BeiGene(BGNE) - 2019 Q4 - Annual Report

Part I Business BeiGene is a global biotechnology company focused on developing and commercializing innovative oncology therapeutics, leveraging its R&D and commercial capabilities in the U.S. and China Overview BeiGene has evolved into a fully-integrated global biotechnology firm with significant commercial, manufacturing, and R&D capabilities - BeiGene has evolved from a research and development company into a fully-integrated global biotechnology firm with significant commercial, manufacturing, and R&D capabilities[10] - The company is currently marketing two internally-developed drugs (BRUKINSA™ and tislelizumab) and three in-licensed drugs (ABRAXANE®, REVLIMID®, and VIDAZA®)[11] - BeiGene's clinical development team consists of over 1,100 people managing more than 60 clinical trials, which have enrolled over 7,500 patients and subjects[12] - A strategic collaboration was formed with Amgen in October 2019 to commercialize Amgen's oncology products in China and co-develop up to 20 of Amgen's pipeline products[13] Our Strategy The company's strategy focuses on maximizing its wholly-owned drugs, leveraging global capabilities, expanding its portfolio through collaborations, and pursuing global growth via China's market - Realize the large commercial opportunities for its wholly-owned drugs, BRUKINSA (zanubrutinib) and tislelizumab, targeting the global BTK inhibitor and PD-1 antibody markets[14][15][16] - Utilize its strategic clinical and commercial capabilities, particularly its 1,100-person global oncology development team and over 900-person commercial team in China, to capitalize on regulatory reforms and improved national reimbursement[17] - Expand its portfolio by leveraging its China-inclusive development and commercial capabilities to secure collaborations and licensing opportunities, such as the one with Amgen[18] - Pursue a new model for global growth by leveraging the large patient population and expanding reimbursement in China to support R&D investment, enabling broader worldwide access with more affordable pricing[19] Our Commercial Products This section details BeiGene's portfolio of commercialized oncology products, including internally developed and in-licensed drugs, along with their indications, mechanisms, and regulatory status Commercial Product Portfolio Summary | PRODUCT | LEAD INDICATIONS | MECHANISM OF ACTION | REGULATORY STATUS | BEIGENE COMMERCIAL RIGHTS | PARTNER | | :--- | :--- | :--- | :--- | :--- | :--- | | BRUKINSA | R/R mantle cell lymphoma | BTK inhibitor | Approved in the United States | Global | N/A | | tislelizumab | R/R classical Hodgkin's lymphoma | Anti-PD-1 antibody | Approved in China | Global | N/A | | ABRAXANE | Breast cancer | Microtubule inhibitor | Approved in China | Mainland China | BMS | | REVLIMID | Multiple myeloma | Anti-angiogenesis, immuno-modulation | Approved in China | Mainland China | BMS | | VIDAZA | Myelodysplastic syndromes, AML, CMML | DNA hypomethylation | Approved in China | Mainland China | BMS | | XGEVA | Giant cell tumor of bone | Anti-RANK ligand antibody | Approved in China | Mainland China | Amgen | | KYPROLIS | Multiple myeloma | Proteasome inhibitor | NDA filed in China | Mainland China | Amgen | | BLINCYTO | Acute lymphocytic leukemia | Anti-CD19 x antiCD3 bispecific (BiTE) antibody | NDA filed in China | Mainland China | Amgen | | SYLVANT | Idiopathic multicentric Castleman disease | IL-6 antagonist | Fast track listed in China | Greater China | EUSA | | QARZIBA | High-risk neuroblastoma | Anti-GD2 antibody | Fast track listed in China | Mainland China | EUSA | Our Pipeline Products BeiGene's pipeline includes internally-discovered late-stage assets like zanubrutinib, tislelizumab, and pamiparib, alongside early-stage candidates and in-licensed products from collaborations - The internally-discovered pipeline is led by late-stage assets zanubrutinib (BTK inhibitor), tislelizumab (PD-1 antibody), and pamiparib (PARP inhibitor), which are being evaluated in numerous pivotal trials across various cancer indications[54] - Early-stage internally-developed clinical candidates include lifirafenib (RAF Dimer), BGB-A333 (PD-L1), BGB-A425 (TIM-3), BGB-A1217 (TIGIT), and BGB-11417 (Bcl-2)[54] - The in-licensed pipeline includes multiple candidates from a collaboration with Amgen, such as AMG 510 (KRAS G12C inhibitor), and candidates from collaborations with Mirati (Sitravatinib) and Zymeworks (ZW25, ZW49)[56][57] Manufacturing and Supply BeiGene operates manufacturing facilities in China for small molecule and biologics, while also relying on third-party Contract Manufacturing Organizations for global supply - BeiGene operates an 11,000 square meter manufacturing facility in Suzhou, China for small molecule and biologics clinical supply, with plans for commercial supply[141] - A commercial-scale biologics manufacturing facility is being built in