REGENXBIO(RGNX) - 2020 Q4 - Annual Report

PART I Information Regarding Forward-Looking Statements This section clarifies that forward-looking statements are subject to risks and uncertainties, potentially causing actual results to differ from expectations - Forward-looking statements are based on current expectations and assumptions, but actual results may differ materially due to risks and uncertainties[10] - Key risk factors include: impact of COVID-19, ability to obtain and maintain regulatory approval for product candidates, timing and success of clinical trials, intellectual property protection, competition, ability to attract/retain key personnel, market size and acceptance, development partnerships, and financial expectations[11][12] - The company disclaims any duty to update forward-looking statements unless required by law[11][12] Industry and Market Data Industry and market data, based on internal and third-party sources, are subject to inherent risks and uncertainties that may cause actual results to differ - Industry and market data are based on internal estimates and third-party sources, believed to be reliable, but are subject to risks and uncertainties[15] ITEM 1. Business REGENXBIO is a clinical-stage gene therapy company leveraging its proprietary NAV® Technology Platform for AAV-mediated antibody delivery and monogenic gene replacement - REGENXBIO is a clinical-stage biotechnology company focused on gene therapy using its proprietary NAV® Technology Platform[17][18] - The platform includes exclusive rights to over 100 novel AAV vectors (NAV Vectors), such as AAV7, AAV8, AAV9, and AAVrh10[18][19] - The company's pipeline addresses genetic diseases through two modalities: AAV-mediated antibody delivery and monogenic gene replacement[18][19] Overview of Business and Technology Platform REGENXBIO is a leading clinical-stage biotechnology company utilizing its proprietary NAV® Technology Platform, which includes over 100 novel AAV vectors - REGENXBIO is a leading clinical-stage biotechnology company focused on gene therapy, using its proprietary NAV® Technology Platform, which includes over 100 novel AAV vectors, to deliver functional genes and produce therapeutic proteins or antibodies[17][18][19] Internal Pipeline: AAV-Mediated Antibody Delivery The company is developing RGX-314 for chronic retinal conditions and gene therapy candidates for Hereditary Angioedema and neurodegenerative diseases - RGX-314 (NAV AAV8 vector) is being developed for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other chronic retinal conditions, aiming for sustained production of an anti-VEGF antibody fragment[20] - Two delivery routes are being advanced: subretinal and suprachoroidal (using SCS Microinjector™)[20] - A gene therapy candidate for Hereditary Angioedema (HAE) using NAV AAV8 vector to deliver an antibody against plasma kallikrein is in development, with an update expected in 2021[22] - A research partnership with Neurimmune AG is exploring novel gene therapies using NAV Vectors to deliver antibodies for chronic neurodegenerative diseases (tauopathies and alpha-synucleinopathies), with an update expected in 2021[23] Internal Pipeline: Monogenic Gene Replacement The company is advancing gene therapies for Duchenne Muscular Dystrophy and severe genetic lysosomal storage diseases, with several IND submissions and trials underway - RGX-202 is a potential one-time gene therapy for Duchenne Muscular Dystrophy (DMD), using NAV AAV8 to deliver a novel microdystrophin transgene, with IND submission expected in mid-2021[25] - NAV AAV9-based programs target severe genetic lysosomal storage diseases: RGX-121 for MPS II (Phase I/II ongoing), RGX-111 for MPS I (Phase I/II initiated), RGX-181 for CLN2 disease (IND submission Q1 2021), and RGX-381 for ocular manifestations of CLN2 disease (IND submission H1 2021)[26][30] Preclinical Programs The company funds preclinical research for product candidates and seeks partnerships to expand its NAV gene therapy pipeline - The company continues to fund preclinical research for potential product candidates and seeks partnerships with academic institutions and biotechnology companies to expand its NAV gene therapy pipeline[28] AAV Vector Production and Manufacturing REGENXBIO is an industry leader in AAV production and manufacturing, establishing robust in-house capabilities and constructing a new cGMP facility - REGENXBIO is an industry leader in AAV production and manufacturing, with in-house knowledge of vector characterization and technical operations[31] - The company has robust suspension cell culture-based production capabilities and is constructing a new cGMP production facility in Rockville, MD, expected to be operational in H1 2022, supporting clinical and commercial production up to 2,000 liters[31] Commercial Licenses to NAV Technology Licensees REGENXBIO sublicenses its NAV Vectors to other biotechnology companies, with over 20 partnered candidates and the FDA-approved Zolgensma® validating the platform - REGENXBIO selectively sublicenses its NAV Vectors to other biotechnology companies (NAV Technology Licensees)[32][33] - As of December 31, 2020, over 20 partnered product candidates were in preclinical and clinical development using the NAV Technology Platform[32][33] - Novartis AG's Zolgensma® (onasemnogene abeparvovec-xioi; AVXS-101), approved by the FDA in May 2019 for SMA Type I, leverages REGENXBIO's NAV AAV9 vector, validating the platform[32][33] Our Strategy REGENXBIO's strategy focuses on advancing its proprietary AAV vector technology, expanding its pipeline, optimizing administration routes, and strengthening manufacturing and intellectual property - Apply proprietary, next-generation AAV vector technology for in vivo gene therapies, leveraging higher expression, increased durability, broad tissue selectivity, and improved manufacturability[35][36][39] - Rapidly advance a broad pipeline using AAV-mediated antibody delivery (e.g., RGX-314 for wet AMD, DR, HAE, neurodegenerative diseases) and monogenic gene replacement (e.g., DMD, MPS II, MPS I, CLN2 disease)[35][36][39] - Utilize advanced routes of administration (e.g., subretinal, suprachoroidal, CNS delivery) for efficient tissue