Amicus Therapeutics(FOLD) - 2023 Q4 - Annual Report

PART I BUSINESS OVERVIEW Amicus Therapeutics is a global biotechnology company focused on rare diseases, marketing Galafold and Pombiliti + Opfolda - Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases[23] - The company's strategy is to create, manufacture, test, and deliver high-quality medicines for rare diseases through internally developed, jointly developed, acquired, or in-licensed products and product candidates, leveraging global capabilities to broaden franchises in Fabry and Pompe disease[24] - Pombiliti + Opfolda received regulatory approvals in 2023 in the E.U. (June), U.K. (August), and U.S. (September)[25] - Total cash, cash equivalents, and marketable securities as of December 31, 2023, was $286.2 million[25] 2023 Commercial Product Revenue Highlights | Product | 2023 Revenue (Millions USD) | Change from Prior Year (Millions USD) | | :-------- | :-------------------------- | :----------------------------------- | | Galafold | $387.8 | +$58.7 | | Pombiliti + Opfolda | $11.6 | N/A | Commercial Products and Product Candidates Details marketed therapies Galafold and Pombiliti + Opfolda for Fabry and Pompe diseases, and next-generation genetic medicines - Galafold (migalastat HCl) is an oral precision medicine for Fabry disease, granted accelerated approval by the FDA in August 2018 and approved in the E.U. and U.K. in May 2016, approved in over 40 countries[25] - Pombiliti + Opfolda (cipaglucosidase alfa-atga/miglustat) is a novel treatment for late-onset Pompe disease, approved in 2023 in the U.S., E.U., and U.K., consisting of an engineered rhGAA enzyme with an enzyme stabilizer[31] - The company is pursuing discovery for next-generation genetic medicines for both Fabry and Pompe diseases[26][32] - Fabry disease is an X-linked lysosomal storage disorder caused by GLA gene mutations, leading to alpha-Gal A enzyme deficiency and accumulation of GL-3 and lyso-Gb3, with recent newborn screening studies suggesting a higher incidence rate than historically estimated[27][28] - Pompe disease is a lysosomal storage disorder resulting from GAA enzyme deficiency, causing glycogen accumulation and progressive muscle weakness, with an estimated 5,000-10,000 patients worldwide[33][34] Strategic Alliances and Arrangements The company evaluates collaborations and acquisitions to enhance resources for rare and orphan diseases - The company evaluates business development opportunities, including collaborations, alliances, partnerships, strategic out-licensing, or acquisitions, to enhance financial, technical, clinical, and commercial resources for rare and orphan diseases[36] Intellectual Property Protects proprietary position through U.S. and foreign patents, covering compositions, methods, and combination therapies - The company protects its proprietary position through U.S. and foreign patent applications covering compositions of matter, methods of manufacture, methods of use, combination therapies, dosing, formulations, and screening methods, as well as trade secrets and know-how[37] - Issued U.S. patents for Galafold's active ingredient, migalastat, expire between 2027 and 2042, while patents for Opfolda and Pombiliti expire between 2033 and 2037[39] - In 2022, the company initiated Hatch-Waxman litigation against Teva, Aurobindo, and Lupin for alleged infringement of Orange Book-listed patents related to generic Galafold[41] Collaboration and License Agreements Outlines key agreements, including a license with Penn for gene therapy and an agreement with GSK for Galafold - A license agreement with the University of Pennsylvania grants rights for pre-clinical research and development of next-generation parvovirus gene therapy products for Pompe and Fabry diseases, with Penn eligible for up to $86.5 million in milestone and royalty payments per indication[44][500] - An agreement with GlaxoSmithKline (GSK) grants global rights to develop and commercialize Galafold, with GSK eligible for up to $40 million in post-approval and sales-based milestones, plus tiered royalties[45][501] Manufacturing Relies on contract manufacturers for active biopharmaceutical ingredients and finished goods, produced under cGMP - The company relies on contract manufacturers for active biopharmaceutical ingredients and finished goods, which are produced under current Good Manufacturing Practice (cGMP)[46] Competition The biotechnology and pharmaceutical industries are highly competitive, with efficacy, safety, convenience, and price as key factors - The biotechnology and pharmaceutical industries are highly competitive, with competition from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology, and