Forte Biosciences(FBRX) - 2022 Q4 - Annual Report

PART I Item 1. Business Forte Biosciences is a biopharmaceutical company advancing its preclinical product candidate, FB-102, for broad autoimmune applications amidst a competitive and highly regulated industry Overview - Forte Biosciences, Inc. is a biopharmaceutical company advancing FB-102, a proprietary therapeutic molecule, through preclinical trials for broad autoimmune applications[13] - FB-102 targets indications such as graft-versus-host disease (GvHD), vitiligo, and alopecia areata (AA), which have multi-billion dollar market sizes[13] - The company expects FB-102 to enter clinical trials in late 2023 or early 2024[20] - As of December 31, 2022, Forte had $41.1 million in cash and cash equivalents[21] Product Candidate (FB-102) and Target Indications - FB-102 is an antagonist of autoimmune disease pathways with potential for durable response, targeting GvHD, vitiligo, and AA[13] - GvHD is a complication of allogeneic HSCT, affecting 30-70% of patients, with a global treatment market estimated at $1.6 billion in 2021, projected to reach $2.8 billion by 2027[14][15] - Vitiligo affects 2 million people in the U.S., with a global treatment market estimated at $1.2 billion in 2018, projected to reach $1.9 billion by 2026[16][17] - Alopecia Areata (AA) affects 700,000 people in the US, with a global treatment market estimated at $2.7 billion in 2020, projected to reach $4.9 billion by 2028[18][19] - There is a significant unmet need for safe and effective therapies in these indications, as existing treatments like JAK inhibitors carry black box warnings[14][16][18][20] Manufacturing and Supply - Forte outsources FB-102 manufacturing to third-party CMOs and preclinical testing to CROs[22] - Reliance on a limited number of suppliers for critical raw materials and services poses a risk of supply interruption, which could harm manufacturing and preclinical development[22] Competition - The biotechnology and pharmaceutical industries are highly competitive, characterized by rapidly advancing technologies[24] - Key competitive factors include efficacy, safety profile, administration method, cost, promotional activity, and intellectual property protection[24] - Competitors include major pharmaceutical and biotechnology companies, academic institutions, and government agencies, many with greater financial resources and expertise[25][26] Intellectual Property - Forte terminated its exclusive license agreement with DHHS for Gram-negative bacteria compositions effective April 2, 2022[27] - The company owns one US patent for Gram-positive and Gram-negative bacteria combinations (expiring 2039), which is not material to the FB-102 program[28] - Forte owns four pending US patent applications related to the FB-102 program, with estimated expiration dates between 2043 and 2044[28] Government Regulation - Drug and biological products are extensively regulated by government authorities in the U.S. and other countries, covering research, development, testing, manufacturing, approval, labeling, marketing, and post-approval monitoring[29] - Obtaining regulatory approvals is a lengthy, expensive process, and non-compliance can lead to severe sanctions, including refusal of approval, withdrawal of approval, fines, and criminal penalties[30] United States Biological Product Development - Forte's product candidates require FDA approval through a Biologic License Application (BLA) process[31] - The process involves extensive preclinical studies, an effective Investigational New Drug (IND) application, IRB approval, human clinical trials (Phase 1, 2, 3), BLA submission and review, and pre-approval inspections of manufacturing facilities for cGMP compliance[31][36] Preclinical Studies and IND - Preclinical studies involve laboratory and animal testing to assess safety and therapeutic rationale, conducted under GLP regulations[32] - An IND application, including preclinical results and clinical study plans, must become effective (typically after 30 days unless FDA raises concerns) before human clinical trials can begin[33] Clinical Trials - Clinical trials involve administering investigational products to humans under qualified investigators, adhering to GCP requirements and IRB approval, with informed consent from participants[34] - Trials are typically conducted in three phases: Phase 1 (safety, metabolism, pharmacologic action in small groups), Phase 2 (dose determination, preliminary efficacy in disease-affected patients), and Phase 3 (demonstrate effectiveness, safety, overall benefit/risk in large patient populations)[36][37][38] - Post-approval (Phase 4) trials may be conducted to gain additional experience or as a condition of BLA approval[38] - Clinical trials can be suspended or terminated by the FDA, sponsor, or IRB due to health risks, non-compliance, or other factors[40] FDA Review Process - After clinical trials, a BLA is submitted to the FDA with preclinical and clinical data, proposed labeling, and manufacturing information to prove safety, purity, and potency[42] - The FDA reviews the BLA, conducts pre-approval inspections of manufacturing facilities for cGMP compliance, and may refer applications to