Aptevo Therapeutics(APVO) - 2018 Q4 - Annual Report

markdown Part I [Item 1. Business](index=3&type=section&id=Item%201.%20Business) Aptevo Therapeutics develops oncology and hematology therapeutics using its ADAPTIR™ platform, supported by IXINITY® revenue [Overview and Strategy](index=3&type=section&id=Overview%20and%20Strategy) - Aptevo is a biotechnology company focused on developing novel therapeutics for oncology and hematology using its proprietary **ADAPTIR™ (modular protein technology) platform**[6](index=6&type=chunk) - The company was spun off from Emergent BioSolutions Inc. on **August 1, 2016**, to focus on development-based biotechnology[7](index=7&type=chunk) - Core strategies include advancing the **ADAPTIR platform** for cancer and autoimmune diseases, developing new products, forming collaborative partnerships for funding and pipeline expansion, and maximizing financial contribution from its marketed product, **IXINITY**, to fund R&D[9](index=9&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Platform Technology and Product Candidates](index=4&type=section&id=Platform%20Technology%20and%20Product%20Candidates) - The **ADAPTIR™ platform** creates monospecific and multispecific immunotherapeutic proteins, such as bispecific molecules, designed to engage immune cells to kill tumors. These molecules have structural advantages over monoclonal antibodies, including a long serum half-life and potentially reduced cytokine release[8](index=8&type=chunk)[13](index=13&type=chunk)[14](index=14&type=chunk) - **APVO436** is a bispecific candidate targeting CD123 and CD3 for hematological malignancies. A Phase 1/1b clinical trial in patients with **AML** and **MDS** commenced in **December 2018**[21](index=21&type=chunk)[22](index=22&type=chunk) - **APVO210** is a targeted cytokine therapeutic for autoimmune and inflammatory diseases like psoriasis and IBD. A Phase 1 clinical trial in healthy volunteers is planned to start in **March 2019**[23](index=23&type=chunk)[27](index=27&type=chunk) - **ALG.APV-527**, partnered with Alligator Bioscience, is a bispecific antibody targeting 4-1BB and 5T4 for various solid tumors. A Clinical Trial Authorization (CTA) filing is planned for **Q4 2019**[28](index=28&type=chunk) - In **2018**, the company discontinued the development programs for APVO414 (for prostate cancer) and otlertuzumab (for peripheral T-cell lymphoma) based on clinical trial results[31](index=31&type=chunk)[32](index=32&type=chunk) [Marketed Product: IXINITY](index=9&type=section&id=Marketed%20Product%3A%20IXINITY) - **IXINITY** is a recombinant human coagulation factor IX approved in the **U.S.** for adults and children (**12+**) with **Hemophilia B** for bleeding control and prevention[42](index=42&type=chunk) - Future plans for **IXINITY** include introducing a new **3,000 IU** assay size in **mid-2019**, commencing a Phase 4 pediatric study in **Q3 2019** to support label expansion, and exploring ex-**U.S.** distribution partnerships[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - The company relies on sole-source third-party manufacturers: **AGC Biologics** for drug substance, **Patheon** for fill-finish services, and **Rovi** for pre-filled syringes[46](index=46&type=chunk)[47](index=47&type=chunk)[50](index=50&type=chunk) - **IXINITY** competes with five other recombinant factor IX products in North America, including standard and enhanced half-life products from Pfizer, Shire, CSL Behring, Bioverativ, and Novo Nordisk[59](index=59&type=chunk) [Sale of Hyperimmune Business](index=12&type=section&id=Sale%20of%20Hyperimmune%20Business) - On **September 28, 2017**, Aptevo completed the sale of its Hyperimmune Business (**WinRho® SDF**, **HepaGam B®**, **VARIZIG®**) to **Saol International Limited**[60](index=60&type=chunk)[61](index=61&type=chunk) Transaction Details | Consideration Component | Amount (USD) | | :--- | :--- | | Upfront Payment | **$65.0 million** | | Escrow Amount (part of upfront) | **$3.3 million** | | Potential Milestone Payment | Up to **$7.5 million** | | Potential A/R Collection | Up to **$2.0 million** | | **Total Potential Consideration** | **Up to $74.5 million** | [Intellectual Property](index=13&type=section&id=Intellectual%20Property) - The company protects its **ADAPTIR platform** through a combination of patents and trade secrets, with patent applications filed in the **U.S.** and numerous other countries. Estimated patent expirations for the platform range from **June 2027 to September 2036**[68](index=68&type=chunk)[72](index=72&type=chunk) - **IXINITY**'s intellectual property is supported by patents licensed from the **University of North Carolina (UNC)** expiring around **2024-2028**, and the company's own patent portfolio with estimated expirations between **2026 and 2030**[52](index=52&type=chunk)[73](index=73&type=chunk) - Patent applications are pending for **APVO436**, while **APVO210** is supported by foundational patents and applications with estimated expirations in **2029-2030**[74](index=74&type=chunk)[75](index=75&type=chunk) [Regulation](index=14&type=section&id=Regulation) - The company's product development is subject to stringent regulation by the **FDA** and other global authorities, involving pre-clinical testing and a multi-phase clinical trial process (Phase 1-4) conducted under **Good Clinical Practice (GCP)**[78](index=78&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - Marketing approval for biologics requires submitting a **Biologics License Application (BLA)** to the **FDA**. The company may seek designations like **Fast Track**, **Breakthrough Therapy**, or **Orphan Drug** to expedite development and review[83](index=83&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - Sales are dependent on reimbursement from third-party payors. The company must comply with various **U.S.