gene therapy companies[47] - Key competitive factors include efficacy, safety, convenience, and price of products[50] Major Competitors and Products (2023 Sales) | Competitor | Indication | Product | Class of Product | Status | 2023 Sales (Millions) | | :--------- | :--------- | :------ | :--------------- | :----- | :-------------------- | | Sanofi | Fabry Disease | Fabrazyme | ERT | Marketed | €991 | | Sanofi | Pompe Disease | Myozyme / Lumizyme | ERT | Marketed | €783 | | Sanofi | Pompe Disease | Nexviazyme / Nexviadyme | ERT | Marketed | €425 | | Takeda | Fabry Disease | Replagal | ERT | Marketed | ¥71,300 | | Chiesi | Fabry Disease | ELFABRIO | ERT | Marketed | $14.7 | Government Regulation Biopharmaceutical products are subject to extensive FDA regulation, including clinical trials, approval pathways, and fraud and abuse laws - Biopharmaceutical products in the U.S. are subject to extensive FDA regulation, including preclinical testing, IND submission, clinical trials (Phases 1-3), NDA/BLA approval, and post-market monitoring[53][54][58][59][62] - The Hatch-Waxman Act provides for patent term extension and an abbreviated pathway (ANDA) for generic drug approval, which involves certifying against listed patents[66][67][68] - Orphan drug designation is granted for drugs treating rare diseases (fewer than 200,000 individuals in the U.S.), providing 7 years of market exclusivity in the U.S. and 10 years in the E.U. and U.K. for the designated indication[75][98] - Expedited review pathways like Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval are available for drugs treating serious conditions or fulfilling unmet medical needs[77][79][80][81] - The company's activities are subject to various federal and state fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act, HIPAA, and Physician Payments Sunshine Act, as well as foreign equivalents[87][88][93] - U.S. healthcare reform, including the Affordable Care Act and the Inflation Reduction Act of 2022 (IRA), impacts drug pricing and reimbursement, though orphan drugs for a single rare disease are currently exempt from IRA's negotiation program[107][108][111] Human Capital Amicus Therapeutics employs 517 full-time staff, committed to an inclusive workplace, transparent communication, and robust training - As of December 31, 2023, Amicus Therapeutics had 517 full-time employees, with 58% of the global workforce, 31% of executive management, and 30% of the Board of Directors being women[114] - The company is committed to fostering an inclusive workplace, supporting employee engagement through transparent communication, and providing robust training on its code of conduct, including anti-bribery and anti-corruption policies[113][115][116][117] Corporate Information Amicus Therapeutics, Inc. was incorporated in Delaware in 2002, with global headquarters in Princeton, NJ - Amicus Therapeutics, Inc. was incorporated in Delaware on February 4, 2002, with its global headquarters in Princeton, NJ[119] RISK FACTORS Significant risks include dependence on Galafold sales, regulatory delays, intense competition, financial losses, and IP challenges - The company heavily depends on sales of Galafold, and any delays in commercialization, market acceptance issues, or generic competition could materially harm its business[19][123] - Failure or delays in obtaining regulatory approvals for products and product candidates (Galafold, Pombiliti + Opfolda, gene therapies) would impair revenue generation, as the approval process is lengthy, expensive, and uncertain[19][126][127] - The company faces substantial competition from major pharmaceutical and biotechnology companies, many with greater resources, which could develop more effective, safer, or cheaper products[19][142][145] - Significant losses have been incurred since inception, and the company anticipates continued losses, requiring substantial additional capital that may not be available on acceptable terms and could lead to dilution or relinquishing rights[21][211][215][216] - Reliance on single-source third-party manufacturers, particularly WuXi Biologics in China for Pombiliti, exposes the company to supply chain disruptions, manufacturing issues, and geopolitical risks[21][147][190][208] - The company's intellectual property, including patents for Galafold and Pombiliti + Opfolda, is subject to challenges, litigation (e.g., Hatch-Waxman), and potential invalidation, which could allow competitors to market similar products[21][231][241][243] - Cybersecurity threats, computer system failures, and challenges in managing artificial intelligence use could disrupt operations, lead to data loss, and incur