targeting and lower titers[35][36][39] - Establish industry leadership in gene therapy manufacturing with internal cGMP facility (operational H1 2022) and strong CMO network[35][36][39] - Strengthen NAV Technology Platform validation through strategic in-licensing, sublicensing, and progress of external licensees (e.g., FDA-approved Zolgensma)[35][36][39] - Maintain and grow an extensive intellectual property portfolio, including over 100 patents and applications for NAV Vectors[35][36][39] The Broad Potential and Application of Gene Therapy Gene therapy offers the potential to treat a broad range of diseases with long-term effects and enables new modalities like gene editing - Gene therapy offers the potential to treat a broad range of diseases by expressing or affecting protein production, targeting mechanisms not effectively addressed by existing drugs[40] - It can create convenient treatment profiles with single administrations for long-term effects and simplify the discovery of treatment candidates[40] - Viral vectors can deliver new modalities like gene editing and RNA-based therapeutics[40] Our Internal Pipeline REGENXBIO is advancing multiple gene therapy candidates, including RGX-314 for retinal conditions, RGX-202 for DMD, and programs for MPS II, MPS I, and CLN2 disease - RGX-314 (Wet AMD, DR): Pivotal program active for subretinal delivery (BLA filing expected 2024), Phase II trials ongoing for suprachoroidal delivery in wet AMD (AAVIATE) and DR (ALTITUDE)[20][21][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60](index=60&type=chunk] - Positive long-term data from Phase I/II wet AMD trial showed durable treatment effect and reduced injection burden[20][21][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60](index=60&type=chunk] - Hereditary Angioedema (HAE): Research program developing NAV AAV8 vector for a therapeutic antibody against plasma kallikrein; program update expected in 2021[22][63][64][65](index=65&type=chunk] - Neurodegenerative Diseases: Partnership with Neurimmune AG for AAV gene therapies delivering antibodies for tauopathies and alpha-synucleinopathies; program update expected in 2021[23][70][71][72][73](index=73&type=chunk] - RGX-202 (DMD): Potential one-time gene therapy using NAV AAV8 for microdystrophin; IND submission expected mid-2021[25][80][81][82](index=82&type=chunk] - RGX-121 (MPS II): Phase I/II trials ongoing for pediatric patients (under 5 and 5-18 years old); well-tolerated with encouraging biomarker signals[26][85][86](index=86&type=chunk][87](index=87&type=chunk] - RGX-111 (MPS I): Phase I/II clinical trial initiated, first patient dosed in December 2020[26][88](index=88&type=chunk] - RGX-181 (CLN2 disease): IND submission for CNS delivery expected Q1 2021, Phase I/II enrollment H1 2021[30][89](index=89&type=chunk] - RGX-381 (Ocular CLN2 disease): IND or foreign equivalent submission for subretinal delivery expected H1 2021[30][89](index=89&type=chunk] AAV Vector Production Platform REGENXBIO possesses internal capabilities for scalable AAV production, including a new cGMP facility under construction, and collaborates with CMOs - REGENXBIO has internal capabilities and infrastructure for scalable AAV production, including an advanced manufacturing and analytics lab[31][91][92][93][94][95](index=95&type=chunk][96](index=96&type=chunk] - The suspension-based manufacturing process is robust and scalable from bench-scale to 1,000-liter cGMP batches, with plans to scale to 2,000-liter bioreactors[31][91][92][93][94][95](index=95&type=chunk][96](index=96&type=chunk] - A new cGMP production facility in Rockville, MD, is under construction, expected to be operational in H1 2022, to support future clinical and commercial production[31][91][92][93][94][95](index=95&type=chunk][96](index=96&type=chunk] - The company also partners with multiple biologics Contract Manufacturing Organizations (CMOs) and has a strategic partnership with FUJIFILM Diosynth Biotechnologies for large-scale cGMP manufacturing[97][98][99][100](index=100&type=chunk] Proprietary Methods REGENXBIO has exclusive rights to proprietary AAV production technology from the University of Pennsylvania, enhancing purification and yield - REGENXBIO has licensed exclusive rights to proprietary technology from the University of Pennsylvania (Penn) for scalable AAV production methods, including efficient secretion of NAV Vectors into the production medium, which simplifies purification and improves yield[101][102][103](index=103&type=chunk] Other Capabilities The company has developed proprietary HEK293 master cell banks and components for clinical vector production, used internally and by licensees - The company has developed and characterized proprietary HEK293 master cell banks and other components for clinical vector production, used internally and by NAV Technology Licensees[104] Commercial Licenses to NAV Technology Licensees REGENXBIO sublicenses its NAV Technology Platform to third parties, expanding the gene therapy pipeline and generating revenue through various fees and royalties - REGENXBIO sublicenses its NAV Technology Platform to third parties to expand the gene therapy pipeline and generate revenue, while focusing on core internal programs[105][106][107](index=107&type=chunk] - As of December 31, 2020, over 20 partnered product candidates were in development[105][106][107](index=107&type=chunk] - License agreements include upfront and annual fees, milestone payments, sublicense fees, and low-single to low-double digit royalties on sales, with obligations to pay licensors a percentage of these revenues[105][106][107](index=107&type=chunk] Gene Therapy Overview and History of Earlier Generation AAV Gene therapy delivers external genes to cells, with AAVs favored for efficiency and safety, and next-generation AAVs showing improved performance over earlier versions - Gene therapy aims to deliver external genes to cells, with in vivo approaches directly administering vectors to target tissues[108][109][110](index=110&type=chunk][111](index=111&type=chunk] - Viral vectors, particularly AAVs, are favored for their efficiency and favorable safety profiles (not known to cause disease in