation also not materially affecting results - The primary market risk is interest income sensitivity from changes in U.S. interest rates, but the impact of a 10% change is considered immaterial due to the short-term, low-risk nature of the investment portfolio[395] - The company maintains cash and cash equivalents at financial institutions in excess of federally insured limits[396] - Inflation increases labor and clinical trial costs, but it is not believed to have had a material effect on the company's results of operations[397] Financial Statements and Supplementary Data This section presents Xencor's audited consolidated financial statements, including key balance sheet and income statement data for 2023, and detailed notes on accounting policies and agreements Consolidated Financial Statements Xencor's consolidated financial statements show total assets of $952.7 million and a net loss of $126.3 million for 2023, with $697.4 million in cash and equivalents Key Financial Data as of December 31, 2023 ($ in thousands) | Metric | Amount | | :--- | :--- | | Balance Sheet: | | | Cash, Cash Equivalents & Marketable Securities | $697,027 | | Total Assets | $952,692 | | Total Liabilities | $283,559 | | Total Stockholders' Equity | $669,133 | | Income Statement (Year Ended): | | | Total Revenues | $168,338 | | Total Operating Expenses | $306,977 | | Net Loss | $(126,250) | | Net Loss Per Share (Basic & Diluted) | $(2.08) | Notes to Financial Statements Notes to financial statements detail collaboration revenues, the accounting treatment of royalty sales, stock-based compensation expenses, and income tax implications from R&D capitalization Revenue by Major Licensee - 2023 ($ in millions) | Licensee | Revenue | | :--- | :--- | | Janssen | $77.8 | | Alexion | $58.6 | | Zenas | $10.0 | | MorphoSys | $8.7 | | Gilead | $6.0 | | Omeros | $5.0 | | Vir | $2.2 | - In November 2023, the company sold future royalty rights to OMERS for $215.0 million. The Ultomiris portion ($192.5 million) was recorded as deferred income, and the Monjuvi portion ($22.5 million) was recorded as debt[621][625] - Total stock-based compensation expense was $53.8 million in 2023, up from $48.9 million in 2022[518] - The company recorded a federal income tax expense of $5.8 million in 2023, primarily due to the TCJA requirement to capitalize and amortize R&D expenses[483][504] Controls and Procedures Management concluded that Xencor's disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with an unqualified audit report from RSM US LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[632] - Based on the COSO framework, management concluded that internal control over financial reporting was effective as of December 31, 2023[633] - The independent registered public accounting firm, RSM US LLP, issued an unqualified audit report on the effectiveness of the company's internal control over financial reporting[636] Part III Directors, Executive Compensation, Security Ownership, and Related Matters Information for Items 10 through 14, covering directors, executive compensation, security ownership, related transactions, and accounting fees, is incorporated by reference from the 2024 proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the registrant's 2024 proxy statement[642][643][644] Part IV Exhibits, Financial Statement Schedules This section lists financial statements and exhibits filed with the annual report, noting the omission of schedules as information is included elsewhere or not applicable - The financial statements listed in Item 8 are filed as part of this Annual Report[647] - All financial statement schedules have been omitted because they are not applicable or the information is included in the financial statements or notes[647] Form 10-K Summary The company reports that there is no Form 10-K summary - None[655]