Mirum(MIRM) - 2024 Q4 - Annual Report

PART I Item 1. Business Mirum Pharmaceuticals is a biopharmaceutical company focused on rare diseases, with three approved medicines: Livmarli, Cholbam, and Chenodal/Ctexli, relying on third-party manufacturing and a specialized commercial team while navigating a competitive and regulated landscape Overview and Strategy Mirum Pharmaceuticals is a biopharmaceutical company with three approved medicines for rare diseases and a pipeline including volixibat and MRM-3379, strategically expanding indications, developing candidates, and acquiring assets - The company has three approved medicines: Livmarli® (maralixibat), Cholbam® (cholic acid), and Chenodal®/Ctexli® (chenodiol)[19] - Mirum completed the acquisition of the Bile Acid Portfolio (chenodiol and Cholbam) from Travere Therapeutics on August 31, 2023[21] - The company is advancing two key product candidates: volixibat for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), and MRM-3379 for fragile X syndrome (FXS)[23][24] - Mirum's strategy focuses on commercializing its approved medicines, developing its pipeline for rare cholestatic and neurocognitive disorders, and expanding its portfolio through acquisitions and in-licensing[25][30] Our Product Pipeline The company's pipeline includes three approved drugs for rare liver diseases and two clinical-stage candidates, with Livmarli, Ctexli, and Cholbam approved, and volixibat and MRM-3379 in clinical trials Mirum Pharmaceuticals Product Pipeline Status | Product Candidate | Indication | Stage | Next Milestone | | :--- | :--- | :--- | :--- | | Livmarli (Maralixibat) | Alagille Syndrome (ALGS) | Approved | FDA & EMA Approved | | | Progressive Familial Intrahepatic Cholestasis (PFIC) | Approved | FDA & EMA Approved | | | Cholestatic Pruritus (Additional Settings) | Phase 3 | Enrollment completion expected 2026 | | Ctexli (Chenodiol) | Cerebrotendinous Xanthomatosis (CTX) | Approved | FDA Approved (Feb 2025) | | Cholbam (Cholic Acid) | Bile acid synthesis disorders and PBD-ZSD | Approved | FDA Approved | | Volixibat | Primary Sclerosing Cholangitis (PSC) | Phase 2b | Enrollment completion expected H2 2025 | | | Primary Biliary Cholangitis (PBC) | Phase 2b | Enrollment completion expected 2026 | | MRM-3379 | Fragile X Syndrome (FXS) | Phase 2 | Initiating 2025 | Our Approved Medicines and Clinical Candidates Mirum's portfolio targets rare diseases with high unmet needs, featuring approved medicines Livmarli, Ctexli, and Cholbam, alongside clinical candidates volixibat and MRM-3379, each with estimated addressable markets exceeding $1 billion - Livmarli is approved for cholestatic pruritus in Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), targeting a combined pediatric patient population of approximately 5,000-6,500 in the U.S. and Europe[31][33][34][37] - Ctexli (chenodiol) was approved in February 2025 for adults with cerebrotendinous xanthomatosis (CTX), a rare bile acid synthesis disorder, with an estimated prevalent patient population in the U.S. of 1,000-2,000, of which only 10% are currently diagnosed[38] - Cholbam (cholic acid) is an FDA-approved treatment for bile acid synthesis disorders and peroxisomal disorders, with an estimated 200 to 300 prevalent patients in the U.S. as candidates for therapy[42] - Volixibat is in development for adult cholestatic liver diseases, specifically Primary Sclerosing Cholangitis (PSC) and Primary Biliary Cholangitis (PBC), with an estimated total addressable market of over $1 billion[44][45][46][47] - MRM-3379 is being advanced for Fragile X Syndrome (FXS), the most common inherited cause of intellectual disability, with an estimated worldwide total addressable market of over $1 billion, and a Phase 2 study planned for 2025[49][50] License, Finance, Royalty Agreements and Asset Purchases Mirum's portfolio is supported by strategic agreements including a 2018 Shire (Takeda) license for Livmarli and volixibat, royalty agreements with Pfizer and Sanofi, the 2023 acquisition of the Bile Acid Portfolio from Travere for $210.4 million upfront, and the 2024 licensing of MRM-3379 from Enthorin for $7.5 million upfront, funded by $305.3 million in convertible notes and a $202.2 million private placement - Entered into a license agreement with Shire (now Takeda) in November 2018 for worldwide rights to Livmarli and volixibat, including up to $109.5 million in milestones for Livmarli (PFIC/ALGS), $25.0 million for each additional Livmarli indication, $30.0 million for volixibat's first indication, and tiered royalties from low double-digits to mid-teens[51][52][53][55] - On August 31, 2023, Mirum acquired the Bile Acid Portfolio (Cholbam and chenodiol) from Travere Therapeutics for $210.4 million upfront, with up to an additional $235.0 million in sales-based milestones[86] - On October 22, 2024, Mirum licensed MRM-3379 from Enthorin Therapeutics for an upfront payment of $7.5 million, with up to $217.5 million in potential regulatory and sales milestones, plus mid-single digit royalties[76] - In April 2023, the company raised $305.3 million in net