Guangzhou, China through a joint venture, with the initial phase completed in September 2019, expected to manufacture tislelizumab[142] - The company relies on third-party Contract Manufacturing Organizations (CMOs) for production, including Catalent for BRUKINSA supply outside of China and Boehringer Ingelheim for tislelizumab supply in China[143][144] Collaborations BeiGene engages in strategic collaborations, notably with Amgen for commercialization and co-development, and with BMS for exclusive distribution rights in mainland China - A strategic collaboration with Amgen, effective January 2, 2020, involves commercializing Amgen's oncology products (XGEVA, KYPROLIS, BLINCYTO) in China and co-funding the global development of 20 Amgen pipeline products, with BeiGene contributing up to $1.25 billion[149][150] - In connection with the Amgen collaboration, Amgen purchased approximately 20.5% of BeiGene's outstanding shares for $2.78 billion[153] - BeiGene holds an exclusive 10-year license from BMS (formerly Celgene) to distribute and promote ABRAXANE, REVLIMID, and VIDAZA in mainland China, effective since August 2017[157][158] Intellectual Property The company protects its drugs and candidates through patents in the U.S. and China, and relies on trade secrets and confidentiality for other aspects of its business - As of January 29, 2020, the company owned 25 issued U.S. patents and 11 issued China patents, along with numerous pending applications internationally to protect its drugs and drug candidates[161] Key Patent Expirations for Internally Developed Drugs | Molecule | Territory | General Subject Matter | Expiration¹ | | :--- | :--- | :--- | :--- | | BRUKINSA™ (Zanubrutinib) | U.S. & China | Compound and composition | 2034 | | Tislelizumab | U.S. & China | Antibodies | 2033 | | Pamiparib | U.S. & China | Compound and composition | 2031 | - The company relies on trade secrets, know-how, and confidentiality agreements to protect aspects of its business not covered by patents, such as manufacturing processes[160][168] Government Regulation The company's operations are subject to extensive and evolving government regulations in the U.S. (FDA) and China (NMPA), covering drug approval, expedited programs, and pricing policies - In the U.S., the FDA regulates drugs and biologics, requiring a rigorous process of preclinical studies and multi-phase clinical trials before an NDA or BLA can be approved for marketing[171][173] - The FDA offers expedited programs such as Fast Track, Accelerated Approval, Breakthrough Designation, and Priority Review to facilitate the development and review of drugs for serious conditions, with Zanubrutinib receiving multiple such designations[194][197][201][203] - In the PRC, the NMPA is the primary regulator, with the revised Drug Administration Law (rDAL) effective December 2019 implementing a nationwide Marketing Authorization Holder (MAH) system, strengthening life-cycle management, and increasing penalties for violations[234][235][236] - China has implemented policies to expedite drug approvals, including accepting foreign clinical trial data, a priority review program for innovative drugs, and a volume-based centralized procurement program to control drug prices[252][268][293] Risk Factors The company faces significant risks including commercialization challenges, uncertain clinical development, extensive government regulation, financial losses, intellectual property issues, reliance on third parties, operational complexities, and specific risks related to doing business in China Risks Related to Commercialization Commercial success is uncertain due to market acceptance challenges, competition from established players, and the company's limited experience in drug launch and marketing - The commercial success of the company's drugs depends on achieving market acceptance from physicians, patients, and payors, which is uncertain due to competition from established treatments and other novel products[326][327] - With limited experience in launching and marketing drugs, the company's ability to generate substantial revenue is at risk if it cannot effectively build its sales capabilities or secure successful third-party collaborations[330][335] - The company faces substantial competition from major pharmaceutical and biotechnology companies with greater financial resources and expertise, which could result in competitors developing or commercializing drugs more successfully[338][342] Risks Related to Clinical Development and Regulatory Approval Drug development is long, expensive, and uncertain, with risks of trial failures, non-predictive early-stage results, and delays due to patient enrollment difficulties - The company's business is highly dependent on the successful clinical development and regulatory approval of its drug candidates, a process that is long, expensive, and has an uncertain outcome[369][370] - Results from