humans)[108][109][110](index=110&type=chunk][111](index=111&type=chunk] - Earlier generation AAV vectors (e.g., AAV1, AAV2) had limitations including low/short-term gene expression, limited tissue selectivity, and high immune response[112][113](index=113&type=chunk] - Next-generation AAVs (AAV7, AAV8, AAV9, AAVrh10) were discovered at Penn by searching for capsid gene sequences in non-human primates and humans, showing improved efficiency[112][113](index=113&type=chunk] Our Proprietary NAV Technology Platform for Gene Delivery REGENXBIO's NAV Technology Platform, based on next-generation AAV vectors, offers superior gene transfer, long-term expression, broad tissue selectivity, lower immune response, and improved manufacturability - REGENXBIO's NAV Technology Platform, based on next-generation AAV vectors licensed from Penn, offers improved properties over earlier AAVs[115][116][117][118](index=118&type=chunk][120](index=120&type=chunk] - Key benefits include: higher gene transfer (10- to 100-fold higher than AAV2 in mouse livers), longer-term gene expression (over eight years in animals and clinical trials), broad and novel tissue selectivity (e.g., AAV9 for CNS delivery, AAV8 for retinal cells), lower immune response (lower neutralizing antibodies and T-cell activation compared to AAV1/AAV2), and improved manufacturability[115][116][117][118](index=118&type=chunk][120](index=120&type=chunk] - The platform is protected by over 100 licensed patents and patent applications, including composition of matter claims for AAV7, AAV8, AAV9, and AAVrh10[121][122][123][124](index=124&type=chunk][127][128][129](index=129&type=chunk] Platform License Agreements and Other Licenses REGENXBIO exclusively licenses its NAV Technology Platform from Penn and GSK, with obligations for milestone payments, royalties, and sublicense fees, and holds other related licenses - REGENXBIO exclusively licenses its NAV Technology Platform from the University of Pennsylvania (Penn) and GlaxoSmithKline LLC (GSK)[130][131][132](index=132&type=chunk][133](index=133&type=chunk] - The Penn license grants exclusive worldwide rights to AAV gene therapy patents, with obligations for milestone payments (up to $20.5M), low-to-mid-single digit royalties on net sales, and low-double to mid-double digit percentages of sublicense royalties[130][131][132](index=132&type=chunk][133](index=133&type=chunk] - The GSK license provides exclusive worldwide sublicenses to NAV Technology patents, with obligations for milestone payments (all paid, up to $1.5M), low-to-mid-single digit royalties, and sublicense fees[134][135](index=135&type=chunk] - Other licenses include agreements with the Regents of the University of Minnesota and Emory University for jointly owned intellectual property related to AAV vectors for CNS delivery, involving upfront fees, annual maintenance fees, royalties, and milestone payments[137][138][139](index=139&type=chunk] Intellectual Property REGENXBIO's success relies on robust intellectual property protection, including over 100 licensed patents for novel AAV vectors and product-specific applications - REGENXBIO's success relies on obtaining and maintaining intellectual property protection for its product candidates, core technologies, and know-how, including patents, trade secrets, and regulatory exclusivities[140][141][142](index=142&type=chunk][143](index=143&type=chunk] - The licensed patent portfolio includes exclusive rights to over 100 patents and patent applications worldwide for novel AAV vectors (AAV7, AAV8, AAV9, AAVrh10) and their uses, with terms expiring as late as 2026 (excluding extensions)[140][141][142](index=142&type=chunk][143](index=143&type=chunk] - Product-specific patent applications for RGX-314, RGX-202, RGX-111/RGX-121, RGX-181, RGX-381, and HAE programs have potential expiration dates ranging from 2034 to 2040[144] - The portfolio also covers therapeutic compositions, specific formulations/delivery methods, AAV engineering technology, diagnostic methods, and scalable manufacturing methods[144] Customers REGENXBIO's revenues are solely from license and royalty fees, with Novartis Gene Therapies, Inc. accounting for approximately 94% of total revenues in 2020 - REGENXBIO's revenues consist solely of license and royalty revenue, with a high concentration among a limited number of licensees[145] - In 2020, one customer (Novartis Gene Therapies, Inc.) accounted for approximately 94% of total revenues[145] Research and Development The company's R&D organization possesses expertise in AAV gene therapy, employing rigorous project management and engaging third parties for preclinical and clinical activities - The company has a research and development organization with expertise in AAV gene therapy, employing rigorous project management and engaging third parties for preclinical research and clinical trials[146] Competition REGENXBIO faces significant competition from biotechnology and pharmaceutical companies in gene therapy and other treatment areas, with competition expected to intensify - REGENXBIO faces significant competition from biotechnology and pharmaceutical companies developing gene therapies and other gene modification methods[147][148](index=148&type=chunk][149](index=149&type=chunk] - Competitors include Adverum Biotechnologies, Novartis AG, Sarepta Therapeutics, and others, many with greater financial and technical resources[147][148](index=148&type=chunk][149](index=149&type=chunk] - Specific competition exists for wet AMD (anti-VEGF therapies like Lucentis, Eylea, Beovu), DR, DMD, MPS II, MPS I, CLN2 disease, and HAE[150][151](index=151&type=chunk] - Competition is expected to intensify with new drugs and technologies, focusing on efficacy, safety, convenience, price, and reimbursement[152] Government Regulation Biological products, including gene therapies, are subject to extensive regulation by the FDA and comparable global authorities across all development and commercialization stages - Biological products, including gene therapies, are subject to extensive regulation by the FDA (CBER) in the U.S. and comparable authorities globally, covering testing, manufacturing, safety, efficacy, labeling, and promotion[153][154](index=154&type=chunk] Human Capital Resources