significant liabilities[274][275][276] UNRESOLVED STAFF COMMENTS No unresolved staff comments from the SEC - No unresolved staff comments[299] CYBERSECURITY The company's cybersecurity program, overseen by the Audit and Compliance Committee, integrates recognized frameworks - The Board of Directors' Audit and Compliance Committee oversees the company's cybersecurity program, which is integrated into the Enterprise Risk Management Program (ERMP) and based on NIST frameworks[300][305] - Key areas of the cybersecurity program include technical safeguards (firewalls, intrusion detection, access controls), periodic assessments and testing (audits, vulnerability testing), incident response and recovery planning, third-party risk management, and mandatory employee training[301][302] - As of December 31, 2023, the company is not aware of any cybersecurity threats that have materially affected or are reasonably likely to materially affect its business strategy, results of operations, or financial condition[304] - The Chief Information Officer (CIO), with over 24 years of experience in information technology and security, leads the implementation of the cybersecurity program[306] PROPERTIES Leases significant office and laboratory facilities in Philadelphia, Marlow, and Princeton, considered adequate for needs Significant Leased Properties (as of December 31, 2023) | Location | Approximate Square Feet | Use | Lease Expiry Date | | :--------- | :---------------------- | :---- | :---------------- | | Philadelphia, Pennsylvania, U.S. | 50,816 | Office and laboratory | September 2034 | | Marlow, United Kingdom | 36,796 | Office | August 2028 | | Princeton, New Jersey, U.S. | 29,972 | Office | January 2034 | - The company believes its current office and laboratory facilities are adequate and suitable for current and anticipated needs[308] LEGAL PROCEEDINGS Information on legal proceedings is incorporated by reference from Note 15 to the Consolidated Financial Statements - Information on legal proceedings is incorporated by reference to Note 15 'Legal Proceedings' of the Notes to Consolidated Financial Statements[310] MINE SAFETY DISCLOSURES No mine safety disclosures to report - No mine safety disclosures[311] PART II MARKET FOR COMMON EQUITY, STOCKHOLDER MATTERS, AND EQUITY PURCHASES Common stock trades on NASDAQ under 'FOLD', no cash dividends, and Q4 2023 issuer purchases for tax withholding - The company's common stock has been traded on the NASDAQ Global Market under the symbol 'FOLD' since May 31, 2007[314] - As of February 13, 2024, the closing price for common stock was $12.80 per share, with 17 holders of record[314] - The company has never declared or paid cash dividends and intends to retain future earnings for business development and growth[315] Cumulative Total Return (Indexed to $100) as of December 31, 2023 | Index | 12/31/2018 | 12/31/2019 | 12/31/2020 | 12/31/2021 | 12/31/2022 | 12/31/2023 | | :------------------------ | :--------- | :--------- | :--------- | :--------- | :--------- | :--------- | | Amicus Therapeutics, Inc. | $100 | $102 | $241 | $121 | $125 | $149 | | NASDAQ Composite | $100 | $135 | $194 | $236 | $157 | $223 | | NASDAQ Biotechnology | $100 | $124 | $156 | $155 | $137 | $146 | Issuer Purchases of Equity Securities (Q4 2023) | Period | Total Shares Purchased | Average Price Paid per Share | | :----------------------------------- | :--------------------- | :--------------------------- | | October 1, 2023 through October 31, 2023 | 47,887 | $10.46 | | November 1, 2023 through November 30, 2023 | 12,420 | $10.66 | | December 1, 2023 through December 31, 2023 | 38,804 | $13.61 | | Total | 99,111 | $11.72 | [RESERVED] This item is reserved and contains no information MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Increased net product sales in 2023, decreased R&D, increased SG&A, and a loss on debt extinguishment - Net product sales increased by $70.1 million in 2023 compared to 2022, primarily due to continued growth of Galafold and the commercial launch of Pombiliti + Opfolda[324] - Research and development costs decreased by $124.3 million, primarily due to the strategic deprioritization of the gene therapy portfolio and reduced clinical manufacturing costs for the Pompe disease program[325] - Selling, general, and administrative expenses increased by $62.2 million, mainly driven by personnel costs supporting the Pombiliti + Opfolda commercial launch and third-party professional fees[325] - The company recognized a $13.9 million loss on extinguishment of debt in 2023 due to the voluntary prepayment of the Senior Secured Term Loan due 2026[326] - As of December 31, 2023, the company had $286.2 