proceeds from an offering of 4.00% Convertible Senior Notes due 2029, with a portion used to terminate a Revenue Interest Purchase Agreement with Oberland[85] Intellectual Property Mirum's intellectual property strategy combines patents, trade secrets, and regulatory exclusivities, with Livmarli protected by method-of-use patents expiring between 2032 and 2040, volixibat by a licensed patent expiring in 2027, MRM-3379 by composition-of-matter patents extending to 2034, and orphan drug exclusivity for Livmarli and volixibat providing market protection - Livmarli is protected by multiple U.S. patents listed in the FDA's Orange Book covering methods of treating ALGS and PFIC, with expiration dates in 2032 and 2040, but the company does not have composition-of-matter patents for Livmarli[90][92][98] - Volixibat's composition and manufacturing methods are covered by a licensed U.S. patent expiring in December 2027[97] - MRM-3379 has issued U.S. patents covering its composition-of-matter, which are set to expire in March 2034, absent any extensions[99] - The company has secured orphan drug exclusivity for Livmarli for ALGS and PFIC in both the U.S. (7 years) and the EU (10 years, extended to 12 for ALGS), and also has orphan drug designation for volixibat for PBC in the U.S. and EU[102] Commercial Operations and Manufacturing Mirum operates a commercial infrastructure in North America and parts of Europe, distributing products through specialty pharmacies and partners, while relying entirely on third-party contract manufacturers for all drug supplies - The company has built a commercial infrastructure to support its approved medicines in North America and certain European countries, using strategic partners and distributors for other markets[107] - In the U.S. and Canada, approved medicines are distributed through a single specialty pharmacy in each country[110] - Mirum does not own or operate manufacturing facilities and depends on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished products[111] Competition Mirum faces significant competition from other pharmaceutical companies, including Ipsen's Bylvay and GSK's linerixibat in the IBAT inhibitor space, off-label medications, generic drugs, and surgical interventions, with its Bile Acid Medicines particularly vulnerable to compounded and generic versions due to lack of exclusivity - Direct competition in the IBAT inhibitor class comes from Ipsen's odevixibat (Bylvay), which is approved for PFIC and ALGS, and GSK's linerixibat, which has positive Phase 3 data in PBC[115][116] - Competition for cholestatic pruritus also includes off-label medications like UDCA, cholestyramine, and rifampin, as well as surgical interventions[117] - Approved medicines Chenodal, Ctexli, and Cholbam may be subject to immediate competition from compounded and generic entrants due to a lack of current patent or non-patent exclusivity[123] - In the FXS space, Shionogi & Co. is pursuing clinical development of a competing PDE4D inhibitor (zatomilast/BPN14770)[125] Government Regulation and Product Approval The company is subject to extensive U.S. and international regulations covering drug development, approval, and post-marketing, including preclinical and clinical trials, expedited programs, cGMP, adverse event reporting, and complex healthcare laws like anti-kickback statutes, HIPAA, GDPR, and evolving pricing and reimbursement systems - The U.S. drug approval process requires extensive preclinical and clinical trials (Phase 1, 2, 3) under an Investigational New Drug (IND) application before submitting a New Drug Application (NDA) to the FDA[127][130][133] - The FDA offers expedited programs such as Fast Track, priority review, accelerated approval, and breakthrough therapy designation to facilitate the development of drugs for serious conditions with unmet medical needs[149][150][151][152] - In the EU, marketing authorization is obtained through a centralized procedure via the EMA or national procedures, with specific regulations for clinical trials (CTR), orphan drugs (10-year market exclusivity), and pediatric development (PIP)[195][196][205][212] - The company is subject to numerous U.S. healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, HIPAA, and the Physician Payments Sunshine Act, which regulate interactions with healthcare providers and protect patient data[163][165][166][167] - Sales depend on coverage and reimbursement from third-party payors, and the company faces pricing pressure from government programs and healthcare reforms like the Affordable Care Act (ACA) and the Inflation Reduction Act (IRA), which includes provisions for Medicare drug price negotiation[175][181][183] Human Capital and Corporate Information As of December 31, 2024, Mirum employed 322 full-time employees, primarily in the U.S., focusing on talent retention through development and engagement, and is headquartered in Foster City, California - As of December 31, 2024, the company had 322 full-time employees, with the majority (241) located in the United States[220] - The company invests in employee growth and