REGENXBIO employs 306 full-time staff, prioritizing talent retention, growth, and diversity through competitive compensation and health and safety measures - As of February 25, 2021, REGENXBIO employed 306 full-time employees, with 243 in R&D and 63 in general administrative functions[208][209](index=209&type=chunk][210](index=210&type=chunk] - The company prioritizes talent retention, growth, and development through competitive compensation, benefits, and professional development programs[208][209](index=209&type=chunk][210](index=210&type=chunk] - A strong commitment to diversity, equity, and inclusion is integral to fostering innovation[211] - Health and safety measures, including work-from-home policies and onsite COVID-19 testing, have been implemented to protect employees[212] Available Information REGENXBIO's SEC filings and material business developments are accessible on www.sec.gov and the company's website - REGENXBIO's SEC filings, including annual, quarterly, and current reports, are available on www.sec.gov and the company's website (www.regenxbio.com**)[213](index=213&type=chunk)[214](index=214&type=chunk] - The company also uses its website and social media channels to communicate material business developments[213][214](index=214&type=chunk] ITEM 1A. Risk Factors This section outlines significant risks across product development, financial position, third-party reliance, manufacturing, commercialization, operations, intellectual property, and common stock ownership - Risks Related to Our NAV Technology Platform and the Development of Our Product Candidates: Novel technology, unpredictable development time/cost, limited clinical results, regulatory approval uncertainty, competition, and potential for undesirable side effects[215] - Risks Related to Our Financial Position: History of net losses, expectation of future losses, need for additional funding, and no revenue from product sales to date[216] - Risks Related to Third Parties: Reliance on third parties for R&D and clinical trials, potential for unsuccessful licensing/collaborations, and sharing of trade secrets[217] - Risks Related to Manufacturing: Complexity of gene therapy manufacturing, potential for production problems, delays in regulatory approval of manufacturing processes, and reliance on third-party manufacturers[218] - Risks Related to the Commercialization of Our Product Candidates: Inability to establish sales/marketing capabilities, delays in development goals, challenges in market acceptance, and uncertainty of insurance coverage/reimbursement[219] - Risks Related to Our Business Operations: Difficulty in identifying additional product candidates, dependence on key employees, potential for misconduct, and compliance with healthcare laws[220] - Risks Related to Our Intellectual Property: Reliance on licensed IP, challenges in obtaining/maintaining patent protection, potential for infringement claims, and changes in patent law[221] - Risks Related to Ownership of Our Common Stock: Volatile operating results, dilution from capital raises, risks from acquisitions/partnerships, and anti-takeover provisions[222][223](index=223&type=chunk] ITEM 1B. Unresolved Staff Comments There are no unresolved staff comments from the SEC to report ITEM 2. Properties REGENXBIO's headquarters and R&D facilities are in Rockville, MD, with a new 177,000 sq ft facility expected operational in H1 2021 - Current corporate headquarters: ~19,000 sq ft in Rockville, MD (lease expires Sep 2021)[393][394](index=394&type=chunk] - Additional office/lab space: ~73,000 sq ft in Rockville, MD, and 15,000 sq ft in New York, NY (leases expire through 2027)[393][394](index=394&type=chunk] - New facility: ~177,000 sq ft office, lab, and manufacturing space in Rockville, MD, under construction, expected to be operational in H1 2021 (lease expires Sep 2036)[393][394](index=394&type=chunk] ITEM 3. Legal Proceedings Legal proceedings with Abeona Therapeutics Inc. are detailed in Note 10 of the consolidated financial statements - Legal proceedings with Abeona Therapeutics Inc. are detailed in Note 10 of the consolidated financial statements[396] ITEM 4. Mine Safety Disclosures This item is not applicable to REGENXBIO Inc PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities REGENXBIO's common stock trades on Nasdaq under 'RGNX', with no cash dividends declared or planned since inception - Common stock is traded on The Nasdaq Global Select Market under the symbol "RGNX"[400][403](index=403&type=chunk][404](index=404&type=chunk] - As of February 25, 2021, there were six holders of record of common stock[400][403](index=403&type=chunk][404](index=404&type=chunk] - The company has not declared or paid cash dividends since inception and does not plan to in the foreseeable future[400][403](index=403&type=chunk][404](index=404&type=chunk] ITEM 6. Selected Financial Data This section presents selected five-year consolidated financial data, highlighting revenue fluctuations, operating losses, and changes in cash and marketable securities Consolidated Statements of Operations Data (in thousands, except per share data) | Years Ended December 31, | 2020 | 2019 | 2018 | 2017 | 2016 | | :------------------------- | :----- | :----- | :----- | :----- | :----- | | Total revenues | $154,567 | $35,233 | $218,505 | $10,393 | $4,589 | | Total operating expenses | 273,800 | 184,231 | 130,405 | 86,278 | 69,929 | | Income (loss) from operations | (119,233) | (148,998) | 88,100 | (75,885) | (65,340) | | Net income (loss) | (111,250) | (94,733) | 99,937 | (73,169) | (62,967) | | Net income (loss) per share: Basic | (2.98) | (2.58) | 2.99 | (2.45) | (2.38) | | Net income (loss) per share: Diluted | (2.98) | (2.58) | 2.73 | (2.45) | (2.38) | | Weighted-average common shares outstanding: Basic | 37,281 | 36,690 | 33,427 | 29,878 | 26,409 | | Weighted-average common shares outstanding: Diluted | 37,281 | 36,690 | 36,648 | 29,878 | 26,409 | [407] Consolidated Balance Sheet Data (in thousands) | December 31, | 2020 | 2019 | 2018 | 2017 | 2016 | | :------------- | :----- | :----- | :----- | :----- | :----- | | Cash and cash equivalents | $338,426 | $69,514 | $75,561 | $46,656 | $24,840 | | Marketable securities | 184,123 | 