advisory committees[45][46] - Approval results in an approval letter, while deficiencies lead to a Complete Response Letter requiring additional data or studies[46] Pediatric Information - Under PREA, BLAs must include pediatric safety and efficacy data for relevant subpopulations, or a justification for deferral/waiver[47] - Sponsors must submit an initial Pediatric Study Plan (PSP) for new active ingredients, indications, or dosage forms, which requires FDA agreement[47] Post-marketing Requirements - Approved products are subject to ongoing FDA regulation, including monitoring, adverse event reporting, promotion/advertising compliance (e.g., no off-label promotion), and potential BLA supplements for modifications[48] - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe product use, which can include medication guides, communication plans, or restricted distribution[49] - Manufacturers must comply with cGMP regulations, register establishments with the FDA, and are subject to periodic unannounced inspections[50][51] Other Regulatory Matters - Post-approval activities are also regulated by other U.S. authorities like CMS, Department of Justice, and state/local governments[53] Other Healthcare Laws - Biopharmaceutical manufacturers are subject to federal and state healthcare laws, including anti-kickback, anti-self-referral, false claims, transparency (Physician Payments Sunshine Act), pricing reporting, and data privacy (HIPAA) laws[54] - Violations can lead to significant administrative, civil, and criminal penalties, fines, exclusion from government healthcare programs, and reputational harm[55] Current and Future Healthcare Reform Legislation - Healthcare reform legislation, such as the Affordable Care Act (ACA) and the Inflation Reduction Act of 2022, aims to reduce healthcare costs and may impact drug pricing, coverage, and profitability[56][57][60] - The Inflation Reduction Act of 2022 allows federal negotiation of drug prices, imposes inflation rebates, and redesigns Medicare Part D, with uncertain impacts on the pharmaceutical industry[60] - State-level legislation is also increasing to control pharmaceutical product pricing and transparency[61] Packaging and Distribution in the United States - Pharmaceutical products are subject to child-resistant packaging requirements and extensive record-keeping, licensing, storage, and security regulations for distribution[62][63] - Non-compliance can lead to legal/regulatory actions, fines, product recalls, and withdrawal of approvals[64] Other U.S. Environmental, Health and Safety Laws and Regulations - Forte is subject to environmental, health, and safety laws governing hazardous materials and waste, with potential liability for contamination or injury[66] - The company maintains workers' compensation insurance but does not have environmental liability or toxic tort claims insurance[67] U.S. Patent-Term Restoration and Marketing Exclusivity - U.S. patents may be eligible for up to five years of patent term extension under the Hatch-Waxman Amendments to compensate for time lost during FDA review[69] - The Biologics Price Competition and Innovation Act (BPCI Act) created an abbreviated approval pathway for biosimilar products, granting reference biological products 12 years of data exclusivity[70][72] - Pediatric exclusivity, if granted, adds six months to existing regulatory exclusivity periods[73] Rest of the World Regulation - Regulatory requirements for clinical trials, product licensing, pricing, and reimbursement vary significantly outside the U.S., including in the European Union[74] - Failure to comply with foreign regulations can lead to fines, withdrawal of approvals, product recalls, and criminal prosecution[75] Additional Laws and Regulations Governing International Operations - Expanding international operations subjects Forte to laws like the Foreign Corrupt Practices Act (FCPA), which prohibits bribery of foreign officials and requires accurate accounting[76] - Compliance with FCPA is complex and expensive, especially in the pharmaceutical industry where government-owned hospitals and doctors are considered foreign officials[77] - Failure to comply with international business practice laws can result in substantial civil and criminal penalties, and suspension from government contracting[79] Coverage and Reimbursement - Commercial success of approved products depends on coverage and adequate reimbursement from third-party payors (government, commercial insurers, managed healthcare organizations)[81] - There is no uniform policy in the U.S., requiring separate negotiations with each payor, which is time-consuming and costly[81] - Increasing cost containment measures and changes in reimbursement rates can adversely affect product marketability and pricing[82][83][84] - Foreign countries often require pricing approval, and prices in the EU tend to be significantly lower than in the U.S.