** government pricing programs, including **Medicare Part B**, **Medicaid Rebate Program**, and the **340B/PHS Drug Pricing Program**, which require providing significant discounts and rebates[92](index=92&type=chunk)[93](index=93&type=chunk)[95](index=95&type=chunk) - The company is subject to healthcare fraud and abuse laws (e.g., **Anti-Kickback Statute**), privacy laws (e.g., **HIPAA**), and anti-corruption laws (e.g., **FCPA**), with non-compliance carrying substantial penalties[98](index=98&type=chunk)[100](index=100&type=chunk)[102](index=102&type=chunk) [Item 1A. Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, regulatory, and intellectual property risks, including a history of losses and reliance on a single product [Financial Risks](index=21&type=section&id=Financial%20Risks) - The company has a history of net losses, reporting a **$53.7 million** net loss for **2018** and an accumulated deficit of **$127.4 million** as of year-end. Future profitability is not assured[115](index=115&type=chunk) - Additional capital will be required to fund operations. Failure to secure funding may force reductions in spending, including suspending or curtailing R&D programs[116](index=116&type=chunk) - The company relies on a single revenue-generating product, **IXINITY**, making its financial performance highly dependent on this product's commercial success[120](index=120&type=chunk) - The credit agreement with **MidCap Financial Trust** imposes restrictive covenants that could limit business operations and cash availability. Failure to comply could result in default and acceleration of debt[125](index=125&type=chunk)[126](index=126&type=chunk) [Product Development and Commercialization Risks](index=26&type=section&id=Product%20Development%20and%20Commercialization%20Risks) - Product candidates may exhibit serious adverse events or undesirable side effects, which could delay or prevent regulatory approval and limit commercial potential[137](index=137&type=chunk) - The company depends on third parties like contract research organizations (**CROs**) to conduct clinical trials. Delays or failures by these third parties could impede development and approval[141](index=141&type=chunk) - Long-term growth depends on successfully developing and commercializing new product candidates from the **ADAPTIR platform**, a process that is complex, expensive, and has a high rate of failure[145](index=145&type=chunk)[147](index=147&type=chunk) - The company faces substantial competition from large pharmaceutical and biotechnology companies with greater resources[148](index=148&type=chunk)[149](index=149&type=chunk) - Success depends on obtaining favorable pricing and reimbursement from third-party payors; cost-containment measures and healthcare reform could negatively impact revenue[152](index=152&type=chunk)[158](index=158&type=chunk) - The company relies on a limited number of sole-source third-party suppliers, including **AGC Biologics** for **IXINITY** drug substance. Manufacturing problems or interruptions could lead to product shortages and lost revenue[165](index=165&type=chunk)[166](index=166&type=chunk) [Regulatory and Compliance Risks](index=33&type=section&id=Regulatory%20and%20Compliance%20Risks) - Product candidates are subject to a lengthy, expensive, and uncertain regulatory approval process with the **FDA** and other global authorities. Failure to obtain approval will prevent commercialization[175](index=175&type=chunk)[177](index=177&type=chunk) - The company may incur significant liability if it is determined to be promoting "off-label" use of its products, which is restricted by regulatory authorities[185](index=185&type=chunk)[186](index=186&type=chunk) - Approved products are subject to continuing regulation, including **cGMP** requirements for manufacturing facilities. Failure to comply can result in enforcement actions, product recalls, or withdrawal of approval[189](index=189&type=chunk)[191](index=191&type=chunk) - Failure to comply with healthcare laws, including fraud and abuse statutes (e.g., Anti-Kickback) and data privacy regulations (e.g., **GDPR**), could result in substantial penalties and harm the business[194](index=194&type=chunk)[209](index=209&type=chunk) - Non-compliance with **U.S.