330,481 | 395,019 | 129,738 | 134,126 | | Working capital | 449,750 | 311,356 | 315,737 | 153,560 | 83,702 | | Total assets | 708,164 | 497,908 | 543,814 | 198,677 | 172,732 | | Non-current liabilities | 248,964 | 14,035 | 12,790 | 1,211 | 1,326 | | Total liabilities | 330,411 | 47,711 | 34,966 | 15,648 | 10,995 | | Common stock and additional paid-in capital | 667,185 | 627,814 | 592,584 | 371,500 | 276,357 | | Total stockholders' equity | 377,753 | 450,197 | 508,848 | 183,029 | 161,737 | [408] ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes REGENXBIO's financial condition and results for 2020 and 2019, covering business overview, pipeline, COVID-19 impact, revenue, expenses, accounting policies, and liquidity - REGENXBIO is a clinical-stage biotechnology company focused on gene therapy, with a broad pipeline using its NAV Technology Platform for AAV-mediated antibody delivery and monogenic gene replacement[411][412] - The COVID-19 pandemic has caused delays in clinical trials and construction of the new cGMP facility, but did not significantly impact 2020 results[423][424][425](index=425&type=chunk] - Revenues primarily consist of license and royalty revenue from the NAV Technology Platform, with no commercial sales of its own products to date[423][424][425][426](index=426&type=chunk] Overview of Business and Product Candidates REGENXBIO is a clinical-stage gene therapy company with a broad pipeline of product candidates, including RGX-314, RGX-202, and programs for MPS and CLN2 diseases - REGENXBIO is a clinical-stage gene therapy company utilizing its NAV Technology Platform for AAV-mediated antibody delivery and monogenic gene replacement[411][412][413](index=413&type=chunk][414](index=414&type=chunk] - Key product candidates include RGX-314 for wet AMD and DR (pivotal program active, Phase II ongoing), HAE program (update expected 2021), neurodegenerative disease program with Neurimmune (update expected 2021), RGX-202 for DMD (IND mid-2021), RGX-121 for MPS II (Phase I/II ongoing), RGX-111 for MPS I (Phase I/II initiated), RGX-181 for CLN2 disease (IND Q1 2021), and RGX-381 for ocular CLN2 disease (IND H1 2021)[411][412][413](index=413&type=chunk][414](index=414&type=chunk][415][416][417][418][419][420][421][422](index=422&type=chunk] - The NAV Technology Platform is licensed to over 20 partnered programs, including the FDA-approved Zolgensma®[411][412][413](index=413&type=chunk][414](index=414&type=chunk] - The COVID-19 pandemic has caused delays in clinical trials and facility construction, but its full future impact on business, operations, and financial condition remains unpredictable[423][424][425](index=425&type=chunk] Financial Overview REGENXBIO's revenues are primarily from license and royalty fees, with operating expenses driven by R&D and G&A, and other income from investments - Revenues are primarily from license and royalty fees from the NAV Technology Platform, including royalties on Zolgensma sales by Novartis Gene Therapies[426][427](index=427&type=chunk][428](index=428&type=chunk] - Operating expenses consist of cost of revenues (upstream fees to licensors), research and development (salaries, preclinical/clinical costs, manufacturing materials), and general and administrative (salaries, professional fees, patent expenses)[429][430](index=430&type=chunk][431](index=431&type=chunk][432](index=432&type=chunk] - R&D expenses are expected to increase as product candidates advance[433] - Other income includes interest income from licensing, investment income (interest and gains/losses on securities), and interest expense from the sale of future Zolgensma royalties[439][440](index=440&type=chunk][441](index=441&type=chunk][442](index=442&type=chunk][443](index=443&type=chunk] Research and Development Expenses (in thousands) | | Years Ended December 31, | | | | :-------------------------- | :----- | :----- | :----- | | | 2020 | 2019 | 2018 | | Direct Expenses | | | | | RGX-314 | $24,083 | $20,713 | $6,580 | | RGX-202 | 14,073 | — | — | | RGX-121 | 10,322 | 3,999 | 4,235 | | RGX-111 | 3,324 | 3,028 | 3,130 | | RGX-181 and RGX-381 | 7,463 | 7,602 | 4,399 | | Other product candidates | 4,674 | 4,823 | 10,849 | | Total direct expenses | 63,939 | 40,165 | 29,193 | | Unallocated Expenses | | | | | Platform and new technologies | 24,936 | 21,083 | 12,431 | | Personnel-related | 63,531 | 50,164 | 34,275 | | Facilities and depreciation expense | 12,488 | 9,511 | 5,816 | | Other unallocated | 1,400 | 3,262 | 2,158 | | Total unallocated expenses | 102,355 | 84,020 | 54,680 | | Total research and development | $166,294 | $124,185 | $83,873 | [435] Critical Accounting Policies and Significant Judgments and Estimates This note details REGENXBIO's critical accounting policies, including revenue recognition, R&D expenses, stock-based compensation, royalty liability, and income taxes - Revenue Recognition (ASC 606): Involves a five-step model to recognize revenue when control of goods/services is transferred[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] - Significant judgment is required for determining contract term (substantive termination penalties), identifying distinct performance obligations, allocating transaction price, and estimating variable consideration (milestones)[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] - Accrued Research and Development Expenses: Estimates are made based on contracts, services performed, and expected performance periods for preclinical/clinical activities and manufacturing[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] - Stock-based Compensation (ASC 718): Expense is recognized based on grant date fair value for stock options (using Black-Scholes model with subjective assumptions like volatility, term, risk-free rate) and restricted stock units (closing price at grant date)[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] - Non-cash Interest Expense on Liability Related to Sale of Future Royalties: A liability is recorded for proceeds from royalty sales, amortized using the effective interest method based on estimated future royalty payments[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] - Income Taxes (ASC 740): Deferred tax assets and liabilities are