development and uses engagement surveys to assess and improve retention, establishing a Culture Team in 2020 to foster an inclusive environment[223][224][225] Item 1A. Risk Factors The company faces substantial risks including commercialization challenges, clinical development uncertainties, intense competition, healthcare reform impacts, reliance on third-party licenses and manufacturing, financial losses, and intellectual property vulnerabilities, alongside cybersecurity threats and key personnel dependency Risks Related to Commercialization and Development The company's success depends on profitable commercialization of approved medicines, facing risks in sales force scaling, reimbursement, and market acceptance, while clinical development is uncertain due to potential trial failures, enrollment delays, and undesirable side effects - The success of the business depends on the ability to profitably market and sell its approved medicines, which is subject to risks like reimbursement availability, physician and patient acceptance, and competition[229] - Failure to obtain and maintain adequate coverage and reimbursement from third-party payors and government programs is a critical risk to commercial success[235] - Clinical development is a lengthy and expensive process with uncertain outcomes, and the company has encountered and may continue to face delays in patient enrollment for its clinical trials in rare diseases[265][269][273] - Approved medicines and product candidates may cause undesirable side effects, which could limit their commercial profile, lead to product liability claims, or result in regulatory actions such as label changes or withdrawal of approval[246] Risks Related to Our Business and Industry Mirum has a history of net losses and anticipates continued losses due to R&D and commercialization expenses, facing significant competition, evolving healthcare legislation like the IRA, reliance on key personnel, and complex data privacy laws - The company has incurred net losses since inception, reporting a net loss of $87.9 million in 2024, and anticipates continued losses as it invests in development and commercialization[289] - Mirum faces significant competition from other biotech and pharmaceutical companies, including those developing other IBAT inhibitors like Ipsen and GSK[311][312][313] - Healthcare reform measures, including the Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining marketing approval and could negatively affect drug prices[298][301] - The business is subject to complex and evolving data privacy laws (e.g., GDPR, CCPA), and failure to comply could result in significant fines, litigation, and reputational harm[350][354][357] Risks Related to Our Reliance on Third Parties The company's operations heavily depend on third-party intellectual property licenses, CROs for clinical trials, and sole-source manufacturers for drug supplies, where any failure could severely disrupt development and commercialization - The company is dependent on intellectual property licensed from third parties, such as Shire (Takeda), Pfizer, and Sanofi, and termination of these licenses could result in the loss of significant rights and harm the business[368] - Mirum relies on third-party Contract Research Organizations (CROs) to conduct its clinical trials, and if these CROs fail to perform their duties successfully or meet deadlines, regulatory approval and commercialization could be delayed[370] - The company completely relies on third parties, including sole-source suppliers, to manufacture and distribute its clinical and commercial drug supplies, and any failure by these manufacturers could disrupt supply and harm the business[374][375] Risks Related to Our Financial Position and Capital Requirements Mirum has consumed substantial cash and requires significant additional financing, with its $316.3 million convertible notes posing risks of dilution and limited operational flexibility, and the usability of its net operating loss carryforwards potentially limited by ownership changes - The company may need substantial additional financing to continue its commercialization and development efforts, and failure to obtain it could force delays or elimination of programs[383] - As of December 31, 2024, the company had $316.3 million in aggregate principal amount of convertible notes, which could limit cash flow and expose the business to financial risks[393] - The conditional conversion feature of the notes was triggered, making them convertible at the holders' option during Q1 2025, which could lead to cash payments or stock dilution[396] - The company has significant federal and state net operating loss (NOL) carryforwards ($156.1 million federal, $94.2 million state), but their usability may be limited by Section 382 ownership change rules[391][846] Risks Related to Our Intellectual Property The company's intellectual property position is risky due to a lack of patent protection for certain approved medicines, reliance on weaker method-of-use patents for Livmarli, and exposure to patent litigation, global IP