million in cash, cash equivalents, and marketable securities[337] - The company believes its current cash position, including expected revenues, is sufficient to fund operations and ongoing research programs for at least the next 12 months[347] Consolidated Results of Operations (Years Ended December 31, in thousands) | Metric | 2023 | 2022 | Change | | :------------------------------------------ | :----- | :----- | :------- | | Net product sales | $399,356 | $329,233 | $70,123 | | Cost of goods sold | $37,326 | $38,599 | $(1,273) | | Cost of goods sold as % of net product sales | 9.3% | 11.7% | (2.4)% | | Research and development | $152,381 | $276,677 | $(124,296) | | Selling, general, and administrative | $275,270 | $213,041 | $62,229 | | Loss on extinguishment of debt | $13,933 | $0 | $13,933 | | Interest expense | $(50,149) | $(37,119) | $(13,030) | | Net loss attributable to common stockholders | $(151,584) | $(236,568) | $84,984 | Consolidated Results of Operations (Years Ended December 31, in thousands) | Metric | 2023 | 2022 | 2021 | | :------------------------------------------ | :----- | :----- | :----- | | Net product sales | $399,356 | $329,233 | $305,514 | | Gross profit | $362,030 | $290,634 | $271,048 | | Research and development | $152,381 | $276,677 | $272,049 | | Selling, general, and administrative | $275,270 | $213,041 | $192,710 | | Loss from operations | $(77,211) | $(212,120) | $(206,434) | | Net loss attributable to common stockholders | $(151,584) | $(236,568) | $(250,460) | | Net loss per common share (basic and diluted) | $(0.51) | $(0.82) | $(0.92) | Net Cash Flow Summary (Years Ended December 31, in thousands) | Activity | 2023 | 2022 | 2021 | | :----------------------------------- | :------- | :------- | :------- | | Net cash used in operating activities | $(69,091) | $(166,575) | $(202,491) | | Net cash provided by investing activities | $98,064 | $92,316 | $78,761 | | Net cash provided by (used in) financing activities | $61,677 | $(7,463) | $212,073 | Overview Amicus Therapeutics is a global biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases - Amicus Therapeutics is a global biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases, with marketed therapies Galafold for Fabry disease and Pombiliti + Opfolda for late-onset Pompe disease[321] Consolidated Results of Operations Details financial performance, including net product sales by product and geographic area, and R&D expenses Net Product Sales by Product (Years Ended December 31, in thousands) | Product | 2023 | 2022 | 2021 | | :-------------------- | :----- | :----- | :----- | | Galafold | $387,777 | $329,046 | $305,514 | | Pombiliti + Opfolda | $11,579 | $187 | $0 | | Total Net Product Sales | $399,356 | $329,233 | $305,514 | Net Product Sales by Geographic Area (Years Ended December 31, in thousands) | Geographic Area | 2023 | 2022 | 2021 | | :---------------- | :----- | :----- | :----- | | U.S. | $146,937 | $115,946 | $95,387 | | Ex-U.S. | $252,419 | $213,287 | $210,127 | | Total Net Product Sales | $399,356 | $329,233 | $305,514 | Research and Development Expenses by Project (Years Ended December 31, in thousands) | Project | 2023 | 2022 | | :-------------------------------- | :----- | :----- | | Galafold (Fabry Disease) | $12,928 | $15,012 | | Pombiliti + Opfolda (Pompe Disease) | $58,826 | $99,584 | | Gene therapy programs | $872 | $48,948 | | Pre-clinical and other programs | $1,681 | $124 | | Total third-party direct project expenses | $74,307 | $163,668 | | Personnel costs | $62,492 | $82,386 | | Other costs | $15,582 | $30,623 | | Total research and development costs | $152,381 | $276,677 | Critical Accounting Policies and Significant Judgments and Estimates Revenue recognition, inventory valuation, and fair value measurements are critical accounting policies - Revenue recognition involves estimating variable consideration (discounts and rebates) based on contractual arrangements, statutory obligations, historical experience, and customer mix, with revenue recognized when performance obligations are satisfied[331][332] - Inventories are stated at the lower of cost and net realizable value, with manufacturing costs expensed as R&D prior to regulatory approval and capitalized thereafter[415] - The company uses fair value measurements for certain assets and liabilities, classifying them into Level 1, 2, or 3 based on the observability of inputs[418][419] Liquidity and Capital Resources Liquidity supported by equity and debt offerings, with cash flow analysis detailing operating, investing, and financing activities - In 2023, the company generated $63.1 million net proceeds from its at-the-market (ATM) equity