** governmental pricing programs (Medicaid, Medicare, **340B**) could lead to reimbursement for underpayments, fines, and exclusion from these programs[202](index=202&type=chunk) [Intellectual Property Risks](index=41&type=section&id=Intellectual%20Property%20Risks) - The company's commercial success depends on its ability to obtain and maintain intellectual property protection for its technology and products, which is uncertain and costly[212](index=212&type=chunk) - The company is opposing a European patent owned by **Baxalta** related to factor IX proteins. An unsuccessful outcome could prevent the company from using its current fill/finish manufacturer or selling **IXINITY** in Europe[223](index=223&type=chunk)[225](index=225&type=chunk) - The company may face patent infringement claims from third parties, which could lead to costly litigation, substantial damages, or force a halt to development or sales of a product[229](index=229&type=chunk) - Failure to protect the confidentiality of proprietary information and trade secrets could allow competitors to develop competing products, adversely affecting the company's value[238](index=238&type=chunk) - A significant disruption or data breach in information technology systems could lead to the loss of trade secrets, exposure of sensitive data, and adversely affect business operations[240](index=240&type=chunk) [Risks Related to Common Stock](index=47&type=section&id=Risks%20Related%20to%20Common%20Stock) - The company's stock price has been and is likely to be volatile, influenced by factors such as clinical trial results, earnings estimates, and competitor announcements[250](index=250&type=chunk) - The common stock is at risk for delisting from the **Nasdaq Global Market** if it fails to meet minimum requirements, such as the **$1.00 minimum bid price**, which would adversely affect liquidity and market price[254](index=254&type=chunk) - Shareholder ownership may be diluted in the future due to equity issuances for acquisitions, capital raising (including under agreements with **Piper Jaffray** and **Lincoln Park**), or employee equity awards[258](index=258&type=chunk)[260](index=260&type=chunk) - Provisions in the company's charter and by-laws, as well as Delaware law, may discourage acquisition proposals or prevent changes in control that stockholders might consider favorable[262](index=262&type=chunk) [Item 1B. Unresolved Staff Comments](index=50&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments - None[269](index=269&type=chunk) [Item 2. Properties](index=50&type=section&id=Item%202.%20Properties) The company leases approximately **51,000 square feet** for its headquarters office and laboratory space in Seattle, Washington. The lease for this facility is set to expire in **April 2020** - The company leases its headquarters and lab space in Seattle, WA, which is approximately **51,000 square feet**. The lease expires in **April 2020**[270](index=270&type=chunk) [Item 3. Legal Proceedings](index=50&type=section&id=Item%203.%20Legal%20Proceedings) Management believes there are currently no pending legal claims or actions against the company that would have a material adverse effect on its financial results, condition, or cash flows - Management believes there are no pending claims or actions that could have a material adverse effect on the company's results of operations, financial condition, or cash flows[271](index=271&type=chunk) [Item 4. Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[272](index=272&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=51&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Aptevo's common stock trades on The **Nasdaq Global Market** under the symbol "APVO". As of **March 14, 2019**, there were **254 holders** of record. The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, retaining earnings for business operations. No unregistered securities were sold in **2018**, except as previously reported, and no shares were repurchased by the company - The company's common stock is listed on The **Nasdaq Global Market** under the symbol "APVO"[274](index=274&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future, intending to retain funds for business operations[276](index=276&type=chunk) - The company did not repurchase any of its common stock during the year ended **December 31, 2018**[278](index=278&type=chunk) [Item 6. Selected Financial Data](index=51&type=section&id=Item%206.%20Selected%20Financial%20Data) This section is not required for the company - Not required[278](index=278&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For FY2018, Aptevo reported a net loss of **$53.7 million**, with IXINITY net revenue growing **111%** to **$23.1 million**, and expects existing cash to fund operations for at least **fifteen months** [Overview and Highlights](index=52&type=section&id=Overview%20and%20Highlights) - The company reported a net loss of **$53.7 million** for the year ended **December 31, 2018**, and had an accumulated deficit of **$127.4 million**[284](index=284&type=chunk) - **IXINITY** net revenue reached a record **$23.1 million** in **2018**, a **111%** increase from **$10.9 million** in **2017**, driven by an expanding patient base[286](index=286&type=chunk) - Key pipeline advancements in **2018** include commencing patient dosing in the Phase 1/1b study of **APVO436** for **AML**/**MDS** and preparing for a Phase 1 study of **APVO210** for autoimmune diseases[287](index=287&type=chunk) - Corporate financing activities included a new term loan agreement with **MidCap**, a **$35 million** equity line with **Lincoln Park Capital**, and a **$22 million** public offering in **March 2019**[289](index=289&type=chunk) [Results of Operations (2018 vs. 2017)](index=54&type=section&id=Results%20of%20Operations%20(2018%20vs.