early-stage clinical trials may not be predictive of later-stage trial outcomes, and drug candidates may fail to demonstrate the required safety and efficacy, leading to significant setbacks[374] - Difficulties in enrolling a sufficient number of patients in clinical trials could cause delays, increase costs, and adversely affect the development timeline for drug candidates[381][382] Risks Related to Extensive Government Regulation The pharmaceutical industry is heavily regulated, and non-compliance can lead to sanctions, while adverse events or unfavorable reimbursement policies could harm commercial prospects - The pharmaceutical industry is heavily regulated in all jurisdictions, and failure to comply with complex and evolving requirements can lead to significant sanctions, including refusal to approve applications, withdrawal of approvals, or product recalls[385][387] - Undesirable adverse events from drug candidates could halt clinical trials, delay or prevent regulatory approval, or result in a restrictive label, significantly harming commercial prospects[403][404] - The availability of reimbursement and favorable pricing from government and third-party payors is critical for commercial success but is not guaranteed and is subject to increasing cost-containment pressures and legislative changes[420][423][424] Risks Related to Our Financial Position and Need for Additional Capital The company has a history of net losses and may require additional financing, while also being exposed to foreign currency exchange risk, particularly with the RMB - The company has a history of significant net losses, with an accumulated deficit of $2.0 billion as of December 31, 2019, and anticipates continued losses as it expands R&D and commercialization efforts[444][445] - The company may need to obtain additional financing to fund its operations, and an inability to do so on acceptable terms could force it to delay, reduce, or eliminate development programs or commercialization efforts[449][453] - Operations are exposed to foreign currency exchange risk, particularly fluctuations in the RMB against the U.S. dollar, which could result in losses and reduce the value of investments[459][461] Risks Related to Our Intellectual Property Protecting intellectual property is crucial but challenging due to the expensive and uncertain patent process, global enforcement difficulties, and potential infringement lawsuits - The company's success depends on its ability to obtain and maintain patent protection for its drugs, but the patent process is expensive and uncertain, and patents may be challenged, invalidated, or circumvented by competitors[470][471][477] - Protecting intellectual property rights globally is difficult and costly, as the laws of some countries, including China, may not protect these rights as robustly as U.S. law[482][484] - The company may face lawsuits from third parties claiming infringement of their intellectual property rights, which could be costly, time-consuming, and could prevent the commercialization of its products[490][491] Risks Related to Our Reliance on Third Parties Reliance on third-party distributors, manufacturers, and CROs exposes the company to risks of supply shortages, quality issues, and delays in regulatory approval or commercialization - The company relies on third-party distributors for its approved drugs, and any failure to maintain an effective distribution channel could adversely affect sales and business operations[511][512] - Reliance on a limited number of third-party manufacturers for commercial and clinical drug supplies exposes the company to risks of supply shortages, quality issues, and compliance failures with GMP requirements[515][517] - The company depends on third-party CROs to conduct preclinical studies and clinical trials, and if these parties fail to perform their duties successfully or meet deadlines, regulatory approval and commercialization could be delayed or prevented[524][525] Risks Related to Our Industry, Business and Operations Operational risks include retaining key personnel, managing rapid growth, vulnerability to IT security breaches, and disruptions from public health crises like COVID-19 - Future success is highly dependent on retaining key executives and attracting qualified scientific, clinical, and commercial personnel in a competitive industry[541][542] - The company has grown rapidly, increasing its employee count by approximately 62% in 2019, and may experience difficulties in managing this growth, which imposes significant responsibilities on management[547][548] - Internal IT systems and those of third-party collaborators are vulnerable to security breaches and failures, which could disrupt development programs and compromise sensitive data[574][575] - Business operations are subject to disruption from public health crises, such as the COVID-19 outbreak, which could negatively impact