recognized, with a full valuation allowance provided due to a history of operating losses, indicating that the benefit of deferred tax assets is unlikely to be realized[444][445](index=445&type=chunk][446](index=446&type=chunk][447](index=447&type=chunk][448](index=448&type=chunk][449](index=449&type=chunk][450](index=450&type=chunk][451](index=451&type=chunk][452](index=452&type=chunk][453](index=453&type=chunk][454](index=454&type=chunk][455](index=455&type=chunk][456](index=456&type=chunk][457](index=457&type=chunk][458](index=458&type=chunk][459](index=459&type=chunk][460](index=460&type=chunk][461](index=461&type=chunk][462](index=462&type=chunk][463](index=463&type=chunk][464](index=464&type=chunk][465](index=465&type=chunk][466](index=466&type=chunk][467](index=467&type=chunk][468](index=468&type=chunk][469](index=469&type=chunk][470](index=470&type=chunk][471](index=471&type=chunk][472](index=472&type=chunk][473](index=473&type=chunk] Results of Operations REGENXBIO's 2020 results show increased license and royalty revenue driven by Zolgensma, offset by higher R&D and G&A expenses, and a decrease in investment income Consolidated Results of Operations (in thousands) | | Years Ended December 31, | Change 2020 vs. 2019 | Change 2019 vs. 2018 | | :-------------------------- | :----- | :----- | :----- | :------------------- | :------------------- | | | 2020 | 2019 | 2018 | | | | Revenues | | | | | | | License and royalty revenue | $154,567 | $35,233 | $218,505 | $119,334 | $(183,272) | | Total revenues | 154,567 | 35,233 | 218,505 | 119,334 | (183,272) | | Operating Expenses | | | | | | | Cost of revenues | 35,714 | 8,241 | 9,640 | 27,473 | (1,399) | | Research and development | 166,294 | 124,185 | 83,873 | 42,109 | 40,312 | | General and administrative | 63,817 | 51,815 | 36,850 | 12,002 | 14,965 | | Provision for credit losses and other | 7,975 | (10) | 42 | 7,985 | (52) | | Total operating expenses | 273,800 | 184,231 | 130,405 | 89,569 | 53,826 | | Income (loss) from operations | (119,233) | (148,998) | 88,100 | 29,765 | (237,098) | | Other Income | | | | | | | Interest income from licensing | 4,271 | 2,951 | 8,946 | 1,320 | (5,995) | | Investment income | 9,723 | 48,559 | 7,070 | (38,836) | 41,489 | | Interest expense | (771) | — | — | (771) | — | | Total other income | 13,223 | 51,510 | 16,016 | (38,287) | 35,494 | | Income (loss) before income taxes | (106,010) | (97,488) | 104,116 | (8,522) | (201,604) | | Income Tax Benefit (Expense) | (5,240) | 2,755 | (4,179) | (7,995) | 6,934 | | Net income (loss) | $(111,250) | $(94,733) | $99,937 | $(16,517) | $(194,670) | [475] - License and Royalty Revenue (2020 vs. 2019): Increased by $119.3M, driven by a $40.8M increase in Zolgensma royalty revenue and an $80.0M milestone payment for achieving $1.0B in cumulative net sales of Zolgensma[476] - Research and Development Expense (2020 vs. 2019): Increased by $42.1M, primarily due to higher personnel costs ($13.2M**), external manufacturing services ($12.2M), clinical trial/regulatory activities ($11.3M), and preclinical studies ($2.5M)[477] - General and Administrative Expense (2020 vs. 2019): Increased by $12.0M, mainly from professional services ($8.8M) and personnel-related costs ($2.9M)[478] - Provision for Credit Losses and Other (2020 vs. 2019): Increased by $8.0M, primarily due to a $7.7M provision for credit losses related to accounts receivable from Abeona Therapeutics Inc[479] - Investment Income (2020 vs. 2019): Decreased by $38.8M, mainly due to lower net gains from marketable equity securities of Prevail Therapeutics Inc. ($37.8M in 2019 vs. $4.8M in 2020) and reduced interest income from marketable debt securities[480] - Income Tax Benefit (Expense) (2020 vs. 2019): Shifted from a $2.8M benefit to a $5.2M expense, primarily due to increased U.S. state income taxes from the sale of Zolgensma royalties to HCR and gains from Prevail securities sales[481] Liquidity and Capital Resources REGENXBIO's liquidity is supported by cash and marketable securities, recent financing activities, and cash flow from operations, though future funding will be required for increasing expenses - Sources of Liquidity: As of Dec 31, 2020, cash, cash equivalents, and marketable securities totaled $522.5M, expected to fund operations for at least 12 months[482][483](index=483&type=chunk][484](index=484&type=chunk][485](index=485&type=chunk][486](index=486&type=chunk][487](index=487&type=chunk][488](index=488&type=chunk] - Recent sources include a $200.0M upfront payment from HCR for Zolgensma royalties (Dec 2020), an $80.0M milestone payment from Novartis Gene Therapies (Oct 2020), and a $189.1M public offering (Aug 2018)[482][483](index=483&type=chunk][484](index=484&type=chunk][485](index=485&type=chunk][486](index=486&type=chunk][487](index=487&type=chunk][488](index=488&type=chunk] - Post-period Event: In Jan 2021, completed a public offering of 4,899,000 shares, generating $216.1M net proceeds[490] - Cash Flows from Operating Activities: Net cash used decreased by $53.6M in 2020 to $54.1M, primarily due to increased revenues from Zolgensma royalties and milestone payments, partially offset by higher operating expenses[491][492](index=492&type=chunk] - Cash Flows from Investing Activities: Net cash provided was $122.8M in 2020, mainly from sales/maturities of marketable securities ($272.7M) offset by purchases of marketable securities ($123.0M) and property/equipment ($26.9M, largely for new headquarters)[493][494](index=494&type=chunk] - Cash Flows from Financing Activities: Net cash provided was $200.2M in 2020, primarily from the $192.8M net proceeds from the Zolgensma royalty sale and $7.4M from stock option exercises/ESPP[495][496](index=496&type=chunk] - Future Funding Requirements: Expects increased R&D and G&A expenses, significant commercialization costs if products are approved, and rising capital expenditures for facility build-out[497] - Will require substantial additional capital, potentially through equity, debt, or strategic partnerships[498] Contractual Obligations, Commitments and Contingencies REGENXBIO's principal commitments include vendor contracts, obligations to licensors, and future Zolgensma royalty payments to HCR, alongside