[85] Employees and Human Capital - As of March 24, 2023, Forte had 6 full-time employees, primarily in R&D, manufacturing, and administration[86] - The company's human capital objectives include identifying, recruiting, retaining, incentivizing, and integrating employees, advisors, and consultants[87] Corporate Information and History - Forte completed a business combination with Tocagen, Inc. on June 15, 2020, with Forte as the surviving entity[88] - Forte was privately held and incorporated in Delaware on May 3, 2017[88] - The company's principal executive office is in Dallas, Texas[89] Item 1A. Risk Factors. Forte Biosciences faces significant risks from its early-stage, single product candidate development, including clinical uncertainty, capital needs, intense competition, regulatory hurdles, and reliance on third parties Risks related to Forte's business, technology and industry - Forte's business is almost entirely dependent on the success of FB-102, having discontinued its previous lead product candidate, FB-401, due to a failed Phase 2 clinical trial[93][94][96][97] - The company has no approved products, a limited operating history, and has incurred net losses in every year since inception, with an accumulated deficit of $87.0 million as of December 31, 2022[98][99][102] - Forte will require additional capital to fund operations and FB-102 development; current cash ($41.1 million as of Dec 31, 2022) is sufficient for at least 12 months, but further funding is uncertain[105] - Clinical development is lengthy, expensive, and uncertain, with high attrition rates; positive early preclinical results are not predictive of later clinical trial success[95][114][120][123][124] - Undesirable side effects from FB-102 could delay or prevent regulatory approval, limit commercial profile, or lead to significant negative consequences post-marketing[120][122][185][186] - Estimates of target patient populations for FB-102 may be inaccurate, potentially limiting market opportunities and profitability[129][130] - Forte faces significant competition from companies with greater financial, technical, and marketing resources[131][132] - Market acceptance of FB-102, if approved, is uncertain and depends on efficacy, safety, convenience, physician/patient willingness, pricing, and reimbursement[133][134] - The COVID-19 pandemic or other public health threats could adversely impact operations, preclinical studies, and financial results[136] - Forte needs to grow its organization and manage this growth effectively, relying substantially on third-party organizations, advisors, and consultants[137][138] - Loss of key management personnel or failure to recruit skilled personnel could impair product development[142][143] - Internal computer systems or those of third parties are vulnerable to security breaches, potentially disrupting operations or leading to data loss and liability[144] - Employees, contractors, and partners may engage in misconduct, including non-compliance with regulatory standards, leading to significant losses and reputational harm[146][147] Risks related to government regulation - Forte's ability to commercialize FB-102 is highly uncertain and dependent on successful completion of preclinical studies, clinical trials, regulatory approvals, and establishing manufacturing and commercial operations[160][161] - Changes in the legal and regulatory environment, including FDA regulations, labeling laws, and consumer protection, could limit business activities or increase costs[163][164] - Inadequate funding or staffing disruptions at regulatory agencies (FDA, SEC) could delay product review and approval[165][166][168] - Relationships with healthcare providers and third-party payors are subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA), with potential for significant penalties and reputational harm[169][170][171][173][174] - Obtaining regulatory approval in one jurisdiction does not guarantee approval in others, and foreign approval processes can be different, lengthy, and costly[175][176] - Delays or failure to obtain regulatory approvals for FB-102 would materially impair Forte's ability to generate revenue[178][184] - Post-marketing, Forte will be subject to ongoing regulatory compliance, including cGMP and GCP, and potential FDA actions like labeling changes, post-marketing studies, or product withdrawal[188][189][190][191] - International operations expose Forte to anti-bribery (FCPA), export control, trade sanctions, and import laws, with violations leading to substantial penalties[195][199][200] Risks related to Forte's intellectual property - Forte's success depends on obtaining and maintaining patent protection for FB-102 and other technologies; there is no assurance that patent applications will issue or be enforceable[201][202][204] - The scope of patent protection may be insufficient, or patents may be lost, allowing competitors to commercialize similar products[205][206][207] - Patents may be challenged, invalidated, or circumvented by third parties, leading to loss of exclusivity or inability to commercialize products[206][207][208][209] - Patent terms may be inadequate to protect competitive position due to the long development and regulatory review periods[210][227] - Failure to obtain patent term extension or data exclusivity could materially harm the business[228] - Forte may face claims challenging inventorship of its patents or other intellectual property, leading to litigation and potential loss of rights[229] - Inability