clinical trials, regulatory interactions, and commercial revenue[592][594] Risks Related to Doing Business in the PRC Operating in China involves risks from highly regulated and changing pharmaceutical laws, uncertainties in legal enforcement, potential PRC resident enterprise tax status, and limited PCAOB audit inspections - The pharmaceutical industry in China is highly regulated and subject to significant changes, which could increase compliance costs or delay commercialization of drugs[616][617] - Uncertainties in the interpretation and enforcement of PRC laws, including the new Foreign Investment Law, could adversely affect business operations and increase compliance costs[621][622][625] - The company may be treated as a PRC resident enterprise for tax purposes, which could subject it to PRC income tax on its worldwide income and subject foreign investors to PRC tax on dividends and capital gains[641][642][645] - The company's auditor is not fully inspected by the PCAOB due to its substantial operations in the PRC, which could deprive investors of the benefits of such inspections and lead to a loss of confidence in financial reporting[654][655][656] Risks Related to Our American Depositary Shares and Ordinary Shares The trading prices of the company's shares are highly volatile, shareholders may have fewer rights as a Cayman Islands company, and significant insider control could deter changes in control - The trading prices of the company's ordinary shares and ADSs can be highly volatile due to a variety of factors, including clinical trial results, regulatory decisions, and market conditions[662][663][664] - As a Cayman Islands company, shareholders may have fewer rights and face more difficulties in protecting their interests compared to shareholders of U.S. or Hong Kong corporations[678][679] - The company's directors, executive officers, and principal shareholders control a significant percentage of outstanding shares, allowing them to exert substantial influence over corporate matters, which could discourage a change in control[710][711] - The company may be classified as a Passive Foreign Investment Company (PFIC) in future taxable years, which could result in adverse U.S. federal income tax consequences for U.S. shareholders[712][713] Properties The company primarily leases its global office and laboratory facilities, with owned properties including a manufacturing site in Guangzhou and offices in Changping, Beijing - The company leases most of its facilities, with major locations in Beijing, Shanghai, Suzhou, and Guangzhou in China; Cambridge, MA, Ridgefield Park, NJ, and Emeryville/San Mateo, CA in the U.S.; and Basel, Switzerland[719] - Owned facilities include the manufacturing site in Guangzhou, China, and the offices and laboratories in Changping, Beijing[719] Legal Proceedings As of the report date, BeiGene is not a party to any legal proceedings expected to have a material adverse effect on its business or financial condition - As of the report date, BeiGene is not involved in any material legal proceedings[721] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities BeiGene's ADSs trade on NASDAQ and ordinary shares on HKEX, with the company intending to retain all earnings for business development rather than paying cash dividends Security Trading Information | Security | Trading Symbol | Exchange | | :--- | :--- | :--- | | American Depositary Shares (ADSs) | BGNE | The NASDAQ Global Select Market | | Ordinary Shares | 06160 | The Stock Exchange of Hong Kong Limited | - The company has adopted a dividend policy stating its intention to retain all available funds and earnings for business development and does not anticipate paying cash dividends in the foreseeable future[726][727] Selected Consolidated Financial Data The company's selected financial data shows significant revenue growth from $1.1 million in 2016 to $428.2 million in 2019, accompanied by increased R&D expenses and widening net losses Selected Consolidated Financial Data (in thousands of U.S. Dollars) | | 2019 | 2018 | 2017 | 2016 | 2015 | | :--- | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $428,212 | $198,220 | $238,387 | $1,070 | $8,816 | | Research and development | $(927,338) | $(679,005) | $(269,018) | $(98,033) | $(58,250) | | Loss from operations | $(959,891) | $(705,769) | $(98,457) | $(117,060) | $(56,745) | | Net loss | $(950,578) | $(674,033) | $(93,299) | $(119,217) | $(57,102) | | Total assets | $1,612,289 | $2,249,684 | $1,046,479 | $405,813 | $116,764 | | Total liabilities | $633,934 | $496,037 | $362,248 | $52,906 | $42,445 | Management's Discussion and Analysis of Financial Condition and Results of Operations Total revenues increased by 116% to $428.2 million in 2019, driven by product and collaboration revenue, while operating expenses rose 54% to $1.39 billion, resulting in a net loss of $950.6 million, with strong liquidity bolstered by a $2.8 billion Amgen infusion Results of Operations Total revenues increased by 116% in 2019 due to product and collaboration revenue, while R&D and SG&A expenses significantly rose, leading to a 41% increase in net loss Comparison of Results of Operations for Years Ended Dec 31, 2019 and 2018 (in thousands) | | 2019 | 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $428,212 | $198,220 | $229,992 | 116% | | Product revenue, net | $222,596 | $130,885 | $91,711 | 70% | | Collaboration revenue | $205,616 | $67,335 | $138,281 | 205% | | Total Expenses | $(1,388,103) | $(903,989) | $(484,114) | 54% | | Cost of sales - product | $(71,190) | $(28,705) | $(42,485) | 148% | | Research and development | $(927,338) | $(679,005) | $(248,333) | 37% | | Selling, general and administrative | $(388,249) | $(195,385) | $(192,864) | 99% | | Loss from operations | $(959,891) | $(705,769) | $(254,122) | 36% | | Net loss | $(950,578) | $(674,033) | $(276,545) | 41% | - The increase in collaboration revenue was primarily due to a $150.0 million payment received upon the termination of the tislelizumab collaboration agreement with BMS[779] - The 37% increase in R&D expense was driven by the advancement of clinical programs for zanubrutinib and tislelizumab and increased internal R&D personnel costs[782][783][785] - The 99% increase in SG&A expense was mainly due to hiring more personnel to support the expansion of commercial organizations in China and the U.S., and increased external selling and marketing expenses[786] Liquidity and Capital Resources The company ended 2019 with $985.5 million in cash and investments, further strengthened by a $2.8 billion Amgen infusion in January 2020, expected to fund operations for at least 12 months Cash Flow Summary (in thousands) | | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(750,269) | $(547,717) | | Net cash provided by (used in) investing activities | $554,163 | $(637,613) | | Net cash provided by financing activities | $85,680 | $1,690,537 | - As of December 31, 2019, the company had $985.5 million in cash, cash equivalents, restricted cash, and short-term investments[792] - On January 2, 2020, the company received approximately $2.8 billion from the sale of ADSs to Amgen in connection with their strategic collaboration[792] - The company expects existing cash and investments, including the Amgen proceeds, to be sufficient to fund operating expenses and capital expenditures for at least the next 12 months[807] Critical Accounting Policies Key accounting policies include revenue recognition (ASC 606) for product sales and collaborations, expensing R&D costs as incurred, and recognizing share-based compensation (ASC 718) based on fair value - Revenue Recognition (ASC 606): Revenue is recognized when a customer obtains control of goods or services, occurring upon delivery for product sales, and involving identification and allocation for distinct performance obligations in collaborations[824][826][830] - Research and Development Expenses: R&D costs are expensed as incurred, clinical trial costs are accrued based on estimates, and upfront/pre-commercial milestone payments for acquired in-process R&D are expensed immediately if they have no alternative future use[838][839][842] - Share-Based Compensation (ASC 718): Equity awards are recognized based on their grant-date fair value using a binomial option-pricing model, requiring subjective assumptions, with compensation expense recorded net of estimated forfeitures[843][848][849] Quantitative and Qualitative Disclosures About Market Risk The company's market risks include interest rate risk impacting investments, credit risk managed through reputable institutions, and foreign currency exchange rate risk, particularly from RMB fluctuations - The primary market risk is from fluctuations in interest rates, which affect the value of the company's cash equivalents and short-term investments, with a hypothetical 100-basis point change impacting the portfolio's fair value by $1.1 million as of December 31, 2019[857] - The company is exposed to foreign currency exchange risk, primarily from the fluctuation of the Chinese RMB against the U.S. dollar, as a significant portion of operations are in the PRC[861][862] - Credit risk is associated with cash, cash equivalents, and short-term investments deposited in various financial institutions, mitigated by using major reputable institutions and investing in high-quality securities[856] Financial Statements and Supplementary Data This section presents the company's audited consolidated financial statements and notes for 2017-2019, along with the independent auditor's unqualified opinions on both the financial statements and internal control over financial reporting Report of Independent Registered Public Accounting Firm Ernst & Young Hua Ming LLP issued unqualified opinions on the consolidated financial statements and internal control