significant operating lease payments - Principal commitments include vendor contracts for research services and purchase commitments, generally terminable upon notice[499] - Obligations to licensors under in-license agreements include sublicense fees, milestone fees, royalties, and patent maintenance costs, which are not fixed and determinable for future periods[500] - Under the royalty purchase agreement with HCR, future Zolgensma royalties (net of licensor payments) are payable to HCR up to a capped amount ($256.0M by Nov 7, 2024, or $296.0M thereafter), with no obligation to repay if royalties are insufficient[501][502](index=502&type=chunk] - Future minimum lease payments for operating leases total $131.7M, with $4.2M due in 2021, $14.7M in 2022-2023, $19.7M in 2024-2025, and $93.1M thereafter[503] Off-Balance Sheet Arrangements REGENXBIO did not have any off-balance sheet arrangements during the periods presented - REGENXBIO did not have any off-balance sheet arrangements during the periods presented[504] ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk This section details REGENXBIO's exposure to interest rate and foreign currency exchange rate risks, with the current impact not considered material - Interest Rate Risk: Primary exposure is from cash equivalents and marketable securities ($522.5M as of Dec 31, 2020)[506][507](index=507&type=chunk] - A hypothetical 100 basis point increase in interest rates would result in an estimated $1.0M decline in the net fair value of interest-sensitive securities[506][507](index=507&type=chunk] - Foreign Currency Exchange Rate Risk: Exposed to fluctuations from transactions in non-U.S. dollar currencies (euros, British pounds, Canadian dollars, Japanese yen)[506][507](index=507&type=chunk] - A hypothetical 10% change in exchange rates is not expected to materially harm the business[506][507](index=507&type=chunk] ITEM 8. Financial Statements and Supplementary Data This item incorporates the audited consolidated financial statements, related notes, and the independent registered public accounting firm's report - The audited consolidated financial statements and supplementary data are included, along with the report from PricewaterhouseCoopers LLP[508][534][535](index=535&type=chunk] Report of Independent Registered Public Accounting Firm PricewaterhouseCoopers LLP issued an unqualified opinion on REGENXBIO's financial statements and internal controls, noting "License revenue - Substantive Termination Penalties" as a critical audit matter - PricewaterhouseCoopers LLP issued an unqualified opinion on REGENXBIO Inc.'s consolidated financial statements and the effectiveness of its internal control over financial reporting as of December 31, 2020[534][535](index=535&type=chunk] - A critical audit matter identified was 'License revenue - Substantive Termination Penalties' due to significant management judgment in determining contract terms for revenue recognition, requiring extensive auditor evaluation[543][544][545](index=545&type=chunk] Consolidated Balance Sheets Consolidated Balance Sheets (in thousands) | As of December 31, | 2020 | 2019 | | :------------------- | :----- | :----- | | Assets | | | | Cash and cash equivalents | $338,426 | $69,514 | | Marketable securities | 137,314 | 226,696 | | Accounts receivable (net) | 42,999 | 38,148 | | Total current assets | 531,197 | 345,032 | | Marketable securities (non-current) | 46,809 | 103,785 | | Property and equipment, net | 56,467 | 28,973 | | Total assets | $708,164 | $497,908 | | Liabilities and Stockholders' Equity | | | | Accounts payable | $10,622 | $6,409 | | Accrued expenses and other current liabilities | 49,082 | 24,846 | | Liability related to sale of future royalties (current) | 18,794 | — | | Total current liabilities | 81,447 | 33,676 | | Liability related to sale of future royalties (non-current) | 174,504 | — | | Total liabilities | 330,411 | 47,711 | | Total stockholders' equity | 377,753 | 450,197 | | Total liabilities and stockholders' equity | $708,164 | $497,908 | [550] Consolidated Statements of Operations and Comprehensive Income (Loss) Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands, except per share data) | Years Ended December 31, | 2020 | 2019 | 2018 | | :------------------------- | :----- | :----- | :----- | | Total revenues | $154,567 | $35,233 | $218,505 | | Cost of revenues | 35,714 | 8,241 | 9,640 | | Research and development | 166,294 | 124,185 | 83,873 | | General and administrative | 63,817 | 51,815 | 36,850 | | Provision for credit losses and other | 7,975 | (10) | 42 | | Total operating expenses | 273,800 | 184,231 | 130,405 | | Income (loss) from operations | (119,233) | (148,998) | 88,100 | | Total other income | 13,223 | 51,510 | 16,016 | | Income (loss) before income taxes | (106,010) | (97,488) | 104,116 | | Income Tax Benefit (Expense) | (5,240) | 2,755 | (4,179) | | Net income (loss) | $(111,250) | $(94,733) | $99,937 | | Comprehensive income (loss) | $(111,815) | $(93,848) | $99,932 | | Net income (loss) per share: Basic | $(2.98) | $(2.58) | $2.99 | | Net income (loss) per share: Diluted | $(2.98) | $(2.58) | $2.73 | [551] Consolidated Statements of Stockholders' Equity Consolidated Statements of Stockholders' Equity (in thousands) | | Shares | Common Stock Amount | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total Stockholders' Equity | | :-------------------------- | :----- | :------------------ | :------------------------- | :------------------------------------------ | :------------------ | :------------------------- | | Balances at December 31, 2017 | 31,295 | $3 | $371,497 | $(715) | $(187,756) | $183,029 | | Balances at December 31, 2018 | 36,120 | 4 | 592,580 | (720) | (83,016) | 508,848 | | Balances at December 31, 2019 | 36,992 | 4 | 627,810 | 205 | (177,822) | 450,197 | | Balances at December 31, 2020 | 37,476 | 4 | 667,181 | (360) | (289,072) | 377,753 | [554] Consolidated Statements of Cash Flows Consolidated Statements of Cash Flows (in thousands) | Years Ended December 31, | 2020 | 2019 | 2018 | | :------------------------- | :----- | :----- | :----- | | Net cash provided by (used in) operating activities | $(54,061) | $(107,705) | $104,648 | | Net cash provided