to protect trade secrets and proprietary rights globally, or their lawful obtainment by competitors, would harm Forte's competitive position[230][231][233][217][218] - Third-party claims of intellectual property infringement could prevent or delay commercialization of FB-102, leading to substantial litigation expenses, damages, or licensing obligations[238][240][241][242][243] - Forte filed a petition for post-grant review of U.S. Patent No. 11,278,505, owned by the University of Massachusetts, which claims broad autoimmune technologies[239] Risks related to Forte's reliance on third parties - Forte relies on third parties (investigators, CROs, CMOs) for preclinical studies, clinical trials, and manufacturing, reducing control over these activities and increasing risks of delays or unsatisfactory performance[248][249][250] - Failure of third-party manufacturers to comply with cGMP regulations or meet specifications could delay or prevent development and commercialization[253][254][255] - Third-party collaborations carry risks, including discretion over efforts, non-performance, competition, and potential termination, which could impact funding and development timelines[256][258][259] - Inability to maintain existing collaborations or enter new ones on favorable terms could force Forte to curtail development or undertake costly activities independently[261] General Risks - The market price of Forte's common stock is highly volatile; a significant decline (e.g., 82% drop after FB-401 trial failure) can occur, and class action securities litigation is a risk[262][265] - Unstable market and economic conditions, including disruptions in financial services, could adversely affect Forte's business, financing ability, and stock price[155][156][158][267] - Complying with public company laws and regulations (e.g., Sarbanes-Oxley Act) incurs significant costs and demands on management[268] - Anti-takeover provisions in charter documents and Delaware law, including a shareholders' rights plan, could make an acquisition more difficult and prevent changes in management[269][270] - Forte does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of stockholder gain[273] - Future sales of common stock by existing stockholders could cause the stock price to decline[274] - Forte has broad discretion in using proceeds from capital raising efforts, which may not align with stockholder preferences or increase investment value[276] - Forte identified a material weakness in its internal control over financial reporting related to the review of its annual income tax provision, which could impair accurate financial reporting[277][279] Item 1B. Unresolved Staff Comments The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[286] Item 2. Properties Forte Biosciences leases adequate office space in Dallas, Texas, under a cancellable agreement - Forte entered into a cancellable lease agreement for office space in Dallas, Texas, in December 2021[287] - The company believes its existing facilities are adequate and suitable for current business requirements[287] Item 3. Legal Proceedings Forte Biosciences is defending against a pending stockholder complaint filed in November 2022 seeking access to company books and records - A stockholder filed a complaint in November 2022 in the Delaware Court of Chancery to access company books and records and seek attorney fees[451] - The legal action is pending, and Forte Biosciences intends to vigorously defend against it[451] Item 4. Mine Safety Disclosures This item is not applicable to Forte Biosciences, Inc - Mine Safety Disclosures are not applicable to the registrant[289] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Forte's common stock trades on Nasdaq under 'FBRX', with 229 stockholders as of March 2023, and the company has never paid cash dividends - Forte's common stock began trading on the Nasdaq Capital Market under the ticker symbol 'FBRX' on June 16, 2020[292] - As of March 24, 2023, there were 229 registered stockholders of record[293] - The company has never declared or paid cash dividends and intends to retain all available funds and future earnings for business operations[294] - No repurchases of common stock were made during the year ended December 31, 2022[297] - No sales of unregistered securities occurred during the year ended December 31, 2022[298] Item 6. Reserved This item is reserved and contains no information - Item 6 is reserved[299] Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations Forte Biosciences, a preclinical biopharmaceutical company, reported a $13.9 million net loss in 2022, driven by reduced R&D, and holds $41.1 million in cash for at least 12 months of operations Overview - Forte Biosciences is a biopharmaceutical company focused on advancing its product candidate, FB-102, through preclinical trials for autoimmune applications like GvHD, vitiligo, and AA[301] - As of December 31, 2022, the company had $41.1 million in cash and cash equivalents[305] - Forte's common stock is publicly traded on the Nasdaq Capital Market under FBRX[305] - The company has an 'at-the-market' (ATM) equity offering program but has reached its current sales limit under Form S-3, restricting further