over financial reporting, highlighting R&D expense accrual as a critical audit matter - The independent auditor, Ernst & Young Hua Ming LLP, issued an unqualified opinion on the consolidated financial statements, stating they present fairly, in all material respects, the financial position and results of operations in conformity with U.S. GAAP[885] - The auditor also issued an unqualified opinion on the company's internal control over financial reporting as of December 31, 2019, based on the COSO framework[894] - The audit identified the accrual of research and development expenses as a critical audit matter due to the significant management judgments and estimates required in determining the accrued balances for outsourced service providers[890][892] Consolidated Financial Statements This section provides the company's consolidated balance sheets, statements of operations, and cash flows, offering a comprehensive overview of its financial performance and position Consolidated Balance Sheet Highlights (As of Dec 31, in thousands) | | 2019 | 2018 | | :--- | :--- | :--- | | Total Assets | $1,612,289 | $2,249,684 | | Cash, cash equivalents, and restricted cash | $620,775 | $740,713 | | Short-term investments | $364,728 | $1,068,509 | | Total Liabilities | $633,934 | $496,037 | | Total Equity | $978,355 | $1,753,647 | Consolidated Statement of Operations Highlights (Year Ended Dec 31, in thousands) | | 2019 | 2018 | 2017 | | :--- | :--- | :--- | | Total Revenues | $428,212 | $198,220 | $238,387 | | Loss from operations | $(959,891) | $(705,769) | $(98,457) | | Net loss | $(950,578) | $(674,033) | $(93,299) | Consolidated Cash Flow Highlights (Year Ended Dec 31, in thousands) | | 2019 | 2018 | 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | $(750,269) | $(547,717) | $12,752 | | Net cash provided by (used in) investing activities | $554,163 | $(637,613) | $(356,319) | | Net cash provided by financing activities | $85,680 | $1,690,537 | $490,356 | Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019, with no material changes during the fourth quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[867][868] - Management's assessment concluded that the company maintained effective internal control over financial reporting as of December 31, 2019, based on the COSO framework[869][870] - No changes in internal control over financial reporting occurred during the fourth quarter of 2019 that have materially affected, or are reasonably likely to materially affect, internal controls[872] Part III Part III of this Annual Report on Form 10-K, covering Items 10 through 14, incorporates information by reference from the company's definitive proxy statement, which will be filed with the SEC within 120 days of the fiscal year-end. These items relate to Directors, Executive Officers, and Corporate Governance; Executive Compensation; Security Ownership; Certain Relationships and Related Transactions; and Principal Accounting Fees and Services Directors, Executive Officers and Corporate Governance The information required for this item is incorporated by reference from the company's definitive proxy statement to be filed with the SEC - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the definitive proxy statement[874] Executive Compensation The information required for this item is incorporated by reference from the company's definitive proxy statement to be filed with the SEC - Information regarding executive compensation is incorporated by reference from the definitive proxy statement[875] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required for this item is incorporated by reference from the company's definitive proxy statement to be filed with the SEC - Information regarding security ownership is incorporated by reference from the definitive proxy statement[876] Certain Relationships and Related Transactions, and Director Independence The information required for this item is incorporated by reference from the company's definitive proxy statement to be filed with the SEC - Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the definitive proxy statement[877] Principal Accounting Fees and Services The information required for this item is incorporated by reference from the company's definitive proxy statement to be filed with the SEC - Information regarding principal accounting fees and services is incorporated by reference from the definitive proxy statement[878] Part IV Exhibits, Financial Statement Schedules This section lists the financial statements and exhibits filed as part of the Annual Report, with financial statement schedules omitted as they are not applicable - The financial statements are filed as part of this Annual Report, and the Exhibit Index lists all filed exhibits[880][881] - No financial statement schedules have been filed as they are not applicable or the required information is included in the financial statements or notes[880]