Prothena(PRTA) - 2020 Q4 - Annual Report

PART I Item 1. Business Prothena is a late-stage clinical biotechnology company developing novel therapeutics for rare peripheral amyloid and neurodegenerative diseases, leveraging protein dysregulation expertise and a broad pipeline Overview This section provides a high-level overview of Prothena's focus on protein dysregulation and its therapeutic pipeline - Prothena is a late-stage clinical company with expertise in protein dysregulation, developing investigational therapeutics for rare peripheral amyloid and neurodegenerative diseases[18] - The company's pipeline includes wholly-owned programs (birtamimab, PRX004, PRX012) and partnered programs (prasinezumab with Roche, PRX005, TDP-43, and an undisclosed target with Bristol-Myers Squibb)[19] Our Strategy This section outlines Prothena's strategic goals and key elements for developing novel therapies for protein dysregulation diseases - Prothena's goal is to be a leading biotechnology company focused on the discovery and development of novel therapies to treat diseases caused by protein dysregulation[21] - The company leverages its protein dysregulation platform to develop therapeutic solutions that directly target pathogenic proteins, aiming to change the course of devastating rare peripheral amyloid and neurodegenerative diseases[23] - Key strategic elements include concentrating R&D in areas of scientific expertise, focusing on diseases with unmet medical needs, pursuing strategic business development and collaborations, and evaluating commercialization strategies[25][31][36][40] Our Research and Development Pipeline This section details Prothena's clinical and preclinical pipeline, encompassing wholly-owned and partnered therapeutic programs - Prothena's R&D pipeline includes three therapeutic antibody programs in clinical development: Birtamimab (AL amyloidosis), prasinezumab (Parkinson's disease, partnered with Roche), and PRX004 (ATTR amyloidosis)[41] - The pipeline also features discovery and late-preclinical stage programs targeting neurological diseases like Alzheimer's (tau, Aβ) and ALS (TDP-43), with tau, TDP-43, and an undisclosed target being part of the BMS collaboration[42] Birtamimab (NEOD001) for the Potential Treatment of AL Amyloidosis This section describes birtamimab, an investigational antibody for AL amyloidosis, its regulatory designations, and clinical trial results - Birtamimab is an investigational humanized antibody for AL amyloidosis, designed to target and clear toxic misfolded light chain proteins that cause organ dysfunction and failure[44] - It has received Fast Track Designation from the FDA for Mayo Stage IV AL amyloidosis patients to reduce mortality risk, and Orphan Drug Designation from both FDA and EMA[45] - A post-hoc analysis of the Phase 3 VITAL Study showed a significant survival benefit for birtamimab in Mayo Stage IV AL amyloidosis patients, with 74% alive at 9 months versus 49% in the control group (hazard ratio of 0.413, p=0.0251)[49] - A confirmatory Phase 3 AFFIRM-AL study is planned under an FDA Special Protocol Assessment (SPA) agreement, enrolling approximately 150 Mayo Stage IV patients with a primary endpoint of all-cause mortality[51][52] Prasinezumab for the Potential Treatment of Parkinson's Disease and Other Synucleinopathies This section details prasinezumab, an investigational antibody for Parkinson's disease, its mechanism, and clinical trial outcomes - Prasinezumab is an investigational humanized monoclonal antibody targeting aggregated alpha-synuclein, developed in collaboration with Roche, aiming to slow the progression of Parkinson's disease[54][57] - Phase 1 studies demonstrated prasinezumab's safety, tolerability, CNS penetration, and a dose-dependent reduction in free serum alpha-synuclein[59] - Part 1 of the Phase 2 PASADENA study showed signals of efficacy on multiple secondary and exploratory clinical endpoints, including a 35% reduction in motor function decline (MDS-UPDRS Part III) and delayed worsening of motor progression[62][63] - Based on these results, Roche and Prothena will advance prasinezumab into a late-stage Phase 2b study in patients with early Parkinson's disease, including those on stable levodopa therapy[67] License, Development, and Commercialization Agreement with Roche This section outlines the financial terms and responsibilities of the collaboration agreement with Roche for α-synuclein antibodies - Prothena entered a License Agreement with Roche in December 2013 for α-synuclein antibodies, receiving an upfront payment of $30.0 million and clinical milestone payments totaling $45.0 million by 2017[70] - For prasinezumab in Parkinson's disease, Prothena and Roche share U.S. development and commercialization costs and profits (30% Prothena, 70% Roche), with Prothena having an option to opt out for U.S. commercial sales milestones (up to $155.0 million) and