%202017)) Revenue Comparison (in thousands) | Revenue Source | 2018 | 2017 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales (IXINITY) | **$23,067** | **$10,949** | **$12,118** | **111%** | | Collaborations | **$0** | **$3,709** | **($3,709)** | **-100%** | Cost of Product Sales and Gross Margin (in thousands) | Metric | 2018 | 2017 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product sales | **$23,067** | **$10,949** | **$12,118** | **111%** | | Cost of product sales | **$11,214** | **$5,010** | **$6,204** | **124%** | | **Gross Profit** | **$11,853** | **$5,939** | **$5,914** | **99.6%** | | **Gross Margin %** | **51%** | **54%** | - | - | Research and Development Expenses by Program (in thousands) | Program | 2018 | 2017 | Change | | :--- | :--- | :--- | :--- | | APVO414 | **$3,699** | **$3,465** | **$234** | | otlertuzumab | **$1,361** | **$1,245** | **$116** | | Pre-clinical, research & discovery | **$29,070** | **$22,330** | **$6,740** | | IXINITY | **$1,255** | **$1,981** | **($726)** | | **Total R&D** | **$35,385** | **$29,021** | **$6,364** | - Selling, general and administrative (SG&A) expenses decreased by **$6.4 million** (**19%**) to **$28.1 million** in **2018** from **$34.5 million** in **2017**, primarily due to reduced personnel and professional services costs[301](index=301&type=chunk) - Income from discontinued operations was **$39.6 million** in **2017**, resulting from the sale of the Hyperimmune Business. There was no income from discontinued operations in **2018**[303](index=303&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) - As of **December 31, 2018**, the company had **$30.6 million** in cash and cash equivalents. Subsequent to year-end, in **March 2019**, the company raised gross proceeds of **$22.0 million** from a public offering[308](index=308&type=chunk) - Existing cash is expected to be sufficient to fund operations for at least **fifteen months** from the filing date. However, additional funding will be required to complete clinical development of pipeline candidates[309](index=309&type=chunk)[323](index=323&type=chunk) - The company has an Amended Credit Agreement with **MidCap**, extending principal repayments to **February 2020**, and equity financing agreements with **Piper Jaffray** (up to **$17.5M**) and **Lincoln Park Capital** (up to **$35.0M**)[314](index=314&type=chunk)[316](index=316&type=chunk)[318](index=318&type=chunk) Cash Flow Summary (in thousands) | Activity | 2018 | 2017 | | :--- | :--- | :--- | | Net cash used in operating activities | **($51,401)** | **($41,573)** | | Net cash provided by investing activities | **$72,776** | **$29,458** | | Net cash (used in) provided by financing activities | **($787)** | **$9,534** | [Critical Accounting Policies](index=60&type=section&id=Critical%20Accounting%20Policies) - The company adopted **ASC 606** for revenue recognition on **January 1, 2018**, using the modified retrospective method, which did not change the timing or amount of previously recognized revenues[329](index=329&type=chunk) - Research and development costs are expensed as incurred. Accruals for third-party **CROs** are estimated based on factors like percentage of work completed and patient enrollment[332](index=332&type=chunk)[334](index=334&type=chunk) - Stock-based compensation expense is measured at the grant-date fair value using the **Black-Scholes model** for options, requiring estimates for volatility, expected term, and other factors[335](index=335&type=chunk) - Deferred tax assets are reduced by a valuation allowance if it is more likely than not that they will not be realized. The company considers future taxable income and tax planning in this assessment[338](index=338&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=62&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is primarily limited to its investment securities. The main objective of its investment strategy is capital preservation for funding operations, achieved by maintaining a portfolio of high-credit-quality securities without assuming significant risk - The company's primary market risk is confined to its investment securities. The investment strategy prioritizes capital preservation by investing in high-credit-quality securities[342](index=342&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=63&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for the years ended **December 31, 2018** and **2017**, including the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Statements of Comprehensive Loss, Statements of Cash Flows, Statement of Changes in Stockholders' Equity, and the accompanying Notes to Consolidated Financial Statements [Consolidated Financial Statements](index=64&type=section&id=Consolidated%20Financial%20Statements) Key Balance Sheet Data (as of Dec 31, in thousands) | Account | 2018 | 2017 | | :--- | :--- | :--- | | Cash and cash equivalents | **$30,635** | **$7,095** | | Total Assets | **$67,494** | **$117,007** | | Total Liabilities | **$37,088** | **$34,972** | | Total Stockholders' Equity | **$30,406** | **$82,035** | Key Statement of Operations Data (Year ended Dec 31, in thousands) | Account | 2018 | 2017 | | :--- | :--- | :--- | | Total revenues | **$23,067** | **$14,658** | | Loss from continuing operations | **($53,689)** | **($32,592)** | | Income from discontinued operations | **$0** | **$39,565** | | **Net (Loss) Income** | **($53,689)** | **$6,973** | | **Net (Loss) Income per Share** | **($2.39)** | **$0.33** | [Notes to Consolidated Financial Statements](index=70&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - The sale of the Hyperimmune Business was completed on **September 28, 2017**, for total consideration of up to **$74.5 million**, resulting in a net gain on sale of **$52.7 million**, which is reported in discontinued operations for **2017**[434](index=434&type=chunk)[435](index=435&type=chunk)[436](index=436&type=chunk) - The collaboration with Alligator Bioscience for **ALG.APV-527** is treated as a collaborative agreement under **ASC 808**, not as a customer contract under **ASC 606**[442](index=442&type=chunk)[447](index=447&type=chunk) - As of **December 31, 2018**, the company had **$19.3 million** in long-term debt, net, under its amended credit agreement with **MidCap**. Principal repayments are scheduled to begin in **2020**[354](index=354&type=chunk)[469](index=469&type=chunk)[470](index=470&type=chunk) - As of **December 31, 2018**, the company had federal net operating loss (NOL) carryforwards of approximately **$96.4 million** and state NOL carryforwards of **$44.5 million**, which are subject to a full valuation allowance[508](index=508&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=94&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[514](index=514&type=chunk) [Item 9A. Controls and Procedures](index=94&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of **December 31, 2018**. Management also assessed internal control over financial reporting and concluded it was effective. There were no material changes to internal controls during the year - Management concluded that as of **December 31, 2018**, the company's disclosure controls and procedures were effective[515](index=515&type=chunk) - Management concluded that as of **December 31, 2018**, the company's internal control over financial reporting was effective[516](index=516&type=chunk) - There were no changes in internal control over financial reporting during the year ended **December 31, 2018**, that have materially affected, or are reasonably likely to materially affect, internal controls[517](index=517&type=chunk) [Item 9B. Other Information](index=94&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[518](index=518&type=chunk) Part III [Item 10. Directors, Executive Officers and Corporate Governance](index=95&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required by this item will be incorporated by reference from the company's definitive proxy statement for its **2019** Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement[520](index=520&type=chunk) [Item 11. Executive Compensation](index=95&type=section&id=Item%2011.%20Executive%20Compensation) Information required by this item will be incorporated by reference from the company's definitive proxy statement for its **2019** Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement[521](index=521&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=95&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required by this item will be incorporated by reference from the company's definitive proxy statement for its **2019** Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement[522](index=522&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=95&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information required by this item will be incorporated by reference from the company's definitive proxy statement for its **2019** Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement[523](index=523&type=chunk) [Item 14. Principal Accountant Fees and Services](index=95&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information required by this item will be incorporated by reference from the company's definitive proxy statement for its **2019** Annual Meeting of Stockholders - Information is incorporated by reference from the definitive proxy statement[524](index=524&type=chunk) Part IV [Item 15. Exhibits, Financial Statement Schedules](index=96&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Form 10-K report. It includes the Consolidated Financial Statements (referenced in Item 8) and a list of exhibits. All financial statement schedules have been omitted as they are not applicable or the required information is included elsewhere - This section lists the consolidated financial statements and exhibits filed with the report. All financial statement schedules are omitted[526](index=526&type=chunk) [Item 16. Form 10-K Summary](index=101&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has chosen not to include the optional Form 10-K summary - The company has chosen not to include the summary permitted by this item[533](index=533&type=chunk)