sales[306] Intellectual Property - Forte terminated its exclusive license agreement with DHHS for Gram-negative bacteria compositions effective April 2, 2022[307][308] - The company owns one US patent (expiring 2039) not material to FB-102, and four pending US patent applications related to FB-102 (expiring 2043-2044)[309] COVID-19 - The COVID-19 pandemic has resulted in significant economic disruption and may adversely affect Forte's operations, financial condition, and liquidity[310] - The full extent, consequences, and duration of the pandemic's impact remain unpredictable[310] Components of Operating Results - Forte has no approved products and has not generated revenue from product sales; future revenue is expected from product sales, royalties, license fees, or milestones from collaborations[311] - Research and development costs are expensed as incurred, including salaries, preclinical studies, clinical trials, and drug manufacturing[312] - General and administrative expenses include professional fees, personnel expenses, and costs associated with being a publicly traded company[315] - Other expenses, net, consist of foreign exchange losses and franchise taxes, offset by interest income[316] Critical Accounting Policies, Significant Judgments and Use of Estimates - The preparation of financial statements requires management to make estimates and assumptions, particularly for research and development expenses and stock-based compensation[317][319] - Stock-based compensation is measured at grant-date fair value using the Black-Scholes option pricing model, with assumptions for expected term, volatility, risk-free interest rate, and dividend yield[320][323][324][325][326] - The volatility input is subjective and requires significant analysis and judgment, as the company has limited historical data[323][325] Results of Operations Consolidated Statements of Operations (in thousands) | Operating Expenses | 2022 ($) | 2021 ($) | Change ($) | |:-------------------|:---------|:---------|:-----------| | Research and development | 5,594 | 13,853 | (8,259) | | General and administrative | 8,302 | 7,633 | 669 |\ | Total operating expenses | 13,896 | 21,486 | (7,590) | | Other income (expenses), net | 17 | (222) | 239 | | Net Loss | (13,879) | (21,708) | (7,829) | - Research and development expenses decreased by $8.3 million in 2022 (YoY), primarily due to a $3.7 million decrease in manufacturing, $3.1 million decrease in preclinical/clinical expenses (FB-401 termination), $0.9 million decrease in payroll, and $0.6 million decrease in other expenses[329] - General and administrative expenses increased by $0.7 million in 2022 (YoY), mainly due to an increase in legal expenses[331] - Other income (expenses), net, improved by $0.239 million in 2022 (YoY), driven by a $150 thousand increase in interest income, $52 thousand reduction in foreign currency losses, and $37 thousand reduction in franchise taxes[332] Liquidity and Capital Resources - Forte has no product sales revenue, has never been profitable, and incurred a net loss of $13.9 million in 2022, with an accumulated deficit of $87.0 million[333] - As of December 31, 2022, cash and cash equivalents were $41.1 million, believed to be sufficient for at least 12 months of operations[336] - The company issued 6.1 million shares of common stock for gross proceeds of approximately $7.7 million under its ATM Facility from July 1 to December 31, 2022[335] - Forte will require additional capital to fund future operations and the development of FB-102, with future capital requirements being difficult to forecast[337] Summary Consolidated Statements of Cash Flows Summary Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | 2022 ($) | 2021 ($) | |:-------------------|:---------|:---------| | Operating activities | (8,185) | (16,677) | | Financing activities | 7,241 | (44) | | Net decrease in cash | (944) | (16,721) | - Net cash used in operating activities decreased from $16.7 million in 2021 to $8.2 million in 2022, primarily due to a lower net loss and changes in operating assets and liabilities[343][344] - Net cash provided by financing activities was $7.2 million in 2022, mainly from the sale of common stock under the ATM Facility, a significant increase from $44 thousand used in 2021[345][346] Indemnification - Forte indemnifies its officers and directors as permitted by Delaware law, believing the fair value of these rights is minimal and has not recorded any liabilities[347] Contractual Obligations - Information on contractual obligations is referenced to Note 4 of the Consolidated Financial Statements[348] Item 7A. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Forte Biosciences is not required to provide quantitative and qualitative disclosures about market risk - Forte Biosciences is a smaller reporting company and is not required to provide disclosures about market risk[349] Item 8. Financial Statements and Supplementary Data The financial statements and supplementary data are included starting on page F-1 of this Annual Report on Form 10-K - The financial statements and supplementary data are included after the Signatures page, starting on page F-1[350] Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Forte Biosciences reported 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[351] Item 9A. Controls and Procedures Forte's disclosure controls were ineffective as of December 31, 2022, due to a material weakness in income tax provision review, though financial statements are deemed fair Evaluation of Disclosure Controls and Procedures - Management, with CEO and CFO participation, evaluated the effectiveness of disclosure controls and procedures as of December 31, 2022[353] - Conclusion: Disclosure controls and procedures were not effective due to a material weakness in the review of the annual income tax provision[353] - Notwithstanding the material weakness, management believes the consolidated financial statements fairly represent the company's financial condition[354] Material Weakness in Internal Control over Financial Reporting - A material weakness is a deficiency that creates a reasonable possibility of a material misstatement in financial statements not being prevented or detected timely[355] - A material weakness was identified in controls related to the review of the annual income tax provision prepared by a third-party firm, specifically regarding the completeness and accuracy of deferred income taxes[356] Material Weakness Remediation - Forte plans to remediate the material weakness by augmenting staff and third-party resources for tax accounting review, strengthening the review process, and implementing additional procedures[357] - The company cannot assure investors that these measures will significantly improve or remediate the identified material weakness[357] Changes in Internal Control over Financial Reporting - Except for the material weakness described, there were no other changes in internal control over financial reporting during the fiscal quarter ended December 31, 2022, that materially affected or are reasonably likely to materially affect internal control over financial reporting[360] Attestation Report of the Registered Public Accounting Firm - As a smaller reporting company and non-accelerated filer, Forte is not required to provide an attestation report on its internal control over financial reporting from its independent registered public accounting firm[361] Inherent Limitations on Effectiveness of Controls - Management believes disclosure controls and internal control over financial reporting provide reasonable assurance but acknowledge inherent limitations, meaning they may not prevent all errors or fraud[362] - Control systems are subject to resource constraints, human judgment errors, circumvention by individuals or collusion, and management override[362] Item 9B. Other Information This item contains no additional information - There is no other information to disclose under this item[363] Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to Forte Biosciences, Inc - Disclosure regarding foreign jurisdictions that prevent inspections is not applicable[364] PART III Item 10. Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance, including the Code of Conduct, is incorporated by reference from the company's Definitive Proxy Statement - Information for this item is incorporated by reference from the Definitive Proxy Statement for the Annual Meeting of Stockholders[366] - The company has adopted a Business and Ethics Code of Conduct, available on its website, applicable to officers, directors, and employees[366] Item 11. Executive Compensation Information regarding executive compensation is incorporated by reference from the company's Definitive Proxy Statement - Information for this item is incorporated by reference from the Definitive Proxy Statement[367] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information regarding security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from the company's Definitive Proxy Statement - Information for this item is incorporated by reference from the Definitive Proxy Statement[368] Item 13. Certain Relationships and Related Transactions, and Director Independence Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's Definitive Proxy Statement - Information for this item is incorporated by reference from the Definitive Proxy Statement[369] Item 14. Principal Accounting Fees and Services Information regarding principal accounting fees and services is incorporated by reference from the company's Definitive Proxy Statement - Information for this item is incorporated by reference from the Definitive Proxy Statement[370] PART IV Item 15. Exhibits, Financial Statement Schedules This section lists exhibits and financial statement schedules, with certain documents incorporated by reference and schedules omitted if information is elsewhere or not applicable - This item lists documents filed as part of the Annual Report, including exhibits incorporated by reference[373] - Financial statements and supplementary data are included after the Signatures page[375] - Financial Statement Schedules are omitted because the required information is included in the financial statements or notes, or they are not applicable[375] Item 16. Form 10-K Summary The company has elected not to include a Form 10-K Summary - The company has elected not to include a summary for Form 10-K[381]