protection challenges, and trade secret vulnerabilities - The company does not have patent protection for commercial forms of chenodiol or Cholbam, making them vulnerable to competition[403][404] - Primary patent protection for Livmarli relies on method-of-use and formulation patents, as there are no composition-of-matter patents, which is a weaker form of protection that may not prevent competitors from marketing an identical product for off-label use[421][422] - The company may face third-party claims of intellectual property infringement, which could lead to costly litigation, development delays, and potentially block the commercialization of its products[442] - Protecting intellectual property rights worldwide is expensive and challenging, as laws in some foreign jurisdictions do not offer the same level of protection as in the U.S[426] Risks Related to Ownership of Our Common Stock Ownership of the company's common stock involves risks of high price volatility, significant control by principal stockholders, potential dilution from future stock sales including an ATM offering, and anti-takeover provisions that could limit market price - The trading price of the company's common stock is likely to be highly volatile, having ranged from a low of $23.57 to a high of $53.16 since January 1, 2024[471] - Principal stockholders and management own a significant percentage of the stock, enabling them to exert substantial control over matters subject to stockholder approval[477] - Future sales of common stock, including under a $200.0 million ATM offering agreement, could result in additional dilution and cause the stock price to fall[479] - Anti-takeover provisions in the company's charter and under Delaware law could delay or prevent a change of control, potentially limiting the market price of the common stock[486] General Risk Factors The company faces general risks from unfavorable geopolitical and macroeconomic conditions, cybersecurity threats to IT systems, complex export/import controls, past material weaknesses in internal controls, and increased costs and compliance burdens as a public company - Unfavorable geopolitical and macroeconomic developments, such as inflation, high interest rates, and military conflicts, could adversely affect the business, financial condition, or results of operations[493] - The company's information technology systems are vulnerable to cybersecurity threats, and a compromise could lead to regulatory action, litigation, business disruption, and reputational harm[494][495] - Material weaknesses in internal control over financial reporting were identified in the past, and while remediated, future weaknesses could impair the ability to produce accurate financial statements on a timely basis[507][509][861] - As the company is no longer an emerging growth company or a smaller reporting company, it will incur significant increased costs related to compliance and reporting as a public company[512] Item 1B. Unresolved Staff Comments The company reports no unresolved staff comments - Not applicable[516] Item 1C. Cybersecurity Mirum has implemented an information security program to manage cybersecurity risks, overseen by the Audit Committee and managed by key personnel, utilizing third-party service providers and a vendor management program - The company has implemented information security processes to identify, assess, and manage material risks from cybersecurity threats[517] - The Board of Directors' Audit Committee is responsible for overseeing the cybersecurity risk management processes[525] - Key management, including the Senior Director of Information Technology/Information Security, CCO, and CFO, are responsible for implementing and maintaining the cybersecurity program[526] - The company uses third-party service providers for various functions and manages associated cybersecurity risks through a vendor management program[522] Item 2. Properties The company leases approximately 36,318 square feet for its headquarters in Foster City, California, and additional office spaces in Basel and Zug, Switzerland, which are deemed adequate for current needs - The company leases its headquarters of 36,318 sq. ft. in Foster City, California, under a lease expiring in August 2029[530] - Mirum also leases office space in Basel, Switzerland (3,200 sq. ft., expires June 2028) and Zug, Switzerland (3,500 sq. ft., expires January 2030)[531] Item 3. Legal Proceedings The company reports no current legal proceedings believed to have a material adverse effect on its financial condition or results of operations - Management believes there are currently no pending claims or actions against the company that could have a material adverse effect on its results of operations, financial condition, or cash flows[532] Item 4. Mine Safety Disclosures This item is not applicable to the company - None[533] PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Mirum's common stock trades on the Nasdaq Global Market under "MIRM", with 49,014,190 shares outstanding as of February 21, 2025, and the company has never paid cash dividends, with