tiered royalties[72] - Roche is primarily responsible for global development and commercialization, with Prothena eligible for up to $350.0 million in additional development, regulatory, and commercial milestones, and up to $175.0 million in ex-U.S. commercial sales milestones, plus tiered ex-U.S. royalties[71][75] PRX004 for the Potential Treatment of ATTR Amyloidosis This section describes PRX004, an investigational antibody for ATTR amyloidosis, its mechanism, and promising Phase 1 clinical results - PRX004 is an investigational antibody designed to deplete abnormal TTR protein and amyloid deposits in hereditary and wild-type ATTR amyloidosis, aiming to improve organ function without affecting native TTR[74][81] - ATTR amyloidosis affects a large patient population globally, with current therapies not adequately addressing the needs of patients with advanced cardiac disease due to amyloid deposition[77][78][34] - A Phase 1 study in hATTR amyloidosis patients demonstrated PRX004's safety and tolerability, showing favorable results including slowing of neuropathy progression (mean change in NIS of +1.29 points at 9 months) and improved cardiac systolic function (mean change in GLS of -1.21% at 9 months) in evaluable patients[85][87][88] - Based on Phase 1 results, Prothena plans to advance PRX004 into a late-stage study for moderate-to-advanced ATTR-cardiomyopathy patients[89] Our Discovery and Preclinical Programs This section highlights Prothena's early-stage pipeline, including programs for Alzheimer's and ALS, and their preclinical findings - Prothena is advancing several discovery and preclinical-stage programs for neurological diseases, including Alzheimer's (PRX012 targeting Aβ, PRX005 targeting tau) and ALS (TDP-43)[90][92] - PRX012 is a next-generation anti-Aβ antibody with higher binding strength to amyloid than aducanumab, aiming for convenient subcutaneous administration to improve patient access[93][94] - PRX005, an investigational anti-tau antibody, demonstrated superior efficacy in preclinical models in blocking tau transmission and slowing pathological progression[97] Master Collaboration Agreement with Bristol-Myers Squibb This section details the financial terms and licensing options of the collaboration agreement with BMS for neurodegenerative disease targets - Prothena entered a Master Collaboration Agreement with Celgene (now BMS) in March 2018 for antibodies targeting Tau, TDP-43, and an undisclosed target, receiving an upfront payment of $100 million and a $50 million equity investment[98] - BMS has options to exclusively license U.S. rights (for $80 million per program upon IND filing) and global rights (for an additional $55 million per program after Phase 1 completion)[99][100] - Prothena is eligible for up to $562.5 million in regulatory and commercial milestones per program, plus tiered royalties on net sales of Collaboration Products[101] Regulation This section outlines the extensive government regulations governing pharmaceutical products, from development to post-approval - Pharmaceutical products are subject to extensive government regulation by authorities like the FDA and EMA, covering development, testing, labeling, manufacturing, marketing, and post-approval[108] - The U.S. biologic product approval process involves submitting an IND, extensive nonclinical and clinical trials (Phase 1, 2, 3), cGMP compliance, BLA submission, and FDA inspections[110][111][115] - The FDA offers expedited program designations (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review) to facilitate and accelerate development and review for serious conditions with unmet medical needs[119] - Post-approval, products are subject to continuous FDA regulation, including record-keeping, adverse event reporting, cGMP compliance, and strict rules on marketing and promotion, with potential for severe sanctions for non-compliance[124][125][127] - Orphan drug designation provides financial incentives and a seven-year exclusive marketing period in the U.S. for drugs treating rare diseases[130] Intellectual Property This section describes Prothena's strategy for protecting its proprietary technology through patents, trade secrets, and licensing agreements - Prothena protects its proprietary technology through patents, trade secrets, and know-how, focusing on immunological approaches to protein dysregulation, amyloidosis, and neurodegeneration[133][134] - The company's patent portfolio includes approximately 6 patent families for AL/AA amyloidosis (birtamimab, expiring 2029), 19 for Parkinson's/synucleinopathies (prasinezumab, expiring 2032), 9 for ATTR amyloidosis (PRX004, expiring 2036), 9 for Alzheimer's (PRX005, PRX012), and 16 for other targets[140] - Prothena holds exclusive licenses from the University of Tennessee (birtamimab), University of California (prasinezumab), and University Health Network (PRX004), with associated royalty