program and $387.4 million net proceeds from a new Senior Secured Term Loan due 2029, along with $29.8 million from a private placement of common stock[334][335] - Net cash used in operating activities was $69.1 million in 2023, a decrease from $166.6 million in 2022, primarily due to a lower net loss and changes in operating assets and liabilities[338][339] - Net cash provided by investing activities was $98.1 million in 2023, mainly from the sale and redemption of marketable securities, partially offset by new purchases and capital expenditures[341] - Net cash provided by financing activities was $61.7 million in 2023, reflecting proceeds from debt and equity offerings, partially offset by the repayment of the Senior Secured Term Loan due 2026[343] Contractual Obligations and Commitments Outlines financial obligations, including debt, operating leases, and milestone payments Contractual Obligations and Commitments (as of December 31, 2023, in millions USD) | Obligation Type | Amount | | :-------------------------- | :----- | | Senior Secured Term Loan due 2029 (incl. interest) | $623.4 | | Operating Lease Liabilities | $89.8 | | GSK Milestone Payments | $9.8 | | Purchase and Manufacturing Obligations | $126.2 | Recent Accounting Pronouncements Recent ASUs will impact future segment reporting and income tax disclosures - ASU No. 2023-07 (Segment Reporting) expands disclosure requirements for significant segment expenses, effective for fiscal years beginning after December 15, 2023[443] - ASU No. 2023-09 (Income Taxes) requires disaggregated income taxes paid and standardizes effective tax rate reconciliation components, effective for fiscal years beginning after December 15, 2024[444] QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Primary market risk exposures are to changes in interest rates and foreign currency exchange rates, with no hedging - The company's primary market risk exposure relates to changes in interest rates in its cash, cash equivalents, and marketable securities, and from its variable-rate Senior Secured Term Loan due 2029[353][354] - A hypothetical 100 basis point increase or decrease in the average interest rate on variable rate debts would result in a $4.1 million change in interest expense as of December 31, 2023[354] - The company faces foreign exchange risk from transactions denominated in non-U.S. dollar currencies, particularly impacting Galafold revenue, but does not currently engage in hedging activities[355] FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Includes management's report, independent auditor's reports, and consolidated financial statements with detailed notes - Management asserts the effectiveness of internal control over financial reporting as of December 31, 2023, based on COSO criteria[361] - Ernst & Young LLP, the independent registered public accounting firm, issued an unqualified opinion on the effectiveness of internal control over financial reporting and the fair presentation of the consolidated financial statements as of December 31, 2023[365][374][375] - A critical audit matter identified was the measurement of variable consideration for Ex-U.S. third-party discounts and rebates due to the volume and varying contractual terms[378][379][380] Consolidated Balance Sheets (as of December 31, in thousands) | Asset/Liability | 2023 | 2022 | | :------------------------------------------ | :----- | :----- | | Assets: | | | | Cash and cash equivalents | $246,994 | $148,813 | | Investments in marketable securities | $39,206 | $144,782 | | Accounts receivable | $87,632 | $66,196 | | Inventories | $59,696 | $23,816 | | Total current assets | $483,061 | $423,816 | | Total Assets | $777,880 | $724,167 | | Liabilities and Stockholders' Equity: | | | | Accrued expenses and other current liabilities | $144,245 | $93,636 | | Contingent consideration payable | $0 | $21,417 | | Total current liabilities | $167,689 | $139,018 | | Long-term debt | $387,858 | $391,990 | | Total liabilities | $617,706 | $601,120 | | Total stockholders' equity | $160,174 | $123,047 | | Total Liabilities and Stockholders' Equity | $777,880 | $724,167 | Consolidated Statements of Operations (Years Ended December 31, in thousands) | Metric | 2023 | 2022 | 2021 | | :------------------------------------------ | :----- | :----- | :----- | | Net product sales | $399,356 | $329,233 | $305,514 | | Gross profit | $362,030 | $290,634 | $271,048 | | Research and development | $152,381 | $276,677 | $272,049 | | Selling, general, and administrative | $275,270 | $213,041 | $192,710 | | Loss from operations | $(77,211) | $(212,120) | $(206,434) | | Net loss attributable to common stockholders | $(151,584) | $(236,568) | $(250,460) | | Net loss per common share (basic and diluted) | $(0.51) | $(0.82) | $(0.92) | Consolidated Statements of Cash Flows (Years Ended December 31, in thousands) | Activity | 2023 | 2022 | 2021 | | :------------------------------------------ | :------- | :------- | :------- | | Net cash used in operating activities | $(69,091) | $(166,575) | $(202,491) | | Net cash provided by investing activities | $98,064 | $92,316 | $78,761 | | Net cash provided by (used in) financing activities | $61,677 | $(7,463) | $212,073 | | Net increase (decrease) in cash, cash equivalents, and restricted cash | $96,962 | $(96,341) | $83,294 | | Cash, cash equivalents, and restricted cash at end of year | $250,077 | $153,115 | $249,456 | PART III CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE No changes in or disagreements with accountants on accounting and financial disclosure - There have been no changes in and disagreements with accountants on accounting and financial disclosure[507] CONTROLS AND PROCEDURES Management concluded disclosure controls and procedures were effective as of December 31, 2023, with no material changes - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2023[508] - No material changes in internal controls over financial reporting occurred during the fourth quarter of 2023[509] OTHER INFORMATION Director Margaret G. McGlynn adopted a Rule 10b5-1 Trading Plan in November 2023 for stock option exercise and share sales Rule 10b5-1 Trading Plan Activity (Q4 2023) | Name | Action Taken (Date) | Rule 10b5-1 Trading Plan Provides for | Duration of Trading Plan | Aggregate Number of Securities | | :---------------- | :------------------ | :------------------------------------ | :----------------------- | :----------------------------- | | Margaret G. McGlynn (Director) | Adoption (November 10, 2023) | Sale | June 12, 2024 | 15,000 | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS This item is not applicable to the company - This item is not applicable[513] DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE Information on directors, executive officers, and corporate governance is incorporated by reference from the company's Proxy Statement - Information on directors, executive officers, and corporate governance is incorporated by reference from the Proxy Statement[517] EXECUTIVE COMPENSATION Information regarding executive compensation is incorporated by reference from the company's Proxy Statement - Information on executive compensation is incorporated by reference from the Proxy Statement[518] SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS Information on security ownership and related stockholder matters is incorporated by reference from the company's Proxy Statement - Information on security ownership of certain beneficial owners and management and related stockholder matters is incorporated by reference from the Proxy Statement[518] CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE Information on certain relationships, related transactions, and director independence is incorporated by reference from the Proxy Statement - Information on certain relationships and related transactions and director independence is incorporated by reference from the Proxy Statement[519] PRINCIPAL ACCOUNTING FEES AND SERVICES Information regarding principal accounting fees and services is incorporated by reference from the company's Proxy Statement - Information on principal accounting fees and services is incorporated by reference from the Proxy Statement[519] PART IV EXHIBITS, FINANCIAL STATEMENT SCHEDULES Lists consolidated financial statements, confirms omission of schedules, and provides a comprehensive index of exhibits - The report includes Management's Report on Consolidated Financial Statements and Internal Control over Financial Reporting, Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Comprehensive Loss, Changes in Stockholders' Equity, Cash Flows, and Notes to Consolidated Financial Statements[522] - All consolidated financial statement schedules are omitted because they are not required or the information is included in the financial statements or notes[523] - A detailed list of exhibits, including equity distribution agreements, merger agreements, corporate charter documents, employment agreements, license agreements, and loan agreements, is provided, indicating whether they are incorporated by reference or filed with the Form 10-K[524][525][526][528] FORM 10-K SUMMARY The company has elected not to include a summary of information required by Form 10-K under this item - The company has elected not to include a summary of information required by Form 10-K[530]