its stock outperforming the Nasdaq Biotechnology Index but underperforming the Nasdaq Composite Index since 2019 - The company's common stock is listed on the Nasdaq Global Market under the symbol "MIRM"[535] - As of February 21, 2025, there were 49,014,190 shares of common stock outstanding[536] - The company has never paid cash dividends and does not intend to in the foreseeable future[537] Cumulative Total Return Comparison (2019-2024) | Investment | 12/31/2019 | 12/31/2020 | 12/31/2021 | 12/31/2022 | 12/31/2023 | 12/31/2024 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Mirum Pharmaceuticals, Inc. | $100.00 | $71.21 | $65.05 | $79.53 | $120.39 | $168.64 | | NASDAQ Composite Index | $100.00 | $143.64 | $174.36 | $116.65 | $167.30 | $215.22 | | NASDAQ Biotechnology Index | $100.00 | $125.69 | $124.89 | $111.27 | $115.42 | $113.84 | Item 6. Reserved This item is reserved Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations In fiscal year 2024, Mirum's total revenue significantly increased to $336.9 million, driven by product sales, while net loss narrowed to $87.9 million despite rising operating expenses, with $293.3 million in cash and investments deemed sufficient for the next 12 months Overview Mirum is a biopharmaceutical company with three approved medicines and a pipeline including volixibat and MRM-3379, having recently acquired the Bile Acid portfolio and in-licensed MRM-3379 - The company has three approved medicines: Livmarli, Cholbam, and Chenodal/Ctexli[550] - Key pipeline assets include volixibat (for PSC and PBC) and MRM-3379 (for Fragile X Syndrome)[552][555] - Completed the acquisition of the Bile Acid portfolio from Travere Therapeutics on August 31, 2023[553] Financial Overview and Recent Developments For the year ended December 31, 2024, Mirum reported a net loss of $87.9 million with $293.3 million in cash and investments, following the in-licensing of MRM-3379 and the acquisition of the Bile Acid Portfolio Key Financial Metrics (Year-End) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Net Loss | $87.9 million | $163.4 million | | Accumulated Deficit | $644.2 million | $556.2 million | | Cash, Cash Equivalents, Restricted Cash & Investments | $293.3 million | $286.3 million | - In-licensed MRM-3379 in October 2024 with a $7.5 million upfront payment and potential future milestones of up to $217.5 million[561] - Acquired the Bile Acid Portfolio from Travere in August 2023 for $210.4 million upfront, with up to $235.0 million in potential sales-based milestones[562] Results of Operations For the year ended December 31, 2024, total revenue increased by 80.8% to $336.9 million, driven by product sales, while total operating expenses rose to $424.5 million, resulting in a narrowed net loss of $87.9 million Results of Operations Summary (in thousands) | Line Item | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $336,888 | $186,374 | $150,514 | | Product sales, net | $336,409 | $178,874 | $157,535 | | Total Operating Expenses | $424,494 | $295,528 | $128,966 | | Cost of sales | $81,643 | $47,039 | $34,604 | | Research and development | $140,630 | $102,609 | $38,021 | | Selling, general and administrative | $202,221 | $145,880 | $56,341 | | Loss from Operations | ($87,606) | ($109,154) | $21,548 | | Net Loss | ($87,942) | ($163,415) | $75,473 | Product Sales, Net Breakdown (in thousands) | Product | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Livmarli | $213,295 | $141,795 | $71,500 | | Bile Acid Medicines | $123,114 | $37,079 | $86,035 | | Total | $336,409 | $178,874 | $157,535 | - The increase in R&D expenses was primarily driven by a $13.0 million increase for volixibat clinical trials, a $7.5 million upfront payment for MRM-3379, and a $9.6 million increase in personnel costs[602] - The increase in SG&A expenses was mainly due to a $27.9 million rise in personnel costs, a $13.3 million increase in marketing and medical affairs, and an $8.1 million increase in professional service fees to support expanded commercial activities[603] Liquidity and Capital Resources As of December 31, 2024, Mirum had $292.8 million in unrestricted cash, cash equivalents, and investments, deemed sufficient for the next 12 months, despite a history of operating losses and an accumulated deficit of $644.2 million, with recent financing including convertible notes and a private placement - As of December 31, 2024, the company had $292.8 million in unrestricted cash, cash equivalents, and investments and an accumulated deficit of $644.2 million[608] - Management believes existing capital is sufficient to fund operations for at least the next 12 months[614] - In April 2023, the company raised $305.3 million in net proceeds from a convertible notes offering and used a portion to terminate a revenue interest purchase agreement[610] - In August 2023, the company raised $202.2 million in net proceeds from a private placement of common stock to fund the upfront payment for the Bile Acid Portfolio Acquisition[609] Summary of Cash Flows (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $10,325 | ($70,944) | | Net cash used in investing activities | ($90,125) | ($107,200) | | Net cash provided by financing activities | $17,699 | $336,600 | | Net (decrease) increase in cash | ($63,398) | $158,323 | Item 7A. Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are interest rate sensitivity on cash and investments, and foreign currency exchange rate risk from European operations, with a hypothetical 10% USD fluctuation potentially impacting net foreign currency assets by approximately $0.7 million - The company's primary market risk exposure is to interest rate sensitivity on its cash and investments and foreign currency exchange rate risk[637][639] - Interest rate risk on the company's $316.3 million in convertible notes is mitigated as the interest rate is fixed[638] - Foreign currency risk stems from operations in Europe, with exposure to the Euro and Swiss Franc, where a hypothetical 10% fluctuation in the USD exchange rate could change the fair value of net foreign currency assets and liabilities by approximately $0.7 million[639][640] Item 8. Financial Statements and Supplementary Data This section presents the company's audited consolidated financial statements for the fiscal year ended December 31, 2024, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, with an unqualified opinion from Ernst & Young LLP Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total Assets | $670,754 | $646,621 | | Cash, Cash Equivalents & Investments | $292,841 | $286,326 | | Intangible assets, net | $249,819 | $252,925 | | Total Liabilities | $445,114 | $397,951 | | Convertible notes payable, net | $308,082 | $306,421 | | Total Stockholders' Equity | $225,640 | $248,670 | Consolidated Statement of Operations Highlights (in thousands) | Account | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Total Revenue | $336,888 | $186,374 | $77,062 | | Total Operating Expenses | $424,494 | $295,528 | $208,282 | | Loss from Operations | ($87,606) | ($109,154) | ($131,220) | | Net Loss | ($87,942) | ($163,415) | ($135,665) | | Net Loss Per Share (Basic & Diluted) | ($1.85) | ($4.00) | ($4.01)/($4.02) | Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[856] Item 9A. Controls and Procedures Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2024, having successfully remediated a prior material weakness related to inventory controls - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[857] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[859] - The company has remediated the material weakness related to the existence and valuation of inventory that was reported as of December 31, 2023[861][862][863] Item 9B. Other Information During Q4 2024, CEO Christopher Peetz and SVP Jody Howe adopted Rule 10b5-1 trading plans to sell up to 120,000 and 105,707 shares, respectively Director and Officer Trading Plan Adoptions (Q4 2024) | Name and Position | Action | Adoption Date | Total Shares to be Sold | | :--- | :--- | :--- | :--- | | Christopher Peetz, CEO | Adopted | Nov 22, 2024 | Up to 120,000 | | Jody Howe, SVP, Global Controller | Adopted | Dec 16, 2024 | Up to 105,707 | Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable[867] PART III Item 10. Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's 2025 Definitive Proxy Statement, which also includes the company's Code of Conduct - The information required by this item is incorporated by reference from the company's 2025 Definitive Proxy Statement[869] - The company maintains a Code of Conduct, the full text of which is available on its corporate website[870] Item 11. Executive Compensation Information regarding executive compensation is incorporated by reference from the company's 2025 Definitive Proxy Statement - The information required by this item is incorporated by reference from the company's 2025 Definitive Proxy Statement[871] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's 2025 Definitive Proxy Statement - The information required by this item is incorporated by reference from the company's 2025 Definitive Proxy Statement[872] 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 2025 Definitive Proxy Statement - The information required by this item is incorporated by reference from the company's 2025 Definitive Proxy Statement[873] Item 14. Principal Accountant Fees and Services Information regarding principal accountant fees and services is incorporated by reference from the company's 2025 Definitive Proxy Statement - The information required by this item is incorporated by reference from the company's 2025 Definitive Proxy Statement[874] PART IV Item 15. Exhibits and Financial Statement Schedules This section lists the financial statements and exhibits filed as part of the Annual Report, with financial statements in Part II, Item 8, and an included Exhibit Index - The financial statements are filed in Part II, Item 8 of the report[877] - Financial statement schedules have been omitted because they are not applicable or required[877] - An index of exhibits filed as part of the report is included[877] Item 16. Form 10-K Summary No Form 10-K summary is provided - None[878]