and milestone payment obligations[139][140][141][142] - The company also has a fully paid, royalty-free, perpetual, and irrevocable exclusive sublicense from Elan (now Perrigo) for α-synuclein related patents[143] Competition This section addresses the highly competitive nature of the pharmaceutical industry and potential impacts on Prothena's drug candidates - The pharmaceutical industry is highly competitive, with Prothena facing competition from major international companies, smaller research firms, and generic/biosimilar manufacturers, many of whom have greater financial and R&D resources[144][145][240] - Competitive products or new treatment methods could render Prothena's drug candidates obsolete or noncompetitive, impacting future revenues and profitability[146][241] Manufacturing This section states Prothena's reliance on third-party manufacturers for all its clinical drug supplies - Prothena relies entirely on third-party manufacturers for clinical supplies of all its drug candidates[147][148][149][150][151][255] - Specific manufacturers include Roche for prasinezumab, Rentschler for PRX004 and birtamimab drug substance, Catalent for birtamimab drug product, Catalent and Berkshire for PRX005, and Catalent for PRX012[147][148][149][150][151] Research and Development This section presents a table of Prothena's research and development expenses over three years Research and Development Expenses (in millions USD) | Year | Amount (millions USD) | | :--- | :--- | | 2020 | $74.9 | | 2019 | $50.8 | | 2018 | $101.2 | Employees This section provides the total number of Prothena employees and those dedicated to R&D activities - As of December 31, 2020, Prothena had 66 employees, with 40 dedicated to research and development activities[152] Information about Segment and Geographic Revenue This section refers to the detailed segment and geographic revenue information in the consolidated financial statements - Segment and geographic revenue information is detailed in Note 2 to the Consolidated Financial Statements[153] Available information This section indicates where Prothena's periodic reports and financial information can be accessed - Prothena files periodic reports with the SEC, available on www.sec.gov and the company's investor relations website, www.prothena.com[154](index=154&type=chunk) Item 1A. Risk Factors Prothena faces significant risks including future losses, capital needs, COVID-19 impacts, uncertain drug development, commercialization challenges, reliance on third parties, intellectual property issues, and stock price volatility - Prothena anticipates incurring losses for the foreseeable future and may never achieve sustained profitability, with net losses of $111.1 million in 2020, $77.7 million in 2019, and $155.6 million in 2018[156] - The company will require substantial additional capital to fund operations, R&D, and commercialization, with existing cash ($295.4 million as of Dec 31, 2020) sufficient for at least the next twelve months but not long-term needs[158][409] - The COVID-19 pandemic has disrupted clinical trials and could materially adversely affect liquidity, operations, and development programs, potentially delaying new trials and increasing costs[165][167] - The success of Prothena's business is highly dependent on its R&D programs, which are subject to significant risks of failure due to efficacy, safety, or trial design issues, and the regulatory approval processes are lengthy, costly, and unpredictable[183][198] - Prothena relies heavily on third parties for clinical trials and manufacturing, leading to potential delays, failures, or supply interruptions[251][255] - Protecting and enforcing intellectual property is crucial but uncertain due to evolving legal standards, potential litigation, and reliance on licensed rights[265][290] Item 1B. Unresolved Staff Comments This section confirms there are no unresolved staff comments to report - There are no unresolved staff comments[330] Item 2. Properties Prothena maintains corporate offices in Dublin, Ireland, and primary U.S. operations, including office and laboratory space, in South San Francisco, California - Prothena's corporate registered address and office are in Dublin, Ireland (133 sq ft, lease expires Nov 2021), and its U.S. operations are in South San Francisco, California (82,000 sq ft, lease expires Dec 2023)[331][332] Item 3. Legal Proceedings This section confirms Prothena is not currently involved in any material legal proceedings - Prothena is not currently a party to any material legal proceedings[334] Item 4. Mine Safety Disclosures This section states that Mine Safety Disclosures are not applicable to Prothena's business operations - Mine Safety Disclosures are not applicable to the company[335] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities This section covers Prothena's stock market listing, dividend policy, share performance, and