by (used in) investing activities | 122,759 | 93,559 | (279,358) | | Net cash provided by financing activities | 200,214 | 8,376 | 204,443 | | Net increase (decrease) in cash and cash equivalents and restricted cash | $268,912 | $(5,770) | $29,733 | | Cash and cash equivalents and restricted cash, End of period | $339,756 | $70,844 | $76,614 | [556] Notes to Consolidated Financial Statements 1. Nature of Business REGENXBIO is a clinical-stage gene therapy company with an accumulated deficit of $289.1 million as of December 31, 2020, requiring additional capital - REGENXBIO is a clinical-stage biotechnology company leveraging its NAV Technology Platform for gene therapy, with one commercial product (Zolgensma®) and over 20 product candidates in development[558] - Accumulated deficit: $289.1 million as of December 31, 2020[559] - Cash, cash equivalents, and marketable securities: $522.5 million as of December 31, 2020, sufficient to fund operations for at least the next 12 months[559] 2. Summary of Significant Accounting Policies This note details REGENXBIO's significant accounting policies, covering revenue recognition, R&D expenses, stock-based compensation, income taxes, and recently adopted pronouncements - The company operates as one operating segment, with the substantial majority of revenues and assets attributed to the U.S[560][561](index=561&type=chunk][562](index=562&type=chunk][563](index=563&type=chunk][564](index=564&type=chunk][565](index=565&type=chunk][566](index=566&type=chunk][567](index=567&type=chunk][568](index=568&type=chunk][569](index=569&type=chunk][570](index=570&type=chunk][571](index=571&type=chunk][572](index=572&type=chunk][573](index=573&type=chunk][574](index=574&type=chunk][575](index=575&type=chunk][576](index=576&type=chunk][577](index=577&type=chunk][578](index=578&type=chunk][579](index=579&type=chunk][580](index=580&type=chunk][581](index=581&type=chunk][582](index=582&type=chunk][583](index=583&type=chunk][584](index=584&type=chunk][585](index=585&type=chunk][586](index=586&type=chunk][587](index=587&type=chunk][588](index=588&type=chunk][589](index=589&type=chunk][590](index=590&type=chunk][591](index=591&type=chunk][592](index=592&type=chunk][593](index=593&type=chunk][594](index=594&type=chunk][595](index=595&type=chunk][596](index=596&type=chunk][597](index=597&type=chunk][598](index=598&type=chunk][599](index=599&type=chunk][600](index=600&type=chunk][601](index=601&type=chunk][602](index=602&type=chunk][603](index=603&type=chunk][604](index=604&type=chunk][605](index=605&type=chunk][606](index=606&type=chunk][607](index=607&type=chunk][608](index=608&type=chunk][609](index=609&type=chunk][610](index=610&type=chunk][611](index=611&type=chunk][612](index=612&type=chunk][613](index=613&type=chunk] - Cash equivalents are highly liquid investments with original maturities of 90 days or less[560][561](index=561&type=chunk][562](index=562&type=chunk][563](index=563&type=chunk][564](index=564&type=chunk][565](index=565&type=chunk][566](index=566&type=chunk][567](index=567&type=chunk][568](index=568&type=chunk][569](index=569&type=chunk][570](index=570&type=chunk][571](index=571&type=chunk][572](index=572&type=chunk][573](index=573&type=chunk][574](index=574&type=chunk][575](index=575&type=chunk][576](index=576&type=chunk][577](index=577&type=chunk][578](index=578&type=chunk][579](index=579&type=chunk][580](index=580&type=chunk][581](index=581&type=chunk][582](index=582&type=chunk][583](index=583&type=chunk][584](index=584&type=chunk][585](index=585&type=chunk][586](index=586&type=chunk][587](index=587&type=chunk][588](index=588&type=chunk][589](index=589&type=chunk][590](index=590&type=chunk][591](index=591&type=chunk][592](index=592&type=chunk][593](index=593&type=chunk][594](index=594&type=chunk][595](index=595&type=chunk][596](index=596&type=chunk][597](index=597&type=chunk][598](index=598&type=chunk][599](index=599&type=chunk][600](index=600&type=chunk][601](index=601&type=chunk][602](index=602&type=chunk][603](index=603&type=chunk][604](index=604&type=chunk][605](index=605&type=chunk][606](index=606&type=chunk][607](index=607&type=chunk][608](index=608&type=chunk][609](index=609&type=chunk][610](index=610&type=chunk][611](index=611&type=chunk][612](index=612&type=chunk][613](index=613&type=chunk] - Restricted cash collateralizes letters of credit for lease agreements[560][561](index=561&type=chunk][562](index=562&type=chunk][563](index=563&type=chunk][564](index=564&type=chunk][565](index=565&type=chunk][566](index=566&type=chunk][567](index=567&type=chunk][568](index=568&type=chunk][569](index=569&type=chunk][570](index=570&type=chunk][571](index=571&type=chunk][572](index=572&type=chunk][573](index=573&type=chunk][574](index=574&type=chunk][575](index=575&type=chunk][576](index=576&type=chunk][577](index=577&type=chunk][578](index=578&type=chunk][579](index=579&type=chunk][580](index=580&type=chunk][581](index=581&type=chunk][582](index=582&type=chunk][583](index=583&type=chunk][584](index=584&type=chunk][585](index=585&type=chunk][586](index=586&type=chunk][587](index=587&type=chunk][588](index=588&type=chunk][589](index=589&type=chunk][590](index=590&type=chunk][591](index=591&type=chunk][592](index=592&type=chunk][593](index=593&type=chunk][594](index=594&type=chunk][595](index=595&type=chunk][596](index=596&type=chunk][597](index=597&type=chunk][598](index=598&type=chunk][599](index=599&type=chunk][600](index=600&type=chunk][601](index=601&type=chunk][602](index=602&type=chunk][603](index=603&type=chunk][604](index=604&type=chunk][605](index=605&type=chunk][606](index=606&type=chunk][607](index=607&type=chunk][608](index=608&type=chunk][609](index=609&type=chunk][610](index=610&type=chunk][611](index=611&type=chunk][612](index=612&type=chunk][613](index=613&type=chunk] - Marketable securities are available-for-sale debt and equity securities, carried at fair value[560][561](index=561&type=chunk][562](index=562&type=chunk][563](index=563&type=chunk][564][565](index=565&type=chunk][566](index=566&type=chunk][567](index=567&type=chunk][568](index=568&type=chunk][569](index=569&type=chunk][570](index=570&type=chunk][571](index=571&type=chunk][572](index=572&type=chunk][573](index=573&type=chunk][57