Irish legal and tax implications for shareholders - Prothena's ordinary shares trade on The Nasdaq Global Select Market under the symbol 'PRTA'[338] - The company has not paid dividends in the past and does not anticipate paying any cash dividends for the foreseeable future, intending to retain future earnings for business development[340][326] 5-Year Cumulative Total Return (Assumed $100 Investment as of 12/31/2015) | Index/Company | 12/31/2015 | 12/31/2016 | 12/31/2017 | 12/31/2018 | 12/31/2019 | 12/31/2020 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Prothena Corporation plc | $100 | $72 | $55 | $15 | $23 | $18 | | Nasdaq Composite Index | $100 | $108 | $138 | $133 | $179 | $257 | | Nasdaq Biotechnology Index | $100 | $78 | $95 | $86 | $107 | $134 | - Irish law imposes restrictions on financial transfers, and dividends on ordinary shares are generally subject to Irish Dividend Withholding Tax (DWT) at 25%, with exemptions for U.S. residents[352][353][354][355] - Gifts or inheritances of Prothena's ordinary shares could be subject to Irish Capital Acquisitions Tax (CAT) at a rate of 33% above certain thresholds, and transfers may be subject to Irish stamp duty[360][361][363][364] Item 6. Selected Financial Data This section provides a five-year summary of Prothena's selected consolidated financial data, highlighting trends in key financial metrics Selected Consolidated Statement of Operations Data (in thousands, except per share amounts) | Metric | 2020 | 2019 | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $564 | $814 | $955 | $27,519 | $1,055 | | License revenue | $289 | $— | $— | $— | $— | | Total revenue | $853 | $814 | $955 | $27,519 | $1,055 | | Research and development | $74,884 | $50,836 | $101,183 | $134,547 | $119,534 | | General and administrative | $38,703 | $35,736 | $42,482 | $48,226 | $41,056 | | Restructuring and related impairment charges (credits) | $— | $(61) | $16,145 | $— | $— | | Total operating expenses | $113,587 | $86,511 | $159,810 | $182,773 | $160,590 | | Loss from operations | $(112,734) | $(85,697) | $(158,855) | $(155,254) | $(159,535) | | Net loss | $(111,144) | $(77,677) | $(155,645) | $(153,237) | $(160,108) | | Basic and diluted net loss per share | $(2.78) | $(1.95) | $(3.93) | $(4.07) | $(4.66) | | Shares used to compute basic and diluted net loss per share | 39,915 | 39,882 | 39,559 | 37,654 | 34,351 | Selected Consolidated Balance Sheet Data (in thousands) | Metric | 2020 | 2019 | 2018 | 2017 | 2016 | | :--- | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents and restricted cash | $298,084 | $378,427 | $431,715 | $421,676 | $390,979 | | Total assets | $332,975 | $419,268 | $498,796 | $496,329 | $459,976 | | Total liabilities | $148,969 | $146,347 | $175,798 | $89,140 | $94,573 | | Shareholders' equity | $184,006 | $272,921 | $322,998 | $407,189 | $365,403 | Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section analyzes Prothena's financial condition and results of operations for 2018-2020, covering revenue, expenses, and liquidity, highlighting R&D spending and capital needs - Prothena's total revenue was $0.9 million in 2020, $0.8 million in 2019, and $1.0 million in 2018, with a 5% increase in 2020 primarily due to new license revenue[384][385][386] - Research and development (R&D) expenses increased by 47% to $74.9 million in 2020, primarily due to higher manufacturing costs for PRX005, birtamimab, PRX012, and PRX004 programs, and increased collaboration expense with Roche[387][391] - General and administrative (G&A) expenses increased by 8% to $38.7 million in 2020, mainly due to higher director and officer insurance premiums[387][397] - Net cash used in operating activities was $80.4 million in 2020, an increase from $53.0 million in 2019, primarily due to higher operating expenses[411][412] - As of December 31, 2020, cash and cash equivalents were $295.4 million, a decrease from $375.7 million in 2019, with the company anticipating a need for additional capital beyond the next twelve months[408][409] Overview This section provides a high-level summary of Prothena's business and pipeline of investigational therapeutics - Prothena is a late-stage clinical company focused on protein dysregulation, with a pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases[372] - The pipeline includes wholly-owned programs (birtamimab, PRX004, PRX012) and partnered programs (prasinezumab with Roche, PRX005, TDP-43, undisclosed target with BMS)[373] Critical Accounting Policies and Estimates This section discusses key accounting policies and estimates, particularly for revenue recognition and R&D expenses, requiring significant management judgment - Critical accounting policies and estimates include revenue recognition (contracts with multiple performance obligations, collaboration revenue, milestone revenue) and research and development expenses, which require significant management judgments and assumptions[375][376][377][379][380][382] Results of Operations This section analyzes Prothena's revenue, operating expenses, other income, and income taxes for the reported periods Total Revenue (in thousands) | Year | Amount | Change YoY | | :--- | :--- | :--- | | 2020 | $853 | 5% | | 2019 | $814 | (15)% | | 2018 | $955 | - | - Collaboration revenue decreased by 31% in 2020 and 15% in 2019, while license revenue of $289 thousand was recognized in 2020 from a new agreement[384][386] Total Operating Expenses (in thousands) | Year | Amount | Change YoY | | :--- | :--- | :--- | | 2020 | $113,587 | 31% | | 2019 | $86,511 | (46)% | | 2018 | $159,810 | - | - R&D expenses increased by 47% in 2020 to $74.9 million, primarily due to higher manufacturing costs for PRX005, birtamimab, PRX012, and PRX004 programs, and increased collaboration expense with Roche[387][391] - G&A expenses increased by 8% in 2020 to $38.7 million, mainly due to higher director and officer insurance premiums[387][397] Restructuring and Related Impairment Charges (Credits) (in thousands) | Year | Amount | Change YoY | | :--- | :--- | :--- | | 2020 | $— | (100)% | | 2019 | $(61) | (100)% | | 2018 | $16,145 | - | - Net other income decreased by 84% in 2020 to $1.3 million, primarily due to lower interest income from cash and money market accounts[403] Provision for (benefit from) Income Taxes (in thousands) | Year | Amount | Change YoY | | :--- | :--- | :--- | | 2020 | $(283) | (175)% | | 2019 | $379 | (181)% | | 2018 | $(470) | - | Liquidity and Capital Resources This section analyzes Prothena's working capital, cash position, cash flow activities, and future capital requirements Liquidity and Capital Resources (in thousands) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | Working capital | $273,436 | $360,661 | | Cash and cash equivalents | $295,380 | $375,723 | | Total assets | $332,975 | $419,268 | | Total liabilities | $148,969 | $146,347 | | Total shareholders' equity | $184,006 | $272,921 | - Working capital decreased by $87.2 million in 2020, primarily due to $113.6 million in cash used for operating expenses[408] - As of December 31, 2020, cash and cash equivalents were $295.4 million, believed to be sufficient for at least the next twelve months, but additional capital will be required for future R&D and commercialization[409][410] Consolidated Statements of Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(80,362) | $(52,969) | $(28,276) | | Net cash used in investing activities | $(196) | $(547) | $(1,729) | | Net cash provided by financing activities | $215 | $228 | $40,044 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(80,343) | $(53,288) | $10,039 | - Net cash provided by financing activities was $0.2 million in 2020 and 2019, significantly lower than $40.0 million in 2018, which included proceeds from Celgene's share subscription[416][417] Contractual Obligations as of December 31, 2020 (in thousands) | Obligation Type | Total | 2021 | 2022 | 2023 | 2024 | 2025 | Thereafter | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Operating leases | $19,077 | $6,192 | $6,350 | $6,535 | $— | $— | $— | | Purchase obligations | $10,900 | $10,900 | $— | $— | $— | $— | $— | | Contractual obligations under license agreements | $785 | $180 | $70 | $70 | $60 | $60 | $345 | | Total | $30,762 | $17,272 | $6,420 | $6,605 | $60 | $60 | $345 | Item 7A. Quantitative and Qualitative Disclosures About Market Risk Prothena's market risk is primarily limited to foreign currency and interest rate fluctuations, with credit risk managed through high-quality financial institutions - Prothena's foreign currency risk is limited, primarily from Euro-denominated contract manufacturing agreements, resulting in a $62,000 loss in 2020 and a $196,000 gain in 2019[424] - Interest rate risk is limited to cash equivalents in money market funds, with interest income fluctuating based on short-term market conditions[425] - Credit risk is concentrated in cash, cash equivalents, and accounts receivable, managed by investing with high-credit quality financial institutions and limiting exposure to any single entity[427] Item 8. Financial Statements and Supplementary Data This section presents Prothena's audited consolidated financial statements, including balance sheets, statements of operations, cash flows, and shareholders' equity, with detailed notes and the auditor's report - KPMG LLP provided an unqualified opinion on Prothena's consolidated financial statements for the three-year period ended December 31, 2020[432] - The company changed its method of accounting for leases as of January 1, 2019, due to the adoption of ASC Topic 842[433] - A critical audit matter identified was the evaluation of accrued research and development costs, particularly those related to clinical research organizations and investigative sites, due to the challenging nature of assessing underlying assumptions and inputs[438][441] Consolidated Balance Sheets (in thousands) | Metric | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $295,380 | $375,723 | | Total current assets | $299,284 | $378,375 | | Total assets | $332,975 | $419,268 | | Total current liabilities | $25,848 | $17,714 | | Total liabilities | $148,969 | $146,347 | | Total shareholders' equity | $184,006 | $272,921 | Consolidated Statements of Operations (in thousands, except per share data) | Metric | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Total revenue | $853 | $814 | $955 | | Research and development | $74,884 | $50,836 | $101,183 | | General and administrative | $38,703 | $35,736 | $42,482 | | Total operating expenses | $113,587 | $86,511 | $159,810 | | Net loss | $(111,144) | $(77,677) | $(155,645) | | Basic and diluted net loss per share | $(2.78) | $(1.95) | $(3.93) | Consolidated Statements of Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(80,362) | $(52,969) | $(28,276) | | Net cash used in investing activities | $(196) | $(547) | $(1,729) | | Net cash provided by financing activities | $215 | $228 | $40,044 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(80,343) | $(53,288) | $10,039 | Consolidated Statements of Shareholders' Equity (in thousands, except share data) | Metric | Dec 31, 2020 | Dec 31, 2019 | Dec 31, 2018 | | :--- | :--- | :--- | :--- | | Ordinary Shares (count) | 39,921,413 | 39,898,561 | 39,863,711 | | Ordinary Shares (amount) | $399 | $399 | $399 | | Additional Paid-in Capital | $966,636 | $944,407 | $920,594 | | Accumulated Deficit | $(783,029) | $(671,885) | $(597,995) | | Total Shareholders' Equity | $184,006 | $272,921 | $322,998 | Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure This section confirms no changes in or disagreements with accountants on accounting and financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure[635] Item 9A. Controls and Procedures Management concluded Prothena's disclosure controls and internal control over financial reporting were effective as of December 31, 2020 - As of December 31, 2020, management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective in providing reasonable assurance for timely and accurate reporting[635] - Management assessed internal control over financial reporting as effective as of December 31, 2020, based on the 'Internal Control-Integrated Framework (2013)' by COSO[637] - No material changes in internal control over financial reporting were identified during the fourth fiscal quarter ended December 31, 2020[638] Item 9B. Other Information This section confirms there is no other information to report under this item - There is no other information to report under this item[641] PART III Item 10. Directors, Executive Officers and Corporate Governance This section provides information on Prothena's executive officers and the company's Code of Conduct - The report provides information on the company's executive officers, including their ages, positions, and tenure[645] - Key executive officers include Gene G. Kinney (President & CEO), Carol D. Karp (Chief Regulatory Officer), Michael J. Malecek (Chief Legal Officer), Tran B. Nguyen (CFO & COO), Brandon S. Smith (Chief Business Officer), Radhika Tripuraneni (Chief Development Officer), Karin L. Walker (Chief Accounting Officer), and Wagner M. Zago (Chief Scientific Officer)[645] - Prothena has a Code of Conduct applicable to all directors, executive officers, and employees, available on its website[653] Item 11. Executive Compensation Executive compensation information is incorporated by reference from the company's definitive proxy statement - Executive compensation information is incorporated by reference from the company's Proxy Statement[654] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information for beneficial owners and management is incorporated by reference from the company's definitive proxy statement - Information on security ownership of certain beneficial owners and management is incorporated by reference from the company's Proxy Statement[654] Item 13. Certain Relationships and Related Transactions, and Director Independence Information on certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive proxy statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the company's Proxy Statement[654] Item 14. Principal Accounting Fees and Services Information on principal accounting fees and services is incorporated by reference from the company's definitive proxy statement - Information on principal accounting fees and services is incorporated by reference from the company's Proxy Statement[655] PART IV Item 15. Exhibits, Financial Statement Schedules This section lists all exhibits and financial statement schedules filed as part of the Form 10-K report - Item 15 lists all exhibits and financial statement schedules filed as part of the Form 10-K report[658][659][660]